FDA AERS Mefloquine, Judicial Watch FOIA report~20120403

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/04/97ISR Number: 100000135Report Type:Expedited (15-DaCompany Report #88781 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vaginal Haemorrhage Foreign Lariam Tablets
Complication Of Pregnancy Health (Mefloquine
Premature Baby Professional Hydrochloride) PS ORAL 250.000MG 1.0
Cervical Incompetence
X PER WEEK
Uterine Haemorrhage
ORAL
Date:11/04/97ISR Number: 100000137Report Type:Expedited (15-DaCompany Report #88780 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vaginal Haematoma Foreign Lariam PS ORAL 250 MG 1.0 X
Cervical Incompetence Health PER WEEK
Haematoma
Professional
Antepartum Haemorrhage
Premature Baby
Date:11/04/97ISR Number: 100000155Report Type:Expedited (15-DaCompany Report #80275 Age:57 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Hypersensitivity Foreign Lariam PS ORAL 250.0000 MG
Angioedema Health 1.0 X PER
Tongue Oedema Professional WEEK ORAL
Skin Test Positive Premarin C
Toxicity To Various
Agents
Date:11/04/97ISR Number: 100000155Report Type:Expedited (15-DaCompany Report #85380 Age:23 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Deafness Neurosensory Foreign Lariam PS ORAL 250.0000 MG
Tinnitus Health 1.0X PER WEEK
Professional
ORAL
Other Augmentin C
Date:11/06/97ISR Number: 3005648-7Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I
Outcome
Life-Threatening
Disability
Other Serious
PT
Thinking Abnormal
Crying
Decreased Appetite

Required
Intervention to
Prevent Permanent
Impairment/Damage
Panic Disorder
Insomnia Related To
Another Mental Condition
Anxiety
Personality Change
Fear
Insomnia
Paraesthesia
03-Apr-2012 09:37 AM Page: 1

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dysarthria
Confusional State
Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration
Asthenia Lariam PS Roche ORAL TABS; 250 MG
Depression
TAB PO ONCE
Chills
WEEKLY;(PT
Abnormal Dreams
D'CD DRUG)
Date:11/10/97ISR Number: 3000073-7Report Type:Expedited (15-DaCompany Report #86849 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cough Foreign Lariam PS ORAL 250.000 MG
Initial or Prolonged Dyspnoea Other 1.0 X PER
Asthenia
WEEK ORAL
Bronchitis Dpt C
Dizziness
Yellow Fever Vaccine C
Red Blood Cell Havrix C
Sedimentation Rate Typhim C
Increased Mercalm C
Vomiting Genhevac B C
Nausea
Pyrexia
Date:11/10/97ISR Number: 3005888-7Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Restlessness Lariam PS
Depression Mefloquine SS
Confusional State
Emotional Disorder
Memory Impairment
Visual Impairment
Anxiety
Date:11/12/97ISR Number: 3000157-3Report Type:Expedited (15-DaCompany Report #89097 Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyspnoea Health Lariam Tablets
Initial or Prolonged Lung Infiltration Professional (Mefloquine
Hydrochloride) PS ORAL
Date:11/12/97ISR Number: 3000321-3Report Type:Expedited (15-DaCompany Report #89246 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Uterine Contractions Foreign Lariam Tablets

Intervention to Abnormal Health (Mefloquine
Prevent Permanent Professional Hydrochloride) PS ORAL 250MG 1 X PER
Impairment/Damage Other WEEK ORAL
03-Apr-2012 09:37 AM Page: 2

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/12/97ISR Number: 3000325-0Report Type:Expedited (15-DaCompany Report #89247 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Amylase Increased Foreign Lariam Tablets
Initial or Prolonged Pancreatitis Health (Mefloquine
Lipase Increased Professional Hydrochloride) PS ORAL 250MG 1 X PER
Other
WEEK, ORAL
Imodium (Loperamide
Hydrochloride) C
Flagyl
(Metronidazole) C
Date:11/12/97ISR Number: 3000331-6Report Type:Expedited (15-DaCompany Report #82871 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tachycardia Foreign Lariam Tablets
Hyperventilation Health (Mefloquiine
Alkalosis Hypokalaemic Professional Hydrochloride) PS ORAL 250MG 1 X PER
Paraesthesia Other WEEK ORAL
Cyclo-Menorette
(Estradiol Valerate/
Estradiol Succinate/
Levonorgestrel) C
Date:11/12/97ISR Number: 3000529-7Report Type:Expedited (15-DaCompany Report #80739 Age:40 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Astrocytoma Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Convulsion Health 1.0 X PER
Complex Partial Seizures Professional WEEK ORAL
Grand Mal Convulsion Phenhydan C
Paresis
Hallucination
Hemiplegia
Aphasia
Speech Disorder
Blood Glucose Decreased
Blood Lactic Acid
Decreased
Brain Neoplasm
Glioma
Simple Partial Seizures
Paralysis
Blood Albumin Abnormal
Hemiparesis
Date:11/17/97ISR Number: 3000972-6Report Type:Expedited (15-DaCompany Report #85820 Age:26 YR Gender:Male I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
PT
Migraine
Headache
Gastroenteritis Bacterial
Trance
Illusion
Paraesthesia
03-Apr-2012 09:37 AM Page: 3

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Diarrhoea
Disturbance In Attention
Restlessness Report Source Product Role Manufacturer Route Dose Duration
Psychotic Disorder Foreign Lariam PS ORAL 250.0000 MG
Health
1.0 X PER
Professional
WEEK ORAL
Ciprobay
C
Date:11/17/97ISR Number: 3006058-9Report Type:Direct Company Report # Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Amnesia Mefloquine PS ORAL 1 TABLET PER
Fatigue
WEEK
Depression Prozac C
Immune System Disorder
Weight Decreased
Decreased Appetite
Date:11/17/97ISR Number: 3006086-3Report Type:Direct Company Report # Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Mefloquine PS ORAL Q WEEK PO
Gastrooesophageal Reflux
Disease
Date:11/19/97ISR Number: 3001851-0Report Type:Expedited (15-DaCompany Report #85820 Age:26 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Restlessness Foreign Lariam PS ORAL 250.000 MG
Initial or Prolonged Sleep Disorder Health 1.0 X PER
Trance Professional WEEK ORAL
Headache Ciprobay C
Psychotic Disorder
Paraesthesia
Migraine
Illusion
Gastroenteritis Bacterial
Suicidal Ideation
Disturbance In Attention
Diarrhoea
Date:11/21/97ISR Number: 3002261-2Report Type:Expedited (15-DaCompany Report #88615 Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspnoea Foreign Lariam PS ORAL 250.0000 MG

Tachycardia Health 1.0 X PER
Arrhythmia Professional WEEK ORAL
Anxiety
03-Apr-2012 09:37 AM Page: 4

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/26/97ISR Number: 3002889-XReport Type:Expedited (15-DaCompany Report #89882 Age:82 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paralysis Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Sensory Disturbance Health 1.0 X PER
Gait Disturbance Professional WEEK ORAL
Hypoaesthesia Insuline C
Coordination Abnormal
Feeling Drunk
Sciatica
Date:11/26/97ISR Number: 3002892-XReport Type:Expedited (15-DaCompany Report #89097 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyspnoea Health Lariam PS ORAL 10.0000 MG/KG
Initial or Prolonged Lung Infiltration Professional DAILY ORAL
Date:12/01/97ISR Number: 3003013-XReport Type:Expedited (15-DaCompany Report #86213 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Muscle Spasms Health Lariam PS ORAL 1.2500 GRAM
Medication Error Professional 1.0 X PER
Pain Other ODOS ORAL
Nausea Tetanus Vaccine C
Tremor Hepatitis Vaccine C
Dizziness Birth Control Pills C
Agitation
Confusional State
Anxiety
Condition Aggravated
Date:12/01/97ISR Number: 3003015-3Report Type:Expedited (15-DaCompany Report #90214 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Bradycardia Foreign Lariam PS ORAL 250.0000 MG
Abdominal Pain Other 1.0 X PER
Syncope
WEEK ORAL
Dizziness
Date:12/01/97ISR Number: 3003374-1Report Type:Expedited (15-DaCompany Report #90289 Age:64 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Skin Infection Foreign Lariam PS ORAL
Urticaria
Consumer
Erysipeloid

Date:12/01/97ISR Number: 3003432-1Report Type:Expedited (15-DaCompany Report #92090 Age:72 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Skin Infection
Urticaria
03-Apr-2012 09:37 AM Page: 5

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Erysipeloid
Report Source Product Role Manufacturer Route Dose Duration
Foreign Lariam PS ORAL
Health
Professional
Date:12/01/97ISR Number: 3003541-7Report Type:Expedited (15-DaCompany Report #89097 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyspnoea Health Lariam PS ORAL 10.0000 MG/KG
Initial or Prolonged Lung Infiltration Professional DAILY ORAL
Date:12/01/97ISR Number: 3082443-4Report Type:Expedited (15-DaCompany Report #90612 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Parkinsonism Health Lariam PS ORAL ORAL
Extrapyramidal Disorder Professional
Date:12/02/97ISR Number: 3003685-XReport Type:Expedited (15-DaCompany Report #87481 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dizziness Health Lariam PS ORAL 250.0000 MG
Other Serious Hypertension Professional 1.0 X PER DAY
Medication Error
ORAL
Vomiting
Fatigue
Oedema
Visual Impairment
Hypoaesthesia
Paraesthesia
Nausea
Dysgeusia
Date:12/02/97ISR Number: 3003799-4Report Type:Expedited (15-DaCompany Report #90767 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Toxic Skin Eruption Foreign Lariam PS ORAL 250.0000MG
Initial or Prolonged Other 1.0 X PER
WEEK ORAL
Date:12/02/97ISR Number: 3003874-4Report Type:Expedited (15-DaCompany Report #90601 Age:36 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depressed Mood Foreign Lariam Tablets
Mood Swings Other (Mefloquine
Ear Infection
Hydrochloride)
Depression Suicidal 250.000 Mg PS ORAL 250.000 MG
Panic Attack
1.0 X PER
Suicidal Ideation
WEEK ORAL
Yellow Fever Vaccine C
03-Apr-2012 09:37 AM Page: 6

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Rabies Vaccine
Havrix
C
C
Date:12/02/97ISR Number: 3003979-8Report Type:Expedited (15-DaCompany Report #85820 Age:26 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Diarrhoea Health 1.0 X PER
Insomnia Professional WEEK ORAL
Illusion
TAB
Paraesthesia Ciprobay SS ORAL 500.0000 MG
Gastroenteritis Bacterial
2.0 X PER DAY
Disturbance In Attention
ORAL
Restlessness
Headache
Psychotic Disorder
Hypoaesthesia
Trance
Date:12/02/97ISR Number: 3003982-8Report Type:Expedited (15-DaCompany Report #59906 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious No Adverse Event Foreign Lariam PS ORAL 250 MG
Health Paludrine C
Professional Typhim Vi C
Nivaquine
C
Date:12/02/97ISR Number: 3004047-1Report Type:Expedited (15-DaCompany Report #90736 Age:75 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hostility Other Lariam PS ORAL 250.0000 MG
Initial or Prolonged Delusion 1.0 X PER
Nervousness
WEEK ORAL
Psychotic Disorder
Agitation
Toxicity To Various
Agents
Hypersensitivity
Hallucination, Auditory
Trance
Aggression
Date:12/02/97ISR Number: 3004049-5Report Type:Expedited (15-DaCompany Report #90607 Age:78 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Dementia Foreign Lariam PS ORAL ORAL
Health
Professional
03-Apr-2012 09:37 AM Page: 7

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/02/97ISR Number: 3004114-2Report Type:Expedited (15-DaCompany Report #89618 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Decreased Appetite Consumer Lariam PS ORAL 250.0000 MG
Abnormal Dreams
1.0 X PER
Crying
WEEK ORAL
Palpitations
Hyperreflexia
Hypoaesthesia
Insomnia
Abnormal Behaviour
Muscle Contractions
Involuntary
Motor Dysfunction
Panic Reaction
Drug Hypersensitivity
Paraesthesia
Date:12/03/97ISR Number: 3003946-4Report Type:Expedited (15-DaCompany Report #88694 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paraesthesia Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Dizziness Consumer 1.0 X PER
Asthenia Health WEEK ORAL 56 DAY
Blood Calcium Increased Professional
Alopecia
Arthralgia
Headache
Hypoaesthesia
Hypoparathyroidism
Hyperhidrosis
Visual Impairment
Date:12/03/97ISR Number: 3007297-3Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Panic Attack Lariam PS 1 PER WEEK
Intervention to
Insomnia
Prevent Permanent Anxiety
Impairment/Damage Agoraphobia
Dyspnoea
Date:12/08/97ISR Number: 3004513-9Report Type:Expedited (15-DaCompany Report #90887 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Muscle Rigidity Foreign Lariam PS ORAL 250.000 MG
Initial or Prolonged Muscle Twitching Other 1.0 X PER

Blood Glucose Decreased WEEK ORAL
03-Apr-2012 09:37 AM Page: 8

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/08/97ISR Number: 3004514-0Report Type:Expedited (15-DaCompany Report #90886 Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Photosensitivity Reaction Foreign Lariam PS ORAL 250.000 MG
Rash Pustular Other 1.0 X PER
Skin Infection
WEEK ORAL
Sakmonella Vaccine C
Immunoglobulins C
Poliomyelitis
Vaccine
C
Date:12/08/97ISR Number: 3004766-7Report Type:Expedited (15-DaCompany Report #90692 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Cough Consumer Lariam PS ORAL 250.0000 MG
Deafness Neurosensory
1.0 X PER
Tinnitus
WEEK ORAL
Date:12/08/97ISR Number: 3004769-2Report Type:Expedited (15-DaCompany Report #89328 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Missed Foreign Lariam PS ORAL 250.0000MG
Health
1.0X PER WEEK
Professional
ORAL
Date:12/09/97ISR Number: 3004654-6Report Type:Expedited (15-DaCompany Report #911054 Age:63 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Electrocardiogram Qrs Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Complex Abnormal Literature 1.0 X PER
Chest Pain
WEEK ORAL
Atrial Flutter
Condition Aggravated
Atrioventricular Block
Palpitations
Heart Rate Increased
Conduction Disorder
Tachycardia
Date:12/09/97ISR Number: 3004657-1Report Type:Expedited (15-DaCompany Report #90945 Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anaemia Foreign Lariam PS ORAL 1.5000 MG
Initial or Prolonged Jaundice Literature
Asthenia

Pyrexia
Malaria
Chills
Chromaturia
Blood Creatinine
Increased
Haemolysis
03-Apr-2012 09:37 AM Page: 9

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/09/97ISR Number: 3004686-8Report Type:Expedited (15-DaCompany Report #91054 Age:63 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chest Pain Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Palpitations Literature 1.0 X PER
Atrial Flutter
WEEK ORAL
Heart Rate Increased
Tachycardia
Date:12/11/97ISR Number: 3007641-7Report Type:Direct Company Report # Age:8 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Coordination Abnormal Mefloquine PS Roche ORAL 125 MG WEEKLY
Initial or Prolonged Photophobia
Gait Disturbance
Asthenia
Headache
Date:12/12/97ISR Number: 3006775-0Report Type:Expedited (15-DaCompany Report #91314 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Abnormal Behaviour Foreign Lariam PS ORAL 250.0000MG
Completed Suicide Other 1.0 X PER
WEEK ORAL
Chlorquine SS UNKNOWN
Date:12/16/97ISR Number: 3008113-6Report Type:Expedited (15-DaCompany Report #91370 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Ulna Fracture Foreign Lariam PS ORAL 250.0000MG
Initial or Prolonged Delusional Disorder, Other 1.0 X PER
Persecutory Type
WEEK ORAL
Suicide Attempt
Radius Fracture
Psychotic Disorder
Pelvic Fracture
Date:12/16/97ISR Number: 3008116-1Report Type:Expedited (15-DaCompany Report #89882 Age:82 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Gait Disturbance Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Paralysis Health 1.0 X PER
Hypoaesthesia Professional WEEK ORAL
Muscular Weakness Daonil C
Insulin
C

Date:12/23/97ISR Number: 3010716-XReport Type:Expedited (15-DaCompany Report #91691 Age:50 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Hallucination, Tactile
Hyperhidrosis
03-Apr-2012 09:37 AM Page: 10

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Malaise
Hallucination, Visual
Report Source Product Role Manufacturer Route Dose Duration
Foreign Lariam PS ORAL 250.0000MG
Other
1.0 X PER
WEEK ORAL
Date:12/30/97ISR Number: 3097260-9Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Nervousness Lariam PS 250MG /WK X3
Feeling Jittery
Malaise
Insomnia
Panic Attack
Date:01/02/98ISR Number: 3014141-7Report Type:Expedited (15-DaCompany Report #JAFRA-36938 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Staphylococcal Infection Foreign Imodium PS Janssen ORAL ORAL
Initial or Prolonged Arthralgia Ercefuryl SS ORAL ORAL
Pyrexia Smecta SS 30 DAY
Aspartate Engerix B SS INTRAMUSCULAR 20 MCG TOTAL
Aminotransferase
INTRAMUSCULAR
Increased Lariam SS ORAL 1 WEEKLY ORAL 7 WK
Arthritis Reactive Tiorfan C ORAL 100 MG ORAL 30 DAY
Diarrhoea
Hepatomegaly
Conjunctivitis
Alanine Aminotransferase
Increased
Date:01/07/98ISR Number: 3015608-8Report Type:Expedited (15-DaCompany Report #90736 Age:75 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Other Lariam PS ORAL 250.0000MG
Initial or Prolonged Delusion 1.0 X PER
Aggression
WEEK ORAL
Nervousness
Toxicity To Various
Agents
Agitation
Trance
Date:01/08/98ISR Number: 3015567-8Report Type:Expedited (15-DaCompany Report #92037 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Foreign Lariam PS 250.0000MG
Initial or Prolonged Suicidal Ideation Consumer 1.0 X PER
Anxiety
WEEK
03-Apr-2012 09:37 AM Page: 11

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/08/98ISR Number: 3016847-2Report Type:Expedited (15-DaCompany Report #92171 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myalgia Foreign Lariam PS ORAL 250 MG 1.0 X
Initial or Prolonged Sick Sinus Syndrome Other PER WEEK ORAL
Post Viral Fatigue Thyroxine C
Syndrome
Date:01/12/98ISR Number: 3016579-0Report Type:Expedited (15-DaCompany Report #92444 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Small For Dates Baby Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Maternal Drugs Affecting Consumer 1.0 X PER
Congenital Anomaly Foetus Other WEEK ORAL
Premature Baby Adepal SS ORAL 1.0000 DOSE
Foetal Growth Restriction
FORM 1.0 X
PER DAY ORAL
Yellow Fever Vaccine SS SUBCUTANEOUS 1.0000 DOSE
FORM 1.0 X
PER ODOS
SUBCUTANEOUS
Hepatitis A Vaccine SS INTRAMUSCULAR 1.0 X PER
ODOS
INTRAMUSCULAR
Hepatitis B Vaccine SS INTRAMUSCULAR 1.0 X PER
ODOS
INTRAMUSCULAR
Date:01/15/98ISR Number: 3018437-4Report Type:Direct Company Report # Age:80 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fall Lariam PS Laroche 1 WEEKLY FOR
Gait Disturbance
8 WKS
Balance Disorder Novaldex C
Date:01/15/98ISR Number: 3053811-1Report Type:Periodic Company Report #WAES 97041992 Age:44 YR Gender:Male I/FU:F
Outcome
PT
Chills
Anxiety
Fatigue
Dizziness
Headache
Myalgia
Nausea
Palpitations
Asthenia

Tinnitus
Accommodation Disorder
Diarrhoea
Decreased Appetite
Abdominal Pain
Depression
Pruritus
Drug Interaction
03-Apr-2012 09:37 AM Page: 12

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dysgeusia
Emotional Disorder
Salivary Hypersecretion Report Source Product Role Manufacturer Route Dose Duration
Consumer Crixivan PS Merck Research
Health
Laboratories Div
Professional Merck Co Inc ORAL 800 MG/Q8H/PO
Lariam Unk SS ORAL PO
Halicon
C
Triazolam
C
Retin-A
C
Valtrex
C
Zerit
C
Cimetidine
C
Epivir
C
(Beta)-Carotene C
Nizoral
C
Date:01/21/98ISR Number: 3017831-5Report Type:Expedited (15-DaCompany Report #92564 Age:17 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Bradycardia Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Gastroenteritis Health 1.0 X PER
Professional
WEEK ORAL
Date:01/22/98ISR Number: 3018708-1Report Type:Direct Company Report # Age:80 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Balance Disorder Lariam PS La Roche
Gait Disturbance Pharmaceutical Co 1 PER WEEK
FOR 8 WEEKS
Nolvadex
C
Date:01/27/98ISR Number: 3019299-1Report Type:Expedited (15-DaCompany Report #92891 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vertigo Foreign Lariam PS ORAL 250.000 MG
Balance Disorder Health 1.0 X PER
Gait Disturbance Professional WEEK ORAL
Geluprane
C
Date:01/27/98ISR Number: 3019406-0Report Type:Expedited (15-DaCompany Report #91568 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viith Nerve Paralysis Foreign Lariam PS ORAL 250.0000 MG
Health
1.0 X PER

Professional WEEK ORAL 28 DAY
Premarin
C
Salazopyrine
C
03-Apr-2012 09:37 AM Page: 13

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/02/98ISR Number: 3021867-8Report Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Palpitations Mefloquine PS ORAL 250 MG PO 8
Initial or Prolonged Fatigue DOSES
Chest Pain
Date:02/02/98ISR Number: 3021875-7Report Type:Expedited (15-DaCompany Report #80873 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Thymus Enlargement Foreign Lariam PS ORAL 250.000 MG
Trisomy 21 Health 1.0 X PER
Congenital Anomaly Professional WEEK ORAL
Ventricular Septal Defect
Acquired
Dysmorphism
Maternal Drugs Affecting
Foetus
Abortion Induced
Date:02/02/98ISR Number: 3021893-9Report Type:Direct Company Report # Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Health Lariam PS ORAL 250 MG WEEKLY 4 WK
Initial or Prolonged Chest Discomfort Professional
Decreased Appetite
Cardiac Disorder
Asthenia
Heart Rate Increased
Date:02/02/98ISR Number: 3021894-0Report Type:Expedited (15-DaCompany Report #89618 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Palpitations Consumer Lariam PS ORAL 250.OOO MG
Insomnia
1.0 X PER
Crying
WEEK ORAL
Decreased Appetite
Hyperreflexia
Panic Attack
Motor Dysfunction
Paraesthesia
Abnormal Dreams
Date:02/02/98ISR Number: 3022891-1Report Type:Expedited (15-DaCompany Report #87335 Age:25 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diarrhoea Foreign Lariam PS ORAL 250.00 MG 1.0
Initial or Prolonged Pyrexia Other X PER WEEK
Embolism Arterial
ORAL
Headache Marvelon C
Hemiparesis
03-Apr-2012 09:37 AM Page: 14

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/98ISR Number: 3022672-9Report Type:Expedited (15-DaCompany Report #90763 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Leukopenia Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Hyperhidrosis Health 1.0 X PER
Myalgia Professional WEEK ORAL
Aspartate
Aminotransferase
Increased
Fatigue
Hepatic Enzyme Increased
Blood Creatine
Phosphokinase Increased
Skin Discolouration
Myopathy
Liver Function Test
Abnormal
Alanine Aminotransferase
Increased
Chest Pain
Pain In Extremity
Diarrhoea
Hypogammaglobulinaemia
Tongue Coated
Cardiovascular Disorder
Muscular Weakness
Myocarditis
Hepatic Steatosis
Gamma-Glutamyltransferase
Increased
Headache
Myoglobin Blood Increased
Date:02/04/98ISR Number: 3022673-0Report Type:Expedited (15-DaCompany Report #92891 Age:54 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Balance Disorder Foreign Lariam PS ORAL 250.0000 MG
Vertigo Health 1.0 X PER
Gait Disturbance Professional WEEK ORAL
Dizziness Geluprane C
Date:02/04/98ISR Number: 3023912-2Report Type:Expedited (15-DaCompany Report #87481 Age:54 YR Gender:Male I/FU:F
Outcome
Disability
Other Serious
PT
Amnesia
Fatigue
Nausea
Hypoaesthesia
Nervous System Disorder

Overdose
Dysgeusia
Hypertension
Oedema
Disturbance In Attention
Visual Field Defect
Paraesthesia
Vomiting
03-Apr-2012 09:37 AM Page: 15

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dizziness
Report Source Product Role Manufacturer Route Dose Duration
Consumer Lariam PS ORAL 250.000 MG
Health
1.0 X PER DAY
Professional
ORAL
Date:02/09/98ISR Number: 3025971-XReport Type:Expedited (15-DaCompany Report #88651 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diplopia Foreign Lariam PS ORAL 250.0000 MG
Vith Nerve Paralysis Health 1.0 X PER
Nausea Professional WEEK ORAL
Headache
TAB
Date:02/09/98ISR Number: 3026005-3Report Type:Expedited (15-DaCompany Report #93517 Age:73 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Heart Rate Decreased Foreign Lariam PS ORAL 250.0000 MG
Hospitalization - Atrioventricular Block Other 1.0 X PER
Initial or Prolonged Complete WEEK ORAL
Required
Dizziness
Intervention to
Pallor
Prevent Permanent
Impairment/Damage
Date:02/10/98ISR Number: 3027135-2Report Type:Expedited (15-DaCompany Report #87481 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Mental Impairment Health Lariam PS ORAL 250.000 MG
Medication Error Professional 2.0 X WEEK
Visual Impairment Other ORAL
Vomiting
Overdose
Hypertension
Drug Level Above
Therapeutic
Dysgeusia
Dizziness
Brain Injury
Visual Acuity Reduced
Amnesia
Fatigue
Paraesthesia
Nausea
Oedema

Date:02/12/98ISR Number: 3027269-2Report Type:Expedited (15-DaCompany Report #92564 Age:16 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Bradycardia
Gastroenteritis
Asthenia
03-Apr-2012 09:37 AM Page: 16

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hypotension
Red Blood Cell
Sedimentation Rate Report Source Product Role Manufacturer Route Dose Duration
Increased Foreign Lariam PS ORAL 250.0000 MG
Health
1.0 X PER
Professional
WEEK ORAL
Date:02/12/98ISR Number: 3028339-5Report Type:Expedited (15-DaCompany Report #93802 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Foreign Lariam PS ORAL 50.000 MG 1.0
Initial or Prolonged Anxiety Other X PER WEEK
Thinking Abnormal
Tremor
Personality Disorder
Abnormal Behaviour
Date:02/12/98ISR Number: 3030309-8Report Type:Expedited (15-DaCompany Report #89882 Age:82 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoaesthesia Foreign Lariam PS ORAL 250.000 MG
Initial or Prolonged Feeling Drunk Health 1.0 X PER
Coordination Abnormal Professional WEEK ORAL
Paralysis Daonil C
Balance Disorder Insuline C
Muscular Weakness
Monoparesis
Date:02/12/98ISR Number: 3030313-XReport Type:Expedited (15-DaCompany Report #87481 Age:54 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hypoaesthesia Consumer Lariam PS ORAL 250.0000 MG
Other Serious Dysgeusia Health 1.0 X PER DAY
Hypertension Professional ORAL
Medication Error
Nausea
Fatigue
Visual Impairment
Dizziness
Disturbance In Attention
Vomiting
Memory Impairment
Brain Injury
Oedema

Date:02/13/98ISR Number: 3030113-0Report Type:Expedited (15-DaCompany Report #JAFRA-36938 Age:25 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Diarrhoea
Hepatic Function Abnormal
Hepatomegaly
Pyrexia
Arthralgia
03-Apr-2012 09:37 AM Page: 17

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Conjunctivitis
Report Source Product Role Manufacturer Route Dose Duration
Foreign Imodium PS Janssen ORAL ORAL
Health Ercefuryl SS ORAL ORAL
Professional Smecta SS 30 DAY
Engerix B SS INTRAMUSCULAR 20 MCG TOTAL,
INTRAMUSCULAR
SUSPENSION 20
MCG
Lariam SS ORAL 1 TABLET
WEEKLY ORAL 7 WK
Tiorfan C ORAL 100MG
CAPSULES 30 DAY
Date:02/18/98ISR Number: 3032216-3Report Type:Expedited (15-DaCompany Report #94117 Age:67 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Polyneuropathy Foreign Lariam PS ORAL 250.0000 MG
Intervention to Gait Disturbance Health 1.0 X PER
Prevent Permanent Spinal Osteoarthritis Professional WEEK ORAL
Impairment/Damage Sciatica
Back Pain
Lumbar Spinal Stenosis
Date:02/18/98ISR Number: 3032221-7Report Type:Expedited (15-DaCompany Report #93891 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Renal Failure Foreign Lariam PS ORAL 250 MG
Cardiac Arrest Consumer ORAL;TAB
Malaria
Date:02/18/98ISR Number: 3036413-2Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Panic Attack Lariam PS PRESCRIBED
Required Convulsion AMOUNTS
Intervention to
Dizziness
Prevent Permanent
Impairment/Damage
Tremor
Vision Blurred
Anxiety
Date:02/19/98ISR Number: 3032366-1Report Type:Expedited (15-DaCompany Report #94074 Age:30 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Depression Foreign Lariam PS ORAL ORAL
Suicidal Ideation
Other
03-Apr-2012 09:37 AM Page: 18

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/23/98ISR Number: 3035857-2Report Type:Expedited (15-DaCompany Report #93243 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Alkaline Foreign Lariam PS ORAL 1500.0000 MG
Phosphatase Increased Health ORAL
Gamma-Glutamyltransferase Professional
Increased
Platelet Count Decreased
White Blood Cell Count
Decreased
Thrombocytopenia
Alanine Aminotransferase
Increased
Date:02/23/98ISR Number: 3035884-5Report Type:Expedited (15-DaCompany Report #94429 Age:4 MON Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Pneumonia Viral Literature Lariam PS ORAL 250 MG 1 X
Maternal Drugs Affecting
PER WEEK ORAL
Foetus
Date:02/23/98ISR Number: 3035887-0Report Type:Expedited (15-DaCompany Report #94430 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Literature Lariam PS ORAL 250 MG 1 X
Foetus
PER WEEK ORAL
Benign Hydatidiform Mole
Date:02/23/98ISR Number: 3036234-0Report Type:Expedited (15-DaCompany Report #94382 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Coordination Abnormal Foreign Lariam PS ORAL 250.0000MG
Agraphia Other 1.0 X PER
WEEK ORAL
Date:02/23/98ISR Number: 3037257-8Report Type:Expedited (15-DaCompany Report #93562 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cardiolipin Antibody Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Positive Health 1.0 X PER
Abortion Spontaneous Professional WEEK ORAL
Dna Antibody Positive
Systemic Lupus
Erythematosus
Pre-Eclampsia

Maternal Drugs Affecting
Foetus
03-Apr-2012 09:37 AM Page: 19

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/23/98ISR Number: 3037262-1Report Type:Expedited (15-DaCompany Report #94371 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Foreign Lariam PS ORAL 250 MG 1 X
Health
PER WEEK ORAL
Professional
Date:02/24/98ISR Number: 3035602-0Report Type:Expedited (15-DaCompany Report #94035 Age:43 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disturbance In Attention Foreign Lariam PS ORAL 250.000 MG
Dyskinesia Other ORAL
Insomnia
Dizziness
Nausea
Date:02/24/98ISR Number: 3035604-4Report Type:Expedited (15-DaCompany Report #94037 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Urticaria Foreign Lariam PS ORAL 250.000 MG
Angioedema Other ORAL
Date:02/24/98ISR Number: 3035607-XReport Type:Expedited (15-DaCompany Report #947072 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psychotic Disorder Foreign Lariam PS ORAL 250.000 MG
Suicidal Ideation Other ORAL
Anxiety
Date:02/24/98ISR Number: 3035611-1Report Type:Expedited (15-DaCompany Report #94073 Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disturbance In Attention Foreign Lariam PS ORAL 250.000 MG
Agitation Other ORAL
Anxiety
Palpitations
Atrial Fibrillation
Date:02/24/98ISR Number: 3035613-5Report Type:Expedited (15-DaCompany Report #94074 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Foreign Lariam PS ORAL 250.000 MG
Suicidal Ideation Other ORAL

Date:02/24/98ISR Number: 3035616-0Report Type:Expedited (15-DaCompany Report #94092 Age:24 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Depression
Psychotic Disorder
03-Apr-2012 09:37 AM Page: 20

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Suicidal Ideation
Anxiety
Report Source Product Role Manufacturer Route Dose Duration
Foreign Lariam PS ORAL 250.000 MG
Other
ORAL
Date:02/24/98ISR Number: 3035620-2Report Type:Expedited (15-DaCompany Report #94093 Age:73 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psychotic Disorder Foreign Lariam PS ORAL 250.000 MG
Renal Failure Acute Other ORAL
Dermatitis
Disorientation
Date:02/24/98ISR Number: 3035623-8Report Type:Expedited (15-DaCompany Report #94101 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Foreign Lariam PS ORAL 250.000 MG
Dyskinesia Other ORAL
Agitation
Date:02/24/98ISR Number: 3035628-7Report Type:Expedited (15-DaCompany Report #04106 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hyperhidrosis Foreign Lariam PS ORAL 250.000 MG
Vomiting Other ORAL
Palpitations
Psychotic Disorder
Diarrhoea
Hallucination
Paralysis
Date:02/24/98ISR Number: 3035644-5Report Type:Expedited (15-DaCompany Report #94124 Age:5 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anaemia Foreign Lariam PS ORAL 250.000 MG
Coombs Direct Test Other ORAL
Positive
Date:02/24/98ISR Number: 3035647-0Report Type:Expedited (15-DaCompany Report #94126 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fatigue Foreign Lariam PS ORAL 250.000 MG

Angina Pectoris Other 1.0 X PER
WEEK ORAL
03-Apr-2012 09:37 AM Page: 21

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/24/98ISR Number: 3035650-0Report Type:Expedited (15-DaCompany Report #94128 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Bronchospasm Foreign Lariam PS ORAL 250.0000 MG
Other
1.0 X PER
WEEK ORAL
Date:02/24/98ISR Number: 3035652-4Report Type:Expedited (15-DaCompany Report #94131 Age:64 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cardiac Failure Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Other 1.0 X PER
WEEK ORAL
Date:02/24/98ISR Number: 3035657-3Report Type:Expedited (15-DaCompany Report #94137 Age:78 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatitis Cholestatic Foreign Lariam PS ORAL 250.0000 MG
Other
1.0 X PER
WEEK ORAL
Date:02/24/98ISR Number: 3035660-3Report Type:Expedited (15-DaCompany Report #94146 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoglycaemia Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Other 1.0 X PER
WEEK ORAL
Date:02/24/98ISR Number: 3103313-9Report Type:Expedited (15-DaCompany Report #94065 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Angioedema Foreign Lariam PS ORAL 250.000 MG
Dermatitis Other ORAL
Depressed Mood
Date:03/02/98ISR Number: 3050236-XReport Type:Direct Company Report # Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Mefloquine PS ORAL 250 MG PO
Date:03/03/98ISR Number: 3040313-1Report Type:Expedited (15-DaCompany Report #94569 Age:12 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Obsessive-Compulsive Health Lariam PS ORAL
Disorder
Professional
Emotional Disorder
Panic Attack
03-Apr-2012 09:37 AM Page: 22

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/03/98ISR Number: 3049890-8Report Type:Direct Company Report # Age:15 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Depressed Level Of Lariam PS Hoffmann-Laroche 250MG WKLY
Hospitalization - Consciousness
Initial or Prolonged Hallucination, Visual
Disability
Myalgia
Required
Muscular Weakness
Intervention to
Depression
Prevent Permanent Pain In Extremity
Impairment/Damage Hypersensitivity
Dizziness
Headache
Paralysis
Bone Pain
Injury
Pain
Pyrexia
Dyspnoea
Psychotic Disorder
Agitation
Paraesthesia
Tinnitus
Educational Problem
Heart Rate Irregular
Coordination Abnormal
Loss Of Consciousness
Insomnia
Chills
Abnormal Behaviour
Sleep Disorder
Hallucination, Auditory
Abnormal Dreams
Palpitations
Cold Sweat
Speech Disorder
Visual Impairment
Influenza Like Illness
Date:03/05/98ISR Number: 3050365-0Report Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Consumer Lariam PS Hoffman La Roche 1 TAB/WEEK
Pain In Extremity
Scab
Insomnia
Dermatitis Bullous
Rash Papular
Urticaria

Date:03/05/98ISR Number: 3050366-2Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Sleep Disorder Consumer Lariam PS Hoffman Laroche 1 TAB/WK
Dermatitis Bullous
03-Apr-2012 09:37 AM Page: 23

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/10/98ISR Number: 3049117-7Report Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Abnormal Dreams Lariam PS ORAL 1 PILL WEEKLY
Photosensitivity Reaction Vitamins C
Scleral Discolouration
Tooth Discolouration
Sleep Disorder
Date:03/10/98ISR Number: 3054941-0Report Type:Expedited (15-DaCompany Report #88694 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Visual Impairment Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Asthenia Consumer 1.0 X PER
Blood Calcium Decreased Health WEEK ORAL
Infectious Mononucleosis Professional
Paraesthesia
Arthralgia
Dizziness
Hyperhidrosis
Mental Disorder
Hypoaesthesia
Arrhythmia
Tension Headache
Alopecia
Sensory Disturbance
Hypoparathyroidism
Headache
Date:03/12/98ISR Number: 3058545-5Report Type:Direct Company Report # Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam PS 1 PER WEEK 5
Required Panic Attack DOSES
Intervention to Birth Control Pills C
Prevent Permanent
Impairment/Damage
Date:03/12/98ISR Number: 3059187-8Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Health Sibutamine PS Knoll ORAL 10 MG QD
Agitation Professional Mefloquine SS Roche ORAL 250 MG Q WEEK
Nervousness

Date:03/16/98ISR Number: 3055731-5Report Type:Expedited (15-DaCompany Report #94329 Age:2 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Inappropriate
Antidiuretic Hormone
Secretion
Diabetes Insipidus
Polyuria
03-Apr-2012 09:37 AM Page: 24

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Polydipsia
Report Source Product Role Manufacturer Route Dose Duration
Foreign Lariam PS ORAL 250 MG 1.0 X
Health
PER WEEK ORAL
Professional
Date:03/16/98ISR Number: 3055732-7Report Type:Expedited (15-DaCompany Report #95577 Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Foreign Lariam PS ORAL 1 DOSE FORM 1
Initial or Prolonged Dehydration Other X PER DAY
Abdominal Pain Upper
ORAL
Cholecystitis
Vomiting
Gastroenteritis
Date:03/17/98ISR Number: 3055864-3Report Type:Expedited (15-DaCompany Report #940202190001 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Foetal Growth Restriction Other Lariam PS ORAL 250.000 MG
Premature Baby
1.0 X PER
Maternal Drugs Affecting
WEEK ORAL
Foetus Iron C
Orasthin
C
Vitamins
C
Date:03/17/98ISR Number: 3055868-0Report Type:Expedited (15-DaCompany Report #940202190002 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Premature Labour Literature Lariam PS ORAL 250.0000 MG
Polyhydramnios Other 1.0 X PER
WEEK ORAL
Meningococci Vaccine C
Cholera Vaccine C
Plague Vaccine C
Immunoglobulins C
Typhoid Vaccine C
Date:03/17/98ISR Number: 3055872-2Report Type:Expedited (15-DaCompany Report #940202190003 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Jaundice Neonatal Literature Lariam PS ORAL 250.0000 MG
Other
1.0 X PER
WEEK ORAL

Iron C
Tuberkulin Tine Test
Ppd
C
Yellow Fever Vaccine C
Influenza Virus C
Immunoglobulins C
Vitamins
C
Oral Contraceptive C
03-Apr-2012 09:37 AM Page: 25

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/17/98ISR Number: 3055892-8Report Type:Expedited (15-DaCompany Report #92796 Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicidal Ideation Health Lariam PS ORAL 1.0 X PER
Initial or Prolonged Flight Of Ideas Professional WEEK ORAL
Psychotic Disorder Birth Control Pills C
Diarrhoea
Paranoia
Hallucination, Auditory
Delusional Disorder,
Unspecified Type
Dystonia
Thinking Abnormal
Agitation
Mood Swings
Date:03/18/98ISR Number: 3056397-0Report Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Tooth Discolouration Lariam PS 1 PILL WEEKLY
Scleral Discolouration Vitamines C
Photosensitivity Reaction
Abnormal Dreams
Sleep Disorder
Date:03/19/98ISR Number: 3057866-XReport Type:Direct Company Report # Age:15 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hallucinations, Mixed Lariam PS 3 TABLETS
Hospitalization - Hyperventilation SINGLE DOSE
Initial or Prolonged Chest Pain
Disability
Insomnia
Required
Abnormal Behaviour
Intervention to
Suicidal Ideation
Prevent Permanent Psychomotor Hyperactivity
Impairment/Damage
Date:03/24/98ISR Number: 3059313-0Report Type:Expedited (15-DaCompany Report #95970 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pancreatitis Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Other 1.0 X PER
WEEK ORAL
Date:03/24/98ISR Number: 3059361-0Report Type:Expedited (15-DaCompany Report #96259 Age:26 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vision Blurred Foreign Lariam PS ORAL 250.0000 MG
Nystagmus Other 1.0 X PER
Bronchospasm
WEEK ORAL
Panic Attack Beecham'S Powders C
Tyrozets
C
Kalms Herbal
C
03-Apr-2012 09:37 AM Page: 26

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/24/98ISR Number: 3059363-4Report Type:Expedited (15-DaCompany Report #96078 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Epilepsy Foreign Lariam PS ORAL 250.0000 MG
Bradycardia Health 1.0 X PER
Loss Of Consciousness Professional WEEK
Paraesthesia
Colitofalk
Amnesia (Mesalamine) C
Date:03/24/98ISR Number: 3059365-8Report Type:Expedited (15-DaCompany Report #95984 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaise Foreign Lariam PS ORAL 250.0000 MG
Insomnia Other 1.0 X PER
Balance Disorder
WEEK ORAL
Oropharyngeal Pain Logynon C
Pyrexia
Coordination Abnormal
Anosmia
Fatigue
Confusional State
Anxiety
Dysgeusia
Date:03/24/98ISR Number: 3060160-4Report Type:Expedited (15-DaCompany Report #96194 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fatigue Foreign Lariam PS ORAL 250.0000 MG
Dizziness Postural Health 1.0 X PER DAY
Depression Professional ORAL
Medication Error
Gamma-Glutamyltransferase
Increased
Nausea
Aspartate
Aminotransferase
Increased
Diarrhoea
Tinnitus
Date:03/24/98ISR Number: 3060164-1Report Type:Expedited (15-DaCompany Report #96200 Age:23 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Bleeding Time Prolonged
Abdominal Pain
C-Reactive Protein
Increased

Headache
Dizziness
Panic Reaction
Encephalitis
Psychotic Disorder
Myalgia
Gastrointestinal Disorder
Anxiety
03-Apr-2012 09:37 AM Page: 27

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Transferrin Increased
Report Source Product Role Manufacturer Route Dose Duration
Foreign Lariam PS ORAL 250.0000 MG
Other
1.O X PER
WEEK ORAL
Hepatitis A
Vaccination
C
Flagyl
C
Yellow Fever Vaccine C
Date:03/24/98ISR Number: 3060304-4Report Type:Expedited (15-DaCompany Report #91489 Age:56 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cerebral Ischaemia Foreign Lariam PS ORAL 250.0000 MG
Clonic Convulsion Health 1.0 X PER
Spinal Disorder Professional WEEK ORAL
Flu Vaccine
(Influenza Virus
Vaccine)
C
Flixotide
C
Salbutamol
C
Prozac
C
Tetracyclin
C
Date:03/24/98ISR Number: 3061536-1Report Type:Expedited (15-DaCompany Report #92796 Age:23 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Thinking Abnormal Health Lariam PS ORAL 1.0 X PER
Initial or Prolonged Diarrhoea Professional WEEK ORAL
Dystonia Birth Control Pills C
Suicidal Ideation
Psychotic Disorder
Delusion
Hallucination, Auditory
Paranoia
Agitation
Mood Altered
Toxicologic Test Abnormal
Date:03/25/98ISR Number: 3058316-XReport Type:Expedited (15-DaCompany Report #96157 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Diplopia Health Lariam PS ORAL 250.0000 MG
Condition Aggravated Professional 1.0 X PER
WEEK ORAL
Estratest
C

Synthroid C
03-Apr-2012 09:37 AM Page: 28

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/27/98ISR Number: 3061119-3Report Type:Direct Company Report # Age:57 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Palpitations Mefloquine PS Hoffman-La Roche ORAL 250MG ONCE A
Dizziness
WEEK PO ONLY
ONE DOSE
Prastitata Natural
Vitamin
C
Date:03/27/98ISR Number: 3065019-4Report Type:Direct Company Report # Age:51 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nervous System Disorder Lariam PS ORAL TAB; 250 MG
Initial or Prolonged Dissociation PO Q 7 DAYS-8
Abnormal Dreams
DOSES , LAST
Ileus Paralytic
2 MONTHS
Date:03/31/98ISR Number: 3060069-6Report Type:Expedited (15-DaCompany Report #93604 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nausea Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Fatigue Health 1.0 X PER DAY 28 DAY
Vomiting
Professional
Overdose
Headache
Dysarthria
Vision Blurred
Somnolence
Depression
Confusional State
Diarrhoea
Date:03/31/98ISR Number: 3063290-6Report Type:Direct Company Report # Age:69 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Insomnia Larium PS Hoffman-La Roche LARIUM -1 A
Urinary Bladder
WEEK
Haemorrhage Primaquine SS PRIMAQUINE -
Haematochezia 1 X DAY 2 WK
Ear Haemorrhage Ogen C
Weight Decreased Synthroid C
Diarrhoea
Date:03/31/98ISR Number: 3067124-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Lariam PS AS
Mood Swings
INSTRUCTED-DO
Hallucination
NT REMEMBER
03-Apr-2012 09:37 AM Page: 29

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/02/98ISR Number: 3059988-6Report Type:Expedited (15-DaCompany Report #96729 Age:57 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Clonic Convulsion Foreign Lariam PS ORAL 250.000 MG
Other
1.0 X PER
WEEK ORAL
Influenza Vaccine C
Flixotide
C
Salbutamol
C
Prozac
C
Tetracycline
C
Date:04/02/98ISR Number: 3059990-4Report Type:Expedited (15-DaCompany Report #94329 Age:2 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diabetes Insipidus Foreign Lariam PS ORAL 50.0000 MG
Polydipsia Health 1.0 X PER
Polyuria Professional WEEK ORAL
Date:04/02/98ISR Number: 3059992-8Report Type:Expedited (15-DaCompany Report #96767 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Pyrexia Health Lariam PS ORAL 250.0000 MG
Intraocular Pressure Test Professional 1.0 X PER
Chills Other WEEK ORAL
Retinal Detachment
Eye Pain
Date:04/03/98ISR Number: 3063293-1Report Type:Expedited (15-DaCompany Report #96727 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Platelet Count Decreased Foreign Lariam PS ORAL 1500.0000 MG
Leukopenia Other DAILY ORAL
Thrombocytopenia
Blood Alkaline
Phosphatase Increased
Gamma-Glutamyltransferase
Increased
Thrombocytosis
White Blood Cell Count
Increased
Aspartate
Aminotransferase
Increased

Date:04/03/98ISR Number: 3063295-5Report Type:Expedited (15-DaCompany Report #967761 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Haemangioma Of Liver Consumer Lariam PS ORAL 250.0000 MG
Nephrolithiasis
1.0 X PER
WEEK ORAL
Tetanus Booster C
Polio Booster
C
03-Apr-2012 09:37 AM Page: 30

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Poliomyelitis
Vaccines
Hepatitis A Vaccine
Hepatitis B Vaccine
C
C
C
Date:04/07/98ISR Number: 3061744-XReport Type:Expedited (15-DaCompany Report #90692 Age:44 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Cough Consumer Lariam PS ORAL 250.0000 MG
Influenza
1.0 X PER
Tinnitus
WEEK ORAL
Deafness Neurosensory
Date:04/07/98ISR Number: 3061746-3Report Type:Expedited (15-DaCompany Report #83677 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Atrial Fibrillation Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Maternal Drugs Affecting Health 1.0 X PER
Required Foetus Professional WEEK ORAL
Intervention to
Prevent Permanent
Impairment/Damage
Date:04/07/98ISR Number: 3061749-9Report Type:Expedited (15-DaCompany Report #93562 Age:32 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Systemic Lupus Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Erythematosus Health 1.0 X PER
Dna Antibody Positive Professional WEEK ORAL
Abortion Spontaneous
Other
Cardiolipin Antibody
Positive
Pre-Eclampsia
Date:04/09/98ISR Number: 3062290-XReport Type:Expedited (15-DaCompany Report #96373 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Ecchymosis Health Lariam PS ORAL 250.0000 MG
Initial or Prolonged Professional 1.0 X PER
WEEK ORAL
Flonase
C
Ventolin
C
Amoxicillin
C
Ortho-Cept
C

Date:04/10/98ISR Number: 3061854-7Report Type:Expedited (15-DaCompany Report #97149 Age:52 YR Gender:Female I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Ileus Paralytic
Dehydration
Feeling Abnormal
03-Apr-2012 09:37 AM Page: 31

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
White Blood Cell Count
Increased
Abnormal Dreams Report Source Product Role Manufacturer Route Dose Duration
Decreased Appetite Health Lariam PS ORAL 250.0000 MG
Nausea Professional 1.0 X PER
Abdominal Pain
WEEK ORAL
Date:04/10/98ISR Number: 3061856-0Report Type:Expedited (15-DaCompany Report #96157 Age:58 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Diplopia Health Lariam PS ORAL 250 MG 1 X
Professional
PER WEEK ORAL
Estratest
C
Synthroid
C
Date:04/14/98ISR Number: 3073100-9Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam PS Roche ONCE PER
Anxiety
WEEEK
Flushing
Thinking Abnormal
Pyrexia
Insomnia
Suicidal Ideation
Diarrhoea
Cold Sweat
Date:04/15/98ISR Number: 3066252-8Report Type:Expedited (15-DaCompany Report #97094 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Allergic Granulomatous Other Lariam PS ORAL 250.0000 MG
Angiitis
1.0 X PER
WEEK PO
Date:04/15/98ISR Number: 3066253-XReport Type:Expedited (15-DaCompany Report #96103 Age:67 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Brain Scan Abnormal Foreign Lariam PS ORAL 250.0000 MG
Delirium
Health
Psychotic Disorder
Professional
Encephalopathy
Mania

Date:04/15/98ISR Number: 3071734-9Report Type:Direct Company Report # Age:64 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Fatigue
Malaise
Night Sweats
Depression
03-Apr-2012 09:37 AM Page: 32

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disturbance In Attention
Confusional State
Blood Pressure Report Source Product Role Manufacturer Route Dose Duration
Fluctuation Lariam PS Roche ORAL 250MGM ; ORAL
Asthenia
;ONCE A WEEK
Paraesthesia Mevacor C
Tenormin
C
Moduretic
C
Date:04/20/98ISR Number: 3065208-9Report Type:Expedited (15-DaCompany Report #97097 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Coma Foreign Lariam PS ORAL 19.3000 MG/KG
Literature
1.O X PER
Health
ODOS ORAL
Professional Pyrimethamine C
Sulfadoxine
C
Date:04/20/98ISR Number: 3066091-8Report Type:Expedited (15-DaCompany Report #97118 Age:5 YR Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Rash Morbilliform Foreign Lariam PS ORAL 50.0000 MG
Initial or Prolonged Neurotoxicity Literature 1.0 X PER
Pyrexia Health WEEK ORAL
Drug Interaction Professional Quinine SS INTRAVENOUS 21.0000 MG/KG
Status Epilepticus
DAILY
Convulsion INTRAVENOUS 7 DAY
Date:04/20/98ISR Number: 3069248-5Report Type:Expedited (15-DaCompany Report #97566 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Health Lariam PS ORAL 250 MG
Deafness Professional (TABLET) 1.0
X PER WEEK
Premarin
C
Date:04/20/98ISR Number: 3073073-9Report Type:Direct Company Report # Age:61 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Insomnia Lariam PS Roche Laboratories 1 PER WEEK
Other Serious
Hyperhidrosis
Anxiety
Disturbance In Attention
Restlessness
Weight Decreased

Eating Disorder
03-Apr-2012 09:37 AM Page: 33

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/20/98ISR Number: 3073074-0Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Ulcer Lariam PS 1 TABLET A
Hospitalization - Blood Pressure Increased DAY FOR ONE
Initial or Prolonged
WEEK THEN ONE
EVERY WEEK
Date:04/21/98ISR Number: 3074855-XReport Type:Direct Company Report # Age:68 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Headache Larium PS ORAL ONE PILL EACH
Balance Disorder
WEEK
Hearing Impaired
Visual Impairment
Date:04/23/98ISR Number: 3071860-4Report Type:Direct Company Report # Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paranoia Health Lariam PS ORAL (1) TAB Q/WK
Initial or Prolonged Delusion Professional ORAL 1 DAY
Other Serious Psychotic Disorder Cipro C
Date:04/24/98ISR Number: 3068735-3Report Type:Expedited (15-DaCompany Report #97094 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Allergic Granulomatous Other Lariam PS ORAL 250 MG 1XPER
Angiitis
WEEK
Unknown
C
Date:04/24/98ISR Number: 3068760-2Report Type:Expedited (15-DaCompany Report #97775 Age:74 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pneumonia Viral Foreign Lariam PS ORAL 250.0000 MG
Initial or Prolonged Pneumonitis Health 1.0 X PER
Alveolitis Allergic Professional WEEK ORAL
Other
Date:04/24/98ISR Number: 3068768-7Report Type:Expedited (15-DaCompany Report #97779 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Foreign Lariam PS ORAL 250 MG 1X PER
Foetus Health WEEK ORAL

Pre-Eclampsia Professional
03-Apr-2012 09:37 AM Page: 34

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/24/98ISR Number: 3068811-5Report Type:Expedited (15-DaCompany Report #83939 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Pre-Eclampsia Foreign Lariam PS ORAL 250.000 MG
Maternal Drugs Affecting Health 1.0 X PER
Foetus Professional WEEK ORAL
Cleft Palate
Date:04/24/98ISR Number: 3072341-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Paranoia Lariam PS Roche ONCE PER WEEK
Depression
Thinking Abnormal
Dermatitis
Feeling Of Body
Temperature Change
Anxiety
Diarrhoea
Suicidal Ideation
Insomnia
Pyrexia
Date:04/27/98ISR Number: 3069033-4Report Type:Expedited (15-DaCompany Report #83939 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Cleft Palate Foreign Lariam PS ORAL 250 MG 1 X
Maternal Drugs Affecting Health PER WEEK ORAL
Foetus
Professional
Date:04/27/98ISR Number: 3069037-1Report Type:Expedited (15-DaCompany Report #97885 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dry Mouth Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Oedema Mouth Health PER WEEK ORAL
Pharyngeal Oedema Professional Levlen C
Date:04/27/98ISR Number: 3070615-4Report Type:Expedited (15-DaCompany Report #96103 Age:67 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psychotic Disorder Foreign Lariam PS ORAL 250 MG 1 X
Delirium Health PER WEEK ORAL
Progressive Multifocal Professional
Leukoencephalopathy
Mania

Date:04/27/98ISR Number: 3072501-2Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I
Outcome
Disability
Required
03-Apr-2012 09:37 AM Page: 35

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Intervention to
Prevent Permanent
Impairment/Damage
PT Report Source Product Role Manufacturer Route Dose Duration
Personality Disorder Mefloquine PS ORAL 250MG WEEKLY
Disorientation
PO
Acute Psychosis
Paranoia
Hallucination, Auditory
Visual Impairment
Agitation
Nausea
Disturbance In Attention
Headache
Date:04/29/98ISR Number: 3072953-8Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fear Health Lariam PS La Roche ORAL 1 TABLET
Other Serious Heat Exhaustion Professional WEEKLY
Paranoia
Insomnia
Nausea
Vomiting
Decreased Appetite
Panic Attack
Alopecia
Palpitations
Date:04/30/98ISR Number: 3074393-4Report Type:Expedited (15-DaCompany Report #98097 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Skull Fracture Foreign Lariam PS ORAL 250 MG 1X PER
Facial Bones Fracture Health WEEK ORAL
Completed Suicide Professional TAB
Aortic Injury
Multiple Injuries
Fall
Date:04/30/98ISR Number: 3074395-8Report Type:Expedited (15-DaCompany Report #98092 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paralysis Foreign Lariam PS ORAL ORAL
Health
Professional

Date:05/04/98ISR Number: 3073979-0Report Type:Expedited (15-DaCompany Report #93422 Age:28 YR Gender:Female I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Rash Pruritic
Insomnia
Hypersensitivity
Swelling
Spider Naevus
03-Apr-2012 09:37 AM Page: 36

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depression
Restlessness
Mental Disorder Report Source Product Role Manufacturer Route Dose Duration
Asthma Other Lariam PS ORAL 250 MG 1 X
Nausea
PER WEEK ORAL
Anxiety Hepatitis A Vaccine C
Vision Blurred Albuterol Inhaler C
Headache
Triphasic Birth
Control Pill
C
Date:05/04/98ISR Number: 3073980-7Report Type:Expedited (15-DaCompany Report #96923 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disturbance In Attention Foreign Lariam PS ORAL ORAL
Amnesia
Health
Brain Neoplasm
Professional
Mental Disorder
Date:05/05/98ISR Number: 3073586-XReport Type:Expedited (15-DaCompany Report #91747 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Foreign Lariam PS ORAL 250 MG 1 X
Foetus Health PER WEEK
Dysmorphism Professional Vaccines Nos C
Date:05/05/98ISR Number: 3073768-7Report Type:Expedited (15-DaCompany Report #98430 Age:74 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspnoea Lariam PS ORAL ORAL
Pulmonary Fibrosis
Date:05/05/98ISR Number: 3073808-5Report Type:Expedited (15-DaCompany Report #97885 Age:30 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoaesthesia Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Dry Mouth Health PER WEEK ORAL
Oedema Mouth Professional Levlen C
Pharyngeal Oedema
Liver Function Test
Abnormal
Date:05/12/98ISR Number: 3075378-4Report Type:Direct Company Report # Age:21 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Larium PS Roche 1 DOSE
Initial or Prolonged Abnormal Behaviour
03-Apr-2012 09:37 AM Page: 37

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/12/98ISR Number: 3076411-6Report Type:Expedited (15-DaCompany Report #9905511 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Psychotic Disorder Foreign Depakene PS Abbott ORAL PO
Epilepsy Consumer Mefloquine SS ORAL PO
Drug Level Below Carbamazepine C
Therapeutic
Drug Interaction
Abnormal Behaviour
Date:05/12/98ISR Number: 3077372-6Report Type:Expedited (15-DaCompany Report #98566 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thinking Abnormal Foreign Lariam PS Global Development ORAL 250 MG 1 X
Mania Other PER DAY ORAL
Date:05/12/98ISR Number: 3077375-1Report Type:Expedited (15-DaCompany Report #87481 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fatigue Health Lariam PS ORAL 250 MG 2 X
Hypertension Professional PER WEEK ORAL
Oedema
Other
Nausea
Sleep Apnoea Syndrome
Overdose
Cough
Eye Irritation
Visual Acuity Reduced
Dizziness
Hypoaesthesia
Bone Pain
Chest Pain
Paraesthesia
Medication Error
Brain Injury
Neck Pain
Nocturia
Dysgeusia
Thinking Abnormal
Vomiting
Upper Respiratory Tract
Infection
Date:05/12/98ISR Number: 3077579-8Report Type:Expedited (15-DaCompany Report #91489 Age:57 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Spinal Cord Injury Foreign Lariam PS ORAL 250 MG 1X PER

Cervical Study WEEK
Cerebral Ischaemia Health Flu Vaccine
Clonic Convulsion Professional (Influenza Virus
Spinal Cord Injury Other Vaccine) C
Thoracic
Flixotide(Fluticason
e Propionate)
C
Salbutamol
(Albuterol)
C
03-Apr-2012 09:37 AM Page: 38

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Prozac (Fluoxetine
Hydrochloride)
Tetracyclin
(Tetracycline)
C
C
Date:05/15/98ISR Number: 3079401-2Report Type:Expedited (15-DaCompany Report #96103 Age:67 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mania Foreign Lariam PS ORAL 250 MG X PER
Encephalopathy Health WEEK ORAL
Delirium
Professional
Psychotic Disorder
Date:05/15/98ISR Number: 3079404-8Report Type:Expedited (15-DaCompany Report #98742 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myocardial Infarction Foreign Lariam PS ORAL 250 MG 1X PER
Initial or Prolonged Health WEEK ORAL
Professional
Date:05/15/98ISR Number: 3079416-4Report Type:Expedited (15-DaCompany Report #89246 Age:37 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Premature Labour Foreign Lariam PS ORAL 250 MG 1XPER
Intervention to Health WEEK ORAL
Prevent Permanent
Professional
Impairment/Damage
Date:05/15/98ISR Number: 3079420-6Report Type:Expedited (15-DaCompany Report #96729 Age:57 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Clonic Convulsion Foreign Lariam PS ORAL 250MG 1XPER
Other
WEEK ORAL
Influenza Vaccine C
Flixotide
C
Salbutamol
C
Prozac
C
Tetracycline
C
Date:05/15/98ISR Number: 3079450-4Report Type:Expedited (15-DaCompany Report #93562 Age:32 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Renal Failure Foreign Larium PS ORAL 250MG X 1 PER

Initial or Prolonged Systemic Lupus Health WEEK ORAL
Erythematosus
Professional
Pre-Eclampsia
Other
Abortion Spontaneous
03-Apr-2012 09:37 AM Page: 39

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/15/98ISR Number: 3079460-7Report Type:Expedited (15-DaCompany Report #98539 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dysmorphism Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Oligohydramnios Other PER WEEK ORAL
Congenital Anomaly Placental Disorder
Maternal Drugs Affecting
Foetus
Date:05/15/98ISR Number: 3079461-9Report Type:Expedited (15-DaCompany Report #97094 Age:66 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Oedema Peripheral Other Lariam PS ORAL 250 MG 1 X
Allergic Granulomatous
PER WEEK ORAL
Angiitis Proventil Inhaler C
Skin Mass Aminophylline C
Fosamax
C
Premarin
C
Flovent
C
Vitamin E
C
Fish Oil
C
Calcium
C
Seliran
C
Multivitamins
C
Accolate
C
Vitamin C
C
Date:05/19/98ISR Number: 3081150-1Report Type:Expedited (15-DaCompany Report #83711 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Health Lariam PS ORAL 250 MG 1 X
Visual Impairment Professional PER WEEK ORAL
Anxiety
Schizophrenia
Abnormal Dreams
Psychotic Disorder
Hallucination, Visual
Date:05/19/98ISR Number: 3081153-7Report Type:Expedited (15-DaCompany Report #80215 Age:53 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Company Lariam PS ORAL 250 MG 1 X
Nausea Representative PER WEEK ORAL
Visual Impairment
Blindness

Date:05/19/98ISR Number: 3081447-5Report Type:Expedited (15-DaCompany Report #85335 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abnormal Behaviour Health Lariam PS ORAL 1 DOSE FROM 1
Initial or Prolonged Aggression Professional X PER WEEK
Hallucination
ORAL
Schizophrenia
03-Apr-2012 09:37 AM Page: 40

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/20/98ISR Number: 3080425-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Visual Impairment Lariam PS 250 MG 1 X
Other Serious Abnormal Dreams WEEK
Mood Altered
Anxiety
Panic Attack
Date:05/20/98ISR Number: 3081830-8Report Type:Expedited (15-DaCompany Report #98794 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Haemolysis Foreign Lariam PS ORAL 250 MG 1 X
Liver Function Test Health PER WEEK ORAL
Abnormal
Professional
Platelet Count Decreased
Date:05/22/98ISR Number: 3082507-5Report Type:Expedited (15-DaCompany Report #96767 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Retinal Detachment Health Lariam PS ORAL 250 MG 1XPER
Malaria Professional WEEK ORAL
Intraocular Pressure
Other
Increased
Pyrexia
Eye Pain
Chills
Hyperhidrosis
Date:05/22/98ISR Number: 3082511-7Report Type:Expedited (15-DaCompany Report #88781 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Premature Baby Foreign Lariam PS ORAL 250 MG 1 X
Uterine Haemorrhage Health PER WEEK ORAL
Respiratory Disorder
Professional
Neonatal
Infection
Uterine Injury
Maternal Drugs Affecting
Foetus
Cervical Incompetence
Haematoma
Vaginal Haemorrhage
Date:05/22/98ISR Number: 3082513-0Report Type:Expedited (15-DaCompany Report #88780 Age:29 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Premature Baby Foreign Lariam PS ORAL 250 MG 1 X
Premature Labour Health PER WEEK ORAL
Vaginal Haemorrhage
Professional
Infection
Cervical Incompetence
Haematoma
03-Apr-2012 09:37 AM Page: 41

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/26/98ISR Number: 3084316-XReport Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Health Mefloquine PS ORAL 1 TAB Q WK ;
Dizziness Professional 250 MG/WK
Feeling Abnormal P.O. 4 WK
Anxiety
Date:05/28/98ISR Number: 3084620-5Report Type:Expedited (15-DaCompany Report #99368 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Infectious Mononucleosis Foreign Lariam PS ORAL 250 MG 1 X
Mouth Ulceration Other PER WEEK ORAL
Post Viral Fatigue
Syndrome
Lymphopenia
Date:06/01/98ISR Number: 3087636-8Report Type:Expedited (15-DaCompany Report #85972 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Foreign Lariam PS ORAL 250 MG 1 X
Foetus Health PER WEEK ORAL
Jaundice Neonatal Professional Cabergoline C
Date:06/01/98ISR Number: 3088034-3Report Type:Expedited (15-DaCompany Report #98742 Age:54 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myocardial Infarction Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Health PER WEEK ORAL
Professional
Date:06/01/98ISR Number: 3088035-5Report Type:Expedited (15-DaCompany Report #99181 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyspnoea Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Hypersensitivity Health PER WEEK ORAL
Asthma
Professional
Date:06/01/98ISR Number: 3088675-3Report Type:Expedited (15-DaCompany Report #80215 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam PS ORAL 250 MG 1 X
Visual Acuity Reduced
PER WEEK ORAL

Nightmare Estrogen C
03-Apr-2012 09:37 AM Page: 42

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/02/98ISR Number: 3088297-4Report Type:Expedited (15-DaCompany Report #98097 Age:37 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Depression Foreign Lariam PS ORAL 250 MG 1X PER
Completed Suicide Health WEEK ORAL
Professional
Other
Date:06/04/98ISR Number: 3089762-6Report Type:Expedited (15-DaCompany Report #99833 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Arthralgia Foreign Lariam PS ORAL 250 MG 1 X
Myalgia Other PER WEEK ORAL
Date:06/04/98ISR Number: 3090175-1Report Type:Expedited (15-DaCompany Report #68408 Age:25 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Spinal Fracture Health Lariam PS ORAL 250 MG 1 X
Hallucination Professional PER WEEK ORAL
Paraplegia
Other
Mental Disorder
Panic Attack
Fall
Date:06/04/98ISR Number: 3090177-5Report Type:Expedited (15-DaCompany Report #99753 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Other Lariam PS ORAL 250 MG 1 X
Agitation
PER WEEK ORAL
Suicide Attempt
Suicidal Ideation
Paranoia
Flushing
Restlessness
Diarrhoea
Date:06/05/98ISR Number: 3179164-6Report Type:Periodic Company Report #95701 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Consumer Lariam Tablets
Nausea
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK 21 DAY

Date:06/08/98ISR Number: 3159668-2Report Type:Periodic Company Report #81017 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Alopecia Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL ORAL
03-Apr-2012 09:37 AM Page: 43

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Synthroid
C
Date:06/08/98ISR Number: 3159671-2Report Type:Periodic Company Report #81018 Age:75 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pruritus Consumer Lariam Tablets
Dizziness Health (Mefloquine
Alopecia Professional Hydrochloride)
Abnormal Dreams 250.000 Mg PS ORAL 250.000 MG
Eye Irritation
1.0 X PER
WEEK (ORAL)
Dyazide
C
Date:06/08/98ISR Number: 3159674-8Report Type:Periodic Company Report #82001 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam Tablets
Thirst
(Mefloquine
Eye Irritation
Hydrochloride)
Hypoaesthesia Oral 250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Zestril
C
Date:06/08/98ISR Number: 3159676-1Report Type:Periodic Company Report #82176 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Consumer Lariam Tablets
Heart Rate Increased
(Mefloquine
Nervousness
Hydrochloride)
Paranoia 250.000 Mg PS ORAL 250.000 MG
Hallucinations, Mixed
1.0 X PER
Anxiety
WEEK ORAL
Date:06/08/98ISR Number: 3159680-3Report Type:Periodic Company Report #82334 Age:48 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Phosphorus Health Lariam Tablets
Increased Professional (Mefloquine
Gamma-Glutamyltransferase
Hydrochloride)
Increased 250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL

Date:06/08/98ISR Number: 3159682-7Report Type:Periodic Company Report #82521 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
03-Apr-2012 09:37 AM Page: 44

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159683-9Report Type:Periodic Company Report #82632 Age:72 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pain In Extremity Health Lariam Tablets
Pain Professional (Mefloquine
Arthralgia
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159684-0Report Type:Periodic Company Report #82726 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disorientation Other Lariam Tablets
Tremor
(Mefloquine
Anxiety
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159685-2Report Type:Periodic Company Report #83053 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amnesia Other Lariam Tablets
Judgement Impaired
(Mefloquine
Panic Disorder
Hydrochloride)
Confusional State 250.000 Mg PS ORAL 1.0000 DOSE
Crying
FORM 1.0 X
PER WEEK ORAL
Date:06/08/98ISR Number: 3159686-4Report Type:Periodic Company Report #83231 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Consumer Lariam Tablets
Sedation
(Mefloquine
Memory Impairment
Hydrochloride)
Vision Blurred 250.000 Mg PS ORAL 250.000 MG
Fatigue
1.0 X PER
Dizziness
WEEK ORAL
Tachycardia
Visual Impairment

Date:06/08/98ISR Number: 3159687-6Report Type:Periodic Company Report #83412 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Urinary Incontinence Other Lariam Tablets
Muscle Spasms
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
03-Apr-2012 09:37 AM Page: 45

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Yellow Fever Vaccine C
Rabies Vaccine C
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159688-8Report Type:Periodic Company Report #83622 Age:48 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gynaecomastia Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Sporanox
(Itraconazole)
250.000 Mg SS ORAL 3.0 X PER MON
ORAL
Vitamin E
C
Vitamin D
C
Vitamin B Complex C
Date:06/08/98ISR Number: 3159690-6Report Type:Periodic Company Report #83624 Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Acuity Reduced Consumer Lariam Tablets
Alopecia
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Premarin
C
Synthroid
C
Date:06/08/98ISR Number: 3159691-8Report Type:Periodic Company Report #83790 Age:64 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Impairment Consumer Lariam Tablets
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.O X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159692-XReport Type:Periodic Company Report #83947 Age:58 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hyporeflexia Consumer Lariam Tablets
Paraesthesia
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Mevacor (Lovastatin) SS ORAL 20.0000 MG
03-Apr-2012 09:37 AM Page: 46

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Premarin
Provera
C
C
DAILY ORAL
Date:06/08/98ISR Number: 3159694-3Report Type:Periodic Company Report #83953 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Alopecia Consumer Lariam Tablets
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.O X PER
WEEK ORAL
Maxidex
C
Date:06/08/98ISR Number: 3159695-5Report Type:Periodic Company Report #84120 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159697-9Report Type:Periodic Company Report #84292 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Consumer Lariam Tablets
Palpitations
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 PER WEEK
ORAL
Date:06/08/98ISR Number: 3159699-2Report Type:Periodic Company Report #84462 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Health Lariam Tablets (
Palpitations Professional Mefloquine
Flashback
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL

Date:06/08/98ISR Number: 3159701-8Report Type:Periodic Company Report #84488 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Other Lariam Tablets
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
03-Apr-2012 09:37 AM Page: 47

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159702-XReport Type:Periodic Company Report #84805 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dermatitis Exfoliative Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL ORAL
Date:06/08/98ISR Number: 3159703-1Report Type:Periodic Company Report #84870 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam Tablets
Diarrhoea
(Mefloquine
Asthenia Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Estrogen (Estrogens
Nos)
C
Date:06/08/98ISR Number: 3159705-5Report Type:Periodic Company Report #84928 Age:55 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Sectral (Acebutolol) C
Date:06/08/98ISR Number: 3159707-9Report Type:Periodic Company Report #84953 Age:57 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Pressure Increased Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159709-2Report Type:Periodic Company Report #84991 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Dyspnoea Other Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
03-Apr-2012 09:37 AM Page: 48

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3159710-9Report Type:Periodic Company Report #85215 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam Tablets
Headache
(Mefloquine
Dizziness Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159711-0Report Type:Periodic Company Report #85238 Age:55 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Feeling Abnormal Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS OCCLUSIVE
DRESSING
250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159712-2Report Type:Periodic Company Report #85358 Age:57 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Pressure Systolic Consumer Lariam Tablets
Decreased
(Mefloquine
Eye Irritation
Hydrochloride)
Nausea 250.000 Mg PS ORAL 250.0000 MG
Insomnia
1.0 X PER
Conjunctivitis Allergic
WEEK ORAL
Date:06/08/98ISR Number: 3159714-6Report Type:Periodic Company Report #85373 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159716-XReport Type:Periodic Company Report #85494 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psoriasis Other Lariam Tablets
Abnormal Dreams
(Mefloquine
Pruritus Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER

WEEK ORAL
03-Apr-2012 09:37 AM Page: 49

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3159719-5Report Type:Periodic Company Report #85538 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Metrorrhagia Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Synthroid
(Levothyroxine
Sodium)
C
Date:06/08/98ISR Number: 3159721-3Report Type:Periodic Company Report #85602 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Ecchymosis Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Cipro (Ciprofloxacin
Hydrochloride) C
Date:06/08/98ISR Number: 3159722-5Report Type:Periodic Company Report #85669 Age:48 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Other Lariam Tablets
Decreased Appetite
(Mefloquine
Hydrochloride) PS ORAL 0.5000 DOSE
FORM 1.0 X
PER WEEK ORAL
Date:06/08/98ISR Number: 3159725-0Report Type:Periodic Company Report #85699 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Oligomenorrhoea Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Hepatitis Vaccine
(Hepatitis Vaccine) C
Typhoid Vaccine
(Typhoid Vaccines) C
Polio Vaccination
(Poliomyelitis
Vaccines)
C

Amoxicillin
(Amoxicillin)
Anaprox (Naproxen
Sodium)
C
C
03-Apr-2012 09:37 AM Page: 50

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3159726-2Report Type:Periodic Company Report #85807 Age:3 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Urticaria Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159727-4Report Type:Periodic Company Report #85892 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dermatitis Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
Contraceptives
(Contraceptives)
C
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159729-8Report Type:Periodic Company Report #86520 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Chills Health Lariam Tablets
Pyrexia Professional (Mefloquine
Myalgia Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159730-4Report Type:Periodic Company Report #86747 Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Emotional Disorder Other Lariam Tablets
Aggression
(Mefloquine
Abnormal Dreams Hydrochloride) PS ORAL 250.0000 MG
Crying
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3159731-6Report Type:Periodic Company Report #86858 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Alopecia Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER

WEEK ORAL
03-Apr-2012 09:37 AM Page: 51

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3159732-8Report Type:Periodic Company Report #87231 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pruritus Health Lariam Tablets
Rash Maculo-Papular Professional (Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Ortho-Novum (Ethinyl
Estradiol Or
Menstranol/
Norethindrone) C
Date:06/08/98ISR Number: 3159734-1Report Type:Periodic Company Report #87256 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Flushing Consumer Lariam Tablets
Insomnia
(Mefloquine
Hydrochloride) PS ORAL 125.0000 MG
2.0 X PER
WEEK ORAL 49 DAY
Zantac (Ranitidine) C
Vivelle Transdermal
System (Estradiol) C
Date:06/08/98ISR Number: 3160383-XReport Type:Periodic Company Report #87379 Age:68 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Consumer Lariam Tablets
Insomnia Health (Mefloquine
Dizziness Professional Hydrochloride)
Nausea 250.000 Mg PS ORAL 250.000 MG
Nasal Congestion
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3160387-7Report Type:Periodic Company Report #87446 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Iron Increased Consumer Lariam Tablets
Hepatomegaly
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL

Date:06/08/98ISR Number: 3160390-7Report Type:Periodic Company Report #87479 Age:41 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Health Lariam Tablets
Nausea Professional (Mefloquine
Hair Disorder
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 PER WEEK
03-Apr-2012 09:37 AM Page: 52

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
ORAL
Date:06/08/98ISR Number: 3160394-4Report Type:Periodic Company Report #87727 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blindness Other Lariam Tablets
Deafness
(Mefloquine
Hydrochloride) PS ORAL ORAL
Date:06/08/98ISR Number: 3160396-8Report Type:Periodic Company Report #87777 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspepsia Consumer Lariam Tablets
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 1.0 PER
WEEK ORAL
Demulen
C
Date:06/08/98ISR Number: 3160398-1Report Type:Periodic Company Report #87993 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pollakiuria Health Lariam Tablets
Thirst Professional (Mefloquine
Hydrochloride) 250.
000 Mg PS ORAL 250.000 MG
1.0 PER WEEK
ORAL
Date:06/08/98ISR Number: 3160401-9Report Type:Periodic Company Report #87999 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Consumer Lariam Tablets
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3160403-2Report Type:Periodic Company Report #88273 Age:65 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vertigo Health Lariam Tablets

Professional (Mefloquine
Hydrochloride) 250.
000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
03-Apr-2012 09:37 AM Page: 53

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3160405-6Report Type:Periodic Company Report #88393 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tremor Consumer Lariam Tablets
Dizziness
(Mefloquine
Lymphadenopathy
Hydrochloride)
Irritability 250.00 Mg PS ORAL 250.000 MG
Nausea
1.0 PER WEEK
Headache
ORAL
Cipro
C
Nordette
C
Date:06/08/98ISR Number: 3160406-8Report Type:Periodic Company Report #89194 Age:34 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Consumer Lariam Tablets
(Mefloquine
Hydrochloride) 250.
000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3160409-3Report Type:Periodic Company Report #89203 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspepsia Consumer Lariam Tablets
Nightmare
(Mefloquine
Insomnia
Hydrochloride)
Headache 250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3160410-XReport Type:Periodic Company Report #89287 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3160412-3Report Type:Periodic Company Report #89617 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Vomiting Consumer Lariam Tablets
Pyrexia
(Mefloquine
Panic Attack
Hydrochloride)
Decreased Appetite 250.000 Mg PS ORAL 250.00 MG 1.0
Dizziness
X PER WEEK
Disturbance In Attention
ORAL
Ortho Novum
C
Hepatitis Vaccine C
03-Apr-2012 09:37 AM Page: 54

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Valium
General Anesthesia
Lortab
Erytromycin
C
C
C
C
Date:06/08/98ISR Number: 3160413-5Report Type:Periodic Company Report #90262 Age:63 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Consumer Lariam Tablets
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Estrace
C
Prilosec
C
Date:06/08/98ISR Number: 3175254-2Report Type:Periodic Company Report #90313 Age:15 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Health Lariam Tablets
Insomnia Professional (Mefloquine
Hydrochloride)
250.00 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3175260-8Report Type:Periodic Company Report #90406 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Emotional Disorder Literature Lariam Tablets
Anxiety Consumer (Mefloquine
Hydrochloride)
250.00 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK, ORAL
Synthroid
C
Date:06/08/98ISR Number: 3175262-1Report Type:Periodic Company Report #91164 Age:69 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viral Infection Consumer Lariam Tablets
Dyspepsia
(Mefloquine
Tachycardia
Hydrochloride)
Tremor 250.00 Mg PS ORAL 250.000 MG

Pyrexia 1.0 X PER
WEEK, ORAL
Glucophage
C
Glyburide
C
Flu Shot
C
Lotensin
C
03-Apr-2012 09:37 AM Page: 55

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3175264-5Report Type:Periodic Company Report #91344 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Consumer Lariam Tablets
Diarrhoea
(Mefloquine
Crying
Hydrochloride)
Dysphoria 250.00 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK, ORAL
Date:06/08/98ISR Number: 3175267-0Report Type:Periodic Company Report #91417 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Other Lariam Tablets
Pressure Of Speech
(Mefloquine
Restlessness
Hydrochloride)
Paranoia 250.00 Mg PS ORAL 250.00 MG 1.0
X PER WEEK,
ORAL
Date:06/08/98ISR Number: 3175269-4Report Type:Periodic Company Report #91527 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Menstruation Irregular Consumer Lariam Tablets
(Mefloquine
Hydrochloride)
250.00 Mg PS ORAL 250.0000 MG
1.0 PER WEEK,
ORAL
Vitamin C
C
Date:06/08/98ISR Number: 3175271-2Report Type:Periodic Company Report #91582 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Consumer Lariam Tablets
Heart Rate Increased
(Mefloquine
Insomnia Hydrochloride) 250
Anxiety Mg PS ORAL 250 MG 1.0 X
PER WEEK,
ORAL
Ortho-Novum 7/7/7 C
Date:06/08/98ISR Number: 3175273-6Report Type:Periodic Company Report #91731 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Restlessness Other Lariam Tablets
Nausea
(Mefloquine
Diarrhoea
Hydrochloride)
Dyspepsia 250.00 Mg PS ORAL 250.00 MG 1.0
Flatulence
X PER WEEK,
Dermatitis
ORAL
Dizziness
03-Apr-2012 09:37 AM Page: 56

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3175275-XReport Type:Periodic Company Report #92041 Age:56 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Prothrombin Time Other Lariam Tablets
Prolonged
(Mefloquine
Hydrochloride)
250.00 Mg PS ORAL 250.00 MG 1.0
PER WEEK,
ORAL
Coumadin
C
Date:06/08/98ISR Number: 3175277-3Report Type:Periodic Company Report #92512 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam Tablets
Diarrhoea
(Mefloquine
Hydrochloride)
250.00 Mg PS ORAL 250.00 MG 1.0
X PER WEEK,
ORAL
Date:06/08/98ISR Number: 3175279-7Report Type:Periodic Company Report #92525 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Health Lariam Tablets
Insomnia Professional (Mefloquine
Visual Acuity Reduced
Hydrochloride)
Paraesthesia 250.00 Mg PS ORAL 250.00 MG 1.0
Thinking Abnormal
X PER ODOS,
Hallucination
ORAL
Date:06/08/98ISR Number: 3175282-7Report Type:Periodic Company Report #92697 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Health Lariam Tablets
Nausea Professional (Mefloquine
Emotional Disorder
Hydrochloride)
Amoebic Dysentery 250.00 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Flagyl
C
Date:06/08/98ISR Number: 3175284-0Report Type:Periodic Company Report #92713 Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Anxiety Consumer Lariam Tablets
Insomnia
(Mefloquine
Hydrochloride)
250.00 Mg PS ORAL 250.00 MG 1.0
X PER WEEK
ORAL
03-Apr-2012 09:37 AM Page: 57

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3175286-4Report Type:Periodic Company Report #92738 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Consumer Lariam Tablets
(Mefloquine
Hydrochloride)
250.00 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK, ORAL
Date:06/08/98ISR Number: 3175288-8Report Type:Periodic Company Report #92825 Age:13 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vomiting Other Lariam Tablets
Agitation
(Mefloquine
Dizziness
Hydrochloride)
Photosensitivity Reaction 250.00 Mg PS ORAL 250.000 MG
Insomnia
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3175290-6Report Type:Periodic Company Report #93510 Age:41 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Arthralgia Consumer Lariam Tablets
Myalgia
(Mefloquine
Hydrochloride)
250.00 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK, ORAL
Date:06/08/98ISR Number: 3175291-8Report Type:Periodic Company Report #93511 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Chromaturia Consumer Lariam Tablets
(Mefloquine
Hydrochloride)
250.00 Mg PS ORAL 250.00 MG 1.0
X PER WEEK,
ORAL
Ortho-Novum 1/35 C
Date:06/08/98ISR Number: 3175292-XReport Type:Periodic Company Report #93513 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Laryngitis Consumer Lariam Tablets

Health (Mefloquine
Professional
Hydrochloride)
250.00 Mg PS ORAL 250.00 MG 1.0
X PER WEEK
ORAL
Amoxycillin
C
03-Apr-2012 09:37 AM Page: 58

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3175294-3Report Type:Periodic Company Report #93921 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Syncope Other Lariam Tablets
Abdominal Pain
(Mefloquine
Dizziness
Hydrochloride)
Vomiting 250.00 Mg PS ORAL 250.00 MG 1.0
X PER ODOS,
ORAL
Date:06/08/98ISR Number: 3175296-7Report Type:Periodic Company Report #93923 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Health Lariam Tablets
Anxiety Professional (Mefloquine
Nervousness Hydrochloride) 250
Mg PS ORAL 250.00 MG 1.0
X PER WEEK
ORAL
Date:06/08/98ISR Number: 3179135-XReport Type:Periodic Company Report #76339 Age:54 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Neurogenic Bladder Health Lariam Tablets
Pollakiuria Professional (Mefloquine
Micturition Urgency
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3179137-3Report Type:Periodic Company Report #77417 Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL ORAL
Typhoid Vaccine
(Thphoid Vaccines) C
Dramamine
(Dimenhydrinate) C
Measles, Mumps, &
Rubella Vaccine
(Measles Virus
Vaccine Live/Mumps
Virus Vaccine
C

Date:06/08/98ISR Number: 3179139-7Report Type:Periodic Company Report #78055 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Health Lariam Tablets
Hypoaesthesia Oral Professional (Mefloquine
Headache
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
03-Apr-2012 09:37 AM Page: 59

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3179140-3Report Type:Periodic Company Report #80073 Age:10 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Sedation Other Lariam Tablets
Petit Mal Epilepsy
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK, ORAL
Date:06/08/98ISR Number: 3179141-5Report Type:Periodic Company Report #80172 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Prostatic Specific Health Lariam Tablets
Antigen Increased Professional (Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK, ORAL
Hytrin (Terazosin
Hydrochloride) C
Date:06/08/98ISR Number: 3179143-9Report Type:Periodic Company Report #80199 Age:56 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Other Lariam Tablets
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK, ORAL
Accupril (Quinapril
Hydrochloride) C
Prempro (Estrogens,
Conjugated/Medroxypr
ogesterone Acetate) C
Date:06/08/98ISR Number: 3179145-2Report Type:Periodic Company Report #80216 Age:65 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam Tablets
Abdominal Pain Upper
(Mefloquine
Muscle Spasms
Hydrochloride)

250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK, ORAL
Klonopin
(Clonazepam)
C
Ritalin
(Methylphenidate
Hydrochloride) C
03-Apr-2012 09:37 AM Page: 60

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Inderal (Propranolol
Hydrochloride)
Paxil (Paroxetine)
C
C
Date:06/08/98ISR Number: 3179146-4Report Type:Periodic Company Report #96623 Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Alopecia Consumer Lariam Tablets
Depression Other (Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3179147-6Report Type:Periodic Company Report #97072 Age:69 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abdominal Pain Upper Consumer Lariam Tablets
Blood Cholesterol
(Mefloquine
Increased Hidrochloride) 250.
000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL 42 DAY
Lipitor
(Atorvastatin
Calcium) SS ORAL ORAL
Hepatitis Injection
(Hepatitis Injection
Nos)
C
Calcium (Calcium
Nos)
C
Magnesium (Magnesium
Nos)
C
Glucosamine Sulfate
(Glucosamine
Sulfate)
C
Vitamin E (Vitamin
E) C
Multivitamins
(Multivitamin Nos) C
Vitamin C (Ascorbid
Acid)
C
Date:06/08/98ISR Number: 3179148-8Report Type:Periodic Company Report #97208 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Health Lariam Tablets

Professional (Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER DAY
ORAL
Kaolin (Kaolin) C
03-Apr-2012 09:37 AM Page: 61

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3179149-XReport Type:Periodic Company Report #97647 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dermatitis Consumer Lariam Tablets
Pruritus
(Mefloquine
Flushing
Hydrochloride)
Rhinorrhoea 250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Premarin (Estrogens,
Conjugated)
C
Date:06/08/98ISR Number: 3179150-6Report Type:Periodic Company Report #97681 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam Tablets
Thinking Abnormal
(Mefloquine
Fatigue
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3179151-8Report Type:Periodic Company Report #63751 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Consumer Lariam Tablets
Initial or Prolonged Nausea (Mefloquine
Disability Vertigo Hydrochloride) PS ORAL ORAL
Visual Impairment
Depression
Decreased Appetite
Anxiety
Date:06/08/98ISR Number: 3179152-XReport Type:Periodic Company Report #67732 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucinations, Mixed Health Lariam Tablets
Initial or Prolonged Professional (Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3179153-1Report Type:Periodic Company Report #54965 Age:51 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Urticaria Consumer Lariam Tablets
Abnormal Dreams User Facility (Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Cotrim
03-Apr-2012 09:37 AM Page: 62

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Sulfamethoxazole/Tr
imethoprim)
C
Date:06/08/98ISR Number: 3179154-3Report Type:Periodic Company Report #62060 Age:64 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam Tablets
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3179155-5Report Type:Periodic Company Report #74666 Age:53 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Estrogens Nos
(Estrogens Nos) C
Date:06/08/98ISR Number: 3179156-7Report Type:Periodic Company Report #77480 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nervousness Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3179157-9Report Type:Periodic Company Report #78054 Age:34 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Exfoliative Rash Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.000 MG
1.0 X PER
WEEK ORAL
Metakelfin
(Pyrimethamine/Sulfa
lene) SS ORAL ORAL

Date:06/08/98ISR Number: 3179158-0Report Type:Periodic Company Report #81052 Age:75 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pruritus Health Lariam Tablets
Professional
(Mefloquine
03-Apr-2012 09:37 AM Page: 63

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3179159-2Report Type:Periodic Company Report #94231 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Consumer Lariam Tablets
Dermatitis
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK
Date:06/08/98ISR Number: 3179160-9Report Type:Periodic Company Report #94304 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vestibular Disorder Health Lariam Tablets
Dizziness Professional (Mefloquine
Tinnitus Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER DAY
Date:06/08/98ISR Number: 3179161-0Report Type:Periodic Company Report #94510 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK
Date:06/08/98ISR Number: 3179162-2Report Type:Periodic Company Report #95230 Age:61 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL 250.0000 M
1.0 X PER
WEEK
Amlodipine
(Amlodipine
Besylate)
C
Cozaar (Losartan
Potassium)
C

Date:06/08/98ISR Number: 3179163-4Report Type:Periodic Company Report #95668 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL
03-Apr-2012 09:37 AM Page: 64

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3179165-8Report Type:Periodic Company Report #95731 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Impairment Health Lariam Tablets
Dizziness Professional (Mefloquine
Depression Hydrochloride) PS ORAL 250.0000 MG
Insomnia
1.0 X PER
Gait Disturbance
WEEK
Cough
Confusional State
Date:06/08/98ISR Number: 3179166-XReport Type:Periodic Company Report #96253 Age:64 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Flushing Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK
Synthroid
(Levothyroxine
Sodium)
C
Date:06/08/98ISR Number: 3179167-1Report Type:Periodic Company Report #96289 Age:57 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Palpitations Health Lariam Tablets
Dizziness Professional (Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK
Date:06/08/98ISR Number: 3179168-3Report Type:Periodic Company Report #96334 Age:41 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Consumer Lariam Tablets
Anxiety
(Mefloquine
Depression Hydrochloride) PS ORAL 250.000 MG
Disturbance In Attention
1.0 X PER
Chills
WEEK
Insomnia Paxil (Paroxetine) C
Confusional State
Flushing
Dizziness

Date:06/08/98ISR Number: 3179169-5Report Type:Periodic Company Report #96379 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 8 DAY
03-Apr-2012 09:37 AM Page: 65

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3179170-1Report Type:Periodic Company Report #96418 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Feeling Cold Other Lariam Tablets
Flushing
(Mefloquine
Nausea Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK
Date:06/08/98ISR Number: 3179171-3Report Type:Periodic Company Report #96622 Age:51 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscle Spasms Other Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 PER WEEK
Date:06/08/98ISR Number: 3179172-5Report Type:Periodic Company Report #80314 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscular Weakness Other Lariam Tablets
Syncope
(Mefloquine
Pallor
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK, ORAL
Date:06/08/98ISR Number: 3179174-9Report Type:Periodic Company Report #80475 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride)
250.000 Mg PS ORAL 250.0000 MG
1.0 X PER
WEEK, ORAL 49 DAY
Date:06/08/98ISR Number: 3179175-0Report Type:Periodic Company Report #80485 Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam Tablets
Nightmare Health (Mefloquine
Neuropathy Peripheral Professional Hydrochloride) PS ORAL 250.0000 MG
Confusional State
1.0 X PER
Palpitations
WEEK, ORAL

Birth Control Pills
(Oral Contraceptive
Nos)
C
03-Apr-2012 09:37 AM Page: 66

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3179968-XReport Type:Periodic Company Report #77585 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypoaesthesia Other Lariam Tablets
Malaria
(Mefloquine
Nausea Hydrochloride) PS ORAL 250.0000 MG
Dysgeusia
1.O X PER
Sunburn
WEEK ORAL
Headache
Abdominal Pain
Diarrhoea
Sensory Disturbance
Paraesthesia
Date:06/08/98ISR Number: 3179969-1Report Type:Periodic Company Report #80918 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Encephalopathy Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL ORAL
Date:06/08/98ISR Number: 3179970-8Report Type:Periodic Company Report #80968 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Epilepsy Consumer Lariam Tablets
Diarrhoea
(Mefloquine
Chills Hydrochloride) PS ORAL 250.0000 MG
Glossodynia
1.0 X PER
Loss Of Consciousness
WEEK ORAL
Hepatic Function Abnormal
Imipramine
Headache
(Imipramine
Pyrexia Hydrochloride) C
Platelet Count Decreased
Premarin (Estrogens,
Conjugated)
C
Date:06/08/98ISR Number: 3179971-XReport Type:Periodic Company Report #81879 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Health Lariam Tablets
Initial or Prolonged Productive Cough Professional (Mefloquine
Aspartate Hydrochloride) PS ORAL 250.000 MG
Aminotransferase
1.0 X PER
Increased
WEEK ORAL
Chills
Pulmonary Congestion

Date:06/08/98ISR Number: 3179972-1Report Type:Periodic Company Report #82256 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Consumer Lariam Tablets
Initial or Prolonged
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
03-Apr-2012 09:37 AM Page: 67

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Robitussin
(Guaifenesin)
Premarin (Estrogens,
Conjugated)
C
C
WEEK ORAL
Date:06/08/98ISR Number: 3179973-3Report Type:Periodic Company Report #83032 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER DAY
ORAL
Date:06/08/98ISR Number: 3179974-5Report Type:Periodic Company Report #84444 Age:18 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Other Lariam Tablets
Initial or Prolonged Diarrhoea (Mefloquine
Pyrexia Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Luvox (Fluvoxamine) SS
Date:06/08/98ISR Number: 3179975-7Report Type:Periodic Company Report #85156 Age:69 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dermatitis Consumer Lariam Tablets
Erythema Multiforme Health (Mefloquine
Professional Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Oruvail (Ketoprofen) SS ORAL ORAL
Fosamax (Alendronate
Sodium)
C
Mevacor (Lovastatin) C
Date:06/08/98ISR Number: 3179976-9Report Type:Periodic Company Report #86443 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Neuropathy Peripheral Health Lariam Tablets
Paraesthesia Professional (Mefloquine
Pain Hydrochloride) PS ORAL 250.0000 MG
Tonic Convulsion
1.0 X PER
Hypoaesthesia
WEEK ORAL

Propulsid
(Cisapride)
Proscar
(Finasteride)
C
C
03-Apr-2012 09:37 AM Page: 68

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3179977-0Report Type:Periodic Company Report #86526 Age:15 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Health Lariam Tablets
Initial or Prolonged Major Depression Professional (Mefloquine
Mood Altered Other Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3179978-2Report Type:Periodic Company Report #90808 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Consumer Lariam Tablets
Aggression Health (Mefloquine
Confusional State Professional Hydrochloride) PS ORAL 250.0000 MG
Tinnitus
1.0 X PER
Fatigue
WEEK ORAL
Depression
Nightmare
Hallucination
Date:06/08/98ISR Number: 3179979-4Report Type:Periodic Company Report #92025 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypoaesthesia Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/08/98ISR Number: 3179980-0Report Type:Periodic Company Report #92026 Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER DAY
ORAL
Ambien (Zolpidem
Tartrate)
C
Norvasc (Amlodipine
Besylate)
C
Alcohol (Alcohol) C
Date:06/08/98ISR Number: 3179981-2Report Type:Periodic Company Report #92537 Age:46 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Pressure Increased Consumer Lariam Tablets
Visual Impairment
(Mefloquine
Hyperventilation Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
03-Apr-2012 09:37 AM Page: 69

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3179982-4Report Type:Periodic Company Report #94951 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chills Consumer Lariam Tablets
Initial or Prolonged Chest Pain Health (Mefloquine
Diarrhoea Professional Hydrochloride) PS ORAL 250.0000 MG
Nausea
1.0 X PER
Malaise
WEEK ORAL
Anxiety
Palpitations
Date:06/08/98ISR Number: 3179983-6Report Type:Periodic Company Report #96220 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mania Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL ORAL
Date:06/08/98ISR Number: 3179984-8Report Type:Periodic Company Report #74928 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Acuity Reduced Consumer Lariam Tablets
Coordination Abnormal
(Mefloquine
Tremor Hydrochloride) PS ORAL 250.0000 MG
Muscle Contractions
1.0 X PER
Involuntary
WEEK ORAL
Date:06/08/98ISR Number: 3179985-XReport Type:Periodic Company Report #75973 Age:9 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Arthralgia Consumer Lariam Tablets
Upper Respiratory Tract
(Mefloquine
Infection Hydrochloride) PS ORAL 187.5000 MG
Dermatitis
1.0 X PER
WEEK ORAL
Imodium (Loperamide
Hydrochloride) C
Augmentin
(Amoxicillin/Clavula
nate Potassium) C
Date:06/08/98ISR Number: 3179986-1Report Type:Periodic Company Report #76016 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Consumer Lariam Tablets

(Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
03-Apr-2012 09:37 AM Page: 70

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/98ISR Number: 3179987-3Report Type:Periodic Company Report #76173 Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dermatitis Health Lariam Tablets
Pruritus Professional (Mefloquine
Hydrochloride) PS ORAL 250.0000 MG
1.0 X PER
WEEK ORAL
Date:06/09/98ISR Number: 3091276-4Report Type:Expedited (15-DaCompany Report #99832 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pneumonitis Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Other PER ONE DOSE
ORAL
Havrix (Hepatitis A
Vaccine)
C
Date:06/09/98ISR Number: 3091279-XReport Type:Expedited (15-DaCompany Report #99823 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maculopathy Foreign Lariam PS ORAL 250 MG 1 X
Other
PER WEEK ORAL
Scopolamine
(Scopolamine
Hydrobromide)
C
Date:06/09/98ISR Number: 3091862-1Report Type:Expedited (15-DaCompany Report #99981 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pneumonitis Health Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Professional PER WEEK ORAL
Date:06/09/98ISR Number: 3091863-3Report Type:Expedited (15-DaCompany Report #98430 Age:72 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pulmonary Fibrosis Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Dyspnoea Health PER WEEK ORAL
Professional Naproxen C
Date:06/09/98ISR Number: 3091876-1Report Type:Expedited (15-DaCompany Report #99913 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Agitation Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Nightmare Other PER WEEK ORAL
Paranoia Cannabis C
Influenza Like Illness
03-Apr-2012 09:37 AM Page: 71

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/10/98ISR Number: 3092795-7Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Memory Impairment Larium PS AS PRESCRIBED
Hospitalization - Decompression Sickness
Initial or Prolonged
Required
Intervention to
Prevent Permanent
Impairment/Damage
Date:06/11/98ISR Number: 3092547-8Report Type:Expedited (15-DaCompany Report #88780 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Premature Baby Foreign Lariam PS ORAL 250 MG 1 X
Cervical Incompetence Health PER WEEK ORAL
Haematoma
Professional
Vaginal Infection
Vaginal Haemorrhage
Premature Labour
Date:06/16/98ISR Number: 3094153-8Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disorientation Lariam PS ONCE A WEEK 6 WK
Initial or Prolonged Panic Attack
Required
Suicidal Ideation
Intervention to
Myocardial Infarction
Prevent Permanent Headache
Impairment/Damage Depression
Date:06/16/98ISR Number: 3094934-0Report Type:Expedited (15-DaCompany Report #94569 Age:12 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Prophylaxis Health Lariam PS ORAL ORAL
Anxiety
Professional
Panic Attack
Emotional Disorder
Obsessive-Compulsive
Disorder
Date:06/16/98ISR Number: 3094936-4Report Type:Expedited (15-DaCompany Report #65435 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Consumer Lariam PS ORAL 250MG 1XPER

Apathy Health WEEK ORAL
Hallucination
Professional
Mental Impairment
Pain
Lethargy
03-Apr-2012 09:37 AM Page: 72

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/19/98ISR Number: 3096992-6Report Type:Expedited (15-DaCompany Report #98742 Age:39 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myocardial Infarction Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Health PER WEEK
Professional
Date:06/19/98ISR Number: 3097002-7Report Type:Expedited (15-DaCompany Report #100462 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Carpal Tunnel Syndrome Foreign Lariam PS ORAL 250 MG 1 X
Arthralgia Consumer PER WEEK ORAL
Myalgia
Date:06/23/98ISR Number: 3097532-8Report Type:Expedited (15-DaCompany Report #98486 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hearing Impaired Foreign Lariam PS ORAL 250 MG 1 X
Audiogram Abnormal Health PER WEEK
Vestibular Disorder Professional ORAL
Dizziness
Date:06/29/98ISR Number: 3100448-1Report Type:Expedited (15-DaCompany Report #101184 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Foreign Lariam PS ORAL 250 MG 1 X
Health
PER WEEK ORAL
Professional
Date:06/29/98ISR Number: 3102153-4Report Type:Periodic Company Report #7395898 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Interaction Health Norvir PS ORAL 300.000 MG PO
Vision Blurred Professional BID
Dizziness Company Lariam SS
Representative Zovirax C
Other Dt4 C
Ddi
C
Lariam
C
Date:07/02/98ISR Number: 3101371-9Report Type:Expedited (15-DaCompany Report #101337 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Viith Nerve Paralysis Foreign Lariam PS ORAL 250 MG X 1
Health
PER WEEK
Professional
ORAL
03-Apr-2012 09:37 AM Page: 73

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/02/98ISR Number: 3101373-2Report Type:Expedited (15-DaCompany Report #96761 Age:41 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nephrolithiasis Consumer Lariam PS ORAL 250 MG 1 X
Haemangioma Of Liver
PER WEEK ORAL
Infection Parasitic
Tetanus Booster
(Tetanus Toxoid) C
Polio Booster
(Poliomyelitis
Vaccines)
C
Hepatitis A Vaccine C
Hepatitis B Vaccine C
Date:07/02/98ISR Number: 3101779-1Report Type:Expedited (15-DaCompany Report #98097 Age:37 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Foreign Lariam PS ORAL 250 MG 1 X
Depression Health PER WEEK ORAL
Abnormal Behaviour
Professional
Other
Date:07/07/98ISR Number: 3102623-9Report Type:Expedited (15-DaCompany Report #101725 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disorientation Foreign Lariam PS ORAL 6 DOSE FORM
Dyslexia Health DAILY ORAL
Headache Professional Chloroquine
Aphasia (Choroquine) C
Dizziness
Toxicity To Various
Agents
Date:07/13/98ISR Number: 3104477-3Report Type:Expedited (15-DaCompany Report #74171 Age:47 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paresis Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Dizziness Health PER ONE DOSE
Required Ileus Paralytic Professional ORAL
Intervention to Guillain-Barre Syndrome Other Epaxal SS INTRAMUSCULAR .5 ML 1 X PER
Prevent Permanent Gait Disturbance ONE DOSE
Impairment/Damage Abdominal Distension INTRAMUSCULAR
Insomnia Arilvax SS SUBCUTANEOUS .5 ML 1 X PER
Gastrointestinal Disorder
ONE DOSE
SUBCUTANEOUS

Date:07/13/98ISR Number: 3105539-7Report Type:Expedited (15-DaCompany Report #98430 Age:72 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyspnoea Foreign Lariam PS ORAL 250 MG 1XPER
Initial or Prolonged Pulmonary Fibrosis Health WEEK ORAL
Professional Naproxen C
03-Apr-2012 09:37 AM Page: 74

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/17/98ISR Number: 3106187-5Report Type:Expedited (15-DaCompany Report #102436 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Foreign Lariam PS
Fatigue
Consumer
Chest Pain
Pain In Extremity
Dyspnoea
Date:07/23/98ISR Number: 3109359-9Report Type:Direct Company Report #4-756-039-6 Age:67 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Fatigue Accolate PS
Arthralgia Lariam SS
Allergic Granulomatous Dyazide C
Angiitis Prednisone C
Gait Disturbance
Myalgia
Granuloma
Date:07/24/98ISR Number: 3109393-9Report Type:Expedited (15-DaCompany Report #96767 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Retinal Detachment Health Lariam PS ORAL 250 MG 1 X
Eye Pain Professional PER WEEK
Hyperhidrosis Other ,ORAL
Malaria
Chills
Intraocular Pressure
Increased
Pyrexia
Date:07/29/98ISR Number: 3110717-7Report Type:Expedited (15-DaCompany Report #100462 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Myalgia Foreign Lariam PS ORAL 250 MG 1 X
Arthralgia Consumer PER WEEK
Paraesthesia
Carpal Tunnel Syndrome
Date:07/29/98ISR Number: 3113067-8Report Type:Direct Company Report # Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Rash Vesicular Lariam PS ORAL PO 1/WEEK 1 WK
Intervention to
Scar

Prevent Permanent
Impairment/Damage
Insomnia
Haemorrhage
Erythema
Wound Secretion
Dermatitis Exfoliative
Pruritus
Discomfort
03-Apr-2012 09:37 AM Page: 75

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/29/98ISR Number: 3123285-0Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Palpitations Larium PS Roche ORAL 250 MG ORAL
Initial or Prolonged Anxiety ONCE PER WEEK
Restlessness
Date:08/03/98ISR Number: 3112339-0Report Type:Expedited (15-DaCompany Report #103417 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Foreign Lariam PS ORAL 250 MG DAILY
Gastrointestinal Consumer ORAL
Hypermotility
Restlessness
Muscular Weakness
Alopecia
Decreased Appetite
Periorbital Oedema
Anxiety
Feeling Abnormal
Oedema
Psychotic Disorder
Abnormal Dreams
Memory Impairment
Lethargy
Date:08/14/98ISR Number: 3117013-2Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Mefloquine PS ORAL 250 MG PO Q
Diarrhoea
1T WEEK
Vomiting Lariam SS
Vertigo
Anxiety
Date:08/18/98ISR Number: 3118491-5Report Type:Expedited (15-DaCompany Report #101725 Age:40 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Foreign Lariam PS ORAL 6 DOSE FORM
Headache Health DAILY ORAL
Disorientation Professional Chloroquine
Dyslexia (Chloroquine) C
Aphasia
Toxicity To Various
Agents

Date:08/19/98ISR Number: 3118885-8Report Type:Expedited (15-DaCompany Report #90892 Age:28 YR Gender:Female I/FU:I
Outcome
Congenital Anomaly
PT
Feeding Disorder Neonatal
Maternal Drugs Affecting
Foetus
Congenital Jaw
03-Apr-2012 09:37 AM Page: 76

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Malformation
Dysmorphism
Report Source Product Role Manufacturer Route Dose Duration
Foreign Lariam PS ORAL 250 MG 1 X
Health
PER WEEK ORAL
Professional
Date:08/19/98ISR Number: 3118889-5Report Type:Expedited (15-DaCompany Report #104255 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Congenital Foreign Lariam PS ORAL 250 MG 1 X
Musculoskeletal Anomaly Health PER WEEK ORAL
Cholestasis
Professional
Dysmorphism
Maternal Drugs Affecting
Foetus
Premature Labour
Liver Function Test
Abnormal
Date:09/02/98ISR Number: 3124912-4Report Type:Expedited (15-DaCompany Report #104882 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Confusional State Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Anxiety Consumer PER WEEK
Dizziness
ORAL
Tachycardia
Arrhythmia
Convulsion
Cardiovascular Disorder
Balance Disorder
Restlessness
Circulatory Collapse
Ventricular Extrasystoles
Asthenia
Date:09/02/98ISR Number: 3124913-6Report Type:Expedited (15-DaCompany Report #104935 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Maternal Drugs Affecting Foreign Lariam PS ORAL 250 MG 1 X
Foetus Health PER WEEK ORAL
Cleft Palate
Professional
Date:09/04/98ISR Number: 3125941-7Report Type:Expedited (15-DaCompany Report #105053 Age:27 YR Gender:Female I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
PT
Tachycardia
Panic Attack
Nausea
Dizziness
Bradycardia
Insomnia
Palpitations
03-Apr-2012 09:37 AM Page: 77

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depression
Report Source Product Role Manufacturer Route Dose Duration
Foreign Lariam PS ORAL 250 MG 1 X
Other
PER WEEK;
ORAL
Date:09/04/98ISR Number: 3126058-8Report Type:Expedited (15-DaCompany Report #104663 Age:55 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Osteoarthritis Health Lariam PS ORAL 250 MG 1 X
Disturbance In Attention Professional PER WEEK ORAL
Joint Swelling
Typhoid Vaccine
Arthralgia (Typhoid Vaccines) SS INTRAMUSCULAR 1 X PER ONE
Fatigue
DOSE
Serum Sickness
INTRAMUSCULAR
Anxiety
Date:09/10/98ISR Number: 3128393-6Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Mefloquine PS ORAL 250MG/WEEK
Depression
ORAL
Anxiety
Hearing Impaired
Aggression
Fatigue
Hallucination
Date:09/14/98ISR Number: 3128291-8Report Type:Expedited (15-DaCompany Report #105284 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicide Attempt Foreign Lariam PS ORAL 250 MG, 750
Hospitalization - Depression Health MG 1 X PER
Initial or Prolonged Restlessness Professional ONE DOSE ORAL
Insomnia
Tranxilium
(Colorazepate
Dipotassium)
C
Atosil (Promethazine
Hydrochloride) C
Resochin
(Chloroquine
Phosphate)
C
Date:09/25/98ISR Number: 3135453-2Report Type:Expedited (15-DaCompany Report #105895 Age:27 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Arrested Labour Foreign Lariam PS ORAL 250 MG 1 X
Intervention to Maternal Drugs Affecting Health PER WEEK ORAL
Prevent Permanent Foetus Professional Clarityne
Impairment/Damage (Loratadine) C
Engerix B (Hepatitis
B Virus Vaccine
03-Apr-2012 09:37 AM Page: 78

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Inactivated)
Atarax (Hydroxyzine
Hydrochloride)
Typhim (Typhoif
Vaccines)
Dpt (Diphteria
Toxoid/Pertussis
Vaccine/Tetaus
Toxoid)
C
C
C
C
Date:09/30/98ISR Number: 3136796-9Report Type:Expedited (15-DaCompany Report #106188 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Fatigue Foreign Lariam PS ORAL 250 MG 1 X
Hospitalization - Haemolytic Anaemia Other PER WEEK ORAL
Initial or Prolonged Influenza Like Illness Aspirin (Aspirin) C
Anxiety
Grippostad C
(Acetaminophen/Ascor
bic
Acid/Caffeine/Chlorp
heniramine Maleate) C
Date:10/02/98ISR Number: 3260324-0Report Type:Periodic Company Report #8-97337-022L Age:69 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Erythema Multiforme Health Oruvail PS ORAL ORAL
Professional Lariam SS ORAL 250 MG WEEKLY
ORAL
Mevacor
C
Cortisone Injection C
Fosamax
C
Date:10/13/98ISR Number: 3142010-0Report Type:Expedited (15-DaCompany Report #106318 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dystonia Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Panic Attack Other PER WEEK ORAL
Grand Mal Convulsion
Date:10/13/98ISR Number: 3142011-2Report Type:Expedited (15-DaCompany Report #106675 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Ovarian Cancer Health Lariam PS ORAL 250 MG 1 X
Professional
PER WEEK ORAL

Date:10/23/98ISR Number: 3145988-4Report Type:Expedited (15-DaCompany Report #106970 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Mania Foreign Lariam PS ORAL 250 MG 1 X
Completed Suicide Other PER WEEK ORAL
Hypomania
Depression
03-Apr-2012 09:37 AM Page: 79

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/23/98ISR Number: 3145989-6Report Type:Expedited (15-DaCompany Report #107015 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dissociative Identity Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Disorder Other PER WEEK ORAL
Hallucination
Panic Attack
Date:11/02/98ISR Number: 3152111-9Report Type:Expedited (15-DaCompany Report #107663 Age:60 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Foreign Lariam PS ORAL ORAL
Health
Professional
Date:11/05/98ISR Number: 3152322-2Report Type:Expedited (15-DaCompany Report #92444 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Maternal Drugs Affecting Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Foetus Health PER WEEK ORAL
Congenital Anomaly Premature Baby Professional Adepal SS ORAL 1 DOSE FORM 1
Foetal Growth Restriction Other X PER DAY
Small For Dates Baby
ORAL
Stamaril SS SUBCUTANEOUS 1 DOSE FORM 1
X PER ONE
DOSE
SUBCUTANEOUS
Havrix SS INTRAMUSCULAR 1440 UNIT/ML
1 X PER ONE
DOSE
INTRAMUSCULAR
Hepatitis SS INTRAMUSCULAR 1 X PER ONE
DOSE
INTRAMUSCULAR
Date:11/10/98ISR Number: 3155903-5Report Type:Expedited (15-DaCompany Report #107875 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Maternal Drugs Affecting Foreign Lariam PS ORAL 250 MG 1 X
Foetus Other PER WEEK ORAL
Benign Congenital
Hypotonia
Congenital Anomaly
Microcephaly
Thalassaemia Alpha
Mental Retardation
Dysmorphism

Strabismus
Developmental Delay
03-Apr-2012 09:37 AM Page: 80

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/10/98ISR Number: 3155959-XReport Type:Expedited (15-DaCompany Report #107840 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Colitis Foreign Lariam PS ORAL TABLETS; ORAL
Initial or Prolonged
Health
Professional
Date:11/12/98ISR Number: 3156945-6Report Type:Expedited (15-DaCompany Report #107872 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fall Foreign Lariam PS ORAL 250MG 1 X PER
Circulatory Collapse Other WEEK ORAL
Fatigue
Grand Mal Convulsion
Loss Of Consciousness
Anhedonia
Epilepsy
Lethargy
Date:11/13/98ISR Number: 3157862-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Crying Consumer Larium PS
Depression
Emotional Disorder
Date:11/17/98ISR Number: 3158657-1Report Type:Expedited (15-DaCompany Report #107663 Age:61 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Foreign Lariam PS ORAL 250 MG 1 X
Health
PER WEEK ORAL
Professional
Date:11/20/98ISR Number: 3160902-3Report Type:Expedited (15-DaCompany Report #65435 Age:33 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Apathy
Pollakiuria
Haematuria
Anxiety
Cholecystitis
Syncope
Constipation
Nausea
Cough

Lethargy
Night Sweats
Nightmare
Chills
Back Pain
Micturition Urgency
Culture Urine Positive
Condition Aggravated
03-Apr-2012 09:37 AM Page: 81

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pyrexia
Headache
Mental Disorder Report Source Product Role Manufacturer Route Dose Duration
Hallucinations, Mixed Consumer Lariam PS ORAL 250 MG 1 X
Pain Health PER WEEK ORAL 14 DAY
Calculus Urinary Professional Lorazepam C
Other Anaprox Ds C
Motrin
C
Toradol
C
Wellbutrin
C
Zovirax
C
Date:11/24/98ISR Number: 3161905-5Report Type:Direct Company Report # Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Lariam PS 250MG,1 PER
Hallucination WEEK FOR 5
Dermatitis WEEKS 5 WK
Convulsion
Flushing
Anxiety
Insomnia
Date:11/30/98ISR Number: 3164083-1Report Type:Expedited (15-DaCompany Report #108878 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cerebral Infarction Foreign Lariam PS ORAL 250 MG 1XPER
Hemianopia Other WEEK ORAL
Hepatitis A Vaccine C
Yellow Fever Vaccine C
Mengivac
C
Typhim
C
Date:11/30/98ISR Number: 3164100-9Report Type:Expedited (15-DaCompany Report #108916 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Foreign Lariam PS ORAL 250 MG 1 X
Other
PER WEEK ORAL
Date:11/30/98ISR Number: 3164195-2Report Type:Expedited (15-DaCompany Report #81879 Age:23 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Chills
Tongue Disorder
Suicidal Ideation

Medication Error
Blood Cholesterol
Increased
Bipolar I Disorder
Pulmonary Congestion
Schizophreniform Disorder
Culture Stool Positive
Hepatic Enzyme Increased
03-Apr-2012 09:37 AM Page: 82

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Aspartate
Aminotransferase
Increased Report Source Product Role Manufacturer Route Dose Duration
Psychotic Disorder Health Lariam PS 250 MG 1 X
Oral Candidiasis Professional PER WEEK ORAL
Cough Typhoid Vaccine C
Diphtheria And
Tetaus Vaccine C
Yellow Fever Vaccine C
Date:12/01/98ISR Number: 3164881-4Report Type:Expedited (15-DaCompany Report #107840 Age:30 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - White Blood Cell Count Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Increased Health PER WEEK ORAL
Red Blood Cell
Professional
Sedimentation Rate
Increased
Thrombocytosis
Colitis Ulcerative
Diarrhoea Haemorrhagic
Date:12/01/98ISR Number: 3164986-8Report Type:Expedited (15-DaCompany Report #108638 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Breast Mass Foreign Lariam PS 250 MG 1 X
Breast Cancer Female Consumer PER WEEK
Premature Labour Other OTHER
Date:12/03/98ISR Number: 3171304-8Report Type:Expedited (15-DaCompany Report #98676 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Psychotic Disorder Foreign Lariam PS ORAL 250 MG 1 X
Hospitalization - Paresis Consumer PER ONE DOSE
Initial or Prolonged Cholera Health ORAL
Headache
Professional
Drug Level Above
Therapeutic
Paraesthesia
Hallucination
Hypoaesthesia
Suicidal Ideation
Restlessness
Date:12/03/98ISR Number: 3171305-XReport Type:Expedited (15-DaCompany Report #109425 Age:46 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Optic Neuritis Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Visual Impairment Other PER WEEK ORAL
Papilloedema Typhim Vi SS INTRAMUSCULAR 1 X PER ONE
DOSE
INTRAMUSCULAR
Engerix B SS INTRAMUSCULAR 1 X PER ONE
03-Apr-2012 09:37 AM Page: 83

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
DOSE
INTRAMUSCULAR
Profenid SS ORAL 1 X PER PRN
ORAL
Propofan SS ORAL 1 X PER PRN
ORAL
Sanmigran
C
Date:12/03/98ISR Number: 3171306-1Report Type:Expedited (15-DaCompany Report #109197 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Ejection Fraction Foreign Lariam PS ORAL 25 MG/KG ORAL
Abnormal Health Lariam SS ORAL 250 MG 1X PER
Tachycardia Professional WEEK ORAL
Medication Error
Dyspnoea
Date:12/08/98ISR Number: 3168310-6Report Type:Expedited (15-DaCompany Report #104882 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Restlessness Consumer PER WEEK ORAL
Feeling Abnormal
Health
Asthenia
Professional
Paraesthesia
Circulatory Collapse
Balance Disorder
Dizziness
Confusional State
Tachycardia
Anxiety
Cardiovascular Disorder
Ventricular Extrasystoles
Arrhythmia
Date:12/08/98ISR Number: 3168484-7Report Type:Expedited (15-DaCompany Report #109778 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypersensitivity Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Other PER WEEK ORAL
Microgynon (Ethinyl
Estradiol/Levonorges
trel)
C
Date:12/08/98ISR Number: 3168488-4Report Type:Expedited (15-DaCompany Report #109038 Age:48 YR Gender:Female I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
PT
Influenza Like Illness
Palpitations
Urticaria
Pyrexia
Chills
Anxiety
Lung Consolidation
03-Apr-2012 09:37 AM Page: 84

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Q Fever
Report Source Product Role Manufacturer Route Dose Duration
Foreign Lariam PS ORAL 250 MG 1 X
Health
PER WEEK ORAL
Professional
Date:12/08/98ISR Number: 3168721-9Report Type:Expedited (15-DaCompany Report #108541 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hyperpyrexia Foreign Lariam PS ORAL 250 MG 1XPER
Initial or Prolonged Gastroenteritis Shigella Study WEEK ORAL
White Blood Cell Count Health Orlistat SS ORAL 3XPER DAY
Increased Professional ORAL
Date:12/10/98ISR Number: 3168961-9Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Lariam PS ORAL 1 PILL PER
Diarrhoea
WEEK
Malaise
Date:12/10/98ISR Number: 3169049-3Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Weight Decreased Larium 250mg
Initial or Prolonged Hallucination (Mefloquine) PS Roche Rh 674414 ORAL ORAL 250MG 1T
Disability Hyperhidrosis TAB WEEKLY
Required Delusion Benztropinue C
Intervention to Bipolar I Disorder Imxiete C
Prevent Permanent Panic Attack Haloperidol C
Impairment/Damage Convulsion
Date:12/10/98ISR Number: 3169225-XReport Type:Expedited (15-DaCompany Report #8-98334-066A Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Papilloedema Foreign Profenid
Initial or Prolonged Optic Neuritis Health (Ketoprofen) PS ORAL AS NEEDED
Visual Impairment Professional ORAL YR
Hepatitis B Vaccine
Injection SS INJECTABLE
Mefloquine Tablet SS ORAL ONE TABLET
WEEKLY; ORAL
Propavan
(Propiomazine

Maleate) SS AS NEEDED YR
Typhoid Vaccine
Injection SS ONE
INJECTION;
INJECTABLE
Cafeine +Paracetamol
+Chlorphenamine
Maleate
03-Apr-2012 09:37 AM Page: 85

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
+Dextropropoxyphene
+Carbasalate Calcium C
Date:12/10/98ISR Number: 3169279-0Report Type:Expedited (15-DaCompany Report #108731 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Atrial Fibrillation Foreign Lariam PS ORAL 250MG 1 X PER
Arrhythmia Health WEEK ORAL
Professional
Date:12/10/98ISR Number: 3169280-7Report Type:Expedited (15-DaCompany Report #96761 Age:41 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Liver Disorder Consumer Lariam PS ORAL 250MG 1 X PER
Haemangioma Of Liver
WEEK ORAL
Nephrolithiasis Tetanus Booster C
Infection Parasitic Polio Booster C
Hepatitis A Vaccine C
Hepatitis B Vaccine C
Date:12/14/98ISR Number: 3170021-8Report Type:Expedited (15-DaCompany Report #B0062044 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Decreased Appetite Foreign Zovirax Tablet PS ORAL ORAL
Initial or Prolonged Vision Blurred Mefloquine
Depression
(Formulation
Vertigo Unknown) SS ORAL ORAL
Asthenia Pristinamycin C
Gait Disturbance
Abdominal Pain
Nausea
Malaise
Date:12/14/98ISR Number: 3170131-5Report Type:Expedited (15-DaCompany Report #110216 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychomotor Hyperactivity Foreign Lariam
PS ORAL 250 MG 1XPER
Initial or Prolonged Muscle Rigidity Other WEEK ORAL
Psychotic Disorder
Speech Disorder
Depersonalisation
Insomnia
Screaming
Crying
Nightmare

Sedation
Confusional State
Delirium
03-Apr-2012 09:37 AM Page: 86

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/14/98ISR Number: 3170215-1Report Type:Expedited (15-DaCompany Report #109968 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Decreased Appetite Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Vision Blurred Other PER WEEK ORAL
Depression Zovirax SS ORAL 800 MG DAILY
Nausea
ORAL
Asthenia Pyostacine C
Vertigo
Gait Disturbance
Abdominal Pain
Fall
Date:12/14/98ISR Number: 3170217-5Report Type:Expedited (15-DaCompany Report #110362 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depersonalisation Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Dizziness Other PER WEEK ORAL
Date:12/14/98ISR Number: 3170236-9Report Type:Expedited (15-DaCompany Report #104407 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chest Discomfort Foreign Lariam (Mefloquine
Initial or Prolonged Lethargy Health Hydrochloride) PS ORAL 250 MG 1 X
Pain Professional PER WEEK ORAL
Loss Of Libido
Restlessness
Anxiety
Abdominal Pain
Panic Attack
Date:12/14/98ISR Number: 3170525-8Report Type:Expedited (15-DaCompany Report #104882 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Asthenia Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Paraesthesia Consumer PER WEEK ORAL
Tachycardia
Health
Confusional State
Professional
Condition Aggravated
Convulsion
Dizziness
Depersonalisation
Balance Disorder
Cardiovascular Disorder
Ventricular Extrasystoles
Circulatory Collapse
Restlessness

Anxiety
Panic Attack
Arrhythmia
03-Apr-2012 09:37 AM Page: 87

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/16/98ISR Number: 3170982-7Report Type:Expedited (15-DaCompany Report #110115 Age:63 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Abscess Other PER ONE DOSE
Nausea
ORAL
Abdominal Pain
C-Reactive Protein
Increased
Dysuria
Diverticulum Intestinal
Diverticulitis
Pyrexia
White Blood Cell Count
Increased
Diarrhoea
Date:12/16/98ISR Number: 3170984-0Report Type:Expedited (15-DaCompany Report #106675 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Ovarian Cancer Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 X
PER WEEK ORAL
Date:12/16/98ISR Number: 3170987-6Report Type:Expedited (15-DaCompany Report #110313 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Loss Of Consciousness Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Grand Mal Convulsion Literature PER WEEK ORAL 21 DAY
Atrial Fibrillation
Health
Blood Cholesterol
Professional
Increased
Urinary Incontinence
Heart Rate Irregular
Date:12/24/98ISR Number: 3174151-6Report Type:Expedited (15-DaCompany Report #58978 Age:31 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Heart Rate Increased
Vertigo
Psychotic Disorder
Feeling Abnormal
Visual Acuity Reduced
Fatigue
Circulatory Collapse

Asthenia
Nervous System Disorder
Nystagmus
Drug Level Above
Therapeutic
Dyspnoea
Amnesia
Dizziness
03-Apr-2012 09:37 AM Page: 88

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disturbance In Attention
Head Injury
Report Source Product Role Manufacturer Route Dose Duration
Consumer
Lariam Tablets
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1XPER
WEEK ORAL
Norflex
C
Date:12/29/98ISR Number: 3176456-1Report Type:Expedited (15-DaCompany Report #102527 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Apallic Syndrome Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Electroencephalogram Health PER WEEK ORAL
Abnormal Professional Chinin C
Nightmare
Other
Amnesia
Dystonia
Depressed Level Of
Consciousness
Drug Effect Decreased
Restlessness
Pyrexia
Asthenia
Thrombocytopenia
Disturbance In Attention
Sinusitis
Malaria
Nervous System Disorder
Date:12/30/98ISR Number: 3176659-6Report Type:Expedited (15-DaCompany Report #108731 Age:58 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Condition Aggravated Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Atrial Fibrillation Health PER WEEK ORAL
Malaise Professional Tetanus Vaccine
Tachycardia (Tetanus Toxoid) C
Arrhythmia
Immunoglobulin
(Globulin, Immune) C
Polio Vaccine
(Poliomyelitis
Vaccines)
C
Date:12/30/98ISR Number: 3176664-XReport Type:Expedited (15-DaCompany Report #95713 Age:29 YR Gender:Female I/FU:I
Outcome
PT

Hospitalization -
Initial or Prolonged
Congenital Anomaly
White Blood Cell Count
Increased
Congenital Anomaly
Blood Glucose Decreased
Hyperbilirubinaemia
Neonatal
Foetal Haemoglobin
Increased
03-Apr-2012 09:37 AM Page: 89

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Platelet Count Decreased
Talipes
Pyrexia Report Source Product Role Manufacturer Route Dose Duration
Congenital Hip Deformity Foreign Lariam PS ORAL 250 MG 1 X
Maternal Drugs Affecting Health PER WEEK ORAL
Foetus
Professional
Hypoglycaemia
Type 1 Diabetes Mellitus
Blood Bilirubin Increased
Date:12/30/98ISR Number: 3176807-8Report Type:Expedited (15-DaCompany Report #107634 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypoaesthesia Health Lariam PS ORAL 250 MG 1 X
Ear Pain Professional PER WEEK ORAL
Hemiparesis
Multiple Sclerosis
Eustachian Tube
Obstruction
Paraesthesia
Date:01/08/99ISR Number: 3178806-9Report Type:Expedited (15-DaCompany Report #111360 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Missed Foreign Lariam PS ORAL 250 MG 1 X
Health
PER WEEK ORAL
Professional Clotrimazol C
Date:01/08/99ISR Number: 3178807-0Report Type:Expedited (15-DaCompany Report #111442 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Neuropathy Peripheral Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Headache Other PER DOSE,
Nightmare
ORAL
Dysgeusia
Date:01/08/99ISR Number: 3178853-7Report Type:Expedited (15-DaCompany Report #109968 Age:27 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nausea Foreign Lariam (Mefloquine
Initial or Prolonged Asthenia Other Hydrochloride) PS ORAL 250 1 X PER
Abdominal Pain
WEEK ORAL
Vertigo
Zovirax (Acyclovir)
Fall 200 Mg SS ORAL 800 MG DAILY
Decreased Appetite
ORAL

Depression Pyostacine
Gait Disturbance (Pristinamycin) C
Vision Blurred
03-Apr-2012 09:37 AM Page: 90

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/08/99ISR Number: 3179344-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pyrexia Lariam PS 1 PILL PER
Tremor
WEEK
Headache
Chills
Date:01/11/99ISR Number: 3179642-XReport Type:Direct Company Report # Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Convulsion Lariam PS Hoffman Laroche 250 MG, I
Insomnia
TABLET PER
Nausea WEEK FOR 10
Vision Blurred
WEEKS
Paraesthesia
Photophobia
Fear
Mania
Psychotic Disorder
Toxicity To Various
Agents
Feeling Of Body
Temperature Change
Fatigue
Paranoia
Dyspnoea
Headache
Decreased Appetite
Dizziness
Date:01/13/99ISR Number: 3180240-2Report Type:Direct Company Report # Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Consumer Lariam PS 1 TABLET PER
Irritability
WEEK
Mood Altered
Insomnia
Palpitations
Dizziness
Date:01/13/99ISR Number: 3180261-XReport Type:Direct Company Report # Age:55 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Loss Of Consciousness Mefloquine PS ORAL 250MG /WK PO
Partial Seizures
Disorientation

Date:01/13/99ISR Number: 3180629-1Report Type:Expedited (15-DaCompany Report #93243 Age:58 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Thrombocytopenia
White Blood Cell Count
03-Apr-2012 09:37 AM Page: 91

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Decreased
Liver Function Test
Abnormal
Thrombocytosis Report Source Product Role Manufacturer Route Dose Duration
Malaria Foreign Lariam PS ORAL 1500 MG DAILY
Health
ORAL
Professional
Other
Date:01/14/99ISR Number: 3180688-6Report Type:Expedited (15-DaCompany Report #96727 Age:58 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thrombocytopenia Foreign Lariam PS ORAL 1500 MG DAILY
Liver Function Test Other ORAL
Abnormal
Blood Alkaline
Phosphatase Increased
White Blood Cell Count
Decreased
Leukopenia
Date:01/14/99ISR Number: 3180722-3Report Type:Expedited (15-DaCompany Report #96727 Age:58 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Leukopenia Foreign Lariam PS ORAL 1500 MG DAILY
White Blood Cell Count Other ORAL
Decreased
Thrombocytopenia
Liver Function Test
Abnormal
Thrombocytosis
Date:01/19/99ISR Number: 3182196-5Report Type:Expedited (15-DaCompany Report #111775 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Cleft Palate Foreign Lariam PS ORAL 250 MG 1 X
Maternal Drugs Affecting Other PER WEEK ORAL
Foetus
Date:01/19/99ISR Number: 3182565-3Report Type:Expedited (15-DaCompany Report #104407 Age:39 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lethargy Foreign Lariam PS ORAL 250 MG 1 X
Initial or Prolonged Abdominal Pain Health PER WEEK ORAL
Anxiety
Professional
Panic Attack

Chest Discomfort
Restlessness
03-Apr-2012 09:37 AM Page: 92

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/22/99ISR Number: 3184622-4Report Type:Expedited (15-DaCompany Report #92891 Age:54 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vertigo Foreign Lariam PS ORAL 250MG 1 X PER
Gait Disturbance Health WEEK ORAL
Balance Disorder Professional Geluprane C
Dizziness
Date:01/25/99ISR Number: 3185409-9Report Type:Expedited (15-DaCompany Report #112058 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Foreign Lariam PS ORAL 250 MG 1X PER
Initial or Prolonged Anxiety Consumer WEEK ORAL 28 DAY
Dizziness
Gastritis
Date:02/04/99ISR Number: 3191986-4Report Type:Expedited (15-DaCompany Report #112683 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicide Attempt Foreign Lariam Tablets
Initial or Prolonged Intentional Overdose Health (Mefloquine
Delusional Disorder, Professional Hydrochloride) PS ORAL 250 MG 1 X
Persecutory Type
PER WEEK ORAL
Psychotic Disorder
Date:02/08/99ISR Number: 3193356-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Delusion Lariam PS ORAL 8/98 ORAL
Adjustment Disorder
Depression
Date:02/09/99ISR Number: 3194845-6Report Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Memory Impairment Mefloquine PS 1 PILL ONCE A
Dermatitis WEEK 2 YR
Alopecia
Date:02/10/99ISR Number: 3195192-9Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I
Outcome
Hospitalization -
PT
Panic Attack

Initial or Prolonged
Saliva Altered
Hypoaesthesia
Balance Disorder
Toxicity To Various
Agents
Muscular Weakness
Paraesthesia
Burning Sensation
03-Apr-2012 09:37 AM Page: 93

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dizziness
Chest Pain
Anxiety Report Source Product Role Manufacturer Route Dose Duration
Headache Lariam PS Roche Labs ORAL 250 MG WEEKLY
Coordination Abnormal
BY MOUTH
Insomnia
Gait Disturbance
Movement Disorder
Malaria
Fatigue
Nightmare
Salivary Hypersecretion
Abdominal Pain
Asthenia
Sensation Of Heaviness
Myalgia
Diarrhoea
Arthralgia
Date:02/16/99ISR Number: 3199935-XReport Type:Expedited (15-DaCompany Report #98676 Age:36 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Bipolar I Disorder Foreign Lariam Tablets
Hospitalization - Loss Of Employment Consumer (Mefloquine
Initial or Prolonged Ulnar Nerve Injury Health Hydrochloride) 250
Depression Professional Mg PS ORAL 250 MG 1 PER
Catatonia
DAY ORAL
Mood Altered
Restlessness
Head Injury
Perseveration
Suicidal Ideation
Paraesthesia
Extrapyramidal Disorder
Hypoaesthesia
Schizophreniform Disorder
Flat Affect
Delusion
Stress
Paresis
Anger
Paranoia
Headache
Abnormal Behaviour
Lethargy
Bradyphrenia
Hallucination
Date:02/17/99ISR Number: 3200611-5Report Type:Expedited (15-DaCompany Report #113215 Age:82 YR Gender:Female I/FU:I

Outcome
Disability
PT
Speech Disorder
Dizziness
Confusional State
Medication Error
Agitation
Deafness
03-Apr-2012 09:37 AM Page: 94

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Coordination Abnormal
Report Source Product Role Manufacturer Route Dose Duration
Literature
Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) PS ORAL ORAL 61 DAY
Date:02/17/99ISR Number: 3200641-3Report Type:Expedited (15-DaCompany Report #113209 Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Overdose Literature Lariam Tablets
Initial or Prolonged Nausea Health (Mefloquine
Jaundice Professional Hydrochloride) 250
Hallucination Mg PS ORAL 1250 MG 1 PER
Hepatic Failure
ONE DOSE ORAL
Chromaturia
Primaquine
Abdominal Pain
(Primaqine
Liver Function Test Phosphate) SS 1260 MG 1 PER
Abnormal
ONE DOSE
Date:02/17/99ISR Number: 3200745-5Report Type:Expedited (15-DaCompany Report #104407 Age:39 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abdominal Pain Foreign Lariam Tablets
Initial or Prolonged Restlessness Health (Mefloquine
Anxiety Professional Hydrochloride) 250
Panic Attack Mg PS ORAL 250 MG 1 X
Chest Discomfort
PER WEEK ORAL
Lethargy
Date:02/18/99ISR Number: 3201276-9Report Type:Direct Company Report # Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hallucination Mefloquine PS Roche Laboratories
Chest Pain
Paraesthesia
Fatigue
Headache
Chills
Date:02/18/99ISR Number: 3201365-9Report Type:Direct Company Report # Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hallucination Lariam PS 1 PILL PER
Hospitalization - Mania WEEK

Initial or Prolonged
Panic Attack
Tachycardia
Mental Disorder
03-Apr-2012 09:37 AM Page: 95

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/18/99ISR Number: 3203383-3Report Type:Expedited (15-DaCompany Report #200209 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Foreign Lariam Tablets
Suicidal Ideation Other (Mefloquine
Paranoia Hydrochloride) PS ORAL 250 MG DAILY
Agitation
ORAL
Date:02/18/99ISR Number: 3203385-7Report Type:Expedited (15-DaCompany Report #200139 Age:4 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Level Above Foreign Lariam Tablets
Initial or Prolonged Therapeutic Health (Mefloquine
Liver Transplant Professional Hydrochloride) 250
Rejection Mg PS ORAL 250 MG 1 PER
Drug Interaction
WEEK ORAL
Fk506 (Tacrolimus) SS
Date:02/19/99ISR Number: 3203427-9Report Type:Expedited (15-DaCompany Report #113217 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Decreased Appetite Foreign Lariam (Mefloquine
Initial or Prolonged Nervousness Literature Hydrochloride) PS ORAL 250 MG 1 PER
Oedema Health WEEK ORAL
Blood Albumin Decreased Professional
Vomiting
Dehydration
Inflammation
Blood Calcium Decreased
Weight Decreased
Hepatomegaly
Endoscopy Upper
Gastrointestinal Tract
Abnormal
Hepatic Failure
Oedema Peripheral
Compartment Syndrome
Abdominal Distension
Liver Function Test
Abnormal
Depression
Blood Potassium Decreased
Diarrhoea
Hepatic Steatosis
Gastroenteritis
Date:02/19/99ISR Number: 3204070-8Report Type:Direct Company Report # Age:51 YR Gender:Unknown I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Decreased Interest Health Lariam PS
Insomnia Professional Halcion C
Disturbance In Attention
Cognitive Disorder
Anxiety
03-Apr-2012 09:37 AM Page: 96

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/22/99ISR Number: 3204969-2Report Type:Expedited (15-DaCompany Report #113209 Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chromaturia Literature Lariam Tablets
Initial or Prolonged Abdominal Pain Health (Mefloquine
Jaundice Professional Hydrochloride) 250
Nausea Mg PS ORAL 1250 MG 1 PER
Liver Function Test
ONE DOSE
Abnormal
ORAL
Hepatic Failure
Primaquine
Hallucination
(Primaquine
Overdose Phosphate) SS 1260 MG 1 PER
ONE DOSE
Date:02/22/99ISR Number: 3205088-1Report Type:Expedited (15-DaCompany Report #98676 Age:36 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicidal Ideation Foreign Lariam Tablets
Hospitalization - Paresis Consumer (Mefloquine
Initial or Prolonged Extrapyramidal Disorder Health Hydrochloride) 250
Restlessness Professional Mg PS ORAL 250 MG 1 PER
Peripheral Nerve Lesion
DAY ORAL
Disturbance In Attention
Lethargy
Hypoaesthesia
Paranoia
Schizophreniform Disorder
Delusion
Paraesthesia
Bipolar I Disorder
Catatonia
Hallucination
Date:02/24/99ISR Number: 3206756-8Report Type:Expedited (15-DaCompany Report #200139 Age:4 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Level Above Foreign Lariam PS ORAL TABLETS, 1
Initial or Prolonged Therapeutic Health PER WEEK ORAL
Transplant Rejection Professional Fk506 (Tacrolimus) SS
Drug Interaction
Date:02/26/99ISR Number: 3208126-5Report Type:Expedited (15-DaCompany Report #200527 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Toxoplasmosis Foreign Lariam PS ORAL 250MG 1 PER
Health
WEEK ORAL
Professional Beriglobin C

Typhoral C
03-Apr-2012 09:37 AM Page: 97

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/26/99ISR Number: 3208128-9Report Type:Expedited (15-DaCompany Report #200442 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Jaundice Health Lariam PS ORAL 250MG 1 PER
Condition Aggravated Professional WEEK ORAL
Haemolytic Anaemia
Date:03/01/99ISR Number: 3209203-5Report Type:Expedited (15-DaCompany Report #200139 Age:4 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Interaction Foreign Lariam Tablets
Initial or Prolonged Liver Transplant Health (Mefloquine
Rejection Professional Hydrochloride) PS ORAL 1 PER WEEK
Drug Level Above
ORAL
Therapeutic Fk506 (Tacrolimus) SS
Date:03/01/99ISR Number: 3209298-9Report Type:Expedited (15-DaCompany Report #201094 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Speech Disorder Other Lariam Tablets
Coordination Abnormal
(Mefloquine
Hydrochloride) PS ORAL ORAL
Date:03/01/99ISR Number: 3209366-1Report Type:Expedited (15-DaCompany Report #200926 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Foreign Laraim Tablets
Initial or Prolonged Delusion Health (Mefloquine
Hepatitis Professional Hydrochloride) PS ORAL 250 MG 1 PER
Schizophrenia
WEEK ORAL
Jaundice
Date:03/03/99ISR Number: 3210714-7Report Type:Direct Company Report # Age:69 YR Gender:Female I/FU:I
Outcome
Disability
Other Serious
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Disturbance In Attention
Feeling Abnormal
Joint Stiffness
Abdominal Pain Upper
Insomnia
Disorientation
Dizziness
Decreased Appetite
Vision Blurred
Chills

Tremor
Fatigue
Abdominal Pain
Vertigo
Arthralgia
Dysgraphia
Nausea
Asthenia
03-Apr-2012 09:37 AM Page: 98

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Confusional State
Anxiety
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Hoffman-La Roche Inc ORAL 250MG ONCE
/WEEK ORALLY
/8 WEEKS
Date:03/03/99ISR Number: 3214303-XReport Type:Direct Company Report # Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Hypersomnia Larium PS ORAL TAB 1T ORAL 2 DAY
Intervention to
Hyperhidrosis
Prevent Permanent Agoraphobia
Impairment/Damage Malaria
Depression
Bipolar Disorder
Date:03/05/99ISR Number: 3214272-2Report Type:Expedited (15-DaCompany Report #201217 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Fibrosis Foreign Lariam PS ORAL
Hepatic Steatosis Other Hepatitis A Vaccine
Ventricular Hypertrophy
(Hepatitis A
Obstruction Vaccine) SS INTRAMUSCULAR
Hepatosplenomegaly
Malaise
Ventricular Fibrillation
Cardiomegaly
Date:03/05/99ISR Number: 3214273-4Report Type:Expedited (15-DaCompany Report #201099 Age:69 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Deafness Neurosensory Health Lariam PS ORAL 250 MG 1 PER
Deafness Professional WEEK
Beta-Blocker (Beta
Blocker Nos)
C
Date:03/08/99ISR Number: 3214076-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hypoaesthesia Lariam PS ONCE.WK
Palpitations
Anxiety
Pain
Dermatitis

Dizziness
03-Apr-2012 09:37 AM Page: 99

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/08/99ISR Number: 3215137-2Report Type:Expedited (15-DaCompany Report #72710 Age:82 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Deafness Literature Lariam PS ORAL 250 MG 1 PER
Speech Disorder Health DAY ORAL
Agitation Professional Cardizem C
Asthenia Propoxyphene C
Coordination Abnormal
Desyrel (Trazodone
Bundle Branch Block Hydrochloride) C
Medication Error Ultram C
Confusional State Depakote C
Respiratory Disorder Apresoline C
Alanine Aminotransferase
Increased
Accidental Overdose
Dizziness
Date:03/08/99ISR Number: 3215139-6Report Type:Expedited (15-DaCompany Report #113215 Age:82 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Deafness Literature Lariam PS ORAL ORAL 61 DAY
Agitation
Health
Confusional State
Professional
Dizziness
Medication Error
Speech Disorder
Coordination Abnormal
Date:03/08/99ISR Number: 3215142-6Report Type:Expedited (15-DaCompany Report #200926 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abnormal Dreams Foreign Lariam PS ORAL 250 MG 1 PER
Initial or Prolonged Aggression Health WEEK ORAL
Feeling Abnormal
Professional
Injury
Jaundice
Stress
Hepatitis
Psychotic Disorder
Schizophrenia
Hepatic Enzyme Increased
Delusion
Asthenia
Mental Disorder
Hallucination
Date:03/08/99ISR Number: 3218790-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Lariam PS 1TAB PER WEEK
Restlessness FOR 3 WEEKS ;
Dizziness
GIVEN SAMPLE
IN MD'S
OFFICE
Celbrex
C
03-Apr-2012 09:37 AM Page: 100

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Diamox
Prempro
C
C
Date:03/17/99ISR Number: 3223037-7Report Type:Expedited (15-DaCompany Report #200209 Age:19 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Agitation Foreign Lariam Tablets
Suicidal Ideation Other (Mefloquine
Nightmare Hydrochloride) 250mg PS ORAL 250 MG 1 PER
Paranoia
WEEK ORAL
Date:03/24/99ISR Number: 3225735-8Report Type:Expedited (15-DaCompany Report #200442 Age:32 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anaemia Haemolytic Health Lariam Tablets
Autoimmune Professional (Mefloquine
Jaundice Hydrochloride) 250
Diarrhoea Mg PS ORAL 250 MG 1 PER
Condition Aggravated
WEEK ORAL
Date:03/25/99ISR Number: 3226364-2Report Type:Expedited (15-DaCompany Report #202374 Age:64 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lethargy Other Lariam Tablets
Initial or Prolonged Dizziness (Mefloquine
Colonic Polyp Hydrochloride) 250
Haemoglobin Decreased Mg PS ORAL 250 MG 1 PER
Chromaturia
WEEK ORAL
Haemolytic Anaemia
Abdominal Pain Lower
Decreased Appetite
Jaundice
Haematocrit Decreased
Neoplasm Malignant
Pain
Body Temperature
Decreased
Dehydration
Date:03/30/99ISR Number: 3230064-2Report Type:Expedited (15-DaCompany Report #202571 Age:65 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Haematuria Foreign Lariam PS ORAL 250 MG 1 PER
Haematoma Health 1 WEEK ORAL
International Normalised Professional Previscan

Ratio Increased (Fluindione) SS ORAL ORAL
Drug Level Above
Therapeutic
Nephrolithiasis
Drug Interaction
03-Apr-2012 09:37 AM Page: 101

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/31/99ISR Number: 3230866-2Report Type:Expedited (15-DaCompany Report #200926 Age:57 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abnormal Dreams Foreign Lariam Tablets
Initial or Prolonged Abnormal Behaviour Health (Mefloquine
Schizophrenia Professional Hydrochloride) PS ORAL 250 MG 1 PER
Hallucination
WEEK ORAL
Asthenia
Hepatitis
Delusion
Jaundice
Aggression
Stress
Gamma-Glutamyltransferase
Increased
Alanine Aminotransferase
Increased
Psychotic Disorder
Feeling Abnormal
Date:04/01/99ISR Number: 3231215-6Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Dizziness Lariam PS
Pyrexia
Deafness
Headache
Malaise
Insomnia
Fatigue
Dermatitis
Nasal Congestion
Pulmonary Congestion
Hallucination
Influenza Like Illness
Pruritus
Fear
Paranoia
Hyperhidrosis
Chills
Vomiting
Decreased Appetite
Aggression
Date:04/02/99ISR Number: 3232453-9Report Type:Expedited (15-DaCompany Report #202998 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nausea Foreign Lariam Tablets
Initial or Prolonged Dizziness Health (Mefloquine

Anxiety Professional Hydrochloride) 250
Hearing Impaired Mg PS ORAL 250 MG 1 PER
1 WEEK ORAL
03-Apr-2012 09:37 AM Page: 102

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/08/99ISR Number: 3236025-1Report Type:Expedited (15-DaCompany Report #203042 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Abnormal Labour Foreign Lariam Tablets
Intervention to Premature Rupture Of Consumer (Mefloquine
Prevent Permanent Membranes Hydrochloride) 250
Impairment/Damage Maternal Drugs Affecting Mg PS ORAL 250 MG 1 PER
Foetus
WEEK ORAL
Uterine Spasm
Prenatal Vitamins
Metrorrhagia
Premature Baby
(Minerals
Nos/Multivitamins
Nos)
C
Date:04/13/99ISR Number: 3239019-5Report Type:Expedited (15-DaCompany Report #202374 Age:64 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Haemolytic Anaemia Consumer Lariam Tablets
Initial or Prolonged Chromaturia Health (Mefloquine
Reticulocyte Count Professional Hydrochloride) 250
Increased Other Mg PS ORAL 250 MG 1 PER
Colonic Polyp
WEEK ORAL
Dehydration
Decreased Appetite
Lethargy
Jaundice
Haematocrit Decreased
Pain
Decreased Activity
Dizziness
Abdominal Pain Lower
Haemoglobin Decreased
Neoplasm Malignant
Amnesia
Pyrexia
Date:04/13/99ISR Number: 3239023-7Report Type:Expedited (15-DaCompany Report #105284 Age:30 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Depression Foreign Lariam Tablets
Hospitalization - Hemiparesis Health (Mefloquine
Initial or Prolonged Insomnia Professional Hydrochloride) PS ORAL 750 MG 1 PER
Head Injury
ONE DOSE ORAL
Restlessness Tranxilium C
Suicide Attempt Atosil C
Resochin
C
Date:04/13/99ISR Number: 3239042-0Report Type:Expedited (15-DaCompany Report #203230 Age: Gender:Female I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Pyrexia
Foreign Travel
Panic Attack
Vomiting
Chest Discomfort
Anxiety
03-Apr-2012 09:37 AM Page: 103

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dehydration
Cough
Report Source Product Role Manufacturer Route Dose Duration
Health
Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250 MG 1 PER
WEEK ORAL
Date:04/13/99ISR Number: 3239440-5Report Type:Expedited (15-DaCompany Report #58978 Age:31 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vertigo Consumer Lariam Tablets
Dizziness
(Mefloquine
Brain Contusion Hydrochloride) PS ORAL 250 MG 1 PER
Amnesia
WEEK ORAL
Disturbance In Attention Norflex C
Feeling Abnormal
Asthenia
Emotional Distress
Nystagmus
Dyspnoea
Heart Rate Increased
Nervous System Disorder
Psychotic Disorder
Injury
Mental Disability
Decreased Activity
Dysgraphia
Fatigue
Visual Impairment
Reading Disorder
Date:04/14/99ISR Number: 3239847-6Report Type:Direct Company Report # Age:61 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Palpitations Health Lariam Tab PS Ud 1/ WK 6 WKS
Required Vertigo Professional
Intervention to
Anxiety
Prevent Permanent Hypertension
Impairment/Damage Myalgia
Date:04/14/99ISR Number: 3239864-6Report Type:Expedited (15-DaCompany Report #107634 Age:37 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Hypertension
Nuclear Magnetic
Resonance Imaging

Abnormal
Blood Immunoglobulin G
Increased
Flushing
Paraesthesia
Hearing Impaired
Hypoaesthesia
Muscular Weakness
03-Apr-2012 09:37 AM Page: 104

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Ear Pain
Sensory Disturbance
Multiple Sclerosis Report Source Product Role Manufacturer Route Dose Duration
Dysgraphia Health Lariam Tablets
Coordination Abnormal Professional (Mefloquine
Demyelination Hydrochloride) 250mg PS ORAL 250 MG 1 PER
Brain Stem Auditory
WEEK ORAL
Evoked Response Abnormal
Motor Dysfunction
Foreign Travel
Ear Discomfort
Cerebral Ischaemia
Date:04/14/99ISR Number: 3239951-2Report Type:Expedited (15-DaCompany Report #203042 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Premature Baby Foreign Lariam PS TRANSPLACENTAL 250 MG 1 PER
Intervention to Maternal Drugs Affecting Consumer WEEK ORAL
Prevent Permanent Foetus Prenatal Vitamins C
Impairment/Damage Muscle Spasms
Metrorrhagia
Premature Rupture Of
Membranes
Abnormal Labour
Date:04/15/99ISR Number: 3240621-5Report Type:Expedited (15-DaCompany Report #102721 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Other Lariam Tablets
Foetus
(Mefloquine
Deafness Congenital Hydrochloride) PS ORAL 250 MG 1 PER
WEEK ORAL
Vitamins
C
Date:04/15/99ISR Number: 3240622-7Report Type:Expedited (15-DaCompany Report #202571 Age:59 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nephrolithiasis Foreign Lariam Tablet
Epistaxis Health (Mefloquine
Drug Interaction Professional Hydrochloride) PS ORAL 250 MG 1 PER
Haematuria
WEEK ORAL
Haematoma
Previscan
Subcutaneous Haematoma (Fluindione) SS ORAL 20 MG 1 PER 1
Renal Colic
DAY ORAL
International Normalised Nitrofurantoine C
Ratio Increased

Date:04/20/99ISR Number: 3243445-8Report Type:Expedited (15-DaCompany Report #203837 Age: Gender:Male I/FU:I
Outcome
Death
PT
Hallucination
Nervous System Disorder
Medication Error
03-Apr-2012 09:37 AM Page: 105

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Completed Suicide
Report Source Product Role Manufacturer Route Dose Duration
Other
Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL ORAL
Date:04/26/99ISR Number: 3246927-8Report Type:Expedited (15-DaCompany Report #204205 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Foreign Lariam Tablets
Asthma Health (Mefloquine
Lethargy Professional Hydrochloride) PS ORAL ORAL
Anxiety
Other
Date:04/26/99ISR Number: 3247086-8Report Type:Expedited (15-DaCompany Report #202374 Age:64 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Biopsy Bone Marrow Consumer Lariam Tablets
Initial or Prolonged Abnormal Health (Mefloquine
Dizziness Professional Hydrochloride) 250
Dehydration Other Mg PS ORAL 250 MG 1 PER
Reticulocyte Count
WEEK ORAL
Increased
Abdominal Pain Lower
Pyrexia
Haemolytic Anaemia
Decreased Appetite
Jaundice
Lethargy
Colon Cancer
Colonic Polyp
Haemoglobin Decreased
Chromaturia
Haematocrit Decreased
Pain
Blood Lactate
Dehydrogenase Increased
Amnesia
Blood Bilirubin Increased
Date:04/27/99ISR Number: 3247569-0Report Type:Expedited (15-DaCompany Report #203042 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Premature Labour Foreign Lariam Tablets
Intervention to Premature Baby Consumer (Mefloquine
Prevent Permanent Maternal Drugs Affecting Hydrochloride) 250

Impairment/Damage Foetus Mg PS ORAL 250 MG 1 PER
Premature Rupture Of
WEEK ORAL
Membranes Prenatal Vitamins C
Small For Dates Baby
Delayed Delivery
Arrested Labour
03-Apr-2012 09:37 AM Page: 106

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/27/99ISR Number: 3247571-9Report Type:Expedited (15-DaCompany Report #204366 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Missed Foreign Lariam Tablets
Abortion Spontaneous Health (Mefloquine
Professional Hydrochloride) PS ORAL ORAL
Date:04/28/99ISR Number: 3249015-XReport Type:Expedited (15-DaCompany Report #104882 Age:25 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Tachycardia Foreign Lariam Tablets
Initial or Prolonged Circulatory Collapse Consumer (Mefloquine
Balance Disorder Health Hydrochloride) PS ORAL ORAL
Paraesthesia
Professional
Ventricular Extrasystoles
Panic Attack
Cardiovascular Disorder
Muscle Spasms
Anxiety
Arrhythmia
Restlessness
Asthenia
Dizziness
Confusional State
Convulsion
Feeling Abnormal
Date:04/30/99ISR Number: 3251229-XReport Type:Expedited (15-DaCompany Report #106318 Age:37 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Grand Mal Convulsion Foreign Lariam Tablets
Initial or Prolonged Dystonia (Mefloquine
Panic Attack Hydrochloride) PS ORAL 250 MG 1 PER
WEEK
Date:04/30/99ISR Number: 3251360-9Report Type:Expedited (15-DaCompany Report #58978 Age:31 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Malaise
Circulatory Collapse
Asthenia
Emotional Distress
Decreased Activity
Feeling Abnormal
Mental Impairment
Disturbance In Attention
Heart Rate Increased

Vertigo
Dyspnoea
Amnesia
Psychotic Disorder
Dizziness
Fatigue
Nervous System Disorder
Injury
03-Apr-2012 09:37 AM Page: 107

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nystagmus
Visual Impairment
Report Source Product Role Manufacturer Route Dose Duration
Health
Lariam Tablets
Professional
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Norflex
C
Date:05/04/99ISR Number: 3253962-2Report Type:Expedited (15-DaCompany Report #202374 Age:64 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Decreased Appetite Consumer Lariam Tablets
Initial or Prolonged Fatigue Health (Mefloquine
Jaundice Professional Hydrochloride) 250
Abdominal Pain Lower Other Mg PS ORAL 250 MG 1 PER
Coombs Direct Test
WEEK ORAL
Positive
Chromaturia
Pain
Body Temperature
Increased
Dizziness
Dehydration
Amnesia
Colonic Polyp
Lethargy
Haemolytic Anaemia
Anaemia Haemolytic
Autoimmune
Colon Cancer
Date:05/11/99ISR Number: 3258994-6Report Type:Expedited (15-DaCompany Report #99483 Age:36 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Nausea
Balance Disorder
Diarrhoea
Paralysis
Tachycardia
Abdominal Pain Upper
Hypoaesthesia
Ear Disorder
Visual Impairment
Pruritus
Panic Attack
Paraesthesia
Tinnitus

Tremor
Dizziness
Flushing
Condition Aggravated
Depression
Anxiety
Toxicity To Various
Agents
03-Apr-2012 09:37 AM Page: 108

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hearing Impaired
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250mg PS ORAL 250 MG 1 PER
Other
ONE DOSE ORAL
Contraceptive
C
Date:05/11/99ISR Number: 3258996-XReport Type:Expedited (15-DaCompany Report #205111 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Palpitations Foreign Lariam Tablets
Initial or Prolonged Dyspnoea Health (Mefloquine
Disability Psychotic Disorder Professional Hydrochloride) 250
Hypoaesthesia Mg PS ORAL 150 MG 1 PER
Confusional State
WEEK ORAL
Anxiety
Muscle Spasms
Date:05/11/99ISR Number: 3259222-8Report Type:Expedited (15-DaCompany Report #205170 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viith Nerve Paralysis Foreign Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250mg PS ORAL 250 MG 1 PER
1 WEEK ORAL
Date:05/13/99ISR Number: 3261143-1Report Type:Expedited (15-DaCompany Report #205270 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Musculoskeletal Stiffness Foreign Lariam Tablets
Initial or Prolonged Visual Impairment Consumer (Mefloquine
Insomnia Hydrochloride) 250
Panic Attack Mg PS ORAL 250 MG 1 PER
Depression
WEEK ORAL
Dizziness
Ketoprofene
Suicidal Ideation (Ketoprofen) C
Fatigue
Ibuprofene
(Ibuprofen)
C
Date:05/20/99ISR Number: 3266172-XReport Type:Expedited (15-DaCompany Report #205574 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disturbance In Attention Foreign Lariam Tablets

Initial or Prolonged Coordination Abnormal Consumer (Mefloquine
Vertigo Hydrochloride) 250
Visual Field Defect Mg PS ORAL 250 MG 1 PER
WEEK ORAL
03-Apr-2012 09:37 AM Page: 109

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/21/99ISR Number: 3267645-6Report Type:Expedited (15-DaCompany Report #205170 Age:31 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viith Nerve Paralysis Foreign Lariam Tablets
Consumer
(Mefloquine
Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:05/21/99ISR Number: 3268957-2Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dissociation Health Mefloquine PS ONCE PER WEEK
Dizziness Professional X 6 WEEKS
Emotional Disorder Ocp'S C
Crying
Date:06/02/99ISR Number: 3275253-6Report Type:Expedited (15-DaCompany Report #99483 Age:36 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Flushing Foreign Lariam Tablets
Initial or Prolonged Blood Cholesterol Health (Mefloquine
Increased Professional Hydrochloride) 250
Diarrhoea Other Mg PS ORAL 250 MG 1 PER
Vestibular Ataxia
ONE DOSE ORAL
Tachycardia Contraceptive C
Pruritus
Balance Disorder
Refraction Disorder
Hypoaesthesia
Paralysis
Tremor
Depression
Anxiety
Abdominal Pain Upper
Tinnitus
Panic Attack
Dizziness
Visual Impairment
Paraesthesia
Ear Discomfort
Date:06/07/99ISR Number: 3285451-3Report Type:Periodic Company Report #200588 Age:18 MON Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Coma Health Lariam Tablets
Initial or Prolonged Malaria Professional (Mefloquine

Chills Hydrochloride) 250
Drug Ineffective Mg PS ORAL 62.5 MG 1 PER
Pyrexia
WEEK ORAL
03-Apr-2012 09:37 AM Page: 110

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3285452-5Report Type:Periodic Company Report #202262 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abdominal Pain Consumer Lariam Tablets
Dizziness
(Mefloquine
Vertigo Hydrochloride) 250
Nystagmus Mg PS ORAL 250 MG 1 PER
Insomnia
WEEK ORAL
Coma Hormone Replacement C
Anxiety
Flatulence
Diarrhoea
Restlessness
Date:06/07/99ISR Number: 3285453-7Report Type:Periodic Company Report #202382 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Other Lariam Tablets
Paranoia
(Mefloquine
Hallucination, Auditory Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285454-9Report Type:Periodic Company Report #203056 Age:6 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amnesia Other Lariam Tablets
Convulsion
(Mefloquine
Confusional State Hydrochloride ) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285455-0Report Type:Periodic Company Report #97937 Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cyst Other Lariam Tablets
(Mefloquine
Hydrochloride ) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285456-2Report Type:Periodic Company Report #98216 Age:70 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dry Skin Other Lariam Tablets

Rash Erythematous (Mefloquiine
Hydrochlorine) 250
Mg PS 250MG
03-Apr-2012 09:37 AM Page: 111

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3285457-4Report Type:Periodic Company Report #98284 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vitreous Detachment Consumer Lariam Tablets
Abnormal Behaviour Health (Mefloquine
Vitreous Floaters Professional Hydrochloride) 250
Photopsia Mg PS ORAL 250 MG 1 PER
Dermatitis
Estrogen/Progesteron
e
C
WEEK ORAL
Date:06/07/99ISR Number: 3285458-6Report Type:Periodic Company Report #99463 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Burning Sensation Health Lariam (Mefloquine
Headache Professional Hydrochloride) 250
Vomiting Mg PS ORAL 250 MG 1 PER
Nausea
WEEK ORAL
Premarin
C
Date:06/07/99ISR Number: 3285459-8Report Type:Periodic Company Report #99776 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Respiratory Disorder Other Lariam Tablets (
Panic Attack
Mefloquine
Hyperhidrosis Hydrochloride) 250
Delirium Mg PS ORAL 250 MG 1 PER
Nightmare
WEEK ORAL
Hallucination
Pyrexia
Date:06/07/99ISR Number: 3285460-4Report Type:Periodic Company Report #99969 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psoriasis Lariam Tablets
(Mefloquine
Hydrocholride) 25omg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285461-6Report Type:Periodic Company Report #101038 Age:43 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Prostatitis Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) 250

Mg PS ORAL 250 MG 1 PER
WEEK ORAL 42 DAY
03-Apr-2012 09:37 AM Page: 112

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3285462-8Report Type:Periodic Company Report #101838 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypertension Consumer Lariam Tablets
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285463-XReport Type:Periodic Company Report #102345 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cystitis Other Lariam Tablets
Nausea
(Mefloquine
Pyrexia Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285464-1Report Type:Periodic Company Report #102654 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Face Oedema Health Lariam Tablets
Urticaria Professional (Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285465-3Report Type:Periodic Company Report #102931 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Face Oedema Health Lariam Tablets
Lip Disorder Professional (Mefloquine
Skin Irritation Hydrochloride) 250
Rash Erythematous Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285466-5Report Type:Periodic Company Report #103254 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Menstruation Irregular Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250 MG 1 PER
WEEK ORAL

Date:06/07/99ISR Number: 3285467-7Report Type:Periodic Company Report #103331 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Throat Irritation Consumer Lariam Tablets
Alopecia
(Mefloquine
Hydrochloride ) 250
Mg
PS
03-Apr-2012 09:37 AM Page: 113

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Ortho-Novum
C
Date:06/07/99ISR Number: 3285468-9Report Type:Periodic Company Report #103366 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hyperhidrosis Other Lariam Tablets
Asthenia
(Mefloquine
Vomiting Hydrochloride) 250
Nausea Mg PS ORAL 250 MG 1 PER
Feeling Jittery
WEEK ORAL
Pyrexia Prempro C
Retching
Chills
Diarrhoea
Date:06/07/99ISR Number: 3285469-0Report Type:Periodic Company Report #103404 Age:50 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asthenia Health Lariam Tablets
Decreased Appetite Professional (Mefloquine
Depression Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL 42 DAY
Date:06/07/99ISR Number: 3285470-7Report Type:Periodic Company Report #103535 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Eye Disorder Health Lariam Tablets
Nervous System Disorder Professional (Mefloquine
Burning Sensation Hydrochloride) 250
Panic Disorder Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285471-9Report Type:Periodic Company Report #98501 Age:56 YR Gender:Female I/FU:I
Outcome
Disability
PT
Insomnia
Anxiety
Tremor
Myalgia
Balance Disorder
Palpitations
Hallucination
Coma
Muscle Twitching

Pyrexia
Headache
Depression
Cough
Dyspnoea
Fatigue
Extrasystoles
Tachycardia
03-Apr-2012 09:37 AM Page: 114

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dizziness
Paranoia
Report Source Product Role Manufacturer Route Dose Duration
Consumer
Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Aspirin
C
Biaxin
C
Date:06/07/99ISR Number: 3285472-0Report Type:Periodic Company Report #99092 Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Health Lariam Tablets
Initial or Prolonged Professional (Mefoquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285473-2Report Type:Periodic Company Report #100159 Age:75 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Emotional Disorder Consumer Lariam Tablets
Depression Health (Mefloquine
Amnesia Professional Hydrochloride) 250
Gait Disturbance Other Mg PS ORAL 250 MG 1 PER
Fatigue
WEEK ORAL
Dizziness Cimetidine C
Back Disorder Prempro C
Questran
C
Mevacor
C
Date:06/07/99ISR Number: 3285474-4Report Type:Periodic Company Report #101158 Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dry Mouth Consumer Lariam Tablets
Dehydration Other (Mefloquine
Dyspnoea Hydrochloride) 250
Paraesthesia Mg PS ORAL 250 MG 1 PER
Diarrhoea
WEEK ORAL
Dizziness Provera C
Chest Discomfort Cipro C
Coma Calcium C
Herbal
C
Estrace
C
Multivitamin W Iron C

Date:06/07/99ISR Number: 3285475-6Report Type:Periodic Company Report #104590 Age:27 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Anxiety
Insomnia
03-Apr-2012 09:37 AM Page: 115

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Mania
Psychotic Disorder
Psychiatric Symptom Report Source Product Role Manufacturer Route Dose Duration
Coma Health Lariam Tablets
Paranoia Professional (Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285476-8Report Type:Periodic Company Report #104852 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Balance Disorder Consumer Lariam Tablets
Initial or Prolonged Mental Impairment (Mefloquine
Asthenia Hydrochloride) 250
Confusional State Mg PS ORAL 250 MG 1 PER
Constipation
WEEK ORAL
Amnesia Allegra C
Myalgia Wellbutrin C
Hyperhidrosis
Fatigue
Arthralgia
Rash Pustular
Sedation
Coma
Agitation
Hypersensitivity
Date:06/07/99ISR Number: 3285477-XReport Type:Periodic Company Report #105631 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diarrhoea Consumer Lariam Tablets
Initial or Prolonged Coma (Mefloquine
Vomiting Hydrochloride) 250
Dehydration Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285478-1Report Type:Periodic Company Report #106904 Age:77 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypertension Consumer Lariam Tablets
Initial or Prolonged Tremor Other (Mefloquine
Tachycardia Hydrochloride) PS ORAL 80 MG 1 PER
Ventricular Extrasystoles
WEEK ORAL
Multivitamin
C
Folic Acid
C
Flomax
C

Baby Aspirin C
03-Apr-2012 09:37 AM Page: 116

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3285479-3Report Type:Periodic Company Report #107363 Age:77 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Coma Consumer Lariam Tablets
Initial or Prolonged Drug Ineffective Health (Mefloquine
Malaria Professional Hydrochloride) 250
Fatigue Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Accutane
C
Aspirin
C
Tenormin
C
Axid
C
Date:06/07/99ISR Number: 3285480-XReport Type:Periodic Company Report #109779 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Coma Other Lariam Tablets
Bipolar I Disorder
(Mefloquine
Mood Swings Hydrochloride) 250
Hallucination Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285481-1Report Type:Periodic Company Report #110102 Age:67 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Health Lariam Tablets
Initial or Prolonged Confusional State Professional (Mefloquine
Hydrochloride) PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285482-3Report Type:Periodic Company Report #111592 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lethargy Other Lariam Tablets
Initial or Prolonged Dizziness (Mefloquine
Movement Disorder Hydrochloride) 250
Coma Mg PS ORAL ORAL
Vision Blurred Prevacid C
Malaise Zestril C
Tremor
Date:06/07/99ISR Number: 3285483-5Report Type:Periodic Company Report #112271 Age:19 MON Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diarrhoea Health Lariam Tablets

Initial or Prolonged Abdominal Pain Professional (Mefloquine
Hydrochloride) PS ORAL 50 MG 1 PER
WEEK ORAL
Bactrim Paediatric C
03-Apr-2012 09:37 AM Page: 117

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3285484-7Report Type:Periodic Company Report #112461 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Coma Consumer Lariam Tablets
Initial or Prolonged Hyperhidrosis (Mefloquine
Malaria Hydrochloride) PS ORAL 250 MG 1 PER
Drug Ineffective
WEEK ORAL
Dehydration Prilosec C
Leukocytosis
Vomiting
Pyrexia
Chills
Abdominal Pain
Diarrhoea
Lethargy
Date:06/07/99ISR Number: 3285485-9Report Type:Periodic Company Report #112492 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Other Lariam Tablets
Initial or Prolonged Vomiting (Mefloquine
Abdominal Pain Hydrochloride) PS ORAL 250 MG 1 PER
Chills
WEEK ORAL
Chest Pain
Coma
Diarrhoea
Hyperhidrosis
Drug Ineffective
Date:06/07/99ISR Number: 3285486-0Report Type:Periodic Company Report #112582 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Weight Decreased Health Lariam Tablets
Personality Change Professional (Mefloquine
Depression Hydrochloride) PS ORAL 1 DOSE FORM
Anxiety
DAILY ORAL
Coma
Date:06/07/99ISR Number: 3285487-2Report Type:Periodic Company Report #113216 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nausea Health Lariam Tablets
Asthenia Professional (Mefloquine
Paraesthesia Hydrochloride) PS ORAL 250 MG DAILY
Depression
ORAL
Fatigue Lamisil C
Disorientation

Date:06/07/99ISR Number: 3285488-4Report Type:Periodic Company Report #200381 Age:35 YR Gender:Female I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Malaria
Coma
03-Apr-2012 09:37 AM Page: 118

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pyrexia
Drug Ineffective
Chills Report Source Product Role Manufacturer Route Dose Duration
Health
Lariam Tablets
Professional
(Mefloquine
Other Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285489-6Report Type:Periodic Company Report #200388 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Health Lariam Tablets
Coma Professional (Mefloquine
Pyrexia Hydrochloride) 250
Panic Attack Mg PS ORAL 250 MG 1 PER
Tremor
WEEK ORAL
Date:06/07/99ISR Number: 3285530-0Report Type:Periodic Company Report #200733 Age:65 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Consumer Lariam Tablets
Headache
(Mefloquine
Palpitations Hydrochloride) 250
Dizziness Mg PS ORAL 250 MG 1 PER
Chills
WEEK ORAL
Panic Attack
Estrogen (Estrogens
Alopecia Nos) C
Nausea
Progestin (Progestin
Hyperhidrosis Nos) C
Chest Pain
Tremor
Anxiety
Decreased Appetite
Vomiting
Paraesthesia
Date:06/07/99ISR Number: 3285531-2Report Type:Periodic Company Report #200897 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Deafness Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Asa (Aspirin)
C
Ibuprofen

(Ibuprofen) C
03-Apr-2012 09:37 AM Page: 119

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3285532-4Report Type:Periodic Company Report #201043 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Other Lariam Tablets
Asthenia
(Mefloquine
Ear Pain Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285533-6Report Type:Periodic Company Report #202058 Age:43 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Urticaria Consumer Lariam Tablets
Ageusia
(Mefloquine
Pruritus Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285534-8Report Type:Periodic Company Report #202788 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Apathy Consumer Lariam Tablets
Flat Affect
(Mefloquine
Aggression Hydrochloride) 250
Mg PS ORAL 1 PER WEEK
ORAL
Date:06/07/99ISR Number: 3285535-XReport Type:Periodic Company Report #202801 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aggression Other Lariam Tablets
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285536-1Report Type:Periodic Company Report #202966 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disturbance In Attention Consumer Lariam Tablets
Dizziness
(Mefloquine
Nausea Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Hydrochlorothiazide

(Hydrochlorothiazide
) C
03-Apr-2012 09:37 AM Page: 120

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3285537-3Report Type:Periodic Company Report #55872 Age:38 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nausea Consumer Lariam Tablets
Chest Pain Health (Mefloquine
Vomiting Professional Hydrochloride) 250
Decreased Appetite Mg PS ORAL 250 MG 1 PER
Muscle Contractions
WEEK ORAL
Involuntary
Hepatitis A Vaccine
Headache
(Hepatitis A
Palpitations Vaccine) C
Paraesthesia
Extrasystoles
Lethargy
Cough
Upper Respiratory Tract
Infection
Pyrexia
Insomnia
Depression
Oropharyngeal Pain
Temperature Intolerance
Weight Decreased
Influenza Like Illness
Date:06/07/99ISR Number: 3285538-5Report Type:Periodic Company Report #72278 Age:24 YR Gender: I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vision Blurred Consumer Lariam Tablets
Gastrointestinal Disorder
(Mefloquine
Amnesia Hyrdrochloride) 250
Pain Mg PS ORAL 250 MG 1 PER
Pyrexia WEEK ORAL 35 DAY
Ear Pain
Headache
Dizziness
Dyspnoea
Fatigue
Asthenia
Confusional State
Malaise
Palpitations
Date:06/07/99ISR Number: 3285539-7Report Type:Periodic Company Report #97647 Age:58 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Flushing Consumer Lariam Tablets
Pruritus
(Mefloquine
Dermatitis Hydrochloride) 250

Rhinorrhoea Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Premarin (Estrogens,
Conjugated)
C
03-Apr-2012 09:37 AM Page: 121

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3285592-0Report Type:Periodic Company Report #103538 Age:17 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Face Oedema Health Lariam Tablets
Coma Professional (Mefloquine
Oropharyngeal Blistering Hydrochloride) 250
Diarrhoea Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Vivotif "Berna"
(Typhoid Vaccines) SS ORAL 1 DOSE FORM 1
PER 2 DAY
ORAL
Atarax
C
Date:06/07/99ISR Number: 3285593-2Report Type:Periodic Company Report #103551 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Consumer Lariam Tablets
Chills
(Mefloquine
Nausea Hydrochloride) 250
Cold Sweat Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Cytotec
C
Hormone Replacement
Therapy
C
Date:06/07/99ISR Number: 3285594-4Report Type:Periodic Company Report #103573 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pyrexia Other Lariam Tablets
Cold Sweat
(Mefloquine
Hypertension Hydrochloride) 250
Dizziness Mg PS ORAL 250 MG 1 PER
Nausea
WEEK ORAL
Cardizem
C
Vasotec
C
Date:06/07/99ISR Number: 3285595-6Report Type:Periodic Company Report #104147 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Decreased Appetite Other Lariam Tablets
Nausea
(Mefloquine
Tremor Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL

Date:06/07/99ISR Number: 3285596-8Report Type:Periodic Company Report #104270 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abdominal Pain Consumer Lariam Tablets
Gastrointestinal Disorder
(Mefloquine
Flatulence Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
03-Apr-2012 09:37 AM Page: 122

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
WEEK ORAL
Date:06/07/99ISR Number: 3285597-XReport Type:Periodic Company Report #104454 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscle Spasms Consumer Lariam Tablets
Fatigue Health (Mefloquine
Neck Pain Professional Hydrochloride) 250
Chest Pain Mg PS ORAL 250 MG 1 PER
Pain In Extremity
WEEK ORAL
Tri-Levlen
C
Date:06/07/99ISR Number: 3285598-1Report Type:Periodic Company Report #105183 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Flushing Other Lariam Tablets
Hypertension
(Mefloquine
Burning Sensation Hydrochloride) 250
Abdominal Pain Mg PS ORAL 250 MG 1 PER
Headache
WEEK ORAL
Palpitations
Date:06/07/99ISR Number: 3285599-3Report Type:Periodic Company Report #105877 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dermatitis Consumer Lariam Tablets
Breast Discharge
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285600-7Report Type:Periodic Company Report #106528 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Corneal Dystrophy Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 26 PER
YEAR ORAL
Date:06/07/99ISR Number: 3285601-9Report Type:Periodic Company Report #106670 Age:68 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypertension Consumer Lariam Tablets

Tinnitus Health (Mefloquine
Tachycardia Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
DOSE ORAL
03-Apr-2012 09:37 AM Page: 123

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3285602-0Report Type:Periodic Company Report #106792 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dysuria Consumer Lariam Tablets
Burning Sensation
(Mefloquine
Hydrochloride) PS ORAL ORAL
Date:06/07/99ISR Number: 3285603-2Report Type:Periodic Company Report #106988 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Serum Ferritin Abnormal Consumer Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Baycol (Cerivastatin
Sodium) SS ORAL .3 MG DAILY
ORAL
Date:06/07/99ISR Number: 3285604-4Report Type:Periodic Company Report #108987 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Consumer Lariam Tablets
Nausea Other (Mefloquine
Myalgia Hydrochloride) 250
Anxiety Mg PS ORAL 250 MG 1 PER
Arthralgia
WEEK ORAL
Aggression
Cough
Pyrexia
Date:06/07/99ISR Number: 3285605-6Report Type:Periodic Company Report #109650 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vertigo Consumer Lariam Tablets
Joint Swelling Health (Mefloquine
Fatigue Professional Hydrochloride) 250
Dizziness Mg PS ORAL 250 MG 1 PER
Asthenia
WEEK ORAL
Lipitor
C
Lopressor
C
Date:06/07/99ISR Number: 3285606-8Report Type:Periodic Company Report #110173 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Metrorrhagia Consumer Lariam Tablets
Menorrhagia
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Ortho-Cyclen
C
03-Apr-2012 09:37 AM Page: 124

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3285607-XReport Type:Periodic Company Report #110773 Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Emotional Distress Other Lariam Tablets
Emotional Disorder
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285608-1Report Type:Periodic Company Report #111195 Age:60 YR Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Skin Hyperpigmentation Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285609-3Report Type:Periodic Company Report #112630 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fatigue Other Lariam Tablets
Visual Impairment
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/07/99ISR Number: 3285610-XReport Type:Periodic Company Report #200634 Age:10 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Antinuclear Antibody Health Lariam Tablets
Positive Professional (Mefloquine
Neutropenia Hydrochloride) PS ORAL ORAL
Date:06/07/99ISR Number: 3285611-1Report Type:Periodic Company Report #200728 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Alkaline Consumer Lariam Tablets
Phosphatase Increased
(Mefloquine
Hepatic Enzyme Increased Hydrochloride) 250
Condition Aggravated Mg PS ORAL 250 MG 1 PER
Gamma-Glutamyltransferase
WEEK ORAL
Increased

Date:06/09/99ISR Number: 3279221-XReport Type:Expedited (15-DaCompany Report #105648 Age: Gender:Female I/FU:I
Outcome
Other Serious
PT
Cardiac Murmur
Maternal Drugs Affecting
Foetus
Antepartum Haemorrhage
03-Apr-2012 09:37 AM Page: 125

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Premature Baby
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/15/99ISR Number: 3285102-8Report Type:Expedited (15-DaCompany Report #104882 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Circulatory Collapse Foreign Lariam Tablets
Initial or Prolonged Asthenia Consumer (Melfloquine
Tachycardia Health Hydrochloride) 250
Confusional State Professional Mg PS ORAL ORAL
Dizziness
Pyrexia
Disturbance In Attention
Helicobacter Gastritis
Feeling Abnormal
Muscle Spasms
Anxiety
Haematochezia
Cardiovascular Disorder
Arrhythmia
Paraesthesia
Abdominal Pain
Balance Disorder
Restlessness
Ventricular Extrasystoles
Panic Attack
Date:06/15/99ISR Number: 3285108-9Report Type:Expedited (15-DaCompany Report #207710 Age:50 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Condition Aggravated Foreign Lariam Tablets
Initial or Prolonged Menometrorrhagia Other (Mefloquine
Required Hydrochloride) 250
Intervention to Mg PS ORAL 250 MG 1 PER
Prevent Permanent
WEEK ORAL
Impairment/Damage
Date:06/17/99ISR Number: 3286062-6Report Type:Expedited (15-DaCompany Report #207703 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abortion Spontaneous Foreign Lariam Tablets

Initial or Prolonged Other (Mefloquine
Hydrochloride) 50 Mg PS ORAL 50 MG DAILY
ORAL
03-Apr-2012 09:37 AM Page: 126

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/17/99ISR Number: 3286067-5Report Type:Expedited (15-DaCompany Report #207919 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Affective Disorder Foreign Lariam Tablets
Nausea Other (Mefloquine
Abnormal Behaviour Hydrochloride) 250
Crying Mg PS ORAL 250 MG 1 PER
Dizziness
WEEK ORAL
Mental Disorder
Suicidal Ideation
Visual Impairment
Mania
Date:06/17/99ISR Number: 3286250-9Report Type:Expedited (15-DaCompany Report #207220 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Purulent Discharge Foreign Lariam Tablets
Initial or Prolonged Lymphocyte Count Health (Mefloquine
Decreased Professional Hydrochloride) 250mg PS ORAL 250MG 1 PER
Monocyte Count Decreased Other WEEK ORAL
Neutrophil Count
Increased
Headache
Haematocrit Decreased
Nasal Congestion
Lymphocyte Morphology
Abnormal
Bacterial Infection
Foreign Travel
Sinusitis
Pyrexia
Date:06/17/99ISR Number: 3287250-5Report Type:Expedited (15-DaCompany Report #207840 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Torticollis Foreign Lariam Tablets
Initial or Prolonged Gastritis Health (Mefloquine
Influenza Like Illness Professional Hydrochloride) 250
Lymphadenopathy Other Mg PS ORAL 250 MG 1 PER
Flushing WEEK ORAL 122 DAY
Heart Rate Increased
Inflammation
White Blood Cell Count
Increased
Pharyngeal Oedema
Myalgia
Oropharyngeal Pain
Ear Disorder
Malaise

Bacterial Infection
03-Apr-2012 09:37 AM Page: 127

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/22/99ISR Number: 3289600-2Report Type:Expedited (15-DaCompany Report #112331 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Premature Rupture Of Foreign Lariam Tablets
Initial or Prolonged Membranes Health (Mefloquine
Haemoglobin Decreased Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK
Date:06/25/99ISR Number: 3292126-3Report Type:Expedited (15-DaCompany Report #208431 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Visual Acuity Reduced Consumer Lariam Tablets
Required Vision Blurred Health (Mefloquine
Intervention to Cataract Operation Professional Hydrochloride) 250
Prevent Permanent Foreign Travel Mg PS ORAL 250 MG 1 PER
Impairment/Damage Cataract WEEK ORAL
Date:06/29/99ISR Number: 3294566-5Report Type:Expedited (15-DaCompany Report #208430 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hearing Impaired Foreign Lariam Tablets
Other
(Mefloquine
Hydrochloride) PS ORAL ORAL
Date:06/29/99ISR Number: 3294570-7Report Type:Expedited (15-DaCompany Report #208480 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Foreign Lariam Tablets
Drug Ineffective Health (Mefloquine
Haemolytic Anaemia Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/30/99ISR Number: 3295144-4Report Type:Expedited (15-DaCompany Report #208901 Age:61 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Decreased Appetite
Gastric Haemorrhage
Mucosal Erosion
Pyrexia
Constipation
Malaria
Haematemesis
Dyspnoea

Ascites
Oesophageal Disorder
Abdominal Distension
Chills
Drug Ineffective
Haematocrit Decreased
Oedema Peripheral
Blood Albumin Decreased
03-Apr-2012 09:37 AM Page: 128

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Gastritis Erosive
Haemoglobin Decreased
Condition Aggravated Report Source Product Role Manufacturer Route Dose Duration
Faeces Discoloured Consumer Lariam Tablets
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Rezulin
C
Aspirin
C
Glucotrol
C
Date:07/09/99ISR Number: 3300329-4Report Type:Expedited (15-DaCompany Report #209222 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Supraventricular Foreign Lariam Tablets
Initial or Prolonged Tachycardia Health (Mefloquine
Professional Hydrochloride) 250
Other Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:07/09/99ISR Number: 3300636-5Report Type:Expedited (15-DaCompany Report #203230 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paraesthesia Health Lariam Tablets
Initial or Prolonged Cough Professional (Mefloquine
Required Nausea Hydrochloride) 250
Intervention to Anxiety Mg PS ORAL 250 MG 1 PER
Prevent Permanent Asthma WEEK ORAL
Impairment/Damage Panic Attack
Dyspnoea
Tinnitus
Dehydration
Chest Discomfort
Vomiting
Pyrexia
Date:07/13/99ISR Number: 3302667-8Report Type:Expedited (15-DaCompany Report #208480 Age:21 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Ineffective Foreign Lariam PS ORAL 250 MG 1 PER
Pyrexia Health WEEK ORAL
Haemolytic Anaemia
Professional
Malaria

Date:07/14/99ISR Number: 3303518-8Report Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disorientation Lariam 250mg PS ORAL 1 PILL WEEKLY
Skin Discolouration
ORALLY
Confusional State Estra C
Nail Disorder
Pain In Extremity
03-Apr-2012 09:37 AM Page: 129

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/16/99ISR Number: 3305371-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Consumer Lariam PS ORAL 250 MG 1X WK
Neurological Symptom
ORALLY
Hallucination, Tactile
Restlessness
Palpitations
Agitation
Date:07/21/99ISR Number: 3308458-6Report Type:Expedited (15-DaCompany Report #210488 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Thrombotic Foreign Lariam Tablets
Initial or Prolonged Thrombocytopenic Purpura Other (Mefloquine
Hydrochloride) PS ORAL 1 DOSE FORM 1
PER ONE DOSE
ORAL
Date:07/23/99ISR Number: 3309996-2Report Type:Expedited (15-DaCompany Report #203230 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Tinnitus Health Lariam Tablets
Initial or Prolonged Paraesthesia Professional (Mefloquine
Required Dehydration Hydrochloride) 250
Intervention to Chest Discomfort Mg PS ORAL 250 MG 1 PER
Prevent Permanent Anxiety WEEK ORAL
Impairment/Damage Vomiting
Cough
Pyrexia
Dyspnoea
Date:07/30/99ISR Number: 3315299-2Report Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Consumer Lariam Tablets
Initial or Prolonged Coordination Abnormal Health (Mefloquine
Bipolar Disorder Professional Hydrochloride) 250
Hypersensitivity Mg PS ORAL 250 MG 1 PER
Tremor
WEEK ORAL
Pyrexia
Lithium (Lithium
Flatulence Nos) SS ORAL 300 MG DAILY
Circulatory Collapse
ORAL
Balance Disorder Lorazepam C
Chest Discomfort Atenolol C
Palpitations
Diarrhoea

Disorientation
Psychotic Disorder
Abdominal Pain
Chest Pain
Vomiting
Syncope
03-Apr-2012 09:37 AM Page: 130

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/02/99ISR Number: 3316743-7Report Type:Expedited (15-DaCompany Report #211408 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Foreign Mefloquine
Dizziness Other Hydrochloride(Mefloq
Suicidal Ideation
uine Hydrochloride)
250 Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Antibiotics Nos C
Date:08/02/99ISR Number: 3316746-2Report Type:Expedited (15-DaCompany Report #211405 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaria Foreign Lariam Tablets
Initial or Prolonged Mood Swings Other (Mefloquine
Abnormal Dreams Hydrochloride) PS ORAL 500 MG 1 PER
Paraesthesia
WEEK ORAL
Condition Aggravated Flucloxacillin C
Pyrexia Amoxycillin C
Malaise
Toxicity To Various
Agents
Chest Pain
Foreign Travel
Agitation
Personality Change
Chills
Headache
Diarrhoea
Anxiety
Date:08/03/99ISR Number: 3316753-XReport Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Consumer Lariam Tablets
Initial or Prolonged Abdominal Pain Health (Mefloquine
Pruritus Professional Hydrochloride) 250
White Blood Cell Count Mg PS ORAL 250 MG 1 PER
Increased
WEEK ORAL
Pyrexia
Lithium (Lithium
Mania Nos) SS ORAL 300 MG DAILY
Drug Hypersensitivity
ORAL
Urticaria Lorazepam C
Nausea Atenolol C
Circulatory Collapse
Coordination Abnormal
Vomiting Projectile
Chest Pain
Medication Error

Chest Discomfort
Diarrhoea
Bipolar Disorder
Palpitations
Tremor
Flatulence
03-Apr-2012 09:37 AM Page: 131

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/03/99ISR Number: 3316767-XReport Type:Expedited (15-DaCompany Report #211570 Age:1 HR Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Heart Valve Replacement Foreign Lariam Tablets
Maternal Drugs Affecting Health (Mefloquine
Foetus Professional Hydrochloride) 250
Heart Disease Congenital Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:08/10/99ISR Number: 3322744-5Report Type:Expedited (15-DaCompany Report #211814 Age:67 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diabetes Mellitus Foreign Lariam Tablets
Initial or Prolonged Diarrhoea Health (Mefloquine
Nephrolithiasis Professional Hydrochloride) 250
Other Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:08/10/99ISR Number: 3322745-7Report Type:Expedited (15-DaCompany Report #211998 Age:61 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pain In Extremity Foreign Lariam Tablets
Gastritis Erosive Health (Mefloquine
Gamma-Glutamyltransferase Professional Hydrochloride) 250
Increased Mg PS ORAL 250 MG 1 PER
Polyneuropathy
WEEK ORAL
Diverticulum
Date:08/10/99ISR Number: 3322775-5Report Type:Expedited (15-DaCompany Report #206437 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Retinopathy Consumer Lariam Tablets
Iris Atrophy Health (Mefloquine
Visual Impairment Professional Hydrochloride) 250
Vitreous Disorder Mg PS ORAL 250 MG 1 PER
Medication Error
WEEK ORAL
Visual Field Defect
Date:08/12/99ISR Number: 3324870-3Report Type:Expedited (15-DaCompany Report #208901 Age:61 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Ascites
Oesophageal Disorder
Drug Ineffective
Pyrexia

Malaria
Oedema Peripheral
Gastric Haemorrhage
Blood Albumin Decreased
Chills
Abdominal Distension
Dyspnoea
Haematemesis
03-Apr-2012 09:37 AM Page: 132

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Phlebitis
Hepatitis
Constipation Report Source Product Role Manufacturer Route Dose Duration
Faeces Discoloured Consumer Lariam Tablets
Intervertebral Disc
(Mefloquine
Disorder Hydrochloride) 250
Mucosal Erosion Mg PS ORAL 250 MG 1 PER
Haemoglobin Decreased
WEEK ORAL
Haematocrit Decreased Rezulin C
Gastrointestinal Aspirin C
Haemorrhage Glucotrol C
Date:08/12/99ISR Number: 3324875-2Report Type:Expedited (15-DaCompany Report #212598 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Haematuria Health Lariam Tablets
Nephrolithiasis Professional (Mefloquine
Hydrochloride) PS ORAL ORAL
Date:08/17/99ISR Number: 3327902-1Report Type:Expedited (15-DaCompany Report #205574 Age:46 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Foreign Lariam Tablets
Initial or Prolonged Eye Movement Disorder Consumer (Mefloquine
Visual Field Defect Health Hydrochloride) 250
Vision Blurred Professional Mg PS ORAL 250 MG 1 PER
Nausea
WEEK ORAL
Nystagmus
Dizziness
Arthropod Bite
Vertigo
Cerebellar Syndrome
Disturbance In Attention
Coordination Abnormal
Phobia
Date:08/17/99ISR Number: 3327972-0Report Type:Expedited (15-DaCompany Report #202262 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viiith Nerve Lesion Consumer Lariam Tablets
Deafness
(Mefloquine
Diarrhoea Hydrochloride) 250
Restlessness Mg PS ORAL 250 MG 1 PER
Vertigo
WEEK ORAL
Anxiety Hormone Replacement C
Intervertebral Disc
Protrusion

Ototoxicity
Insomnia
Flatulence
Nystagmus
Abdominal Pain Lower
Dizziness
03-Apr-2012 09:37 AM Page: 133

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/17/99ISR Number: 3328019-2Report Type:Expedited (15-DaCompany Report #211301 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Brachial Plexopathy Foreign Lariam Tablets
Paralysis Health (Mefloquine
Foreign Travel Professional Hydrochloride) 250
Neuropathy Peripheral Mg PS ORAL 250 MG 1 PER
Muscular Weakness
Desmopressin
(Desmopressin
Acetate)
C
WEEK ORAL
Date:08/17/99ISR Number: 3328996-XReport Type:Direct Company Report # Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Insomnia Health Mefloquin / 125 Mg PS 1TBL/ 1 TBL
Dyspepsia
Professional
Asthenia
Fatigue
Decreased Appetite
Malaise
Diarrhoea
Weight Decreased
Apathy
Depression
Dysphoria
Mental Impairment
Decreased Activity
Date:08/19/99ISR Number: 3330225-8Report Type:Expedited (15-DaCompany Report #213079 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Myelodysplastic Syndrome Foreign Lariam Tablets
Seronegative Arthritis Other (Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Ciprofloxacin
(Ciprofloxacin) SS ORAL 500 MG DAILY
ORAL
Doxycycline
C
Erythromycin
C
Date:08/24/99ISR Number: 3333682-6Report Type:Expedited (15-DaCompany Report #213259 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyspnoea Foreign Lariam Tablets

Initial or Prolonged Erythema Health (Mefloquine
Urticaria Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
1 WEEK ORAL
03-Apr-2012 09:37 AM Page: 134

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/25/99ISR Number: 3333861-8Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Larium / 250 Mg /
Initial or Prolonged Sedation Hoffman La Roche PS Hoffman Laroche 250MG ONCE A
Other Serious Bite WEEK
Movement Disorder
Loss Of Consciousness
Eye Movement Disorder
Crying
Date:08/26/99ISR Number: 3334601-9Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Lariam, 250mg, La
Amnesia Roche PS La Roche 1 PILL/WK
Fatigue
(LATE
Abnormal Dreams JUNE-JULY) 6 WK
Dizziness Immunization For Tb C
Cold Sweat
Immunization For
Malaise Polio C
Chills
Immunization For
Pyrexia Yellow Fever C
Panic Attack
Immunization For Hep
Anxiety A C
Date:08/26/99ISR Number: 3335379-5Report Type:Expedited (15-DaCompany Report #213489 Age:1 HR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Deafness Congenital Other Lariam Tablets
Maternal Drugs Affecting
(Mefloquine
Foetus Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:08/31/99ISR Number: 3338457-XReport Type:Expedited (15-DaCompany Report #213701 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Agitation Foreign Lariam Tablets
Initial or Prolonged Malaria Other (Mefloquine
Personality Change Hydrochloride) 250
Drug Ineffective Mg PS ORAL 250 MG 1 PER
Sedation
WEEK ORAL
Toxicity To Various Polio Vaccination C
Agents
Yellow Fever Vaccine C
Tetanus Vaccines C
Havrix
C

Typhoid Vaccines C
03-Apr-2012 09:37 AM Page: 135

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/31/99ISR Number: 3338460-XReport Type:Expedited (15-DaCompany Report #213852 Age:64 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Tinnitus Foreign Lariam Tablets
Intervention to Hearing Impaired Health (Mefloquine
Prevent Permanent Professional Hydrochloride) 250
Impairment/Damage Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Thyroid Medication C
Date:09/02/99ISR Number: 3339917-8Report Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Circulatory Collapse Consumer Lariam Tablets
Initial or Prolonged White Blood Cell Count Health (Mefloquine
Increased Professional Hydrochloride) 250
Chest Discomfort Mg PS ORAL 250 MG 1 PER
Vomiting Projectile
WEEK ORAL
Drug Hypersensitivity
Lithium (Lithium
Diarrhoea Nos) SS ORAL 300 MG DAILY
Coordination Abnormal
ORAL
Mania Lorazepam C
Palpitations Atenolol C
Urticaria
Pyrexia
Flatulence
Insomnia
Abdominal Pain
Pruritus
Chest Pain
Bipolar Disorder
Tremor
Date:09/03/99ISR Number: 3342519-0Report Type:Expedited (15-DaCompany Report #214112 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Intracranial Pressure Foreign Lariam Tablets
Initial or Prolonged Increased Health (Mefloquine
Fatigue Professional Hydrochloride) 250
Papilloedema Mg PS ORAL 250 MG 1 PER
Diplopia
WEEK ORAL
Oedema Peripheral
Contraceptive
Headache (Contraceptive Nos) C
Date:09/09/99ISR Number: 3344621-6Report Type:Expedited (15-DaCompany Report #214408 Age:43 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Muscle Rigidity Consumer Lariam Tablets
Malaise
(Mefloquine
Pain Hydrochloride) 250
Tremor Mg PS ORAL 250 MG 1 PER
Foreign Travel
WEEK ORAL
Parkinson'S Disease
03-Apr-2012 09:37 AM Page: 136

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/14/99ISR Number: 3347516-7Report Type:Expedited (15-DaCompany Report #214499 Age:17 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Alopecia Other Lariam Tablets
Amenorrhoea
(Mefloquine
Abdominal Pain Hydrochloride) 250
Infertility Mg PS ORAL 250 MG 1 PER
Diarrhoea
WEEK ORAL
Date:09/14/99ISR Number: 3347543-XReport Type:Expedited (15-DaCompany Report #214801 Age:61 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatitis C Other Lariam Tablets
Oedema
(Mefloquine
Dyspnoea Hydrochloride) 250
Condition Aggravated Mg PS ORAL 250 MG 1 PER
Heart Rate Irregular
WEEK ORAL
Date:09/14/99ISR Number: 3347546-5Report Type:Expedited (15-DaCompany Report #214510 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myocarditis Foreign Lariam Tablets
Initial or Prolonged Sweat Gland Disorder Health (Mefloquine
Hormone Level Abnormal Professional Hydrochloride) 250
Thyroid Atrophy Mg PS ORAL 250 MG 1 PER
Constipation
WEEK ORAL
Amenorrhoea
Echo Virus Infection
Viral Infection
Decreased Appetite
Alcohol Intolerance
Asthenia
Oligomenorrhoea
Paraesthesia
Feeling Cold
Hypotension
Blood Thyroid Stimulating
Hormone Abnormal
Hypothyroidism
Bradycardia
Autonomic Nervous System
Imbalance
Syncope
Date:09/22/99ISR Number: 3354848-5Report Type:Expedited (15-DaCompany Report #215354 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Embolism Arterial Foreign Lariam Tablets
Initial or Prolonged Peripheral Ischaemia Health (Mefloquine
Cardiac Fibrillation Professional Hydrochloride) 250
Mg PS ORAL ORAL
03-Apr-2012 09:37 AM Page: 137

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/22/99ISR Number: 3354987-9Report Type:Expedited (15-DaCompany Report #215735 Age:47 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Foreign Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Prochlorperazine C
Date:09/23/99ISR Number: 3356130-9Report Type:Expedited (15-DaCompany Report #215428 Age:66 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Consumer Lariam Tablets
Initial or Prolonged Oliguria Other (Mefloquine
Panic Reaction Hydrochloride) 250
Agitation Mg PS ORAL 250 MG 1
Dehydration
PER WEEK
Urinary Retention
ORAL
Tamoxifen
C
Fosamax
C
Date:09/23/99ISR Number: 3356132-2Report Type:Expedited (15-DaCompany Report #215861 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Circulatory Collapse Foreign Lariam Tablets
Electrocardiogram Qt Health (Mefloquine
Prolonged Professional Hydrochloride) 250
Heart Rate Decreased Mg PS ORAL 250 MG 1
PER WEEK
ORAL
Date:09/23/99ISR Number: 3356134-6Report Type:Expedited (15-DaCompany Report #214112 Age:18 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Oedema Peripheral Foreign Lariam Tablets
Initial or Prolonged Benign Intracranial Health (Mefloquine
Hypertension Professional Hydrochloride) 250
Vith Nerve Paralysis Mg PS ORAL 250 MG 1
Papilloedema
PER WEEK
Diplopia
ORAL
Contraceptive
C
Date:09/23/99ISR Number: 3356136-XReport Type:Expedited (15-DaCompany Report #215743 Age:47 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Palpitations Foreign Lariam Tablets
Initial or Prolonged Malaria Health (Mefloquine
Abdominal Pain Professional Hydrochloride) 250
Nodal Arrhythmia Mg PS ORAL 250 MG 1
Paraesthesia
PER WEEK
Syncope
ORAL
03-Apr-2012 09:37 AM Page: 138

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/23/99ISR Number: 3356139-5Report Type:Expedited (15-DaCompany Report #215573 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Screaming Foreign Lariam Tablets
Initial or Prolonged Anxiety Other (Mefloquine
Dizziness Hydrochloride) 250
Disturbance In Attention Mg PS ORAL 250 MG 1
Crying
PER WEEK
Tremor
ORAL
Arrhythmia
Emotional Disorder
Confusional State
Hyperventilation
Nausea
Arthralgia
Headache
Pain In Extremity
Date:09/27/99ISR Number: 3359736-6Report Type:Expedited (15-DaCompany Report #215834 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thrombotic Foreign Lariam Tablets
Thrombocytopenic Purpura Health (Mefloquine
Professional Hydrochloride) 250
Other Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:09/28/99ISR Number: 3360051-5Report Type:Expedited (15-DaCompany Report #215428 Age:66 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Oliguria Consumer Lariam Tablets
Initial or Prolonged Insomnia Health (Mefloquine
Dehydration Professional Hydrochloride) 250
Panic Reaction Mg PS ORAL 250 MG 1 PER
Anxiety
WEEK
Urinary Retention
Tamoxifen (Tamoxifen
Agitation Citrate) C
Circadian Rhythm Sleep
Fosamax (Alendronate
Disorder Sodium) C
Date:09/28/99ISR Number: 3360064-3Report Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Chest Pain
Vomiting Projectile
Mania
Coordination Abnormal

Bipolar Disorder
White Blood Cell Count
Increased
Drug Hypersensitivity
Psychotic Disorder
Circulatory Collapse
Pruritus
Pyrexia
03-Apr-2012 09:37 AM Page: 139

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Chest Discomfort
Urticaria
Insomnia Report Source Product Role Manufacturer Route Dose Duration
Abdominal Pain Consumer Lariam Tablets
Palpitations Health (Mefloquine
Disorientation Professional Hydrochloride) 250
Tremor Mg PS ORAL 250 MG 1 PER
Vomiting
Diarrhoea
WEEK
Lithium (Lithium
Nos) SS ORAL 300 MG DAILY
Lorazepam
(Lorazepam)
Atenolol (Atenolol)
C
C
Date:09/28/99ISR Number: 3360067-9Report Type:Expedited (15-DaCompany Report #216020 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Eclampsia Foreign Lariam Tablets
Pregnancy Health (Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
1 WEEK
Moneva (Ethinyl
Estradiol/Gestodine) C
Date:09/28/99ISR Number: 3360071-0Report Type:Expedited (15-DaCompany Report #215907 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Speech Disorder Health Lariam Tablets
Nervousness Professional (Mefloquine
Psychotic Disorder Other Hydrochloride) 250
Agitation Mg PS ORAL 250 MG 1 PER
Suicidal Ideation
Anxiety
Oral Contraception
(Oral Contraceptive
Nos)
C
WEEK
Date:09/28/99ISR Number: 3361765-3Report Type:Expedited (15-DaCompany Report #215928 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypervitaminosis Health Lariam Tablets
Initial or Prolonged Hepatitis Professional (Mefloquine
Liver Function Test Hydrochloride) 250
Abnormal Mg PS ORAL 250 MG 1 PER
Blood Bilirubin Increased
WEEK ORAL
Foreign Travel
Vitamin Nos (Vitamin
Jaundice Nos) SS

Kernicterus
03-Apr-2012 09:37 AM Page: 140

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/28/99ISR Number: 3361769-0Report Type:Expedited (15-DaCompany Report #211998 Age:61 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diverticulum Intestinal Foreign Lariam Tablets
Initial or Prolonged Gastritis Erosive Health (Mefloquine
Required Paraesthesia Professional Hydrochloride) 250
Intervention to Csf Protein Increased Mg PS ORAL 250 MG 1 PER
Prevent Permanent Peripheral Sensory WEEK ORAL
Impairment/Damage Neuropathy
Gamma-Glutamyltransferase
Increased
Pain In Extremity
Date:10/01/99ISR Number: 3362900-3Report Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abdominal Pain Consumer Lariam Tablets
Initial or Prolonged Hypersensitivity Health (Mefloquine
Condition Aggravated Professional Hydrochloride) 250
Urticaria Mg PS ORAL 250 MG 1 PER
Pyrexia
WEEK ORAL
Dry Skin
Lithium (Lithium
Circulatory Collapse Nos) SS ORAL 300 MG DAILY
Coordination Abnormal
ORAL
Chest Discomfort
Lorazepam
Vomiting (Lorazepam) C
Bipolar Disorder Atenolol (Atenolol) C
Tremor
White Blood Cell Count
Increased
Diarrhoea
Pruritus
Flatulence
Insomnia
Palpitations
Vomiting Projectile
Date:10/01/99ISR Number: 3363208-2Report Type:Expedited (15-DaCompany Report #216164 Age:13 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Asthenia Foreign Lariam Tablets
Initial or Prolonged Neuropathy Peripheral Health (Mefloquine
Fatigue Professional Hydrochloride) PS ORAL 250 MG 3 PER
Aggression
DAY ORAL
Sleep Disorder
Gait Disturbance
Fansidar
(Pyrimethamine/Sulad
oxine)
C

Date:10/01/99ISR Number: 3363211-2Report Type:Expedited (15-DaCompany Report #211301 Age:16 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paralysis Foreign Lariam Tablets
Muscular Weakness Health (Mefloquine
Neuropathy Peripheral Professional Hydrochloride) 250
Other Mg PS ORAL 250 MG 1 PER
03-Apr-2012 09:37 AM Page: 141

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Desmopressin
(Desmopressin
Acetate)
C
WEEK ORAL
Date:10/01/99ISR Number: 3363214-8Report Type:Expedited (15-DaCompany Report #213623 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Foreign Lariam Tablets
Foetus Health (Mefloquine
Pregnancy Professional Hydrochloride) 250
Foetal Distress Syndrome Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Jodetten (Potassium
Iodine)
C
Vitaferro (Ferrous
Sulfate)
C
Lafol (Folic Acid) C
Date:10/05/99ISR Number: 3364678-6Report Type:Expedited (15-DaCompany Report #215428 Age:66 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Consumer Lariam Tablets
Initial or Prolonged Urinary Retention Other (Mefloquine
Disability Agitation Hydrochloride) 250mg PS ORAL 250 MG 1 PER
Panic Attack
WEEK ORAL
Oliguria
Tamoxifen (Tamoxifen
Urinary Tract Infection Citrate) C
Dehydration
Fosamax (Alendronate
Anxiety Sodium) C
Date:10/05/99ISR Number: 3364679-8Report Type:Expedited (15-DaCompany Report #215735 Age:47 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Foreign Lariam Tablets
Decreased Activity Health (Mefloquine
Professional Hydrochloride) 250mg PS ORAL 250 MG 1 PER
WEEK ORAL
Prochlorperazine
(Prochlorperazine) C
Date:10/08/99ISR Number: 3369296-1Report Type:Expedited (15-DaCompany Report #216832 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Back Pain Health Lariam Tablets
Initial or Prolonged Nervous System Disorder Professional (Mefloquine

Grand Mal Convulsion Hydrochloride) 250
Movement Disorder Mg PS ORAL 250 MG 1
Gait Disturbance
PER WEEK
Foreign Travel
ORAL
Loss Of Consciousness
03-Apr-2012 09:37 AM Page: 142

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/13/99ISR Number: 3371543-7Report Type:Expedited (15-DaCompany Report #216747 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Skin Discolouration Other Lariam Tablets
Emotional Disorder
(Mefloquine
Injury Hydrochloride) 250mg PS ORAL 250 MG 1 PER
Lichen Planus
WEEK ORAL
Date:10/13/99ISR Number: 3371544-9Report Type:Expedited (15-DaCompany Report #216810 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Emotional Disorder Other Lariam Tablets
Lichen Planus
(Mefloquine
Skin Discolouration Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:10/13/99ISR Number: 3371546-2Report Type:Expedited (15-DaCompany Report #206437 Age:37 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Scintillating Scotoma Health Lariam Tablets
Retinopathy Professional (Mefloquine
Retinal Depigmentation Other Hydrochloride) 250
Iris Atrophy Mg PS ORAL 250 MG 1 PER
Macular Oedema
WEEK ORAL
Visual Field Defect
Pigmentation Disorder
Visual Impairment
Vitreous Disorder
Date:10/13/99ISR Number: 3371556-5Report Type:Expedited (15-DaCompany Report #216859 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Skin Discolouration Other Lariam Tablets
Lichen Planus
(Mefloquine
Emotional Disorder Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:10/14/99ISR Number: 3372847-4Report Type:Expedited (15-DaCompany Report #217046 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Sudden Death Foreign Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250

Mg PS ORAL ORAL
Na
SS
Paludrine
(Choroguanide
Hydrochloride) C
Diane 35
(Cyproterone
Acetate/Ethinyl
03-Apr-2012 09:37 AM Page: 143

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Estradiol)
C
Date:10/14/99ISR Number: 3372852-8Report Type:Expedited (15-DaCompany Report #216957 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nausea Foreign Lariam Tablets
Initial or Prolonged Fatigue Other (Mefloquine
Arthralgia Hydrochloride) 250
Hepatic Fibrosis Mg PS ORAL 250 MG 1 PER
Autoimmune Hepatitis
WEEK ORAL
Liver Function Test Na SS
Abnormal
Dpt Injection
Bile Duct Stone
(Diphtheria
Blood Bilirubin Increased
Toxoid/Pertussis
Hepatic Pain
Vaccine/Tetanus
Jaundice Toxoid) C
Hepatomegaly
Immunoglobulin Human
Normal (Globulin,
Immune)
C
Date:10/14/99ISR Number: 3372855-3Report Type:Expedited (15-DaCompany Report #216944 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Abortion Spontaneous Foreign Lariam Tablets
Maternal Drugs Affecting Other (Mefloquine
Foetus Hydrochloride) 250
Limb Malformation Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Na
SS
Date:10/15/99ISR Number: 3372126-5Report Type:Direct Company Report # Age:67 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Health Lariam 250mg Po PS ORAL 250 MG PO QWK
Acute Stress Disorder Professional TOOK 1/2
TABLET BIW 3 MON
Date:10/15/99ISR Number: 3374199-2Report Type:Expedited (15-DaCompany Report #216908 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Autoimmune Hepatitis Health Lariam Tablets
Initial or Prolonged Blood Bilirubin Increased Professional (Mefloquine
Gamma-Glutamyltransferase Hydrochloride) 250mg PS ORAL 250 MG 1 PER
Increased
1 WEEK ORAL
Jaundice
Polio Vaccine
Aspartate
(Poliomyelitis

Aminotransferase Vaccines) C
Increased
Hepatitis B Vaccine
Alanine Aminotransferase
(Hepatitis B Virus
Increased
Vaccine Inactivated) C
03-Apr-2012 09:37 AM Page: 144

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/18/99ISR Number: 3377417-XReport Type:Expedited (15-DaCompany Report #200442 Age:36 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Haemolytic Anaemia Health Lariam Tablets
Anaemia Professional (Mefloquine/Hydrochl
Foreign Travel oride) 250 Mg PS ORAL 250 MG 1 PER
Haptoglobin Decreased
WEEK ORAL
Blood Bilirubin Increased
Jaundice
Diarrhoea
Reticulocyte Count
Increased
Date:10/19/99ISR Number: 3375976-4Report Type:Expedited (15-DaCompany Report #215628 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cytogenetic Abnormality Foreign Lariam Tablets
Pregnancy Health (Mefloquine
Neck Deformity Professional Hydrochloride) 250
Maternal Drugs Affecting Mg PS ORAL 250 MG 1 PER
Foetus
WEEK ORAL
Ultrasound Scan Abnormal
Date:10/19/99ISR Number: 3376135-1Report Type:Expedited (15-DaCompany Report #215861 Age:51 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pulse Absent Foreign Lariam Tablets
Initial or Prolonged Circulatory Collapse Health (Mefloquine
Electrocardiogram Qt Professional Hydrochloride) 250
Prolonged Other Mg PS ORAL 250 MG 1 PER
Cholinergic Syndrome
WEEK ORAL
Date:10/19/99ISR Number: 3376138-7Report Type:Expedited (15-DaCompany Report #217368 Age:61 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chills Foreign Lariam Tablets
Initial or Prolonged Red Blood Cell Other (Mefloquine
Sedimentation Rate Hydrochloride) 250
Increased Mg PS ORAL 250 MG 1 PER
Liver Function Test
WEEK ORAL
Abnormal
Arthralgia
Pyrexia
Date:10/21/99ISR Number: 3378793-4Report Type:Expedited (15-DaCompany Report #216747 Age: Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Injury Other Lariam Tablets
Lichen Planus
(Mefloquine
Emotional Disorder Hydrochloride) 250
Family Stress Mg PS ORAL 250 MG 1 PER
Skin Discolouration
WEEK ORAL
03-Apr-2012 09:37 AM Page: 145

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/21/99ISR Number: 3378796-XReport Type:Expedited (15-DaCompany Report #216859 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Skin Discolouration Other Lariam Tablets
Emotional Disorder
(Mefloquine
Lichen Planus Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:10/25/99ISR Number: 3381772-4Report Type:Expedited (15-DaCompany Report #215928 Age:35 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Jaundice Health Lariam Tablets
Initial or Prolonged Liver Function Test Professional (Mefloquine
Abnormal Hydrochloride) 250
Hypervitaminosis Mg PS ORAL 250 MG 1 PER
Blood Bilirubin Increased
Vitamin Nos (Vitamin
Nos)
SS
WEEK ORAL
Date:10/25/99ISR Number: 3382580-0Report Type:Expedited (15-DaCompany Report #217696 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Sleep Disorder Foreign Lariam Tablets
Balance Disorder Other (Mefloquine
Weight Decreased Hydrochloride) 250
Memory Impairment Mg PS ORAL 250 MG 1 PER
Decreased Appetite
WEEK ORAL
Visual Impairment
Date:10/27/99ISR Number: 3383793-4Report Type:Expedited (15-DaCompany Report #217808 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaise Foreign Lariam Tablets
Initial or Prolonged Depressed Mood Health (Mefloquine
Hallucination Professional Hydrochloride) 250
Memory Impairment Other Mg PS ORAL 250 MG 1 PER
Insomnia
WEEK ORAL
Confusional State
Anxiety
Decreased Appetite
Restlessness
Foreign Travel
Visual Impairment
Balance Disorder
Diarrhoea

Date:10/28/99ISR Number: 3383896-4Report Type:Expedited (15-DaCompany Report #206437 Age:37 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Iris Atrophy
Retinopathy
Macular Oedema
03-Apr-2012 09:37 AM Page: 146

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Iris Disorder
Visual Impairment
Retinal Pigmentation Report Source Product Role Manufacturer Route Dose Duration
Vitreous Disorder Health Lariam Tablets
Professional
(Mefloquine
Other Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK
Date:10/29/99ISR Number: 3386323-6Report Type:Expedited (15-DaCompany Report #217046 Age:27 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Brain Oedema Foreign Lariam Tablets
Sudden Death Health (Mefloquine
Pulmonary Oedema Professional Hydrochloride) 250
Toxicity To Various Mg PS ORAL 250 MG 1 PER
Agents
1 WEEK ORAL
Cyanosis Diane 35
Pulmonary Congestion
(Cyproterone
Toxicologic Test Abnormal
Acetate/Ethinyl
Estradiol)
C
Ethyl Alcohol
(Alcohol)
C
Paludrine
(Chloroguanide
Hydrochloride) C
Date:10/29/99ISR Number: 3386327-3Report Type:Expedited (15-DaCompany Report #218344 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Haemangioma Foreign Lariam Tablets
Abortion Induced Other (Mefloquine
Foetal Disorder Hydrochloride) 250
Maternal Drugs Affecting Mg PS ORAL 250 MG 1 PER
Foetus
WEEK ORAL
Date:11/01/99ISR Number: 3387632-7Report Type:Expedited (15-DaCompany Report #202330 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Maternal Drugs Affecting Foreign Lariam Tablets
Foetus Health (Mefloquine
Pregnancy Professional Hydrochloride) 250
Ventricular Septal Defect Mg PS ORAL 250 MG 1
PER WEEK
ORAL

Date:11/04/99ISR Number: 3388785-7Report Type:Expedited (15-DaCompany Report #209222 Age:27 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Supraventricular Foreign Lariam Tablets
Initial or Prolonged Tachycardia Health (Mefloquine
Professional Hydrochloride) 250
Other Mg PS ORAL 250 MG 1
03-Apr-2012 09:37 AM Page: 147

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
PER WEEK
ORAL
Date:11/04/99ISR Number: 3388786-9Report Type:Expedited (15-DaCompany Report #104160 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Tricuspid Valve Foreign Lariam Tablets
Required Incompetence Health (Mefloquine
Intervention to Cardiomegaly Professional Hydrochloride) 250
Prevent Permanent Heart Disease Congenital Mg PS ORAL 250 MG 1
Impairment/Damage Pregnancy PER WEEK
Maternal Drugs Affecting
ORAL
Foetus
Cyanosis Neonatal
Date:11/04/99ISR Number: 3388787-0Report Type:Expedited (15-DaCompany Report #218871 Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Foreign Lariam Tablets
Initial or Prolonged Visual Field Defect Health (Mefloquine
Anxiety Professional Hydrochloride) 250
Nightmare Mg PS ORAL 250 MG 1
PER WEEK
ORAL
Pondocillin
(Pivampicillin
Hydrochloride) C
Klorokinfosfat
(Chloroquine
Phosphate)
C
Date:11/05/99ISR Number: 3390188-6Report Type:Expedited (15-DaCompany Report #218942 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Foreign Lariam Tablets
Electroencephalogram Health (Mefloquine
Abnormal Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:11/09/99ISR Number: 3391768-4Report Type:Expedited (15-DaCompany Report #218954 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Foreign Lariam PS ORAL 250 MG 1 PER
Initial or Prolonged Delusion Health WEEK
Muscle Disorder
Professional

Hypotonia
Cachexia
Personality Change
03-Apr-2012 09:37 AM Page: 148

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/09/99ISR Number: 3391823-9Report Type:Expedited (15-DaCompany Report #218956 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paralysis Foreign Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:11/09/99ISR Number: 3391874-4Report Type:Expedited (15-DaCompany Report #218938 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Foreign Lariam Tablets
Initial or Prolonged Diarrhoea Health (Mefloquine
Blood Bilirubin Increased Professional Hydrochloride) 250
Dizziness Mg PS ORAL ORAL 1 DAY
Leukocytosis
Pyrexia
Date:11/09/99ISR Number: 3391875-6Report Type:Expedited (15-DaCompany Report #218945 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Arrhythmia Foreign Lariam Tablets
Depression Health (Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:11/09/99ISR Number: 3391907-5Report Type:Expedited (15-DaCompany Report #218933 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Brain Scan Abnormal Foreign Lariam Tablets
Nervous System Disorder Health (Mefloquine
Dyspnoea Professional Hydrochloride) 250
Paraesthesia Mg PS ORAL ORAL
Date:11/12/99ISR Number: 3396228-2Report Type:Expedited (15-DaCompany Report #218934 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aphasia Foreign Lariam Tablets
Mental Disorder Health (Mefloquine
Grand Mal Convulsion Professional Hydrochloride) 250
Dyskinesia Mg PS ORAL 250 MG 1 PER
WEEK ORAL

Date:11/12/99ISR Number: 3396231-2Report Type:Expedited (15-DaCompany Report #218937 Age:59 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Dizziness
Pallor
Gastric Ulcer Haemorrhage
03-Apr-2012 09:37 AM Page: 149

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Melaena
Abdominal Distension
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Vaccine Nos (Vaccine
Nos)
C
Date:11/12/99ISR Number: 3396477-3Report Type:Expedited (15-DaCompany Report #8-98334-066A Age:46 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Visual Impairment Health Profenid Capsule
Initial or Prolonged Papilloedema Professional (Ketoprofen) PS ORAL ASS NEEDED
Optic Ischaemic Other Propavan SS AS NEEDED
Neuropathy Mefloquine SS ORAL ONE TABLET
Optic Neuritis WEEKLY 3 WK
Hepatitis B Vaccine SS PARENTERAL 1 MON
Mefloquine
C
Hepatitis B Vaccine C
Caffeine
+Paracetamol
+Chlorphenamine
Maleate
+Dextropropoxyphene C
Propavan
(Propiomazine
Maleate)
C
Typhoid Vaccine C
Date:11/15/99ISR Number: 3398080-8Report Type:Expedited (15-DaCompany Report #219447 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cerebellar Syndrome Foreign Lariam Tablets
Initial or Prolonged Other (Mefloquine
Hydrochloride) 250
Mg
PS
Date:11/15/99ISR Number: 3398082-1Report Type:Expedited (15-DaCompany Report #205111 Age:30 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Anxiety
Palpitations
Suicidal Ideation
Fatigue

Insomnia
Foreign Travel
Muscle Spasms
Dyspnoea
Hypoaesthesia
Psychotic Disorder
Visual Impairment
Confusional State
03-Apr-2012 09:37 AM Page: 150

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dizziness
Depression
Musculoskeletal Stiffness Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam Tablets
Consumer
(Mefloquine
Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Ketoprofene
(Ketoprofene)
C
Ibuprofene
(Ibuprofene)
C
Date:11/15/99ISR Number: 3398085-7Report Type:Expedited (15-DaCompany Report #219442 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abnormal Behaviour Foreign Lariam Tablets
Initial or Prolonged Visual Impairment Other (Mefloquine
Aggression Hydrochloride) 250
Delirium Mg PS ORAL 250 MG 1 PER
Foreign Travel
WEEK ORAL
Schizophrenia
Speech Disorder
Anxiety
Date:11/15/99ISR Number: 3398090-0Report Type:Expedited (15-DaCompany Report #205270 Age:30 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Foreign Lariam Tablets
Initial or Prolonged Insomnia Consumer (Mefloquine
Musculoskeletal Stiffness Hydrochloride) 250
Fatigue Mg PS ORAL 250 MG 1 PER
Foreign Travel
WEEK ORAL
Panic Attack
Ketoprofene
Suicidal Ideation (Ketoprofene) C
Visual Impairment
Ibuprofene
Dizziness (Ibuprofene) C
Date:11/15/99ISR Number: 3398476-4Report Type:Expedited (15-DaCompany Report #218871 Age:45 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Foreign Lariam Tablets
Initial or Prolonged Anxiety Health (Mefloquine
Visual Field Defect Professional Hydrochloride) 250
Nightmare Mg PS ORAL ORAL
Pondocillin
(Pivampicillin

Hydrochloride) C
Klorokinfosfat
(Chloroquine
Phosphate)
C
03-Apr-2012 09:37 AM Page: 151

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/16/99ISR Number: 3399224-4Report Type:Expedited (15-DaCompany Report #109425 Age:46 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Visual Impairment Foreign Lariam Tablets
Initial or Prolonged Optic Neuritis Other (Mefloquine
Papilloedema Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Profenid
(Ketoprofen) SS ORAL 1 PER PRN
ORAL
Propofan
(Acetaminophen/Caffe
ine/Calcium
Carbimide/Chlorpheni
ramine SS ORAL 1 PER PRN
ORAL
Engerix B (Hepatitis
B Virus Vaccine
Inactivated) 20 Mcg
Ml SS INTRAMUSCULAR INTRAMUSCULAR
Typhim Vi
C
Sanmigram
C
Date:11/17/99ISR Number: 3398607-6Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Mefloquene PS ORAL WEEKLY 250MG
Insomnia ORAL 1 WK
Panic Attack
Depression
Heart Rate Increased
Dehydration
Date:11/18/99ISR Number: 3399120-2Report Type:Direct Company Report # Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Insomnia Lariam PS
Crying
Suicidal Ideation
Psychotic Disorder
Abnormal Behaviour
Flat Affect
Foreign Travel
Depression
Date:11/18/99ISR Number: 3402652-1Report Type:Expedited (15-DaCompany Report #219962 Age:65 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Deafness Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL 250 MG
1 PER WEEK
ORAL
03-Apr-2012 09:37 AM Page: 152

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/19/99ISR Number: 3402792-7Report Type:Expedited (15-DaCompany Report #219706 Age:71 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Skin Discolouration Consumer Lariam Tablets
Oedema
(Mefloquine
Pyrexia Hydrochloride) 250
Upper Respiratory Tract Mg PS ORAL 250 MG 1 PER
Infection
WEEK ORAL
Rash Erythematous
Cipro (Ciprofloxacin
Tenderness Hydrochloride) 500
Burning Sensation Mg SS ORAL 500 MG DAILY
Tendonitis
ORAL
Erythema Multiforme
Aspirin (Baby
Arthralgia Aspirin) C
Cough
Fosamax (Alendronate
Drug Interaction Sodium) C
Pallor
Premarin (Estrogens,
Conjugated)
C
Date:11/22/99ISR Number: 3405855-5Report Type:Expedited (15-DaCompany Report #220064 Age:13 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Skin Exfoliation Consumer Lariam Tablets
Initial or Prolonged Dermatitis Exfoliative (Mefloquine
Hypersensitivity Hydrochloride) 250
Vomiting Mg PS ORAL 250 MG 1 PER
Dehydration
WEEK ORAL
Rash Maculo-Papular
Pain In Extremity
Face Oedema
Viral Infection
Rash Pruritic
Rash Erythematous
Date:11/23/99ISR Number: 3405398-9Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Jaundice Health Larium PS ORAL ORAL TABLET
Initial or Prolonged Liver Function Test Professional PER WEEK
Required Abnormal (047)
Intervention to Toxicity To Various Polio + Engenix B
Prevent Permanent Agents Vaccines C
Impairment/Damage Blood Bilirubin Increased
Date:11/23/99ISR Number: 3415180-4Report Type:Expedited (15-DaCompany Report #215471 Age:79 YR Gender:Male I/FU:I
Outcome
PT

Other Serious
Sciatica
Abdominal Pain
Gamma-Glutamyltransferase
Increased
Blood Uric Acid Increased
Diarrhoea
Nausea
Malaise
03-Apr-2012 09:37 AM Page: 153

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Asthenia
Blood Cholesterol
Increased Report Source Product Role Manufacturer Route Dose Duration
Decreased Appetite Foreign Lariam Tablets
Myalgia Consumer (Mefloquine
Joint Ankylosis Health Hydrochloride) 250
Retching Professional Mg PS ORAL 250 MG 1 PER
Abnormal Faeces
WEEK ORAL
Date:11/23/99ISR Number: 3415182-8Report Type:Expedited (15-DaCompany Report #220347 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cardiac Arrest Foreign Lariam Tablets
Other
(Mefloquine
Hydrochloride) PS ORAL 250 MG 1 PER
WEEK ORAL
Date:11/23/99ISR Number: 3415185-3Report Type:Expedited (15-DaCompany Report #220219 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Eclampsia Foreign Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Ibuprofen
(Ibuprofen)
C
Duspatal (Mebeverine
Hydrochloride) C
Hepatitis A Vaccine C
Date:11/26/99ISR Number: 3409794-5Report Type:Expedited (15-DaCompany Report #104160 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Pregnancy Foreign Lariam Tablets
Required Maternal Drugs Affecting Health (Mefloquine
Intervention to Foetus Professional Hydrochloride) 250
Prevent Permanent Tricuspid Valve Mg PS TRANSPLACENTAL 250 MG 1 PER
Impairment/Damage Incompetence WEEK ORAL
Cyanosis Neonatal
Heart Disease Congenital
Date:11/26/99ISR Number: 3409969-5Report Type:Expedited (15-DaCompany Report #213726 Age:25 YR Gender:Female I/FU:I
Outcome
PT

Disability
Required
Intervention to
Prevent Permanent
Impairment/Damage
Scotoma
Brain Oedema
Haemoglobin Decreased
Blood Potassium Increased
Blood Urea Increased
Blood Creatinine
Increased
Vomiting
03-Apr-2012 09:37 AM Page: 154

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dialysis
Alanine Aminotransferase
Increased Report Source Product Role Manufacturer Route Dose Duration
Visual Acuity Reduced Foreign Lariam PS ORAL 1000 MG DAILY
Visual Impairment Health ORAL
White Blood Cell Count Professional Gabexate Mesilate
Increased (Gabexate) SS INTRAVENOUS 800 MG 2 PER
Platelet Count Decreased
DAY
Blood Bilirubin Increased
INTRAVENOUS
Colour Blindness
Minocycline
Cardiovascular Disorder
Hydrochloride
Nuclear Magnetic
(Minocycline
Resonance Imaging Hydrochloride) SS INTRAVENOUS 100 MG 2 PER
Abnormal
DAY
Renal Disorder
INTRAVENOUS
Aspartate
Quinimax
Aminotransferase
Increased
(Cinchonidine/Cincho
nine/Quinidine/Quini
ne) SS INTRAVENOUS 500 MG 2 PER
DAY
INTRAVENOUS
Date:12/01/99ISR Number: 3411908-8Report Type:Expedited (15-DaCompany Report #215628 Age: Gender: I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Cystic Lymphangioma Foreign Lariam Tablets
Foetal Disorder Health (Mefloquine
Pregnancy Professional Hydrochloride) 250
Maternal Drugs Affecting Mg PS ORAL 250 MG 1 PER
Foetus
WEEK ORAL
Abortion Induced
Trisomy 21
Date:12/03/99ISR Number: 3413305-8Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Lariam Standard (For
Convulsion Anti-Malarial PS STRADARD USE
Neuropathy Peripheral
Abnormal Dreams
Anxiety
Dizziness
Panic Attack
Paranoia
Depression
Palpitations
Disorientation
Foreign Travel
Visual Impairment

Muscle Spasms
Emotional Distress
Panic Disorder
03-Apr-2012 09:37 AM Page: 155

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/03/99ISR Number: 3413543-4Report Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mania Consumer Lariam Tablets
Initial or Prolonged Diarrhoea Health (Mefloquine
Disorientation Professional Hydrochloride) 250
Leukocytosis Mg PS ORAL 250 MG 1 PER
Pruritus
WEEK ORAL
Bipolar Disorder
Lithium (Lithium
Palpitations Nos) SS ORAL 300 MG DAILY
Hypertension
ORAL
Drug Hypersensitivity
Lorazepam
Vomiting Projectile (Lorazepam) C
Tremor Atenolol (Atenolol) C
Circulatory Collapse
Abdominal Pain
Chest Discomfort
Urticaria
Dry Skin
Pyrexia
Insomnia
Coordination Abnormal
Flatulence
Date:12/03/99ISR Number: 3413545-8Report Type:Expedited (15-DaCompany Report #220944 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Mental Disorder Foreign Lariam Tablets
Suicide Attempt Health (Mefloquine
Paranoia Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:12/06/99ISR Number: 3414688-5Report Type:Expedited (15-DaCompany Report #204459 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Foetal Malposition Foreign Lariam Tablets
Intervention to Prolonged Labour Health (Mefloquine
Prevent Permanent Ultrasound Scan Abnormal Professional Hydrochloride) 250
Impairment/Damage Maternal Drugs Affecting Mg PS ORAL 250 MG 1 PER
Foetus
WEEK ORAL
Na
SS
Date:12/07/99ISR Number: 3415578-4Report Type:Expedited (15-DaCompany Report #203725 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Premature Baby Foreign Lariam Tablets

Initial or Prolonged Maternal Drugs Affecting Health (Mefloquine
Foetus Professional Hydrochcloride) 250
Premature Labour Mg PS ORAL 250 MG 1 PER
WEEK
03-Apr-2012 09:37 AM Page: 156

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/09/99ISR Number: 3417792-0Report Type:Expedited (15-DaCompany Report #221602 Age:47 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusional Disorder, Foreign Lariam Tablets
Persecutory Type Other (Mefloquine
Hepatitis Hydrochloride) PS ORAL 250 MG 1 PER
WEEK ORAL
Date:12/09/99ISR Number: 3417793-2Report Type:Expedited (15-DaCompany Report #220219 Age:31 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Eclampsia Foreign Lariam Tablets
Pregnancy Health (Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Ibuprofen
(Ibuprofen)
C
Duspatal (Mebeverine
Hydrochloride) C
Hepatitis A Vaccine
(Hepatitis A
Vaccine)
C
Date:12/09/99ISR Number: 3417794-4Report Type:Expedited (15-DaCompany Report #200926 Age:57 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Feeling Abnormal Foreign Lariam Tablets
Initial or Prolonged Jaundice Health (Mefloquine
Stress Professional Hydrochloride) PS ORAL 250 MG 1 PER
Asthenia
WEEK ORAL
Hallucination
Lariam Tablets
Abnormal Dreams
(Mefloquine
Foreign Travel Hydrochloride) SS ORAL 250 MG 1 PER
Psychotic Disorder
WEEK ORAL
Aggression
Delusion
Hepatitis
Hepatic Enzyme Increased
Date:12/14/99ISR Number: 3421134-4Report Type:Expedited (15-DaCompany Report #216908 Age:35 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Toxicity To Various Health Lariam Tablets
Initial or Prolonged Agents Professional (Mefloquine
Autoimmune Hepatitis Hydrochloride) 250
Liver Function Test Mg PS ORAL 250 MG 1 PER

Abnormal 1 WEEK ORAL
Hepatocellular Injury
Polio Vaccine
Jaundice
(Poliomyelitis
Vaccines)
C
Hepatitis B Vaccine
(Hepatitis B Virus
Vaccine Inactivated) C
03-Apr-2012 09:37 AM Page: 157

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/14/99ISR Number: 3421219-2Report Type:Expedited (15-DaCompany Report #215861 Age:49 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Circulatory Collapse Foreign Lariam Tablets
Hospitalization - Heart Rate Decreased Consumer (Mefloquine
Initial or Prolonged Cholinergic Syndrome Health Hydrochloride) 200
Pulse Absent Professional Mg PS ORAL 200 MG 1 PER
Apnoea Other 1 WEEK ORAL
Electrocardiogram Qt
Prolonged
Date:12/14/99ISR Number: 3422046-2Report Type:Expedited (15-DaCompany Report #215928 Age:35 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Scleral Discolouration Consumer Lariam Tablets
Initial or Prolonged Hypervitaminosis Health (Mefloquine
Jaundice Professional Hydrochloride) 250
Hepatitis Mg PS ORAL 250 MG 1 PER
Hepatocellular Injury
WEEK ORAL
Toxicity To Various
Vitamin Nos (Vitamin
Agents Nos) SS
Blood Bilirubin Increased
Liver Function Test
Abnormal
Spleen Disorder
Autoimmune Disorder
Hepatic Necrosis
Date:12/20/99ISR Number: 3426590-3Report Type:Expedited (15-DaCompany Report #222412 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaria Foreign Laroxyl
Initial or Prolonged Neuropathy Peripheral Health (Amitriptyline
Professional Hydrochloride) PS UNK
Lariam (Mefloquine
Hydrochloride) SS ORAL 1 DOSE FORM 1
PER WEEK ORAL
Lariam (Mefloquine
Hydrochloride) SS ORAL ORAL
Rohypnol
(Flunitrazepam) SS ORAL ORAL
Fumafer (Ferrous
Fumarate)
C
Stilnox (Zolpidem
Tartrate)
C
Date:12/21/99ISR Number: 3426942-1Report Type:Expedited (15-DaCompany Report #221071 Age:73 YR Gender:Male I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
PT
Malaise
Electroencephalogram
Abnormal
Pallor
Fatigue
Bradycardia
03-Apr-2012 09:37 AM Page: 158

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sedation
Balance Disorder
Cardiomegaly Report Source Product Role Manufacturer Route Dose Duration
Candidiasis Foreign Lariam Tablets
Myalgia Consumer (Mefloquine
Depressed Level Of Hydrochloride) 250
Consciousness Mg PS ORAL 250 MG 1 PER
Weight Decreased
WEEK ORAL
Pyrexia Timolol (Timolol) C
Hypertension
Influenza Vaccine
Vomiting
(Influenza Virus
Headache Vaccine) C
Bradyphrenia
Atarax (Hydroxyine
Oesophagitis Hydrochloride) C
Osteoarthritis
Bradypnoea
Date:12/21/99ISR Number: 3426947-0Report Type:Expedited (15-DaCompany Report #214472 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cerebellar Atrophy Foreign Lariam Tablets
Dysgraphia Health (Mefloquine
Fear Professional Hydrochloride) 250
Balance Disorder Mg PS ORAL 250 MG 1 PER
Dysarthria
WEEK ORAL
Movement Disorder
Coordination Abnormal
Cerebellar Syndrome
Clumsiness
Date:12/29/99ISR Number: 3434420-9Report Type:Expedited (15-DaCompany Report #223142 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Biopsy Bone Marrow Health Lariam Tablets
Initial or Prolonged Abnormal Professional (Mefloquine
Platelet Count Decreased Hydrochloride) 250
Mouth Haemorrhage Mg PS ORAL 250 MG 1 PER
White Blood Cell Count
WEEK ORAL
Decreased
Bone Marrow Failure
Epistaxis
Petechiae
Haematocrit Decreased
Date:01/04/00ISR Number: 3435387-XReport Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Depression Lariam (Mefoquine)
Tremor 250mg-La Roche PS La-Roche 1 TABLET EACH
Insomnia
WEEK
Movement Disorder
Panic Attack
Heart Rate Increased
03-Apr-2012 09:37 AM Page: 159

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/06/00ISR Number: 3439115-3Report Type:Expedited (15-DaCompany Report #220064 Age:13 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Palmar Erythema Health Lariam Tablets
Initial or Prolonged Pain In Extremity Professional (Mefloquine
Dermatitis Hydrochloride) 250
Rash Generalised Mg PS ORAL 250 MG 1 PER
Face Oedema
WEEK ORAL
Vomiting
Dehydration
Pruritus
Rash Pruritic
Rash Papular
Skin Exfoliation
Date:01/06/00ISR Number: 3439121-9Report Type:Expedited (15-DaCompany Report #223797 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Abortion Induced Foreign Lariam Tablets
Trisomy 21 Health (Mefloquine
Pregnancy Professional Hydrochloride) 250
Mg PS ORAL ORAL
Date:01/12/00ISR Number: 3443106-6Report Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fatigue Lariam (Mefloquine) PS 250MG, MOUTH
Decreased Appetite
ONCE WEEKLY
Chills
Depression
Anxiety
Panic Attack
Paraesthesia
Parosmia
Hypoaesthesia
Muscle Spasms
Insomnia
Dermatitis
Headache
Date:01/12/00ISR Number: 3443550-7Report Type:Expedited (15-DaCompany Report #215212 Age:68 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Flatulence Foreign Mefloquine
Pancreatitis Other Hydrochloride
Cholelithiasis
(Mefloquine
Pancreatic Disorder Hydrochloride) 250

Abdominal Pain Mg PS ORAL ORAL
Dyspepsia
Blood Amylase Increased
03-Apr-2012 09:37 AM Page: 160

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/12/00ISR Number: 3443552-0Report Type:Expedited (15-DaCompany Report #215378 Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Chest Pain Foreign Lariam Tablets
Chest Discomfort Other (Mefloquine
Palpitations Hydrochloride) 250
Ventricular Extrasystoles Mg PS ORAL 250 MG 1 PER
Dyspnoea
Brevinor-1 (Ethinyl
Estradiol /
Norethindrone)
C
WEEK ORAL
Date:01/12/00ISR Number: 3443559-3Report Type:Expedited (15-DaCompany Report #223961 Age:67 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myasthenic Syndrome Foreign Lariam Tablets
Initial or Prolonged Antibody Test Positive Other (Mefloquine
Eye Disorder Hydrochloride) 250
Eyelid Ptosis Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Sotalex (Sotalol
Hydrochloride) C
Piascledine
(Avocado/Soybean
Oil)
C
Date:01/12/00ISR Number: 3443767-1Report Type:Expedited (15-DaCompany Report #215513 Age:16 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Foreign Lariam Tablets
Depersonalisation Other (Mefloquine
Depression Hydrochloride) 250
Paranoia Mg PS ORAL 250 MG 1 PER
Dissociative Disorder
WEEK ORAL
Anxiety
Fear
Date:01/12/00ISR Number: 3443770-1Report Type:Expedited (15-DaCompany Report #215542 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pyrexia Foreign Lariam Tablets
Hepatitis Cholestatic Other (Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Noroxin
(Norfloxacin) SS 1 DOSE FORM

DAILY
Vancomycin
Hydrochloride
(Vancomycin
Hydrochloride) SS
Imodium (Loperamide
Hydrochloride) SS 1 DOSE FORM
DAILY
03-Apr-2012 09:37 AM Page: 161

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/19/00ISR Number: 3445475-XReport Type:Expedited (15-DaCompany Report #106318 Age:37 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blister Foreign Lariam Tablets
Initial or Prolonged Dystonia Other (Mefloquine
Hallucination Hydrochloride) 250
Panic Attack Mg PS ORAL 250 MG 1 PER
Dermatitis
WEEK ORAL
Grand Mal Convulsion
Oral Contraceptive
Insomnia
Nos (Oral
Contraceptive Nos) C
Sedative Nos
(Sedative Nos) C
Date:01/19/00ISR Number: 3445477-3Report Type:Expedited (15-DaCompany Report #215861 Age:49 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Cardiac Arrest Foreign Lariam Tablets
Hospitalization - Cholinergic Syndrome Consumer (Mefloquine
Initial or Prolonged Circulatory Collapse Health Hydrochloride) 250
Pulse Absent Professional Mg PS ORAL 250 MG 1 PER
Electrocardiogram Qt Other 1 WEEK ORAL
Prolonged
Apnoea
Date:01/19/00ISR Number: 3445854-0Report Type:Expedited (15-DaCompany Report #224407 Age:57 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Herpes Simplex Foreign Lariam Tablets
Hepatitis Consumer (Mefloquine
Blood Immunoglobulin G Health Hydrochloride) 250
Increased Professional Mg PS ORAL 250 MG 1 PER
Liver Function Test
WEEK ORAL
Abnormal
Date:01/19/00ISR Number: 3446071-0Report Type:Expedited (15-DaCompany Report #224923 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Foreign Lariam Tablets
Initial or Prolonged Suicide Attempt Health (Mefloquine
Theft Professional Hydrochloride) PS ORAL 1.5 DOSE FORM
Acute Psychosis
1 PER WEEK
ORAL 14 DAY
Date:01/19/00ISR Number: 3446254-XReport Type:Expedited (15-DaCompany Report #220347 Age:49 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cardiac Arrest Foreign Lariam Tablets
Other
(Mefloquine
Hydrochloride) PS ORAL 250 MG 1 PER
WEEK ORAL
03-Apr-2012 09:37 AM Page: 162

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/21/00ISR Number: 3446442-2Report Type:Expedited (15-DaCompany Report #218871 Age:45 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Foreign Lariam Tablets
Initial or Prolonged Nightmare Health (Mefloquine
Visual Field Defect Professional Hydrochloride) 250
Paranoia Mg PS ORAL ORAL
Anxiety
Kodimagnyl
(Aspirin/Codeine
Phosphate)
C
Panodil
(Acetaminophen) C
Klorokinfosfat
(Chloroquine
Phosphate)
C
Pondocillin
(Pivampicillin
Hydrochloride) C
Date:01/28/00ISR Number: 3447825-7Report Type:Direct Company Report # Age:34 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Gait Disturbance Larium (Mefloquin) PS
Nervous System Disorder
Paralysis
Feeling Abnormal
Date:01/28/00ISR Number: 3448097-XReport Type:Expedited (15-DaCompany Report #223142 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Thrombocytopenia Health Lariam Tablets
Hospitalization - Petechiae Professional (Mefloquine
Initial or Prolonged Epistaxis Hydrochloride) 250
Disability Leukopenia Mg PS ORAL 250 MG 1 PER
Haematocrit Decreased
WEEK ORAL
Mouth Haemorrhage
Megakaryocytes Abnormal
Bone Marrow Failure
Date:01/28/00ISR Number: 3448154-8Report Type:Expedited (15-DaCompany Report #225350 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Tinnitus Foreign Lariam Tablets
Intervention to Deafness Consumer (Mefloquine
Prevent Permanent Hydrochloride) 250
Impairment/Damage Mg PS ORAL 250 MG 1 PER
WEEK ORAL

Date:02/02/00ISR Number: 3451029-1Report Type:Expedited (15-DaCompany Report #226681 Age: Gender:Male I/FU:I
Outcome PT Report Source
Disability Haemolysis Foreign
Health
03-Apr-2012 09:37 AM Page: 163

Professional
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Product Role Manufacturer Route Dose Duration
Lariam Tablets
(Mefloquine
Hydrochloride) 250
Mg PS ORAL ORAL
Date:02/04/00ISR Number: 3452318-7Report Type:Expedited (15-DaCompany Report #216832 Age:30 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Loss Of Consciousness Health Lariam Tablets
Initial or Prolonged Back Pain Professional (Mefloquine
Grand Mal Convulsion Hydrochloride) 250
Neurological Symptom Mg PS ORAL 250 MG 1 PER
Movement Disorder
WEEK ORAL
Gait Disturbance
Date:02/08/00ISR Number: 3454673-0Report Type:Expedited (15-DaCompany Report #227211 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Oesophagitis Foreign Lariam Tablets
Oesophageal Pain Other (Mefloquine
Sensation Of Pressure Hydrochloride) 250
Bundle Branch Block Right Mg PS ORAL 250 MG 1 PER
Supraventricular 1 WEEK, ORAL 28 DAY
Extrasystoles
Dyspnoea
Date:02/08/00ISR Number: 3454675-4Report Type:Expedited (15-DaCompany Report #227013 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Asthenia Foreign Lariam Tablets
Initial or Prolonged Cerebrovascular Accident Health (Mefloquine
Disability Feeling Abnormal Professional Hudrochloride) 250
Thrombocytopenia Mg PS ORAL 250 MG 1 PER
Cerebral Infarction
1 WEEK, ORAL
Date:02/08/00ISR Number: 3455315-0Report Type:Expedited (15-DaCompany Report #220944 Age:59 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicide Attempt Foreign Lariam Tablets
Paranoia Health (Mefloquine
Mental Disorder Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER

WEEK ORAL
03-Apr-2012 09:37 AM Page: 164

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/09/00ISR Number: 3455449-0Report Type:Expedited (15-DaCompany Report #215471 Age:79 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pain In Extremity Foreign Lariam Tablets
Blood Cholesterol Consumer (Mefloquine
Increased Health Hydrochloride) 250
Decreased Appetite Professional Mg PS ORAL 250 MG 1 PER
Retching
WEEK ORAL
Polymyalgia Rheumatica
Joint Ankylosis
Abnormal Faeces
Diarrhoea
Arthralgia
Malaise
Asthenia
Sciatica
Myalgia
Foreign Travel
Nausea
Abdominal Pain
Date:02/11/00ISR Number: 3457006-9Report Type:Expedited (15-DaCompany Report #215928 Age:35 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypervitaminosis Consumer Lariam Tablets
Initial or Prolonged Hepatitis Health (Mefloquine
Liver Function Test Professional Hydrochloride) 250
Abnormal Mg PS ORAL 250 MG 1 PER
Autoimmune Disorder
WEEK ORAL
Spleen Disorder
Vitamin Nos (Vitamin
Blood Bilirubin Increased Nos) SS
Hepatic Necrosis
Jaundice
Date:02/11/00ISR Number: 3457009-4Report Type:Expedited (15-DaCompany Report #217772 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Condition Aggravated Foreign Lariam Tablets
Initial or Prolonged Ventricular Hypertrophy Other (Mefloquine
Bradycardia Hydrochloride) 250
Drug Interaction Mg PS ORAL 250 MG 1 PER
Hypertension
WEEK ORAL
Muscular Weakness
Timoptol Eye Drops
Ejection Fraction (Timolol Maleate) 5
Abnormal Mg/Ml SS OPHTHALMIC .05 DOSE FORM
Dizziness
DAILY
OPHTHALMIC
Bethahistine
Hydrochloride

(Bethahistine) C
03-Apr-2012 09:37 AM Page: 165

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/11/00ISR Number: 3457011-2Report Type:Expedited (15-DaCompany Report #215889 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Foreign Travel Foreign Lariam Tablets
Initial or Prolonged Eye Pain Health (Mefloquine
Csf Lymphocyte Count Professional Hydrochloride) 250
Increased Mg PS ORAL 250 MG 1 PER
Csf White Blood Cell WEEK ORAL 56 DAY
Count Positive
Optic Neuritis
Headache
Vision Blurred
Visual Acuity Reduced
C-Reactive Protein
Increased
Blood Glucose Increased
Sinusitis
Blood Triglycerides
Increased
Glucose Tolerance
Impaired
Meningitis
Date:02/14/00ISR Number: 3457666-2Report Type:Expedited (15-DaCompany Report #224407 Age:57 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Liver Function Test Foreign Lariam Tablets
Abnormal Health (Mefloquine
Blood Immunoglobulin G Professional Hydrochloride) 250
Increased Mg PS ORAL 250 MG 1 PER
Hepatitis
WEEK ORAL
Herpes Simplex
Date:02/15/00ISR Number: 3458375-6Report Type:Expedited (15-DaCompany Report #227783 Age:8 WK Gender:Male I/FU:I
Outcome
Other Serious
PT
Hypotonia
Maternal Drugs Affecting
Foetus
Chondromalacia
Congenital Gastric
Anomaly
Congenital Hair Disorder
Microphthalmos
Gastrooesophageal Reflux
Disease
Finger Deformity
Oesophageal Dilatation
Feeding Disorder Neonatal

Microcephaly
Congenital Anomaly
Congenital Nose
Malformation
Vomiting
Dyskinesia Oesophageal
Dysmorphism
Blood Pressure Increased
03-Apr-2012 09:37 AM Page: 166

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Oesophageal Achalasia
Congenital Central
Nervous System Anomaly Report Source Product Role Manufacturer Route Dose Duration
Neck Deformity Foreign Lariam Tablets
Developmental Delay Literature (Mefloquine
Salivary Hypersecretion Health Hydrochloride) PS ORAL 250 MG 1 PER
Convulsion Professional WEEK ORAL
Joint Contracture
Micrognathia
Respiratory Arrest
Ear Malformation
Date:02/16/00ISR Number: 3458485-3Report Type:Direct Company Report # Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Panic Attack Lariam/Roche PS Roche BUCCAL 6 TABLE
Disability Dizziness BUCCAL
Asthenia
Disturbance In Attention
Eye Pain
Date:02/16/00ISR Number: 3458909-1Report Type:Expedited (15-DaCompany Report #217772 Age:53 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Ventricular Hypertrophy Foreign Lariam Tablets
Initial or Prolonged Muscular Weakness Other (Mefloquine
Bradycardia Hydrochloride) 250
Hypertension Mg PS ORAL 250 MG 1 PER
Ejection Fraction
WEEK ORAL
Abnormal
Timoptol Eye Drops
Dizziness
(Timolol Maleate)
Drug Interaction 5mg/Ml SS OPHTHALMIC .05 MG DOSE
FORM DAILY
OPHTHALMIC
Betahistine
Hydrochloride
(Betahistine)
C
Date:02/17/00ISR Number: 3459446-0Report Type:Expedited (15-DaCompany Report #207736 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Maternal Drugs Affecting Foreign Lariam Tablets
Foetus Health (Mefloquine
Congenital Cystic Kidney Professional Hydrochloride) 250
Disease Mg PS ORAL 250 MG 1 PER
Congenital Anomaly
WEEK ORAL
Renal Hypertrophy

Date:02/18/00ISR Number: 3459354-5Report Type:Expedited (15-DaCompany Report #58978 Age:31 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Back Pain
Vestibular Disorder
03-Apr-2012 09:37 AM Page: 167

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sensation Of Pressure
Dyspnoea
Hyperhidrosis Report Source Product Role Manufacturer Route Dose Duration
Balance Disorder Consumer Lariam Tablets
Anxiety Health (Mefloquine
Ear Discomfort Professional Hydrochloride) 250
Drug Hypersensitivity Mg PS ORAL 250 MG 1 PER
Cerebellar Ataxia
WEEK ORAL
Nystagmus
Norflex
Thrombocytopenia
(Orphenadrine
Headache Citrate) C
Tachycardia
Accident
Chest Pain
Road Traffic Accident
Palpitations
Vomiting
Asthenia
Confusional State
Vertigo
Spinal Fracture
Syncope
Clonic Convulsion
Anaemia
Fatigue
Neck Pain
Amnesia
Abdominal Pain
Sinus Headache
Dizziness
Gait Disturbance
Disturbance In Attention
Nausea
Feeling Abnormal
Platelet Count Abnormal
Scoliosis
Epistaxis
Date:02/18/00ISR Number: 3459955-4Report Type:Expedited (15-DaCompany Report #228385 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mania Health Lariam Tablets
Initial or Prolonged Psychotic Disorder Professional (Mefloquine
Thinking Abnormal Hydrochloride) 250
Bipolar Disorder Mg PS ORAL 250 MG 1 PER
Weight Decreased
WEEK ORAL
Psychomotor Hyperactivity
Chloroquine
Magical Thinking (Chloroquine) C
Foreign Travel
Abnormal Behaviour

Date:02/18/00ISR Number: 3459957-8Report Type:Expedited (15-DaCompany Report #224949 Age:67 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Malaise
Hypoxia
Oedema Peripheral
03-Apr-2012 09:37 AM Page: 168

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pruritus
Pain In Extremity
Dyspnoea Exertional Report Source Product Role Manufacturer Route Dose Duration
Dehydration Foreign Lariam Tablets
Subcutaneous Emphysema Consumer (Mefloquine
Vein Pain Hydrochloride) 250
Dry Skin Mg PS ORAL 250 MG 1 PER
Pneumothorax Traumatic
1 WEEK ORAL
Pleural Effusion
Pain
Blood Alkaline
Phosphatase Increased
Jaundice
Lung Consolidation
Diarrhoea
Ecchymosis
Blood Sodium Increased
Fall
Bacterial Test Positive
Rib Fracture
Bronchospasm
Blood Bilirubin Increased
Decreased Appetite
Injury
Liver Function Test
Abnormal
Haemorrhoids
Cholestasis
Chromaturia
Wound Infection
Pulmonary Oedema
Dyspnoea
Staphylococcal Infection
Date:02/18/00ISR Number: 3459961-XReport Type:Expedited (15-DaCompany Report #213259 Age:18 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaise Foreign Lariam (Mefloquine
Initial or Prolonged Pharyngitis Health Hydrochloride) PS ORAL 250 MG 1 PER
Drug Hypersensitivity Professional 1 WEEK ORAL
Cough
Clamoxyl Duo
Erythema
(Amoxicillin
Urticaria
Sodium/*Clavulanate
Pyrexia Potassium) SS ORAL 2 GRAM DAILY
Eyelid Oedema
Dyspnoea
ORAL
Imudon (Lysates,
Bacterial) SS ORAL ORAL
Doliprane
(Acetaminophen)
Hexomedine
Collutoire
C

(Hexamidine/Tetracai
ne Hydrochloride)
C
03-Apr-2012 09:37 AM Page: 169

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/23/00ISR Number: 3461482-5Report Type:Expedited (15-DaCompany Report #228826 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aplastic Anaemia Consumer Lariam Tablets
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL 42 DAY
Date:02/24/00ISR Number: 3462565-6Report Type:Expedited (15-DaCompany Report #228880 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Euphoric Mood Consumer Lariam Tablets
Initial or Prolonged Dizziness (Mefloquine
Nausea Hydrochloride) 250
Photophobia Mg PS ORAL 250 MG 1 PER
Palpitations
Dimetapp
(Brompheniramine
Maleate/*Phenylephri
ne
Hydrochloride/Phenyl C
WEEK ORAL
Date:02/24/00ISR Number: 3462569-3Report Type:Expedited (15-DaCompany Report #228555 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Splenomegaly Foreign Lariam Tablets
Diarrhoea Literature (Mefloquine
Fear Health Hydrochloride) 250
Dizziness Professional Mg PS ORAL 500 MG 1 PER
Oropharyngeal Pain
ONE DOSE ORAL
Hypoaesthesia
Co-Trimoxazol
Burning Sensation
(Sulfamethoxazole/Tr
Panic Disorder imethoprim) C
Peripheral Coldness
Penicillin V
Psychotic Disorder (Penicillin V) C
Chills
Intravenous Glucose
Confusional State (Glucose) C
Intentional Self-Injury
Paracetamol
Depression (Acetaminophen) C
Anxiety
Codeine Phosphate
Myocarditis (Codeine Phosphate) C
Pyrexia
Fansidar
Bone Pain
(Pyrimethamine/Sulfa
Completed Suicide doxine) C
Dyspnoea Quinine (Quinine) C
Disorientation
Headache
Antimalarial Agent
Nos (Antimalarial
Agent Nos)
C

Aspirin (Aspirin) C
03-Apr-2012 09:37 AM Page: 170

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/24/00ISR Number: 3462570-XReport Type:Expedited (15-DaCompany Report #225350 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Audiogram Abnormal Foreign Lariam Tablets
Intervention to Tinnitus Consumer (Mefloquine
Prevent Permanent Deafness Health Hydrochloride) 250
Impairment/Damage Professional Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:02/24/00ISR Number: 3462575-9Report Type:Expedited (15-DaCompany Report #223797 Age: Gender:Unknown I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Congenital Anomaly Foreign Lariam Tablets
Trisomy 21 Health (Mefloquine
Pregnancy Professional Hydrochloride) 250
Abortion Induced Mg PS ORAL 250 MG 1 PER
Maternal Drugs Affecting
WEEK ORAL
Foetus
Date:02/24/00ISR Number: 3462577-2Report Type:Expedited (15-DaCompany Report #211640 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Foreign Lariam Tablets
Initial or Prolonged Paralysis Other (Mefloquine
Disability Gait Disturbance Hydrochloride) 250
Myalgia Mg PS ORAL 250 MG 1 PER
Facial Pain
WEEK ORAL
Pain In Extremity
Headache
Asthenia
Polyneuropathy
Date:02/24/00ISR Number: 3462580-2Report Type:Expedited (15-DaCompany Report #228268 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Premature Separation Of Foreign Lariam Tablets
Initial or Prolonged Placenta Health (Mefloquine
Menometrorrhagia Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
ONE DOSE ORAL
Date:02/28/00ISR Number: 3464073-5Report Type:Direct Company Report # Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Photophobia Lariam (Mefloquine) PS TABLET WEEKLY

Headache FOR 7 WEEKS
Ear Discomfort
Hypersensitivity
03-Apr-2012 09:37 AM Page: 171

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/28/00ISR Number: 3464099-1Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Lariam (Mefloquine) PS ORAL 1 TABLET
WEEKLY FOR 7
WEEKS (ORAL)
Date:02/29/00ISR Number: 3465856-8Report Type:Expedited (15-DaCompany Report #228826 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aplastic Anaemia Consumer Lariam Tablets
(Mefloquine
Hydrochloride) PS ORAL ORAL 42 DAY
Date:02/29/00ISR Number: 3465857-XReport Type:Expedited (15-DaCompany Report #229472 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fall Foreign Lariam Tablets
Neuropathy Peripheral Health (Mefloquine
Diarrhoea Professional Hydrochloride) PS ORAL 250 MG 1 PER
Coordination Abnormal
WEEK ORAL
Paraesthesia Oral Atenolol (Atenolol) C
Gait Disturbance
Date:03/01/00ISR Number: 3467533-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Disturbance In Attention Health Laraim PS TABLET
Other Serious Anxiety Professional WEEKLY
Hallucination
Feeling Abnormal
Restlessness
Muscle Twitching
Depression
Sleep Disorder
Paranoia
Alopecia
Date:03/02/00ISR Number: 3468068-7Report Type:Expedited (15-DaCompany Report #223959 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paranoia Foreign Lariam Tablets
Initial or Prolonged Deja Vu Other (Mefloquine
Illusion Hydrochloride) 250
Anxiety Mg PS ORAL 250 MG 1 PER

Panic Attack WEEK ORAL
Insomnia
Delirium
Depersonalisation
Abnormal Behaviour
Hallucination, Auditory
Confusional State
Mental Disorder
03-Apr-2012 09:37 AM Page: 172

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/03/00ISR Number: 3468986-XReport Type:Expedited (15-DaCompany Report #222412 Age:40 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Neuropathy Peripheral Foreign Laroxyl
Initial or Prolonged Asthenia Health (Amitriptyline
Insomnia Professional Hydrochloride) 25 Mg PS ORAL 25 MG DAILY
Red Blood Cell
ORAL
Sedimentation Rate
Lariam Tablets
Increased
(Mefloquine
Hyporeflexia Hydrochloride) 250
Depression Mg SS ORAL 250 MG 1 PER
Malaria
WEEK ORAL
Stilnox (Zolpidem
Tartrate)
C
Fumafer (Ferrous
Fumarate)
C
Quinine (Quinine) C
Rohypnol
(Flunitrazepam) C
Date:03/08/00ISR Number: 3471240-3Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Nausea Lariam PS 1 TABLET /
Influenza Like Illness
ONCE A WEEK
Pyrexia
Vertigo
Tremor
Medication Error
Depression
Headache
Dizziness
Lethargy
Date:03/09/00ISR Number: 3472238-1Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Mefloquine PS ORAL 250MG 1 PO QD
Insomnia
Anxiety
Date:03/09/00ISR Number: 3473493-4Report Type:Expedited (15-DaCompany Report #230147 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Consumer Lariam Tablets
Initial or Prolonged Monoparesis (Mefloquine
Hydrochloride) PS

Date:03/09/00ISR Number: 3473498-3Report Type:Expedited (15-DaCompany Report #227783 Age:8 WK Gender:Male I/FU:F
Outcome
Other Serious
PT
Congenital
Musculoskeletal Anomaly
03-Apr-2012 09:37 AM Page: 173

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Vomiting
Microcephaly
Salivary Hypersecretion Report Source Product Role Manufacturer Route Dose Duration
Congenital Nose Foreign Lariam Tablets
Malformation Literature (Mefloquine
Oesophageal Dilatation Health Hydrochloride) PS ORAL 250 MG 1 PER
Growth Retardation Professional WEEK ORAL
Developmental
Coordination Disorder
Dyskinesia Oesophageal
Gastrooesophageal Reflux
Disease
Congenital Jaw
Malformation
Micrognathia
Congenital Hair Disorder
Developmental Delay
Hypertension
Congenital Oral
Malformation
Convulsion
Microphthalmos
Respiratory Disorder
Neonatal
Hypercapnia
Respiratory Arrest
Hypotonia
Hypertonia
Feeding Disorder
Maternal Drugs Affecting
Foetus
Oesophageal Achalasia
Congenital Gastric
Anomaly
Congenital Central
Nervous System Anomaly
Mental Impairment
Joint Contracture
Microstomia
Autosomal Chromosome
Anomaly
Dysmorphism
Congenital Foot
Malformation
Ear Malformation
Date:03/10/00ISR Number: 3474446-2Report Type:Expedited (15-DaCompany Report #75640 Age: Gender:Unknown I/FU:F
Outcome
Congenital Anomaly
PT
Hypercapnia
Clumsy Child Syndrome

Oesophageal Achalasia
Feeding Disorder
Muscular Dystrophy
Pregnancy
Congenital Jaw
Malformation
Hypertension
Obstructive Airways
03-Apr-2012 09:37 AM Page: 174

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorder
Maternal Drugs Affecting
Foetus
Growth Retardation Report Source Product Role Manufacturer Route Dose Duration
Autoimmune Disorder Foreign Lariam Tablets
Hypotonia Health (Mefloquine
Dysmorphism Professional Hydrochloride) 250
Mental Disorder Mg PS ORAL 250 MG 1 PER
Microcephaly
WEEK ORAL
Multiple Congenital
Abnormalities
Malnutrition
Oesophageal Disorder
Gastrooesophageal Reflux
Disease
Date:03/10/00ISR Number: 3474449-8Report Type:Expedited (15-DaCompany Report #207736 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Congenital Anomaly Foreign Lariam Tablets
Congenital Cystic Kidney Consumer (Mefloquine
Disease Health Hydrochloride) 250
Renal Hypertrophy Professional Mg PS ORAL 250 MG 1 PER
Pregnancy
WEEK ORAL
Maternal Drugs Affecting
Foetus
Date:03/13/00ISR Number: 3474365-1Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lethargy Lariam 250mg
Initial or Prolonged Headache Hoffmann-La Roche
Other Serious Dysentery Inc PS Hoffmann-La Roche
Asthenia Inc ORAL 250MG WEEKLY
Decreased Appetite
ORAL
Nausea Metrodozole C
Vertigo Tinidozole C
Dizziness Anti-Biotics C
Pyrexia
Diarrhoea
Date:03/14/00ISR Number: 3475522-0Report Type:Expedited (15-DaCompany Report #230503 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dysphonia Foreign Lariam Tablets
Depression Other (Mefloquine
Gait Disturbance Hydrochloride) PS ORAL 250 MG ORAL
Speech Disorder

Date:03/14/00ISR Number: 3475572-4Report Type:Expedited (15-DaCompany Report #230342 Age: Gender:Male I/FU:I
Outcome
Other Serious
PT
Overdose
Nervous System Disorder
03-Apr-2012 09:37 AM Page: 175

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Gamma-Glutamyltransferase
Increased
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) PS ORAL ORAL 7 DAY
Date:03/14/00ISR Number: 3475596-7Report Type:Expedited (15-DaCompany Report #224949 Age:67 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Jaundice Foreign Lariam Tablets
Initial or Prolonged Ecchymosis Consumer (Mefloquine
Haemorrhoids Hydrochloride ) 250
Dyspnoea Exertional Mg PS ORAL 250 MG 1 PER
Decreased Appetite
1 WEEK ORAL
Wound Infection
Pulmonary Oedema
Fall
Subcutaneous Emphysema
Chromaturia
Pruritus
Pain
Pneumothorax
Blood Bilirubin Increased
Hypoxia
Lung Consolidation
Pleural Effusion
Bronchospasm
Cholestasis
Malaise
Diarrhoea
Liver Function Test
Abnormal
Rib Fracture
Staphylococcal Infection
Oedema Peripheral
Benign Prostatic
Hyperplasia
Haemothorax
Vein Pain
Dry Skin
Injury
Dehydration
Date:03/14/00ISR Number: 3475600-6Report Type:Expedited (15-DaCompany Report #229994 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dyspnoea Health Lariam Tablets
Professional
(Mefloquine

Hydrochloride) PS ORAL ORAL
03-Apr-2012 09:37 AM Page: 176

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/15/00ISR Number: 3475487-1Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination, Visual Mefloquine (Lariam)
Initial or Prolonged Paranoia Roche Pharm. 250 Mg PS Roche Pharm. ORAL ORAL 1/ WEEK
Disability
Arthralgia
Required
Confusional State
Intervention to
Panic Attack
Prevent Permanent
Impairment/Damage
Date:03/16/00ISR Number: 3476231-4Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Health Lariam PS
Anxiety
Professional
Date:03/20/00ISR Number: 3478147-6Report Type:Expedited (15-DaCompany Report #231049 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Asthenia Foreign Lariam Tablets
Initial or Prolonged Vomiting Health (Mefloquine
Nausea Professional Hydrochloride) PS ORAL 1 DOSE FORM 1
Nystagmus
PER WEEK ORAL
Dizziness
Date:03/21/00ISR Number: 3478539-5Report Type:Expedited (15-DaCompany Report #225350 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Tinnitus Foreign Lariam Tablets
Intervention to Deafness Consumer (Mefloquine
Prevent Permanent Health Hydrochloride) 250
Impairment/Damage Professional Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:03/23/00ISR Number: 3479213-1Report Type:Expedited (15-DaCompany Report #224949 Age:67 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Bronchospasm
Chest X-Ray Abnormal
Vein Pain
Chromaturia
Wound Infection
Gait Disturbance
Dry Skin

Injury
Tenderness
Pain
Jaundice
Ecchymosis
Alanine Aminotransferase
Increased
Cholestasis
03-Apr-2012 09:37 AM Page: 177

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hypoxia
Diarrhoea
Emphysema Report Source Product Role Manufacturer Route Dose Duration
Decreased Appetite Foreign Lariam Tablets
Pruritus Consumer (Mefloquine
Oedema Peripheral Hydrochloride) 250
Dyspnoea Exertional Mg PS ORAL 250 MG 1 PER
Pulmonary Oedema
1 WEEK ORAL
Haemorrhoids
Staphylococcal Infection
Gamma-Glutamyltransferase
Increased
Blood Alkaline
Phosphatase Increased
Pleural Effusion
Pneumothorax
Blood Bilirubin Increased
Haemorrhage
Rib Fracture
Dehydration
Date:03/23/00ISR Number: 3479216-7Report Type:Expedited (15-DaCompany Report #231053 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Muscular Weakness Foreign Lariam Tablets
Initial or Prolonged Paraesthesia Other (Mefloquine
Sensory Disturbance Hydrochloride) 250
Hyporeflexia Mg PS ORAL 250 MG 1 PER
Bacterial Infection
WEEK ORAL
Myalgia
Proscar
Gait Disturbance (Finasteride) C
Csf Protein Increased
Dyspnoea
Guillain-Barre Syndrome
Antibody Test Positive
Dizziness
Date:03/23/00ISR Number: 3479288-XReport Type:Direct Company Report # Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dizziness Lariam (Mefloquine)
Initial or Prolonged Dyspnoea 250mg PS Hoffman Laroche 1 WEEKLY FOR
Disability Headache 7 WKS
Other Serious
Vomiting
Panic Attack
Fatigue
Chills
Palpitations
Paraesthesia

Diarrhoea
Hallucination
Tremor
03-Apr-2012 09:37 AM Page: 178

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/23/00ISR Number: 3479360-4Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Mefloquine
Hyperhidrosis
Hydrochloride
Palpitations (Lariam) PS 1T WEEKLY
Fear
Date:03/27/00ISR Number: 3480434-2Report Type:Expedited (15-DaCompany Report #214472 Age:49 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dysgraphia Foreign Lariam
Clumsiness Health Tablets(Mefloquine
Cerebellar Atrophy Professional Hydrochloride) 250
Neurological Examination Mg PS ORAL 250 MG 1 PER
Abnormal
WEEK ORAL
Coordination Abnormal
Dysarthria
Cerebellar Syndrome
Movement Disorder
Balance Disorder
Date:03/30/00ISR Number: 3482118-3Report Type:Expedited (15-DaCompany Report #231507 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Haemolysis Foreign Lariam Tablets
Initial or Prolonged Inborn Error Of Literature (Mefloquine
Required Metabolism Health Hydrochloride) PS ORAL 1.5 GRAM
Intervention to Malaria Professional DAILY 1 PER 8
Prevent Permanent Fatigue HOUR ORAL
Impairment/Damage Anaemia
Pyrexia
Chromaturia
Date:04/05/00ISR Number: 3484145-9Report Type:Expedited (15-DaCompany Report #231049 Age:32 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Asthenia Foreign Lariam Tablets
Initial or Prolonged Vomiting Health (Mefloquine
Vertigo Professional Hydrochloride) PS ORAL 1 DOSE FORM 1
Nystagmus
PER WEEK ORAL
Alanine Aminotransferase
Increased
Ventoline (Albuterol
Or Albuterol
Sulfate)
C

Date:04/05/00ISR Number: 3484146-0Report Type:Expedited (15-DaCompany Report #231053 Age:62 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Dyspnoea
Csf Protein Increased
Gait Disturbance
Guillain-Barre Syndrome
Bacterial Infection
03-Apr-2012 09:37 AM Page: 179

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sensory Disturbance
Myalgia
Dizziness Report Source Product Role Manufacturer Route Dose Duration
Blood Immunoglobulin G Foreign Lariam Tablets
Increased Other (Mefloquine
Hyporeflexia Hydrochloride) 250
Muscular Weakness Mg PS ORAL 250 MG 1 PER
Paraesthesia
Proscar
(Finasteride)
C
WEEK ORAL
Date:04/05/00ISR Number: 3484147-2Report Type:Expedited (15-DaCompany Report #218956 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Guillain-Barre Syndrome Foreign Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250
Other Mg PS ORAL 250 MG 1 PER
WEEK ORAL 70 DAY
Date:04/05/00ISR Number: 3484148-4Report Type:Expedited (15-DaCompany Report #218954 Age:23 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Personality Change Foreign Lariam Tablets
Initial or Prolonged Pyrexia Health (Mefloquine
Delusion Professional Hydrochloride) 250
Neurodermatitis Other Mg PS ORAL 250 MG 1 PER
Hypotonia WEEK ORAL 61 DAY
Dermatitis
Psychotic Disorder
Cachexia
Diarrhoea
Abscess
Muscle Disorder
Date:04/05/00ISR Number: 3484149-6Report Type:Expedited (15-DaCompany Report #218938 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Leukocytosis Foreign Lariam Tablets
Initial or Prolonged Diarrhoea Health (Mefloquine
Dizziness Professional Hydrochloride) 250
Pyrexia Other Mg PS ORAL ORAL
Vomiting
Blood Bilirubin Increased

Date:04/05/00ISR Number: 3484150-2Report Type:Expedited (15-DaCompany Report #218934 Age:32 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Expressive Language Foreign Lariam Tablets
Disorder Health (Mefloquine
Dyskinesia Professional Hydrochloride) 250
Mental Disorder Other Mg PS ORAL 250 MG 1 PER
Grand Mal Convulsion
WEEK ORAL
03-Apr-2012 09:37 AM Page: 180

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/05/00ISR Number: 3484151-4Report Type:Expedited (15-DaCompany Report #218937 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gastric Ulcer Haemorrhage Foreign Lariam Tablets
Melaena Health (Mefloquine
Dizziness Professional Hydrochloride) 250
Pallor Other Mg PS ORAL 250 MG 1 PER
Abdominal Distension
Vaccines Nos
(Vaccine Nos)
C
WEEK ORAL
Date:04/05/00ISR Number: 3484152-6Report Type:Expedited (15-DaCompany Report #218933 Age:65 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspnoea Foreign Lariam Tablets
Paraesthesia Health (Mefloquine
Nervous System Disorder Professional Hydrochloride) 250
Brain Scan Abnormal Other Mg PS ORAL ORAL
Date:04/05/00ISR Number: 3484159-9Report Type:Expedited (15-DaCompany Report #232718 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Psychotic Disorder Foreign Lariam Tablets
Intervention to Dystonia Other (Mefloquine
Prevent Permanent Hydrochloride) PS ORAL 1 PER 1 WEEK
Impairment/Damage
Chlorpromazine
(Chlorpromazine)
SS
ORAL
Date:04/05/00ISR Number: 3484160-5Report Type:Expedited (15-DaCompany Report #232293 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Sedation Foreign Lariam Tablets
Initial or Prolonged Depression Health (Mefloquine
Circulatory Collapse Professional Hydrochloride) PS ORAL ORAL 7 DAY
Date:04/05/00ISR Number: 3484188-5Report Type:Expedited (15-DaCompany Report #218942 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Foreign Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250
Other Mg PS ORAL 250 MG 1 PER
WEEK ORAL

Date:04/06/00ISR Number: 3485079-6Report Type:Expedited (15-DaCompany Report #218953 Age:30 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Blood Glucose Decreased
Circadian Rhythm Sleep
Disorder
03-Apr-2012 09:37 AM Page: 181

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Drug Interaction
Loss Of Consciousness
Bite Report Source Product Role Manufacturer Route Dose Duration
Muscle Spasms Foreign Lariam Tablets
Prostatitis Health (Mefloquine
Grand Mal Convulsion Professional Hydrochloride) 250
Tremor Other Mg PS ORAL ORAL
Urethritis
Tongue Disorder
Rytmonorm
(Propafenone
Hydrochloride) 300
Mg SS ORAL ORAL
Polio Vaccine
(Poliomyelitis
Vaccines)
Hepatitis A Vaccine
(Hepatitis A
Vaccine)
Diphtheria Vaccine
(Diphtheria Toxoid)
Tetanus Vaccine
(Tetanus Toxoid)
C
C
C
C
Date:04/07/00ISR Number: 3485171-6Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dizziness Lariam 250 Mg Roche PS Roche ORAL 1 WEEK ORAL
Congenital Anomaly Pyrexia
Required
Dysuria
Intervention to
Headache
Prevent Permanent Insomnia
Impairment/Damage Diarrhoea
Arthralgia
Hypoaesthesia
Paraesthesia
Back Pain
Oropharyngeal Pain
Neck Pain
Date:04/07/00ISR Number: 3485372-7Report Type:Expedited (15-DaCompany Report #20000400108 Age:69 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hemiplegia Foreign Prilosec PS ORAL 40 MG QD PO
Initial or Prolonged Haemorrhage Health Lariam SS
Cerebral Artery Occlusion Professional Imovane SS
Aphasia
Sedation
Atrial Fibrillation

Date:04/07/00ISR Number: 3485913-XReport Type:Expedited (15-DaCompany Report #232768 Age:32 YR Gender:Female I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Feeling Hot
Paraesthesia
Dizziness
Antinuclear Antibody
03-Apr-2012 09:37 AM Page: 182

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Positive
Nausea
Weight Increased
Disturbance In Attention Report Source Product Role Manufacturer Route Dose Duration
Vision Blurred Foreign Lariam Tablets
Balance Disorder Health (Mefloquine
Vertigo Professional Hydrochloride) PS ORAL ORAL
Decreased Appetite
Wolff-Parkinson-White
Syndrome
Hypophagia
Peripheral Coldness
Headache
Abdominal Pain
Demyelination
Hyperacusis
Date:04/07/00ISR Number: 3485989-XReport Type:Expedited (15-DaCompany Report #232633 Age:69 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cerebral Artery Occlusion Foreign Lariam Tablets
Initial or Prolonged Atrial Flutter Other (Mefloquine
Aphasia Hydrochloride) 250
Cerebral Infarction Mg PS ORAL 250 MG 1 PER
Sedation
ONE DOSE ORAL
Cerebrovascular Accident
Mopral (Omeprazole)
Hemiplegia 20 Mg SS ORAL 40 MG DAILY
Pyrexia
ORAL
Imovane (Zopiclone)
7.5 Mg SS ORAL 7.5 MG DAILY
ORAL
Date:04/07/00ISR Number: 3485993-1Report Type:Expedited (15-DaCompany Report #232902 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Lacrimation Decreased Foreign Lariam Tablets
Dizziness Health (Mefloquine
Accommodation Disorder Professional Hydrochloride) 250
Vertigo Other Mg PS ORAL ORAL
Eye Pain
Resochin
Feeling Abnormal
(Chloroquine
Condition Aggravated Phosphate) C
Headache
Vision Blurred
Nystagmus
Gait Disturbance
Date:04/13/00ISR Number: 3487950-8Report Type:Expedited (15-DaCompany Report #233138 Age:22 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Foreign Lariam Tablets
Depression Health (Mefloquine
Suicidal Ideation Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
03-Apr-2012 09:37 AM Page: 183

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/13/00ISR Number: 3488028-XReport Type:Expedited (15-DaCompany Report #229994 Age:19 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dyspnoea Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) PS ORAL ORAL
Date:04/14/00ISR Number: 3488468-9Report Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Larium PS ORAL 1 TABLE ONCE
Nightmare
PER ORAL
Anxiety
Fear
Panic Attack
Hallucination
Date:04/17/00ISR Number: 3489298-4Report Type:Expedited (15-DaCompany Report #228385 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mania Health Lariam Tablets
Initial or Prolonged Weight Decreased Professional (Mefloquine
Psychotic Disorder Hydrochloride) 250
Abnormal Behaviour Mg PS ORAL 250 MG 1PER
Psychomotor Hyperactivity
WEEK ORAL
Magical Thinking Chloroquine C
Date:04/17/00ISR Number: 3489299-6Report Type:Expedited (15-DaCompany Report #233759 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disturbance In Attention Consumer Lariam Tablets
Depression
(Mefloquine
Pulmonary Oedema Hydrochloride) PS ORAL ORAL
Mountain Sickness Acute
Abnormal Dreams
Lethargy
Nightmare
Date:04/18/00ISR Number: 3488728-1Report Type:Direct Company Report # Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Convulsion Lariam PS 250MG WEEKLY
Dilantin SS 400MG DAILY

Date:04/18/00ISR Number: 3489912-3Report Type:Expedited (15-DaCompany Report #233467 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amnesia Foreign Lariam Tablets
Visual Impairment Other (Mefloquine
Reading Disorder Hydrochloride) PS
03-Apr-2012 09:37 AM Page: 184

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/18/00ISR Number: 3489913-5Report Type:Expedited (15-DaCompany Report #233599 Age:70 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Atrial Fibrillation Foreign Lariam Tablets
Initial or Prolonged Syncope Other (Mefloquine
Hydrochloride) PS ORAL DOSE FORM 1
PER WEEK,
ORAL
Date:04/19/00ISR Number: 3490412-5Report Type:Expedited (15-DaCompany Report #233987 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Foreign Lariam Tablets
Initial or Prolonged Feeling Abnormal Other (Mefloquine
Visual Impairment Hydrochloride) 250
Disturbance In Attention Mg PS ORAL 250 MG 1 PER
Fatigue
WEEK ORAL
Orthostatic Hypotension
Ibuprofen
Memory Impairment (Ibuprofen) C
Hypoaesthesia
Retching
Speech Disorder
Date:04/20/00ISR Number: 3490517-9Report Type:Expedited (15-DaCompany Report #233963 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Haptoglobin Decreased Foreign Lariam Tablets
Initial or Prolonged Haemolytic Anaemia Health (Mefloquine
Medication Error Professional Hydrochloride) PS ORAL ORAL
Date:04/24/00ISR Number: 3492276-2Report Type:Expedited (15-DaCompany Report #232768 Age:32 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Malaise
Feeling Hot
Blood Glucose Decreased
Wolff-Parkinson-White
Syndrome
Multiple Sclerosis
Dizziness
Vision Blurred
Weight Increased
Dehydration
Pyrexia
Antinuclear Antibody
Positive
Lethargy

Demyelination
Hyperacusis
Headache
Asthenia
Vertigo
Vomiting
Disorientation
Peripheral Coldness
03-Apr-2012 09:37 AM Page: 185

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Balance Disorder
Migraine
Nausea Report Source Product Role Manufacturer Route Dose Duration
Fatigue Foreign Lariam Tablets
Abdominal Pain Health (Mefloquine
Paraesthesia Professional Hydrochloride) PS ORAL ORAL
Sensation Of Foreign Body
Disturbance In Attention
Dysphagia
Date:04/24/00ISR Number: 3492277-4Report Type:Expedited (15-DaCompany Report #234272 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Cough Foreign Lariam Tablets
Loss Of Consciousness Health (Mefloquine
Professional Hydrochloride) PS ORAL ORAL
Date:04/26/00ISR Number: 3494185-1Report Type:Expedited (15-DaCompany Report #234319 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Foreign Lariam Tablets
Paresis Health (Mefloquine
Delusion Professional Hydrochloride) PS ORAL 250 MG 1 PER
Anxiety
WEEK ORAL
Sleep Disorder
Alopecia
Date:04/28/00ISR Number: 3494447-8Report Type:Expedited (15-DaCompany Report #234391 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Amnesia Consumer Lariam Tablets
Accidental Overdose
(Mefloquine
Loss Of Control Of Legs Hydrochloride) 250
Blindness Transient Mg PS ORAL 250 MG 2 PER
Nausea
DAY ORAL
Medication Error
Date:05/02/00ISR Number: 3495586-8Report Type:Expedited (15-DaCompany Report #231507 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Foreign Lariam Tablets
Initial or Prolonged Haemolytic Anaemia Literature (Mefloquine
Required Anaemia Health Hydrochloride) PS ORAL 1.5 GRAM
Intervention to Malaria Professional DAILY 1 PER 8
Prevent Permanent Inborn Error Of HOUR ORAL

Impairment/Damage
Metabolism
Fatigue
Chromaturia
03-Apr-2012 09:37 AM Page: 186

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/03/00ISR Number: 3495850-2Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Bronchitis Consumer Lariam (Mefloquine)
Intervention to Dyspnoea 250 Mg Once A Week PS Hoffman-Roche
Prevent Permanent Tachycardia Pharmaceuticals ORAL PO ONCE A
Impairment/Damage Anxiety WEEK 250 MG
Levoquin
C
Date:05/03/00ISR Number: 3495910-6Report Type:Direct Company Report # Age:63 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Fatigue Health Larium (Mefloquine
Intervention to Headache Professional Hcl) 250 Mg PS 1 TABLET
Prevent Permanent Insomnia (250MG) PER
Impairment/Damage Abnormal Dreams WEEK
Skin Discolouration
Malaise
Palpitations
Hypertension
Date:05/03/00ISR Number: 3497235-1Report Type:Expedited (15-DaCompany Report #234271 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Syncope Foreign Lariam Tablets
Initial or Prolonged Malaise Other (Mefloquine
Blood Cholesterol Hydrochloride) PS ORAL ORAL
Increased
Pleural Fibrosis
Renal Cyst
Hypertension
Sinoatrial Block
Nausea
Date:05/04/00ISR Number: 3495964-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Consumer Lariam PS ORAL ONCE A 3
Fear
TIMES ORAL
Fear Of Disease
Date:05/04/00ISR Number: 3502895-2Report Type:Direct Company Report # Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hallucination Mefloquine PS

Abnormal Dreams
03-Apr-2012 09:37 AM Page: 187

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/05/00ISR Number: 3497017-0Report Type:Expedited (15-DaCompany Report #234723 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Foreign Mefloquine
Drug Interaction Literature Hydrochloride
Health
(Mefloquine
Professional Hydrochloride) PS
Ofloxacin
(Ofloxacin)
SS
Date:05/05/00ISR Number: 3497133-3Report Type:Expedited (15-DaCompany Report #234722 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Foreign Mefloquine
Drug Interaction Literature Hydrochloride
Health
(Mefloquine
Professional Hydrochloride) PS
Sparfloxacin
(Sparfloxacin) SS
Date:05/05/00ISR Number: 3497134-5Report Type:Expedited (15-DaCompany Report #234734 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Foreign Mefloquine
Drug Interaction Literature Hydrochloride
Health
(Mefloquine
Professional Hydrochloride) PS
Ciprofloxacin
(Ciprofloxacin) SS
Date:05/05/00ISR Number: 3497136-9Report Type:Expedited (15-DaCompany Report #234751 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cough Foreign Lariam Tablets
Initial or Prolonged Loss Of Consciousness Consumer (Mefloquine
Hydrochloride) PS ORAL 250 MG 1 PER
WEEK ORAL
Date:05/08/00ISR Number: 3497838-4Report Type:Expedited (15-DaCompany Report #234954 Age:68 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vith Nerve Paralysis Foreign Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) 250
Other Mg PS ORAL ORAL

Date:05/08/00ISR Number: 3497843-8Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Anxiety
Constipation
03-Apr-2012 09:37 AM Page: 188

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorientation
Fatigue
Dizziness Report Source Product Role Manufacturer Route Dose Duration
Larium 250mg Roche PS Roche ORAL ORALLY
Date:05/08/00ISR Number: 3498350-9Report Type:Expedited (15-DaCompany Report #233329 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Feeling Drunk Health Inc ORAL 250 MG 1 PER
Dizziness Professional WEEK ORAL
Balance Disorder
Memory Impairment
Nystagmus
Date:05/08/00ISR Number: 3498353-4Report Type:Expedited (15-DaCompany Report #234272 Age:44 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Loss Of Consciousness Foreign Lariam PS Hoffmann La Roche
Cough Health Inc ORAL ORAL
Professional
Allopurinol
(Allopurinol)
C
Date:05/11/00ISR Number: 3498920-8Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Consumer Lariam PS ORAL 1 PER WEEK
Crying Other ORAL
Hallucination
Gastrointestinal Disorder
Panic Attack
Sedation
Mood Altered
Balance Disorder
Visual Impairment
Date:05/16/00ISR Number: 3500997-8Report Type:Expedited (15-DaCompany Report #235343 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Epileptic Aura Foreign Lariam Tablets
Aphasia Health (Mefloquine
Loss Of Consciousness Professional Hydrochloride) 250
Other Mg PS Hoffmann La Roche
Inc ORAL 250 MG 1 PER
WEEK ORAL

Date:05/17/00ISR Number: 3501085-7Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
03-Apr-2012 09:37 AM Page: 189

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disability
PT Report Source Product Role Manufacturer Route Dose Duration
Nausea Consumer Lariam-Mefloquine
Back Pain 250mg Roche PS Roche ORAL 250MG 1 PER
Emotional Disorder
WEEK ORAL
Dizziness
Diarrhoea
Muscle Spasms
Loss Of Consciousness
Anxiety
Hypoaesthesia
Paraesthesia
Panic Attack
Pain In Extremity
Tinnitus
Abnormal Dreams
Neck Pain
Headache
Abdominal Pain
Date:05/24/00ISR Number: 3504590-2Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Health Mefloquine-Lariam-/
Paranoia Professional 250 Mg. PS ORAL 1 WEEK ORAL 1 WK
Paraesthesia
Panic Attack
Pyrexia
Dyspnoea
Palpitations
Sleep Disorder
Diarrhoea
Dizziness
Decreased Appetite
Weight Decreased
Nervousness
Cold Sweat
Date:05/26/00ISR Number: 3505463-1Report Type:Expedited (15-DaCompany Report #234272 Age:44 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cough Foreign Lariam PS Hoffmann La Roche
Syncope Health Inc ORAL ORAL
Professional
Allopurinol
(Allopurinol)
C

Date:05/31/00ISR Number: 3506616-9Report Type:Expedited (15-DaCompany Report #236845 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Pregnancy Foreign Lariam PS Hoffmann La Roche
Intervention to Abortion Incomplete Health Inc ORAL 250 MG 1 PER
Prevent Permanent Antepartum Haemorrhage Professional WEEK ORAL
Impairment/Damage Maternal Drugs Affecting
Foetus
03-Apr-2012 09:37 AM Page: 190

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/00ISR Number: 3507011-9Report Type:Expedited (15-DaCompany Report #236875 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Abdominal Pain Upper Foreign Lariam PS Hoffmann La Roche
Health Inc ORAL ORAL
Professional
Other
Date:06/02/00ISR Number: 3507714-6Report Type:Expedited (15-DaCompany Report #940320860001 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anaemia Foreign Lariam PS Hoffmann La Roche
Hepatitis A Antibody Consumer Inc ORAL 250 MG 1 PER
Positive Health WEEK ORAL
Pain
Professional
Complement Factor
Decreased
Red Blood Cell
Sedimentation Rate
Decreased
Gastrointestinal Disorder
Sleep Disorder
Condition Aggravated
Tinnitus
Dyspnoea
Arrhythmia
Immunosuppression
Swelling
Blood Cholesterol
Increased
Blepharitis
Pain In Jaw
Immunology Test Abnormal
Trigeminal Nerve Disorder
Lymphadenopathy
Fatigue
Blood Immunoglobulin G
Increased
Angiopathy
Immune System Disorder
Laryngeal Disorder
Autoimmune Disorder
Antinuclear Antibody
Positive
Mononucleosis Heterophile
Test Positive
Cd4 Lymphocytes Decreased
Arterial Disorder
Hyperaesthesia
Arthropathy

Date:06/02/00ISR Number: 3507717-1Report Type:Expedited (15-DaCompany Report #236161 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Purpura Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Renal Impairment Health Inc ORAL 1 DOSE FORM 1
Hepatic Enzyme Increased Professional PER WEEK ORAL
03-Apr-2012 09:37 AM Page: 191

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Previscan
(Fluindione) SS ORAL ORAL
Lasilix (Furosemide) C
Seloken (Metoprolol
Tartrate)
C
Pyostacine
(Pristinamycin) C
Cordarone
(Amiodarone)
C
Levothyrox
(Levothyroxine
Sodium)
C
Date:06/02/00ISR Number: 3507718-3Report Type:Expedited (15-DaCompany Report #233138 Age:21 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicidal Ideation Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Electroencephalogram Health Inc ORAL 250 MG 1 PER
Abnormal Professional WEEK ORAL
Depression
Social Avoidant Behaviour
Hallucination, Auditory
Gait Disturbance
Disturbance In Attention
Anxiety
Personality Disorder
Rash Erythematous
Mood Swings
Decreased Appetite
Psychotic Disorder
Feeling Abnormal
Cognitive Disorder
Insomnia
Delusion
Blood Bilirubin Increased
Date:06/05/00ISR Number: 3507999-6Report Type:Direct Company Report # Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypertension Lariam 500mg PS
Initial or Prolonged Pyrexia
Migraine
Toxicity To Various
Agents
Depressed Mood
Diarrhoea
Nightmare

Date:06/06/00ISR Number: 3509002-0Report Type:Expedited (15-DaCompany Report #237147 Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Urinary Retention Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Dermatitis Other Inc ORAL 250 MG ORAL
Suspected
Unspecified Drug
03-Apr-2012 09:37 AM Page: 192

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Generic
Component(S)
Unknown) SS ORAL 1 DOSE FORM
DAILY ORAL
Date:06/06/00ISR Number: 3509005-6Report Type:Expedited (15-DaCompany Report #236953 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatic Enzyme Increased Lariam PS Hoffmann La Roche
Myopathy Inc ORAL 250 MG 1 PER
Nerve Root Lesion WEEK ORAL 35 DAY
Blood Creatine
Phosphokinase Increased
Paraesthesia
Drug Level Above
Therapeutic
Insomnia
Date:06/06/00ISR Number: 3510082-7Report Type:Periodic Company Report #211352 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Interaction Health Lariam PS Hoffmann La Roche
Chills Professional Inc ORAL 250 MG 1 PER
Pyrexia
1 WEEK ORAL
Cipro SS ORAL 1 DOSE FORM
ORAL
Date:06/06/00ISR Number: 3510083-9Report Type:Periodic Company Report #211684 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Acne Consumer Lariam PS Hoffmann La Roche
Nightmare Inc ORAL 250 MG 1 PER
Photophobia
WEEK ORAL
Ibuprofen
C
Date:06/06/00ISR Number: 3510084-0Report Type:Periodic Company Report #212626 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vision Blurred Other Lariam PS Hoffmann La Roche
Dyspepsia Inc ORAL 250 MG 1 PER
WEEK ORAL
Date:06/06/00ISR Number: 3510085-2Report Type:Periodic Company Report #212649 Age:35 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fatigue Consumer Lariam PS Hoffmann La Roche
Eosinophilia Inc ORAL 250 MG 1 PER
Haematuria
WEEK ORAL
Vision Blurred
Blood Pressure Increased
03-Apr-2012 09:37 AM Page: 193

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/06/00ISR Number: 3510086-4Report Type:Periodic Company Report #212713 Age:54 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Heart Rate Increased Other Lariam PS Hoffmann La Roche
Coordination Abnormal Inc ORAL 250 MG 1 PER
Tremor
WEEK ORAL
Hyperhidrosis Progesterone C
Anxiety Ogen C
Headache
Date:06/06/00ISR Number: 3510087-6Report Type:Periodic Company Report #215004 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Consumer Lariam PS Hoffmann La Roche
Anxiety Inc ORAL 250 MG 1 PER
Arthralgia
WEEK ORAL
Abnormal Dreams
Date:06/06/00ISR Number: 3510088-8Report Type:Periodic Company Report #216929 Age:56 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gingival Erosion Health Lariam PS Hoffmann La Roche
Professional Inc ORAL 250 MG 1 PER
1 WEEK ORAL
Calcium Supplements C
Date:06/06/00ISR Number: 3510089-XReport Type:Periodic Company Report #217582 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Consumer Lariam PS Hoffmann La Roche
Fatigue Inc ORAL ORAL
Dizziness
Oropharyngeal Pain
Date:06/06/00ISR Number: 3510090-6Report Type:Periodic Company Report #218907 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amenorrhoea Consumer Lariam PS Hoffmann La Roche
Health Inc ORAL 250 MG 1 PER
Professional
WEEK ORAL
Birth Control Pills SS ORAL ORAL
Date:06/06/00ISR Number: 3510091-8Report Type:Periodic Company Report #219666 Age:55 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaise Health Lariam PS Hoffmann La Roche
Vertigo Professional Inc ORAL ORAL
03-Apr-2012 09:37 AM Page: 194

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/06/00ISR Number: 3510094-3Report Type:Periodic Company Report #219667 Age:61 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Health Lariam PS Hoffmann La Roche
Asthenia Professional Inc ORAL ORAL
Mental Impairment
Balance Disorder
Date:06/06/00ISR Number: 3510097-9Report Type:Periodic Company Report #219671 Age:60 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vertigo Health Lariam PS Hoffmann La Roche
Malaise Professional Inc ORAL ORAL
Date:06/06/00ISR Number: 3510098-0Report Type:Periodic Company Report #219674 Age:60 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Feeling Abnormal Health Lariam PS Hoffmann La Roche
Malaise Professional Inc ORAL 250 MG 1 PER
WEEK ORAL
Date:06/06/00ISR Number: 3510100-6Report Type:Periodic Company Report #220897 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Sedation Consumer Lariam PS Hoffmann La Roche
Mood Swings Inc ORAL 250 MG DAILY
Red Blood Cell Count
ORAL
Increased
Oral Contraceptive
Dizziness Nos C
Electrocardiogram
Abnormal
Conversion Disorder
Electrocardiogram Change
Nightmare
Psychotic Disorder
Confusional State
Disorientation
Paranoia
Insomnia
Crying
Night Sweats
Hallucination
Date:06/06/00ISR Number: 3510103-1Report Type:Periodic Company Report #220939 Age:36 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Consumer Lariam PS Hoffmann La Roche
Anxiety Other Inc ORAL 250 MG 1 PER
Depression
WEEK ORAL
Dehydration Lotensin C
Panic Attack
Heart Rate Increased
03-Apr-2012 09:37 AM Page: 195

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/06/00ISR Number: 3510106-7Report Type:Periodic Company Report #222392 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Body Temperature Consumer Lariam PS Hoffmann La Roche
Increased Inc ORAL 250 MG 1 PER
Nasopharyngitis
WEEK ORAL
Fatigue
Blood Pressure Diastolic
Increased
Urinary Tract Infection
Tachycardia
Anxiety
Dizziness
Decreased Appetite
Productive Cough
Dyspnoea
Oropharyngeal Pain
Pyrexia
Date:06/06/00ISR Number: 3510107-9Report Type:Periodic Company Report #223365 Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fatigue Health Lariam PS Hoffmann La Roche
Diarrhoea Professional Inc ORAL 500 MG DAILY
ORAL 49 DAY
Date:06/06/00ISR Number: 3510109-2Report Type:Periodic Company Report #223368 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Oedema Peripheral Consumer Lariam PS Hoffmann La Roche
Lethargy Inc ORAL 250 MG 1 PER
WEEK ORAL 28 DAY
Date:06/06/00ISR Number: 3510111-0Report Type:Periodic Company Report #224970 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Health Lariam PS Hoffmann La Roche
Tachycardia Professional Inc ORAL 250 MG 1 PER
Dizziness
WEEK ORAL
Pyrexia Fosamax C
Anxiety
Diarrhoea
Hypoaesthesia
Upper Respiratory Tract
Infection
Fatigue
Dysphoria

Hypoaesthesia Oral
Disturbance In Attention
Dyspnoea
Abdominal Pain
Hypoventilation
03-Apr-2012 09:37 AM Page: 196

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/06/00ISR Number: 3510113-4Report Type:Periodic Company Report #227110 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Health Lariam PS Hoffmann La Roche
Chest Discomfort Professional Inc ORAL 250 MG 1 PER
Chest Pain
WEEK ORAL
Anxiety
Date:06/06/00ISR Number: 3510116-XReport Type:Periodic Company Report #200733 Age:65 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Panic Attack Consumer Lariam PS Hoffmann La Roche
Nausea Inc ORAL 250 MG 1 PER
Headache
WEEK ORAL
Anxiety
Estrogen (Estrogens
Paraesthesia Nos) C
Tremor
Progestin (Progestin
Dizziness Nos) C
Hyperhidrosis
Palpitations
Abnormal Dreams
Decreased Appetite
Chills
Chest Pain
Alopecia
Vomiting
Date:06/06/00ISR Number: 3510118-3Report Type:Periodic Company Report #201043 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asthenia Other Lariam PS Hoffmann La Roche
Ear Disorder Inc ORAL 250 MG 1 PER
Eye Disorder
WEEK ORAL
Discomfort
Headache
Date:06/06/00ISR Number: 3510120-1Report Type:Periodic Company Report #930201053001 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Health Lariam PS Hoffmann La Roche
Asthenia Professional Inc ORAL ORAL
Tachycardia
Irritability
Hyperacusis
Insomnia
Disturbance In Attention
Paranoia

Date:06/06/00ISR Number: 3510124-9Report Type:Periodic Company Report #208413 Age:36 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Tachycardia
Flushing
03-Apr-2012 09:37 AM Page: 197

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dizziness
Syncope
Hypotension Report Source Product Role Manufacturer Route Dose Duration
Health Lariam PS Hoffmann La Roche
Professional Inc ORAL 1 PER WEEK
ORAL
Synthroid
(Levothyroxine
Sodium)
C
Date:06/06/00ISR Number: 3510127-4Report Type:Periodic Company Report #209051 Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nuclear Magnetic Health Lariam PS Hoffmann La Roche
Resonance Imaging Professional Inc ORAL 250 MG 1 PER
Abnormal
WEEK ORAL
Tinnitus
Malaria
Alopecia
Vision Blurred
Drug Ineffective
Date:06/06/00ISR Number: 3510131-6Report Type:Periodic Company Report #211281 Age:64 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscle Spasms Other Lariam PS Hoffmann La Roche
Syncope Inc ORAL 250 MG 1 PER
Abdominal Pain
WEEK ORAL
Coordination Abnormal
Diarrhoea
Dizziness
Date:06/06/00ISR Number: 3510134-1Report Type:Periodic Company Report #212816 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Condition Aggravated Consumer Lariam PS Hoffmann La Roche
Balance Disorder Health Inc ORAL 250 MG 1 PER
Panic Attack Professional WEEK ORAL
Phobia
Date:06/06/00ISR Number: 3510137-7Report Type:Periodic Company Report #213466 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Eye Movement Disorder Health Lariam PS Hoffmann La Roche
Loss Of Consciousness Professional Inc ORAL 250 MG 1 PER

Crying ONE DOSE ORAL
Convulsion
Bite
Tremor
Amnesia
Fall
03-Apr-2012 09:37 AM Page: 198

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/06/00ISR Number: 3510140-7Report Type:Periodic Company Report #214497 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pyrexia Other Lariam PS Hoffmann La Roche
Drug Ineffective Inc ORAL 250 MG 1 PER
Malaria
WEEK ORAL
Diarrhoea
Headache
Date:06/06/00ISR Number: 3510142-0Report Type:Periodic Company Report #217162 Age:65 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Health Lariam PS Hoffmann La Roche
Pyrexia Professional Inc ORAL 250 MG 1 PER
Drug Ineffective
1 WEEK ORAL
Haematocrit Decreased
Chills
White Blood Cell Count
Decreased
Platelet Count Decreased
Date:06/06/00ISR Number: 3510147-XReport Type:Periodic Company Report #223678 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Alopecia Consumer Lariam PS Hoffmann La Roche
Dizziness Inc ORAL 250 MG 1 PER
Hallucination
WEEK ORAL
Vomiting
Suicidal Ideation
Date:06/06/00ISR Number: 3510150-XReport Type:Periodic Company Report #227106 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dyspnoea Health Lariam PS Hoffmann La Roche
Constipation Professional Inc ORAL 250 MG 1 PER
Choking Other WEEK ORAL
Muscle Twitching
Ortho-Novum (Ethinyl
Diarrhoea
Estradiol Or
Panic Attack
Mestranol/Norethidro
ne)
C
Aspirin (Aspirin) C
Date:06/06/00ISR Number: 3510154-7Report Type:Periodic Company Report #230635 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Syncope Health Lariam PS Hoffmann La Roche
Hyperhidrosis Professional Inc ORAL 20 MG 1 PER
Dyspnoea
WEEK ORAL
Oxygen Saturation
Decreased
Bradycardia
03-Apr-2012 09:37 AM Page: 199

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/06/00ISR Number: 3510156-0Report Type:Periodic Company Report #205795 Age:50 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Iritis Health Lariam PS Hoffmann La Roche
Scotoma Professional Inc ORAL ORAL
Eye Pain
Dermatitis Atopic
Blindness
Date:06/06/00ISR Number: 3510158-4Report Type:Periodic Company Report #205967 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tongue Disorder Health Lariam PS Hoffmann La Roche
Professional Inc ORAL 250 MG 1 PER
WEEK ORAL
Relafen (Nabmetone) C
Prednisone
(Prednisone)
C
Plaquenil
(Hydrochloroquine
Sulfate)
C
Date:06/06/00ISR Number: 3510160-2Report Type:Periodic Company Report #207060 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Other Lariam PS Hoffmann La Roche
Petechiae Inc ORAL 250 MG 1 PER
WEEK ORAL
Date:06/06/00ISR Number: 3510164-XReport Type:Periodic Company Report #208862 Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fatigue Health Lariam PS Hoffmann La Roche
Pyrexia Professional Inc ORAL 250 MG 1 PER
Blood Thyroid Stimulating
WEEK ORAL
Hormone Increased
Vitamin C (Ascorbic
Liver Function Test Acid) C
Abnormal
Inhaler Nos
Chills (Inhalant Nos) C
Multivitamin
(Multivitamin Nos) C
Beta-Carotene (Beta
Carotene)
C
Unknown Drug
(Generic
Component(S)
Unknown)
C

Ventolin Inhaler
(Albuterol)
Calcium (Calcium
Nos)
C
C
03-Apr-2012 09:37 AM Page: 200

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/06/00ISR Number: 3510165-1Report Type:Periodic Company Report #208888 Age:60 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Acuity Reduced Other Lariam PS Hoffmann La Roche
Gout Inc ORAL 250 MG 1 PER
WEEK ORAL
Date:06/06/00ISR Number: 3510169-9Report Type:Periodic Company Report #209840 Age:16 YR Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Haematuria Health Lariam PS Hoffmann La Roche
Professional Inc ORAL ORAL
Date:06/06/00ISR Number: 3510172-9Report Type:Periodic Company Report #211009 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Pressure Increased Health Lariam PS Hoffmann La Roche
Pallor Professional Inc ORAL 250 MG 1 PER
Dizziness
WEEK ORAL
Date:06/06/00ISR Number: 3510191-2Report Type:Periodic Company Report #228486 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Consumer Lariam PS Hoffmann La Roche
Vertigo Inc ORAL 1.25 GRAM 1
Memory Impairment
PER ONE DOSE
Disturbance In Attention
ORAL
Chills
Headache
Tinnitus
Insomnia
Date:06/06/00ISR Number: 3510193-6Report Type:Periodic Company Report #231666 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Feeling Abnormal Consumer Lariam PS Hoffmann La Roche
Depression
Inc
Fatigue Ativan (Lorazepam) C
Celexa (Citalopram) C
Date:06/06/00ISR Number: 3510194-8Report Type:Periodic Company Report #232888 Age:21 YR Gender:Male I/FU:I
Outcome
PT

Other Serious
Feeling Abnormal
Asthma
Vertigo
Panic Attack
Paranoia
Anxiety
Fatigue
Insomnia
03-Apr-2012 09:37 AM Page: 201

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Restlessness
Report Source Product Role Manufacturer Route Dose Duration
Health Lariam PS Hoffmann La Roche
Professional Inc ORAL 1 PER WEEK
ORAL
Date:06/06/00ISR Number: 3510196-1Report Type:Periodic Company Report #112461 Age:54 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lethargy Consumer Lariam PS Hoffmann La Roche
Initial or Prolonged Chills Health Inc ORAL 250 MG 1 PER
Drug Ineffective Professional WEEK ORAL
Diarrhoea
Prilosec
Hyperhidrosis (Omeprazole) C
Vomiting
Malaria
Abdominal Pain
Dehydration
Leukocytosis
Pyrexia
Date:06/06/00ISR Number: 3510198-5Report Type:Periodic Company Report #202382 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paranoia Other Lariam PS Hoffmann La Roche
Initial or Prolonged Depression Inc ORAL 250 MG 1 PER
Delusion
WEEK ORAL
Date:06/06/00ISR Number: 3510200-0Report Type:Periodic Company Report #203056 Age:6 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Confusional State Other Lariam PS Hoffmann La Roche
Convulsion Inc ORAL 250 MG 1 PER
Amnesia
WEEK ORAL
Date:06/08/00ISR Number: 3510582-XReport Type:Expedited (15-DaCompany Report #237264 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Spinal Fracture Foreign Lariam PS Hoffmann La Roche
Convulsion Consumer Inc ORAL ORAL
Dizziness
Fall
Drug Ineffective

Date:06/08/00ISR Number: 3510583-1Report Type:Expedited (15-DaCompany Report #237590 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Intra-Uterine Death Foreign Lariam PS Hoffmann La Roche
Accidental Exposure Health Inc
Professional
03-Apr-2012 09:37 AM Page: 202

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/00ISR Number: 3510584-3Report Type:Expedited (15-DaCompany Report #237544 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaria Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Malaise Health Inc
Professional
Date:06/08/00ISR Number: 3510585-5Report Type:Expedited (15-DaCompany Report #237143 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Hallucination Other Inc ORAL 1 DOSE FORM
Arthralgia
ORAL
Aspartate
Aminotransferase
Increased
Alanine Aminotransferase
Increased
Jaundice
Nausea
Asthenia
Date:06/08/00ISR Number: 3510586-7Report Type:Expedited (15-DaCompany Report #236875 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Pain Foreign Lariam PS Hoffmann La Roche
Health Inc ORAL ORAL
Professional
Other
Date:06/09/00ISR Number: 3510997-XReport Type:Expedited (15-DaCompany Report #237587 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Intra-Uterine Death Foreign Lariam PS Hoffmann La Roche
Accidental Exposure Health Inc
Professional
Date:06/09/00ISR Number: 3517524-1Report Type:Periodic Company Report #73316 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Rash Pruritic Consumer Accutane PS Hlr Technology ORAL 20 MG 3 PER
Dermatitis
DAY ORAL
Skin Wrinkling
Lariam Tablets
(Mefloquine
Hydrochloride) 250

Mg SS ORAL 250 MG 1 PER
1 WEEK ORAL
Ortho Novum (Ethinyl
Estradiol Or
Mestranol/Norethindr
one)
C
Synthroid
(Levothyroxine
03-Apr-2012 09:37 AM Page: 203

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sodium)
C
Date:06/13/00ISR Number: 3513543-XReport Type:Expedited (15-DaCompany Report #237062 Age:65 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Agitation Other Inc ORAL 1 DOSE FORM 1
Anxiety
PER WEEK ORAL
Delirium
Date:06/15/00ISR Number: 3514429-7Report Type:Expedited (15-DaCompany Report #237672 Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vision Blurred Foreign Lariam PS Hoffmann La Roche
Cataract Consumer Inc ORAL ORAL
Visual Impairment
Disturbance In Attention
Date:06/20/00ISR Number: 3516339-8Report Type:Expedited (15-DaCompany Report #215628 Age: Gender:Unknown I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Ultrasound Antenatal Foreign Lariam PS Hoffmann La Roche
Screen Abnormal Health Inc ORAL 250 MG 1 PER
Trisomy 21 Professional WEEK ORAL
Amniocentesis Abnormal
Abortion Induced
Foetal Disorder
Maternal Drugs Affecting
Foetus
Cystic Lymphangioma
Pregnancy
Date:06/20/00ISR Number: 3516343-XReport Type:Expedited (15-DaCompany Report #237264 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Foreign Lariam PS Hoffmann La Roche
Malaria Consumer Inc ORAL ORAL
Paraesthesia
Spinal Fracture
Fall
Drug Ineffective
Feeling Abnormal
Dizziness
Headache

Date:06/21/00ISR Number: 3517156-5Report Type:Expedited (15-DaCompany Report #237147 Age:39 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Anuria
Thrombocytosis
Urinary Retention
Pyrexia
03-Apr-2012 09:37 AM Page: 204

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dysuria
Erythema
Hypokalaemia Report Source Product Role Manufacturer Route Dose Duration
Exfoliative Rash Foreign Lariam PS Hoffmann La Roche
C-Reactive Protein Other Inc ORAL 250 MG ORAL
Increased
Suspected
Skin Disorder
Unspecified Drug
Cystitis
(Generic
Neurogenic Bladder
Component(S)
Pyelonephritis Unknown) SS 6 DOSE FORM
Dermatitis
DAILY
Suspected
Unspecified Drug
(Generic
Component(S)
Unknown) SS ORAL 1 DOSE FORM
DAILY ORAL
Date:06/21/00ISR Number: 3517158-9Report Type:Expedited (15-DaCompany Report #238384 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Liver Function Test Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Abnormal Health Inc ORAL ORAL
Abdominal Pain
Professional
Date:06/23/00ISR Number: 3518681-3Report Type:Expedited (15-DaCompany Report #238706 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tendon Rupture Foreign Lariam PS Hoffmann La Roche
Other Inc ORAL ORAL 70 DAY
Atenolol (Atenolol) C
Date:06/26/00ISR Number: 3520477-3Report Type:Expedited (15-DaCompany Report #238943 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoproteinaemia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Blood Bilirubin Increased Health Inc ORAL 250 MG 1 PER
Jaundice Professional WEEK ORAL
Ascites
Date:06/27/00ISR Number: 3520664-4Report Type:Expedited (15-DaCompany Report #238749 Age: Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Malaria
Tremor

Disability
Hallucination
Sensory Disturbance
Pupils Unequal
Chest Pain
Coordination Abnormal
Fatigue
Drug Ineffective
Headache
03-Apr-2012 09:37 AM Page: 205

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Visual Impairment
Emotional Disorder
Depression Report Source Product Role Manufacturer Route Dose Duration
Pain In Extremity Foreign Lariam PS Hoffmann La Roche
Blood Pressure Increased Consumer Inc ORAL ORAL
Paranoia
Muscle Twitching
Disturbance In Attention
Circulatory Collapse
Nightmare
Abnormal Dreams
Asthenia
Nervous System Disorder
Feeling Of Body
Temperature Change
Date:06/27/00ISR Number: 3520667-XReport Type:Expedited (15-DaCompany Report #237264 Age:50 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Paraesthesia Foreign Lariam PS Hoffmann La Roche
Dizziness Consumer Inc ORAL 250 MG 1 PER
Headache Health WEEK ORAL
Malaria
Professional
Feeling Abnormal
Drug Ineffective
Spinal Fracture
Pain
Fall
Convulsion
Date:06/27/00ISR Number: 3520673-5Report Type:Expedited (15-DaCompany Report #237544 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaise Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Malaria Health Inc ORAL ORAL
Professional
Date:06/28/00ISR Number: 3521532-4Report Type:Expedited (15-DaCompany Report #232833 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Sleep Disorder Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Nausea Health Inc ORAL ORAL
Tremor
Professional
Depression
Mental Disorder
Neuropathy Peripheral
Depressed Mood

Date:06/28/00ISR Number: 3521542-7Report Type:Expedited (15-DaCompany Report #231053 Age:62 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Hyporeflexia
Csf Protein Increased
03-Apr-2012 09:37 AM Page: 206

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Lumbar Puncture Abnormal
Dizziness
Gait Disturbance Report Source Product Role Manufacturer Route Dose Duration
Antibody Test Positive Foreign Lariam PS Hoffmann La Roche
Myalgia Other Inc ORAL 250 MG 1 PER
Muscular Weakness
WEEK ORAL
Polyneuropathy
Proscar
Balance Disorder (Finasteride) C
Dyspnoea
Paraesthesia
Date:06/29/00ISR Number: 3522435-1Report Type:Expedited (15-DaCompany Report #238730 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Pressure Systolic Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Increased Other Inc ORAL 45 MG 1 PER
Required Calcinosis WEEK ORAL
Intervention to Enterococcal Bacteraemia Budesonide
Prevent Permanent Computerised Tomogram (Budesonide) C
Impairment/Damage Abnormal Warfarin (Warfarin
Vomiting Sodium) C
Low Cardiac Output
Bumetanide
Syndrome (Bumetanide) C
Malaise
Metformin
Red Blood Cell (Metformin) C
Sedimentation Rate
Amiodarone
Increased (Amiodarone) C
Pyrexia
Loss Of Consciousness
Hepatitis B Antibody
Positive
Urinary Tract Infection
Hepatitis
Dehydration
C-Reactive Protein
Increased
Liver Function Test
Abnormal
Hepatic Function Abnormal
Asthenia
Torsade De Pointes
Culture Urine Positive
Circulatory Collapse
Electrocardiogram Qt
Prolonged
Date:06/29/00ISR Number: 3522437-5Report Type:Expedited (15-DaCompany Report #239189 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Amyotrophic Lateral Foreign Lariam PS Hoffmann La Roche
Sclerosis Other Inc ORAL ORAL
03-Apr-2012 09:37 AM Page: 207

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/05/00ISR Number: 3524097-6Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Insomnia
Lariam 250mg
Vomiting Hoffman/Roche PS Hoffman/Roche ORAL 250MG ONCE
Feeling Cold
WEEKLY ORAL
Flushing
Tylenol-Acetaminioph
Pain en C
Pyrexia
Cold Sweat
Diarrhoea
Decreased Appetite
Date:07/05/00ISR Number: 3524160-XReport Type:Expedited (15-DaCompany Report #236161 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Purpura Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Hepatic Infarction Health Inc ORAL 1 DOSE FORM 1
Renal Impairment Professional PER WEEK ORAL
Hepatic Enzyme Increased
Previscan
(Fluindione) SS ORAL ORAL
Lasilix
C
Seloken
C
Pyostacine
C
Praxilene
C
Cordarone
C
Levothyrox
C
Date:07/05/00ISR Number: 3524263-XReport Type:Direct Company Report # Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gastrointestinal Pain Lariam 250mg
Fatigue
(Hoffman Laroche
Back Pain Ltd) PS Hoffman Laroche Ltd ORAL 1 PILL , 1 X
WEEK, ORAL
047
Date:07/05/00ISR Number: 3524267-7Report Type:Direct Company Report # Age:57 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Gastrointestinal Pain
Lariam -250mg
Eye Pain
(Hoffmann-La Roche,
Vomiting Ltd) PS Hoffmann-La Roche,
Dizziness Ltd ORAL 1 PILL, 1X
Headache
WEEK, ORAL
Diarrhoea 047
Balance Disorder

Rash Pruritic
Abdominal Pain Upper
Discomfort
03-Apr-2012 09:37 AM Page: 208

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/05/00ISR Number: 3524360-9Report Type:Expedited (15-DaCompany Report #237264 Age:50 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Spinal Fracture Foreign Lariam PS Hoffmann La Roche
Pain Consumer Inc ORAL 250 MG 1 PER
Malaria Health WEEK ORAL
Convulsion
Professional
Paraesthesia
Drug Ineffective
Fall
Headache
Feeling Abnormal
Dizziness
Date:07/05/00ISR Number: 3524794-2Report Type:Expedited (15-DaCompany Report #239438 Age:60 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Deafness Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Drug Level Above Other Inc ORAL ORAL
Therapeutic
Quinimax
Medication Error
(Cinchonidine/Cincho
Tinnitus
nine/Quinidine/Quini
Electrocardiogram Qt ne) SS ORAL ORAL
Prolonged
Vomiting
Date:07/07/00ISR Number: 3526201-2Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Consumer Larium / Mefloquin
Initial or Prolonged Depression 250mg PS ORAL 250MG/
Amnesia
WEEKLY/ ORAL
Headache
Insomnia
Abnormal Behaviour
Cranial Nerve Disorder
Judgement Impaired
Dislocation Of Vertebra
Emotional Disorder
Toxicity To Various
Agents
Nervous System Disorder
Decreased Appetite
Date:07/07/00ISR Number: 3526638-1Report Type:Expedited (15-DaCompany Report #228555 Age:33 YR Gender:Male I/FU:F
Outcome
PT

Death
Splenomegaly
Psychotic Disorder
Completed Suicide
Pyrexia
Malaise
Bone Pain
Oropharyngeal Pain
Burning Sensation
03-Apr-2012 09:37 AM Page: 209

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Panic Disorder
Dyspnoea
Peripheral Coldness Report Source Product Role Manufacturer Route Dose Duration
Dizziness Foreign Lariam PS Hoffmann La Roche
Disorientation Literature Inc ORAL 500 MG 1 PER
Headache Health ONE DOSE ORAL
Malaria Professional Co-Trimoxazol C
Depression Other Penicillin V C
Anxiety Intravenous Glucose C
Hypoaesthesia Paracetamol C
Fear Codeine Phosphate C
Cardiomyopathy Fansidar C
Chills Quinine C
Confusional State Antimalarial Agent C
Myocarditis Aspirin C
Diarrhoea
Date:07/11/00ISR Number: 3527822-3Report Type:Expedited (15-DaCompany Report #239809 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Obsessive-Compulsive Foreign Lariam PS Hoffmann La Roche
Disorder Other Inc ORAL 250 MG 1 PER
Anxiety
WEEK ORAL
Aggression
Date:07/11/00ISR Number: 3527823-5Report Type:Expedited (15-DaCompany Report #203837 Age:54 YR Gender:Male I/FU:F
Outcome
Death
PT
Insomnia
Decreased Appetite
Agitation
Chills
Flushing
Staring
Lethargy
Obsessive-Compulsive
Disorder
Nervous System Disorder
Depression
Hallucination
Hyperhidrosis
Weight Decreased
Coma
Fatigue
Completed Suicide
Urinary Hesitation
Feeling Abnormal
Anxiety
Delusional Disorder,

Persecutory Type
Amnesia
Cognitive Disorder
Musculoskeletal Stiffness
Delirium
Adjustment Disorder
Polydipsia
Hallucinations, Mixed
03-Apr-2012 09:37 AM Page: 210

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Mental Disorder
Report Source Product Role Manufacturer Route Dose Duration
Consumer Lariam PS Hoffmann La Roche
Inc ORAL 250 MG 1 PER
1 WEEK ORAL
Date:07/11/00ISR Number: 3527825-9Report Type:Expedited (15-DaCompany Report #235479 Age:76 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Corneal Disorder Health Lariam PS Hoffmann La Roche
Corneal Oedema Professional Inc ORAL ORAL
Date:07/12/00ISR Number: 3528437-3Report Type:Expedited (15-DaCompany Report #236649 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nausea Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Fatigue Health Inc ORAL 1 DOSE FORM 1
Decreased Appetite Professional PER WEEK ORAL
Abdominal Pain
Oesophageal Candidiasis
Gastritis
Date:07/14/00ISR Number: 3529989-XReport Type:Expedited (15-DaCompany Report #239896 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatitis E Foreign Lariam PS Hoffmann La Roche
Hypertriglyceridaemia Health Inc ORAL 250 MG 1 PER
Blood Immunoglobulin A Professional WEEK ORAL
Increased
Sortis (Atorvastatin
Blood Immunoglobulin M Calcium) SS 30 MG DAILY
Increased
Havrix (Hepatitis A
Serum Ferritin Increased Vaccine) C
High Density Lipoprotein
Omeprazole
Decreased (Omeprazole) C
Jaundice
Hb-Vax-Dna
Cholestasis
(Hepatitis B Virus
Blood Bilirubin Increased
Vaccine Inactivated) C
Liver Function Test
Hepatitis B
Abnormal
Immunoglobulin
Hypercholesterolaemia
(Hepatitis B Immune
Blood Immunoglobulin G Globulin) C
Increased
Beloc Zok Mite
Monocytosis
(Metoprolol
Hepatitis Succinate) C
Delix (Ramipril) C
Ass (Aspirin)
C

Date:07/20/00ISR Number: 3532363-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome
Required
Intervention to
03-Apr-2012 09:37 AM Page: 211

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Prevent Permanent
Impairment/Damage
PT Report Source Product Role Manufacturer Route Dose Duration
Dizziness Lariam 250mg Laroche PS Laroche ORAL 250MG WEEKLY
Lethargy
ORAL
Disturbance In Attention Bi-Est C
Mental Impairment Estriol/Estradiol C
Nausea Progesterone C
Emotional Distress
Date:07/21/00ISR Number: 3534058-9Report Type:Expedited (15-DaCompany Report #240830 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Foreign Lariam PS Hoffmann La Roche
Injury Other Inc ORAL ORAL
Date:07/24/00ISR Number: 3533956-XReport Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Mefloquin PS ORAL SMALL WEEKLY
Initial or Prolonged Paranoia / LARGE
ONE TIME /
ORAL
Deployment Vaccines
For Us Army And Gulf
War 90-91
C
Date:07/24/00ISR Number: 3533962-5Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Mefloqine Lariam
Initial or Prolonged Decreased Appetite Roche PS Roche ORAL 1 PILL WEEK
Required Weight Decreased ORAL
Intervention to
Depression
Prevent Permanent Anxiety
Impairment/Damage
Date:07/25/00ISR Number: 3534612-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Insomnia Lariam Mephloquine PS Roche Laboratories ORAL 1/10 DAYS
Fatigue
ORAL
Attention
Deficit/Hyperactivity
Disorder

Headache
Disturbance In Attention
Anxiety
Amnesia
Communication Disorder
Tinnitus
Hearing Impaired
03-Apr-2012 09:37 AM Page: 212

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/25/00ISR Number: 3535273-0Report Type:Expedited (15-DaCompany Report #213831 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Premature Baby Foreign Lariam PS Hoffmann La Roche
Maternal Drugs Affecting Health Inc ORAL 250 MG 1 PER
Foetus Professional WEEK ORAL
Zovirax
C
Date:07/26/00ISR Number: 3535783-6Report Type:Expedited (15-DaCompany Report #241048 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cerebellar Syndrome Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Csf White Blood Cell Other Inc ORAL 150 MG 1 PER
Count Positive
ONE DOSE ORAL
Physical Examination
Abnormal
Coma
Pyrexia
Blood Pressure Diastolic
Decreased
Csf Protein Increased
Bradycardia
Confusional State
Encephalitis
Agitation
Hallucination, Visual
Musculoskeletal Stiffness
Abnormal Behaviour
Date:07/27/00ISR Number: 3536477-3Report Type:Expedited (15-DaCompany Report #219219 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Pregnancy Foreign Lariam PS Hoffmann La Roche
Maternal Drugs Affecting Health Inc ORAL 250 MG 1 PER
Foetus Professional WEEK ORAL
Neonatal Disorder
Cardiac Murmur
Congenital Anomaly
Date:07/28/00ISR Number: 3537250-2Report Type:Direct Company Report # Age:71 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asthenia Lariam PS
Abnormal Dreams

Date:08/01/00ISR Number: 3539212-8Report Type:Expedited (15-DaCompany Report #240839 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypomania Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Health Inc ORAL 250 MG 1 PER
Disability Professional WEEK ORAL
03-Apr-2012 09:37 AM Page: 213

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/01/00ISR Number: 3539316-XReport Type:Expedited (15-DaCompany Report #240830 Age:24 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Foreign Lariam PS Hoffmann La Roche
Haemorrhage Other Inc ORAL ORAL
Nightmare
Injury
Amnesia
Date:08/01/00ISR Number: 3539356-0Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Health Lariam PS Hoffmann La Roche
Headache Professional Inc ORAL 250 MG 1 PER
Vertigo
WEEK ORAL
Dizziness
Depression
Panic Attack
Date:08/01/00ISR Number: 3539359-6Report Type:Expedited (15-DaCompany Report #241539 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tremor Foreign Lariam PS Hoffmann La Roche
Health Inc ORAL 250 MG 1 PER
Professional WEEK ORAL 14 DAY
Date:08/01/00ISR Number: 3539361-4Report Type:Expedited (15-DaCompany Report #241249 Age:18 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Foreign Lariam PS Hoffmann La Roche
Social Avoidant Behaviour Health Inc ORAL ORAL
Intentional Overdose Professional Paracetamol/Pseudoep
Suicide Attempt
hedrine
(Acetaminophen/Pseud
oephedrine
Hydrochloride) SS
Date:08/01/00ISR Number: 3539370-5Report Type:Expedited (15-DaCompany Report #241194 Age:3 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Deafness Congenital Foreign Lariam PS Hoffmann La Roche
Maternal Drugs Affecting Health Inc ORAL ORAL 61 DAY
Foetus
Professional
Psychomotor Retardation

Date:08/02/00ISR Number: 3539668-0Report Type:Direct Company Report # Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Medication Error Consumer Lariam PS Roche 250MG TABLET
03-Apr-2012 09:37 AM Page: 214

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/07/00ISR Number: 3544183-4Report Type:Expedited (15-DaCompany Report #233963 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Lactate Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Dehydrogenase Increased Health Inc ORAL ORAL
Leukopenia Professional Prodafalgan C
Haptoglobin Decreased Potassium C
Haemolytic Anaemia Quinimax C
Overdose
Balance Disorder
Medication Error
Thrombocytopenia
Dizziness
Hypokalaemia
Date:08/07/00ISR Number: 3544187-1Report Type:Expedited (15-DaCompany Report #241950 Age:11 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Malaria Foreign Lariam PS Hoffmann La Roche
Hospitalization - Malaise Health Inc ORAL 250 MG 1 PER
Initial or Prolonged Anaphylactic Shock Professional WEEK ORAL
Date:08/10/00ISR Number: 3547668-XReport Type:Expedited (15-DaCompany Report #232139 Age:33 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Astigmatism
Staphylococcal Infection
Hypoaesthesia
Feeling Abnormal
Vertigo
Pyrexia
Alanine Aminotransferase
Increased
Gastritis
Visual Impairment
Nystagmus
Temperature Regulation
Disorder
Facial Nerve Disorder
Tinnitus
Malaise
Palpitations
Hearing Impaired
Nervous System Disorder
Arthritis
Diarrhoea
Conduction Disorder
Binocular Eye Movement
Disorder

Antibody Test Negative
Neck Pain
Gait Disturbance
Hyporeflexia
Csf Test Abnormal
Balance Disorder
Eye Movement Disorder
Diplopia
03-Apr-2012 09:37 AM Page: 215

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Folliculitis
Eye Disorder
Hyperreflexia Report Source Product Role Manufacturer Route Dose Duration
Hypertension Foreign Lariam PS Hoffmann La Roche
Paraesthesia Health Inc ORAL 250 MG 1 PER
Optic Disc Disorder Professional 15 DAY ORAL
Influenza Like Illness
Hepatosplenomegaly
Rash Pustular
Date:08/11/00ISR Number: 3549527-5Report Type:Expedited (15-DaCompany Report #238191 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Foreign Lariam PS Hoffmann La Roche
Fatigue Health Inc ORAL 1 DOSE FORM 1
Syncope Professional PER WEEK ORAL
Diarrhoea
Vertigoheel
Dizziness
(Ambra/Cocculus/Coni
Disturbance In Attention um/Petrolatum) C
Balance Disorder
Date:08/11/00ISR Number: 3549531-7Report Type:Expedited (15-DaCompany Report #241757 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disturbance In Attention Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Conjunctival Hyperaemia Consumer Inc ORAL ORAL
Fatigue
Other
Sedation
Eyelid Oedema
Abdominal Pain
Panic Attack
Decreased Activity
Visual Impairment
Nervous System Disorder
Date:08/11/00ISR Number: 3549536-6Report Type:Expedited (15-DaCompany Report #237672 Age:55 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Balance Disorder Foreign Lariam PS Hoffmann La Roche
Condition Aggravated Consumer Inc ORAL 250 MG 1 PER
Cataract Other WEEK ORAL
Visual Impairment
Vision Blurred
Confusional State
Memory Impairment
Alopecia
Disturbance In Attention

Fatigue
Dizziness
03-Apr-2012 09:37 AM Page: 216

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/15/00ISR Number: 3551061-3Report Type:Expedited (15-DaCompany Report #242221 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Retinal Haemorrhage Foreign Lariam PS Hoffmann La Roche
Health Inc ORAL ORAL
Professional
Date:08/15/00ISR Number: 3551062-5Report Type:Expedited (15-DaCompany Report #238943 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoproteinaemia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Jaundice Health Inc ORAL 250 MG 1 PER
Ascites Professional WEEK ORAL
Blood Bilirubin Increased
Date:08/16/00ISR Number: 3551060-1Report Type:Expedited (15-DaCompany Report #240839 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypomania Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Health Inc ORAL 250 MG 1 PER
Disability Professional WEEK ORAL
Date:08/16/00ISR Number: 3551475-1Report Type:Expedited (15-DaCompany Report #242474 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Hydrocephalus Foreign Lariam PS Hoffmann La Roche
Cerebellar Hypoplasia Health Inc ORAL ORAL 28 DAY
Hearing Impaired
Professional
Visual Impairment
Congenital Anomaly
Convulsion
Electroencephalogram
Abnormal
Maternal Drugs Affecting
Foetus
Date:08/17/00ISR Number: 3552270-XReport Type:Expedited (15-DaCompany Report #58978 Age:31 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Nausea
Back Pain
Fatigue
Affective Disorder
Stress
Anger

Spinal Disorder
Clonic Convulsion
Amnesia
Multiple Sclerosis
Emotional Disorder
Balance Disorder
Nervous System Disorder
Diarrhoea
03-Apr-2012 09:37 AM Page: 217

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hypoaesthesia
Ligament Sprain
Asthenia Report Source Product Role Manufacturer Route Dose Duration
Irritability Consumer Lariam PS Hoffmann La Roche
Fasciitis Health Inc ORAL 250 MG 1 PER
Infarction Professional WEEK ORAL
Arthropathy
Norflex
Panic Attack
(Orphenadrine
Gait Disturbance Citrate) C
Dyspnoea
Vertigo
Syncope
Coordination Abnormal
Nervousness
Dermatitis
Throat Tightness
Road Traffic Accident
Hearing Impaired
Drug Hypersensitivity
Spinal Fracture
Derealisation
Arthralgia
Neck Pain
Cerebellar Ataxia
Anxiety
Sinus Headache
Dizziness
Disturbance In Attention
Feeling Abnormal
Vestibular Disorder
Sensation Of Pressure
Disorientation
Headache
Opticokinetic Nystagmus
Tests Abnormal
Confusional State
Oropharyngeal Pain
Heart Rate Increased
Pain
Nystagmus
Vomiting
Dysphagia
Date:08/17/00ISR Number: 3552322-4Report Type:Expedited (15-DaCompany Report #242515 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Vomiting Other Inc ORAL 250 MG 1 PER
Hallucination
1 WEEK ORAL
Depression
Sedation

Confusional State
03-Apr-2012 09:37 AM Page: 218

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/18/00ISR Number: 3553097-5Report Type:Direct Company Report # Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaise Lariam 250mg Roche PS Roche ORAL 250MG ONCE
Bipolar I Disorder
PER ORAL
Depression
Mood Swings
Anxiety
Hallucination
Lethargy
Psychiatric Symptom
Visual Acuity Reduced
Hypoaesthesia
Date:08/18/00ISR Number: 3553806-5Report Type:Expedited (15-DaCompany Report #242746 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depressed Level Of Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Consciousness Other Inc ORAL ORAL
Encephalitis
Stamaril Unidose
Disorientation
(Yellow Fever
Lymphocytosis Vaccine) SS SUBCUTANEOUS 1 DOSE FORM 1
PER DAY
SUBCUTANEOUS
Date:08/22/00ISR Number: 3554807-3Report Type:Direct Company Report # Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Panic Attack
Lariam-Mefloquine
Insomnia
Hcl-250mg Hoffman-La
Depression Roche PS Hoffman-La Roche ORAL 1 TABLET WEEK
Suicidal Ideation
ORAL
Paranoia
Headache
Anxiety
Date:08/22/00ISR Number: 3555499-XReport Type:Expedited (15-DaCompany Report #215928 Age:35 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Jaundice Consumer Lariam PS Hoffmann La Roche
Initial or Prolonged Hepatic Necrosis Health Inc ORAL 250 MG 1 PER
Liver Function Test Professional WEEK ORAL
Abnormal Vitamin Nos SS
Toxicity To Various
Agents
Spleen Disorder
Autoimmune Disorder

Blood Bilirubin Increased
03-Apr-2012 09:37 AM Page: 219

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/23/00ISR Number: 3556414-5Report Type:Expedited (15-DaCompany Report #242880 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amnesia Health Lariam PS Hoffmann La Roche
Fear Professional Inc ORAL 1 DOSE FORM 1
Alopecia Other PER WEEK ORAL
Depression
Crying
Dizziness
Nausea
Toxicity To Various
Agents
Thinking Abnormal
Panic Reaction
Feeling Jittery
Delusion
Nightmare
Abdominal Distension
Diarrhoea
Anxiety
Date:08/24/00ISR Number: 3557763-7Report Type:Expedited (15-DaCompany Report #243099 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Consumer Lariam PS Hoffmann La Roche
Other
Inc
Date:08/24/00ISR Number: 3557764-9Report Type:Expedited (15-DaCompany Report #243090 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nervousness Consumer Lariam PS Hoffmann La Roche
Initial or Prolonged Urinary Tract Infection Other Inc ORAL ORAL
Headache
Flushing
Tremor
Muscle Spasms
Palpitations
Fear
Diarrhoea
Phobia
Myalgia
Asthenia
Weight Decreased
Malaise
Dizziness
Date:08/25/00ISR Number: 3557765-0Report Type:Expedited (15-DaCompany Report #243085 Age:28 YR Gender:Male I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
PT
Panic Attack
Circulatory Collapse
Dizziness
Disturbance In Attention
Chest Pain
Pyrexia
03-Apr-2012 09:37 AM Page: 220

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Syncope
Palpitations
Anxiety Report Source Product Role Manufacturer Route Dose Duration
Paraesthesia Consumer Lariam PS Hoffmann La Roche
Other Inc ORAL ORAL
Date:08/25/00ISR Number: 3559237-6Report Type:Expedited (15-DaCompany Report #243079 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Extrasystoles Foreign Lariam PS Hoffmann La Roche
Maternal Drugs Affecting Health Inc 35 DAY
Foetus
Professional
Polyhydramnios
Pregnancy
Date:08/25/00ISR Number: 3559244-3Report Type:Expedited (15-DaCompany Report #243061 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Stillbirth Consumer Lariam PS Hoffmann La Roche
Accidental Exposure Other Inc
Maternal Drugs Affecting
Foetus
Date:08/25/00ISR Number: 3559246-7Report Type:Expedited (15-DaCompany Report #243107 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pregnancy Consumer Lariam PS Hoffmann La Roche
Intra-Uterine Death Other Inc ORAL ORAL
Accidental Exposure
Date:08/25/00ISR Number: 3559248-0Report Type:Expedited (15-DaCompany Report #243034 Age:80 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Sedation Foreign Lariam PS Hoffmann La Roche
Life-Threatening Gastric Perforation Health Inc ORAL 2 DOSE FORM 1
Nuclear Magnetic Professional PER ONE DOSE
Resonance Imaging
ORAL
Abnormal
Stupor
Cardio-Respiratory Arrest
Date:08/30/00ISR Number: 3561960-4Report Type:Expedited (15-DaCompany Report #237587 Age: Gender:Unknown I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Intra-Uterine Death Foreign Lariam PS Hoffmann La Roche
Accidental Exposure Health Inc ORAL ORAL
Professional
Other
03-Apr-2012 09:37 AM Page: 221

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/30/00ISR Number: 3561965-3Report Type:Expedited (15-DaCompany Report #243061 Age: Gender:Unknown I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Intra-Uterine Death Consumer Lariam PS Hoffmann La Roche
Stillbirth Other Inc
Pregnancy
Accidental Exposure
Date:08/30/00ISR Number: 3561967-7Report Type:Expedited (15-DaCompany Report #243107 Age: Gender:Unknown I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Accidental Exposure Consumer Lariam PS Hoffmann La Roche
Intra-Uterine Death Other Inc ORAL ORAL
Date:08/30/00ISR Number: 3561969-0Report Type:Expedited (15-DaCompany Report #224923 Age:22 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicide Attempt Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Abnormal Behaviour Consumer Inc ORAL 1.5 DOSE FORM
Hallucination Health 1 PER WEEK
Acute Psychosis Professional ORAL 14 DAY
Other
Date:08/30/00ISR Number: 3561972-0Report Type:Expedited (15-DaCompany Report #243661 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Dizziness Consumer Inc ORAL ORAL
Fatigue Other Chloroquine Hcl
Dissociation
(Chloroquine
Gait Disturbance
Hydrochloride
Eating Disorder (Injection)) C
Anxiety
Vomiting
Speech Disorder
Panic Attack
Hallucination
Balance Disorder
Dyspnoea
Date:08/30/00ISR Number: 3562000-3Report Type:Expedited (15-DaCompany Report #243398 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Mental Disorder Health Inc ORAL 7 DOSE FORM 1

Abnormal Behaviour Professional PER ONE DOSE
Nervous System Disorder
ORAL
Hemiparesis
Cerebral Venous
Thrombosis
Malaria
03-Apr-2012 09:37 AM Page: 222

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/30/00ISR Number: 3562002-7Report Type:Expedited (15-DaCompany Report #243587 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Bipolar Disorder Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Mania Consumer Inc ORAL ORAL
Other
Date:08/30/00ISR Number: 3562005-2Report Type:Expedited (15-DaCompany Report #237590 Age: Gender:Unknown I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Intra-Uterine Death Foreign Lariam PS Hoffmann La Roche
Pregnancy Health Inc ORAL ORAL
Accidental Exposure
Professional
Other
Date:08/31/00ISR Number: 3562208-7Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Insomnia Lariam PS ORAL 1 PER WEEK
Heart Rate Increased
ORAL
Nausea
Abdominal Pain
Date:09/01/00ISR Number: 3562944-2Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Abnormal Dreams Larium PS
Anxiety
Paraesthesia
Flushing
Insomnia
Chills
Date:09/01/00ISR Number: 3564122-XReport Type:Expedited (15-DaCompany Report #243633 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dysgraphia Foreign Lariam PS Hoffmann La Roche
Migraine Consumer Inc ORAL ORAL
Reading Disorder
Other
Visual Acuity Reduced
Disturbance In Attention
Date:09/01/00ISR Number: 3564123-1Report Type:Expedited (15-DaCompany Report #243603 Age: Gender:Female I/FU:I

Outcome
Other Serious
PT
Vomiting
Hepatitis
Headache
Nausea
Disorientation
Dizziness
03-Apr-2012 09:37 AM Page: 223

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sedation
Hyperhidrosis
Hepatocellular Injury Report Source Product Role Manufacturer Route Dose Duration
Weight Decreased Consumer Lariam PS Hoffmann La Roche
Haematemesis Other Inc ORAL ORAL
Nightmare
Tremor
Date:09/01/00ISR Number: 3564124-3Report Type:Expedited (15-DaCompany Report #243535 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Bradycardia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Paraesthesia Other Inc ORAL 250 MG 1 PER
Chest Pain
WEEK ORAL
Date:09/06/00ISR Number: 3565002-6Report Type:Expedited (15-DaCompany Report #242880 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thinking Abnormal Lariam Tablets PS Roche 15 DAY
Feeling Jittery
Diarrhoea
Alopecia
Abdominal Pain
Crying
Dizziness
Delusion
Malaise
Depression
Nightmare
Nausea
Anxiety
Fear
Amnesia
Panic Reaction
Abdominal Distension
Date:09/06/00ISR Number: 3565005-1Report Type:Expedited (15-DaCompany Report #243099 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Lariam Tablets PS Roche
Personality Change
Date:09/06/00ISR Number: 3565007-5Report Type:Expedited (15-DaCompany Report #243090 Age: Gender:Female I/FU:F
Outcome
PT

Hospitalization -
Initial or Prolonged
Asthenia
Flushing
Muscle Spasms
Malaise
Diarrhoea
Weight Decreased
Fear
Dizziness
03-Apr-2012 09:37 AM Page: 224

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nervousness
Urinary Tract Infection
Tremor Report Source Product Role Manufacturer Route Dose Duration
Headache Lariam Tablets PS Roche
Palpitations
Myalgia
Phobia
Date:09/06/00ISR Number: 3565032-4Report Type:Expedited (15-DaCompany Report #243085 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Syncope Lariam Tablets PS Roche
Initial or Prolonged Chest Pain
Palpitations
Paraesthesia
Panic Attack
Tension
Dizziness
Disturbance In Attention
Circulatory Collapse
Anxiety
Date:09/06/00ISR Number: 3565049-XReport Type:Expedited (15-DaCompany Report #244099 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Neuralgia Lariam Tablets PS Roche
Pruritus Zoloft C
Urticaria Neurontin C
Muscular Weakness Vioxx C 123 DAY
Balance Disorder Provera C FOR 12 DAYS
Fatigue
BETWEEN JUL
Haematoma
1999 AND JULY
Cartilage Injury 2000 AT 2.5
Ecchymosis
MG.
CURRENTLY
Muscle Disorder Synthroid C
Dizziness Premarin C
Date:09/07/00ISR Number: 3565856-3Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Lariam Tablets PS Roche ESTIMATED 5
Initial or Prolonged Anxiety DOSES IN
Disability Panic Attack TOTAL. 21 DAY
Headache
Vertigo
Dizziness

Date:09/07/00ISR Number: 3565886-1Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Headache
Panic Attack
Depression
03-Apr-2012 09:37 AM Page: 225

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Vertigo
Dizziness
Anxiety Report Source Product Role Manufacturer Route Dose Duration
Lariam Tablets PS Roche ESTIMATED 5
DOSES IN
TOTAL. 21 DAY
Date:09/07/00ISR Number: 3565888-5Report Type:Expedited (15-DaCompany Report #243398 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Personality Change Due To Lariam Tablets PS Roche
Initial or Prolonged A General Medical
Condition
Gastroenteritis
Nervous System Disorder
Diarrhoea
Encephalitis
Faecal Incontinence
Fatigue
Extensor Plantar Response
Psychomotor Retardation
Confusional State
Vomiting
Urinary Incontinence
Hemiparesis
Mental Disorder
Date:09/07/00ISR Number: 3565942-8Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Attack Lariam Tablets PS Roche ESTIMATED 5
Initial or Prolonged Headache DOSES IN
Disability Dizziness TOTAL. 21 DAY
Anxiety
Depression
Vertigo
Date:09/07/00ISR Number: 3565949-0Report Type:Expedited (15-DaCompany Report #243398 Age:35 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Vomiting
Faecal Incontinence
Urinary Incontinence
Encephalitis
Gastroenteritis
Diarrhoea
Personality Change Due To

A General Medical
Condition
Hemiparesis
Mental Disorder
Fatigue
Confusional State
Nervous System Disorder
Psychomotor Retardation
03-Apr-2012 09:37 AM Page: 226

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Extensor Plantar Response
Report Source Product Role Manufacturer Route Dose Duration
Lariam Tablets PS Roche
Date:09/07/00ISR Number: 3566017-4Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Lariam Tablets PS Roche ESTIMATED 5
Initial or Prolonged Headache DOSES IN
Disability Vertigo TOTAL. 21 DAY
Depression
Panic Attack
Date:09/07/00ISR Number: 3565858-7Report Type:Expedited (15-DaCompany Report #243398 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Oliguria Lariam Tablets PS Roche
Initial or Prolonged Nervous System Disorder
Fatigue
Hemiparesis
Gastroenteritis
Encephalitis Viral
Extensor Plantar Response
Overdose
Personality Change Due To
A General Medical
Condition
Diarrhoea
Cerebral Venous
Thrombosis
Confusional State
Toxicity To Various
Agents
Vomiting
Mental Disorder
Date:09/08/00ISR Number: 3566999-0Report Type:Expedited (15-DaCompany Report #72278 Age:24 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Visual Impairment
Abdominal Pain
Skin Irritation
Hearing Impaired
Pain
Full Blood Count Abnormal
Syncope

Campbell De Morgan Spots
Deafness
Neutropenia
Lymphadenopathy
Vision Blurred
Diarrhoea
Eosinophil Count
Increased
03-Apr-2012 09:37 AM Page: 227

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Skin Papilloma
Renal Colic
Pco2 Abnormal
Muscle Spasms
Dizziness
Cough
Neck Pain
Bone Marrow Failure
Coordination Abnormal
Migraine
Depersonalisation
Nausea
Chills
Asthenia
Cyst
Oropharyngeal Pain
Amnesia
Biopsy Bone Marrow
Abnormal
Lipids Abnormal
Blood Potassium Decreased
Arthralgia
Abscess
Basophilia
Penile Ulceration
Hyperhidrosis
Blood Lactate
Dehydrogenase Increased
Abdominal Tenderness
Pharyngitis
Bladder Pain
Dissociation
Liver Function Test
Abnormal
Amoebiasis
Haemorrhoids
Hypokalaemia
Paraesthesia
Haematocrit Increased
Asthenopia
Vertigo
Blood Heavy Metal
Increased
Herpes Simplex
Dysphagia
Rash Pustular
Drug Level Below
Therapeutic
Hyperglycaemia
Hypersensitivity
Hypoglycaemia
Fatigue
Confusional State

Hypersomnia
Pain In Extremity
Swelling
Red Blood Cell Count
Increased
Disorientation
Tinnitus
Tremor
03-Apr-2012 09:37 AM Page: 228

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dyspnoea
Ear Pain
Schistosomiasis Report Source Product Role Manufacturer Route Dose Duration
Hepatic Pain Lariam Tablets PS Roche 35 DAY
Malaria
Thinking Abnormal
Back Pain
Feeling Abnormal
Bradycardia
Palpitations
Blood Phosphorus
Decreased
Vestibular Disorder
Pyrexia
Flatulence
Malaise
Blood Urea Increased
Muscular Weakness
Balance Disorder
Gastrointestinal Disorder
Anxiety
Blood Triglycerides
Increased
Headache
Date:09/08/00ISR Number: 3567004-2Report Type:Expedited (15-DaCompany Report #216747 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Skin Discolouration Lariam Tablets PS Roche 50 DAY
Skin Infection
Scar
Agitation
Emotional Disorder
Skin Necrosis
Lichen Planus
Fear
Psychosexual Disorder
Date:09/08/00ISR Number: 3568264-4Report Type:Expedited (15-DaCompany Report #244099 Age:48 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Haematoma
Myalgia
Muscle Disorder
Muscle Spasms
Dizziness
Asthenia
Ecchymosis
Pruritus

Urticaria
Depression
Ammonia Increased
Balance Disorder
Cartilage Injury
Muscular Weakness
Paraesthesia
Asthenopia
03-Apr-2012 09:37 AM Page: 229

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Fatigue
Neuralgia
Burning Sensation Report Source Product Role Manufacturer Route Dose Duration
Tetany Health Lariam PS Hoffmann La Roche
Professional Inc ORAL ORAL
Zoloft
C
Vioxx
C
Premarin
C
Provera
C
Synthroid
C
Neurontin
C
Date:09/08/00ISR Number: 3568266-8Report Type:Expedited (15-DaCompany Report #242880 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Health Lariam PS Hoffmann La Roche
Toxicity To Various Professional Inc ORAL 1 DOSE FORM 1
Agents Other PER WEEK ORAL
Feeling Jittery
Anxiety
Thinking Abnormal
Depression
Nightmare
Amnesia
Nausea
Dizziness
Abdominal Distension
Phobia
Panic Reaction
Pain
Diarrhoea
Alopecia
Abdominal Pain
Date:09/08/00ISR Number: 3568316-9Report Type:Expedited (15-DaCompany Report #72278 Age:24 YR Gender:Unknown I/FU:I
Outcome
Other Serious
PT
Coordination Abnormal
Malaria
Vision Blurred
Basophil Count Increased
Blood Potassium Decreased
Liver Function Test
Abnormal
Blood Heavy Metal
Increased
Dyspnoea
Hearing Impaired
Asthenopia

Nausea
Muscular Weakness
Anxiety
Palpitations
Lipids Abnormal
Diarrhoea
Tinnitus
Amoebiasis
03-Apr-2012 09:37 AM Page: 230

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Syncope
Penile Ulceration
Depersonalisation
Malaise
Visual Impairment
Feeling Abnormal
Bradycardia
Antibody Test Positive
Amnesia
Skin Irritation
Paraesthesia
Hypersensitivity
Vestibular Disorder
Vertigo
Disorientation
Schistosomiasis
Abscess
Photopsia
Hyperhidrosis
Fatigue
Abdominal Pain
Balance Disorder
Confusional State
Oropharyngeal Pain
Blood Triglycerides
Increased
Swelling
Eye Disorder
Pharyngitis
Muscle Spasms
Dysphagia
Pyrexia
Rash Pustular
Hypoglycaemia
Low Density Lipoprotein
Increased
Migraine
Drug Level Below
Therapeutic
Pain In Extremity
Lymphocyte Count
Increased
Bladder Pain
Pain
Tremor
Ear Pain
Flatulence
Headache
Lymphadenopathy
Asthenia
Hypersomnia
Biopsy Bone Marrow
Abnormal

Neutrophil Count
Decreased
Blood Phosphorus
Decreased
Blood Cholesterol
Increased
Full Blood Count Abnormal
Neck Pain
03-Apr-2012 09:37 AM Page: 231

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Campbell De Morgan Spots
Thinking Abnormal
Back Pain Report Source Product Role Manufacturer Route Dose Duration
Chills Consumer Lariam PS Hoffmann La Roche
Cyst Inc ORAL 250 MG 1 PER
Gastrointestinal Disorder WEEK ORAL 35 DAY
White Blood Cell Count
Decreased
Monocyte Count Increased
Herpes Simplex
Arthralgia
Dizziness
Cough
Date:09/08/00ISR Number: 3568345-5Report Type:Expedited (15-DaCompany Report #230098 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Agitation Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Crying Consumer Inc ORAL 250 MG ORAL
Conversion Disorder Health Hismanal C
Hypertension Professional Jodthyrox C
Furuncle
Psychotic Disorder
Dizziness
Fatigue
Abdominal Discomfort
Depression
Agoraphobia
Retching
Tinnitus
Hyperventilation
Hyperhidrosis
Nausea
Paraesthesia
Mental Disorder
Blood Pressure Systolic
Increased
Chills
Date:09/08/00ISR Number: 3568346-7Report Type:Expedited (15-DaCompany Report #219219 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Neonatal Disorder Foreign Lariam PS Hoffmann La Roche
Cardiac Murmur Health Inc ORAL 250 MG 1 PER
Maternal Drugs Affecting Professional WEEK ORAL
Foetus
Congenital Anomaly

Date:09/08/00ISR Number: 3568522-3Report Type:Expedited (15-DaCompany Report #243099 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Foreign Lariam PS Hoffmann La Roche
Consumer
Inc
Other
03-Apr-2012 09:37 AM Page: 232

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/08/00ISR Number: 3568523-5Report Type:Expedited (15-DaCompany Report #243085 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disturbance In Attention Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Paraesthesia Consumer Inc ORAL ORAL
Dizziness
Other
Anxiety
Circulatory Collapse
Panic Attack
Syncope
Chest Pain
Anhedonia
Pyrexia
Malaise
Palpitations
Date:09/08/00ISR Number: 3568524-7Report Type:Expedited (15-DaCompany Report #243090 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myalgia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Dizziness Consumer Inc ORAL ORAL
Phobia
Other
Malaise
Weight Decreased
Tremor
Headache
Flushing
Diarrhoea
Urinary Tract Infection
Muscle Spasms
Asthenia
Palpitations
Date:09/08/00ISR Number: 3569032-XReport Type:Expedited (15-DaCompany Report #234391 Age:56 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Amnesia Consumer Lariam PS Hoffmann La Roche
Emotional Distress Inc ORAL 250 MG 2 PER
Overdose DAY 42 DAY
Nausea
Loss Of Control Of Legs
Medication Error
Blindness Transient
Brain Injury
Decreased Activity
Date:09/08/00ISR Number: 3567013-3Report Type:Expedited (15-DaCompany Report #244150 Age:11 YR Gender:Female I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
PT
Tachycardia
Malaise
Dizziness
Fatigue
Chills
Loss Of Consciousness
03-Apr-2012 09:37 AM Page: 233

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hypotension
Report Source Product Role Manufacturer Route Dose Duration
Lariam Tablets PS Roche 15 DAY
Date:09/08/00ISR Number: 3567021-2Report Type:Expedited (15-DaCompany Report #244148 Age: Gender:Not SpecifiI/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Lariam Tablets PS Roche 34 DAY
Foetus
Talipes
Klinefelter'S Syndrome
Pregnancy
Abortion Induced
Date:09/11/00ISR Number: 3568894-XReport Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Consumer Lariam 250 Mg Tablet
Paraesthesia Roche PS Roche ORAL 1 TABLET ONCE
Burning Sensation
A WEEK ORAL
Headache
Panic Attack
Crying
Melaena
Depression
Lethargy
Dizziness
Anxiety
Disturbance In Attention
Diarrhoea
Date:09/11/00ISR Number: 3569224-XReport Type:Expedited (15-DaCompany Report #216747 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Emotional Disorder Other Lariam PS Hoffmann La Roche
Fear Inc ORAL 250 MG 1 PER
Injury
WEEK ORAL
Agitation
Lichen Planus
Infection
Skin Discolouration
Date:09/11/00ISR Number: 3569299-8Report Type:Expedited (15-DaCompany Report #244150 Age:11 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dizziness Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Fatigue Other Inc ORAL 250 MG 1PER
Tachycardia
WEEK ORAL
Hypotension
Malaise
Chills
Loss Of Consciousness
03-Apr-2012 09:37 AM Page: 234

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/11/00ISR Number: 3569301-3Report Type:Expedited (15-DaCompany Report #244148 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Talipes Foreign Lariam PS Hoffmann La Roche
Maternal Drugs Affecting Other Inc ORAL 250 MG 1 PER
Foetus
WEEK ORAL
Klinefelter'S Syndrome
Abortion Induced
Pregnancy
Date:09/11/00ISR Number: 3569673-XReport Type:Expedited (15-DaCompany Report #216747 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Skin Discolouration Other Lariam PS Hoffmann La Roche
Injury Inc ORAL 250 MG 1 PER
Agitation
WEEK ORAL
Infection
Fear
Emotional Disorder
Lichen Planus
Date:09/11/00ISR Number: 3570099-3Report Type:Expedited (15-DaCompany Report #72278 Age:24 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Coordination Abnormal
Lymphadenopathy
Asthenia
Gastrointestinal Disorder
Lipids Abnormal
Diarrhoea
Swelling
Neck Pain
Hypouricaemia
Lymphadenitis
Neutrophil Count
Decreased
Hypercholesterolaemia
Thinking Abnormal
Back Pain
Malaise
Balance Disorder
Anxiety
Blood Phosphorus
Decreased
Disorientation
Tinnitus
Ear Pain
Headache
Rash Pustular

Ear Discomfort
Skin Papilloma
Gait Disturbance
Penile Ulceration
Malaria
Confusional State
Vertigo
Schistosomiasis
03-Apr-2012 09:37 AM Page: 235

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Feeling Drunk
Haematocrit Increased
Abdominal Tenderness
Haemoglobin Increased
Arthralgia
Vision Blurred
Hypersomnia
Palpitations
Muscle Spasms
Haemorrhoids
Cough
Pyrexia
Campbell De Morgan Spots
Bone Marrow Failure
Nasopharyngitis
Hyperglycaemia
Depersonalisation
Migraine
Drug Ineffective
Oropharyngeal Pain
Skin Irritation
Paraesthesia
Hypersensitivity
Asthenopia
Full Blood Count Abnormal
Liver Function Test
Abnormal
Dizziness
Hypokalaemia
Syncope
Abscess
Toxicity To Various
Agents
Eosinophil Count
Increased
Enthesopathy
Amoebiasis
Nausea
Chills
Muscular Weakness
Hearing Impaired
Tenderness
Gastrointestinal Pain
Chronic Fatigue Syndrome
Hypoglycaemia
Herpes Simplex
Vestibular Disorder
Bladder Pain
Tremor
Dysphagia
Dyspnoea
Flatulence
Spleen Disorder

High Density Lipoprotein
Increased
Viral Infection
Condition Aggravated
Monocyte Count Increased
Blood Heavy Metal
Increased
Hyperhidrosis
03-Apr-2012 09:37 AM Page: 236

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Fatigue
Visual Impairment
Pharyngitis Streptococcal Report Source Product Role Manufacturer Route Dose Duration
Feeling Abnormal Consumer Lariam PS Hoffmann La Roche
Abdominal Pain Health Inc ORAL 250 MG 1 PER
Bradycardia Professional WEEK ORAL 35 DAY
Cyst
Other
Amnesia
Pain In Extremity
Pain
Red Blood Cell Count
Increased
Nystagmus
Date:09/12/00ISR Number: 3568900-2Report Type:Expedited (15-DaCompany Report #244099 Age:48 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Lariam Tablets PS Roche
Haematoma Zoloft C
Urticaria Vioxx C 123 DAY
Ecchymosis Premarin C
Paraesthesia Provera C FOR 12 DAYS
Myalgia
BETWEEN JUL
Muscular Weakness
1999 AND JULY
Asthenia 2000 AT 2.5
Balance Disorder
MG.
CURRENTLY
Dizziness Synthroid C
Cartilage Injury Neurontin C
Burning Sensation
Fatigue
Tetany
Pruritus
Muscle Disorder
Muscle Spasms
Date:09/12/00ISR Number: 3568893-8Report Type:Expedited (15-DaCompany Report #241248 Age:49 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Barotrauma Lariam Tablets PS Roche
Initial or Prolonged
Date:09/13/00ISR Number: 3569968-XReport Type:Expedited (15-DaCompany Report #241757 Age:37 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Eyelid Oedema Lariam Tablets PS Roche 27 DAY
Initial or Prolonged Panic Attack

Abdominal Pain
Conjunctival Hyperaemia
Visual Impairment
Disturbance In Attention
Fatigue
Sedation
03-Apr-2012 09:37 AM Page: 237

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/13/00ISR Number: 3571074-5Report Type:Expedited (15-DaCompany Report #243398 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Mental Disorder Health Inc ORAL 7 DOSE FORM 1
Urinary Incontinence Professional PER ONE DOSE
Personality Change Due To
ORAL
A General Medical
Condition
Faecal Incontinence
Toxicity To Various
Agents
Vomiting
Hemiparesis
Psychomotor Retardation
Confusional State
Nervous System Disorder
Diarrhoea
Gastroenteritis
Overdose
Encephalitis
Date:09/13/00ISR Number: 3571321-XReport Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vertigo Health Lariam PS Hoffmann La Roche
Initial or Prolonged Depression Professional Inc ORAL 250 MG 1 PER
Disability Headache WEEK PO
Anxiety
Panic Attack
Date:09/14/00ISR Number: 3571509-8Report Type:Expedited (15-DaCompany Report #241248 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Barotrauma Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Health Inc ORAL ORAL
Professional
Date:09/14/00ISR Number: 3571842-XReport Type:Expedited (15-DaCompany Report #244099 Age:48 YR Gender:Female I/FU:F
Outcome
Other Serious
PT
Muscular Weakness
Balance Disorder
Burning Sensation
Urticaria
Tetany
Cartilage Injury

Depression
Ecchymosis
Myalgia
Haematoma
Injury
Neuralgia
Paraesthesia
Ammonia Increased
03-Apr-2012 09:37 AM Page: 238

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pruritus
Asthenia
Muscle Disorder Report Source Product Role Manufacturer Route Dose Duration
Asthenopia Health Lariam PS Hoffmann La Roche
Muscle Spasms Professional Inc ORAL ORAL
Fatigue Zoloft C
Dizziness Vioxx C
Premarin
C
Provera
(Medroxyprogesterone
) C
Synthroid
C
Neurontin
C
Date:09/14/00ISR Number: 3570925-8Report Type:Expedited (15-DaCompany Report #220387 Age: Gender:Unknown I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Induced Labour Lariam Tablets PS Roche 58 DAY
Postmature Baby Logynon C
Pregnancy
Abnormal Labour
Date:09/14/00ISR Number: 3570928-3Report Type:Expedited (15-DaCompany Report #244551 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aplastic Anaemia Lariam Tablets PS Roche 29 DAY
Fatigue
Date:09/15/00ISR Number: 3572844-XReport Type:Expedited (15-DaCompany Report #241757 Age:37 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Conjunctival Hyperaemia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Eyelid Oedema Consumer Inc ORAL ORAL
Visual Impairment
Health
Disturbance In Attention Professional
Fatigue
Sedation
Abdominal Pain
Panic Attack
Date:09/15/00ISR Number: 3571353-1Report Type:Expedited (15-DaCompany Report #244484 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Lariam Tablets PS Roche 71 DAY
Viith Nerve Paralysis

Date:09/18/00ISR Number: 3572388-5Report Type:Expedited (15-DaCompany Report #244551 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fatigue Lariam Tablets PS Roche 29 DAY
Aplastic Anaemia
03-Apr-2012 09:37 AM Page: 239

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/18/00ISR Number: 3574528-0Report Type:Expedited (15-DaCompany Report #220387 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Caesarean Section Foreign Lariam PS Hoffmann La Roche
Pregnancy Health Inc ORAL 250 MG 1 PER
Abnormal Labour Professional WEEK ORAL
Logynon (Ethinyl
Estradiol /
Levonorgestrel) C
Date:09/19/00ISR Number: 3573038-4Report Type:Expedited (15-DaCompany Report #235479 Age:76 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Corneal Oedema Lariam Tablets PS Roche
Corneal Disorder
Vision Blurred
Date:09/19/00ISR Number: 3573039-6Report Type:Expedited (15-DaCompany Report #242474 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Hydrocephalus Lariam Tablets PS Roche 28 DAY
Maternal Drugs Affecting
Foetus
Congenital Anomaly
Cerebellar Hypoplasia
Pregnancy
Ultrasound Antenatal
Screen Abnormal
Convulsion
Visual Impairment
Hearing Impaired
Date:09/19/00ISR Number: 3573049-9Report Type:Expedited (15-DaCompany Report #243079 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Bradycardia Lariam Tablets PS Roche 35 DAY
Arrhythmia Neonatal
Palpitations
Maternal Drugs Affecting
Foetus
Polyhydramnios
Extrasystoles
Neonatal Disorder
Date:09/19/00ISR Number: 3573350-9Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I

Outcome
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Nausea
Anxiety
Fear
Diarrhoea
Dissociation
Dizziness
03-Apr-2012 09:37 AM Page: 240

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Headache
Asthenia
Paraesthesia Report Source Product Role Manufacturer Route Dose Duration
Hallucination Larium PS
Balance Disorder
Somnambulism
Abnormal Dreams
Depression
Date:09/19/00ISR Number: 3574500-0Report Type:Expedited (15-DaCompany Report #244484 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Tinnitus Foreign Lariam PS Hoffmann La Roche
Intervention to Viith Nerve Paralysis Health Inc ORAL 250 MG 1 PER
Prevent Permanent Professional WEEK ORAL
Impairment/Damage
Date:09/19/00ISR Number: 3575054-5Report Type:Expedited (15-DaCompany Report #235479 Age:76 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Corneal Oedema Health Lariam PS Hoffmann La Roche
Professional Inc ORAL ORAL
Date:09/19/00ISR Number: 3575202-7Report Type:Expedited (15-DaCompany Report #245061 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Physical Assault Foreign Lariam PS Hoffmann La Roche
Other Inc ORAL ORAL
Date:09/19/00ISR Number: 3575223-4Report Type:Expedited (15-DaCompany Report #244870 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Foreign Lariam PS Hoffmann La Roche
Other Inc ORAL ORAL
Tetavax (Adsorbed
Tetanus Vaccine) C
Havrix (Hepatitis A
Vaccine)
C
Typhim Iv (Typhoid
Vaccines)
C
Date:09/19/00ISR Number: 3575225-8Report Type:Expedited (15-DaCompany Report #244736 Age:30 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Idiopathic Foreign Lariam PS Hoffmann La Roche
Thrombocytopenic Purpura Health Inc ORAL ORAL
Purpura
Professional
03-Apr-2012 09:37 AM Page: 241

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/19/00ISR Number: 3575226-XReport Type:Expedited (15-DaCompany Report #243079 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Palpitations Foreign Lariam PS Hoffmann La Roche
Polyhydramnios Health Inc ORAL 250 MG 1 PER
Extrasystoles Professional WEEK ORAL 35 DAY
Pregnancy
Bradycardia
Maternal Drugs Affecting
Foetus
Date:09/19/00ISR Number: 3575228-3Report Type:Expedited (15-DaCompany Report #242474 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Hearing Impaired Foreign Lariam PS Hoffmann La Roche
Congenital Hydrocephalus Health Inc ORAL ORAL 28 DAY
Congenital Anomaly
Professional
Vision Abnormal Neonatal
Convulsion Neonatal
Electroencephalogram
Abnormal
Apgar Score Low
Developmental Delay
Maternal Drugs Affecting
Foetus
Cerebellar Hypoplasia
Date:09/19/00ISR Number: 3573037-2Report Type:Expedited (15-DaCompany Report #244736 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Idiopathic Lariam Tablets PS Roche
Thrombocytopenic Purpura
Date:09/19/00ISR Number: 3573045-1Report Type:Expedited (15-DaCompany Report #244870 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Lariam Tablets PS Roche
Havrix C 1 DAY
Typhim Vi C 1 DAY
Tetavax C 1 DAY
Date:09/19/00ISR Number: 3573048-7Report Type:Expedited (15-DaCompany Report #245061 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Physical Assault Lariam Tablets PS Roche

Human Bite
Injury
03-Apr-2012 09:37 AM Page: 242

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/20/00ISR Number: 3575612-8Report Type:Expedited (15-DaCompany Report #245128 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Extrapyramidal Disorder Foreign Lariam PS Hoffmann La Roche
Gastrooesophageal Reflux Health Inc ORAL 1 DOSE FORM 1
Disease Professional PER WEEK ORAL
Primperan
C
Date:09/20/00ISR Number: 3576586-6Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fear Lariam Cant Remember
Psychotic Disorder
500mg?? Hoffman
Disturbance In Attention Laroche PS Hoffman Laroche ORAL ONE PER ORAL
Hallucination
Abnormal Dreams
Irritability
Panic Attack
Sleep Disorder
Date:09/20/00ISR Number: 3573885-9Report Type:Expedited (15-DaCompany Report #245128 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gastrooesophageal Reflux Lariam Tablets PS Roche 63 DAY
Disease Primperan C 1 DAY
Extrapyramidal Disorder
Date:09/21/00ISR Number: 3575082-XReport Type:Expedited (15-DaCompany Report #200841 Age:42 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Accommodation Disorder
Fatigue
Insomnia
Nausea
Vision Blurred
Hyperventilation
Lacrimation Increased
Paraesthesia
Hallucination, Visual
Psychomotor Retardation
Diplopia
Arrhythmia
Emotional Disorder
Crying
Asthenia
Paraplegia
Tinnitus

Malaise
Dry Mouth
Balance Disorder
Diarrhoea
Fall
Dyspnoea
Speech Disorder
Anxiety
03-Apr-2012 09:37 AM Page: 243

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Respiratory Disorder
Convulsion
Memory Impairment Report Source Product Role Manufacturer Route Dose Duration
Stress Lariam Tablets PS Roche CUMULATIVE
Movement Disorder DOSAGE= 750
Cognitive Disorder MG 380 DAY
Hydrocephalus
Meningococcal
Mental Disorder Vaccine C 1 DAY
Heterophoria Flu Vaccine C 1 DAY
Disturbance In Attention
Visual Impairment
Sedation
Panic Attack
Tremor
Dysphagia
Reading Disorder
Date:09/21/00ISR Number: 3576532-5Report Type:Direct Company Report # Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Lariam PS ORAL 1 PILL PER
Depersonalisation
WEEK ORAL
Anxiety
Abnormal Dreams
Dizziness
Nausea
Date:09/25/00ISR Number: 3578070-2Report Type:Expedited (15-DaCompany Report #245128 Age:15 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nervousness Primperan PS 1 DAY
Gastrooesophageal Reflux Lariam Tablets SS Roche 63 DAY
Disease
Throat Tightness
Tremor
Extrapyramidal Disorder
Date:09/25/00ISR Number: 3578162-8Report Type:Expedited (15-DaCompany Report #245128 Age:15 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Extrapyramidal Disorder Primperan PS 1 DAY
Tremor Lariam Tablets SS Roche 63 DAY
Nervousness
Throat Tightness
Gastrooesophageal Reflux
Disease

Date:09/25/00ISR Number: 3578203-8Report Type:Expedited (15-DaCompany Report #245128 Age:15 YR Gender:Female I/FU:F
Outcome
Other Serious
PT
Extrapyramidal Disorder
Tremor
Gastrooesophageal Reflux
03-Apr-2012 09:37 AM Page: 244

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disease
Nervousness
Report Source Product Role Manufacturer Route Dose Duration
Lariam Tablets PS Roche 63 DAY
Primperan SS 1 DAY
Date:09/25/00ISR Number: 3578365-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Attack Larium 250 Mg PS Q WEEK PO
Initial or Prolonged Dyspnoea
Dizziness
Date:09/25/00ISR Number: 3579511-7Report Type:Expedited (15-DaCompany Report #245128 Age:15 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Throat Tightness Foreign Lariam PS Hoffmann La Roche
Extrapyramidal Disorder Health Inc ORAL 1 DOSE FORM 1
Tremor Professional PER WEEK ORAL
Gastrooesophageal Reflux Primperan SS ORAL 1 DOSE FORM 2
Disease
PER DAY ORAL
Nervousness
Date:09/26/00ISR Number: 3578972-7Report Type:Expedited (15-DaCompany Report #237672 Age:55 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vision Blurred Lariam Tablets PS Roche 57 DAY
Confusional State
Memory Impairment
Alopecia
Cataract
Disturbance In Attention
Fatigue
Visual Impairment
Visual Field Defect
Dizziness
Balance Disorder
Date:09/26/00ISR Number: 3580409-9Report Type:Expedited (15-DaCompany Report #237672 Age:55 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Memory Impairment Foreign Lariam PS Hoffmann La Roche
Vision Blurred Consumer Inc ORAL 250 MG 1 PER
Fatigue Health WEEK; ORAL
Confusional State
Professional

Visual Field Defect Other
Balance Disorder
Disturbance In Attention
Dizziness
Cataract
Visual Impairment
Alopecia
03-Apr-2012 09:37 AM Page: 245

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/26/00ISR Number: 3580555-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fear Lariam PS 1
Anxiety
Panic Disorder
Date:09/27/00ISR Number: 3581501-5Report Type:Expedited (15-DaCompany Report #245340 Age:16 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyskinesia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Health Inc ORAL ORAL
Professional
Date:09/27/00ISR Number: 3580067-3Report Type:Expedited (15-DaCompany Report #245340 Age:16 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyskinesia Lariam Tablets PS Roche
Initial or Prolonged
Date:09/29/00ISR Number: 3582445-5Report Type:Expedited (15-DaCompany Report #245721 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Mefloquine
Initial or Prolonged Depressed Mood Hydrochloride PS Roche
Panic Attack Fluoxetine C
Date:10/02/00ISR Number: 3584867-5Report Type:Direct Company Report # Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Lariam PS ORAL 1TAB PO Q WK
Hypoaesthesia
FOR 16 WKS
Date:10/02/00ISR Number: 3584214-9Report Type:Expedited (15-DaCompany Report #245885 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amnesia Lariam Tablets PS Roche 1462 DAY
Depression
Decreased Activity
Anxiety

Date:10/02/00ISR Number: 3584219-8Report Type:Expedited (15-DaCompany Report #245766 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Acuity Reduced Lariam Tablets PS Roche
Papilloedema
03-Apr-2012 09:37 AM Page: 246

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/03/00ISR Number: 3586759-4Report Type:Expedited (15-DaCompany Report #245766 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Acuity Reduced Foreign Lariam PS Hoffmann La Roche
Papilloedema Health Inc ORAL ORAL
Professional
Other
Date:10/03/00ISR Number: 3586870-8Report Type:Expedited (15-DaCompany Report #245974 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Syncope Foreign Lariam PS Hoffmann La Roche
Intervention to Anaphylactic Reaction Consumer Inc ORAL ORAL
Prevent Permanent Ill-Defined Disorder
Impairment/Damage
Date:10/03/00ISR Number: 3586878-2Report Type:Expedited (15-DaCompany Report #245885 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Foreign Lariam PS Hoffmann La Roche
Amnesia Other Inc ORAL ORAL
Depression
Date:10/03/00ISR Number: 3585187-5Report Type:Expedited (15-DaCompany Report #245974 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anaphylactic Shock Lariam Tablets PS Roche
Date:10/04/00ISR Number: 3586112-3Report Type:Expedited (15-DaCompany Report #245994 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Ischaemic Stroke Mefloquine
Initial or Prolonged Haemorrhage Intracranial Hydrochloride PS Roche
Hemianopia Homonymous Aspirin Cardio C
Cerebral Infarction
Date:10/04/00ISR Number: 3587874-1Report Type:Expedited (15-DaCompany Report #246098 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Impairment Foreign Lariam PS Hoffmann La Roche
Aphasia Other Inc ORAL ORAL 28 DAY
Anxiety
Paranoia

Date:10/04/00ISR Number: 3586113-5Report Type:Expedited (15-DaCompany Report #246098 Age:22 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Anxiety
Visual Impairment
03-Apr-2012 09:37 AM Page: 247

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Paranoia
Aphasia
Report Source Product Role Manufacturer Route Dose Duration
Lariam Tablets PS Roche 28 DAY
Date:10/05/00ISR Number: 3587508-6Report Type:Expedited (15-DaCompany Report #241950 Age:11 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Malaria Lariam Tablets PS Roche
Hospitalization - Tachycardia
Initial or Prolonged Hypotension
Loss Of Consciousness
Malaise
Date:10/06/00ISR Number: 3588421-0Report Type:Expedited (15-DaCompany Report #61443 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Delirium Lariam Tablets PS Roche 22 DAY
Initial or Prolonged Mental Disorder Lysanxia C
Depression
Anxiety
Suicide Attempt
Overdose
Abnormal Behaviour
Date:10/06/00ISR Number: 3589373-XReport Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Autism Spectrum Disorder Larium PS WEEKLY
Initial or Prolonged Maternal Drugs Affecting
Disability
Foetus
Congenital Anomaly Nervous System Disorder
Grand Mal Convulsion
Date:10/06/00ISR Number: 3590758-6Report Type:Expedited (15-DaCompany Report #61443 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Depression Other Inc ORAL 250 MG 1 PER
Anxiety
WEEK ORAL
Persecutory Delusion Lysanxia (Prazepam) C
Partner Stress
Abnormal Behaviour
Delirium
Suicide Attempt

Date:10/10/00ISR Number: 3591920-9Report Type:Expedited (15-DaCompany Report #216859 Age:20 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Emotional Disorder
Rhinorrhoea
03-Apr-2012 09:37 AM Page: 248

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Lymphadenopathy
Erythema
Bronchospasm Report Source Product Role Manufacturer Route Dose Duration
Headache Health Lariam PS Hoffmann La Roche
Pharyngitis Streptococcal Professional Inc ORAL 250 MG 1 PER
Pharyngitis Other WEEK ORAL
Lichen Planus
Skin Discolouration
Date:10/11/00ISR Number: 3593063-7Report Type:Expedited (15-DaCompany Report #246417 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Foreign Lariam PS Hoffmann La Roche
Mania Other Inc ORAL 1 PER WEEK
Psychotic Disorder
ORAL
Depression
Schizophreniform Disorder
Delusion
Paranoia
Date:10/11/00ISR Number: 3593064-9Report Type:Expedited (15-DaCompany Report #245340 Age:17 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Grand Mal Convulsion Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Speech Disorder Health Inc ORAL ORAL
Malaria
Professional
Clonic Convulsion
Disorientation
Pyrexia
Chorea
Vomiting
Dyskinesia
Agitation
Abnormal Behaviour
Date:10/11/00ISR Number: 3593110-2Report Type:Expedited (15-DaCompany Report #246415 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pyrexia Foreign Lariam PS Hoffmann La Roche
Tremor Other Inc ORAL 1 DOSE FORM 1
Delirium
PER WEEK ORAL
Asthenia
Date:10/12/00ISR Number: 3592579-7Report Type:Expedited (15-DaCompany Report #245340 Age:17 YR Gender:Male I/FU:F

Outcome
Hospitalization -
Initial or Prolonged
PT
Malaria
Chorea
Speech Disorder
Dyskinesia
Disorientation
Agitation
Clonic Convulsion
03-Apr-2012 09:37 AM Page: 249

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pyrexia
Abnormal Behaviour
Vomiting Report Source Product Role Manufacturer Route Dose Duration
Health Lariam Tablets PS Roche 2 DAY
Professional
Date:10/12/00ISR Number: 3592642-0Report Type:Expedited (15-DaCompany Report #216859 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Lymphadenopathy Health Lariam Tablets PS Roche 50 DAY
Nasal Congestion
Professional
Pharyngitis
Bronchospasm
Emotional Disorder
Emotional Distress
Erythema
Lichen Planus
Skin Discolouration
Rash Erythematous
Oropharyngeal Pain
Rhinorrhoea
Headache
Date:10/12/00ISR Number: 3593005-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Sleep Terror Larium , F.
Disability Delusion Hoffmann-La Roche
Other Serious Suicidal Ideation Ltd PS F. Hoffmann-La Roche
Required Disturbance In Attention Ltd ORAL 250-MG, WEEK,
Intervention to Paranoia ORAL
Prevent Permanent Screaming
Impairment/Damage Anxiety
Date:10/12/00ISR Number: 3594160-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tachycardia Lariam-Mefloquin PS 1 TABLET PER
Hyperventilation
WEEK
Anxiety
Influenza
Depression
Disturbance In Attention
Insomnia
Feeling Abnormal
Hypertension
Irritable Bowel Syndrome

Paranoia
Panic Attack
Fatigue
03-Apr-2012 09:37 AM Page: 250

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/12/00ISR Number: 3594368-6Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paranoia Lariam PS Roche ORAL ONE PER 8 WKS
Initial or Prolonged Restlessness ORAL
Disability
Myocardial Infarction
Required
Hypertension
Intervention to
Musculoskeletal Stiffness
Prevent Permanent
Impairment/Damage
Fatigue
Confusional State
Tachycardia
Headache
Sedation
Muscle Spasms
Depression
Weight Increased
Panic Attack
Insomnia
Muscle Disorder
Chest Pain
Date:10/12/00ISR Number: 3592569-4Report Type:Expedited (15-DaCompany Report #246415 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tremor Lariam Tablets PS Roche
Pyrexia
Delirium
Asthenia
Date:10/12/00ISR Number: 3592586-4Report Type:Expedited (15-DaCompany Report #246417 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psychotic Disorder Lariam Tablets PS Roche
Delusion
Schizophreniform Disorder
Depression
Paranoia
Mania
Hallucination
Date:10/13/00ISR Number: 3594815-XReport Type:Expedited (15-DaCompany Report #246414 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psychotic Disorder Foreign Lariam PS Hoffmann La Roche
Pyrexia Other Inc ORAL ORAL
Delirium
Dermatitis

Delusion
Rash Maculo-Papular
Paranoia
Neurosis
Confusional State
03-Apr-2012 09:37 AM Page: 251

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/16/00ISR Number: 3594523-5Report Type:Expedited (15-DaCompany Report #216859 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pharyngitis Lariam Tablets PS Roche 50 DAY
Thermal Burn
Lichen Planus
Skin Discolouration
Emotional Disorder
Lymphadenopathy
Bronchospasm
Pharyngitis Streptococcal
Erythema
Rhinorrhoea
Headache
Date:10/16/00ISR Number: 3594525-9Report Type:Expedited (15-DaCompany Report #216747 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Skin Discolouration Lariam Tablets PS Roche 50 DAY
Infection
Skin Exfoliation
Economic Problem
Fibrous Histiocytoma
Agitation
Eczema
Hyperkeratosis
Lichen Planus
Marital Problem
Libido Decreased
Emotional Distress
Lichenification
Depression
Fear
Neurosis
Neurodermatitis
Dermatitis
Blister
Folliculitis
Emotional Disorder
Pruritus
Skin Disorder
Condition Aggravated
Date:10/16/00ISR Number: 3594532-6Report Type:Expedited (15-DaCompany Report #216810 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Skin Discolouration Lariam Tablets PS Roche 50 DAY
Lichen Planus
Emotional Distress

Skin Disorder
Emotional Disorder
Depression
03-Apr-2012 09:37 AM Page: 252

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/16/00ISR Number: 3595588-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disturbance In Attention Lariam 250 Mg Roche
Abnormal Dreams Laboratories PS Roche Laboratories ORAL 250 MG 1X
Joint Stiffness
WEEK/4 ORAL
Dermatitis
Dizziness
Syncope
Back Pain
Diarrhoea
Date:10/16/00ISR Number: 3595592-9Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Pain Larium Roche PS Roche 1 OTHER
Required
Phobia
Intervention to
Panic Reaction
Prevent Permanent Dizziness
Impairment/Damage Paranoia
Headache
Abnormal Dreams
Lethargy
Hallucination
Hypersomnia
Date:10/16/00ISR Number: 3595866-1Report Type:Expedited (15-DaCompany Report #216810 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Skin Discolouration Other Lariam PS Hoffmann La Roche
Skin Disorder Inc ORAL 250 MG 1 PER
Depression
WEEK; ORAL
Emotional Disorder
Lichen Planus
Date:10/16/00ISR Number: 3595867-3Report Type:Expedited (15-DaCompany Report #216859 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Lymphadenopathy Health Lariam PS Hoffmann La Roche
Skin Discolouration Professional Inc ORAL 250 MG 1 PER
Rhinorrhoea Other WEEK; ORAL
Pharyngitis Streptococcal
Headache
Rash Erythematous
Emotional Disorder
Pharyngitis
Oropharyngeal Pain

Lichen Planus
Skin Disorder
Bronchospasm
Thermal Burn
03-Apr-2012 09:37 AM Page: 253

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/16/00ISR Number: 3595868-5Report Type:Expedited (15-DaCompany Report #216747 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Lichen Planus Other Lariam PS Hoffmann La Roche
Agitation Inc ORAL 250 MG 1 PER
Ulcer
WEEK ORAL
Blister
Folliculitis
Skin Lesion
Pruritus
Medication Error
Partner Stress
Skin Exfoliation
Eczema
Necrosis
Marital Problem
Skin Hyperpigmentation
Hyperkeratosis
Infection
Neurodermatitis
Skin Discolouration
Condition Aggravated
Emotional Disorder
Fear
Date:10/16/00ISR Number: 3596305-7Report Type:Expedited (15-DaCompany Report #246861 Age:54 YR Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Deep Vein Thrombosis Foreign Lariam PS Hoffmann La Roche
Other Inc ORAL 250 MG 1 PER
WEEK ORAL
Date:10/16/00ISR Number: 3594515-6Report Type:Expedited (15-DaCompany Report #246414 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psychotic Disorder Lariam Tablets PS Roche 1 DAY
Confusional State
Pyrexia
Delirium
Paranoia
Delusion
Neurosis
Rash Maculo-Papular
Date:10/16/00ISR Number: 3594534-XReport Type:Expedited (15-DaCompany Report #246861 Age:54 YR Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Deep Vein Thrombosis Mefloquine
Hydrochloride PS Roche 29 DAY
03-Apr-2012 09:37 AM Page: 254

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/17/00ISR Number: 3595469-9Report Type:Expedited (15-DaCompany Report #245766 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Acuity Reduced Lariam Tablets PS Roche
Scotoma
Optic Nerve Glioma
Leukaemia
Visual Field Defect
Optic Neuropathy
Lipoma
Meningioma
Sarcoidosis
Empty Sella Syndrome
Optic Ischaemic
Neuropathy
Lymphoma
Papilloedema
Metastasis
Date:10/17/00ISR Number: 3596671-2Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Lariam Mefloquine
Restlessness 250 Mg PS Roche Lab. ORAL ONE
Panic Disorder
TABLE/WEEKLY/
ORAL
Date:10/19/00ISR Number: 3597344-2Report Type:Expedited (15-DaCompany Report #235163 Age: Gender:Not SpecifiI/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Missed Lariam Tablets PS Roche 32 DAY
Pregnancy
Date:10/20/00ISR Number: 3598149-9Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vertigo Lariam Tablets PS Roche ESTIMATED 5
Initial or Prolonged Anxiety DOSES IN
Disability Panic Attack TOTAL. 21 DAY
Dizziness
Headache
Depression
Date:10/20/00ISR Number: 3598174-8Report Type:Expedited (15-DaCompany Report #211570 Age:1 HR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Cardiac Valve Disease Lariam Tablets PS Roche
Mitral Valve Incompetence
Heart Disease Congenital
Maternal Drugs Affecting
Foetus
03-Apr-2012 09:37 AM Page: 255

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/20/00ISR Number: 3599182-3Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Level Above Health Lariam PS Hoffmann La Roche
Initial or Prolonged Therapeutic Professional Inc ORAL 250 MG 1 PER
Disability Anxiety WEEK ORAL
Panic Attack
Vertigo
Dizziness
Depression
Headache
Date:10/20/00ISR Number: 3599647-4Report Type:Expedited (15-DaCompany Report #235163 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Pregnancy Foreign Lariam PS Hoffmann La Roche
Intervention to Abortion Missed Health Inc ORAL 1 DOSE FORM
Prevent Permanent Professional 1PER WEEK
Impairment/Damage
ORAL
Date:10/20/00ISR Number: 3599649-8Report Type:Expedited (15-DaCompany Report #247262 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicide Attempt Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Health Inc ORAL 1 DOSE FORM 1
Professional
PER WEEK ORAL
Date:10/20/00ISR Number: 3599650-4Report Type:Expedited (15-DaCompany Report #211570 Age:1 HR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Congenital Mitral Valve Foreign Lariam PS Hoffmann La Roche
Incompetence Health Inc ORAL 250 MG 1 PER
Heart Disease Congenital Professional WEEK ORAL
Cardiac Valve Disease
Maternal Drugs Affecting
Foetus
Heart Valve Replacement
Date:10/20/00ISR Number: 3599651-6Report Type:Expedited (15-DaCompany Report #247267 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoxia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Lung Infiltration Other Inc ORAL ORAL
Pneumonitis
Pyrexia

Dyspnoea
03-Apr-2012 09:37 AM Page: 256

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/20/00ISR Number: 3599766-2Report Type:Expedited (15-DaCompany Report #245766 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Papilloedema Foreign Lariam PS Hoffmann La Roche
Visual Field Defect Health Inc ORAL ORAL
Visual Acuity Reduced
Professional
Empty Sella Syndrome
Lipoma
Optic Neuritis
Retinal Exudates
Optic Neuropathy
Optic Nerve Disorder
Date:10/20/00ISR Number: 3598163-3Report Type:Expedited (15-DaCompany Report #247262 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicide Attempt Lariam Tablets PS Roche
Initial or Prolonged
Date:10/20/00ISR Number: 3598168-2Report Type:Expedited (15-DaCompany Report #247267 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoxia Lariam Tablets PS Roche 2 DAY
Initial or Prolonged Pneumonitis
Dyspnoea
Pyrexia
Date:10/23/00ISR Number: 3599859-XReport Type:Direct Company Report # Age:34 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Amnesia Consumer Larium -Mefloquine-
Nightmare Roche PS Roche ORAL ONE PILL WEEK
Insomnia
ORAL
Fatigue
Vertigo
Dizziness
Confusional State
Listless
Paranoia
Disturbance In Attention
Lethargy
Headache
Depression
Date:10/23/00ISR Number: 3600682-8Report Type:Expedited (15-DaCompany Report #245745 Age:36 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Menorrhagia Foreign Lariam PS Hoffmann La Roche
Intervention to Consumer Inc ORAL 250 MG 1 PER
Prevent Permanent
WEEK ORAL
Impairment/Damage
03-Apr-2012 09:37 AM Page: 257

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/23/00ISR Number: 3599102-1Report Type:Expedited (15-DaCompany Report #245745 Age:36 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vaginal Haemorrhage Lariam Tablets PS Roche 36 DAY
Menorrhagia
Date:10/24/00ISR Number: 3600623-3Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Larium Once A Week PS ORAL ONCE A WEEK
Mental Impairment
ORAL
Amnesia
Disturbance In Attention
Date:10/24/00ISR Number: 3601395-9Report Type:Expedited (15-DaCompany Report #247406 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Foreign Lariam PS Hoffmann La Roche
Dyskinesia Other Inc ORAL 250 MG 1 PER
Eye Movement Disorder
WEEK ORAL
Movement Disorder
Salmonella Vaccine
Disorientation (Typhoid Vaccines) C
Date:10/24/00ISR Number: 3599672-3Report Type:Expedited (15-DaCompany Report #247406 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disorientation Lariam Tablets PS Roche 15 DAY
Abnormal Dreams Salmonella Vaccine C 1 DAY
Eye Movement Disorder
Movement Disorder
Date:10/26/00ISR Number: 3601036-0Report Type:Expedited (15-DaCompany Report #243034 Age:80 YR Gender:Female I/FU:F
Outcome
Death
Life-Threatening
PT
Stupor
Abdominal Pain
Gastrointestinal Disorder
Extensor Plantar Response
X-Ray Gastrointestinal
Tract Abnormal
Nuclear Magnetic
Resonance Imaging
Abnormal
Mental Disorder Due To A
General Medical Condition

Gastric Perforation
Cardio-Respiratory Arrest
Angiopathy
Dyspnoea
Gastrointestinal Sounds
Abnormal
Sedation
Cardiac Failure
03-Apr-2012 09:37 AM Page: 258

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abdominal Tenderness
C-Reactive Protein
Increased Report Source Product Role Manufacturer Route Dose Duration
Hypophagia Lariam Tablets PS Roche 1 DAY
Arrhythmia
Shock
Respiratory Failure
Flatulence
Blood Lactate
Dehydrogenase Increased
Depressed Level Of
Consciousness
Asthenia
Confusional State
Cardiac Murmur
Oedema
Date:10/26/00ISR Number: 3601049-9Report Type:Expedited (15-DaCompany Report #246474 Age:61 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Psoriasis Lariam Tablets PS Roche 280 DAY
Date:10/27/00ISR Number: 3602925-3Report Type:Expedited (15-DaCompany Report #246474 Age:61 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Psoriasis Health Lariam PS Hoffmann La Roche
Professional Inc ORAL 1 PER WEEK
ORAL
Date:10/27/00ISR Number: 3603403-8Report Type:Expedited (15-DaCompany Report #243034 Age:80 YR Gender:Female I/FU:F
Outcome
Death
Life-Threatening
PT
Asthenia
Endoscopy Abnormal
Abdominal Pain
Extensor Plantar Response
Gastric Perforation
Confusional State
Abdominal Tenderness
Respiratory Failure
Cardiac Failure
X-Ray Gastrointestinal
Tract Abnormal
Respiratory Disorder
Shock
Blood Lactate
Dehydrogenase Increased

Ill-Defined Disorder
Mental Disorder Due To A
General Medical Condition
Nuclear Magnetic
Resonance Imaging
Abnormal
C-Reactive Protein
Increased
03-Apr-2012 09:37 AM Page: 259

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Condition Aggravated
Ileus Paralytic
Cardio-Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration
Dyspnoea Foreign Lariam PS Hoffmann La Roche
Arrhythmia Health Inc ORAL 2 DOSE FORM 1
Professional
PER ONE DOSE
ORAL
Date:10/30/00ISR Number: 3602885-5Report Type:Expedited (15-DaCompany Report #87481 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Thinking Abnormal Lariam Tablets PS Roche 180 DAY
Bone Pain Lamisil C
Feeling Abnormal
Job Dissatisfaction
Sleep Apnoea Syndrome
Vomiting
Loss Of Employment
Brain Injury
Amnesia
Burning Sensation
Oedema
Respiratory Disorder
Disorientation
Dizziness
Drug Level Above
Therapeutic
Disturbance In Attention
Visual Impairment
Hypertension
Medication Error
Pain
Mental Impairment
Mastoid Disorder
Neck Pain
Nausea
Asthenia
Accidental Overdose
Vision Blurred
Depression
Sleep Disorder
Upper Respiratory Tract
Infection
Visual Acuity Reduced
Paraesthesia
Neurological Symptom
Cough
Hypoaesthesia
Nocturia
Fatigue
Dysgeusia

Oedema Peripheral
Mental Disorder
03-Apr-2012 09:37 AM Page: 260

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/30/00ISR Number: 3602919-8Report Type:Expedited (15-DaCompany Report #200841 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Tremor Lariam Tablets PS Roche CUMULATIVE
Initial or Prolonged Asthenia DOSAGE= 750
Disability Disturbance In Attention MG 380 DAY
Visual Impairment
Meningococcal
Convulsion Vaccine C 1 DAY
Abnormal Behaviour Flu Vaccine C 1 DAY
Mental Disorder
Condition Aggravated
Lacrimation Increased
Stress
Arrhythmia
Hallucination
Dyspnoea
Diplopia
Malaise
Sedation
Paraesthesia
Fall
Movement Disorder
Crying
Fatigue
Hallucination, Visual
Panic Attack
Nausea
Speech Disorder
Balance Disorder
Dysphagia
Tinnitus
Hyperventilation
Vision Blurred
Accommodation Disorder
Dry Mouth
Diarrhoea
Hydrocephalus
Heterophoria
Date:10/30/00ISR Number: 3603006-5Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Lariam-Mefloquine PS 1 / WEEK
Required
Nightmare
Intervention to
Insomnia
Prevent Permanent Mania
Impairment/Damage Mental Disorder
Depression
Nervous System Disorder

Date:10/30/00ISR Number: 3603605-0Report Type:Direct Company Report # Age:36 YR Gender:Female I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Psychotic Disorder
Paranoia
Hallucinations, Mixed
Feeling Abnormal
03-Apr-2012 09:37 AM Page: 261

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Persecutory Delusion
Report Source Product Role Manufacturer Route Dose Duration
Larium PS 1 PER WEEK
Date:10/30/00ISR Number: 3603668-2Report Type:Expedited (15-DaCompany Report #247733 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Field Defect Foreign Lariam PS Hoffmann La Roche
Health Inc ORAL 1 DOSE FORM 1
Professional
PER WEEK ORAL
Other
Date:10/30/00ISR Number: 3603957-1Report Type:Expedited (15-DaCompany Report #87481 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hypoaesthesia Literature Lariam PS Hoffmann La Roche
Nausea Health Inc ORAL 250 MG 2 PER
Depression Professional WEEK ORAL
Paraesthesia
Lamisil
Vomiting (Terbinafine) C
Disorientation
Visual Impairment
Asthenia
Medication Error
Dysgeusia
Oedema
Hypertension
Dizziness
Fatigue
Accidental Overdose
Date:10/30/00ISR Number: 3602890-9Report Type:Expedited (15-DaCompany Report #247733 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Field Defect Lariam Tablets PS Roche THE PATIENT
RECEIVED A
TOTAL OF 2
TABLETS. 16 DAY
Date:11/01/00ISR Number: 3604078-4Report Type:Expedited (15-DaCompany Report #245340 Age:17 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Stupor
Insomnia

Ear Disorder
Ventricular Hypertrophy
Clonic Convulsion
Blood Bilirubin Increased
Tinnitus
Dizziness
Neutrophilia
C-Reactive Protein
03-Apr-2012 09:37 AM Page: 262

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Increased
Headache
Speech Disorder
Confusional State Report Source Product Role Manufacturer Route Dose Duration
Anxiety Lariam Tablets PS Roche 2 DAY
Dyskinesia Advil C
Agitation
Drug Tolerance Decreased
Electroencephalogram
Abnormal
Abnormal Behaviour
Vomiting
Pyrexia
Diplopia
Thrombocytosis
Chorea
Date:11/01/00ISR Number: 3605361-9Report Type:Direct Company Report # Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspnoea Larium Mefloquine PS OROPHARINGEAL 1 PILL 1 TIME
Fatigue
W
Dizziness
OROPHARINGEAL
Chills
Vision Blurred
Drug Hypersensitivity
Hypoaesthesia
Anxiety
Headache
Nausea
Dehydration
Pyrexia
Date:11/01/00ISR Number: 3605668-5Report Type:Expedited (15-DaCompany Report #245340 Age:17 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Clonic Convulsion
Insomnia
Malaria
Confusional State
Anxiety
C-Reactive Protein
Increased
Leukocytosis
Stupor
Electroencephalogram
Abnormal
Headache
Chorea
Blood Lactate

Dehydrogenase Increased
Thrombocytosis
Ventricular Hypertrophy
Dizziness
Pyrexia
Diplopia
Haematocrit Decreased
Vomiting
03-Apr-2012 09:37 AM Page: 263

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Tinnitus
Agitation
Depressed Level Of Report Source Product Role Manufacturer Route Dose Duration
Consciousness Foreign Lariam PS Hoffmann La Roche
White Blood Cells Urine Health Inc ORAL ORAL
Positive Professional Advil (Ibuprofen) C
Blood Bilirubin Increased Other
Disorientation
Speech Disorder
Abnormal Behaviour
Cardiomegaly
Dyskinesia
Date:11/02/00ISR Number: 3605199-2Report Type:Expedited (15-DaCompany Report #247893 Age:66 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Syncope Consumer Lariam Tablets PS Roche 61 DAY
Initial or Prolonged Muscle Spasms Plendil C
Epistaxis Moduretic C
Mouth Haemorrhage
Date:11/03/00ISR Number: 3605736-8Report Type:Expedited (15-DaCompany Report #245128 Age:15 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Primperan PS 1 DAY
Tremor Lariam Tablets SS Roche 63 DAY
Extrapyramidal Disorder
Gastrooesophageal Reflux
Disease
Throat Tightness
Date:11/03/00ISR Number: 3605741-1Report Type:Expedited (15-DaCompany Report #230098 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hyperhidrosis Lariam Tablets PS Roche 22 DAY
Initial or Prolonged Tinnitus Jodthyrox C 731 DAY
Depression Hismanal C
Psychotic Disorder
Paraesthesia
Furuncle
Mental Disorder
Agoraphobia
Retching
Dizziness
Blood Pressure Systolic
Increased
Nausea

Chills
03-Apr-2012 09:37 AM Page: 264

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/06/00ISR Number: 3608144-9Report Type:Expedited (15-DaCompany Report #245128 Age:15 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tremor Foreign Lariam PS Hoffmann La Roche
Extrapyramidal Disorder Health Inc ORAL 1 DOSE FORM
Gastrooesophageal Reflux Professional 1 PER WEEK
Disease
Nervousness
ORAL
Primperan
(Metoclopramide
Hydrochloride) SS ORAL 1 DOSE FORM
2 PER DAY
ORAL
Date:11/06/00ISR Number: 3608146-2Report Type:Expedited (15-DaCompany Report #230098 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hyperhidrosis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Fatigue Consumer Inc ORAL 250 MG ORAL
Retching Health Hismanal
Crying Professional (Astemizole) C
Agoraphobia
Hismanal
Phobia (Astemizole) C
Dizziness
Jodthyrox
Anxiety
(Levothyroxine
Tinnitus
Sodium/Potassium
Agitation Iodide) C
Conversion Disorder
Abdominal Discomfort
Nausea
Chills
Depression
Obsessive-Compulsive
Disorder
Mental Disorder
Hyperventilation
Psychotic Disorder
Blood Pressure Systolic
Increased
Stress
Paraesthesia
Furuncle
Date:11/06/00ISR Number: 3608353-9Report Type:Expedited (15-DaCompany Report #244563 Age:47 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Depression
Paraesthesia
Mental Impairment
Syncope

Adjustment Disorder
Orgasm Abnormal
Emotional Disorder
Weight Decreased
Fear
Fatigue
Asthenia
Stress
03-Apr-2012 09:37 AM Page: 265

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disturbance In Attention
Vision Blurred
Feeling Abnormal Report Source Product Role Manufacturer Route Dose Duration
Emotional Distress Health Lariam PS Hoffmann La Roche
Abnormal Dreams Professional Inc ORAL ORAL
Anxiety
Other
Crying
Psychiatric Symptom
Panic Attack
Obsessive-Compulsive
Personality Disorder
Dizziness
Tremor
Insomnia
Libido Decreased
Mood Swings
Bradyphrenia
Date:11/06/00ISR Number: 3606583-3Report Type:Expedited (15-DaCompany Report #244563 Age:47 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Impairment Lariam Tablets PS Roche
Initial or Prolonged Feeling Abnormal
Tremor
Vision Blurred
Fatigue
Anxiety
Orgasm Abnormal
Obsessive-Compulsive
Disorder
Emotional Disorder
Disturbance In Attention
Asthenia
Abnormal Dreams
Dizziness
Sleep Disorder
Depression
Syncope
Weight Decreased
Libido Decreased
Panic Attack
Paraesthesia
Date:11/08/00ISR Number: 3608713-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Lariam / Mefloquine
Required Heart Rate Increased / 250mg / Roche PS Roche ORAL 250MG ONCE A
Intervention to Feeling Abnormal WEEK ORAL

Prevent Permanent
Impairment/Damage
Social Phobia
Dizziness
Insomnia
Hypertension
Confusional State
Panic Attack
03-Apr-2012 09:37 AM Page: 266

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/08/00ISR Number: 3608796-3Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dizziness Melfoquine Lariam PS ORAL 1 1PER WEEK
Initial or Prolonged Angina Pectoris ORAL
Disability Fatigue Felodipine C
Required
Intervention to
Prevent Permanent
Impairment/Damage
Date:11/08/00ISR Number: 3608799-9Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chest Pain Mefloquine (Lariam) PS ORAL 1 1 PER WEEK
Initial or Prolonged
ORAL
Disability Felodipine C
Required Morphine C
Intervention to
Prevent Permanent
Impairment/Damage
Date:11/13/00ISR Number: 3610011-1Report Type:Expedited (15-DaCompany Report #60555 Age:45 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Lariam Tablets PS Roche 8 DAY
Initial or Prolonged Chest Pain Dormonoct C
Anxiety Prothiaden C
Palpitations
Date:11/13/00ISR Number: 3610049-4Report Type:Expedited (15-DaCompany Report #85415 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Dizziness Lariam Tablets PS Roche 22 DAY
Nightmare
Alopecia
Depression
Suicidal Ideation
Nausea
Date:11/13/00ISR Number: 3611050-7Report Type:Expedited (15-DaCompany Report #60555 Age:45 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chest Pain Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Palpitations Other Inc ORAL 250 MG 1 PER

Depression WEEK ORAL
Anxiety
Dormonoct
(Loprazolam)
C
Prothiaden
(Dothiepin
Hydrochloride) C
03-Apr-2012 09:37 AM Page: 267

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/13/00ISR Number: 3610058-5Report Type:Expedited (15-DaCompany Report #910100239001 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicide Attempt Lariam Tablets PS Roche 15 DAY
Hospitalization - Depression
Initial or Prolonged
Disability
Date:11/14/00ISR Number: 3612201-0Report Type:Expedited (15-DaCompany Report #216859 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Lymphadenopathy Health Lariam PS Hoffmann La Roche
Intervention to Pharyngitis Professional Inc ORAL 250 MG 1 PER
Prevent Permanent Rhinorrhoea Other WEEK ORAL
Impairment/Damage Thermal Burn
Skin Discolouration
Oropharyngeal Pain
Emotional Disorder
Emotional Distress
Lichen Planus
Pharyngitis Streptococcal
Erythema
Refraction Disorder
Bronchospasm
Sinus Congestion
Headache
Date:11/15/00ISR Number: 3611274-9Report Type:Expedited (15-DaCompany Report #216859 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Lariam Tablets PS Roche 50 DAY
Skin Discolouration
Thermal Burn
Lichen Planus
Rhinorrhoea
Refraction Disorder
Lymphadenopathy
Emotional Disorder
Erythema
Pharyngitis
Date:11/15/00ISR Number: 3611309-3Report Type:Expedited (15-DaCompany Report #237590 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Intra-Uterine Death Lariam Tablets PS Roche 550 DAY

Date:11/15/00ISR Number: 3611310-XReport Type:Expedited (15-DaCompany Report #237587 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Intra-Uterine Death Lariam Tablets PS Roche 550 DAY
03-Apr-2012 09:37 AM Page: 268

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/15/00ISR Number: 3611397-4Report Type:Direct Company Report # Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Lariam 250mg Roche
Dizziness Lab Inc PS Roche Lab Inc ORAL 3 1 PER WEEK
Insomnia
ORAL
Paranoia
Abnormal Dreams
Abnormal Behaviour
Mood Altered
Confusional State
Depression
Date:11/15/00ISR Number: 3612397-0Report Type:Expedited (15-DaCompany Report #85415 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Nausea Foreign Lariam PS Hoffmann La Roche
Alopecia Other Inc ORAL 250 MG 1 PER
Depression
WEEK ORAL
Dizziness
Nightmare
Suicidal Ideation
Date:11/15/00ISR Number: 3612515-4Report Type:Expedited (15-DaCompany Report #237587 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Accidental Exposure Foreign Lariam PS Hoffmann La Roche
Abortion Missed Consumer Inc ORAL ORAL
Intra-Uterine Death
Health
Professional
Other
Date:11/15/00ISR Number: 3612728-1Report Type:Expedited (15-DaCompany Report #910100239001 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicidal Ideation Health Lariam PS Hoffmann La Roche
Hospitalization - Overdose Professional Inc ORAL 1 DOSE FORM
Initial or Prolonged Dysthymic Disorder 1 PER WEEK
Disability Tremor ORAL
Suicide Attempt
Agitation
Nervousness
Depression
Date:11/15/00ISR Number: 3612784-0Report Type:Expedited (15-DaCompany Report #237590 Age: Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Missed Foreign Lariam PS Hoffmann La Roche
Intra-Uterine Death Consumer Inc ORAL ORAL
Maternal Drugs Affecting Health
Foetus
Professional
Accidental Exposure
Other
03-Apr-2012 09:37 AM Page: 269

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/16/00ISR Number: 3612864-XReport Type:Expedited (15-DaCompany Report #244563 Age:47 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Decreased Appetite Health Lariam PS Hoffmann La Roche
Initial or Prolonged Pneumonia Professional Inc ORAL ORAL
Required Tremor Other
Intervention to
Chills
Prevent Permanent
Impairment/Damage
Orgasm Abnormal
Panic Attack
Eosinophilia
Haemoglobin Decreased
Feeling Abnormal
Musculoskeletal Stiffness
Lymphadenopathy
Dry Mouth
Emotional Disorder
Sleep Disorder
Cognitive Disorder
Headache
Vision Blurred
Asthenia
Bradycardia
Paraesthesia
Obsessive-Compulsive
Disorder
Diarrhoea
Mental Impairment
Dehydration
Syncope
Disturbance In Attention
Bronchitis
Skin Lesion
Abnormal Dreams
Fatigue
Depression
Anxiety
Dizziness
Upper Respiratory Tract
Infection
Libido Decreased
Mood Swings
Stress
Dysuria
Weight Decreased
Date:11/16/00ISR Number: 3613028-6Report Type:Expedited (15-DaCompany Report #234234 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Stillbirth Foreign Lariam PS Hoffmann La Roche
Premature Labour Health Inc ORAL 1 PER WEEK
Placental Insufficiency Professional ORAL

Caesarean Section Meningococcal
Maternal Drugs Affecting
Vaccine
Foetus
(Meningococcal
Vaccines Nos)
Diphtheria Vaccine
(Diphtheria Toxoid)
Cholera Vaccine
(Cholera Vaccine)
C
C
C
03-Apr-2012 09:37 AM Page: 270

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Typhus Vaccine
(Typhus Vaccine)
Hepatitis A Vaccine
(Hepatitis A
Vaccine)
C
C
Date:11/16/00ISR Number: 3613117-6Report Type:Expedited (15-DaCompany Report #248735 Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Interaction Foreign Lariam PS Hoffmann La Roche
International Normalised Health Inc ORAL ORAL
Ratio Increased Professional Warfarin (Warfarin
Sodium)
SS
Co Proxamol
(Acetaminophen /
Prophoxyphene
Hydrochloride) C
Date:11/17/00ISR Number: 3613227-3Report Type:Direct Company Report # Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Arthropathy Lariam 1 Pill Weekly PS 1 PILL
Initial or Prolonged Diarrhoea
Other Serious
Vomiting
Abdominal Pain
Arthritis
Date:11/21/00ISR Number: 3613999-8Report Type:Expedited (15-DaCompany Report #85415 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicidal Ideation Lariam Tablets PS Roche 22 DAY
Alopecia
Nightmare
Depression
Dizziness
Nausea
Date:11/21/00ISR Number: 3614000-2Report Type:Expedited (15-DaCompany Report #89618 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscle Contractions Lariam Tablets PS Roche 8 DAY
Involuntary
Paraesthesia
Insomnia
Abnormal Dreams

Psychotic Disorder
Crying
Hyperreflexia
Panic Reaction
Palpitations
Hypoaesthesia
Hyperhidrosis
Decreased Appetite
03-Apr-2012 09:37 AM Page: 271

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/21/00ISR Number: 3614035-XReport Type:Expedited (15-DaCompany Report #910100239001 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicide Attempt Lariam Tablets PS Roche 15 DAY
Hospitalization - Depression
Initial or Prolonged
Disability
Date:11/21/00ISR Number: 3614074-9Report Type:Expedited (15-DaCompany Report #930202261001 Age:41 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Reaction Lariam PS Roche 11 DAY
Initial or Prolonged Diarrhoea
Disability
Decreased Appetite
Vertigo
Abnormal Behaviour
Hyperhidrosis
Visual Impairment
Dermatitis
Chromaturia
Weight Decreased
White Blood Cell Count
Increased
Suicidal Ideation
Gastritis
Nausea
Fatigue
Hyperaesthesia
Depression
Balance Disorder
Pollakiuria
Anxiety
Crying
Dyspepsia
Malaise
Pharyngeal Disorder
Date:11/21/00ISR Number: 3615482-2Report Type:Expedited (15-DaCompany Report #910100239001 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Overdose Health Lariam PS Hoffmann La Roche
Hospitalization - Suicide Attempt Professional Inc ORAL 1 DOSE FORM 1
Initial or Prolonged Suicidal Ideation PER WEEK ORAL
Disability
Tremor
Agitation
Nervousness
Depression
Dysthymic Disorder

Date:11/21/00ISR Number: 3615623-7Report Type:Expedited (15-DaCompany Report #930202261001 Age:41 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Hyperhidrosis
Fatigue
Dyspepsia
03-Apr-2012 09:37 AM Page: 272

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Injury
Gastritis
White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration
Increased Consumer Lariam PS Hoffmann La Roche
Suicidal Ideation Health Inc ORAL 250 MG 1 PER
Balance Disorder Professional WEEK ORAL
Diarrhoea
Other
Weight Decreased
Abnormal Faeces
Insomnia
Chromaturia
Dermatitis
Depression
Anxiety
Malaise
Visual Impairment
Abnormal Behaviour
Paraesthesia
Pollakiuria
Decreased Appetite
Nausea
Foreign Body
Feeling Abnormal
Crying
Vertigo
Date:11/21/00ISR Number: 3615624-9Report Type:Expedited (15-DaCompany Report #89618 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Movement Disorder Consumer Lariam PS Hoffmann La Roche
Dyspnoea Other Inc ORAL 250 MG 1 PER
Decreased Appetite
WEEK ORAL
Psychotic Disorder
Insomnia
Hyperhidrosis
Hypophagia
Hyperreflexia
Hypoaesthesia
Palpitations
Panic Attack
Abnormal Dreams
Crying
Paraesthesia
Muscle Contractions
Involuntary
Date:11/21/00ISR Number: 3615641-9Report Type:Expedited (15-DaCompany Report #248917 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Neuritis Foreign Lariam PS Hoffmann La Roche
Inner Ear Disorder Consumer Inc ORAL ORAL
Dizziness
Dermatitis
03-Apr-2012 09:37 AM Page: 273

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/21/00ISR Number: 3615646-8Report Type:Expedited (15-DaCompany Report #85415 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Depression Suicidal Foreign Lariam PS Hoffmann La Roche
Dizziness Other Inc ORAL 250 MG 1 PER
Alopecia
WEEK ORAL
Nausea
Nightmare
Date:11/21/00ISR Number: 3614037-3Report Type:Expedited (15-DaCompany Report #249131 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gamma-Glutamyltransferase Lariam Tablets PS Roche
Increased
Blood Alkaline
Phosphatase Increased
Date:11/21/00ISR Number: 3614045-2Report Type:Expedited (15-DaCompany Report #249135 Age:61 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Respiratory Arrest Lariam Tablets PS Roche
Doxycyclin
C
Date:11/21/00ISR Number: 3614079-8Report Type:Expedited (15-DaCompany Report #248917 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Ear Disorder Lariam Tablets PS Roche TWO DOSES OF
Dermatitis
LARIAM TAKEN,
ONE ON 7 JAN
00 AND ONE ON
14 JAN 00. 9 DAY
Date:11/22/00ISR Number: 3615108-8Report Type:Expedited (15-DaCompany Report #203837 Age:54 YR Gender:Male I/FU:F
Outcome
Death
PT
Weight Decreased
Agitation
Flushing
Delusional Disorder,
Persecutory Type
Nervous System Disorder
Cognitive Disorder
Urinary Hesitation
Hyperhidrosis
Fatigue

Musculoskeletal Stiffness
Depression
Polydipsia
Delirium
Anxiety
Insomnia
Abnormal Dreams
Completed Suicide
03-Apr-2012 09:37 AM Page: 274

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Amnesia
Chills
Headache Report Source Product Role Manufacturer Route Dose Duration
Decreased Appetite Lariam Tablets PS Roche 50 DAY
Obsessive-Compulsive
Disorder
Hallucinations, Mixed
Adjustment Disorder
Date:11/22/00ISR Number: 3616466-0Report Type:Expedited (15-DaCompany Report #248917 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Foreign Lariam PS Hoffmann La Roche
Ear Disorder Consumer Inc ORAL ORAL
Neuritis
Dermatitis
Balance Disorder
Vestibular Disorder
Date:11/22/00ISR Number: 3616467-2Report Type:Expedited (15-DaCompany Report #85415 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Nausea Foreign Lariam PS Hoffmann La Roche
Dizziness Other Inc ORAL 250 MG 1 PER
Alopecia
WEEK ORAL
Nightmare
Depression
Suicidal Ideation
Date:11/22/00ISR Number: 3616469-6Report Type:Expedited (15-DaCompany Report #249131 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Red Blood Cell Foreign Lariam PS Hoffmann La Roche
Sedimentation Rate Health Inc ORAL ORAL
Increased
Professional
Liver Function Test
Abnormal
Gamma-Glutamyltransferase
Increased
Blood Uric Acid Increased
Blood Alkaline
Phosphatase Increased
Blood Iron Decreased
Condition Aggravated

Date:11/22/00ISR Number: 3616470-2Report Type:Expedited (15-DaCompany Report #249135 Age:61 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Respiratory Arrest Foreign Lariam PS Hoffmann La Roche
Convulsion Other Inc ORAL ORAL
Circulatory Collapse
Doxycyclin
(Doxycycline)
C
03-Apr-2012 09:37 AM Page: 275

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/22/00ISR Number: 3617622-8Report Type:Expedited (15-DaCompany Report #203837 Age:54 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Sleep Disorder Consumer Lariam PS Hoffmann La Roche
Nervous System Disorder Other Inc ORAL 250 MG 1 PER
Insomnia
WEEK ORAL
Fatigue
Depression
Musculoskeletal Stiffness
Polydipsia
Anxiety
Social Problem
Dissociation
Hallucinations, Mixed
Delusion
Flushing
Delirium
Obsessive-Compulsive
Disorder
Decreased Appetite
Chills
Memory Impairment
Mental Impairment
Weight Decreased
Delusional Disorder,
Persecutory Type
Amnesia
Lethargy
Personality Disorder
Nightmare
Dysgraphia
Staring
Cognitive Disorder
Adjustment Disorder
Hyperhidrosis
Abnormal Dreams
Agitation
Completed Suicide
Urinary Hesitation
Fear
Headache
Date:11/24/00ISR Number: 3617901-4Report Type:Expedited (15-DaCompany Report #249282 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Atrioventricular Block Foreign Lariam PS Hoffmann La Roche
Health Inc ORAL 250 MG 1 PER
Professional
WEEK ORAL

Date:11/27/00ISR Number: 3616037-6Report Type:Expedited (15-DaCompany Report #249282 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Atrioventricular Block Lariam Tablets PS Roche 45 DAY
03-Apr-2012 09:37 AM Page: 276

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/28/00ISR Number: 3616670-1Report Type:Expedited (15-DaCompany Report #225972 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Kidney Malformation Health Lariam Tablets PS Roche 42 DAY
Hypospadias Professional Magne-B6 C
Maternal Drugs Affecting Tardyferon C
Foetus Speciafoldine C
Aspegic
C
Date:11/28/00ISR Number: 3616675-0Report Type:Expedited (15-DaCompany Report #232768 Age:27 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vision Blurred Health Lariam Tablets PS Roche
Initial or Prolonged Demyelination Professional
Peripheral Coldness
Disturbance In Attention
Pyrexia
Fatigue
Vertigo
Abdominal Pain
Lethargy
Headache
Wolff-Parkinson-White
Syndrome
Dizziness
Balance Disorder
Hyperacusis
Nausea
Weight Increased
Antinuclear Antibody
Positive
Migraine
Eating Disorder
Disorientation
Vomiting
Paraesthesia
Feeling Hot
Dehydration
Dysphagia
Date:11/28/00ISR Number: 3617657-5Report Type:Expedited (15-DaCompany Report #225972 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Maternal Drugs Affecting Lariam Tablets PS Roche 42 DAY
Foetus Magne-B6 C
Kidney Malformation Tardyferon C
Hypospadias Speciafoldine C
Aspegic
C

Date:11/28/00ISR Number: 3617658-7Report Type:Expedited (15-DaCompany Report #214112 Age:18 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Oedema Peripheral
Headache
Nightmare
03-Apr-2012 09:37 AM Page: 277

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Weight Decreased
Vith Nerve Paralysis
Fatigue Report Source Product Role Manufacturer Route Dose Duration
Csf Pressure Decreased Lariam Tablets PS Roche 71 DAY
Benign Intracranial Contraceptive C
Hypertension
Csf Protein Increased
Papilloedema
Diplopia
Date:11/28/00ISR Number: 3617664-2Report Type:Expedited (15-DaCompany Report #232768 Age:27 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hyperacusis Lariam Tablets PS Roche
Initial or Prolonged Dehydration
Weight Increased
Fatigue
Wolff-Parkinson-White
Syndrome
Migraine
Disorientation
Abdominal Pain
Paraesthesia
Pyrexia
Dizziness
Lethargy
Balance Disorder
Vision Blurred
Antinuclear Antibody
Positive
Anxiety
Angiopathy
Demyelination
Vomiting
Depression
Peripheral Coldness
Dysphagia
Vertigo
Headache
Disturbance In Attention
Eating Disorder
Malaise
Nausea
Feeling Hot
Date:11/28/00ISR Number: 3617700-3Report Type:Expedited (15-DaCompany Report #248975 Age:54 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Neuropathy Peripheral Lariam Tablets PS Roche 42 DAY

Lethargy
Paraesthesia
Myalgia
03-Apr-2012 09:37 AM Page: 278

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/28/00ISR Number: 3617710-6Report Type:Expedited (15-DaCompany Report #249339 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lichen Planus Lariam Tablets PS Roche 80 DAY
Initial or Prolonged Pruritus
Blister
Date:11/28/00ISR Number: 3617714-3Report Type:Expedited (15-DaCompany Report #249491 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cognitive Disorder Lariam Tablets PS Roche
Gait Disturbance
Amnesia
Dyspraxia
Date:11/28/00ISR Number: 3617717-9Report Type:Expedited (15-DaCompany Report #249476 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Petit Mal Epilepsy Lariam Tablets PS Roche 8 DAY
Date:11/28/00ISR Number: 3618062-8Report Type:Expedited (15-DaCompany Report #225972 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Congenital Anomaly Foreign Lariam PS Hoffmann La Roche
Hypospadias Health Inc ORAL 250 MG 1 PER
Maternal Drugs Affecting Professional WEEK ORAL
Foetus
Magen-86 (Magnesium
Renal Disorder
Nos/Pyridoxine
Placental Disorder Hydrochloride) C
Tardyferon (Ferrous
Sulfate)
C
Speciafolidine
(Folic Acid)
C
Aspegic (Aspirin
Dl-Lysine)
C
Date:11/28/00ISR Number: 3618065-3Report Type:Expedited (15-DaCompany Report #232768 Age:27 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Paraesthesia
Vomiting
Hypoaesthesia
Feeling Hot
Hyperacusis
Peripheral Coldness

Vision Blurred
Balance Disorder
Lethargy
Weight Increased
Eating Disorder
Disturbance In Attention
Antinuclear Antibody
Positive
03-Apr-2012 09:37 AM Page: 279

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Migraine
Malaise
Abdominal Pain Report Source Product Role Manufacturer Route Dose Duration
Vertigo Foreign Lariam PS Hoffmann La Roche
Blood Glucose Decreased Health Inc ORAL ORAL
Dizziness
Professional
Dehydration
Disorientation
Dysphagia
Headache
Fatigue
Anxiety
Wolff-Parkinson-White
Syndrome
Pyrexia
Demyelination
Date:11/29/00ISR Number: 3619066-1Report Type:Expedited (15-DaCompany Report #248735 Age:55 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious International Normalised Foreign Lariam PS Hoffmann La Roche
Ratio Increased Health Inc ORAL 1 PER WEEK
Drug Interaction Professional ORAL
Warfarin (Warfarin
Sodium)
SS
Co Proxamol
(Acetaminophen/
Propoxyphene
Hydrochloride) C
Date:11/29/00ISR Number: 3619067-3Report Type:Expedited (15-DaCompany Report #248975 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Neuropathy Peripheral Foreign Lariam PS Hoffmann La Roche
Lethargy Health Inc ORAL 1 PER WEEK
Pain In Extremity Professional ORAL
Paraesthesia
Date:11/29/00ISR Number: 3619068-5Report Type:Expedited (15-DaCompany Report #214112 Age:18 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Csf Protein Increased Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Diplopia Health Inc ORAL 250 MG 1 PER
Nightmare Professional WEEK ORAL
Fatigue
Contraceptive
Vith Nerve Paralysis (Contraceptive Nos) C
Oedema Peripheral

Papilloedema
Benign Intracranial
Hypertension
03-Apr-2012 09:37 AM Page: 280

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/30/00ISR Number: 3618871-5Report Type:Expedited (15-DaCompany Report #249379 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Arrhythmia Lariam Tablets PS Roche 36 DAY
Initial or Prolonged Bradycardia
Hypertension
Date:11/30/00ISR Number: 3618882-XReport Type:Expedited (15-DaCompany Report #249874 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Agitation Lariam Tablets PS Roche 31 DAY
Electroencephalogram
Abnormal
Psychotic Disorder
Balance Disorder
Amnesia
Insomnia
Emotional Distress
Nightmare
Headache
Visual Impairment
Educational Problem
Date:12/01/00ISR Number: 3620945-XReport Type:Expedited (15-DaCompany Report #249874 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Headache Other Lariam PS Hoffmann La Roche
Insomnia Inc ORAL ORAL
Emotional Distress
Electroencephalogram
Abnormal
Nightmare
Amnesia
Psychotic Disorder
Learning Disorder
Agitation
Visual Impairment
Balance Disorder
Date:12/01/00ISR Number: 3621130-8Report Type:Expedited (15-DaCompany Report #249379 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Bradycardia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Arrhythmia Health Inc ORAL 250 MG 1 PER
Hypertension Professional WEEK ORAL
Other

Date:12/06/00ISR Number: 3622972-5Report Type:Expedited (15-DaCompany Report #242660 Age:53 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Parosmia Lariam Tablets PS Roche
Nasopharyngitis Stamaril Unidose C 1 DAY
Ageusia Havrix C 1 DAY
03-Apr-2012 09:37 AM Page: 281

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Prophylactic
Medication
C
Date:12/06/00ISR Number: 3622973-7Report Type:Expedited (15-DaCompany Report #249748 Age:55 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Agitation Lariam Tablets PS Roche
Initial or Prolonged Confusional State
Mutism
Hypertonia
Delusion
Acute Psychosis
Speech Disorder
Disorientation
Date:12/07/00ISR Number: 3623547-4Report Type:Expedited (15-DaCompany Report #249977 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Dizziness Lariam Tablets PS Roche 1 DAY
Decreased Appetite Havrix C 1 DAY
Malaise Typhim C 1 DAY
Skull Fracture
Drowning
Head Injury
Hypophagia
Fatigue
Restlessness
Haemorrhage Subcutaneous
Mutism
Scratch
Confusional State
Personality Change
Fall
Influenza Like Illness
Brain Contusion
Depression
Aggression
Skull Fractured Base
Date:12/07/00ISR Number: 3624751-1Report Type:Expedited (15-DaCompany Report #249748 Age:55 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Agitation Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Confusional State Literature Inc
Persecutory Delusion
Health
Pyrexia
Professional
Delusion

Hypertonia
Mutism
Disorientation
Speech Disorder
Acute Psychosis
03-Apr-2012 09:37 AM Page: 282

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/07/00ISR Number: 3624753-5Report Type:Expedited (15-DaCompany Report #242660 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nasopharyngitis Foreign Lariam PS Hoffmann La Roche
Anosmia Consumer Inc ORAL 1 DOSE FORM
Ageusia Health 1 PER WEEK
Professional
Stamaril Unidose
(Yellow Fever
Vaccine)
Havrix (Hepatitis A
Vaccine)
Prophylactic
Medication
(Prophylactic
Medication Nos)
C
C
C
ORAL
Date:12/08/00ISR Number: 3624451-8Report Type:Expedited (15-DaCompany Report #249746 Age:43 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Decreased Appetite Mefloquine
Initial or Prolonged Persecutory Delusion Hydrochloride PS Roche
Depressed Mood Zopiclone C
Abnormal Behaviour Bromazepam C
Depression
Delusion Of Reference
Hallucinations, Mixed
Soliloquy
Insomnia
Anger
Suicidal Ideation
Crying
Anxiety
Date:12/08/00ISR Number: 3625505-2Report Type:Expedited (15-DaCompany Report #249977 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Dizziness Foreign Lariam PS Hoffmann La Roche
Skull Fractured Base Other Inc ORAL 250 MG 1 PER
Depression
WEEK ORAL
Brain Contusion
Havrix (Hepatitis A
Mutism Vaccine) C
Fall
Typhim (Typhoid
Head Injury Vaccines) C
Restlessness
Skull Fracture
Fatigue
Confusional State
Victim Of Crime

Scratch
Drowning
Haemorrhage Subcutaneous
Decreased Appetite
Malaise
Personality Change
03-Apr-2012 09:37 AM Page: 283

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/11/00ISR Number: 3625248-5Report Type:Expedited (15-DaCompany Report #250469 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pain In Extremity Lariam Tablets PS Roche
Hypoaesthesia
Optic Neuritis
Neurological Symptom
Date:12/11/00ISR Number: 3625253-9Report Type:Expedited (15-DaCompany Report #250135 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Coma Lariam Tablets PS Roche 8 DAY
Initial or Prolonged Convulsion Neuroleptic Nos C 1 DAY
Overdose Gardenal C 1 DAY
Agitation
Unknown
Toxicity To Various Benzodiazepines C 1 DAY
Agents
Date:12/11/00ISR Number: 3627203-8Report Type:Expedited (15-DaCompany Report #249746 Age:43 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicidal Ideation Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Depression Literature Inc
Decreased Appetite Health Zopiclone
Delusion Professional (Zopiclone) C
Hallucinations, Mixed
Bromazepam
(Bromazepam)
C
Date:12/12/00ISR Number: 3626644-2Report Type:Expedited (15-DaCompany Report #250525 Age:15 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Weight Decreased Lariam Tablets PS Roche 22 DAY
Renal Failure
Date:12/12/00ISR Number: 3627119-7Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Psychotic Disorder Lariam PS ORAL ONE WEE ORAL
Date:12/12/00ISR Number: 3627669-3Report Type:Expedited (15-DaCompany Report #250469 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Neurological Symptom Health Lariam PS Hoffmann La Roche

Hypoaesthesia Professional Inc ORAL ORAL
Pain In Extremity
Optic Neuritis
03-Apr-2012 09:37 AM Page: 284

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/12/00ISR Number: 3628092-8Report Type:Expedited (15-DaCompany Report #250135 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Coma Other Inc ORAL 250 MG 1 PER
Agitation
WEEK ORAL
Neuroleptic Nos
(Neuroleptic Nos) C
Gardenal
(Phenobarbital) C
Unknown
Benzodiazepines
(Benzodiazepine Nos) C
Date:12/13/00ISR Number: 3627583-3Report Type:Expedited (15-DaCompany Report #228520 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Bradycardia Lariam Tablets PS Roche CUMULATIVE
Maternal Drugs Affecting DOSE 2000 MG. 60 DAY
Foetus
Date:12/13/00ISR Number: 3629372-2Report Type:Expedited (15-DaCompany Report #250525 Age:15 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Renal Failure Foreign Lariam PS Hoffmann La Roche
Weight Decreased Health Inc ORAL ORAL
Professional
Date:12/14/00ISR Number: 3628891-2Report Type:Expedited (15-DaCompany Report #250525 Age:15 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Renal Failure Health Lariam Tablets PS Roche 22 DAY
Weight Decreased
Professional
Blood Albumin Increased
Date:12/14/00ISR Number: 3630418-6Report Type:Expedited (15-DaCompany Report #228520 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Bradycardia Foreign Lariam PS Hoffmann La Roche
Intervention to Maternal Drugs Affecting Consumer Inc ORAL 250 MG 1 PER
Prevent Permanent Foetus WEEK ORAL
Impairment/Damage

Date:12/15/00ISR Number: 3630208-4Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Paranoia Lariam 250 Mg
Pyrexia Hoffman-La-Roche PS Hoffman-La-Roche ORAL 1-250 MG 10
Delirium
DAYS ORAL
Tremor
03-Apr-2012 09:37 AM Page: 285

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/15/00ISR Number: 3630214-XReport Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Feeling Abnormal Lariam PS ORAL ONCE ORAL
Panic Reaction
Mental Impairment
Date:12/15/00ISR Number: 3630289-8Report Type:Expedited (15-DaCompany Report #250670 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Personality Change Lariam Tablets PS Roche
Agitation Antimalarial Nos SS
Triludan
SS
Date:12/15/00ISR Number: 3631006-8Report Type:Expedited (15-DaCompany Report #248735 Age:55 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious International Normalised Lariam Tablets PS Roche
Ratio Increased Co Proxamol C
Drug Interaction Warfarin I
Date:12/15/00ISR Number: 3631966-5Report Type:Expedited (15-DaCompany Report #250525 Age:15 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Weight Decreased Foreign Lariam PS Hoffmann La Roche
Renal Failure Health Inc ORAL 1 DOSE FORM
Professional
1 PER WEEK
ORAL
Date:12/18/00ISR Number: 3633587-7Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Inappropriate Affect Lariam PS Hoffmann-Laroche ORAL 1 TABLE DAY
Other Serious Crying ORAL
Insomnia
Anxiety
Mental Impairment
Panic Reaction
Date:12/19/00ISR Number: 3632679-6Report Type:Expedited (15-DaCompany Report #250403 Age:61 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Bradycardia Lariam Tablets PS Roche 21 DAY

Hospitalization - Ventricular Fibrillation Moduretic C
Initial or Prolonged Blood Potassium Decreased
Head Injury
Condition Aggravated
Syncope
Torsade De Pointes
Electrocardiogram Qt
Prolonged
03-Apr-2012 09:37 AM Page: 286

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/20/00ISR Number: 3633799-2Report Type:Expedited (15-DaCompany Report #250469 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypoaesthesia Lariam Tablets PS Roche REPORTED THE
Emotional Disorder
PATIENT TOOK
Pain In Extremity
THREE LARIAM
Neurological Symptom
TABLETS.
Date:12/20/00ISR Number: 3633802-XReport Type:Expedited (15-DaCompany Report #251020 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myositis Lariam Tablets PS Roche
Initial or Prolonged Phlebitis Contraceptive Pill C
Date:12/20/00ISR Number: 3634802-6Report Type:Expedited (15-DaCompany Report #250403 Age:61 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Ventricular Fibrillation Foreign Lariam PS Hoffmann La Roche
Hospitalization - Torsade De Pointes Health Inc ORAL 250 MG 1 PER
Initial or Prolonged Condition Aggravated Professional WEEK ORAL
Electrocardiogram Qt Other Moduretic (Amiloride
Prolonged
Hydrochloride/Hydroc
Heart Disease Congenital hlorothiazide) C
Bradycardia
Blood Potassium Decreased
Syncope
Head Injury
Date:12/20/00ISR Number: 3635602-3Report Type:Expedited (15-DaCompany Report #250670 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Personality Change Foreign Lariam PS Hoffmann La Roche
Agitation Health Inc
Professional
Antimalarial Nos
(Antimalarial Agent
Nos)
SS
Triludan
(Terfenadine)
SS
Date:12/21/00ISR Number: 3634463-6Report Type:Expedited (15-DaCompany Report #910100239001 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Depression Lariam Tablets PS Roche 15 DAY
Hospitalization - Nervousness
Initial or Prolonged Tremor

Disability
Dysthymic Disorder
Suicide Attempt
03-Apr-2012 09:37 AM Page: 287

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/22/00ISR Number: 3635906-4Report Type:Expedited (15-DaCompany Report #251020 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Swelling Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Pain Health Inc ORAL 250MG, 1 PER
Erythema Professional WEEK ORAL
Phlebitis
Myositis
Contraceptive Pill
(Oral Contraceptive
Nos)
C
Date:12/22/00ISR Number: 3636105-2Report Type:Expedited (15-DaCompany Report #250469 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypoaesthesia Health Lariam PS Hoffmann La Roche
Pain In Extremity Professional Inc ORAL ORAL
Neurological Symptom
Date:12/22/00ISR Number: 3637192-8Report Type:Periodic Company Report #A031374 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Consumer Zithromax PS Pfizer Chemicals Div
Vertigo Pfizer Inc ORAL 500.00 MG
TOTAL: ORAL
Lariam
SS
Date:12/26/00ISR Number: 3638713-1Report Type:Expedited (15-DaCompany Report #910100239001 Age:20 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Depression Health Lariam PS Hoffmann La Roche
Hospitalization - Tremor Professional Inc ORAL 1 DOSE FORM 1
Initial or Prolonged Condition Aggravated WEEK ORAL
Disability
Nervousness
Obsessive-Compulsive
Disorder
Suicidal Ideation
Agitation
Dysthymic Disorder
Suicide Attempt
Date:01/02/01ISR Number: 3639580-2Report Type:Expedited (15-DaCompany Report #247262 Age:47 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Interaction Health Lariam Tablets PS Roche 46 DAY
Initial or Prolonged Spinal Fracture Professional Prozac I
Suicide Attempt Xanax I

Depression
03-Apr-2012 09:37 AM Page: 288

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/02/01ISR Number: 3639591-7Report Type:Expedited (15-DaCompany Report #247262 Age:47 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Spinal Fracture Health Lariam Tablets PS Roche 46 DAY
Initial or Prolonged Depression Professional Prozac C
Suicide Attempt Xanax C
Date:01/02/01ISR Number: 3639595-4Report Type:Expedited (15-DaCompany Report #251020 Age:28 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myositis Health Lariam Tablets PS Roche
Initial or Prolonged Phlebitis Professional Contraceptive Pill C
Vasculitis
Date:01/02/01ISR Number: 3639605-4Report Type:Expedited (15-DaCompany Report #251435 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Sleep Disorder Lariam Tablets PS Roche 750 MG AND
Headache
THEN SIX
Tremor
HOURS LATER
Dizziness 500 MG. 1 DAY
Stupor
Flushing
Vomiting
Date:01/02/01ISR Number: 3639613-3Report Type:Expedited (15-DaCompany Report #251577 Age:60 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Epilepsy Lariam Tablets PS Roche 18 DAY
Initial or Prolonged Confusional State
Date:01/02/01ISR Number: 3639619-4Report Type:Expedited (15-DaCompany Report #251466 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Lariam Tablets PS Roche PATIENT
Diarrhoea
RECEIVED 1 X
Decreased Appetite 750 MG AND 6
Vomiting HOURS LATER 1
Anxiety X 500 MG. 1 DAY
Shock
Dizziness
Date:01/02/01ISR Number: 3640343-2Report Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam 250 Mg PS ORAL 1 PER 7 WEEKS
Required
ORAL
Intervention to Lariam SS ORAL 1 PER 2 WEEKS
Prevent Permanent
ORAL
Impairment/Damage Benzodiazapines C
Paxil
C
03-Apr-2012 09:37 AM Page: 289

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sleeping Aids
C
Date:01/03/01ISR Number: 3641446-9Report Type:Expedited (15-DaCompany Report #251577 Age:60 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Epilepsy Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Confusional State Health Inc ORAL ORAL
Professional
Date:01/03/01ISR Number: 3641477-9Report Type:Expedited (15-DaCompany Report #247262 Age:47 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fracture Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Drug Interaction Health Inc ORAL 1 DOSE FORM
Suicide Attempt Professional 1 PER 1 WEEK
Depression
ORAL
Prozac (Fluoxetine
Hydrochloride) SS ORAL 1 DOSE FORM
DAILY ORAL
Xanax (Alprazolam)
0.25 Mg SS ORAL 0.5 MG DAILY
ORAL
Date:01/03/01ISR Number: 3641530-XReport Type:Expedited (15-DaCompany Report #247262 Age:47 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicide Attempt Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Spinal Fracture Health Inc ORAL 1 DOSE FORM 1
Depression Professional PER WEEK
ORAL
Prozac (Fluoxetine
Hydrochloride) C
Xanax (Alprazolam) C
Date:01/03/01ISR Number: 3641657-2Report Type:Expedited (15-DaCompany Report #251466 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Foreign Lariam PS Hoffmann La Roche
Diarrhoea Health Inc ORAL 1250 MG,
Shock Professional DAILY, ORAL
Anxiety
Decreased Appetite
Vomiting
Dizziness

Date:01/03/01ISR Number: 3641658-4Report Type:Expedited (15-DaCompany Report #251435 Age:36 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Vomiting
Dizziness
Nausea
03-Apr-2012 09:37 AM Page: 290

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Headache
Stupor
Flushing Report Source Product Role Manufacturer Route Dose Duration
Sleep Disorder Foreign Lariam PS Hoffmann La Roche
Tremor Other Inc ORAL 1250 MG
DAILY, ORAL
Date:01/03/01ISR Number: 3641659-6Report Type:Expedited (15-DaCompany Report #251020 Age:28 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vasculitis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Myositis Health Inc ORAL 250 MG, 1 PER
Phlebitis Professional WEEK, ORAL
Contraceptive Pill
(Oral Contraceptive
Nos)
C
Date:01/04/01ISR Number: 3640928-3Report Type:Expedited (15-DaCompany Report #251435 Age:36 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Sleep Disorder Consumer Lariam Tablets PS Roche 750 MG AND
Flushing
THEN SIX
Tremor
HOURS LATER
Nausea 500 MG. 1 DAY
Dizziness
Headache
Stupor
Vomiting
Date:01/05/01ISR Number: 3642323-XReport Type:Expedited (15-DaCompany Report #249929 Age:38 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Face Oedema
Depression
Road Traffic Accident
Jaundice
Gastritis
Thinking Abnormal
Blood Alkaline
Phosphatase Increased
Diarrhoea
Urticaria
Weight Decreased
Insomnia
Malaise
Constipation
Drug Hypersensitivity

Respiratory Rate
Increased
Hepatomegaly
Haematemesis
Haemoglobin Decreased
Liver Tenderness
Decreased Appetite
Abnormal Dreams
03-Apr-2012 09:37 AM Page: 291

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Fatigue
Chills
Feeling Hot Report Source Product Role Manufacturer Route Dose Duration
Night Sweats Lariam Tablets PS Roche 32 DAY
Heart Rate Increased
Urinary Tract Infection
Date:01/05/01ISR Number: 3642795-0Report Type:Expedited (15-DaCompany Report #251435 Age:36 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Stupor Foreign Lariam PS Hoffmann La Roche
Flushing Other Inc ORAL 1250 MG DAILY
Dizziness
ORAL
Headache
Sleep Disorder
Vomiting
Tremor
Date:01/08/01ISR Number: 3642763-9Report Type:Expedited (15-DaCompany Report #251768 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Abortion Induced Lariam Tablets PS Roche
Pregnancy
Maternal Drugs Affecting
Foetus
Limb Malformation
Date:01/08/01ISR Number: 3643675-7Report Type:Expedited (15-DaCompany Report #249929 Age:38 YR Gender:Female I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Haemoglobin Decreased
Abnormal Dreams
Disturbance In Attention
Depression
Feeling Hot
Respiratory Rate
Increased
Blister
Hallucination, Visual
Night Sweats
Urticaria
Hepatomegaly
Liver Disorder
Heart Rate Increased
Body Temperature
Increased
Thinking Abnormal

Diarrhoea
Haematemesis
Insomnia
Chills
Face Oedema
Gastritis
Malaise
Urinary Tract Infection
03-Apr-2012 09:37 AM Page: 292

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Constipation
Road Traffic Accident
Decreased Appetite Report Source Product Role Manufacturer Route Dose Duration
Rash Pruritic Foreign Lariam PS Hoffmann La Roche
Consumer Inc ORAL 250 MG 1 PER
Other
WEEK ORAL
Date:01/09/01ISR Number: 3643443-6Report Type:Expedited (15-DaCompany Report #246474 Age:61 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Psoriasis Health Lariam Tablets PS Roche 280 DAY
Gait Disturbance
Professional
Date:01/09/01ISR Number: 3643457-6Report Type:Expedited (15-DaCompany Report #247733 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Field Defect Health Lariam Tablets PS Roche THE PATIENT
Pituitary Tumour Benign Professional RECEIVED A
TOTAL OF 2
TABLETS. 16 DAY
Date:01/09/01ISR Number: 3644647-9Report Type:Expedited (15-DaCompany Report #251768 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Maternal Drugs Affecting Foreign Lariam PS Hoffmann La Roche
Foetus Health Inc ORAL 1 DOSE FORM
Foetal Disorder Professional 1 PER WEEK
Pregnancy
ORAL
Abortion Induced
Limb Reduction Defect
Date:01/10/01ISR Number: 3645682-7Report Type:Expedited (15-DaCompany Report #247733 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pituitary Tumour Benign Foreign Lariam PS Hoffmann La Roche
Visual Field Defect Health Inc ORAL 1 DOSE FORM 1
Professional
PER WEEK ORAL
Date:01/10/01ISR Number: 3645686-4Report Type:Expedited (15-DaCompany Report #246474 Age:61 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Decreased Activity Health Lariam PS Hoffmann La Roche
Psoriasis Professional Inc ORAL 1 PER WEEK

03-Apr-2012 09:37 AM Page: 293
ORAL

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/11/01ISR Number: 3645661-XReport Type:Expedited (15-DaCompany Report #251020 Age:28 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Phlebitis Health Lariam Tablets PS Roche
Initial or Prolonged Myositis Professional Contraceptive Pill C
Vasculitis
Date:01/12/01ISR Number: 3647272-9Report Type:Expedited (15-DaCompany Report #251020 Age:28 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vasculitis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Myositis Health Inc ORAL 250 MG 1 PER
Phlebitis Professional WEEK ORAL
Contraceptive Pill
(Oral Contraceptive
Nos)
C
Date:01/16/01ISR Number: 3647463-7Report Type:Expedited (15-DaCompany Report #252294 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Back Pain Lariam Tablets PS Roche 43 DAY
Prostatic Specific Multivitamins C
Antigen Increased
Dysuria
Haematuria
Date:01/16/01ISR Number: 3647467-4Report Type:Expedited (15-DaCompany Report #234319 Age:20 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disturbance In Attention Lariam Tablets PS Roche 112 DAY
Anxiety
Paresis
Hallucination
Illusion
Alopecia
Sensory Disturbance
Sleep Disorder
Delusion
Mental Disorder
Nightmare
Date:01/16/01ISR Number: 3647469-8Report Type:Expedited (15-DaCompany Report #252574 Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Lariam Tablets PS Roche TWO DOSES

Initial or Prolonged Hyperventilation TAKEN. 9 DAY
Loss Of Consciousness
Convulsion
Dyspnoea
Mental Disorder
03-Apr-2012 09:37 AM Page: 294

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/17/01ISR Number: 3648112-4Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Face Oedema Mefloquine PS ORAL 1 TAB Q 7
Intervention to Urticaria DAYS P.O.;
Prevent Permanent Eyelid Oedema FROM ONSET OF
Impairment/Damage Joint Swelling RASH FOR 10
Pruritus DAYS 10 DAY
Anaphylactoid Reaction
Date:01/17/01ISR Number: 3649402-1Report Type:Expedited (15-DaCompany Report #234319 Age:20 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Foreign Lariam PS Hoffmann La Roche
Disturbance In Attention Health Inc ORAL 250 MG 1 PER
Delusion Professional WEEK ORAL
Illusion
Other
Alopecia
Sensory Disturbance
Nightmare
Anxiety
Mental Disorder
Paresis
Sleep Disorder
Date:01/17/01ISR Number: 3649403-3Report Type:Expedited (15-DaCompany Report #252574 Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Disorder Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Pyrexia Health Inc ORAL 1 PER 1 WEEK
Hyperventilation Professional ORAL
Tetany
Dyspnoea
Convulsion
Loss Of Consciousness
Date:01/17/01ISR Number: 3649448-3Report Type:Expedited (15-DaCompany Report #252294 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Prostatic Specific Consumer Lariam PS Hoffmann La Roche
Antigen Increased Inc ORAL 250 MG 1 PER
Dysuria
WEEK ORAL
Haematuria
Multivitamins Nos
Back Pain (Multivitamins Nos) C

Date:01/22/01ISR Number: 3651513-1Report Type:Expedited (15-DaCompany Report #252739 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Chest Pain Lariam Tablets PS Roche 54 DAY
Hospitalization - Dyspnoea Climen C
Initial or Prolonged Bradycardia
03-Apr-2012 09:37 AM Page: 295

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/23/01ISR Number: 3652329-2Report Type:Expedited (15-DaCompany Report #252778 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Persecutory Delusion Lariam Tablets PS Roche 11 DAY
Mood Altered Stamaril Unidose C 1 DAY
Paranoia
Suicide Attempt
Hallucination, Auditory
Insomnia
Date:01/23/01ISR Number: 3652402-9Report Type:Direct Company Report # Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Medication Error Mefloquine PS
Date:01/23/01ISR Number: 3653816-3Report Type:Expedited (15-DaCompany Report #252739 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Back Pain Foreign Lariam PS Hoffmann La Roche
Hospitalization - Dyspnoea Health Inc ORAL ORAL
Initial or Prolonged Chest Pain Professional Climen C
Bradycardia
Date:01/24/01ISR Number: 3653477-3Report Type:Expedited (15-DaCompany Report #252788 Age:74 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Behaviour Lariam Tablets PS Roche
Delusion
Date:01/24/01ISR Number: 3653480-3Report Type:Expedited (15-DaCompany Report #252779 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Uterine Leiomyoma Lariam Tablets PS Roche 29 DAY
Gestational Diabetes
Gonorrhoea
Appendicitis
Date:01/24/01ISR Number: 3654504-XReport Type:Expedited (15-DaCompany Report #252778 Age:35 YR Gender:Male I/FU:I
Outcome
Life-Threatening
PT
Asthenia
Nightmare
Paranoia

Hallucination, Auditory
Headache
Psychotic Disorder
Anxiety
Sleep Disorder
Dizziness
Irritability
Suicide Attempt
03-Apr-2012 09:37 AM Page: 296

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Persecutory Delusion
Report Source Product Role Manufacturer Route Dose Duration
Foreign Lariam PS Hoffmann La Roche
Other Inc ORAL 250 MG 1 PER
WEEK ORAL
Stamaril Unidose
(Yellow Fever
Vaccine)
C
Date:01/25/01ISR Number: 3654162-4Report Type:Expedited (15-DaCompany Report #249232 Age:22 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Affective Disorder Lariam Tablets PS Roche TOTAL DOSE OF
Anxiety
LARIAM TAKEN
Diarrhoea
BY THE
Delusion PATIENT: 2
Vision Blurred TABLETS. 8 DAY
Depression
Paranoia
Asthenia
Insomnia
Nightmare
Date:01/25/01ISR Number: 3655969-XReport Type:Expedited (15-DaCompany Report #252779 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Appendicitis Foreign Lariam PS Hoffmann La Roche
Pregnancy Health Inc ORAL DOSE FORM 1
Gestational Diabetes Professional PER WEEK ORAL
Gonorrhoea
Uterine Leiomyoma
Date:01/25/01ISR Number: 3655974-3Report Type:Expedited (15-DaCompany Report #252788 Age:74 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Behaviour Foreign Lariam PS Hoffmann La Roche
Delusion Health Inc ORAL 1 PER WEEK
Professional
ORAL
Date:01/26/01ISR Number: 3654951-6Report Type:Expedited (15-DaCompany Report #252788 Age:74 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Lariam Tablets PS Roche

Date:01/29/01ISR Number: 3656105-6Report Type:Expedited (15-DaCompany Report #235479 Age:76 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Corneal Oedema Lariam Tablets PS Roche
03-Apr-2012 09:37 AM Page: 297

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/29/01ISR Number: 3656134-2Report Type:Expedited (15-DaCompany Report #252730 Age:70 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Pressure Increased Lariam Tablets PS Roche
Ventricular Hypertrophy
Date:01/29/01ISR Number: 3657437-8Report Type:Expedited (15-DaCompany Report #252788 Age:74 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Foreign Lariam PS Hoffmann La Roche
Abnormal Behaviour Health Inc ORAL 1 PER WEEK
Professional
ORAL
Date:01/30/01ISR Number: 3657556-6Report Type:Expedited (15-DaCompany Report #252730 Age:70 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Ventricular Hypertrophy Foreign Lariam PS Hoffmann La Roche
Blood Pressure Increased Health Inc 250 MG 1 PER
Professional
WEEK
Date:01/30/01ISR Number: 3659264-4Report Type:Expedited (15-DaCompany Report #235479 Age:76 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Corneal Oedema Health Lariam PS Hoffmann La Roche
Corneal Transplant Professional Inc ORAL ORAL
Date:01/31/01ISR Number: 3657664-XReport Type:Expedited (15-DaCompany Report #252574 Age:21 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyspnoea Lariam Tablets PS Roche TWO DOSES
Initial or Prolonged Loss Of Consciousness TAKEN. 9 DAY
Convulsion
Mental Disorder
Pyrexia
Date:02/01/01ISR Number: 3659145-6Report Type:Expedited (15-DaCompany Report #252574 Age:21 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Loss Of Consciousness Health Inc ORAL 1 PER 1 WEEK
Mental Disorder Professional ORAL
Tetany
Dyspnoea

Hyperventilation
03-Apr-2012 09:37 AM Page: 298

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/02/01ISR Number: 3658970-5Report Type:Expedited (15-DaCompany Report #249748 Age:55 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disorientation Lariam Tablets PS Roche
Initial or Prolonged Delusion
Hypertonia
Persecutory Delusion
Agitation
Acute Psychosis
Confusional State
Speech Disorder
Mutism
Date:02/02/01ISR Number: 3658974-2Report Type:Expedited (15-DaCompany Report #253219 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Atrial Fibrillation Lariam Tablets PS Roche
Date:02/02/01ISR Number: 3658987-0Report Type:Expedited (15-DaCompany Report #253380 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Blood Pressure Increased Lariam Tablets PS Roche 70 DAY
Retinal Haemorrhage
Unspecified
Vision Blurred Immunizations C
Date:02/02/01ISR Number: 3658988-2Report Type:Expedited (15-DaCompany Report #244551 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aplastic Anaemia Lariam Tablets PS Roche 29 DAY
Date:02/02/01ISR Number: 3659017-7Report Type:Expedited (15-DaCompany Report #253574 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hypoaesthesia Lariam Tablets PS Roche 57 DAY
Hallucination
Tinnitus
Agoraphobia
Paraesthesia
Palpitations
Paranoia
Date:02/02/01ISR Number: 3659019-0Report Type:Expedited (15-DaCompany Report #253632 Age:53 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Clonic Convulsion Lariam Tablets PS Roche 33 DAY
Hypercholesterolaemia
03-Apr-2012 09:37 AM Page: 299

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/02/01ISR Number: 3660323-0Report Type:Expedited (15-DaCompany Report #249232 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Foreign Lariam PS Hoffmann La Roche
Paranoia Consumer Inc ORAL 1 DOSE FORM 1
Depression
PER 1 WEEK
Asthenia
ORAL
Affective Disorder
Anxiety
Nightmare
Diarrhoea
Delusion
Vision Blurred
Date:02/02/01ISR Number: 3660344-8Report Type:Expedited (15-DaCompany Report #249748 Age:55 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disorientation Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Persecutory Delusion Literature Inc
Psychotic Disorder
Health
Agitation
Professional
Mutism
Confusional State
Hypertonia
Pyrexia
Speech Disorder
Date:02/05/01ISR Number: 3659704-0Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dry Eye Lariam PS ORAL 1 PER WEEK
Fatigue
ORAL
Dry Mouth
Feeling Abnormal
Balance Disorder
Tremor
Nausea
Date:02/05/01ISR Number: 3662891-1Report Type:Expedited (15-DaCompany Report #253574 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hallucination Foreign Lariam PS Hoffmann La Roche
Nausea Other Inc ORAL DOSE FORM
Paraesthesia
ORAL
Palpitations
Dizziness
Hypoaesthesia

Agoraphobia
Visual Impairment
Tinnitus
Paranoia
03-Apr-2012 09:37 AM Page: 300

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/05/01ISR Number: 3662893-5Report Type:Expedited (15-DaCompany Report #253380 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hypertension Foreign Lariam PS Hoffmann La Roche
Vision Blurred Consumer Inc ORAL ORAL 70 DAY
Retinal Haemorrhage
Unspecified
Immunizations
(Immunisation) C
Date:02/05/01ISR Number: 3662894-7Report Type:Expedited (15-DaCompany Report #253632 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Cholesterol Foreign Lariam PS Hoffmann La Roche
Increased Health Inc ORAL 250 MG 1 PER
Clonic Convulsion Professional WEEK ORAL
Date:02/06/01ISR Number: 3660174-7Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vertigo Lariam Tablets PS Roche ESTIMATED 5
Initial or Prolonged Panic Attack DOSES IN
Disability Depression TOTAL. 21 DAY
Headache
Date:02/07/01ISR Number: 3661122-6Report Type:Expedited (15-DaCompany Report #220210 Age:17 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Lariam Tablets PS Roche
Initial or Prolonged Obesity
Hypertension
Chlamydial Infection
Vision Blurred
Visual Impairment
Pupillary Disorder
Measles Antibody Positive
Antinuclear Antibody
Positive
Inflammation
Drug Hypersensitivity
Accommodation Disorder
Folate Deficiency
Binocular Eye Movement
Disorder
Smooth Muscle Antibody
Positive
Cytogenetic Abnormality
Laboratory Test Abnormal

Diplopia
Coagulopathy
Platelet Count Decreased
03-Apr-2012 09:37 AM Page: 301

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/07/01ISR Number: 3661137-8Report Type:Expedited (15-DaCompany Report #247340 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Vertigo Positional Lariam Tablets PS Roche FOR MANY
Motor Dysfunction
YEARS.
Nightmare
Dizziness
Date:02/07/01ISR Number: 3661805-8Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Health Lariam PS Hoffmann La Roche
Initial or Prolonged Vertigo Professional Inc ORAL 250 MG 1 PER
Disability Panic Attack WEEK ORAL
Dizziness
Headache
Anxiety
Date:02/08/01ISR Number: 3662801-7Report Type:Expedited (15-DaCompany Report #220210 Age:17 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Antinuclear Antibody Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Positive Consumer Inc ORAL 250 MG 1 PER
Hypertension Health WEEK ORAL
Visual Acuity Reduced
Professional
Vision Blurred
Platelet Count Decreased
Inflammation
Headache
Laboratory Test Abnormal
Iris Disorder
Diplopia
Csf Test Abnormal
Binocular Eye Movement
Disorder
Dna Antibody Positive
Measles Antibody Positive
Pupillary Reflex Impaired
Chlamydial Infection
Sinusitis
Herpes Simplex
Visual Impairment
Folate Deficiency
Infectious Mononucleosis
Accommodation Disorder
Herpes Zoster

Date:02/08/01ISR Number: 3662860-1Report Type:Expedited (15-DaCompany Report #247340 Age:42 YR Gender:Male I/FU:I
Outcome
Disability
PT
Nightmare
Gait Disturbance
Vertigo Positional
Vomiting
Dizziness
03-Apr-2012 09:37 AM Page: 302

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Motor Dysfunction
Report Source Product Role Manufacturer Route Dose Duration
Consumer Lariam PS Hoffmann La Roche
Inc ORAL ORAL
Date:02/09/01ISR Number: 3662550-5Report Type:Expedited (15-DaCompany Report #254219 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam Tablets PS Roche 49 DAY
Suicidal Ideation
Disturbance In Attention
Sinusitis
Hallucination
Influenza Like Illness
Abnormal Dreams
Anxiety
Insomnia
Lethargy
Date:02/12/01ISR Number: 3663406-4Report Type:Expedited (15-DaCompany Report #254186 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tongue Oedema Lariam Tablets PS Roche 42 DAY
Angioedema Vit B12 C LAST
Face Oedema
INJECTION WAS
02 JAN 2001.
Zestoretic
C
Ranitidine
C
Date:02/12/01ISR Number: 3663685-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Oropharyngeal Pain Larium PS
Mood Swings
Decreased Activity
Nausea
Pain In Extremity
Rickettsiosis
Insomnia
Sleep Attacks
Fatigue
Fibromyalgia
Arthralgia

Date:02/12/01ISR Number: 3664102-XReport Type:Expedited (15-DaCompany Report #254219 Age: Gender:Male I/FU:I
Outcome
Disability
PT
Sinusitis
Anxiety
Suicidal Ideation
Depression
Hallucination
03-Apr-2012 09:37 AM Page: 303

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Insomnia
Disturbance In Attention
Influenza Like Illness Report Source Product Role Manufacturer Route Dose Duration
Abnormal Dreams Consumer Lariam PS Hoffmann La Roche
Lethargy Inc ORAL ORAL
Date:02/13/01ISR Number: 3664562-4Report Type:Expedited (15-DaCompany Report #254226 Age:64 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Inborn Error Of Lariam Tablets PS Roche
Initial or Prolonged Metabolism
Blood Lactate
Dehydrogenase Increased
Biopsy Bronchus Abnormal
Haemoglobin Decreased
Lung Disorder
Haematocrit Decreased
White Blood Cell Count
Increased
Pneumonitis
Lymphocyte Count
Decreased
Blood Alkaline
Phosphatase Increased
Neutrophil Count
Increased
Malaise
Laboratory Test Abnormal
Date:02/13/01ISR Number: 3666432-4Report Type:Expedited (15-DaCompany Report #254186 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Angioedema Foreign Lariam Tablets
Intervention to Face Oedema Health (Mefloquine
Prevent Permanent Tongue Oedema Professional Hydrochloride) 250
Impairment/Damage Mg PS ORAL 250 MG 1 PER
WEEK ORAL 42 DAY
Vit B12
(Cyanocobalamin) C
Zestoretic
(Hydrochlorothiazide
/Lisinopril)
C
Ranitidine
(Ranitidine)
C
Date:02/14/01ISR Number: 3664745-3Report Type:Expedited (15-DaCompany Report #254230 Age:68 YR Gender:Male I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
PT
Nausea
Asthenia
Cardiac Murmur
Venous Pressure Jugular
Increased
Hepatomegaly
Blood Urea Increased
03-Apr-2012 09:37 AM Page: 304

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Red Blood Cell
Sedimentation Rate
Increased Report Source Product Role Manufacturer Route Dose Duration
Hepatitis
Mefloquine
Decreased Appetite Hydrochloride PS Roche 42 DAY
Atrial Flutter Allopurinol SS Roche
Fatigue Spironolactone C
Blood Creatinine Warfarin C
Increased Propafenone C
Jaundice Digoxin C
Chest X-Ray Abnormal Furosemide C
Electrocardiogram
Abnormal
Dehydration
Condition Aggravated
Date:02/14/01ISR Number: 3667666-5Report Type:Expedited (15-DaCompany Report #254226 Age:64 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pneumonia Foreign Lariam Tablets
Initial or Prolonged Inborn Error Of Literature (Mefloquine
Metabolism Health Hydrochloride) 250
Lung Disorder Professional Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:02/15/01ISR Number: 3665573-5Report Type:Expedited (15-DaCompany Report #249135 Age:61 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Respiratory Arrest Lariam Tablets PS Roche
Hospitalization - Loss Of Consciousness Ibuprofen C 20 DAY
Initial or Prolonged Condition Aggravated Doxycyclin C 20 DAY
Electroencephalogram
Abnormal
Pulse Absent
Ventricular Extrasystoles
Hypertension
Echocardiogram Abnormal
Electrocardiogram T Wave
Amplitude Decreased
Convulsion
Electrocardiogram St
Segment Depression
Supraventricular
Extrasystoles
Date:02/15/01ISR Number: 3665580-2Report Type:Expedited (15-DaCompany Report #254480 Age: Gender:Not SpecifiI/FU:I

Outcome
Congenital Anomaly
PT
Dysmorphism
Skull Malformation
Congenital Foot
Malformation
Cleft Palate
Congenital Anomaly
Syndactyly
03-Apr-2012 09:37 AM Page: 305

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Low Set Ears
Pregnancy
Maternal Drugs Affecting Report Source Product Role Manufacturer Route Dose Duration
Foetus Lariam Tablets PS Roche 28 DAY
Abortion Induced
Yellow Fever Vaccine C
Congenital Eye Disorder
Thymus Disorder
Congenital Central
Nervous System Anomaly
Date:02/15/01ISR Number: 3666602-5Report Type:Expedited (15-DaCompany Report #254230 Age:68 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Foreign Mefloquine
Initial or Prolonged Venous Pressure Jugular Literature Hydrochloride
Increased Health (Mefloquine
Asthenia Professional Hydrochloride) PS 250 MG 1 PER
Dehydration WEEK 42 DAY
Blood Urea Increased
Allopurinol
Nausea (Allopurinol) SS 100 MG DAILY
International Normalised
Warfarin (Warfarin
Ratio Increased Sodium) C
White Blood Cell Count
Propafenone
Increased
(Propafenone
Hepatotoxicity Hydrochloride) C
Decreased Appetite
Spironolactone
Cardiac Murmur (Spironolactone) C
Platelet Count Decreased
Chest X-Ray Abnormal
Hepatomegaly
Atrial Flutter
Red Blood Cell
Sedimentation Rate
Increased
Hepatitis
Date:02/16/01ISR Number: 3668044-5Report Type:Expedited (15-DaCompany Report #254480 Age: Gender:Unknown I/FU:I
Outcome
Congenital Anomaly
PT
Thymus Disorder
Congenital Jaw
Malformation
Congenital Nose
Malformation
Abortion Induced
Cleft Palate
Dysmorphism
Maternal Drugs Affecting
Foetus

Skull Malformation
Congenital Foot
Malformation
Multiple Congenital
Abnormalities
Congenital Central
Nervous System Anomaly
Congenital Eye Disorder
03-Apr-2012 09:37 AM Page: 306

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Syndactyly
Ear Malformation
Report Source Product Role Manufacturer Route Dose Duration
Foreign Lariam PS Hoffmann La Roche
Other Inc ORAL 250 MG 1 PER
WEEK ORAL 28 DAY
Yellow Fever Vaccine
(Yellow Fever
Vaccine)
C
Date:02/16/01ISR Number: 3668050-0Report Type:Expedited (15-DaCompany Report #249135 Age:61 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Convulsive Threshold Foreign Lariam PS Hoffmann La Roche
Hospitalization - Lowered Other Inc ORAL 250 MG 1 PER
Initial or Prolonged Respiratory Arrest WEEK ORAL
Supraventricular
Ibuprofen
Extrasystoles (Ibuprofen) C
Coronary Artery Disease
Doxycyclin
Convulsion (Doxycycline) C
Myocardial Ischaemia
Circulatory Collapse
Cardiac Disorder
Ventricular Extrasystoles
Hypertension
Date:02/20/01ISR Number: 3666693-1Report Type:Expedited (15-DaCompany Report #220210 Age:17 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Dysgraphia
Reading Disorder
Accommodation Disorder
Visual Impairment
Diplopia
Drug Hypersensitivity
Thrombocytosis
Lipids Increased
Antibody Test Positive
Binocular Eye Movement
Disorder
Folate Deficiency
Smooth Muscle Antibody
Positive
Csf Test Abnormal
Obesity
Dna Antibody Positive
Nuclear Magnetic
Resonance Imaging Brain
Abnormal

Visual Evoked Potentials
Abnormal
Hypertension
Laboratory Test Abnormal
Pupillary Disorder
Measles Antibody Positive
Headache
Inflammation
03-Apr-2012 09:37 AM Page: 307

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Viral Infection
Report Source Product Role Manufacturer Route Dose Duration
Lariam Tablets PS Roche
Date:02/20/01ISR Number: 3667169-8Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Lariam PS ORAL 1 A WEEK ORAL
Panic Attack
Muscular Weakness
Feeling Of Body
Temperature Change
Vision Blurred
Balance Disorder
Date:02/20/01ISR Number: 3669532-8Report Type:Expedited (15-DaCompany Report #254595 Age:54 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dermatomyositis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Health Inc ORAL 250 MG 1 PER
Disability Professional WEEK ORAL
Date:02/21/01ISR Number: 3667469-1Report Type:Expedited (15-DaCompany Report #254186 Age:50 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Angioedema Health Lariam Tablets PS Roche
Professional Ranitidine SS
Vit B12 C LAST
INJECTION WAS
02 JAN 2001.
Zestoretic
C
Date:02/21/01ISR Number: 3669477-3Report Type:Expedited (15-DaCompany Report #220210 Age:17 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Inflammation
Diplopia
Infectious Mononucleosis
Apolipoprotein A-I
Increased
Vision Blurred
Iris Disorder
Binocular Eye Movement
Disorder

Folate Deficiency
Blood Immunoglobulin G
Increased
Accommodation Disorder
Herpes Zoster
Hypertension
Headache
Dysgraphia
03-Apr-2012 09:37 AM Page: 308

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Viral Infection
Chlamydial Infection
Thrombocytosis Report Source Product Role Manufacturer Route Dose Duration
Reading Disorder Foreign Lariam PS Hoffmann La Roche
Geniculate Ganglionitis Consumer Inc ORAL 250 MG 1 PER
Health
WEEK ORAL
Professional
Date:02/22/01ISR Number: 3669931-4Report Type:Expedited (15-DaCompany Report #254186 Age:50 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Angioedema Foreign Lariam PS Hoffmann La Roche
Intervention to Health Inc ORAL 250 MG 1 PER
Prevent Permanent Professional WEEK ORAL
Impairment/Damage
Ranitidine
(Ranitidine) SS ORAL ORAL
Vit B12
(Cyanocobalamin) C
Zestoretic
(Hydrohlorothiazide/
Lisnopril)
C
Date:02/26/01ISR Number: 3669114-8Report Type:Expedited (15-DaCompany Report #252730 Age:70 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Pressure Increased Lariam Tablets PS Roche 9 DAY
Ventricular Hypertrophy
Date:02/27/01ISR Number: 3670332-3Report Type:Expedited (15-DaCompany Report #203837 Age:53 YR Gender:Male I/FU:F
Outcome
Death
PT
Amnesia
Flushing
Hepatic Steatosis
Agitation
Weight Decreased
Cardiomegaly
Nightmare
Chills
Depression
Adjustment Disorder
Obsessive-Compulsive
Disorder
Urinary Hesitation
Delusional Disorder,
Persecutory Type
Decreased Appetite

Nervous System Disorder
Musculoskeletal Stiffness
Polydipsia
Ventricular Hypertrophy
Insomnia
Abnormal Dreams
Completed Suicide
Anxiety
03-Apr-2012 09:37 AM Page: 309

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hallucinations, Mixed
Headache
Hyperhidrosis Report Source Product Role Manufacturer Route Dose Duration
Delirium Consumer Lariam Tablets PS Roche 50 DAY
Cognitive Disorder
Arteriosclerosis
Date:02/27/01ISR Number: 3671565-2Report Type:Expedited (15-DaCompany Report #252730 Age:70 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypertension Foreign Lariam PS Hoffmann La Roche
Ventricular Hypertrophy Health Inc ORAL 250 MG 1 PER
Professional
WEEK ORAL
Date:02/28/01ISR Number: 3671793-6Report Type:Expedited (15-DaCompany Report #200111100GDS Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Interaction Foreign Avelox PS Bayer Corp
Hypertension Other Pharmaceutical Div ORAL 400 MG DAILY
Heart Rate Increased
ORAL
Mefloquine SS ORAL 250 MG DAILY
ORAL
Altace
C
Moduret
C
Date:02/28/01ISR Number: 3671960-1Report Type:Expedited (15-DaCompany Report #203837 Age:53 YR Gender:Male I/FU:F
Outcome
Death
PT
Depression
Hyperhidrosis
Arterial Injury
Hallucinations, Mixed
Musculoskeletal Stiffness
Hepatic Steatosis
Staring
Agitation
Lethargy
Spinal Fracture
Subarachnoid Haemorrhage
Abnormal Behaviour
Psychotic Disorder
Decreased Appetite
Polydipsia
Flushing
Urinary Hesitation
Delusional Disorder,
Persecutory Type

Hepatic Necrosis
Insomnia
Delirium
Obsessive-Compulsive
Disorder
Abnormal Dreams
Amnesia
Cardiomegaly
03-Apr-2012 09:37 AM Page: 310

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Ventricular Hypertrophy
Arteriosclerosis
Respiratory Disorder Report Source Product Role Manufacturer Route Dose Duration
Injury Consumer Lariam PS Hoffmann La Roche
Chills Other Inc ORAL 250 MG 1 PER
Anxiety
1 WEEK ORAL
Cognitive Disorder
Weight Decreased
Headache
Fatigue
Completed Suicide
Nervous System Disorder
Nightmare
Adjustment Disorder
Date:03/01/01ISR Number: 3672141-8Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nausea Lariam / 250 Mg PS ORAL 1 TABLET
Initial or Prolonged Dry Mouth WEEKLY ORAL
Other Serious
Anxiety
Dyspnoea
Pain
Fatigue
Tinnitus
Insomnia
Migraine
Visual Impairment
Muscular Weakness
Headache
Coordination Abnormal
Heart Rate Increased
Date:03/07/01ISR Number: 3674831-XReport Type:Expedited (15-DaCompany Report #255461 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dystonia Lariam Tablets PS Roche
Initial or Prolonged Contraceptive Pill C
Date:03/07/01ISR Number: 3674843-6Report Type:Expedited (15-DaCompany Report #250525 Age:14 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Speech Disorder
Gastroenteritis
Insomnia
Back Pain
Sedation

Memory Impairment
Psychiatric Symptom
Nightmare
Renal Failure
Irritability
Laboratory Test Abnormal
Learning Disorder
Eczema
03-Apr-2012 09:37 AM Page: 311

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Diarrhoea
Alpha 2 Globulin
Decreased Report Source Product Role Manufacturer Route Dose Duration
Educational Problem Lariam Tablets PS Roche THE PATIENT
Hypogammaglobulinaemia RECEIVED 8
Crying
TABLETS IN
Asthenia TOTAL. 50 DAY
Blood Albumin Increased
Alpha 1 Globulin
Decreased
Fatigue
Condition Aggravated
Protein Total Increased
Anxiety
Bronchitis
Herpes Virus Infection
Weight Decreased
Date:03/07/01ISR Number: 3675235-6Report Type:Direct Company Report # Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Dizziness Lariam
Hospitalization - Anxiety Hoffman/Laroche PS Hoffman / Larouche ORAL ONE PILL
Initial or Prolonged Suicidal Ideation ONCE WEEKLY
Disability Diarrhoea ORAL
Required
Panic Reaction
Intervention to
Hallucinations, Mixed
Prevent Permanent
Impairment/Damage
Nightmare
Crying
Insomnia
Fear
Decreased Activity
Date:03/08/01ISR Number: 3676534-4Report Type:Expedited (15-DaCompany Report #250525 Age:14 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Back Pain Foreign Lariam PS Hoffmann La Roche
Weight Decreased Health Inc ORAL 1 DOSE FORM
Bronchitis Professional 1 PER WEEK
Nightmare
ORAL
Fatigue
Herpes Virus Infection
Gastroenteritis
Eczema
Renal Failure
Irritability
Anxiety
Asthenia
Insomnia

Pyrexia
Crying
Psychiatric Symptom
03-Apr-2012 09:37 AM Page: 312

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/08/01ISR Number: 3676700-8Report Type:Expedited (15-DaCompany Report #200111100GDS Age:46 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Foreign Avelox PS Bayer Corp
Drug Interaction Health Pharmaceutical Div ORAL 400 MG DAILY
Vomiting Professional ORAL
Headache Other Mefloquine SS ORAL 250 MG DAILY
Hypertension
ORAL
Heart Rate Increased Altace C
Sensation Of Pressure Moduret C
Dry Mouth
Date:03/08/01ISR Number: 3676818-XReport Type:Expedited (15-DaCompany Report #255461 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dystonia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Other Inc ORAL 250 MG 1 PER
WEEK ORAL
Contraceptive Pill
(Oral Contraceptive
Nos)
C
Date:03/09/01ISR Number: 3676793-8Report Type:Expedited (15-DaCompany Report #255903 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hallucination, Visual Lariam Tablets PS Roche 29 DAY
Panic Reaction
Amnesia
Nightmare
Insomnia
Headache
Date:03/09/01ISR Number: 3676802-6Report Type:Expedited (15-DaCompany Report #255897 Age:56 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatitis Lariam Tablets PS Roche 27 DAY
Ethambutol C 154 DAY
Pirazinamide C 154 DAY
Date:03/12/01ISR Number: 3678135-0Report Type:Expedited (15-DaCompany Report #254595 Age:54 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pain Lariam Tablets PS Roche 32 DAY
Initial or Prolonged Blood Creatinine
Disability
Increased

Myalgia
Dermatomyositis
Malaise
Dermatitis
03-Apr-2012 09:37 AM Page: 313

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/12/01ISR Number: 3680792-XReport Type:Expedited (15-DaCompany Report #255903 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Headache Foreign Lariam PS Hoffmann La Roche
Amnesia Other Inc ORAL 250 MG 1 PER
Insomnia
WEEK ORAL
Panic Reaction
Nightmare
Hallucination
Date:03/12/01ISR Number: 3680802-XReport Type:Expedited (15-DaCompany Report #255897 Age:56 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Jaundice Foreign Lariam PS Hoffmann La Roche
Hepatitis Other Inc ORAL 250 MG DAILY
ORAL
Ethambutol
(Ethambutol
Hydrochloride) C
Pirazinamide
(Pyrazinamide) C
Date:03/13/01ISR Number: 3680675-5Report Type:Expedited (15-DaCompany Report #254595 Age:54 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dermatomyositis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Malaise Health Inc ORAL 250 MG 1 PER
Disability Dermatitis Professional WEEK ORAL
Blood Creatinine
Increased
Myalgia
Date:03/14/01ISR Number: 3680020-5Report Type:Expedited (15-DaCompany Report #253034 Age:49 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Erythema Nodosum Lariam Tablets PS Roche 33 DAY
Initial or Prolonged Pyrexia
Date:03/15/01ISR Number: 3681154-1Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucinations, Mixed Mefloquine PS ORAL PO ( 3 TABS
Initial or Prolonged Psychotic Disorder TOTAL)
Panic Attack
Delusional Disorder,

Persecutory Type
03-Apr-2012 09:37 AM Page: 314

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/15/01ISR Number: 3682140-8Report Type:Expedited (15-DaCompany Report #253034 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Erythema Nodosum Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Pyrexia Health Inc ORAL ORAL
Professional
Date:03/16/01ISR Number: 3681869-5Report Type:Expedited (15-DaCompany Report #235171 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delivery Lariam Tablets PS Roche THE PATIENT
Abnormal Labour
TOOK A TOTAL
OF 7 TABLETS
WHILE SHE WAS
A FEW WEEKS 50 DAY
Date:03/20/01ISR Number: 3684540-9Report Type:Expedited (15-DaCompany Report #252574 Age:21 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Disorder Lariam Tablets PS Roche TWO DOSES
Initial or Prolonged Loss Of Consciousness TAKEN (THREE
Dyspnoea
TABLETS IN
Hyperventilation
TOTAL).
Convulsion
Pyrexia
Date:03/20/01ISR Number: 3684549-5Report Type:Expedited (15-DaCompany Report #256591 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Alveolitis Lariam Tablets PS Roche
Initial or Prolonged Prozac C
Date:03/20/01ISR Number: 3685099-2Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Social Avoidant Behaviour Lariam PS Roche ORAL 1 WEEKLY ORAL
Agitation
Ear Disorder
Mental Disorder
Emotional Disorder
Depression
Date:03/20/01ISR Number: 3685682-4Report Type:Direct Company Report # Age:58 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Asthma Lariam PS 1 TABLET
Intervention to Hypoaesthesia WEEKLY
Prevent Permanent
Impairment/Damage
Insomnia
Discomfort
Feeling Jittery
03-Apr-2012 09:37 AM Page: 315

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/21/01ISR Number: 3687541-XReport Type:Expedited (15-DaCompany Report #256591 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Alveolitis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Health Inc ORAL 250 MG 1 PER
Professional
Prozac (Fluoxetine
Hydrochloride)
C
1 WEEK ORAL
Date:03/21/01ISR Number: 3687543-3Report Type:Expedited (15-DaCompany Report #252574 Age:21 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Disorder Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Pyrexia Health Inc ORAL 1 PER 1 WEEK
Po2 Decreased Professional ORAL
Agitation
Fear
Depressed Level Of
Consciousness
Arthralgia
Respiratory Disorder
Depression
Convulsion
Dyspnoea
Malaise
Fatigue
Stress
Blood Ph Increased
Tenderness
Apnoea
Panic Attack
Hyperventilation
Electroencephalogram
Abnormal
Nausea
Loss Of Consciousness
Restlessness
Autonomic Nervous System
Imbalance
Date:03/22/01ISR Number: 3688672-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dizziness Lariam 250mg Roche
Initial or Prolonged Panic Attack Lab PS Roche Lab ORAL 250MG ONCE A
Balance Disorder
WEEK ORAL
Anxiety
Nausea
Diarrhoea

Disorientation
03-Apr-2012 09:37 AM Page: 316

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/23/01ISR Number: 3688177-7Report Type:Expedited (15-DaCompany Report #256731 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Sudden Death Lariam Tablets PS Roche
Drug Interaction Acetylcysteine C
Hypertrophic Dirithromycin I
Cardiomyopathy Halofantrine I
Date:03/26/01ISR Number: 3690128-6Report Type:Expedited (15-DaCompany Report #256731 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Hypertrophic Literature Lariam PS Hoffmann La Roche
Cardiomyopathy Health Inc ORAL ORAL
Malaria Professional Halofantrine
Sudden Death
(Halofantrine
Drug Interaction Hydrochloride) SS ORAL ORAL
Bronchopneumonia
Dirithromycin
Circulatory Collapse (Dirithromycin) SS ORAL ORAL
Headache
Acetylcysteine
(Acetylcysteine) C
Date:03/29/01ISR Number: 3691252-4Report Type:Expedited (15-DaCompany Report #252574 Age:21 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Mental Disorder Foreign Lariam Tablets PS Roche 4 TABLETS
Hospitalization - Pyrexia Health TAKEN IN
Initial or Prolonged Loss Of Consciousness Professional TOTAL. 21 DAY
Influenza Like Illness
Convulsion
Dyspnoea
Hyperventilation
Date:03/29/01ISR Number: 3691267-6Report Type:Expedited (15-DaCompany Report #256952 Age:65 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tachycardia Lariam Tablets PS Roche 6 DAY
Atrial Fibrillation
Anxiety
Date:03/29/01ISR Number: 3692700-6Report Type:Expedited (15-DaCompany Report #252574 Age:21 YR Gender:Female I/FU:F
Outcome
Life-Threatening
Hospitalization -
Initial or Prolonged
PT
Autonomic Neuropathy
Restlessness
Convulsion

Pyrexia
Agitation
Cyanosis
Psychotic Disorder
Malaise
Fatigue
Hyperventilation
Electroencephalogram
03-Apr-2012 09:37 AM Page: 317

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abnormal
Stress
Panic Attack
Apnoea Report Source Product Role Manufacturer Route Dose Duration
Influenza Like Illness Foreign Lariam PS Hoffmann La Roche
Neck Pain Health Inc ORAL 250 MG 1PER
Fear Professional WEEK ORAL
Drug Effect Decreased
Other
Blood Ph Increased
Depressed Level Of
Consciousness
Depression
Mental Disorder
Muscle Spasms
Nausea
Loss Of Consciousness
Pco2 Decreased
Arthralgia
Dyspnoea
Date:03/30/01ISR Number: 3692381-1Report Type:Expedited (15-DaCompany Report #256952 Age:65 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam Tablets PS Roche 6 DAY
Tachycardia
Atrial Fibrillation
Date:03/30/01ISR Number: 3693076-0Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chest Pain Lariam PS Roche ORAL ONCE ORAL
Initial or Prolonged Abnormal Dreams
Other Serious
Dizziness
Required
Gait Disturbance
Intervention to
Prevent Permanent
Impairment/Damage
Date:04/02/01ISR Number: 3693472-1Report Type:Expedited (15-DaCompany Report #257483 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Renal Failure Lariam Tablets PS Roche
Initial or Prolonged
Date:04/02/01ISR Number: 3693489-7Report Type:Expedited (15-DaCompany Report #257610 Age:10 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Myalgia Lariam Tablets PS Roche REPORTED DOSE
Nausea = 192.5
Blood Creatine
MG/WEEK,
Phosphokinase Increased TOTAL DOSE =
5 TABLETS. 22 DAY
03-Apr-2012 09:37 AM Page: 318

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/03/01ISR Number: 3694495-9Report Type:Expedited (15-DaCompany Report #256591 Age:58 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Alveolitis Foreign Lariam Tablets PS Roche 29 DAY
Initial or Prolonged Health Prozac C
Professional
Date:04/03/01ISR Number: 3694515-1Report Type:Expedited (15-DaCompany Report #257527 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disturbance In Attention Foreign Lariam Tablets PS Roche 29 DAY
Confusional State
Consumer
Balance Disorder
Anxiety
Amnesia
Crying
Date:04/03/01ISR Number: 3694523-0Report Type:Expedited (15-DaCompany Report #257719 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dissociation Health Lariam Tablets PS Roche SEVEN TABLETS
Dizziness Professional TAKEN IN
Amnesia
TOTAL.
Suicidal Ideation
Headache
Balance Disorder
Confusional State
Hypertension
Anxiety
Agoraphobia
Date:04/03/01ISR Number: 3694813-1Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Impairment Lariam Hoffman
Palpitations Laroche PS Hoffman Laroche ORAL 1 WEEK ORAL
Dizziness
Panic Attack
Tremor
Date:04/03/01ISR Number: 3695222-1Report Type:Expedited (15-DaCompany Report #257483 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Renal Failure Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Epilepsy Health Inc ORAL DOSE FORM 1

Dialysis Professional PER WEEK ORAL
03-Apr-2012 09:37 AM Page: 319

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/03/01ISR Number: 3695224-5Report Type:Expedited (15-DaCompany Report #257610 Age:10 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aspartate Foreign Lariam PS Hoffmann La Roche
Aminotransferase Other Inc ORAL 192.5 MG ORAL
Increased
Muscle Spasms
Myalgia
Blood Creatine
Phosphokinase Increased
Nausea
Blood Lactate
Dehydrogenase Increased
Date:04/04/01ISR Number: 3695248-8Report Type:Expedited (15-DaCompany Report #246474 Age:61 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Psoriasis Lariam Tablets PS Roche 280 DAY
Date:04/04/01ISR Number: 3695261-0Report Type:Expedited (15-DaCompany Report #256317 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fatigue Lariam Tablets PS Roche 3288 DAY
Diarrhoea Unknown Medication C MEDICATIONS
Myalgia
TAKEN IN
Alopecia
1994,1995 AND
Mental Impairment 1999.
Depression Doxycycline C
Anxiety
Sleep Disorder
Mood Swings
Weight Decreased
Nightmare
Date:04/04/01ISR Number: 3696973-5Report Type:Expedited (15-DaCompany Report #257719 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Confusional State Consumer Lariam PS Hoffmann La Roche
Hypertension Health Inc ORAL ORAL
Feeling Abnormal
Professional
Headache
Amnesia
Dissociative Disorder
Anxiety
Agoraphobia
Balance Disorder
Dizziness

Suicidal Ideation
03-Apr-2012 09:37 AM Page: 320

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/04/01ISR Number: 3697929-9Report Type:Expedited (15-DaCompany Report #257527 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Amnesia Foreign Lariam PS Hoffmann La Roche
Intervention to Disturbance In Attention Other Inc ORAL 1 DOSE FORM 1
Prevent Permanent Balance Disorder PER WEEK ORAL
Impairment/Damage Crying
Confusional State
Anxiety
Date:04/04/01ISR Number: 3697932-9Report Type:Expedited (15-DaCompany Report #256591 Age:58 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Alveolitis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Health Inc ORAL 250 MG 1 PER
Professional
Prozac (Fluoxetine
Hydrochloride)
C
1 WEEK ORAL
Date:04/05/01ISR Number: 3699597-9Report Type:Expedited (15-DaCompany Report #256317 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Disturbance In Attention Other Lariam PS Hoffmann La Roche
Myalgia
Inc
Fatigue
Unknown Medication
Irritability
(Generic
Anxiety
Component(S)
Sleep Disorder Unknown) C
Mood Swings
Doxycycline
Alopecia (Doxycycline) C
Mental Impairment
Muscular Weakness
Nightmare
Diarrhoea
Weight Decreased
Depression
Date:04/05/01ISR Number: 3699598-0Report Type:Expedited (15-DaCompany Report #246474 Age:61 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Psoriasis Health Lariam PS Hoffmann La Roche
Gait Disturbance Professional Inc ORAL 1 PER WEEK
ORAL
Date:04/05/01ISR Number: 3699935-7Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Myalgia Lariam / 250 Mg. /
Required Influenza Like Illness Roche PS Roche ORAL 1 TABLET 1 PR
Intervention to Malaise WK/8 ORAL
Prevent Permanent Feeling Abnormal
Impairment/Damage
03-Apr-2012 09:37 AM Page: 321

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/09/01ISR Number: 3701040-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Vertigo Positional Lariam (Tablets
Depression 250mg) PS 1 TAB ONCE
Dehydration WEEKLY 10 WK
Sleep Disorder Milk Thistle C
Headache Vitamins C
Circadian Rhythm Sleep Ginger C
Disorder Tums C
Chest Pain Aspirin C
Weight Increased
Dizziness
Abnormal Dreams
Ear Infection
Balance Disorder
Stress
Fall
Mountain Sickness Acute
Anxiety
Date:04/09/01ISR Number: 3701071-8Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chest Pain Lariam Roche PS Roche ORAL ONCE ORAL
Initial or Prolonged Dizziness
Other Serious
Abnormal Dreams
Required
Feeling Abnormal
Intervention to
Gait Disturbance
Prevent Permanent
Impairment/Damage
Date:04/10/01ISR Number: 3701155-4Report Type:Expedited (15-DaCompany Report #246474 Age:61 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Psoriasis Lariam Tablets PS Roche 280 DAY
Date:04/11/01ISR Number: 3702283-XReport Type:Expedited (15-DaCompany Report #258083 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatitis Lariam Tablets PS Roche 42 DAY
Abdominal Pain
Evening Primrose Oil C
Calcium Carbonate C
Ibuprofen
C

Date:04/11/01ISR Number: 3703089-8Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Lariam PS ORAL 1 TABLE
Insomnia
WEEKLY ORAL
Pain
Dehydration
Vomiting
03-Apr-2012 09:37 AM Page: 322

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/11/01ISR Number: 3703237-XReport Type:Direct Company Report # Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Affective Disorder Lariam / 250mg PS ORAL 250 MG ONCE A
Decreased Appetite
WEEK ORAL
Lethargy
Headache
Dermatitis
Date:04/11/01ISR Number: 3703278-2Report Type:Direct Company Report # Age:75 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Urinary Incontinence Lariam (Mefloquine)
Circulatory Collapse
250 Mg. Roche
Loss Of Consciousness Laboratories PS Roche Laboratories 1 TABLET
Fall
WEEKLY
Dyskinesia BEGINNING 1
WEEK BEFORE
TRIP
Date:04/11/01ISR Number: 3703298-8Report Type:Expedited (15-DaCompany Report #246474 Age:61 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Psoriasis Health Lariam PS Hoffmann La Roche
Skin Lesion Professional Inc ORAL 1 PER WEEK
ORAL
Date:04/12/01ISR Number: 3704261-3Report Type:Expedited (15-DaCompany Report #258083 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abdominal Pain Foreign Lariam PS Hoffmann La Roche
Hepatitis Other Inc ORAL 250 MG DAILY
ORAL
Evening Primrose Oil
(Evening Primrose
Oil)
C
Calcium Carbonate
(Calcium Carbonate) C
Ibuprofen
(Ibuprofen)
C
Date:04/16/01ISR Number: 3720297-0Report Type:Expedited (15-DaCompany Report #EM2001-0474 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Rash Pruritic Study Proleukin

Injection Site Health (Aldesleukin)Injecti
Inflammation Professional on PS Chiron Corporation SUBCUTANEOUS 4.5 MIU BID,
Gait Disturbance
SUBCUTAN
Injection Site Pain
Lariam (Mefloquine) SS
Injection Site Reaction Ddi (Didanosine) C
Hypersensitivity
Hydrocortisone
Urticaria (Hydrocortisone) C
Nevirapine
03-Apr-2012 09:37 AM Page: 323

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Nevirapine)
Sudafed
(Pseudoephedrine
Hydrochloride)
Tylenol
(Paracetamol)
Nizoral
(Ketoconazole)
Motrin (Ibuprofen)
Zerit (Stavudine)
Indinavir
(Indinavir)
Multivitamins
(Ergocalciferol,
Ascorbic Acid, Folic
Acid, Thiamine
Hydrochloide,
C
C
C
C
C
C
C
C
Date:04/17/01ISR Number: 3705506-6Report Type:Expedited (15-DaCompany Report #235171 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delivery Lariam Tablets PS Roche THE PATIENT
Abnormal Labour
TOOK A TOTAL
OF 7 TABLETS
WHILE SHE WAS
A FEW WEEKS 50 DAY
Date:04/17/01ISR Number: 3705513-3Report Type:Expedited (15-DaCompany Report #246098 Age:22 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Impairment Lariam Tablets PS Roche 28 DAY
Anxiety
Aphasia
Speech Disorder
Paranoia
Date:04/17/01ISR Number: 3705516-9Report Type:Expedited (15-DaCompany Report #257483 Age:50 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Renal Failure Lariam Tablets PS Roche
Initial or Prolonged Rhabdomyolysis
Malaise
Diarrhoea
Date:04/17/01ISR Number: 3705518-2Report Type:Expedited (15-DaCompany Report #252788 Age:74 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Lariam Tablets PS Roche
Abnormal Behaviour
03-Apr-2012 09:37 AM Page: 324

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/17/01ISR Number: 3706802-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Fatigue Larium PS ORAL ORAL
Anxiety
Arthralgia
Depression
Convulsion
Suicidal Ideation
Anger
Thinking Abnormal
Sleep Disorder
Date:04/18/01ISR Number: 3707820-7Report Type:Expedited (15-DaCompany Report #235171 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Abnormal Labour Foreign Lariam PS Hoffmann La Roche
Intervention to Caesarean Section Health Inc ORAL 250 MG 1 PER
Prevent Permanent Professional WEEK ORAL
Impairment/Damage
Date:04/18/01ISR Number: 3707821-9Report Type:Expedited (15-DaCompany Report #246098 Age:22 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aphasia Foreign Lariam PS Hoffmann La Roche
Anxiety Other Inc ORAL ORAL 28 DAY
Visual Impairment
Paranoia
Speech Disorder
Date:04/18/01ISR Number: 3707822-0Report Type:Expedited (15-DaCompany Report #252788 Age:74 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Foreign Lariam PS Hoffmann La Roche
Abnormal Behaviour Health Inc ORAL 1 DOSE FORM 1
Professional
PER WEEK ORAL
Date:04/18/01ISR Number: 3707823-2Report Type:Expedited (15-DaCompany Report #257483 Age:50 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaise Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Diarrhoea Health Inc ORAL 1 DOSE FORM 1
Dialysis Professional PER WEEK ORAL
Rhabdomyolysis
Renal Failure

Epilepsy
03-Apr-2012 09:37 AM Page: 325

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/23/01ISR Number: 3708595-8Report Type:Expedited (15-DaCompany Report #246098 Age:22 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Speech Disorder Lariam Tablets PS Roche 28 DAY
Anxiety
Paranoia
Visual Impairment
Date:04/24/01ISR Number: 3709086-0Report Type:Expedited (15-DaCompany Report #242380 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Platelet Count Decreased Lariam Tablets PS Roche 28 DAY
Hyperuricaemia
Intravascular Haemolysis
Menometrorrhagia
Liver Function Test
Abnormal
Date:04/24/01ISR Number: 3711028-9Report Type:Expedited (15-DaCompany Report #246098 Age:22 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Foreign Lariam PS Hoffmann La Roche
Anxiety Other Inc ORAL ORAL 28 YR
Aphasia
Speech Disorder
Visual Impairment
Date:04/25/01ISR Number: 3710150-0Report Type:Expedited (15-DaCompany Report #258981 Age:53 YR Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Interaction Lariam Tablets PS Roche 9 DAY
Hypersensitivity Multivitamins C
Indinavir
C
Zerit
C
Ddi
C
Hydrocortisone C
Nevirapine
C
Sudafed
C
Tylenol
C
Nizoral
C
Motrin
C
Proleukin I Roche 124 DAY
Date:04/25/01ISR Number: 3710156-1Report Type:Expedited (15-DaCompany Report #258834 Age:56 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tremor Mefloquine
Depression Hydrochloride PS Roche 10 DAY
Insomnia Avaxim C 1 DAY
03-Apr-2012 09:37 AM Page: 326

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/25/01ISR Number: 3711519-0Report Type:Expedited (15-DaCompany Report #242380 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Hyperuricaemia Foreign Lariam PS Hoffmann La Roche
Intervention to Platelet Count Decreased Health Inc ORAL ORAL 28 DAY
Prevent Permanent Menometrorrhagia Professional
Impairment/Damage Intravascular Haemolysis
Pregnancy
Hepatic Function Abnormal
Date:04/26/01ISR Number: 3711060-5Report Type:Expedited (15-DaCompany Report #252788 Age:74 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Behaviour Lariam Tablets PS Roche 8 DAY
Delusion Toco C
Xatral
C
Aricept
C
Tanakan
C
Date:04/26/01ISR Number: 3711849-2Report Type:Expedited (15-DaCompany Report #258834 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Foreign Lariam PS Hoffmann La Roche
Tremor Other Inc ORAL 25 MG DAILY
Insomnia
Avaxim (Hepatitis A
Vaccine)
C
ORAL
Date:04/26/01ISR Number: 3711913-8Report Type:Expedited (15-DaCompany Report #258981 Age:53 YR Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Erythema Health Lariam PS Hoffmann La Roche
Swelling Professional Inc ORAL ORAL
Injection Site Oedema Other Proleukin
Dermatitis (Aldeslukin) SS SUBCUTANEOUS 4.5 MILLIONIU
Injection Site Reaction
2 PER 1 DAY
Hypersensitivity
SUBCUTANEOUS
Injection Site Ddi (Didanosine) C
Inflammation
Hydrocortizone
Rash Pruritic (Hydrocortizone) C
Urticaria
Nevirapine
Drug Interaction (Nevirapine) C
Injection Site Pain
Sudafed
(Pseudophedrine
Hydrochloride) C
Tylenol
(Acetaminophen) C

Nizoral
(Ketoconazole)
Motrin (Ibuprofen)
Zerit (Stavudine)
Indinavir
(Indinavir)
Multivitamins
(Multivitamin Nos)
C
C
C
C
C
03-Apr-2012 09:37 AM Page: 327

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/27/01ISR Number: 3713509-0Report Type:Expedited (15-DaCompany Report #252788 Age:74 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Foreign Lariam PS Hoffmann La Roche
Abnormal Behaviour Consumer Inc ORAL 1 DOSE FORM 1
PER WEEK ORAL
Toco (Vitamin E) C
Xatral (Alfuzosin
Hydrochloride) C
Aricept (Donepezil) C
Tanakan (Ginkgo) C
Date:05/02/01ISR Number: 3714650-9Report Type:Expedited (15-DaCompany Report #220210 Age:17 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Accommodation Disorder Lariam Tablets PS Roche 47 DAY
Initial or Prolonged
Date:05/02/01ISR Number: 3714658-3Report Type:Expedited (15-DaCompany Report #259221 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Dysmorphism Lariam Tablets PS Roche 15 DAY
Congenital Foot Arilvax SS 1 DAY
Malformation Vivotif "Berna" SS 1 DAY
Limb Reduction Defect
Congenital Hand
Malformation
Congenital Central
Nervous System Anomaly
Thymus Disorder
Date:05/03/01ISR Number: 3716049-8Report Type:Expedited (15-DaCompany Report #259450 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Urticaria Lariam Tablets PS Roche 30 DAY
Initial or Prolonged Face Oedema
Dyspnoea
Laryngeal Oedema
Date:05/03/01ISR Number: 3717035-4Report Type:Expedited (15-DaCompany Report #259221 Age: Gender:Female I/FU:I
Outcome
Congenital Anomaly
PT
Thymus Disorder
Congenital Central
Nervous System Anomaly

Dysmorphism
Congenital Hand
Malformation
Localised Oedema
Limb Reduction Defect
Congenital Foot
Malformation
Tricuspid Valve Disease
03-Apr-2012 09:37 AM Page: 328

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abortion Induced
Maternal Drugs Affecting
Foetus Report Source Product Role Manufacturer Route Dose Duration
Congenital Cardiovascular Foreign Lariam PS Hoffmann La Roche
Anomaly Health Inc ORAL 250 MG 1
Professional
PER WEEK
Other
ORAL
Arilvax (Yellow
Fever Vaccine) SS 1 PER ONE
DOSE
Vivotif "Berna"
(Typhoid Vaccines) SS ORAL 1 PER ONE
DOSE ORAL
Date:05/03/01ISR Number: 3717038-XReport Type:Expedited (15-DaCompany Report #220210 Age:17 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Refraction Disorder Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Diplopia Consumer Inc ORAL 250 MG 1
Hypertension Health PER WEEK
Antinuclear Antibody Professional ORAL
Positive
Vision Blurred
Platelet Count Decreased
Herpes Zoster
Weight Increased
Neuritis
Lipids Increased
Headache
Thrombocytosis
Pupillary Disorder
Binocular Eye Movement
Disorder
Nuclear Magnetic
Resonance Imaging
Abnormal
Laboratory Test Abnormal
Csf Test Abnormal
Nervous System Disorder
Infectious Mononucleosis
Chlamydial Infection
Visual Acuity Reduced
Accommodation Disorder
Herpes Simplex
Folate Deficiency
Measles
Inflammation
Date:05/04/01ISR Number: 3716893-7Report Type:Expedited (15-DaCompany Report #259699 Age:72 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Haemorrhagic Stroke Lariam Tablets PS Roche 37 DAY
Drug Interaction Cozaar Comp C 285 DAY
Circulatory Collapse Warfarin I
International Normalised
Ratio Increased
03-Apr-2012 09:37 AM Page: 329

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/04/01ISR Number: 3717913-6Report Type:Expedited (15-DaCompany Report #259450 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Urticaria Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Pruritus Other Inc ORAL 1 DOSE FORM 1
Pain
PER WEEK ORAL
Face Oedema
Dyspnoea
Laryngeal Oedema
Erythema
Date:05/07/01ISR Number: 3717719-8Report Type:Direct Company Report # Age:68 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Asthenia Lariam / 250 Mg. /
Initial or Prolonged Blood Pressure Increased Laroche Laboritorys, PS 250 MG ONCE A
Disability Dizziness WK 6 WKS
Congenital Anomaly
Other Serious
Hyperventilation
Disorientation
Dyspnoea
Tinnitus
Date:05/07/01ISR Number: 3718783-2Report Type:Expedited (15-DaCompany Report #259699 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death International Normalised Foreign Lariam PS Hoffmann La Roche
Ratio Increased Other Inc ORAL 250 MG 1 PER
Haemorrhagic Stroke
WEEK ORAL
Circulatory Collapse
Warfarin (Warfarin
Drug Interaction Sodium) SS ORAL 4 MG 1 PER 2
DAY ORAL
Cozaar Comp
(Hydrochlorothiazide
/Losartan Potassium) C
Date:05/08/01ISR Number: 3718309-3Report Type:Expedited (15-DaCompany Report #235171 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Labour Lariam Tablets PS Roche THE PATIENT
Pregnancy
TOOK A TOTAL
Caesarean Section
OF 7 TABLETS
Maternal Drugs Affecting
WHILE SHE WAS
Foetus A FEW WEEKS 50 DAY
Date:05/09/01ISR Number: 3719103-XReport Type:Expedited (15-DaCompany Report #251328 Age: Gender:Not SpecifiI/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Limb Reduction Defect Lariam Tablets PS Roche
03-Apr-2012 09:37 AM Page: 330

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/09/01ISR Number: 3719121-1Report Type:Expedited (15-DaCompany Report #259776 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gamma-Glutamyltransferase Lariam Tablets PS Roche 1 DAY
Increased
Blood Thyroid Stimulating
Hormone Increased
Sleep Disorder
Blood Cholesterol
Increased
Blood Triglycerides
Increased
Alanine Aminotransferase
Increased
Blood Pressure Increased
Malaise
Muscle Spasms
Thyroxine Decreased
Xanthelasma
Date:05/09/01ISR Number: 3719124-7Report Type:Expedited (15-DaCompany Report #259784 Age: Gender:Not SpecifiI/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Asthenia Lariam Tablets PS Roche THE PATIENT
Initial or Prolonged Nausea HAD RECEIVED
Pyelonephritis
THREE DOSE
Vomiting
FORMS IN
Gastritis TOTAL. 14 DAY
Date:05/09/01ISR Number: 3721171-6Report Type:Expedited (15-DaCompany Report #235171 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Caesarean Section Foreign Lariam PS Hoffmann La Roche
Intervention to Abnormal Labour Health Inc ORAL 250 MG 1 PER
Prevent Permanent Professional WEEK ORAL
Impairment/Damage
Other
Date:05/10/01ISR Number: 3720252-0Report Type:Expedited (15-DaCompany Report #259927 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Interaction Lariam Tablets PS Roche THE PATIENT
Initial or Prolonged Haematochezia TOOK 3 DOSES
OF LARIAM
BEFORE DATE
OF ONSET.
Marcumar I Roche

Date:05/10/01ISR Number: 3721537-4Report Type:Expedited (15-DaCompany Report #259776 Age:49 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Thyroxine Decreased
Muscle Spasms
Blood Pressure Increased
03-Apr-2012 09:37 AM Page: 331

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Blood Triglycerides
Increased
Blood Thyroid Stimulating Report Source Product Role Manufacturer Route Dose Duration
Hormone Increased Foreign Lariam PS Hoffmann La Roche
Lipids Increased Health Inc ORAL ORAL
Gamma-Glutamyltransferase Professional
Increased
Alanine Aminotransferase
Increased
Malaise
Sleep Disorder
Blood Cholesterol
Increased
Xanthelasma
Date:05/10/01ISR Number: 3721538-6Report Type:Expedited (15-DaCompany Report #259784 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyelonephritis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Vomiting Health Inc ORAL 1 DOSE FORM 1
Gastritis Professional PER WEEK ORAL
Asthenia
Date:05/10/01ISR Number: 3721539-8Report Type:Expedited (15-DaCompany Report #251328 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Pregnancy Foreign Lariam PS Hoffmann La Roche
Limb Malformation Health Inc ORAL 1 DOSE FORM 1
Maternal Drugs Affecting Professional PER WEEK ORAL
Foetus
Limb Reduction Defect
Date:05/11/01ISR Number: 3720799-7Report Type:Expedited (15-DaCompany Report #260010 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Lariam PS Roche 46 DAY
Initial or Prolonged Hallucination
Suffocation Feeling
Date:05/11/01ISR Number: 3720804-8Report Type:Expedited (15-DaCompany Report #259933 Age:62 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypertension Lariam PS Roche 60 DAY
Panic Attack
Fatigue

Asthenia
03-Apr-2012 09:37 AM Page: 332

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/11/01ISR Number: 3720906-6Report Type:Direct Company Report # Age:68 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hyperventilation Lariam / 250 Mg. /
Initial or Prolonged Asthenia Laroche Laboritorys, PS Laroche Laboritorys 250 MG. ONE
Disability Disorientation A WK. 6 WKS
Congenital Anomaly
Other Serious
Dyspnoea
Blood Pressure Increased
Tinnitus
Dizziness
Date:05/14/01ISR Number: 3721765-8Report Type:Expedited (15-DaCompany Report #259776 Age:49 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thyroid Function Test Lariam Tablets PS Roche 1 DAY
Abnormal
Malaise
Blood Pressure Increased
Xanthelasma
Sleep Disorder
Alanine Aminotransferase
Increased
Lipids Increased
Gamma-Glutamyltransferase
Increased
Muscle Spasms
Date:05/15/01ISR Number: 3723039-8Report Type:Expedited (15-DaCompany Report #259927 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Haematochezia Lariam Tablets PS Roche THE PATIENT
Initial or Prolonged
TOOK 3 DOSES
OF LARIAM
BEFORE DATE
OF ONSET.
Marcumar
C
Date:05/16/01ISR Number: 3724398-2Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Lariam 250 Mg Tablet
Coordination Abnormal Roche Labs PS Roche Labs 1 TABLET PER
Fatigue
WEEK
Photophobia I.G. Shot C
Nausea
Insomnia
Disturbance In Attention

Hearing Impaired
Sensation Of Pressure
Headache
Dizziness
Sedation
Memory Impairment
Burning Sensation
Speech Disorder
03-Apr-2012 09:37 AM Page: 333

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/16/01ISR Number: 3724861-4Report Type:Expedited (15-DaCompany Report #259933 Age:62 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Asthenia Consumer Lariam PS Hoffmann La Roche
Intervention to Dyspnoea Inc ORAL 1 PER WEEK
Prevent Permanent Hypertension ORAL
Impairment/Damage Disorientation
Panic Attack
Myocardial Infarction
Dizziness
Emotional Disorder
Bronchitis
Fatigue
Pneumonia Mycoplasmal
Chest Pain
Anxiety
Blood Pressure Increased
Date:05/16/01ISR Number: 3725229-7Report Type:Expedited (15-DaCompany Report #260010 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Anxiety Other Inc ORAL 250 MG 1 PER
Suffocation Feeling
WEEK ORAL
Date:05/17/01ISR Number: 3724379-9Report Type:Direct Company Report #USP 54068 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Medication Error Lariam PS Roche
Monograph For
Mefloquine
Hydrochloride SS Micromedex
Date:05/17/01ISR Number: 3724772-4Report Type:Expedited (15-DaCompany Report #259927 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - International Normalised Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Ratio Increased Consumer Inc ORAL ORAL
Haematochezia
Marcumar
(Phenprocoumon) C
Date:05/18/01ISR Number: 3724986-3Report Type:Expedited (15-DaCompany Report #259784 Age: Gender:Not SpecifiI/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyelonephritis Lariam Tablets PS Roche THE PATIENT

Initial or Prolonged Vomiting HAD RECEIVED
Nausea
THREE DOSE
Asthenia
FORMS IN
Gastritis TOTAL. 14 DAY
03-Apr-2012 09:37 AM Page: 334

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/18/01ISR Number: 3725008-0Report Type:Expedited (15-DaCompany Report #260506 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abdominal Pain Lariam PS Roche THREE TABLETS
Initial or Prolonged Gastritis TAKEN IN
Asthenia TOTAL. 14 DAY
Vomiting Stamaril Unidose C 1 DAY
Pyelonephritis
Nausea
Date:05/18/01ISR Number: 3725014-6Report Type:Expedited (15-DaCompany Report #247738 Age: Gender:Not SpecifiI/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pregnancy Lariam PS Roche THREE TABLETS
Uterine Hypertonus
TAKEN IN
TOTAL. 14 DAY
Stamaril Unidose C 1 DAY
Date:05/21/01ISR Number: 3725705-7Report Type:Expedited (15-DaCompany Report #203837 Age:54 YR Gender:Male I/FU:F
Outcome
Death
Hospitalization -
Initial or Prolonged
PT
Hallucinations, Mixed
Flushing
Nervous System Disorder
Delirium
Anxiety
Musculoskeletal Stiffness
Decreased Appetite
Adjustment Disorder
Amnesia
Pyrexia
Petit Mal Epilepsy
Blood Lactate
Dehydrogenase Increased
Delusional Disorder,
Persecutory Type
Cognitive Disorder
Chills
Blood Cortisol Increased
Depression
Urinary Hesitation
Headache
Weight Decreased
Photopsia
Erythema
Claustrophobia
Hepatic Steatosis
Hyperhidrosis
Erectile Dysfunction

Completed Suicide
Agitation
Insomnia
Fatigue
Liver Function Test
Abnormal
Obsessive-Compulsive
Disorder
03-Apr-2012 09:37 AM Page: 335

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Polydipsia
Abnormal Dreams
Report Source Product Role Manufacturer Route Dose Duration
Lariam Tablets PS Roche 49 DAY
Date:05/21/01ISR Number: 3726835-6Report Type:Expedited (15-DaCompany Report #260506 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abdominal Pain Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Vomiting Health Inc ORAL 1 DOSE FORM 1
Nausea Professional PER WEEK ORAL
Pyelonephritis Stamaril Unidose C
Asthenia
Uterine Contractions
During Pregnancy
Gastritis
Date:05/21/01ISR Number: 3726836-8Report Type:Expedited (15-DaCompany Report #247738 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Breech Presentation Foreign Lariam PS Hoffmann La Roche
Pyelonephritis Health Inc ORAL 1 DOSE FORM
Uterine Hypertonus Professional 1 PER WEEK
ORAL
Stamaril Unidose
(Yellow Fever
Vaccine)
C
Date:05/21/01ISR Number: 3726936-2Report Type:Expedited (15-DaCompany Report #259784 Age: Gender: I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyelonephritis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Gastritis Health Inc ORAL 1 DOSE FORM 1
Breech Presentation Professional PER WEEK ORAL
Vomiting
Maternal Drugs Affecting
Foetus
Asthenia
Date:05/22/01ISR Number: 3726521-2Report Type:Expedited (15-DaCompany Report #260569 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Weight Decreased Lariam PS Roche 8 DAY
Initial or Prolonged Vomiting

Date:05/23/01ISR Number: 3727977-1Report Type:Expedited (15-DaCompany Report #203837 Age:54 YR Gender:Male I/FU:F
Outcome
Death
Hospitalization -
Initial or Prolonged
PT
Urinary Hesitation
Hepatic Steatosis
Photopsia
03-Apr-2012 09:37 AM Page: 336

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Erythema
Abnormal Dreams
Polydipsia Report Source Product Role Manufacturer Route Dose Duration
Petit Mal Epilepsy Consumer Lariam PS Hoffmann La Roche
Hallucinations, Mixed Other Inc ORAL 250 MG 1
Amnesia
PER 1 WEEK
Blood Cortisol Increased ORAL 49 DAY
Delirium
Stress
Pyrexia
Erectile Dysfunction
Adjustment Disorder
Agitation
Nervous System Disorder
Cognitive Disorder
Claustrophobia
Musculoskeletal Stiffness
Hyperhidrosis
Flushing
Delusional Disorder,
Persecutory Type
Headache
Blood Lactate
Dehydrogenase Increased
Completed Suicide
Depression
Obsessive-Compulsive
Disorder
Liver Function Test
Abnormal
Date:05/23/01ISR Number: 3728418-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Claustrophobia Larium Roche PS Roche ORAL 1 WEEKLY ORAL
Anxiety
Paranoia
Hallucination
Date:05/24/01ISR Number: 3728060-1Report Type:Direct Company Report # Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hypersensitivity Lariam PS ORAL 1 TABLET
ORALLY
Date:05/24/01ISR Number: 3728649-XReport Type:Expedited (15-DaCompany Report #260569 Age:29 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Weight Decreased Health Inc ORAL 250 MG 1 PER
Professional
WEEK ORAL
03-Apr-2012 09:37 AM Page: 337

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/29/01ISR Number: 3728985-7Report Type:Expedited (15-DaCompany Report #259927 Age:73 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Haematochezia Lariam Tablets PS Roche 36 DAY
Initial or Prolonged Diverticulitis Aspirin Protect 100 C 584 DAY
Marcumar
C
Date:05/29/01ISR Number: 3728990-0Report Type:Expedited (15-DaCompany Report #260569 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Lariam PS Roche 8 DAY
Initial or Prolonged Weight Decreased
Date:05/29/01ISR Number: 3728996-1Report Type:Expedited (15-DaCompany Report #260745 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nerve Root Lesion Lariam PS Roche FOUR TIMES IN
TOTAL. 29 DAY
Date:05/29/01ISR Number: 3729002-5Report Type:Expedited (15-DaCompany Report #260795 Age:65 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Extrasystoles Lariam PS Roche 1 DAY
Transient Ischaemic Aspirin C
Attack Mvi C
Atrial Fibrillation
Date:05/30/01ISR Number: 3729600-9Report Type:Expedited (15-DaCompany Report #257983 Age:55 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cystitis Lariam Tablets PS Roche 32 DAY
Myalgia
Influenza Like Illness
Insomnia
Arthralgia
Prostatic Specific
Antigen Increased
Neuritis
Back Pain
Pyrexia
Prostatic Disorder
Anxiety
Urinary Retention
Fatigue

Date:05/31/01ISR Number: 3731355-9Report Type:Expedited (15-DaCompany Report #260795 Age:65 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Atrial Fibrillation
Transient Ischaemic
Attack
03-Apr-2012 09:37 AM Page: 338

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Extrasystoles
Report Source Product Role Manufacturer Route Dose Duration
Health Lariam PS Hoffmann La Roche
Professional Inc ORAL 250 MG 1 PER
ONE DOSE;ORAL
Aspirin (Aspirin) C
Mvi (Multivitamin
Nos)
C
Date:05/31/01ISR Number: 3731408-5Report Type:Expedited (15-DaCompany Report #259927 Age:73 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Arthralgia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Faeces Discoloured Consumer Inc ORAL 1 DOSE FORM 1
Required Haematochezia PER WEEK ORAL
Intervention to Diverticulitis Aspirin Protect 100
Prevent Permanent Haemoglobin Decreased (Aspirin) C
Impairment/Damage
Marcumar
(Phenprocoumon) C
Date:05/31/01ISR Number: 3731786-7Report Type:Expedited (15-DaCompany Report #257983 Age:55 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pyrexia Foreign Lariam PS Hoffmann La Roche
Prostatic Disorder Health Inc ORAL 1 DOSE FORM
Neuritis Professional 1 PER WEEK
Bladder Disorder
ORAL
Urinary Incontinence
Cystitis
Arthralgia
Insomnia
Urinary Retention
Influenza Like Illness
Urinary Tract Infection
Vestibular Disorder
Prostatic Specific
Antigen Increased
Hyperhidrosis
Back Pain
Fatigue
Myalgia
Anxiety
Date:05/31/01ISR Number: 3731789-2Report Type:Expedited (15-DaCompany Report #260745 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Paraesthesia Foreign Lariam PS Hoffmann La Roche
Coordination Abnormal Other Inc ORAL 1 DOSE FORM
Nerve Root Lesion
1 PER WEEK
ORAL
03-Apr-2012 09:37 AM Page: 339

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/31/01ISR Number: 3731790-9Report Type:Expedited (15-DaCompany Report #260569 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Weight Decreased Health Inc ORAL 250 MG 1
Professional
PER WEEK
ORAL
Date:06/01/01ISR Number: 3731768-5Report Type:Expedited (15-DaCompany Report #260852 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypoaesthesia Lariam PS Roche 46 DAY
Tremor Diovan C
Mental Disorder Roxibion C 10 DAY
Insomnia
Restlessness
Pneumonia
Anxiety
Hyperhidrosis
Date:06/04/01ISR Number: 3733157-6Report Type:Expedited (15-DaCompany Report #260852 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Foreign Lariam PS Hoffmann La Roche
Hyperhidrosis Health Inc ORAL 250 MG 1 PER
Pneumonia Professional WEEK ORAL
Mental Disorder Diovan (Valsartan) C
Tremor
Roxibion
Insomnia (Roxithromycin) C
Restlessness
Hypoaesthesia
Date:06/04/01ISR Number: 3733741-XReport Type:Direct Company Report # Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Blood Pressure Increased Lariam PS OROPHARINGEAL 1 WEEK
Dizziness
OROPHARINGEAL
Anxiety
Date:06/05/01ISR Number: 3733342-3Report Type:Expedited (15-DaCompany Report #247738 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Uterine Hypertonus Lariam PS Roche THREE TABLETS
Delivery
TAKEN IN
TOTAL. 14 DAY

Stamaril Unidose C 1 DAY
03-Apr-2012 09:37 AM Page: 340

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/01ISR Number: 3733356-3Report Type:Expedited (15-DaCompany Report #259776 Age:49 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Xanthelasma Lariam Tablets PS Roche 1 DAY
Sleep Disorder
Malaise
Blood Pressure Increased
Muscle Spasms
Thyroid Function Test
Abnormal
Alanine Aminotransferase
Increased
Gamma-Glutamyltransferase
Increased
Lipids Increased
Date:06/05/01ISR Number: 3733358-7Report Type:Expedited (15-DaCompany Report #260506 Age:33 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Interaction Lariam PS Roche THREE TABLETS
Initial or Prolonged Asthenia TAKEN IN
Sedation TOTAL. 14 DAY
Abdominal Pain Stamaril Unidose I 1 DAY
Balance Disorder
Uterine Contractions
During Pregnancy
Gastritis
Vertigo
Vomiting In Pregnancy
Caesarean Section
Pyelonephritis
Nausea
Date:06/05/01ISR Number: 3733365-4Report Type:Expedited (15-DaCompany Report #261224 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Arrhythmia Lariam PS Roche 2 DAY
Initial or Prolonged Vertigo Nivaquine SS 50 DAY
Tremor Paludrine C
Dysarthria
Myalgia
Agitation
Pyrexia
Headache
Arthralgia
Date:06/05/01ISR Number: 3734384-4Report Type:Periodic Company Report #257975 Age:58 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Chest Pain Consumer Lariam PS Hoffmann La Roche
Feeling Hot Inc ORAL ORAL
Calcium (Calcium
Nos)
C
Prempro (Estrogens
Conjugated/Medroxypr
03-Apr-2012 09:37 AM Page: 341

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
ogesterone Acetate)
C
Date:06/05/01ISR Number: 3734385-6Report Type:Periodic Company Report #113216 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Asthenia Health Lariam PS Hoffmann La Roche
Disorientation Professional Inc ORAL 250 MG DAILY,
Nausea
ORAL
Fatigue
Lamisil(Terbinafene) C
Paraesthesia
Depression
Date:06/05/01ISR Number: 3734386-8Report Type:Periodic Company Report #222392 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Pressure Diastolic Consumer Lariam PS Hoffmann La Roche
Increased Health Inc ORAL 250 MG 1 PER
Tachycardia Professional WEEK ORAL
Dizziness
Pyrexia
Sputum Discoloured
Decreased Appetite
Anxiety Disorder
Body Temperature
Increased
Dyspnoea
Nasopharyngitis
Fatigue
Oropharyngeal Pain
Urinary Tract Infection
Date:06/05/01ISR Number: 3734387-XReport Type:Periodic Company Report #910200285001 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Weight Decreased Health Lariam PS Hoffmann La Roche
Insomnia Professional Inc ORAL 250 MG 1 PER
Hallucination
WEEK ORAL
Depression
Methotrexate
Depersonalisation (Methotrexate) C
Date:06/05/01ISR Number: 3734388-1Report Type:Periodic Company Report #231044 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Health Lariam PS Hoffmann La Roche
Ear Infection Professional Inc ORAL 250MG 1 PER
WEEK ORAL

Date:06/05/01ISR Number: 3734391-1Report Type:Periodic Company Report #232888 Age:21 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Restlessness
Insomnia
03-Apr-2012 09:37 AM Page: 342

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Paranoia
Asthma
Anxiety Report Source Product Role Manufacturer Route Dose Duration
Fatigue Health Lariam PS Hoffmann La Roche
Feeling Abnormal Professional Inc ORAL 1 PER WEEK
Vertigo
ORAL
Panic Attack
Date:06/05/01ISR Number: 3734395-9Report Type:Periodic Company Report #246930 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscle Contractions Health Lariam PS Hoffmann La Roche
Involuntary Professional Inc ORAL 250 MG 1 PER
1 WEEK ORAL
Date:06/05/01ISR Number: 3734397-2Report Type:Periodic Company Report #248729 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nasopharyngitis Health Lariam PS Hoffmann La Roche
Oropharyngeal Pain Professional Inc ORAL 1 DOSE FORM 1
Other
PER WEEK ORAL
Date:06/05/01ISR Number: 3734399-6Report Type:Periodic Company Report #249132 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Chest Pain Other Lariam PS Hoffmann La Roche
Sensory Disturbance Inc ORAL ORAL
Insomnia
Dizziness
Date:06/05/01ISR Number: 3734400-XReport Type:Periodic Company Report #249387 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam PS Hoffmann La Roche
Dyspepsia Inc ORAL 250 MG 1 PER
Disturbance In Attention
WEEK ORAL
Dizziness
Hearing Impaired
Date:06/05/01ISR Number: 3734401-1Report Type:Periodic Company Report #253140 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vomiting Consumer Lariam PS Hoffmann La Roche

Nausea Inc ORAL 250 MG 1 PER
Vaginal Haemorrhage
WEEK ORAL
Diarrhoea
03-Apr-2012 09:37 AM Page: 343

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/01ISR Number: 3734402-3Report Type:Periodic Company Report #253766 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vision Blurred Health Lariam PS Hoffmann La Roche
Electrocardiogram Professional Inc ORAL 500 MG DAILY,
Abnormal ORAL 6 DAY
Blood Potassium Decreased
Hypoaesthesia
Palpitations
Dizziness
Date:06/05/01ISR Number: 3734405-9Report Type:Periodic Company Report #255250 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blepharitis Health Lariam PS Hoffmann La Roche
Eyelid Oedema Professional Inc ORAL 1 PER WEEK,
Rash Erythematous
ORAL
Date:06/05/01ISR Number: 3734407-2Report Type:Periodic Company Report #255378 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Agitation Consumer Lariam PS Hoffmann La Roche
Dysarthria Inc ORAL 250 MG ORAL
Confusional State
Anxiety
Coordination Abnormal
Feeling Jittery
Dyspnoea
Headache
Date:06/05/01ISR Number: 3734408-4Report Type:Periodic Company Report #256761 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Health Lariam PS Hoffmann La Roche
Vertigo Professional Inc ORAL ORAL
Tremor
Agitation
Date:06/05/01ISR Number: 3734409-6Report Type:Periodic Company Report #257150 Age:63 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Health Lariam PS Hoffmann La Roche
Abnormal Dreams Professional Inc ORAL 250 MG 1 PER
Blood Triglycerides
WEEK ORAL
Increased

Date:06/05/01ISR Number: 3734410-2Report Type:Periodic Company Report #242997 Age: Gender:Male I/FU:I
Outcome
Other Serious
PT
Constipation
Headache
03-Apr-2012 09:37 AM Page: 344

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Diarrhoea
Malaise
Dizziness Report Source Product Role Manufacturer Route Dose Duration
Health Lariam PS Hoffmann La Roche
Professional Inc ORAL ORAL
Date:06/05/01ISR Number: 3734411-4Report Type:Periodic Company Report #243284 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viral Infection Health Lariam PS Hoffmann La Roche
Pruritus Professional Inc ORAL 250MG, 1 PER
Asthenia
WEEK ORAL
Fatigue
Amnesia
Date:06/05/01ISR Number: 3734412-6Report Type:Periodic Company Report #243594 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Chest Pain Consumer Lariam PS Hoffmann La Roche
Abnormal Dreams Other Inc ORAL ORAL 56 DAY
Date:06/05/01ISR Number: 3734413-8Report Type:Periodic Company Report #243604 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Consumer Lariam PS Hoffmann La Roche
Headache Other Inc ORAL ORAL
Lethargy
Migraine
Nasopharyngitis
Date:06/05/01ISR Number: 3734414-XReport Type:Periodic Company Report #243612 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Impairment Consumer Lariam PS Hoffmann La Roche
Jaundice Other Inc ORAL 1 PER WEEK
Abnormal Dreams
ORAL
Panic Attack
Asthenia
Anger
Paranoia
Date:06/05/01ISR Number: 3734415-1Report Type:Periodic Company Report #243613 Age: Gender: I/FU:I

Outcome
Other Serious
PT
Headache
Depression
Lethargy
Paraesthesia
Feeling Abnormal
Dizziness
Nausea
03-Apr-2012 09:37 AM Page: 345

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Epistaxis
Report Source Product Role Manufacturer Route Dose Duration
Consumer Lariam PS Hoffmann La Roche
Other Inc ORAL ORAL
Date:06/05/01ISR Number: 3734416-3Report Type:Periodic Company Report #243638 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nervous System Disorder Consumer Lariam PS Hoffmann La Roche
Other Inc ORAL ORAL
Date:06/05/01ISR Number: 3734417-5Report Type:Periodic Company Report #243640 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Consumer Lariam PS Hoffmann La Roche
Anxiety Other Inc ORAL ORAL
Emotional Disorder
Date:06/05/01ISR Number: 3734418-7Report Type:Periodic Company Report #243646 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Lethargy Consumer Lariam PS Hoffmann La Roche
Diarrhoea Other Inc ORAL ORAL
Dizziness Tinidazole C
Constipation
1 Concomitant
Pyrexia
Drug(Generic
Abnormal Faeces Components Unknown) C
Headache
Cipro (Ciprofloxacin
Haematochezia Hydrochloride) C
Abdominal Pain Upper
Fatigue
Visual Field Defect
Hallucination
Nausea
Feeling Abnormal
Decreased Appetite
Date:06/05/01ISR Number: 3734419-9Report Type:Periodic Company Report #244422 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Jaundice Consumer Lariam PS Hoffmann La Roche
Panic Attack Other Inc ORAL 1 PER WEEK
Nausea
ORAL
Asthenia

Visual Impairment
Abnormal Dreams
Anger
Paranoia
03-Apr-2012 09:37 AM Page: 346

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/01ISR Number: 3734423-0Report Type:Periodic Company Report #236092 Age:57 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hyperhidrosis Consumer Lariam PS Hoffmann La Roche
Dermatitis Inc ORAL 1 DOSE FORM 1
Diarrhoea
PER WEEK ORAL
Pruritus
Sleep Disorder
Nightmare
Abnormal Faeces
Date:06/05/01ISR Number: 3734429-1Report Type:Periodic Company Report #238527 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aspartate Health Lariam PS Hoffmann La Roche
Aminotransferase Professional Inc ORAL ORAL
Increased
Blood Bilirubin Increased
Alanine Aminotransferase
Increased
Date:06/05/01ISR Number: 3734432-1Report Type:Periodic Company Report #238874 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Joint Swelling Health Lariam PS Hoffmann La Roche
Professional Inc ORAL 250 MG 1 PER
1 WEEK ORAL
Oral Contraceptive
Nos (Oral
Contraceptive Nos) C
Date:06/05/01ISR Number: 3734434-5Report Type:Periodic Company Report #239398 Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cardiac Disorder Health Lariam PS Hoffmann La Roche
Professional Inc ORAL 750MG 1 PER
ONE DOSE ORAL
Probenecid 500 Mg SS ORAL 500 MG 1 PER
12 HOUR ORAL
Amoxicillin 875mg SS ORAL 2625 MG 1 PER
12 HOUR ORAL
Date:06/05/01ISR Number: 3734437-0Report Type:Periodic Company Report #239624 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Rectal Haemorrhage Consumer Lariam PS Hoffmann La Roche
Inc ORAL 250 MG 1 PER
WEEK ORAL
Antibiotics Nos C
03-Apr-2012 09:37 AM Page: 347

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/01ISR Number: 3734441-2Report Type:Periodic Company Report #240270 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Upper Respiratory Tract Consumer Lariam PS Hoffmann La Roche
Infection Inc ORAL ORAL
Date:06/05/01ISR Number: 3734446-1Report Type:Periodic Company Report #240729 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Health Lariam PS Hoffmann La Roche
Decreased Appetite Professional Inc ORAL 250 MG 1 PER
Speech Disorder
DAY ORAL
Date:06/05/01ISR Number: 3734447-3Report Type:Periodic Company Report #242526 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pruritus Consumer Lariam PS Hoffmann La Roche
Urticaria Inc ORAL ORAL
Date:06/05/01ISR Number: 3734448-5Report Type:Periodic Company Report #242575 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Influenza Like Illness Health Lariam PS Hoffmann La Roche
Professional Inc ORAL ORAL
Date:06/05/01ISR Number: 3734449-7Report Type:Periodic Company Report #242830 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hyperkeratosis Health Lariam PS Hoffmann La Roche
Dermatitis Professional Inc ORAL ORAL
Date:06/05/01ISR Number: 3734460-6Report Type:Periodic Company Report #243644 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam PS Hoffmann La Roche
Dissociation Other Inc ORAL ORAL
Hallucination
Headache
Coordination Abnormal
Abnormal Dreams
Malaise
Abdominal Pain
Dermatitis

Flushing
Dizziness
Chills
Decreased Appetite
Disturbance In Attention
Urticaria
03-Apr-2012 09:37 AM Page: 348

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/01ISR Number: 3734461-8Report Type:Periodic Company Report #247060 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Health Lariam PS Hoffmann La Roche
Initial or Prolonged Headache Professional Inc ORAL 250 MG 1 PER
Psychotic Disorder
WEEK ORAL
Dermatitis Dimetapp C
Abdominal Pain Necon C
Agitation Oral Contraceptions C
White Blood Cell Count Pepto Bismol C
Decreased
Hepatic Enzyme Increased
Sinusitis
Hallucination
Nasopharyngitis
Confusional State
Date:06/05/01ISR Number: 3734465-5Report Type:Periodic Company Report #248977 Age:71 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Health Lariam PS Hoffmann La Roche
Nausea Professional Inc ORAL 250 MG 1 PER
ONE DOSE ORAL
Date:06/05/01ISR Number: 3734469-2Report Type:Periodic Company Report #249134 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Health Lariam PS Hoffmann La Roche
Fear Professional Inc ORAL ORAL
Insomnia
Other
Disturbance In Attention
Date:06/05/01ISR Number: 3734473-4Report Type:Periodic Company Report #249872 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Health Lariam PS Hoffmann La Roche
Professional Inc ORAL ORAL
Date:06/05/01ISR Number: 3734475-8Report Type:Periodic Company Report #250139 Age:15 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hyperventilation Consumer Lariam PS Hoffmann La Roche
Hospitalization - Chest Pain Other Inc ORAL 750 MG 1 PER
Initial or Prolonged Suicidal Ideation ONE DOSE ORAL
Hallucination

Insomnia
Bipolar I Disorder
Psychomotor Hyperactivity
Emotional Disorder
03-Apr-2012 09:37 AM Page: 349

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/01ISR Number: 3734478-3Report Type:Periodic Company Report #254302 Age:63 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thinking Abnormal Health Lariam PS Hoffmann La Roche
Hypomania Professional Inc ORAL 250 MG 1 PER
Paranoia
WEEK ORAL
Inappropriate Affect
Date:06/05/01ISR Number: 3734482-5Report Type:Periodic Company Report #255796 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Peripheral Nerve Injury Consumer Lariam PS Hoffmann La Roche
Diarrhoea Inc ORAL 1 DOSE FORM 1
Panic Attack
PER WEEK ORAL
Weight Decreased
Muscular Weakness
Balance Disorder
Anxiety
Nausea
Date:06/05/01ISR Number: 3734485-0Report Type:Periodic Company Report #257836 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Health Lariam PS Hoffmann La Roche
Psychiatric Symptom Professional Inc ORAL ORAL
Other
Date:06/05/01ISR Number: 3734488-6Report Type:Periodic Company Report #258349 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Consumer Lariam PS Hoffmann La Roche
Drug Ineffective Inc ORAL ORAL
Date:06/05/01ISR Number: 3734490-4Report Type:Periodic Company Report #243098 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Motion Sickness Consumer Lariam PS Hoffmann La Roche
Balance Disorder Other Inc ORAL ORAL
Vision Blurred
Date:06/05/01ISR Number: 3734493-XReport Type:Periodic Company Report #243433 Age:18 YR Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Delusion Health Lariam PS Hoffmann La Roche
Initial or Prolonged Paranoia Professional Inc ORAL ORAL
Psychotic Disorder
Agitation
03-Apr-2012 09:37 AM Page: 350

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/01ISR Number: 3734495-3Report Type:Periodic Company Report #2433584 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Asthenia Consumer Lariam PS Hoffmann La Roche
Initial or Prolonged Circulatory Collapse Other Inc ORAL ORAL
Headache
Insomnia
Tearfulness
Feeling Abnormal
Decreased Appetite
Amnesia
Paraesthesia
Dizziness
Date:06/05/01ISR Number: 3734497-7Report Type:Periodic Company Report #243588 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Consumer Lariam PS Hoffmann La Roche
Other Inc ORAL ORAL 35 DAY
Date:06/05/01ISR Number: 3734499-0Report Type:Periodic Company Report #243623 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Emotional Disorder Consumer Lariam PS Hoffmann La Roche
Dizziness Other Inc ORAL ORAL
Decreased Appetite
Lethargy
Weight Decreased
Abnormal Dreams
Hallucination
Date:06/05/01ISR Number: 3734502-8Report Type:Periodic Company Report #243631 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Consumer Lariam PS Hoffmann La Roche
Dyspnoea Other Inc ORAL ORAL
Date:06/05/01ISR Number: 3734504-1Report Type:Periodic Company Report #243632 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Consumer Lariam PS Hoffmann La Roche
Paranoia Other Inc ORAL ORAL 91 DAY
Diarrhoea
Insomnia
Hyperhidrosis

Movement Disorder
Nightmare
Loss Of Consciousness
Depression
Fatigue
Gastroenteritis
Visual Impairment
Panic Attack
03-Apr-2012 09:37 AM Page: 351

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/01ISR Number: 3734507-7Report Type:Periodic Company Report #243636 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pyrexia Consumer Lariam PS Hoffmann La Roche
Malaria Other Inc ORAL ORAL
Chills
Hyperhidrosis
Date:06/05/01ISR Number: 3734508-9Report Type:Periodic Company Report #243637 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Consumer Lariam PS Hoffmann La Roche
Dizziness Other Inc ORAL ORAL
Date:06/05/01ISR Number: 3734509-0Report Type:Periodic Company Report #243639 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Consumer Lariam PS Hoffmann La Roche
Hallucination Other Inc ORAL ORAL
Headache
Paraesthesia
Panic Attack
Tremor
Vomiting
Diarrhoea
Date:06/05/01ISR Number: 3735154-3Report Type:Periodic Company Report #236542 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Crying Consumer Lariam PS Hoffmann La Roche
Hallucination, Auditory Health Inc ORAL 250 MG 1 PER
Amnesia Professional WEEK ORAL
Thinking Abnormal
Hallucination, Tactile
Hallucination, Visual
Suicidal Ideation
Hyperglycaemia
Hyperventilation
Jamais Vu
Blood Urea Increased
Anxiety
Psychotic Disorder
Tremor
Date:06/05/01ISR Number: 3735158-0Report Type:Periodic Company Report #236861 Age:26 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Health Lariam PS Hoffmann La Roche
Tachycardia Professional Inc ORAL 250 MG 1 PER
Psychotic Disorder
WEEK ORAL
Sleep Terror
Anxiety
Ortho-Cyclen
(Ethinyl
Estradiol/Norgestima
03-Apr-2012 09:37 AM Page: 352

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
te)
C
Date:06/05/01ISR Number: 3735160-9Report Type:Periodic Company Report #237292 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Confusional State Health Lariam PS Hoffmann La Roche
Tremor Professional Inc ORAL 250 MG 1 PER
Hallucination
WEEK ORAL
Depression
Amnesia
Abnormal Dreams
Psychotic Disorder
Crying
Anxiety
Date:06/05/01ISR Number: 3735161-0Report Type:Periodic Company Report #238170 Age:57 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hypoaesthesia Consumer Lariam PS Hoffmann La Roche
Inc ORAL 250 MG 1 PER
WEEK ORAL
Vitamin E
C
Date:06/05/01ISR Number: 3735163-4Report Type:Periodic Company Report #240640 Age:15 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Health Lariam PS Hoffmann La Roche
Paranoia Professional Inc ORAL 250 MG 1 PER
WEEK ORAL
Date:06/05/01ISR Number: 3735166-XReport Type:Periodic Company Report #241120 Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Asthenia Consumer Lariam PS Hoffmann La Roche
Vomiting Inc ORAL 1250 MG
Headache
DAILY, ORAL
Malaria
Pyrexia
Tremor
Dysgraphia
Diarrhoea
Hallucination
Nausea

Date:06/05/01ISR Number: 3735169-5Report Type:Periodic Company Report #241190 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Dissociation Consumer Lariam PS Hoffmann La Roche
Intervention to Depression Inc ORAL 250 MG 1 PER
Prevent Permanent Anxiety WEEK ORAL
Impairment/Damage Hallucination
03-Apr-2012 09:37 AM Page: 353

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/01ISR Number: 3735171-3Report Type:Periodic Company Report #241282 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Health Lariam PS Hoffmann La Roche
Hallucination Professional Inc ORAL 250 MG 1 PER
Confusional State
ONE DOSE ORAL
Diarrhoea
Depression
Insomnia
Delirium
Date:06/05/01ISR Number: 3735172-5Report Type:Periodic Company Report #241412 Age:64 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypertension Health Lariam PS Hoffmann La Roche
Professional Inc ORAL ORAL
Date:06/05/01ISR Number: 3735173-7Report Type:Periodic Company Report #243081 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Consumer Lariam PS Hoffmann La Roche
Amnesia Other Inc ORAL 1 PER WEEK
Fear
ORAL
Road Traffic Accident
Feeling Of Despair
Chest Discomfort
Lethargy
Palpitations
Photophobia
Skin Disorder
Visual Acuity Reduced
Depression
Date:06/06/01ISR Number: 3733847-5Report Type:Expedited (15-DaCompany Report #261363 Age:10 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Onycholysis Lariam PS Roche 385 DAY
Hepatitis
Vaccination
C
Vivotif "Berna" C
Date:06/08/01ISR Number: 3736478-6Report Type:Expedited (15-DaCompany Report #261224 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Agitation Foreign Lariam PS Hoffmann La Roche

Initial or Prolonged Myalgia Other Inc ORAL 1.5 GRAM ORAL
Vertigo
Nivaquine
Arrhythmia
(Chloroquine
Headache Sulfate) SS ORAL ORAL
Pyrexia
Paludrine
Arthralgia
(Chloroguanide
Dysarthria Hydrochloride) C
Tremor
03-Apr-2012 09:37 AM Page: 354

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/01ISR Number: 3736491-9Report Type:Expedited (15-DaCompany Report #260506 Age:33 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Infectious Peritonitis Health Inc ORAL 250 MG 1 PER
Asthenia Professional WEEK ORAL
Abdominal Pain Other Stamaril Unidose
Pregnancy
(Yellow Fever
Sedation Vaccination) SS
Gastritis
Nausea
Vertigo
Abscess
Caesarean Section
Arterial Occlusive
Disease
Pyelonephritis
Balance Disorder
Post Procedural
Complication
Uterine Hypertonus
Date:06/08/01ISR Number: 3736492-0Report Type:Expedited (15-DaCompany Report #259776 Age:49 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thyroid Function Test Foreign Lariam PS Hoffmann La Roche
Abnormal Health Inc ORAL ORAL
Xanthelasma
Professional
Sleep Disorder
Other
Muscle Spasms
Alanine Aminotransferase
Increased
Lipids Increased
Malaise
Gamma-Glutamyltransferase
Increased
Blood Pressure Increased
Date:06/08/01ISR Number: 3736494-4Report Type:Expedited (15-DaCompany Report #247738 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pyelonephritis Foreign Lariam PS Hoffmann La Roche
Uterine Hypertonus Health Inc ORAL 250 MG 1 PER
Breech Presentation Professional WEEK ORAL
Premature Rupture Of Other Stamaril Unidose
Membranes
(Yellow Fever
Maternal Drugs Affecting Vaccine) C
Foetus
Caesarean Section

Date:06/08/01ISR Number: 3736496-8Report Type:Expedited (15-DaCompany Report #261363 Age:10 YR Gender:Female I/FU:I
Outcome PT Report Source
Other Serious Onycholysis Foreign
Health
03-Apr-2012 09:37 AM Page: 355

Professional
Other
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Product Role Manufacturer Route Dose Duration
Lariam PS Hoffmann La Roche
Inc ORAL ORAL 385 DAY
Hepatitis
Vaccinatioin
(Hepatitis Vaccine) C
Vivotif "Berna"
(Typhoid Vaccines) C
Date:06/08/01ISR Number: 3736661-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Eyelid Oedema Larium PS
Intervention to Burning Sensation Depakote SS
Prevent Permanent
Impairment/Damage
Face Oedema
Medication Error
Liver Disorder
Skin Disorder
Date:06/11/01ISR Number: 3736292-1Report Type:Expedited (15-DaCompany Report #247340 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Motor Dysfunction Lariam Tablets PS Roche FOR MANY
Nightmare
YEARS.
Vertigo Positional
Dizziness
Vomiting
Date:06/11/01ISR Number: 3736334-3Report Type:Expedited (15-DaCompany Report #261664 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vaginal Haemorrhage Lariam PS Roche 8 DAY
Date:06/11/01ISR Number: 3736338-0Report Type:Expedited (15-DaCompany Report #261561 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Placenta Praevia Lariam PS Roche 30 DAY
Initial or Prolonged
Date:06/11/01ISR Number: 3736345-8Report Type:Expedited (15-DaCompany Report #261498 Age:72 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death International Normalised Lariam PS Roche 37 DAY
Ratio Increased Cozaar Comp C 285 DAY
Drug Interaction Warfarin I VARYING DOSES
Haemorrhagic Stroke
AS PER INR.
03-Apr-2012 09:37 AM Page: 356

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/11/01ISR Number: 3736693-1Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Palpitations Larium PS BUCCAL 1 TABLE
Panic Attack
WEEKLY BUCCAL
Anxiety Loratadine C
Muscle Spasms
Nightmare
Date:06/12/01ISR Number: 3738728-9Report Type:Expedited (15-DaCompany Report #261561 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Placenta Praevia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Health Inc ORAL 1 DOSE FORM
Professional
1 PER WEEK
ORAL
Date:06/12/01ISR Number: 3738880-5Report Type:Expedited (15-DaCompany Report #261664 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vaginal Haemorrhage Health Lariam PS Hoffmann La Roche
Professional Inc ORAL 250 MG 1 PER
WEEK ORAL
Date:06/12/01ISR Number: 3738885-4Report Type:Expedited (15-DaCompany Report #247340 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nightmare Consumer Lariam PS Hoffmann La Roche
Vomiting Inc ORAL ORAL
Gait Disturbance
Vertigo Positional
Dizziness
Motor Dysfunction
Date:06/13/01ISR Number: 3738150-5Report Type:Direct Company Report # Age:62 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Lariam 250mg Roche PS Roche ORAL 1 TABLET PER
Fatigue
WEEK BY MOUTH
Disorientation Ambien C
Hypertension Cardizem C
Dizziness Biaxin C
Panic Attack Premarin C
Dyspnoea Provera C
Chest Pain Captopril C

Cipro C
03-Apr-2012 09:37 AM Page: 357

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/13/01ISR Number: 3738958-6Report Type:Expedited (15-DaCompany Report #261498 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Haemorrhagic Stroke Foreign Lariam PS Hoffmann La Roche
Drug Interaction Other Inc ORAL 250 MG 1 PER
International Normalised
Ratio Increased
Warfarin (Warfarin
Sodium) SS ORAL ORAL
Cozaar Comp
(Hydrochlorothiazide
/Losartan Potassium) C
WEEK ORAL
Date:06/15/01ISR Number: 3740168-3Report Type:Expedited (15-DaCompany Report #259927 Age:73 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diverticulitis Lariam Tablets PS Roche 36 DAY
Initial or Prolonged Gastrointestinal Aspirin Protect 100 SS 372 DAY
Haemorrhage Marcumar SS Roche
Date:06/15/01ISR Number: 3740171-3Report Type:Expedited (15-DaCompany Report #260569 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Lariam PS Roche 8 DAY
Initial or Prolonged Weight Decreased
Date:06/18/01ISR Number: 3740645-5Report Type:Expedited (15-DaCompany Report #259750 Age:94 DY Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Staring Lariam Tablets PS Roche 3 DAY
Inappropriate Affect
Panic Reaction
Date:06/18/01ISR Number: 3741496-8Report Type:Expedited (15-DaCompany Report #259927 Age:73 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Haemoglobin Decreased Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Diverticulitis Consumer Inc ORAL 1 DOSE FORM 1
Arthralgia Health PER WEEK ORAL
Gastrointestinal Professional Aspirin Protect 100
Haemorrhage (Aspirin) SS ORAL 100 MG DAILY
ORAL
Marcumar
(Phenprocoumon) SS ORAL 0.5 DOSE FORM
DAILY ORAL

Date:06/18/01ISR Number: 3741720-1Report Type:Expedited (15-DaCompany Report #260569 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Pregnancy Health Inc ORAL 250 MG 1 PER
Weight Decreased Professional WEEK ORAL
03-Apr-2012 09:37 AM Page: 358

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/20/01ISR Number: 3742310-7Report Type:Expedited (15-DaCompany Report #259933 Age:62 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asthenia Lariam PS Roche 74 DAY
Hypertension Ambien C AT NIGHT.
Fatigue Biaxin C TAKEN FOR 1
Panic Attack WEEK. 7 DAY
Premarin
C
Medroxyprogesterone C
Cipro C TAKEN FOR 1
WEEK 7 DAY
Captopril C 34 DAY
Cardizem
C
Date:06/20/01ISR Number: 3743711-3Report Type:Expedited (15-DaCompany Report #259750 Age:94 DY Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Inappropriate Affect Foreign Lariam PS Hoffmann La Roche
Panic Reaction Health Inc ORAL 62.5 MG ORAL
Staring
Professional
Hallucination
Date:06/21/01ISR Number: 3743483-2Report Type:Expedited (15-DaCompany Report #261561 Age:30 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Placenta Praevia Lariam PS Roche 30 DAY
Initial or Prolonged
Date:06/21/01ISR Number: 3743490-XReport Type:Expedited (15-DaCompany Report #260121 Age:51 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Creatine Lariam PS Roche 1056 DAY
Phosphokinase Increased Voltarene C
Blood Lactate Apranax C
Dehydrogenase Increased
Asthenia
Date:06/21/01ISR Number: 3743545-XReport Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Paraesthesia Larium PS ORAL ORAL
Insomnia
Chest Pain
Hypoaesthesia
Anxiety

Date:06/22/01ISR Number: 3745665-2Report Type:Expedited (15-DaCompany Report #259933 Age:62 YR Gender:Female I/FU:F
Outcome
Required
Intervention to
03-Apr-2012 09:37 AM Page: 359

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Prevent Permanent
Impairment/Damage
PT Report Source Product Role Manufacturer Route Dose Duration
Pneumonia Mycoplasmal Consumer Lariam PS Hoffmann La Roche
Chest Pain Inc ORAL 1 PER WEEK
Dizziness
ORAL
Asthenia
Ambien (Zolpidem
Disorientation Tartrate) C
Emotional Disorder
Biaxin
Blood Pressure Increased (Clarithromycin) C
Anxiety
Premarin (Estrogens,
Fatigue Conjugated) C
Hypertension
Medroxyprogesterone
Bronchitis
(Medroxyprogesterone
Fear Acetate) C
Panic Attack
Cipro (Ciprofloxacin
Dyspnoea Hydrochloride) C
Captopril
C
Cardizem (Diltiazem
Hydrochloride) C
Date:06/25/01ISR Number: 3745221-6Report Type:Expedited (15-DaCompany Report #244451 Age: Gender:Not SpecifiI/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Intra-Uterine Death Lariam PS Roche 50 DAY
Date:06/25/01ISR Number: 3745817-1Report Type:Direct Company Report # Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Sleep Disorder Larium PS ORAL 6/13/2001
Intervention to Influenza Like Illness 10/4/2001
Prevent Permanent Nervousness ORAL
Impairment/Damage Oropharyngeal Pain
Anxiety
Nasal Congestion
Ear Pain
Malaise
Date:06/25/01ISR Number: 3746822-1Report Type:Expedited (15-DaCompany Report #261561 Age:30 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Placenta Praevia Foreign Lariam (Mefloquine
Initial or Prolonged Caesarean Section Health Hydrochloride) 250
Pregnancy Professional Mg PS Hoffmann La Roche
Other Inc ORAL 250 MG 1 PER
WEEK ORAL

Date:06/25/01ISR Number: 3746823-3Report Type:Expedited (15-DaCompany Report #260121 Age:51 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Blood Lactate
Dehydrogenase Increased
Asthenia
03-Apr-2012 09:37 AM Page: 360

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Blood Creatine
Phosphokinase Increased
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam (Mefloquine
Health Hydrochloride) 250
Professional Mg PS Hoffmann La Roche
Inc ORAL 250 MG 1 PER
WEEK ORAL
Voltarene
(Diclofenac Sodium) C
Apranax (Naproxen
Sodium)
C
Date:06/26/01ISR Number: 3746273-XReport Type:Expedited (15-DaCompany Report #262670 Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Ineffective Lariam PS Roche 133 DAY
Malaria
Bacterial Infection
Date:06/26/01ISR Number: 3748077-0Report Type:Expedited (15-DaCompany Report #244451 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Maternal Drugs Affecting Foreign Lariam PS Hoffmann La Roche
Foetus Health Inc ORAL 250 MG, 1 PER
Pregnancy Professional WEEK ORAL
Intra-Uterine Death
Congenital Anomaly
Abortion Missed
Date:06/27/01ISR Number: 3748407-XReport Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Psychotic Disorder Lariam -(Mefloquine) PS Hoffman-Laroche 1 X WEEK FOR
Hospitalization - Anxiety 3 WKS (3
Initial or Prolonged Hallucination PILLS) 3 WK
Disability
Depression
Other Serious
Nightmare
Required
Paraesthesia
Intervention to
Heart Rate Irregular
Prevent Permanent
Impairment/Damage
Respiratory Arrest
Heart Rate Increased
Convulsion
Hallucination, Auditory

Date:06/28/01ISR Number: 3748646-8Report Type:Expedited (15-DaCompany Report #261500 Age:30 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Malaria
Asthenia
Gastric Ulcer
Irritability
Nausea
03-Apr-2012 09:37 AM Page: 361

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Insomnia
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche THE PATIENT
RECEIVED 3
TABLETS, THEN
TWO TABLETS
AND LATER ONE 2 DAY
Lariam SS Roche
Quinine
C
Mopral
C
Date:06/28/01ISR Number: 3749664-6Report Type:Expedited (15-DaCompany Report #262670 Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Bacterial Infection Foreign Lariam PS Hoffmann La Roche
Ill-Defined Disorder Consumer Inc ORAL 250 MG 1 PER
Drug Ineffective WEEK ORAL 133 DAY
Malaria
Diarrhoea
Date:07/02/01ISR Number: 3751059-6Report Type:Expedited (15-DaCompany Report #261500 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Irritability Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Drug Effect Decreased Health Inc ORAL ORAL
Malaria Professional Lariam (Mefloquine
Hepatic Function Abnormal Hydrochloride) SS ORAL ORAL
Gastric Ulcer Quinine C
Ileus Paralytic Mopral (Oemprazole) C
Insomnia
Nausea
Asthenia
Date:07/05/01ISR Number: 3751625-8Report Type:Expedited (15-DaCompany Report #260745 Age:52 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Guillain-Barre Syndrome Lariam PS Roche FOUR TABLETS
Initial or Prolonged IN TOTAL. 29 DAY
Tetanus Vaccine C
Yellow Fever Vaccine C
Cholera Vaccine C
Poliomyelitis
Vaccine
C
Hepatitis Vaccine C

Date:07/05/01ISR Number: 3751630-1Report Type:Expedited (15-DaCompany Report #259147 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Polymyalgia Rheumatica Lariam PS Roche
Nausea
Erythema Infectiosum
03-Apr-2012 09:37 AM Page: 362

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/05/01ISR Number: 3751640-4Report Type:Expedited (15-DaCompany Report #261224 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dysarthria Consumer Lariam PS Roche 2 DAY
Initial or Prolonged Tremor Nivaquine SS 50 DAY
Vertigo Paludrine C
Asthenia
Myalgia
Arthralgia
Headache
Pyrexia
Agitation
Vestibular Disorder
Arrhythmia
Date:07/05/01ISR Number: 3751672-6Report Type:Expedited (15-DaCompany Report #259147 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Erythema Infectiosum Health Lariam PS Roche
Polymyalgia Rheumatica Professional
Nausea
Date:07/05/01ISR Number: 3751687-8Report Type:Expedited (15-DaCompany Report #260745 Age:52 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Guillain-Barre Syndrome Consumer Lariam PS Roche FOUR TABLETS
Initial or Prolonged IN TOTAL. 29 DAY
Tetanus Vaccine C
Yellow Fever Vaccine C
Cholera Vaccine C
Poliomyelitis
Vaccine
C
Hepatitis Vaccine C
Date:07/05/01ISR Number: 3751701-XReport Type:Expedited (15-DaCompany Report #261224 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dysarthria Consumer Lariam PS Roche 2 DAY
Initial or Prolonged Asthenia Nivaquine SS 50 DAY
Headache Paludrine C
Arthralgia
Vestibular Disorder
Pyrexia
Agitation
Tremor
Myalgia
Vertigo

Arrhythmia
03-Apr-2012 09:37 AM Page: 363

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/05/01ISR Number: 3751721-5Report Type:Expedited (15-DaCompany Report #263420 Age:66 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Amnesia Lariam PS Roche 36 DAY
Confusional State Edecrin C
Naprosyn
C
Asa
C
Date:07/10/01ISR Number: 3754734-2Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Lariam Tablets PS Roche ESTIMATED 5
Initial or Prolonged Vertigo DOSES IN
Disability Headache TOTAL. 21 DAY
Anxiety
Panic Attack
Date:07/10/01ISR Number: 3754747-0Report Type:Expedited (15-DaCompany Report #261469 Age:32 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Decreased Appetite Lariam PS Roche 43 DAY
Anxiety Leios C
Coordination Abnormal
Night Sweats
Hepatitis A Antibody
Positive
Depression
Panic Attack
Liver Function Test
Abnormal
Memory Impairment
Flushing
Dizziness
Chills
Nausea
Diarrhoea
Date:07/10/01ISR Number: 3755913-0Report Type:Expedited (15-DaCompany Report #263420 Age:66 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Confusional State Consumer Lariam PS Hoffmann La Roche
Amnesia Inc ORAL 250 MG 1 PER
WEEK ORAL
Edecrin (Ethacrynate
Sodium Or Ethacrynic
Acid)
C
Naprosyn (Naproxen) C

Asa (Aspirin) C
03-Apr-2012 09:37 AM Page: 364

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/10/01ISR Number: 3756155-5Report Type:Expedited (15-DaCompany Report #261224 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Electroencephalogram Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Abnormal Other Inc ORAL 1.5 GRAM ORAL
Malaria
Nivaquine
Agitation
(Chloroquine
Myalgia Sulfate) SS ORAL ORAL
Headache
Paludrine
Dysarthria
(Chloroguanide
Asthenia Hydrochloride) C
Arrhythmia
Arthralgia
Tremor
Vestibular Disorder
Vertigo
Pyrexia
Date:07/10/01ISR Number: 3756157-9Report Type:Expedited (15-DaCompany Report #260745 Age:52 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mumps Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Bacterial Infection Other Inc ORAL 1 DOSE FORM 1
Guillain-Barre Syndrome
PER WEEK ORAL
Tetanus Vaccine
(Tetanus Toxoid) C
Yellow Fever Vaccine C
Cholera Vaccine
(Cholera Vaccine) C
Poliomyelitis
Vaccine
(Poliomyelitis
Vaccines)
C
Hepatitis Vaccine
(Hepatitis Vaccine) C
Date:07/10/01ISR Number: 3756283-4Report Type:Expedited (15-DaCompany Report #259147 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Polymyalgia Rheumatica Consumer Lariam PS Hoffmann La Roche
Erythema Infectiosum Inc ORAL ORAL
Nausea
Date:07/11/01ISR Number: 3755609-5Report Type:Expedited (15-DaCompany Report #262670 Age:23 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Ineffective Lariam PS Roche 133 DAY

Initial or Prolonged
Bacterial Infection
Ill-Defined Disorder
Diarrhoea
Malaria
03-Apr-2012 09:37 AM Page: 365

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/11/01ISR Number: 3755616-2Report Type:Expedited (15-DaCompany Report #263822 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Cardiac Arrest Lariam PS Roche 15 DAY
Grand Mal Convulsion
Date:07/12/01ISR Number: 3756377-3Report Type:Expedited (15-DaCompany Report #249874 Age:14 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Musculoskeletal Pain Lariam PS Roche TOTAL OF 5
Aphasia WEEKLY DOSES. 29 DAY
Nightmare Claritin-D C
Headache Biaxin C
Amnesia
Insomnia
Sensory Loss
Dyspnoea
Muscular Weakness
Abnormal Dreams
Weight Decreased
Dizziness
Palpitations
Hyperventilation
Nuclear Magnetic
Resonance Imaging
Abnormal
Alcoholism
Thirst
Influenza Like Illness
Injury
Blood Pressure Decreased
Anhedonia
Encephalopathy
Psychotic Disorder
Emotional Distress
Paraesthesia
Mental Disorder
Educational Problem
Electroencephalogram
Abnormal
Agitation
Visual Impairment
Balance Disorder
Sleep Disorder
Tinnitus
Hypophagia
Cold Sweat
Emotional Disorder

Date:07/12/01ISR Number: 3757198-8Report Type:Expedited (15-DaCompany Report #241365 Age:24 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Vertigo
Panic Attack
Depression
Headache
Anxiety
03-Apr-2012 09:37 AM Page: 366

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dizziness
Report Source Product Role Manufacturer Route Dose Duration
Consumer Lariam PS Hoffmann La Roche
Health Inc ORAL 250MG 1 PER
Professional
WEEK ORAL
Date:07/12/01ISR Number: 3757293-3Report Type:Expedited (15-DaCompany Report #261469 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Foreign Lariam PS Hoffmann La Roche
Panic Attack Consumer Inc ORAL 1 DOSE FORM 1
Nausea Health PER WEEK ORAL
Diarrhoea Professional Leios (Ethinyl
Depression
Estradiol/Levonorges
Hepatitis A trel) C
Chills
Coordination Abnormal
Agitation
Memory Impairment
Night Sweats
Abnormal Faeces
Anxiety
Decreased Appetite
Flushing
Date:07/13/01ISR Number: 3757307-0Report Type:Expedited (15-DaCompany Report #263895 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Rhabdomyolysis Lariam PS Roche
Initial or Prolonged
Date:07/13/01ISR Number: 3758782-8Report Type:Expedited (15-DaCompany Report #263822 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Grand Mal Convulsion Consumer Lariam PS Hoffmann La Roche
Cardiac Arrest Inc ORAL 250 MG 1 PER
1 WEEK ORAL
Date:07/13/01ISR Number: 3758798-1Report Type:Expedited (15-DaCompany Report #262670 Age:23 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Ill-Defined Disorder Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Diarrhoea Consumer Inc ORAL 250 MG 1 PER
Required Malaria Health WEEK ORAL 133 DAY

Intervention to Bacterial Infection Professional
Prevent Permanent Drug Ineffective
Impairment/Damage
03-Apr-2012 09:37 AM Page: 367

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/16/01ISR Number: 3759497-2Report Type:Expedited (15-DaCompany Report #249874 Age:14 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Palpitations Other Lariam PS Hoffmann La Roche
Headache Inc ORAL 250 MG 1 PER
Encephalopathy
WEEK ORAL
Emotional Distress
Claritin-D
Educational Problem
(Loratadine/Pseudoep
Hyperventilation hedrine Sulfate) C
Blood Pressure Decreased
Biaxin
Cognitive Disorder (Clarithromycin) C
Influenza Like Illness
Musculoskeletal Pain
Insomnia
Dyspnoea
Weight Decreased
Dizziness
Visual Impairment
Muscular Weakness
Cold Sweat
Hypophagia
Nightmare
Thirst
Electroencephalogram
Abnormal
Paraesthesia
Sensory Loss
Hypoaesthesia
Agitation
Balance Disorder
Dysarthria
Amnesia
Abnormal Dreams
Psychotic Disorder
Emotional Disorder
Injury
Nuclear Magnetic
Resonance Imaging
Abnormal
Mental Disorder
Coordination Abnormal
Date:07/17/01ISR Number: 3760015-3Report Type:Direct Company Report # Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hypophagia Lariam PS ORAL 1 PILL/ 4
Other Serious Lethargy DAYS/ ORAL
Anxiety
Hallucination
Fear

Date:07/17/01ISR Number: 3760208-5Report Type:Expedited (15-DaCompany Report #263895 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Rhabdomyolysis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Consumer Inc ORAL ORAL
03-Apr-2012 09:37 AM Page: 368

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/19/01ISR Number: 3760951-8Report Type:Direct Company Report # Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Amnesia Lariam (250 Mg)
Intervention to Abnormal Dreams (Mefloquine Hcl)
Prevent Permanent Sleep Disorder (Hoffmann-Laroche
Impairment/Damage Hallucinations, Mixed Inc.) PS Hoffman-Laroche Inc ORAL 1 250 MG
Chills
TABLET TAKEN
Depression
OARLLY
Anxiety
Headache
Disturbance In Attention
Paraesthesia
Gastrointestinal Disorder
Confusional State
Balance Disorder
Dizziness
Memory Impairment
Date:07/19/01ISR Number: 3761240-8Report Type:Expedited (15-DaCompany Report #264097 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Retinal Pigmentation Mefloquine
Angiogram Abnormal Hydrochloride PS Roche 190 DAY
Date:07/19/01ISR Number: 3764530-8Report Type:Periodic Company Report #1409764A Age:18 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicide Attempt Foreign Tylenol PS Mcneil Consumer
Apathy Other Products Co Div
Paranoia Mcneilab Inc UNKNOWN DOSE
Intentional Overdose Pseudoephedrine SS
Lariam (Meloquine)
250 Mg SS ORAL UNKNOWN DOSE,
PO
Date:07/23/01ISR Number: 3762418-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Larium/Mefloquine
Paraesthesia 250 Mg Roche PS Roche ORAL 250 MG ONCE A
Syncope
WEEK ORAL
Dizziness Orthocept C
Insomnia
Anxiety
Muscle Spasms
Paranoia

Date:07/23/01ISR Number: 3763556-8Report Type:Expedited (15-DaCompany Report #264097 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source
Other Serious Eye Disorder Foreign
Health
03-Apr-2012 09:37 AM Page: 369

Professional
Other
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Product Role Manufacturer Route Dose Duration
Lariam PS Hoffmann La Roche
Inc ORAL ORAL
Date:07/23/01ISR Number: 3763734-8Report Type:Expedited (15-DaCompany Report #256731 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Drug Interaction Literature Lariam PS Hoffmann La Roche
Malaria Health Inc ORAL ORAL
Circulatory Collapse Professional Halofantrine
Bronchopneumonia
(Halofantrine
Electrocardiogram Qt Hydrochloride) SS ORAL ORAL
Prolonged
Dirithromycin
Sudden Death (Dirithromycin) C ORAL ORAL
Arrhythmia Acetylcysteine C
Hypertrophic
Cardiomyopathy
Date:07/23/01ISR Number: 3764087-1Report Type:Expedited (15-DaCompany Report #249748 Age:55 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Confusional State Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Acute Psychosis Literature Inc
Hypertonia
Health
Professional
Date:07/24/01ISR Number: 3763645-8Report Type:Expedited (15-DaCompany Report #260795 Age:65 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Extrasystoles Health Lariam PS Roche 1 DAY
Transient Ischaemic Professional Aspirin C
Attack Mvi C
Atrial Fibrillation
Date:07/24/01ISR Number: 3763650-1Report Type:Expedited (15-DaCompany Report #263895 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Rhabdomyolysis Health Lariam PS Roche 22 DAY
Initial or Prolonged Headache Professional
Dizziness

Date:07/24/01ISR Number: 3763651-3Report Type:Expedited (15-DaCompany Report #263420 Age:66 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fatigue Health Lariam PS Roche 36 DAY
Confusional State Professional Edecrin C
Amnesia Naprosyn C
Depression Asa C
03-Apr-2012 09:37 AM Page: 370

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/25/01ISR Number: 3764221-3Report Type:Expedited (15-DaCompany Report #264611 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Health Lariam PS Roche A TOTAL OF
Initial or Prolonged Confusional State Professional THREE DOSES
Automatism
WERE
Hypochondriasis RECEIVED. 1 DAY
Agitation
Persecutory Delusion
Anxiety
Aggression
Amnesia
Date:07/25/01ISR Number: 3764225-0Report Type:Expedited (15-DaCompany Report #264612 Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Mefloquine
Anxiety Hydrochloride PS Roche MEFLOQUINE
Depression
WAS GIVEN
Suicidal Ideation
DURING A
Obsessive-Compulsive
PREVIOUS TRIP
Disorder
ABOUT SIX
Date:07/25/01ISR Number: 3765689-9Report Type:Expedited (15-DaCompany Report #264219 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death International Normalised Foreign Lariam PS Hoffmann La Roche
Hospitalization - Ratio Increased Other Inc 1 PER WEEK
Initial or Prolonged Pupils Unequal Warfarin Sodium
Haemorrhagic Stroke (Warfarin Sodium) 5
Hypothermia Mg SS 4 MG 1 PER 2
Bradycardia
DAY
Precerebral Artery
Cozaar (Losartan
Occlusion Potassium) C
Corneal Reflex Decreased
Arteriosclerosis
Hypotension
Hyporeflexia
Brain Oedema
Brain Scan Abnormal
Tachycardia
Drug Interaction
Respiratory Arrest
Date:07/25/01ISR Number: 3765695-4Report Type:Expedited (15-DaCompany Report #264199 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Thyroiditis Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Arthralgia Health Inc ORAL 1 DOSE FORM 1
Disability Psoriasis Professional PER ONE DOSE
Drug Interaction
ORAL
Lexomil SS ORAL 2 PER DAY
ORAL
Effexor SS ORAL 2 DOSE FORM
DAILY ORAL
03-Apr-2012 09:37 AM Page: 371

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Teralithe SS ORAL 400 MG 3 PER
DAY ORAL
Seropram SS ORAL 2 DOSE FORM
DAILY ORAL
Havlane
C
Plaquenil
C
Date:07/26/01ISR Number: 3765431-1Report Type:Expedited (15-DaCompany Report #256317 Age:54 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Sleep Disorder Lariam Tablets PS Roche 3288 DAY
Mood Swings Unknown Medication C MEDICATIONS
Diarrhoea
TAKEN IN
Mental Impairment
1994,1995 AND
Myalgia 1999.
Nightmare Doxycycline C
Anxiety
Fatigue
Depression
Weight Decreased
Alopecia
Date:07/26/01ISR Number: 3765442-6Report Type:Expedited (15-DaCompany Report #264404 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Lariam PS Roche 2 DAY
Initial or Prolonged Paranoia Proguanil C
Flushing Chloroquine C
Delusion
Confusional State
Date:07/26/01ISR Number: 3766229-0Report Type:Expedited (15-DaCompany Report #263420 Age:66 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Consumer Lariam PS Hoffmann La Roche
Confusional State Inc ORAL 250 MG 1 PER
Amnesia
Fatigue
Edecrin (Ethacrynate
Sodium Or Ethacrynic
Acid)
Asa (Aspirin)
C
C
WEEK ORAL
Date:07/26/01ISR Number: 3766252-6Report Type:Expedited (15-DaCompany Report #260795 Age:65 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Atrial Fibrillation Health Lariam PS Hoffmann La Roche
Heart Rate Irregular Professional Inc ORAL 250 MG, 1 PER
Transient Ischaemic
DOSE; ORAL
Attack Aspirin C
Extrasystoles
Mvi (Multivitamin
Speech Disorder Nos) C
03-Apr-2012 09:37 AM Page: 372

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/26/01ISR Number: 3766523-3Report Type:Expedited (15-DaCompany Report #263895 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoaesthesia Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Chest Pain Consumer Inc ORAL
Dizziness
Health
Rhabdomyolysis
Professional
Dyspnoea
Headache
Date:07/27/01ISR Number: 3767003-1Report Type:Expedited (15-DaCompany Report #264611 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Confusional State Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Persecutory Delusion Literature Inc ORAL 250 MG 1 PER
Automatism Health WEEK ORAL 1 DAY
Amnesia
Professional
Agitation
Other
Aggression
Hypochondriasis
Insomnia
Anxiety
Drug Level Above
Therapeutic
Pyrexia
Date:07/27/01ISR Number: 3767008-0Report Type:Expedited (15-DaCompany Report #264612 Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Foreign Lariam PS Hoffmann La Roche
Suicidal Ideation Literature Inc ORAL 250 MG 1 PER
Insomnia Health WEEK ORAL
Obsessive-Compulsive
Professional
Disorder
Other
Feeling Abnormal
Depression
Date:07/30/01ISR Number: 3766773-6Report Type:Expedited (15-DaCompany Report #264705 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Bipolar Disorder Mefloquine
Hydrochloride PS Roche THE PATIENT
TOOK A TOTAL
OF 1750MG.

Date:07/30/01ISR Number: 3766776-1Report Type:Expedited (15-DaCompany Report #203837 Age:53 YR Gender:Male I/FU:F
Outcome
Death
Hospitalization -
Initial or Prolonged
PT
Delirium
Agitation
Depression
Nervous System Disorder
Abnormal Dreams
03-Apr-2012 09:37 AM Page: 373

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Polydipsia
Photopsia
Delusional Disorder, Report Source Product Role Manufacturer Route Dose Duration
Persecutory Type Lariam Tablets PS Roche THE PATIENT
Hepatic Steatosis
RECEIVED A
Erectile Dysfunction
TOTAL OF NINE
Weight Decreased
TABLETS OF
Cognitive Disorder LARIAM. 67 DAY
Chills
Musculoskeletal Stiffness
Erythema
Blood Lactate
Dehydrogenase Increased
Blood Cortisol Increased
Claustrophobia
Obsessive-Compulsive
Disorder
Hallucinations, Mixed
Hyperhidrosis
Amnesia
Anxiety
Liver Function Test
Abnormal
Pyrexia
Completed Suicide
Flushing
Urinary Hesitation
Insomnia
Headache
Adjustment Disorder
Fatigue
Decreased Appetite
Petit Mal Epilepsy
Date:07/30/01ISR Number: 3766777-3Report Type:Expedited (15-DaCompany Report #264819 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaria Lariam PS Roche 93 DAY
Initial or Prolonged Drug Ineffective
Date:07/30/01ISR Number: 3768298-0Report Type:Expedited (15-DaCompany Report #256317 Age:54 YR Gender:Male I/FU:F
Outcome
Disability
PT
Irritability
Memory Impairment
Diarrhoea
Nightmare
Alopecia
Personality Disorder

Weight Decreased
Tension
Mood Swings
Obsessive-Compulsive
Disorder
Sleep Disorder
Mental Impairment
Muscular Weakness
03-Apr-2012 09:37 AM Page: 374

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Anxiety
Stress
Disturbance In Attention Report Source Product Role Manufacturer Route Dose Duration
Myalgia Other Lariam PS Hoffmann La Roche
Malaise
Inc
Fatigue
Unknown Medication
Depression
(Generic
Judgement Impaired
Component(S)
Unknown)
C
Doxycycline
(Doxycycline)
C
Date:07/30/01ISR Number: 3769075-7Report Type:Expedited (15-DaCompany Report #264404 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Flushing Health Inc ORAL 250 MG ORAL
Paranoia Professional Proguanil
Delusion
(Chloroguanide
Confusional State Hydrochloride) C
Chloroquine
C
Date:08/01/01ISR Number: 3769118-0Report Type:Expedited (15-DaCompany Report #203837 Age:53 YR Gender:Male I/FU:F
Outcome
Death
Hospitalization -
Initial or Prolonged
PT
Insomnia
Blood Lactate
Dehydrogenase Increased
Arterial Injury
Erythema
Obsessive-Compulsive
Disorder
Cognitive Disorder
Weight Decreased
Adjustment Disorder
Anxiety
Petit Mal Epilepsy
Nervous System Disorder
Headache
Chills
Hepatic Fibrosis
Spinal Cord Injury
Cervical
Subarachnoid Haemorrhage
Hepatic Function Abnormal
Fatigue
Polydipsia
Flushing
Urinary Hesitation

Agitation
Claustrophobia
Delusional Disorder,
Persecutory Type
Hepatic Necrosis
Completed Suicide
Delirium
Hallucinations, Mixed
03-Apr-2012 09:37 AM Page: 375

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hepatitis
Hepatic Steatosis
Erectile Dysfunction Report Source Product Role Manufacturer Route Dose Duration
Decreased Appetite Consumer Lariam PS Hoffmann La Roche
Blood Cortisol Increased Other Inc ORAL 250 MG 1 PER
Injury
1 WEEK ORAL
Cardiomegaly
Amnesia
Hyperhidrosis
Abnormal Dreams
Depression
Respiratory Disorder
Spinal Fracture
Laceration
Musculoskeletal Stiffness
Pyrexia
Photopsia
Date:08/01/01ISR Number: 3769201-XReport Type:Expedited (15-DaCompany Report #264705 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Foreign Lariam PS Hoffmann La Roche
Delusion Literature Inc 250 MG
Bipolar Disorder
Health
Electrocardiogram Qt
Professional
Prolonged
Date:08/01/01ISR Number: 3769641-9Report Type:Expedited (15-DaCompany Report #264819 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Foreign Lariam PS Hoffmann La Roche
Initial or Prolonged Weight Decreased Consumer Inc ORAL 1 DOSE FORM 1
Hyperhidrosis
PER WEEK ORAL
Malaise
Spinal Fracture
Fatigue
Malaria
Drug Ineffective
Date:08/02/01ISR Number: 3769264-1Report Type:Expedited (15-DaCompany Report #265424 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Leukopenia Lariam PS Roche 37 DAY
Date:08/03/01ISR Number: 3770284-1Report Type:Expedited (15-DaCompany Report #265284 Age:62 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Health Lariam PS Roche
Dizziness Professional Malarone SS 4 DAY
Tinnitus
Cardiac Arrest
03-Apr-2012 09:37 AM Page: 376

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/06/01ISR Number: 3770939-9Report Type:Expedited (15-DaCompany Report #265419 Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Abnormal Behaviour Lariam PS Roche 411 DAY
Emotional Disorder
Irritability
Hallucination
Date:08/07/01ISR Number: 3771367-2Report Type:Expedited (15-DaCompany Report #265329 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Illusion Lariam PS Roche
Dysarthria
Hallucination
Panic Attack
Disturbance In Attention
Date:08/07/01ISR Number: 3771784-0Report Type:Expedited (15-DaCompany Report #265284 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Health Lariam PS Hoffmann La Roche
Dizziness Professional Inc ORAL ORAL
Tinnitus Other Malarone
Cardiac Arrest
(Atovaquone/Chlorogu
anide Hydrochloride) SS ORAL ORAL
Date:08/07/01ISR Number: 3771899-7Report Type:Direct Company Report # Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Personality Change Lariam (Mefloquine)
Initial or Prolonged Abnormal Behaviour 250mg PS ORAL 250 MG PO +
Required Confusional State TAB QID
Intervention to
Insomnia
Prevent Permanent Feeling Abnormal
Impairment/Damage Disorientation
Date:08/07/01ISR Number: 3772128-0Report Type:Expedited (15-DaCompany Report #265424 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Dyspnoea Foreign Lariam PS Hoffmann La Roche
Pneumococcal Infection Other Inc ORAL 250 MG 1 PER
Leukopenia
1 WEEK ORAL
Pneumothorax
Cough
Blood Culture Positive

Pneumonia
03-Apr-2012 09:37 AM Page: 377

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/08/01ISR Number: 3771798-0Report Type:Expedited (15-DaCompany Report #252574 Age:21 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Mental Disorder Health Lariam Tablets PS Roche 4 TABLETS
Hospitalization - Agitation Professional TAKEN IN
Initial or Prolonged Pyrexia TOTAL. 21 DAY
Disability
Hyperventilation
Coma
Respiratory Failure
Convulsion
Influenza Like Illness
Date:08/08/01ISR Number: 3772873-7Report Type:Expedited (15-DaCompany Report #265419 Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hallucination Foreign Lariam (Mefloquine
Irritability Other Hydrochloride) PS Hoffmann La Roche
Abnormal Behaviour Inc ORAL 250 MG ORAL
Emotional Disorder
Date:08/09/01ISR Number: 3773720-XReport Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Neuropathy Peripheral Mefloquin PS 1 DAY
Convulsion
Visual Acuity Reduced
Insomnia
Disorientation
Tremor
Vertigo
Fatigue
Balance Disorder
Headache
Date:08/09/01ISR Number: 3775106-0Report Type:Expedited (15-DaCompany Report #252574 Age:21 YR Gender:Female I/FU:F
Outcome
Life-Threatening
Hospitalization -
Initial or Prolonged
Disability
PT
Malaise
Depressed Level Of
Consciousness
Autonomic Nervous System
Imbalance
Fear
Muscle Spasms
Hyperventilation
Agitation
Respiratory Arrest

Anxiety
Dyspnoea
Nausea
Respiratory Disorder
Convulsion
Pyrexia
Blood Ph Increased
Depression
03-Apr-2012 09:37 AM Page: 378

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pco2 Increased
Mental Disorder
Cyanosis Report Source Product Role Manufacturer Route Dose Duration
Respiratory Failure Foreign Lariam PS Hoffmann La Roche
Fatigue Health Inc ORAL 250 MG 1 PER
Apnoea Professional 1 WEEK ORAL
Coma
Other
Loss Of Consciousness
Stress
Influenza Like Illness
Restlessness
Arthralgia
Date:08/13/01ISR Number: 3774908-4Report Type:Expedited (15-DaCompany Report #64270 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Tremor Lariam PS Roche 154 DAY
Anxiety
Circulatory Collapse
Chronic Fatigue Syndrome
Hyperhidrosis
Bradycardia
Muscle Spasms
Dizziness
Headache
Date:08/13/01ISR Number: 3774917-5Report Type:Expedited (15-DaCompany Report #264404 Age:22 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paranoia Lariam PS Roche 2 DAY
Initial or Prolonged Psychotic Disorder Proguanil C 1 DAY
Flushing Chloroquine C 1 DAY
Confusional State
Delusion
Date:08/15/01ISR Number: 3778531-7Report Type:Expedited (15-DaCompany Report #64270 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Chronic Fatigue Syndrome Foreign Lariam PS Hoffmann La Roche
Dizziness Literature Inc ORAL 250 MG ORAL
Anxiety
Other
Headache
Bradycardia
Hyperhidrosis
Tremor
Muscle Spasms
Circulatory Collapse

Date:08/15/01ISR Number: 3778546-9Report Type:Expedited (15-DaCompany Report #264404 Age:22 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Psychotic Disorder
Delusion
03-Apr-2012 09:37 AM Page: 379

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorientation
Paranoia
Confusional State Report Source Product Role Manufacturer Route Dose Duration
Flushing Foreign Lariam PS Hoffmann La Roche
Health Inc ORAL 250 MG ORAL
Professional
Proguanil
Other
(Chloroguanide
Hydrochloride) C
Chloroquine
(Chloroquine)
C
Date:08/17/01ISR Number: 3778887-5Report Type:Expedited (15-DaCompany Report #265854 Age:17 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Bronchospasm Lariam PS Roche 1 DAY
Date:08/17/01ISR Number: 3779696-3Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Larium 25o Mg Roche PS Roche ORAL PO
Insomnia Typhoid Vi C
Nausea Ipol C
Date:08/21/01ISR Number: 3781466-7Report Type:Expedited (15-DaCompany Report #265854 Age:17 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Bronchospasm Foreign Lariam PS Hoffmann La Roche
Health Inc ORAL 1 DOSE FORM
Professional
DAILY ORAL
Date:08/21/01ISR Number: 3781711-8Report Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Lariam / 250 / La
Initial or Prolonged Depression Roche/Hoffman PS La Roche/Hoffman SUBLINGUAL 1 TABLE /
Other Serious Abnormal Dreams ONCE A WEEK /
Psychomotor Hyperactivity
SUBLINGUAL
Nervousness
Nausea
Panic Attack
Anxiety
Dizziness
Flatulence
Cold Sweat

Date:08/23/01ISR Number: 3782314-1Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I
Outcome
Life-Threatening
Required
Intervention to
03-Apr-2012 09:37 AM Page: 380

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Prevent Permanent
Impairment/Damage
PT Report Source Product Role Manufacturer Route Dose Duration
Ecchymosis Lariam PS 1 TAB 250MG
Grand Mal Convulsion
EACH WK FOR
Fall
156 WKS
PATIENT TOOK
1 DOSE ON
Date:08/23/01ISR Number: 3782498-5Report Type:Direct Company Report # Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Larium PS ORAL ONCE WEEK
Paranoia
ORAL
Depression
Date:08/28/01ISR Number: 3783549-4Report Type:Expedited (15-DaCompany Report #266589 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Feeling Jittery Lariam PS Roche 36 DAY
Initial or Prolonged Paraesthesia Alcohol C
Panic Attack
Toxicity To Various
Agents
Anxiety
Palpitations
Confusional State
Date:08/28/01ISR Number: 3783984-4Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Panic Attack
Larium 228.0 Mg Of
Abnormal Dreams Free Base/ Roche PS Roche ORAL 1 TABLE/ PER
Palpitations
WEEK/ ORAL
Muscle Spasms
Abdominal Pain
Fatigue
Insomnia
Convulsion
Date:08/30/01ISR Number: 3785111-6Report Type:Expedited (15-DaCompany Report #264819 Age:31 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Ineffective Lariam PS Roche 46 DAY
Initial or Prolonged Malaria

Date:08/30/01ISR Number: 3785996-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
03-Apr-2012 09:37 AM Page: 381

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disability
PT Report Source Product Role Manufacturer Route Dose Duration
Anxiety Mefloquine / Larium PS ONE PILL
Panic Attack
WEEKLY
Dizziness
Fatigue
Paraesthesia
Vision Blurred
Movement Disorder
Eye Pain
Abnormal Dreams
Dyspnoea
Date:08/30/01ISR Number: 3786101-XReport Type:Expedited (15-DaCompany Report #266589 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Palpitations Consumer Lariam (Mefloquine
Initial or Prolonged Anxiety Hydrochloride) 250
Toxicity To Various Mg PS ORAL 250 MG 1
Agents
PER WEEK ORAL
Feeling Jittery Alcohol (Alcohol) C
Paraesthesia
Confusional State
Panic Attack
Date:09/03/01ISR Number: 3787527-0Report Type:Expedited (15-DaCompany Report #264819 Age:31 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hyperhidrosis Foreign Lariam (Mefloquine
Initial or Prolonged Meningitis Viral Consumer Hydrochloride ) 250
Back Injury Health Mg PS ORAL 250 MG 1 PER
Spinal Fracture Professional WEEK ORAL
Weight Decreased
Malaria
Drug Ineffective
Date:09/04/01ISR Number: 3786713-3Report Type:Expedited (15-DaCompany Report #267025 Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dementia Lariam PS Roche 1 DAY
Chloroquine
C
Date:09/05/01ISR Number: 3787956-5Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nightmare Lariam PS ORAL 1PILL WEEKLY
Vertigo
ORAL
Mental Disorder Claritin C
03-Apr-2012 09:37 AM Page: 382

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/05/01ISR Number: 3788705-7Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Lariam 250 Mg
Initial or Prolonged Affective Disorder (Mefloquine Hcl)
Other Serious Psychotic Disorder (Roche Laboratories) PS Roche Laboratories 250 MG 1 X
Disturbance In Attention
WEEK
Insomnia Halofentrine C
Anxiety
Hyperhidrosis
Pyrexia
Hallucination
Neurotoxicity
Diarrhoea
Panic Attack
Dizziness
Tinnitus
Date:09/06/01ISR Number: 3789407-3Report Type:Expedited (15-DaCompany Report #267025 Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Cerebral Atrophy Foreign Lariam PS
Health
Chloroquine
Professional (Chloroquine) C
Date:09/10/01ISR Number: 3789468-1Report Type:Expedited (15-DaCompany Report #203837 Age:53 YR Gender:Male I/FU:F
Outcome
Death
Hospitalization -
Initial or Prolonged
PT
Hyperhidrosis
Hepatic Steatosis
Abnormal Dreams
Amnesia
Photopsia
Blood Cortisol Increased
Nervous System Disorder
Urinary Hesitation
Agitation
Weight Decreased
Adjustment Disorder
Erythema
Delusional Disorder,
Persecutory Type
Flushing
Insomnia
Petit Mal Epilepsy
Completed Suicide
Polydipsia
Delirium
Fatigue

Musculoskeletal Stiffness
Blood Lactate
Dehydrogenase Increased
Obsessive-Compulsive
Disorder
Depression
Headache
Anxiety
03-Apr-2012 09:37 AM Page: 383

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Decreased Appetite
Liver Function Test
Abnormal Report Source Product Role Manufacturer Route Dose Duration
Pyrexia Lariam Tablets PS Roche THE PATIENT
Chills
RECEIVED A
Hallucinations, Mixed
TOTAL OF NINE
Cognitive Disorder
TABLETS OF
Erectile Dysfunction LARIAM. 67 DAY
Claustrophobia
Date:09/10/01ISR Number: 3789481-4Report Type:Expedited (15-DaCompany Report #265469 Age:48 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Loss Of Libido Lariam PS Roche 1 DAY
Sensory Loss Mirtazapine C
Anorgasmia Prempak-C C DOSE
DESCRIBED AS
0.125 ONCE
PER DAY. NO
UNITS OF
Fluoxetine C 1462 DAY
Date:09/13/01ISR Number: 3792786-4Report Type:Expedited (15-DaCompany Report #265469 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Sexual Dysfunction Foreign Lariam (Melfloquine
Loss Of Libido Health Hydrochloride) PS ORAL ORAL
Sensory Loss Professional Mirtazapine C
Anorgasmia
Local Swelling
Prempak-C
(Estrogens,
Conjugated/Norgestre
l) C
Fluoxetine
C
Date:09/13/01ISR Number: 3793046-8Report Type:Expedited (15-DaCompany Report #203837 Age:53 YR Gender:Male I/FU:F
Outcome
Death
Hospitalization -
Initial or Prolonged
PT
Adjustment Disorder
Polydipsia
Anxiety
Delirium
Musculoskeletal Stiffness
Delusional Disorder,
Persecutory Type
Decreased Appetite
Abnormal Dreams
Dermatitis

Amnesia
Hyperkeratosis
Blood Cortisol Increased
Petit Mal Epilepsy
Weight Decreased
Hallucinations, Mixed
Hepatic Necrosis
Erectile Dysfunction
03-Apr-2012 09:37 AM Page: 384

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Agitation
Fatigue
Flushing Report Source Product Role Manufacturer Route Dose Duration
Liver Disorder Consumer Lariam Tablets
Urinary Hesitation Other (Melfloquine
Hepatic Function Abnormal Hydrochloride) 250
Headache Mg PS ORAL 250 MG 1 PER
Insomnia
1 WEEK ORAL
Hyperhidrosis
Depression
Injury
Claustrophobia
Arteriosclerosis
Pyrexia
Hepatic Steatosis
Photopsia
Neoplasm
Obsessive-Compulsive
Disorder
Cognitive Disorder
Cardiomegaly
Chills
Completed Suicide
Inflammation
Nervous System Disorder
Rash Erythematous
Date:09/17/01ISR Number: 3793857-9Report Type:Direct Company Report # Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Lariam 250 Mg
Panic Attack Hoffman-Laroche PS Hoffman-Laroche ORAL 1 250 WEEK
Anxiety
ORAL
Paraesthesia Sudafed C
Paranoia
Suicidal Ideation
Depression
Heart Rate Increased
Hallucination
Hypoaesthesia
Date:09/17/01ISR Number: 3793869-5Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hyperhidrosis Larium PS Roche ORAL 250 MG/
Tremor
1X/WEEK/ ORAL
Respiratory Disorder
Tachycardia
Panic Attack

Date:09/21/01ISR Number: 3796268-5Report Type:Expedited (15-DaCompany Report #252449 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Ventricular Septal Defect Lariam Tablets PS Roche 60 DAY
Initial or Prolonged Congenital Pneumonia Typhoral C
03-Apr-2012 09:37 AM Page: 385

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Yellow Fever Vaccine C 1 DAY
Date:09/24/01ISR Number: 3797262-0Report Type:Expedited (15-DaCompany Report #267335 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Tremor Lariam PS Roche 8 DAY
Initial or Prolonged Hallucination
Sleep Disorder
Confusional State
Anxiety
Date:09/24/01ISR Number: 3797270-XReport Type:Expedited (15-DaCompany Report #268058 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Brain Oedema Lariam PS Roche
Initial or Prolonged Depression Aspirin Soluble C
Headache
Pyrexia
Influenza Like Illness
Liver Function Test
Abnormal
Date:09/24/01ISR Number: 3797282-6Report Type:Expedited (15-DaCompany Report #268319 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Brain Neoplasm Lariam PS Roche
Date:09/24/01ISR Number: 3797771-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Throat Tightness Lariam PS Roche
Initial or Prolonged Respiratory Rate Pharmaceuticals ORAL ONE PILL/ PER
Disability Increased WEEK/ ORAL
Panic Attack
Ear Pain
Emotional Disorder
Paraesthesia
Insomnia
Heart Rate Increased
Vertigo
Dyspnoea
Hypoaesthesia
Tremor
Burning Sensation
Feeling Abnormal

Anxiety
Palpitations
03-Apr-2012 09:37 AM Page: 386

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/25/01ISR Number: 3797740-4Report Type:Expedited (15-DaCompany Report #259147 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Polymyalgia Rheumatica Lariam PS Roche
Erythema Infectiosum
Dengue Fever
Nausea
Date:09/25/01ISR Number: 3797747-7Report Type:Expedited (15-DaCompany Report #268381 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thrombocytopenia Lariam PS Roche
Haematoma
Date:09/26/01ISR Number: 3798430-4Report Type:Expedited (15-DaCompany Report #265854 Age:17 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Bronchospasm Lariam PS Roche 1 DAY
Date:09/26/01ISR Number: 3799276-3Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Syncope Mefloquine PS ORAL WEEKLY ORAL
Gastrooesophageal Reflux
Disease
Abdominal Distension
Heart Rate Increased
Discomfort
Dizziness
Myalgia
Fatigue
Anxiety
Muscle Spasms
Headache
Date:09/27/01ISR Number: 3799042-9Report Type:Expedited (15-DaCompany Report #267025 Age:55 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dementia Lariam PS Roche 43 DAY
Chloroquine
C
Date:09/27/01ISR Number: 3801651-5Report Type:Expedited (15-DaCompany Report #252449 Age: Gender:Female I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
PT
Chlamydial Infection
Pregnancy
Cyanosis
Ventricular Septal Defect
Acquired
Congenital Pneumonia
Neonatal Respiratory
03-Apr-2012 09:37 AM Page: 387

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Distress Syndrome
Maternal Drugs Affecting
Foetus
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam Tablets
Health
(Mefloquine
Professional Hydrochloride) PS ORAL ORAL
Typhoral (Typhoid
Vaccines)
C
Yellow Fever Vaccine
(Yellow Feve
Vaccine)
C
Date:09/28/01ISR Number: 3800344-8Report Type:Expedited (15-DaCompany Report #268717 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Asthenia Lariam PS Roche
Palpitations
Dry Mouth
Agitation
Anxiety
Tinnitus
Date:09/28/01ISR Number: 3800349-7Report Type:Expedited (15-DaCompany Report #268666 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Alkaline Lariam PS Roche
Initial or Prolonged Phosphatase Increased
Jaundice
Aspartate
Aminotransferase
Increased
Date:09/28/01ISR Number: 3802046-0Report Type:Direct Company Report # Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Disturbance In Attention Lariam 250 Mg Tablet PS ORAL 250 MG ONCE A
Other Serious Pain WEEK ORAL
Influenza Like Illness
Insomnia
Dizziness
Headache
Arthralgia
Date:10/01/01ISR Number: 3801850-2Report Type:Expedited (15-DaCompany Report #268622 Age:2 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Bilirubin Increased Lariam PS Roche
Aspartate
Aminotransferase
Increased
03-Apr-2012 09:37 AM Page: 388

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/01/01ISR Number: 3803270-3Report Type:Expedited (15-DaCompany Report #267335 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Foreign Lariam (Mefloquine
Initial or Prolonged Sleep Disorder Health Hydrochloride) PS ORAL 250 MG 1 PER
Tremor Professional WEEK ORAL
Hallucination
Confusional State
Date:10/01/01ISR Number: 3803271-5Report Type:Expedited (15-DaCompany Report #268058 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Liver Function Test Foreign Lariam
Initial or Prolonged Abnormal Other (Mefloquine
Brain Oedema Hydrochloride) PS ORAL ORAL
Influenza Like Illness
Aspirin Soluble
Pyrexia (Aspirin) C
Hepatocellular Injury
Headache
Depression
Date:10/01/01ISR Number: 3804291-7Report Type:Expedited (15-DaCompany Report #268319 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Brain Neoplasm Consumer Lariam (Mefloquine
Hydrochloride) PS ORAL ORAL
Date:10/02/01ISR Number: 3802203-3Report Type:Expedited (15-DaCompany Report #268857 Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Diabetes Mellitus Mefloquine
Inadequate Control Hydrochloride PS Roche 2 DAY
Insulin
C
Date:10/02/01ISR Number: 3802214-8Report Type:Expedited (15-DaCompany Report #268799 Age:41 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mania Lariam PS Roche THE PATIENT
Initial or Prolonged Faecal Incontinence WAS REPORTED
Nightmare
TO HAVE TAKEN
Insomnia TWO DOSES. 8 DAY
Urinary Incontinence Prozac C
Paranoia
Tachycardia
Hallucination

Date:10/02/01ISR Number: 3804021-9Report Type:Expedited (15-DaCompany Report #268381 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source
Other Serious Haematoma Foreign
Thrombocytopenia
Health
03-Apr-2012 09:37 AM Page: 389

Professional
Other
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Product Role Manufacturer Route Dose Duration
Lariam (Mefloquine
Hydrochloride) PS
Date:10/02/01ISR Number: 3804064-5Report Type:Expedited (15-DaCompany Report #259147 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Polymyalgia Rheumatica Consumer Lariam (Mefloquine
Asthenia Hydrochloride) PS ORAL ORAL
Joint Effusion
Arthralgia
Decreased Appetite
Dengue Fever
Erythema Infectiosum
Bone Pain
Date:10/03/01ISR Number: 3803283-1Report Type:Expedited (15-DaCompany Report #268895 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Melaena Lariam PS Roche
Ziac
C
Lipitor
C
Date:10/03/01ISR Number: 3805396-7Report Type:Expedited (15-DaCompany Report #268622 Age:2 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Bilirubin Increased Foreign Lariam (Mefloquine
Aspartate Health Hydrochloride) PS ORAL ORAL
Aminotransferase
Professional
Increased
Date:10/03/01ISR Number: 3805674-1Report Type:Expedited (15-DaCompany Report #265854 Age:17 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Bronchospasm Foreign Lariam (Mefloquine
Choking Health Hydrochloride) PS ORAL 1 DOSE FORM
Professional
DAILY ORAL
Date:10/04/01ISR Number: 3804837-9Report Type:Expedited (15-DaCompany Report #268666 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Jaundice Foreign Lariam (Mefloquine
Initial or Prolonged Blood Albumin Increased Health Hydrochloride) PS ORAL 250 MG 1 PER
Aspartate Professional WEEK ORAL
Aminotransferase
Increased
Blood Alkaline
Phosphatase Increased
Blood Bilirubin Increased
03-Apr-2012 09:37 AM Page: 390

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/04/01ISR Number: 3804838-0Report Type:Expedited (15-DaCompany Report #268717 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dry Mouth Foreign Lariam (Mefloquine
Anxiety Other Hydrochloride) 250
Agitation Mg PS ORAL ORAL
Tinnitus
Palpitations
Asthenia
Date:10/04/01ISR Number: 3804840-9Report Type:Expedited (15-DaCompany Report #267025 Age:55 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Cerebral Atrophy Foreign Lariam (Mefloquine
Cognitive Disorder Health Hydrochloride) 250
Professional Mg PS
Other
Chloroquine
(Chloroquine)
C
Date:10/04/01ISR Number: 3805279-2Report Type:Expedited (15-DaCompany Report #268857 Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Decreased Activity Foreign Mefloquine
Hypoglycaemia Health Hydrochloride PS ORAL 250 MG 1 PER
Diabetes Mellitus Professional DAY ORAL
Inadequate Control Other Insulin (Insulin) C
Date:10/04/01ISR Number: 3805297-4Report Type:Expedited (15-DaCompany Report #268799 Age:41 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Palpitations Consumer Lariam (Mefloquine
Initial or Prolonged Hallucination Hydrochloride) PS ORAL 250 MG 1 PER
Paranoia
WEEK ORAL
Faecal Incontinence
Prozac (Fluoxetine
Insomnia Hydrochloride) C
Urinary Incontinence
Mania
Tachycardia
Nightmare
Date:10/05/01ISR Number: 3806709-2Report Type:Expedited (15-DaCompany Report #268895 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Melaena Consumer Lariam (Mefloquine
Faeces Discoloured Hydrochloride) PS ORAL ORAL

Ziac (Bisoprolol
Fumarate/Hydrochloro
thiazide)
Lipitor
(Atorvastatin
Calcium)
C
C
03-Apr-2012 09:37 AM Page: 391

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/09/01ISR Number: 3806216-7Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fatigue Mefoquine 250mg La
Decreased Appetite Roche PS La Roche ORAL 250MG WEEKLY
Weight Decreased
ORAL
Tremor
Vision Blurred
Ill-Defined Disorder
Disturbance In Attention
Lethargy
Frequent Bowel Movements
Myalgia
Date:10/11/01ISR Number: 3806934-0Report Type:Expedited (15-DaCompany Report #203837 Age:53 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Polydipsia Consumer Lariam Tablets PS Roche THE PATIENT
Hospitalization - Decreased Appetite RECEIVED A
Initial or Prolonged Photopsia TOTAL OF NINE
Claustrophobia
TABLETS OF
Hyperhidrosis LARIAM. 67 DAY
Abnormal Dreams
Cognitive Disorder
Agitation
Completed Suicide
Anxiety
Petit Mal Epilepsy
Erythema
Fatigue
Liver Function Test
Abnormal
Obsessive-Compulsive
Disorder
Weight Decreased
Headache
Urinary Hesitation
Amnesia
Insomnia
Hallucinations, Mixed
Depression
Flushing
Delirium
Adjustment Disorder
Delusional Disorder,
Persecutory Type
Hepatic Steatosis
Nervous System Disorder
Chills
Musculoskeletal Stiffness
Pyrexia

Erectile Dysfunction
Blood Lactate
Dehydrogenase Increased
Blood Cortisol Increased
03-Apr-2012 09:37 AM Page: 392

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/11/01ISR Number: 3806935-2Report Type:Expedited (15-DaCompany Report #263895 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dizziness Health Lariam PS Roche 22 DAY
Initial or Prolonged Headache Professional
Rhabdomyolysis
Date:10/12/01ISR Number: 3807758-0Report Type:Expedited (15-DaCompany Report #269202 Age:63 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Haemorrhage Lariam PS Roche
Skin Necrosis Metformin Hcl C
Drug Interaction Marcumar I Roche
Date:10/15/01ISR Number: 3809502-XReport Type:Expedited (15-DaCompany Report #203837 Age:53 YR Gender:Male I/FU:F
Outcome
Death
Hospitalization -
Initial or Prolonged
PT
Chills
Anxiety
Petit Mal Epilepsy
Weight Decreased
Pyrexia
Cardiomegaly
Spinal Cord Injury
Hepatic Necrosis
Amnesia
Fatigue
Delirium
Musculoskeletal Stiffness
Hepatic Steatosis
Delusional Disorder,
Persecutory Type
Liver Function Test
Abnormal
Spinal Cord Injury
Cervical
Blood Lactate
Dehydrogenase Increased
Blood Cortisol Increased
Depression
Laceration
Arterial Injury
Injury
Hyperhidrosis
Decreased Appetite
Flushing
Headache
Dermatitis
Erectile Dysfunction

Hyperkeratosis
Abnormal Dreams
Agitation
Completed Suicide
Urinary Hesitation
Adjustment Disorder
Insomnia
Cyst
03-Apr-2012 09:37 AM Page: 393

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Subarachnoid Haemorrhage
Claustrophobia
Nervous System Disorder Report Source Product Role Manufacturer Route Dose Duration
Spinal Fracture Consumer Lariam Tablets
Arteriosclerosis Coronary Other (Mefloquine
Artery Hydrochloride) 250
Polydipsia Mg PS Hoffman-La Roche ORAL 250 MG 1 PER
Obsessive-Compulsive
1 WEEK, ORAL
Disorder
Cognitive Disorder
Hallucinations, Mixed
Photopsia
Erythema
Hepatitis
Brain Scan Abnormal
Date:10/15/01ISR Number: 3809714-5Report Type:Expedited (15-DaCompany Report #263895 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Iris Adhesions Foreign Lariam (Melfloquine
Initial or Prolonged Headache Consumer Hydrochloride) PS ORAL ORAL
Rhabdomyolysis
Health
Antibody Test Positive Professional
Chest Pain
Dizziness
Dyspnoea
Astigmatism
Muscle Atrophy
Date:10/16/01ISR Number: 3809077-5Report Type:Expedited (15-DaCompany Report #263420 Age:66 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fatigue Lariam PS Roche 36 DAY
Confusional State Edecrin C
Depression Naprosyn C
Amnesia Asa C
Date:10/16/01ISR Number: 3809095-7Report Type:Expedited (15-DaCompany Report #269729 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viith Nerve Paralysis Lariam PS Roche 1 DAY
Paraesthesia
Date:10/16/01ISR Number: 3810178-6Report Type:Expedited (15-DaCompany Report #269202 Age:63 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Ulcer Foreign Lariam (Mefloquine
Drug Interaction Other Hydrochloride) 250
Skin Necrosis Mg PS ORAL 250 MG 1 PER
Haemorrhage Subcutaneous
WEEK ORAL
Marcumar
(Phenprocoumon) 3 Mg SS ORAL 1.5 MG DAILY
ORAL
03-Apr-2012 09:37 AM Page: 394

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Metformin Hcl
(Metformin
Hydrochloride)
C
Date:10/17/01ISR Number: 3809774-1Report Type:Expedited (15-DaCompany Report #268895 Age:60 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gastric Haemorrhage Lariam PS Roche 1584 DAY
Ziac
C
Lipitor
C
Date:10/18/01ISR Number: 3811130-7Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Mephaquin (Mepha
Nightmare
Ltd) Alsch-Basil,
Switzerland PS Mepha Ltd ONE TABLET Q
WEEK
Date:10/18/01ISR Number: 3811971-6Report Type:Expedited (15-DaCompany Report #263420 Age:66 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hypoxia Consumer Lariam (Mefloquine
Depression Hydrochloride) 250
Confusional State Mg PS ORAL 250 MG 1 PER
Fatigue
Amnesia
Edecrin (Ethacrynate
Sodium Or Ethacrynic
Acid)
Naprosyn (Naproxen)
Asa (Aspirin)
C
C
C
WEEK ORAL
Date:10/18/01ISR Number: 3812046-2Report Type:Expedited (15-DaCompany Report #269729 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Eye Irritation Foreign Lariam PS ORAL 250 MG 1 PER
Hypoaesthesia Other WEEK ORAL
Paraesthesia
Viith Nerve Paralysis
Date:10/19/01ISR Number: 3812448-4Report Type:Expedited (15-DaCompany Report #268895 Age:60 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Melaena Consumer Lariam (Mefloquine
Haematemesis Hydrochloride) PS ORAL ORAL
Gastrointestinal
Ziac (Bisoprolol
Haemorrhage
Fumarate/Hydrochloro
thiazide)
C
Lipitor
(Atorvastatin
Calcium)
C
03-Apr-2012 09:37 AM Page: 395

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/22/01ISR Number: 3813829-5Report Type:Expedited (15-DaCompany Report #253217 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Placental Insufficiency Lariam Tablets PS Roche 3 DOSES TAKEN
Initial or Prolonged Placental Disorder IN TOTAL ON
Premature Labour 28 DEC 2000,
Oligohydramnios 04 JAN 2001
AND 11 JAN 15 DAY
Ass-Ratiopharm C 5 DAY
Codein C 1 DAY
Gelsemium C 29 DAY
Cimicifuga C 29 DAY
Paracetamol C 29 DAY
Acc Brausetabletten C 5 DAY
Superpep C 1 DAY
Date:10/22/01ISR Number: 3813843-XReport Type:Expedited (15-DaCompany Report #263895 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Lariam PS Roche 22 DAY
Initial or Prolonged Rhabdomyolysis
Dizziness
Date:10/22/01ISR Number: 3813867-2Report Type:Expedited (15-DaCompany Report #268622 Age:2 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Bilirubin Increased Lariam PS Roche
Aspartate
Aminotransferase
Increased
Date:10/23/01ISR Number: 3811978-9Report Type:Expedited (15-DaCompany Report #237587 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Intra-Uterine Death Lariam PS Roche 550 DAY
Accidental Exposure
Date:10/24/01ISR Number: 3812634-3Report Type:Expedited (15-DaCompany Report #242880 Age:42 YR Gender:Female I/FU:F
Outcome
Disability
PT
Panic Reaction
Alopecia
Anxiety
Depression
Neurological Symptom

Thinking Abnormal
Demyelination
Hemiparesis
Vision Blurred
Nausea
Dysgraphia
Optic Neuritis
Memory Impairment
03-Apr-2012 09:37 AM Page: 396

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abdominal Pain
Delusion
Amnesia Report Source Product Role Manufacturer Route Dose Duration
Diarrhoea Lariam PS Roche 15 DAY
Abdominal Distension
Nightmare
Dizziness
Date:10/24/01ISR Number: 3813739-3Report Type:Expedited (15-DaCompany Report #268622 Age:2 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Bilirubin Increased Foreign Lariam (Mefloquine
Aspartate Health Hydrochloride) 250
Aminotransferase Professional Mg PS ORAL ORAL
Increased
Other
Date:10/24/01ISR Number: 3813743-5Report Type:Expedited (15-DaCompany Report #253217 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Placental Insufficiency Foreign Lariam Tablets
Initial or Prolonged Foetal Growth Restriction Health (Mefloquine
Placental Disorder Professional Hydrochloride) PS ORAL 1 DOSE FORM
Premature Labour
1 PER WEEK
Maternal Drugs Affecting
ORAL
Foetus
Ass-Ratiopharm
Oligohydramnios (Aspirin) C
Codein (Codeine) C
Gelsemium
(Gelsemium)
C
Cimicifuga
(Cimicifuga)
C
Paracetamol
(Acetaminophen) C
Acc Brausetabletten
(Acetylcysteine) C
Superpep
(Dimenhydrinate) C
Date:10/24/01ISR Number: 3813776-9Report Type:Expedited (15-DaCompany Report #263895 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Iris Adhesions Foreign Lariam (Mefloquine
Initial or Prolonged Rhabdomyolysis Consumer Hydrochloride) PS ORAL ORAL
Paraesthesia
Health
Dyspnoea
Professional
Chest Pain
Dizziness

Eye Injury
Astigmatism
Headache
Pulmonary Embolism
Pupillary Reflex Impaired
03-Apr-2012 09:37 AM Page: 397

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/25/01ISR Number: 3815531-2Report Type:Expedited (15-DaCompany Report #237587 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Accidental Exposure Foreign Lariam (Mefloquine
Maternal Drugs Affecting Consumer Hydrochloride) 250
Foetus Health Mg PS ORAL ORAL
Intra-Uterine Death
Professional
Pregnancy
Other
Date:10/26/01ISR Number: 3815722-0Report Type:Expedited (15-DaCompany Report #242880 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nausea Health Lariam (Mefloquine
Toxicity To Various Professional Hydrochloride) PS ORAL 1 DOSE FORM
Agents Other 1 PER WEEK
Delusion
ORAL
Neuralgia
Abdominal Pain
Depression
Amnesia
Hypoaesthesia
Thinking Abnormal
Optic Neuritis
Herpes Zoster
Headache
Hemiparesis
Antinuclear Antibody
Positive
Panic Reaction
Dizziness
Paraesthesia
Abdominal Distension
Memory Impairment
Demyelination
Pain
Alopecia
Dysgraphia
Vision Blurred
Anxiety
Diarrhoea
Nightmare
Date:10/30/01ISR Number: 3816587-3Report Type:Expedited (15-DaCompany Report #257525 Age:63 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depressed Level Of Lariam Tablets PS Roche ONLY ONE DOSE
Initial or Prolonged Consciousness TAKEN. 1 DAY
Aphasia
Amnesia

Date:10/30/01ISR Number: 3816590-3Report Type:Expedited (15-DaCompany Report #253217 Age: Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Placental Disorder
Premature Labour
03-Apr-2012 09:37 AM Page: 398

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Placental Insufficiency
Oligohydramnios
Report Source Product Role Manufacturer Route Dose Duration
Lariam Tablets PS Roche 3 DOSES TAKEN
IN TOTAL ON
28 DEC 2000,
04 JAN 2001
AND 11 JAN 15 DAY
Ass-Ratiopharm C 5 DAY
Codein C 1 DAY
Gelsemium C 29 DAY
Cimicifuga C 29 DAY
Paracetamol C 29 DAY
Acc Brausetabletten C 5 DAY
Superpep C 1 DAY
Date:10/30/01ISR Number: 3817332-8Report Type:Direct Company Report # Age:34 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Larium PS 1 TABLE
Depression
WEEKLY
Date:10/31/01ISR Number: 3817244-XReport Type:Expedited (15-DaCompany Report #256317 Age:54 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Weight Decreased Lariam PS Roche 3288 DAY
Diarrhoea Unknown Medication C MEDICATIONS
Nightmare
TAKEN IN
Fatigue
1994,1995 AND
Anxiety 1999.
Myalgia Doxycycline C
Bipolar Disorder
Depression
Alopecia
Mental Impairment
Mood Swings
Sleep Disorder
Date:11/01/01ISR Number: 3819874-8Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Feeling Abnormal Lariam 250 Mg Roche PS Roche ORAL 1 TABLE WEEK
Required Palpitations ORAL
Intervention to
Ventricular Extrasystoles
Prevent Permanent
Impairment/Damage
Panic Attack
Dissociation
Hyperhidrosis

Dyspnoea
Anxiety
03-Apr-2012 09:37 AM Page: 399

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/02/01ISR Number: 3818568-2Report Type:Expedited (15-DaCompany Report #300688 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Coordination Abnormal Lariam PS Roche
Disturbance In Attention
Dizziness
Date:11/02/01ISR Number: 3819609-9Report Type:Expedited (15-DaCompany Report #253217 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Placental Disorder Foreign Lariam
Initial or Prolonged Foetal Growth Restriction Health (Mefloquine
Maternal Drugs Affecting Professional Hydrochloride) PS TRANSPLACENTAL 1 DOSE FORM 1
Foetus
PER WEEK ORAL
Oligohydramnios
Ass-Ratiopharm
Premature Labour (Aspirin) C
Calcinosis Codein (Codeine) C
Placental Insufficiency
Gelsemium
(Gelsemium)
C
Cimicifuga
(Cimicifuga)
C
Paracetamol
(Acetaminophen) C
Acc Brausetabletten
(Acetylcysteine) C
Superpep
(Dimenhydrinate) C
Date:11/02/01ISR Number: 3819610-5Report Type:Expedited (15-DaCompany Report #257525 Age:63 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Aphasia Foreign Lariam
Initial or Prolonged Speech Disorder Other (Mefloquine
Depressed Level Of Hydrochloride)250 Mg PS ORAL 250 MG 1 PER
Consciousness
ONE DOSE ORAL
Amnesia
Date:11/02/01ISR Number: 3819850-5Report Type:Expedited (15-DaCompany Report #256317 Age:54 YR Gender:Male I/FU:F
Outcome
Disability
PT
Disturbance In Attention
Memory Impairment
Cognitive Disorder
Judgement Impaired
Bipolar Disorder
Mood Swings
Alopecia

Depression
Anxiety
Diarrhoea
Myalgia
Fatigue
Sleep Disorder
Mental Impairment
Muscular Weakness
03-Apr-2012 09:37 AM Page: 400

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Weight Decreased
Obsessive-Compulsive
Disorder Report Source Product Role Manufacturer Route Dose Duration
Nightmare Other Lariam (Mefloquine
Hydrochloride) PS
Doxycycline
(Doxycycline)
C
Date:11/06/01ISR Number: 3820350-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nausea Lariam (Mefloquine)
Fatigue 250 Mg Tablets PS ORAL ONCE A WEEK
Disturbance In Attention
ORAL
Dizziness
Feeling Abnormal
Pyrexia
Date:11/08/01ISR Number: 3821839-7Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Larium PS
Psychotic Disorder
Depression
Date:11/15/01ISR Number: 3824467-2Report Type:Expedited (15-DaCompany Report #263822 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Grand Mal Convulsion Lariam PS Roche 15 DAY
Movement Disorder
Tinnitus
Vision Blurred
Cardiac Arrest
Hearing Impaired
Dizziness
Date:11/19/01ISR Number: 3825625-3Report Type:Expedited (15-DaCompany Report #251768 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Limb Malformation Lariam PS Roche
Date:11/19/01ISR Number: 3827544-5Report Type:Expedited (15-DaCompany Report #263822 Age:62 YR Gender:Male I/FU:F

Outcome
Life-Threatening
PT
Dizziness
Pulse Absent
Tinnitus
Thinking Abnormal
Headache
Muscle Twitching
Vision Blurred
03-Apr-2012 09:37 AM Page: 401

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Memory Impairment
Cardiac Arrest
Grand Mal Convulsion Report Source Product Role Manufacturer Route Dose Duration
Deafness Health Lariam (Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
1 WEEK ORAL
Date:11/21/01ISR Number: 3829085-8Report Type:Expedited (15-DaCompany Report #251768 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Pregnancy Foreign Lariam (Mefloquine
Maternal Drugs Affecting Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Foetus Professional PER WEEK ORAL
Limb Reduction Defect
Abortion Induced
Date:11/21/01ISR Number: 3829480-7Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Coordination Abnormal Lariam 250 Mg PS ORAL 1 ORAL
Dizziness
Date:11/26/01ISR Number: 3828569-6Report Type:Expedited (15-DaCompany Report #203837 Age:53 YR Gender:Male I/FU:F
Outcome
Death
Hospitalization -
Initial or Prolonged
PT
Abnormal Dreams
Fatigue
Delusional Disorder,
Persecutory Type
Insomnia
Erythema
Depression
Hepatic Steatosis
Weight Decreased
Cognitive Disorder
Polydipsia
Amnesia
Chills
Petit Mal Epilepsy
Hyperhidrosis
Flushing
Nervous System Disorder
Decreased Appetite
Claustrophobia
Headache
Adjustment Disorder

Anxiety
Musculoskeletal Stiffness
Liver Function Test
Abnormal
Erectile Dysfunction
Completed Suicide
Pyrexia
Agitation
03-Apr-2012 09:37 AM Page: 402

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Blood Lactate
Dehydrogenase Increased
Blood Cortisol Increased Report Source Product Role Manufacturer Route Dose Duration
Obsessive-Compulsive Lariam Tablets PS Roche THE PATIENT
Disorder
RECEIVED A
Hallucinations, Mixed
TOTAL OF NINE
Urinary Hesitation
TABLETS OF
Delirium LARIAM. 67 DAY
Photopsia Cyproheptadine C AT BEDTIME.
Date:11/26/01ISR Number: 3828570-2Report Type:Expedited (15-DaCompany Report #215428 Age:66 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Urinary Retention Lariam Tablets PS Roche 28 DAY
Initial or Prolonged Panic Disorder Without Tamoxifen C
Disability Agoraphobia Fosamax C
Nightmare
Urinary Tract Infection
Dehydration
Anxiety
Schizophrenia
Agitation
Insomnia
Date:11/26/01ISR Number: 3828571-4Report Type:Expedited (15-DaCompany Report #86887 Age:43 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Peripheral Sensory Lariam Tablets PS Roche 49 DAY
Neuropathy
Ill-Defined Disorder
Suicidal Ideation
Myalgia
Tinnitus
Epistaxis
Sleep Disorder
Csf Protein Abnormal
Flushing
Pain
Asthenia
Malaise
Convulsion
Nervousness
Date:11/26/01ISR Number: 3828603-3Report Type:Expedited (15-DaCompany Report #301583 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nervous System Disorder Lariam PS Roche 8 TABLETS

Initial or Prolonged Gastrointestinal Disorder TAKEN OVER 2
DAYS.
03-Apr-2012 09:37 AM Page: 403

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/26/01ISR Number: 3828607-0Report Type:Expedited (15-DaCompany Report #302003 Age:43 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam PS Roche 46 DAY
Paraesthesia
Demyelination
Asthenia
Date:11/28/01ISR Number: 3831370-0Report Type:Expedited (15-DaCompany Report #215428 Age:66 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Consumer Lariam Tablets
Initial or Prolonged Panic Reaction Other (Mefloquine
Disability Schizophrenia Hydrochloride) 250
Agitation Mg PS ORAL 250 MG 1 PER
Anxiety
WEEK ORAL
Nightmare
Tamoxifen (Tamoxifen
Urinary Retention Citrate) C
Emotional Disorder
Fosamax (Alendronate
Circadian Rhythm Sleep Sodium) C
Disorder
Oliguria
Dehydration
Date:11/28/01ISR Number: 3831775-8Report Type:Expedited (15-DaCompany Report #203837 Age:53 YR Gender:Male I/FU:F
Outcome
Death
Hospitalization -
Initial or Prolonged
PT
Decreased Appetite
Arterial Injury
Erectile Dysfunction
Insomnia
Blood Lactate
Dehydrogenase Increased
Respiratory Disorder
Hepatic Fibrosis
Weight Decreased
Hallucinations, Mixed
Nervous System Disorder
Subarachnoid Haemorrhage
Photopsia
Abnormal Dreams
Obsessive-Compulsive
Disorder
Claustrophobia
Ventricular Hypertrophy
Musculoskeletal Stiffness
Delusional Disorder,
Persecutory Type
Chills

Completed Suicide
Blood Cortisol Increased
Depression
Arteriosclerosis
Hepatic Function Abnormal
Amnesia
Anxiety
Delirium
03-Apr-2012 09:37 AM Page: 404

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pyrexia
Hepatic Steatosis
Headache Report Source Product Role Manufacturer Route Dose Duration
Hyperhidrosis Consumer Lariam Tablets
Agitation Other (Mefloquine
Flushing Hydrochloride) 250
Petit Mal Epilepsy Mg PS ORAL 250 MG 1 PER
Urinary Hesitation
1 WEEK ORAL
Rash Erythematous
Cyproheptadine
Fatigue
(Cyproheptadine
Polydipsia Hydrochloride) C
Injury
Erythema
Cognitive Disorder
Spinal Fracture
Adjustment Disorder
Date:11/28/01ISR Number: 3831847-8Report Type:Expedited (15-DaCompany Report #86887 Age:43 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fatigue Foreign Lariam Tablets
Flushing Consumer (Mefloquine
Blood Immunoglobulin G Health Hydrochloride) PS ORAL ORAL 49 DAY
Increased
Professional
Sleep Disorder
Other
Convulsion
Herpes Simplex
Myalgia
Skin Atrophy
Antinuclear Antibody
Positive
Malaise
Laboratory Test Abnormal
Tinnitus
Suicidal Ideation
Asthenia
Muscular Weakness
Norepinephrine Increased
Peripheral Sensory
Neuropathy
Feeling Of Body
Temperature Change
Infectious Mononucleosis
Nervousness
Chest Pain
Blood Albumin Decreased
Epistaxis
Herpes Zoster

Date:11/28/01ISR Number: 3831980-0Report Type:Expedited (15-DaCompany Report #301583 Age:37 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Abdominal Pain
Affective Disorder
Hallucination
Paranoia
Headache
03-Apr-2012 09:37 AM Page: 405

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Insomnia
Dizziness
Agitation Report Source Product Role Manufacturer Route Dose Duration
Nausea Foreign Lariam (Mefloquine
Gastrointestinal Disorder Literature Hydrocloride) PS ORAL ORAL
Anxiety
Health
Mental Disorder
Professional
Confusional State
Constipation
Date:11/28/01ISR Number: 3832228-3Report Type:Expedited (15-DaCompany Report #302003 Age:43 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Electromyogram Abnormal Foreign Lariam (Mefloquine
Demyelination Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Neuropathy Peripheral Professional PER WEEK ORAL
Asthenia
Muscle Contractions
Involuntary
Anxiety
Paraesthesia
Date:12/04/01ISR Number: 3833485-XReport Type:Expedited (15-DaCompany Report #302763 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Haematuria Lariam PS Roche
Date:12/05/01ISR Number: 3836429-XReport Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Atrioventricular Block Mefloquine PS
Initial or Prolonged Second Degree Claritin C
Motrin
C
Date:12/07/01ISR Number: 3836514-2Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nervous System Disorder Lariam
Initial or Prolonged Hoffman-Laroche PS Hoffman-Laroche 1 PILL 1 TIME
Other Serious
Date:12/07/01ISR Number: 3837755-0Report Type:Expedited (15-DaCompany Report #302763 Age:21 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Haematuria Foreign Lariam (Mefloquine
Other Hydrochloride) 250
Mg PS 1 DOSE FORM 1
PER WEEK
03-Apr-2012 09:37 AM Page: 406

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/10/01ISR Number: 3836508-7Report Type:Expedited (15-DaCompany Report #252788 Age:74 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Behaviour Lariam Tablets PS Roche 8 DAY
Delusion Tanakan C
Ludiomil C TAKEN AT
BEDTIME.
Toco
C
Aspegic C TAKEN AT
BEDTIME.
Aricept
C
Xatral
C
Date:12/12/01ISR Number: 3839260-4Report Type:Expedited (15-DaCompany Report #252788 Age:74 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Foreign Lariam Tablets
Abnormal Behaviour Health (Mefloquine
Professional Hydrochloride) PS ORAL 1 DOSE FORM 1
PER WEEK ORAL
Tanakan (Ginkgo) C
Ludiomil
(Maprotiline
Hydrochloride) C
Toco (Vitamin E) C
Aspegic (Aspirin
Dl-Lysine)
C
Aricept (Donepezil) C
Xatral (Alfuzosin
Hydrochloride) C
Date:12/18/01ISR Number: 3839742-5Report Type:Expedited (15-DaCompany Report #303413 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsions Local Lariam PS Roche 3 DAY
Initial or Prolonged Epilepsy Corticosteroids C
Date:12/18/01ISR Number: 3839747-4Report Type:Expedited (15-DaCompany Report #303343 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Nausea Lariam PS Roche
Hospitalization - Cardiac Arrest
Initial or Prolonged Fatigue
Date:12/18/01ISR Number: 3840025-8Report Type:Expedited (15-DaCompany Report #269729 Age:29 YR Gender:Female I/FU:F

Outcome
Other Serious
PT
Eye Irritation
Headache
Fatigue
Viith Nerve Paralysis
Dizziness
Paraesthesia
03-Apr-2012 09:37 AM Page: 407

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Diplopia
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche 1 DAY
Date:12/19/01ISR Number: 3842512-5Report Type:Expedited (15-DaCompany Report #303413 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Foreign Lariam (Mefloquine
Initial or Prolonged Loss Of Consciousness Health Hydrochloride) PS ORAL ORAL 3 DAY
Grand Mal Convulsion Professional Corticosteroids
Depression
(Corticosteroid Nos) C
Date:12/19/01ISR Number: 3842514-9Report Type:Expedited (15-DaCompany Report #303343 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Fatigue Foreign Lariam (Mefloquine
Hospitalization - Meningism Health Hydrochloride) PS ORAL 250 MG 1 PER
Initial or Prolonged Cerebral Ischaemia Professional WEEK ORAL
Loss Of Consciousness
Cardiac Arrest
Date:12/20/01ISR Number: 3843382-1Report Type:Expedited (15-DaCompany Report #269729 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diplopia Foreign Lariam (Mefloquine
Dizziness Other Hydrochloride) 250
Burning Sensation Mg PS ORAL 250 MG 1 PER
Fatigue
WEEK ORAL
Headache
Hypoaesthesia
Viith Nerve Paralysis
Paraesthesia
Date:12/21/01ISR Number: 3842639-8Report Type:Expedited (15-DaCompany Report #303685 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Catatonia Lariam PS Roche 1 DAY
Initial or Prolonged Psychomotor Retardation
Confusional State
Amnesia
Date:12/21/01ISR Number: 3842640-4Report Type:Expedited (15-DaCompany Report #303614 Age:38 YR Gender:Male I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
PT
Alanine Aminotransferase
Increased
Aspartate
Aminotransferase
Increased
Blood Creatine
03-Apr-2012 09:37 AM Page: 408

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Phosphokinase Increased
Myalgia
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche 44 DAY
Date:12/27/01ISR Number: 3845437-4Report Type:Expedited (15-DaCompany Report #303614 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Alanine Aminotransferase Foreign Lariam (Mefloquine
Initial or Prolonged Increased Other Hydrochloride) PS ORAL ORAL
Oedema
Muscle Disorder
Inflammation
Myalgia
Aspartate
Aminotransferase
Increased
Blood Creatine
Phosphokinase Increased
Back Pain
Date:12/27/01ISR Number: 3845439-8Report Type:Expedited (15-DaCompany Report #303685 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Confusional State Foreign Lariam (Mefloquine
Initial or Prolonged Catatonia Health Hydrochloride) PS ORAL 5 DOSE FORM
Amnesia Professional DAILY ORAL
Psychomotor Retardation Other
Date:12/31/01ISR Number: 3845986-9Report Type:Direct Company Report #CTU 157943 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Emotional Disorder Mefloquine PS 1 TAB Q WEEK
Fatigue
Dizziness
Headache
Chills
Confusional State
Depression
Insomnia
Nightmare
Anxiety
Date:01/02/02ISR Number: 3846227-9Report Type:Expedited (15-DaCompany Report #86887 Age:43 YR Gender:Female I/FU:F

Outcome
Disability
PT
Convulsion
Malaise
Nervousness
Sleep Disorder
Pain
Asthenia
Tinnitus
03-Apr-2012 09:37 AM Page: 409

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Muscular Weakness
Peripheral Sensory
Neuropathy Report Source Product Role Manufacturer Route Dose Duration
Suicidal Ideation Lariam Tablets PS Roche 49 DAY
Csf Protein Abnormal
Flushing
Epistaxis
Myalgia
Ill-Defined Disorder
Date:01/04/02ISR Number: 3849007-3Report Type:Expedited (15-DaCompany Report #86887 Age:43 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Feeling Hot Foreign Lariam Tablets
Loss Of Consciousness Consumer (Mefloquine
Peripheral Sensory Health Hydrochloride) 250
Neuropathy Professional Mg PS ORAL ORAL 49 DAY
Decreased Activity
Other
Epistaxis
Nervousness
Tinnitus
Hepatitis B Surface
Antigen Positive
Asthenia
Pain
Arthropod Bite
Back Pain
Lipoatrophy
Convulsion
Csf Oligoclonal Band
Present
Neck Pain
Sleep Disorder
Angina Pectoris
Antibody Test Positive
Fatigue
Malaise
Myalgia
Suicidal Ideation
Csf Protein Abnormal
Muscular Weakness
Paraesthesia
Epstein-Barr Virus
Antibody Positive
Feeling Cold
Hypoaesthesia
Date:01/07/02ISR Number: 3848563-9Report Type:Expedited (15-DaCompany Report #303413 Age:25 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsions Local Lariam PS Roche 11 DAY
Initial or Prolonged Epilepsy Corticosteroids C
03-Apr-2012 09:37 AM Page: 410

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/07/02ISR Number: 3848564-0Report Type:Expedited (15-DaCompany Report #303976 Age:48 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Headache Lariam PS Roche 21 DAY
Extrasystoles
Convulsion
Cardiac Arrest
Bradycardia
Visual Impairment
Date:01/07/02ISR Number: 3849817-2Report Type:Direct Company Report #CTU 158576 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Arrhythmia Lariam Roche PS Roche ORAL 1 TABLE WEEK
Hospitalization - Ventricular Tachycardia ORAL
Initial or Prolonged
Date:01/08/02ISR Number: 3849126-1Report Type:Expedited (15-DaCompany Report #304340 Age:15 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depressed Level Of Lariam PS Roche 32 DAY
Initial or Prolonged Consciousness
Disability
Visual Acuity Reduced
Suicidal Ideation
Macular Oedema
Myalgia
Hemiparesis
Hypoaesthesia
Hallucination
Headache
Date:01/09/02ISR Number: 3849476-9Report Type:Expedited (15-DaCompany Report #302003 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam PS Roche 59 DAY
Asthenia
Date:01/09/02ISR Number: 3849479-4Report Type:Expedited (15-DaCompany Report #304145 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Guillain-Barre Syndrome Lariam PS Roche
Date:01/09/02ISR Number: 3850223-5Report Type:Expedited (15-DaCompany Report #303976 Age:48 YR Gender:Male I/FU:I

Outcome
Life-Threatening
PT
Cardiac Arrest
Extrasystoles
Eye Pain
Grand Mal Convulsion
Bradycardia
Headache
03-Apr-2012 09:37 AM Page: 411

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Visual Impairment
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam (Mefloquine
Other Hydrochloride) PS ORAL 1 DOSE FORM 1
PER WEEK ORAL
Date:01/09/02ISR Number: 3850225-9Report Type:Expedited (15-DaCompany Report #303413 Age:25 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Epilepsy Foreign Lariam (Mefloquine
Initial or Prolonged Grand Mal Convulsion Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Depression Professional PER WEEK ORAL
Corticosteroids
(Corticosteroids
Nos)
C
Date:01/10/02ISR Number: 3850029-7Report Type:Expedited (15-DaCompany Report #263822 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Grand Mal Convulsion Lariam PS Roche 15 DAY
Hearing Impaired
Movement Disorder
Tinnitus
Vision Blurred
Cardiac Arrest
Date:01/10/02ISR Number: 3851407-2Report Type:Expedited (15-DaCompany Report #304340 Age:15 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depressed Level Of Other Lariam (Mefloquine
Initial or Prolonged Consciousness Hydrochloride) 250
Disability Myalgia Mg PS ORAL 250 MG 1 PER
Hypoaesthesia
WEEK ORAL
Paraesthesia
Hemiparesis
Hemiplegia
Hallucination
Headache
Suicidal Ideation
Depression
Eye Swelling
Blindness
Date:01/11/02ISR Number: 3850921-3Report Type:Expedited (15-DaCompany Report #259087 Age: Gender:Not SpecifiI/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Abortion Induced Lariam Tablets PS Roche 8 DAY
Anencephaly
03-Apr-2012 09:37 AM Page: 412

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/11/02ISR Number: 3852084-7Report Type:Expedited (15-DaCompany Report #304145 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Guillain-Barre Syndrome Foreign Lariam (Mefloquine
Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:01/11/02ISR Number: 3852090-2Report Type:Expedited (15-DaCompany Report #302003 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Electromyogram Abnormal Foreign Lariam (Mefloquine
Affective Disorder Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Dysaesthesia Professional PER WEEK ORAL
Muscle Contractions
Involuntary
Anxiety
Demyelinating
Polyneuropathy
Asthenia
Date:01/14/02ISR Number: 3852358-XReport Type:Expedited (15-DaCompany Report #263822 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Cardiac Arrest Health Lariam (Mefloquine
Grand Mal Convulsion Professional Hydrochloride) 250
Headache Mg PS ORAL 250 MG 1 PER
Memory Impairment
1 WEEK ORAL
Deafness
Obstructive Airways
Disorder
Pulse Absent
Dizziness
Thinking Abnormal
Movement Disorder
Vision Blurred
Tinnitus
Date:01/14/02ISR Number: 3852926-5Report Type:Expedited (15-DaCompany Report #259087 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Abortion Induced Foreign Lariam Tablets
Maternal Drugs Affecting Health (Mefloquine
Foetus Professional Hydrochloride) PS ORAL 1 DOSE FORM 1
Anencephaly
PER WEEK ORAL

Date:01/17/02ISR Number: 3854155-8Report Type:Expedited (15-DaCompany Report #304615 Age: Gender:Male I/FU:I
Outcome
Congenital Anomaly
PT
Ear Malformation
Hydrocephalus
Dysmorphism
Maternal Exposure During
03-Apr-2012 09:37 AM Page: 413

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pregnancy
Abortion Induced
Pregnancy
Maternal Drugs Affecting Report Source Product Role Manufacturer Route Dose Duration
Foetus Foreign Lariam (Mefloquine
Haemorrhage Other Hydrochloride) PS ORAL 1 DOSE FORM 1
Deformity Of Orbit
PER WEEK ORAL
Thrombocytopenia
Date:01/21/02ISR Number: 3854428-9Report Type:Expedited (15-DaCompany Report #304615 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Multiple Congenital Lariam PS Roche 21 DAY
Abnormalities
Maternal Drugs Affecting
Foetus
Hydrocephalus
Chondromatosis
Ear Malformation
Dysmorphism
Date:01/21/02ISR Number: 3854429-0Report Type:Expedited (15-DaCompany Report #305025 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Withdrawal Syndrome Mefloquine
Panic Disorder Hydrochloride PS Roche 430 DAY
Date:01/21/02ISR Number: 3854469-1Report Type:Expedited (15-DaCompany Report #305014 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chronic Myeloid Leukaemia Lariam PS Roche 265 DAY
Initial or Prolonged
Date:01/22/02ISR Number: 3855316-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11660594 Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaria Aprovel Tabs PS Bristol-Myers Squibb
Initial or Prolonged Liver Function Test Company ORAL 3 MON
Abnormal Lariam SS ORAL 6 WK
Pyrexia
Hepatitis B Virus
Vaccine
C
Hepatitis A Virus
Vaccine
C
Typhoid Vaccine C
Yellow Fever Vaccine C

Date:01/22/02ISR Number: 3857526-9Report Type:Expedited (15-DaCompany Report #305025 Age:54 YR Gender:Male I/FU:I
Outcome
Required
Intervention to
Prevent Permanent
03-Apr-2012 09:37 AM Page: 414

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Impairment/Damage
PT Report Source Product Role Manufacturer Route Dose Duration
Drug Withdrawal Syndrome Foreign Mefloquine
Panic Disorder Other Hydrochloride
(Mefloquine
Hydrochloride) PS ORAL 1 PER DAY
ORAL
Date:01/22/02ISR Number: 3857527-0Report Type:Expedited (15-DaCompany Report #304615 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Amniotic Cavity Disorder Foreign Lariam (Melfloquine
Abortion Induced Other Hydrochloride) PS ORAL DOSE FORM 1
Dysmorphism PER WEEK ORAL 21 DAY
Foetal Disorder
Deformity Of Orbit
Hydrocephalus
Thrombocytopenia
Maternal Drugs Affecting
Foetus
Cerebral Haemorrhage
Foetal
Date:01/23/02ISR Number: 3856157-4Report Type:Expedited (15-DaCompany Report #301407 Age:23 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vision Blurred Lariam PS Roche 36 DAY
Disturbance In Attention Zyban SS 7 DAY
Vertigo Trinordiol C
Insomnia
Tremor
Dry Mouth
Hyperhidrosis
Energy Increased
Date:01/23/02ISR Number: 3859719-3Report Type:Expedited (15-DaCompany Report #305014 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chronic Myeloid Leukaemia Foreign Lariam (Mefloquine
Initial or Prolonged Other Hydrochloride) PS ORAL 250 MG DAILY
ORAL
Date:01/23/02ISR Number: 3860005-6Report Type:Direct Company Report #CTU 159881 Age:59 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Hearing Impaired Lariam -Mefloquine-
Intervention to 250 Mg Roch PS Roch ORAL 250 MG
Prevent Permanent
WEEKLY ORAL
Impairment/Damage Tri-Estrogen +
Progesterone
C
03-Apr-2012 09:37 AM Page: 415

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/23/02ISR Number: 3860023-8Report Type:Direct Company Report #CTU 159878 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nausea Lariam 250mg Roche PS Roche ORAL 1 TABLE WEEK
Insomnia
ORAL
Memory Impairment
Panic Attack
Decreased Appetite
Anxiety
Depression
Disturbance In Attention
Nervousness
Fatigue
Date:01/24/02ISR Number: 3860046-9Report Type:Direct Company Report #CTU 159858 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Lariam (250 Mg)
Initial or Prolonged Paranoia (Tablets (Ud),Roche
Required Panic Disorder Labs) PS Roche Labs ORAL 250MG 1
Intervention to Dizziness TABLET ORALLY
Prevent Permanent Fatigue WEEKLY
Impairment/Damage Hallucination
Abnormal Dreams
Heart Rate Increased
Nausea
Date:01/25/02ISR Number: 3860071-8Report Type:Expedited (15-DaCompany Report #301407 Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tremor Foreign Lariam
Dry Mouth Health (Mefloquine
Hyperhidrosis Professional Hydrochloride) PS ORAL 1 DOSE FORM 1
Vertigo
PER WEEK ORAL
Vision Blurred
Zyban (Bupropion
Energy Increased Hydrochloride) SS ORAL 1 DOSE FORM
Insomnia
Disturbance In Attention
Trinordiol (Ethinyl
Estradiol/Levonorges
trel)
C
DAILY ORAL
Date:01/28/02ISR Number: 3861035-0Report Type:Expedited (15-DaCompany Report #305169 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asthenia Foreign Lariam (Mefloquine
Shock Other Hydrochloride) 250
Weight Decreased Mg PS ORAL 1 DOSE FORM

Confusional State DAILY ORAL
Nausea
Decreased Appetite
Fatigue
Apathy
03-Apr-2012 09:37 AM Page: 416

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/31/02ISR Number: 3860653-3Report Type:Expedited (15-DaCompany Report #256017 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Kidney Malformation Lariam Tablets PS Roche
Date:01/31/02ISR Number: 3861555-9Report Type:Direct Company Report #CTU 160493 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Disturbance In Attention Lariam
Malaise
(Mefloquine)(250 Mg
Night Sweats
/ Roche
Palpitations Laboratories) PS Roche Laboratories ORAL 250MG PO Q
Headache WEEK X 7
Fatigue
WEEKS
Date:01/31/02ISR Number: 3862951-6Report Type:Expedited (15-DaCompany Report #256017 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Maternal Drugs Affecting Foreign Lariam Tablets
Foetus Health (Mefloquine
Pregnancy Professional Hydrochloride) PS ORAL 1 DOSEFORM 1
Congenital Genitourinary
PER WEEK ORAL
Abnormality
Date:02/04/02ISR Number: 3862342-8Report Type:Expedited (15-DaCompany Report #302003 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asthenia Lariam PS Roche 59 DAY
Anxiety
Date:02/04/02ISR Number: 3862356-8Report Type:Expedited (15-DaCompany Report #305855 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mouth Ulceration Mefloquine
Erythema Multiforme Hydrochloride PS Roche 25 DAY
Date:02/05/02ISR Number: 3863086-9Report Type:Expedited (15-DaCompany Report #305877 Age:42 YR Gender:Not SpecifiI/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pulmonary Congestion Lariam PS Roche DESCRIBED AS
Dyspnoea
3 TABLETS IN
THE MORNING,
2 IN THE

MIDDLE OF THE 1 DAY
03-Apr-2012 09:37 AM Page: 417

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/05/02ISR Number: 3865088-5Report Type:Direct Company Report #CTU 160910 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Thinking Abnormal Lariam PS ORAL 1 PILL
Initial or Prolonged Dissociation EVERYDAY/2MN
Fear
ORAL
Anxiety
Hypothyroidism
Dysentery
Feeling Abnormal
Paranoia
Stress
Date:02/06/02ISR Number: 3866167-9Report Type:Expedited (15-DaCompany Report #305855 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mouth Ulceration Foreign Mefloquine
Weight Decreased Other Hydrochloride
Erythema Multiforme
(Mefloquine
Hydrochloride) PS ORAL 250 MG ORAL
Date:02/07/02ISR Number: 3865776-0Report Type:Direct Company Report #CTU 161186 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aphasia Larium PS ORAL ONE PILL
ONCE A WEEK
ORAL
Date:02/07/02ISR Number: 3866397-6Report Type:Direct Company Report #CTU 161175 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Memory Impairment Mefloquine (Larium) PS ORAL 1 TABLE WEEK
Hallucination
ORAL
Disorientation
Confusional State
Date:02/07/02ISR Number: 3866467-2Report Type:Direct Company Report #CTU 161208 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fear Lariam Hoffmann-La
Anxiety Roche PS Hoffmann-La Roche ORAL ONE 250 MG
ONCE A WEEK
ORAL

Date:02/07/02ISR Number: 3867764-7Report Type:Expedited (15-DaCompany Report #305877 Age:42 YR Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Lung Infiltration Foreign Lariam (Mefloquine
Dyspnoea Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG
ORAL
03-Apr-2012 09:37 AM Page: 418

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/08/02ISR Number: 3866762-7Report Type:Direct Company Report #CTU 161353 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Larium (?Standard
Headache For Malaria) PS ORAL 1 TABLE
Diarrhoea
WEEKLY ORAL
Vertigo
Abdominal Pain
Decreased Appetite
Nausea
Visual Impairment
Date:02/08/02ISR Number: 3866871-2Report Type:Direct Company Report #CTU 161327 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Insomnia Larium 250mg Roche
Required Anxiety Pharacuticals PS Roche Pharacuticals ORAL 250MG ONE A
Intervention to Suicidal Ideation WEEK ORAL
Prevent Permanent
Impairment/Damage
Delusion
Depression
Nightmare
Date:02/08/02ISR Number: 3866875-XReport Type:Direct Company Report #CTU 161331 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Initial Insomnia Lariam 250mg Roche PS Roche 1/WEEK
Nervousness Echinacea C
Fear
Topical Insect Spray C
Agitation Multi-Vitamin C
Date:02/12/02ISR Number: 3866799-8Report Type:Expedited (15-DaCompany Report #261498 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death International Normalised Consumer Lariam PS Roche 37 DAY
Ratio Increased Cozaar Comp C 285 DAY
Haemorrhagic Stroke Warfarin I VARYING DOSES
Drug Interaction
AS PER INR.
Date:02/12/02ISR Number: 3866804-9Report Type:Expedited (15-DaCompany Report #251768 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Limb Reduction Defect Health Lariam PS Roche
Pregnancy
Professional
Abortion Induced
Maternal Drugs Affecting

Foetus
Maternal Exposure During
Pregnancy
03-Apr-2012 09:37 AM Page: 419

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/12/02ISR Number: 3867634-4Report Type:Direct Company Report #CTU 161443 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Larium PS ONCE A TABLET
Panic Attack
Date:02/12/02ISR Number: 3867716-7Report Type:Direct Company Report #CTU 161424 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Larium PS ORAL 1 WEEK ORAL
Initial or Prolonged Malaise Xanax C
Other Serious
Chest Pain
Paranoia
Chest Discomfort
Panic Attack
Date:02/12/02ISR Number: 3867740-4Report Type:Direct Company Report #CTU 161427 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Paranoia Mefloquine Hci 250
Hospitalization - Blood Pressure Increased Mg Hoffman-Laroche PS Hoffman-Laroche ORAL 250 MG DAILY
Initial or Prolonged Pyrexia ORAL
Heart Rate Increased Cephalexin C
Tongue Disorder Valium C
Hallucination
Hypersensitivity
Date:02/12/02ISR Number: 3868199-3Report Type:Direct Company Report #CTU 161515 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Menstrual Disorder Lariam PS 1 WEEK
Paranoia
Depression
Nightmare
Insomnia
Personality Change
Hallucination
Dizziness
Date:02/14/02ISR Number: 3869224-6Report Type:Direct Company Report #CTU 161586 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Insomnia Lariam PS ORAL ONE WEEK ORAL
Nightmare
Panic Attack

Phobia Of Flying
03-Apr-2012 09:37 AM Page: 420

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/14/02ISR Number: 3869307-0Report Type:Direct Company Report #CTU 161585 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Behaviour Lariam PS ORAL 1 PILL ORAL
Malaise
Conversion Disorder
Confusional State
Depression
Palpitations
Panic Attack
Anxiety
Claustrophobia
Crying
Mental Disorder
Date:02/14/02ISR Number: 3870022-8Report Type:Direct Company Report #CTU 161642 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Larium PS ONE TABLE
Obsessive-Compulsive
ONCE A WEEK
Disorder
Nightmare
Date:02/15/02ISR Number: 3869297-0Report Type:Expedited (15-DaCompany Report #264219 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Drug Interaction Lariam PS Roche
Hospitalization - Speech Disorder Cozaar C
Initial or Prolonged Brain Oedema Warfarin Sodium I
Brain Death
Pupils Unequal
Bradycardia
Aphasia
Hemiplegia
International Normalised
Ratio Increased
Tachycardia
Haemorrhagic Stroke
Blood Pressure Systolic
Increased
Hypotension
Date:02/15/02ISR Number: 3869736-5Report Type:Direct Company Report #CTU 161716 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Lariam PS ORAL STANDARD ONCE
Initial or Prolonged Dehydration A WEEK ORAL

Dizziness
Pain
Depression
Photosensitivity Reaction
Vomiting
03-Apr-2012 09:37 AM Page: 421

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/15/02ISR Number: 3871175-8Report Type:Expedited (15-DaCompany Report #259699 Age:72 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Drug Interaction Foreign Lariam (Mefloquine
International Normalised Other Hydrochloride) PS ORAL 250 MG 1 PER
Ratio Increased
WEEK ORAL
Circulatory Collapse
Warfarin (Warfarin
Cerebral Haemorrhage Sodium) SS ORAL 4 MG 1 PER 2
DAY ORAL
Cozaar Comp
(Hydrochlorothiazide
/Losartan Potassium) C
Date:02/15/02ISR Number: 3871379-4Report Type:Expedited (15-DaCompany Report #261498 Age:72 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Potentiating Drug Foreign Lariam (Mefloquine
Interaction Other Hydrochloride) PS ORAL 250 MG 1 PER
Cerebral Haemorrhage
WEEK ORAL
International Normalised
Warfarin (Warfarin
Ratio Increased Sodium) SS ORAL ORAL
Cozaar Comp
(Hydrochlorothiazide
/Losartan Potassium) C
Date:02/15/02ISR Number: 3871385-XReport Type:Expedited (15-DaCompany Report #261498 Age:72 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Cerebral Haemorrhage Foreign Lariam (Mefloquine
International Normalised Other Hydrochloride) PS ORAL 250 MG 1 PER
Ratio Increased
WEEK ORAL
Potentiating Drug
Warfarin (Warfarin
Interaction Sodium) SS ORAL ORAL
Cozaar Comp
(Hydrochlorothiazide
/Losartan Potassium) C
Date:02/18/02ISR Number: 3869837-1Report Type:Expedited (15-DaCompany Report #263822 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Grand Mal Convulsion Lariam PS Roche 15 DAY
Movement Disorder Malarone SS 4 DAY
Tinnitus
Vision Blurred
Cardiac Arrest
Hearing Impaired

Date:02/18/02ISR Number: 3869840-1Report Type:Expedited (15-DaCompany Report #303413 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Epilepsy Lariam PS Roche 12 DAY
Initial or Prolonged Convulsions Local Epitomax C 1590 DAY
Diane
C
03-Apr-2012 09:37 AM Page: 422

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Corticosteroids
Erythromycine
C
C
Date:02/18/02ISR Number: 3869843-7Report Type:Expedited (15-DaCompany Report #265284 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cardiac Arrest Lariam PS Roche
Grand Mal Convulsion Malarone SS 4 DAY
Tinnitus
Date:02/19/02ISR Number: 3870399-3Report Type:Expedited (15-DaCompany Report #259699 Age:72 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Drug Interaction Lariam PS Roche 37 DAY
Hospitalization - Haemorrhagic Stroke Cozaar Comp C 285 DAY
Initial or Prolonged International Normalised Warfarin I
Ratio Increased
Date:02/19/02ISR Number: 3871276-4Report Type:Direct Company Report #CTU 161854 Age:34 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Larium 250mg
Vomiting Hoffmann-La Roche PS Hoffmann-La Roche ORAL 1 TABLE PER
Malaise
WEEK ORAL
Panic Attack
Date:02/19/02ISR Number: 3872467-9Report Type:Expedited (15-DaCompany Report #264219 Age:72 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Brain Oedema Foreign Lariam (Melfoquine
Hospitalization - Drug Interaction Other Hydrochloride) 250
Initial or Prolonged Aphasia Mg PS 1 PER WEEK
Facial Paresis
Warfarin Sodium
Haemorrhagic Stroke (Warfarin Sodium) 5
Hypotension Mg SS 4 MG 1 PER 2
Blood Pressure Systolic
DAY
Increased
Cozaar (Losartan
Bradycardia Potassium) C
Hemiparesis
Hypothermia
Papilloedema
International Normalised
Ratio Increased
Hyporeflexia
Pupils Unequal

Tachycardia
03-Apr-2012 09:37 AM Page: 423

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/20/02ISR Number: 3873797-7Report Type:Expedited (15-DaCompany Report #263822 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Grand Mal Convulsion Health Lariam (Mefloquine
Dizziness Professional Hydrochloride)250 Mg PS ORAL 250 MG 1 PER
Deafness Other 1 WEEK ORAL
Memory Impairment
Malarone
Muscle Twitching
(Atovawuone/Chlorogu
Tinnitus ande Hydrochloride) SS ORAL ORAL
Obstructive Airways
Disorder
Headache
Cardiac Arrest
Confusional State
Vision Blurred
Date:02/20/02ISR Number: 3873798-9Report Type:Expedited (15-DaCompany Report #265284 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Health Lariam (Mefloquine
Dizziness Professional Hydrochloride) PS ORAL ORAL
Tinnitus Other Malarone
Cardiac Arrest
(Atovaquone/Chlorogu
anide Hydrochloride) SS ORAL ORAL
Date:02/20/02ISR Number: 3873922-8Report Type:Expedited (15-DaCompany Report #303413 Age:24 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Nervous System Disorder
Convulsion
Weight Increased
Antinuclear Antibody
Positive
Dystonia
Epilepsy
Loss Of Consciousness
Rash Erythematous
Tremor
Aphthous Stomatitis
Arthralgia
Depression
Electroencephalogram
Abnormal
Joint Ankylosis
Carpal Tunnel Syndrome
Hypersensitivity
Inflammation
Sinusitis
Sensation Of Heaviness

Feeling Abnormal
Drug Tolerance Decreased
Anaemia
Gastrointestinal Disorder
Peroneal Nerve Palsy
Skin Disorder
Bronchitis
Nuclear Magnetic
03-Apr-2012 09:37 AM Page: 424

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Resonance Imaging Brain
Abnormal
Paraesthesia
Partial Seizures Report Source Product Role Manufacturer Route Dose Duration
Sensory Disturbance Foreign Lariam (Mefloquine
Clonic Convulsion Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Professional
PER WEEK ORAL
Epitomax
(Topiramate)
C
Diane (Cyproterone
Acetate/Ethinyl
Estradiol)
C
Corticosteriods Nos
(Corticosteroid Nos) C
Erythromycine
(Erythromycin)
C
Date:02/21/02ISR Number: 3872711-8Report Type:Direct Company Report #CTU 161966 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Lariam PS ONE PER
Dizziness
Influenza Like Illness
Pyrexia
Nausea
Pain
Hyperhidrosis
Malaise
Oropharyngeal Pain
Chills
Date:02/21/02ISR Number: 3873492-4Report Type:Expedited (15-DaCompany Report #259699 Age:72 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Hemiplegia Foreign Lariam (Mefloquine
Hospitalization - Brain Oedema Other Hydrochloride) PS ORAL 250 MG 1 PER
Initial or Prolonged Pupils Unequal WEEK ORAL
Cerebral Haemorrhage
Warfarin (Warfarin
Extensor Plantar Response Sodium) SS ORAL 4 MG 1 PER 2
Hemiparesis
DAY ORAL
Tachycardia
Cozaar Comp
Bradycardia
(Hydrochlorothiazide
Drug Interaction
/Losartan Potassium) C
Aphasia
Coma
Papilloedema
Hypertension
Hyporeflexia
Hypotension
International Normalised

Ratio Increased
03-Apr-2012 09:37 AM Page: 425

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/22/02ISR Number: 3871938-9Report Type:Expedited (15-DaCompany Report #307365 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Headache Lariam PS Roche 8 DAY
Fear
Depression
Dry Mouth
Paraesthesia
Dizziness
Anxiety
Date:02/26/02ISR Number: 3875863-9Report Type:Expedited (15-DaCompany Report #307365 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dry Mouth Foreign Lariam (Mefloquine
Dizziness Consumer Hydrochloride) 250
Paraesthesia Mg PS ORAL 1 DOSE FORM
Anxiety DAILY ORAL
Depression
Headache
Hypoaesthesia
Date:02/27/02ISR Number: 3874072-7Report Type:Expedited (15-DaCompany Report #303413 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypersensitivity Lariam PS Roche 12 DAY
Initial or Prolonged Feeling Abnormal Epitomax C 1590 DAY
Partial Seizures Diane C
Epilepsy Corticosteroids C
Brain Scan Abnormal Erythromycine C
Clonic Convulsion
Mouth Ulceration
Bronchitis
Convulsions Local
Sinusitis
Carpal Tunnel Syndrome
Date:02/27/02ISR Number: 3874950-9Report Type:Direct Company Report #CTU 162354 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Lariam 250mg Roche PS Roche
Abnormal Dreams
Dizziness
Mood Swings

Date:02/28/02ISR Number: 3877137-9Report Type:Direct Company Report #CTU 162536 Age:36 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Disturbance In Attention
Myalgia
Dizziness
Sensation Of Heaviness
Decreased Appetite
03-Apr-2012 09:37 AM Page: 426

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Neuralgia
Sleep Disorder
Vision Blurred Report Source Product Role Manufacturer Route Dose Duration
Asthenia Mefloquine (Lariam) PS ORAL 250 MG PO Q
Weight Decreased
WEEK
Medication Error Vit C C
Diarrhoea Vit E C
Ventricular Extrasystoles Calcium Carbonate C
Levothyroxin
C
B Vits
C
Date:02/28/02ISR Number: 3878070-9Report Type:Expedited (15-DaCompany Report #303413 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Arrhythmia Foreign Lariam (Mefloquine
Initial or Prolonged Depression Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Joint Ankylosis Professional PER WEEK ORAL
Sensory Loss
Epitomax
Sinusitis (Topiramate) C
Clonic Convulsion
Diane (Cyproterone
Dystonia
Acetate/Ethinyl
Paraesthesia Estradiol) C
Partial Seizures
Corticosteroids
Systemic Inflammatory
(Corticosteroid Nos) C
Response Syndrome
Erythromycine
Bronchitis (Erythromycin) C
Condition Aggravated
Hypersensitivity
Tremor
Feeling Abnormal
Rash Erythematous
Epigastric Discomfort
Aphthous Stomatitis
Carpal Tunnel Syndrome
Loss Of Consciousness
Nuclear Magnetic
Resonance Imaging
Abnormal
Sensation Of Heaviness
Convulsion
Epilepsy
Skin Disorder
Date:03/01/02ISR Number: 3877283-XReport Type:Direct Company Report #CTU 162584 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Larium PS ORAL ONE PILL
Mental Disorder
WEEKLY ORAL
Memory Impairment

Date:03/01/02ISR Number: 3877309-3Report Type:Direct Company Report #CTU 162608 Age:30 YR Gender:Female I/FU:I
Outcome
Disability
PT
Tremor
Anxiety Disorder
03-Apr-2012 09:37 AM Page: 427

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hyperventilation
Panic Attack
Depression Report Source Product Role Manufacturer Route Dose Duration
Mefloquine PS ORAL ORAL
Date:03/01/02ISR Number: 3878265-4Report Type:Direct Company Report #CTU 162642 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Larium PS ORAL DON''T ONCE A
Hallucination
WEEK ORAL
Irritability
Insomnia
Nightmare
Date:03/01/02ISR Number: 3878287-3Report Type:Direct Company Report #CTU 162674 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Lariam PS ORAL 1 PILL WEEK
Decreased Appetite
ORAL
Psychotic Disorder Xalatan C
Muscle Spasms Allese C
Pyrexia
Night Sweats
Vomiting
Weight Decreased
Date:03/04/02ISR Number: 3877211-7Report Type:Direct Company Report #CTU 162600 Age:56 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaise Lariam 4oz Took For
Initial or Prolonged Heart Rate Increased 5 Weeks PS 1 PER WEEK
FOR 6 WEEKS
Date:03/04/02ISR Number: 3878268-XReport Type:Direct Company Report #CTU 162647 Age:34 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam PS Hoffman La Roche ORAL 250 MG WEEKLY
Psychotic Disorder
ORAL
Toothache Erythromycin C
Nightmare Flagyl C
Panic Disorder Ponstan Forte -
Paranoia Mefanamic Acid C
Screaming Ibuprofen C
Convulsion
Crying

Date:03/06/02ISR Number: 3879593-9Report Type:Direct Company Report #CTU 162890 Age:30 YR Gender:Male I/FU:I
Outcome
PT
Anxiety
Insomnia
03-Apr-2012 09:37 AM Page: 428

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Irritability
Nightmare
Panic Reaction Report Source Product Role Manufacturer Route Dose Duration
Memory Impairment Lariam 250mg Roche PS Roche BUCCAL 1 WEEKS
Mental Disorder
BUCCAL
Disturbance In Attention
Feeling Of Body
Temperature Change
Nervousness
Date:03/07/02ISR Number: 3881201-8Report Type:Direct Company Report #CTU 162987 Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Feeling Abnormal
Mefloquine -Lariam-
Vomiting 250 Mg PS `
Eyelid Ptosis
Lid Lag
Headache
Eyelid Function Disorder
Speech Disorder
Fall
Vertigo
Date:03/08/02ISR Number: 3879919-6Report Type:Expedited (15-DaCompany Report #308528 Age:66 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Prothrombin Time Mefloquine
Hospitalization - Prolonged Hydrochloride PS Roche
Initial or Prolonged Drug Interaction Carvedilol C
Betoptic
C
Captopril
C
Digoxin
C
Warfarin
I
Date:03/11/02ISR Number: 3880623-9Report Type:Expedited (15-DaCompany Report #308514 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Moderate Mental Lariam PS Roche
Retardation
Date:03/12/02ISR Number: 3881606-5Report Type:Direct Company Report #CTU 163184 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam 1 Pill Per
Sinusitis Week PS ORAL 1 WEEKLY

Hyperventilation ORAL
Disorientation Vit E C
Claustrophobia Anti-Biotic C
Multi-Herbal Med C
03-Apr-2012 09:37 AM Page: 429

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/12/02ISR Number: 3882986-7Report Type:Expedited (15-DaCompany Report #308514 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Congenital Neurological Foreign Lariam (Mefloquine
Degeneration Other Hydrochloride) PS 250 MG 1 PER
Maternal Drugs Affecting
WEEK
Foetus
Mental Retardation
Pregnancy
Neonatal Disorder
Date:03/13/02ISR Number: 3882388-3Report Type:Direct Company Report #CTU 163302 Age:71 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Confusional State Lariam 250mg PS 1 PILL ONCE A
Mental Impairment
WEEK
Convulsion
Abnormal Behaviour
Date:03/13/02ISR Number: 3882791-1Report Type:Expedited (15-DaCompany Report #308528 Age:66 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Abdominal Distension Foreign Mefloquine
Hospitalization - Cardiomegaly Health Hydrochloride
Initial or Prolonged Gallop Rhythm Present Professional (Mefloquine
Blood Pressure Decreased Hydrochloride) PS 250 MG 1 PER
Computerised Tomogram
WEEK
Abnormal
Warfarin (Warfarin
Anaemia Sodium) SS
Drug Interaction Digoxin (Digoxin) C
Haemorrhage
Captopril
Infectious Peritonitis (Captopril) C
Congestive Cardiomyopathy
Betoptic (Betaxolol
Melaena Hydrochloride) C
Tachycardia
Carvedilol
Ejection Fraction (Carvedilol) C
Decreased
Ascites
Ileus Paralytic
Abdominal Tenderness
Prothrombin Time
Prolonged
Date:03/14/02ISR Number: 3882692-9Report Type:Direct Company Report #CTU 163449 Age:7 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hallucination Lariam PS

Hospitalization -
Initial or Prolonged
Required
Intervention to
Prevent Permanent
Impairment/Damage
Dyspnoea
03-Apr-2012 09:37 AM Page: 430

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/14/02ISR Number: 3882716-9Report Type:Direct Company Report #CTU 163401 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Myalgia Lariam PS ORAL 1 TABLE
Anxiety
WEEKLY ORAL
Depression
Headache
Palpitations
Insomnia
Dizziness
Paranoia
Vision Blurred
Angina Pectoris
Arthralgia
Date:03/15/02ISR Number: 3883529-4Report Type:Direct Company Report #CTU 163518 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Lariam PS ORAL ONCE WEEK
Disorientation
ORAL
Panic Disorder
Flashback
Delusion
Fear
Date:03/19/02ISR Number: 3884395-3Report Type:Expedited (15-DaCompany Report #308974 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pulmonary Toxicity Mefloquine
Initial or Prolonged Hydrochloride PS Roche
Date:03/19/02ISR Number: 3886232-XReport Type:Direct Company Report #CTU 163734 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam -Mefloquin
Palpitations
Hci- 250 Mg Roche
Chest Pain Laboratories PS Roche Laboratories ORAL 1 PER WEEK
Confusional State
ORAL
Nightmare
Insomnia
Date:03/19/02ISR Number: 3886246-XReport Type:Direct Company Report #CTU 163742 Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Lariam

Dizziness Hoffmann-Laroche PS Hoffmann-Laroche ORAL 1 TABLE ONCE
Palpitations
A WEEK ORAL
Anxiety
Nightmare
03-Apr-2012 09:37 AM Page: 431

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/21/02ISR Number: 3886508-6Report Type:Direct Company Report #CTU 163886 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoaesthesia Lariam 250mg Roche PS Roche ORAL ONE TABLET WK
Initial or Prolonged Chest Pain / ORAL
Other Serious
Arrhythmia
Date:03/21/02ISR Number: 3886963-1Report Type:Expedited (15-DaCompany Report #308974 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoxia Foreign Mefloquine
Initial or Prolonged Lung Disorder Literature Hydrochloride
Cough Health (Mefloquine
White Blood Cell Count Professional Hydrochloride) PS
Increased
Tachypnoea
Biopsy Lung Abnormal
Dyspnoea
Rales
C-Reactive Protein
Increased
Lung Infiltration
Blood Lactate
Dehydrogenase Increased
Haematocrit Decreased
Blood Pressure Diastolic
Decreased
Diarrhoea
Haemoglobin Decreased
Pulmonary Toxicity
Date:03/22/02ISR Number: 3886649-3Report Type:Expedited (15-DaCompany Report #262856 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Multiple Congenital Lariam PS Roche 1 DAY
Abnormalities
Date:03/22/02ISR Number: 3886657-2Report Type:Expedited (15-DaCompany Report #308521 Age:12 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abdominal Pain Lariam PS Roche
Initial or Prolonged Sleep Disorder
Headache
Muscle Twitching
Malaise
Vomiting
Balance Disorder

Date:03/26/02ISR Number: 3888125-0Report Type:Expedited (15-DaCompany Report #308521 Age:12 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Malaise
Sleep Disorder
03-Apr-2012 09:37 AM Page: 432

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pyrexia
Headache
Abdominal Pain Report Source Product Role Manufacturer Route Dose Duration
Balance Disorder Lariam PS Roche 23 DAY
Muscle Twitching
Vomiting
Date:03/26/02ISR Number: 3889699-6Report Type:Expedited (15-DaCompany Report #262856 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Breech Presentation Foreign Lariam (Mefloquine
Pregnancy Health Hydrochloride) PS ORAL 250 MG 1 PER
Caesarean Section Professional WEEK ORAL
Low Set Ears
Premature Baby
Maternal Drugs Affecting
Foetus
Congenital Hand
Malformation
Skull Malformation
Date:03/26/02ISR Number: 3889700-XReport Type:Expedited (15-DaCompany Report #308521 Age:12 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Muscle Twitching Foreign Lariam (Mefloquine
Initial or Prolonged Sleep Disorder Health Hydrochloride) PS
Abdominal Pain
Professional
Headache
Vomiting
Asthenia
Gait Disturbance
Malaise
Date:03/27/02ISR Number: 3890784-3Report Type:Direct Company Report #CTU 164380 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Depression Lariam PS 250MG WEEKLY
Sleep Disorder
Headache
Abnormal Dreams
Paraesthesia
Anxiety
Date:03/28/02ISR Number: 3891877-7Report Type:Expedited (15-DaCompany Report #308521 Age:12 YR Gender:Male I/FU:F

Outcome
Hospitalization -
Initial or Prolonged
PT
Balance Disorder
Headache
Sleep Disorder
Malaise
Pyrexia
Vomiting
Muscle Twitching
03-Apr-2012 09:37 AM Page: 433

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Asthenia
Abdominal Pain
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam
Health
(Mefloquine
Professional Hydrochloride) PS ORAL ORAL
Other
Date:03/29/02ISR Number: 3891942-4Report Type:Direct Company Report #CTU 164490 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Nervousness Lariam PS ORAL ONE CAPSUL
Hospitalization - Overdose WEEKLY ORAL
Initial or Prolonged Anxiety
Disability
Other Serious
Depression
Suicidal Ideation
Suicide Attempt
Condition Aggravated
Mania
Agitation
Bipolar Disorder
Date:03/29/02ISR Number: 3891958-8Report Type:Direct Company Report #CTU 164480 Age:64 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Larium PS ORAL ONE PILL
Fear
WEEKLY ORAL
Estrogen
C
Progesterone
C
Synthroid
C
Date:03/29/02ISR Number: 3891961-8Report Type:Direct Company Report #CTU 164482 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fibromyalgia Lariam/Mefloquin PS ORAL WEEKLY ORAL
Other Serious
Depression
Suicidal Ideation
Date:04/01/02ISR Number: 3892044-3Report Type:Expedited (15-DaCompany Report #309830 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cerebellar Ataxia Lariam PS Roche
Initial or Prolonged Nivaquine SS
Paludrine
SS
Artemether C PO. 4 DAY

Date:04/03/02ISR Number: 3895454-3Report Type:Expedited (15-DaCompany Report #309830 Age:52 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Muscular Weakness
Plasmodium Falciparum
03-Apr-2012 09:37 AM Page: 434

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Infection
Tachypnoea
Blood Pressure Decreased
Heart Rate Increased Report Source Product Role Manufacturer Route Dose Duration
Confusional State Foreign Lariam (Mefloquine
Aggression Other Hydrochloride) PS ORAL ARTEMETHER
Dehydration
(ARTEMETHER)
Loss Of Consciousness
Paludrine
Asthenia
(Chloroguanide
Cerebellar Ataxia Hydrochloride) 100
Diarrhoea Mg SS ORAL 1 DOSE FORM
DAILY ORAL
Artemether
(Artemether) SS 200 MG
MULTIPLE
Date:04/08/02ISR Number: 3895865-6Report Type:Expedited (15-DaCompany Report #309830 Age:52 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cerebellar Ataxia Lariam PS Roche
Initial or Prolonged Paludrine SS
Nivaquine
SS
Artemether SS PO. 4 DAY
Date:04/08/02ISR Number: 3898379-2Report Type:Direct Company Report #CTU 165199 Age:43 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Lariam PS ORAL 1 PER WK/5
ORAL
Date:04/09/02ISR Number: 3896411-3Report Type:Expedited (15-DaCompany Report #310770 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Ankle Fracture Lariam PS Roche
Palpitations Fragmin C DAILY DOSE
Chest Pain
REPORTED AS
Ventricular Extrasystoles
2500 IE.
Anxiety
Electrocardiogram Qt
Prolonged
Date:04/10/02ISR Number: 3897120-7Report Type:Expedited (15-DaCompany Report #310741 Age: Gender:Not SpecifiI/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche 22 DAY

Date:04/10/02ISR Number: 3898007-6Report Type:Expedited (15-DaCompany Report #309830 Age:52 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Diarrhoea
Muscular Weakness
Cerebellar Ataxia
03-Apr-2012 09:37 AM Page: 435

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pyrexia
Loss Of Consciousness
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam (Mefloquine
Other Hydrochloride) PS ORAL ORAL
Paludrine
(Chloroguanide
Hydrochloride) SS ORAL 1 DOSE FORM
DAILY ORAL
Nivaquine
(Chloroquine
Sulfate) SS ORAL ORAL
Artemether
(Artemether) SS 200 MG
MULTIPLE
Date:04/10/02ISR Number: 3899376-3Report Type:Direct Company Report #CTU 165430 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Lariam 250 Mg PS
Discomfort Flagyl C
Dizziness Zithromax C
Nausea Prilosec C
Anxiety Supplements C
Eye Pain Librax C
Mood Swings Elavil C
Biaxin
C
Vitamins,
C
Date:04/11/02ISR Number: 3899398-2Report Type:Expedited (15-DaCompany Report #310770 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Electrocardiogram Qt Foreign Lariam (Mefloquine
Prolonged Other Hydrochloride) 250
Anxiety Mg PS ORAL
Chest Pain
Fragmin (Dalteparin
Palpitations Sodium) C
Ventricular Extrasystoles
Date:04/12/02ISR Number: 3899745-1Report Type:Expedited (15-DaCompany Report #310741 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pregnancy Foreign Lariam (Mefloquine
Maternal Drugs Affecting Other Hydrochloride) PS ORAL 250 MG 1 PER
Foetus
WEEK ORAL
Abortion Spontaneous

Date:04/12/02ISR Number: 3900290-5Report Type:Direct Company Report #CTU 165624 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Nightmare Larium PS 1 PER
Disorientation
Fear
03-Apr-2012 09:37 AM Page: 436

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/15/02ISR Number: 3900029-3Report Type:Direct Company Report #CTU 165643 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Insomnia Lariam PS 1 DOSE PER
Nervousness
WEEK X 6 WKS
Panic Attack
Flushing
Bladder Disorder
Date:04/17/02ISR Number: 3900592-2Report Type:Expedited (15-DaCompany Report #310850 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Neutropenia Lariam PS Roche
Initial or Prolonged Haemoglobin Decreased Kinin C 10 DAY
Pyrexia
Leukopenia
Date:04/17/02ISR Number: 3900596-XReport Type:Expedited (15-DaCompany Report #310913 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pollakiuria Lariam PS Roche 1 DAY
Abnormal Dreams
Date:04/22/02ISR Number: 3904484-4Report Type:Direct Company Report #CTU 166347 Age:67 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paranoia Mefloquine 250mg PS ORAL 250MG WEEKLY
Initial or Prolonged Delusion ORAL
Confusional State Bisoprolol C
Agitation Estradiol C
Pressure Of Speech
Date:04/23/02ISR Number: 3904592-8Report Type:Expedited (15-DaCompany Report #311417 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thrombocytopenia Lariam PS Roche 1 DAY
Neutropenia Aspirine C
Efferalgan
C
Date:04/24/02ISR Number: 3905788-1Report Type:Expedited (15-DaCompany Report #311387 Age:48 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Coordination Abnormal Lariam PS Roche 24 DAY

Initial or Prolonged
Dizziness
Diplopia
Vomiting
03-Apr-2012 09:37 AM Page: 437

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/24/02ISR Number: 3906283-6Report Type:Direct Company Report #CTU 166528 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Influenza Lariam PS ONCE A WEEK,
Depression
8 DOSES
Decreased Activity
Date:04/25/02ISR Number: 3906132-6Report Type:Expedited (15-DaCompany Report #310913 Age:28 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pollakiuria Lariam PS Roche 1 DAY
Abnormal Dreams
Date:04/26/02ISR Number: 3906880-8Report Type:Expedited (15-DaCompany Report #269045 Age:25 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Rash Lariam PS Roche 32 DAY
Abdominal Pain
Hyperaesthesia
Arthralgia
Diarrhoea
Liver Function Test
Abnormal
Vomiting
Date:04/26/02ISR Number: 3907842-7Report Type:Expedited (15-DaCompany Report #311417 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Febrile Convulsion Foreign Lariam (Mefloquine
Thrombocytopenia Health Hydrochloride) PS ORAL 6 DOSE FORM
Neutropenia Professional DAILY ORAL
Aspirine (Aspirin) C
Efferalgan
(Acetaminophen) C
Date:04/26/02ISR Number: 3907914-7Report Type:Expedited (15-DaCompany Report #311387 Age:48 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dizziness Foreign Lariam (Mefloquine
Initial or Prolonged Diplopia Other Hydrochloride) PS ORAL 250 MG 1 PER
Encephalitis
WEEK ORAL
Coordination Abnormal
Vomiting

Date:04/29/02ISR Number: 3907812-9Report Type:Expedited (15-DaCompany Report #309533 Age:33 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cardiac Failure Lariam PS Roche 1 DAY
Ventricular Hypokinesia
03-Apr-2012 09:37 AM Page: 438

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/29/02ISR Number: 3907824-5Report Type:Expedited (15-DaCompany Report #311417 Age:29 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Neutropenia Lariam PS Roche 1 DAY
Thrombocytopenia Aspirine C
Efferalgan
C
Date:05/01/02ISR Number: 3909145-3Report Type:Expedited (15-DaCompany Report #310913 Age:28 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pollakiuria Lariam PS Roche 1 DAY
Abnormal Dreams
Date:05/01/02ISR Number: 3911255-1Report Type:Expedited (15-DaCompany Report #269045 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Diarrhoea Foreign Lariam(Mefloquine
Rash Health Hydrochloride) 250
Arthralgia Professional Mg PS ORAL 250 MG 1 PER
Liver Function Test Other WEEK ORAL
Abnormal
Vomiting
Abdominal Pain
Hyperaesthesia
Date:05/01/02ISR Number: 3911290-3Report Type:Expedited (15-DaCompany Report #311417 Age:29 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thrombocytopenia Foreign Lariam (Mefloquine
Neutropenia Health Hydrochloride) PS ORAL 6 DOSE FORM
Febrile Convulsion Professional DAILY ORAL
Aspirine (Aspirin) C
Efferalgan
(Acetaminophen) C
Date:05/01/02ISR Number: 3911292-7Report Type:Expedited (15-DaCompany Report #309533 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cardiac Failure Foreign Lariam (Mefloquine
Dilatation Ventricular Health Hydrochloride) PS ORAL ORAL
Professional
Date:05/01/02ISR Number: 3911529-4Report Type:Direct Company Report #CTU 167187 Age:50 YR Gender:Female I/FU:I

Outcome
Other Serious
PT
Burning Sensation
Anxiety
Insomnia
Feeling Cold
Dizziness
Dyspnoea
03-Apr-2012 09:37 AM Page: 439

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Feeling Jittery
Pain
Chills Report Source Product Role Manufacturer Route Dose Duration
Tremor
Lariam 250 -Mg
Paraesthesia Tablets Roche PS Roche ORAL 1 TABLE 1
Palpitations
PER WEEK
ORAL
Date:05/02/02ISR Number: 3909837-6Report Type:Expedited (15-DaCompany Report #311387 Age:48 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Dizziness Consumer Lariam PS Roche 24 DAY
Hospitalization - Coordination Abnormal
Initial or Prolonged Vomiting
Diplopia
Encephalitis Viral
Immune System Disorder
Date:05/02/02ISR Number: 3909838-8Report Type:Expedited (15-DaCompany Report #312383 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vith Nerve Paralysis Lariam PS Roche 37 DAY
Date:05/03/02ISR Number: 3910667-XReport Type:Expedited (15-DaCompany Report #312383 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vith Nerve Paralysis Lariam PS Roche 37 DAY
Date:05/03/02ISR Number: 3912167-XReport Type:Direct Company Report #CTU 167303 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Dyspnoea Larium PS ORAL 1 PILL 1X
Other Serious Heart Rate Decreased WEEK ORAL
Palpitations Aspirin C
Arrhythmia Birth Control Pills C
Mental Disorder
Nightmare
Panic Attack
Dizziness
Paranoia
Hyperhidrosis
Anxiety
Nervousness

Date:05/06/02ISR Number: 3912508-3Report Type:Direct Company Report #CTU 167374 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Suicidal Ideation Mefloquine (Lariam) PS ORAL 1 DAY ORAL
Anxiety
Panic Attack
03-Apr-2012 09:37 AM Page: 440

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/07/02ISR Number: 3912580-0Report Type:Expedited (15-DaCompany Report #311387 Age:48 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Coordination Abnormal Foreign Lariam (Mefloquine
Hospitalization - Vomiting Other Hydrochloride) PS ORAL 250 MG 1 PER
Initial or Prolonged Diplopia WEEK ORAL
Encephalitis Viral
Dizziness
Date:05/07/02ISR Number: 3912581-2Report Type:Expedited (15-DaCompany Report #312383 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vith Nerve Paralysis Foreign Lariam (Mefloquine
Health Hydrochloride) PS ORAL 1 DOSE FORM
Professional
1 PER WEEK
ORAL
Date:05/07/02ISR Number: 3912886-5Report Type:Expedited (15-DaCompany Report #312383 Age:51 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vith Nerve Paralysis Foreign Lariam (Mefloquine
Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Professional
PER WEEK ORAL
Date:05/10/02ISR Number: 3913789-2Report Type:Expedited (15-DaCompany Report #312621 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypoaesthesia Oral Lariam PS Roche 15 DAY
Viith Nerve Paralysis
Paraesthesia Oral
Date:05/14/02ISR Number: 3915583-5Report Type:Expedited (15-DaCompany Report #264418 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Premature Baby Lariam PS Roche
Premature Separation Of Quinine Sulfate C 24 HOUR
Placenta
PERIODS EVERY
8 HOURS, 10
MG/KG.
TREATED 03 TO 25 DAY
Date:05/14/02ISR Number: 3915591-4Report Type:Expedited (15-DaCompany Report #311132 Age:49 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Deafness Lariam PS Roche 36 DAY
Tinnitus
Ear Discomfort
03-Apr-2012 09:37 AM Page: 441

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/14/02ISR Number: 3915609-9Report Type:Expedited (15-DaCompany Report #311320 Age:41 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Field Defect Lariam PS Roche 363 DAY
Date:05/14/02ISR Number: 3916964-6Report Type:Expedited (15-DaCompany Report #312621 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nuclear Magnetic Health Lariam (Mefloquine
Resonance Imaging Professional Hydrochloride) 250
Abnormal Mg PS ORAL 250 MG 1
Hypoaesthesia Oral
PER WEEK
Paraesthesia Oral
ORAL
Viith Nerve Paralysis
Date:05/15/02ISR Number: 3916379-0Report Type:Direct Company Report #CTU 168079 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Behaviour Mefloquine PS ONE TABLET A
Anger
WEEK
Date:05/16/02ISR Number: 3916689-7Report Type:Expedited (15-DaCompany Report #312628 Age:25 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Influenza Like Illness Lariam PS Roche
Date:05/16/02ISR Number: 3917735-7Report Type:Direct Company Report #CTU 168204 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Arthralgia Lariam PS ONCE A
Nausea
Neck Pain
Pyrexia
Myalgia
Headache
Muscle Spasms
Pain
Movement Disorder
Back Pain
Gait Disturbance
Chills
Date:05/16/02ISR Number: 3917737-0Report Type:Direct Company Report #CTU 168205 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Balance Disorder Lariam PS ONCE A
Dysstasia
Gait Disturbance
Feeling Abnormal
03-Apr-2012 09:37 AM Page: 442

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/17/02ISR Number: 3917198-1Report Type:Expedited (15-DaCompany Report #313299 Age:70 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gastrointestinal Lariam PS Roche 77 DAY
Haemorrhage
Date:05/17/02ISR Number: 3917205-6Report Type:Expedited (15-DaCompany Report #313197 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Agitation Mefloquine
Initial or Prolonged Psychotic Disorder Hydrochloride PS Roche 1 DAY
Disability Hallucination, Auditory Cannabis Sativa C
Dependent Personality
Disorder
Paranoia
Date:05/20/02ISR Number: 3919404-6Report Type:Expedited (15-DaCompany Report #312628 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Chills Foreign Lariam (Mefloquine
Pain Health Hydrochloride) PS 250 MG 1 PER
Influenza Like Illness Professional WEEK
Date:05/20/02ISR Number: 3919494-0Report Type:Expedited (15-DaCompany Report #311320 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Visual Field Defect Health Lariam (Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:05/20/02ISR Number: 3919569-6Report Type:Expedited (15-DaCompany Report #264418 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Apgar Score Low Consumer Lariam (Mefloquine
Intervention to Pregnancy Hydrochloride) 250
Prevent Permanent Caesarean Section Mg PS ORAL 250 MG 1 PER
Impairment/Damage Maternal Drugs Affecting WEEK ORAL
Foetus
Premature Baby
Premature Separation Of
Placenta

Date:05/20/02ISR Number: 3919652-5Report Type:Expedited (15-DaCompany Report #311132 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Ear Discomfort Foreign Lariam (Mefloquine
Deafness Health Hydrochloride) 250
Tinnitus Professional Mg PS ORAL 250 MG 1 PER
Other
WEEK; ORAL
03-Apr-2012 09:37 AM Page: 443

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/21/02ISR Number: 3920502-1Report Type:Direct Company Report #CTU 168520 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Major Depression Lariam PS 250 MG/WK
Suicidal Ideation
Date:05/22/02ISR Number: 3922870-3Report Type:Expedited (15-DaCompany Report #313197 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Foreign Mefloquine
Initial or Prolonged Agitation Other Hydrochloride(Mefloq
Disability Dependent Personality uine Hydrochloride) PS ORAL DOSE FORM E
Disorder
DAILY ORAL
Hallucination, Auditory
Cannabis
Paranoia Sativa(Cannabis) C
Date:05/22/02ISR Number: 3922872-7Report Type:Expedited (15-DaCompany Report #313299 Age:70 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gastrointestinal Foreign Lariam (Mefloquine
Haemorrhage Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:05/23/02ISR Number: 3920961-4Report Type:Direct Company Report #CTU 168739 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Depression Lariam PS Roche ORAL 1 PILL WEEK
Disability Palpitations ORAL
Required Paranoia Ortho-Tricyclen C
Intervention to
Pyrexia
Prevent Permanent
Impairment/Damage
Vertigo
Suicidal Ideation
Heart Rate Increased
Panic Reaction
Fatigue
Sleep Disorder
Headache
Mood Swings
Date:05/23/02ISR Number: 3920972-9Report Type:Direct Company Report #CTU 168747 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Mefloguine Roche PS Roche ORAL NOT SURE 1
Feeling Abnormal
WEEKLY ORAL

Dizziness Cipro C
Palpitations
Visual Impairment
Panic Attack
03-Apr-2012 09:37 AM Page: 444

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/29/02ISR Number: 3924251-5Report Type:Expedited (15-DaCompany Report #304145 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pyrexia Health Lariam PS Roche
Respiratory Disorder
Professional
Rash
Guillain-Barre Syndrome
Date:05/29/02ISR Number: 3924280-1Report Type:Expedited (15-DaCompany Report #313979 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Drug Withdrawal Syndrome Lariam PS Roche 121 DAY
Mood Altered
Depression
Anxiety
Date:05/29/02ISR Number: 3924281-3Report Type:Expedited (15-DaCompany Report #313825 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Paranoia Lariam PS Roche
Death
Mood Altered
Date:05/31/02ISR Number: 3927273-3Report Type:Expedited (15-DaCompany Report #313825 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Personality Change Foreign Lariam (Mefloquine
Asphyxia Other Hydrochloride) PS
Fear
Feeling Abnormal
Paranoia
Date:05/31/02ISR Number: 3927275-7Report Type:Expedited (15-DaCompany Report #304145 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Rash Foreign Lariam (Mefloquine
Guillain-Barre Syndrome Health Hydrochloride)250mg PS ORAL 250 MG 1 PER
Pyrexia Professional WEEK ORAL
Date:05/31/02ISR Number: 3927276-9Report Type:Expedited (15-DaCompany Report #313979 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Foreign Lariam (Mefloquine

Mood Altered Other Hydrochloride) PS ORAL 250 MG DAILY
Drug Withdrawal Syndrome
ORAL
Anxiety
03-Apr-2012 09:37 AM Page: 445

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/04/02ISR Number: 3932755-4Report Type:Periodic Company Report #258485 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 1 DOSE FORM 1
PER WEEK ORAL
Date:06/04/02ISR Number: 3932756-6Report Type:Periodic Company Report #258606 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Other Lariam Tablets
Hallucination
(Mefloquine
Hydrochloride) PS ORAL ORAL
Date:06/04/02ISR Number: 3932757-8Report Type:Periodic Company Report #258950 Age:62 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Consumer Lariam Tablets
Initial or Prolonged Diplopia (Mefloquine
Hallucination Hydrochloride) 250
Balance Disorder Mg PS ORAL 250 MG 1 PER
Coordination Abnormal
WEEK ORAL
Nightmare
Doxycycline
Insomnia (Doxycyline) C
Mental Disorder
Prempro (Estrogens,
Conjugated/Medroypro
gesterone Acetate) C
Cardizem (Diltiazem
Hydrochloride) C
Cipro (Ciprofloxacin
Hydrochloride) C
Lasix (Furosemide) C
Date:06/04/02ISR Number: 3932758-XReport Type:Periodic Company Report #259310 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Anxiety Health Lariam Tablets
Intervention to Decreased Appetite Professional (Mefloquine
Prevent Permanent Depression Hydrochloride) 250
Impairment/Damage Hypomania Mg PS ORAL 250 MG 1 PER
Agitation
WEEK ORAL
Insomnia
Disturbance In Attention
Hyperaesthesia

Date:06/04/02ISR Number: 3932759-1Report Type:Periodic Company Report #259529 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Consumer Lariam Tablets
Initial or Prolonged Haemoglobin Decreased (Mefloquine
Malaria Hydrochloride) 250
03-Apr-2012 09:37 AM Page: 446

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Centrum
(Ascorbic/Cholecalci
ferol/Cr./Cu./Folic
Acid/Iodine/Iron/Iv SS ORAL 1 DOSE FORM 1
PER DAY ORAL
Date:06/04/02ISR Number: 3932760-8Report Type:Periodic Company Report #262967 Age:63 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Bradycardia Health Lariam Tablets
Initial or Prolonged Dysarthria Professional (Mefloquine
Arrhythmia Hydrochloride) 250
Insomnia Mg PS ORAL 250 MG 1 PER
DAY ORAL
Date:06/04/02ISR Number: 3932761-XReport Type:Periodic Company Report #263260 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aggression Health Lariam Tablets
Lethargy Professional (Mefloquine
Psychotic Disorder Hydrochloride) 250
Hallucination Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/04/02ISR Number: 3932762-1Report Type:Periodic Company Report #266436 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/04/02ISR Number: 3932763-3Report Type:Periodic Company Report #266437 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL

Date:06/04/02ISR Number: 3932764-5Report Type:Periodic Company Report #266439 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Health Lariam Tablets
Professional
(Mefloquine
Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
03-Apr-2012 09:37 AM Page: 447

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/04/02ISR Number: 3943960-5Report Type:Periodic Company Report #266440 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Health Lariam (Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/04/02ISR Number: 3943961-7Report Type:Periodic Company Report #266772 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Palpitations Health Lariam (Mefloquine
Initial or Prolonged Dizziness Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
DAY ORAL
Allegra (Fexofenadne
Hydrochloride) C
Premarin (Estrogens) C
Date:06/04/02ISR Number: 3943962-9Report Type:Periodic Company Report #269411 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination, Visual Literature Mefloquine
Initial or Prolonged Paranoia Other Hydrochloride
Depression
(Mefloquine
Confusional State Hydrochloride) PS ORAL 250 MG 1 PER
Anxiety WEEK ORAL 21 DAY
Cognitive Disorder
Date:06/04/02ISR Number: 3943963-0Report Type:Periodic Company Report #304961 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Health Lariam (Mefloquine
Initial or Prolonged Heart Rate Increased Professional Hydrochloride) PS ORAL 1 PER WEEK
Anxiety
ORAL
Malaria
Birth Control Pill
Tremor
(Oral Contractptive
Nos)
C
Luvox (Fluvoxamine) C
Date:06/04/02ISR Number: 3943964-2Report Type:Periodic Company Report #237292 Age:25 YR Gender:Female I/FU:F
Outcome
Required
Intervention to
PT
Hyperventilation
Psychotic Disorder

Prevent Permanent
Impairment/Damage
Anxiety
Hallucination, Auditory
Crying
Hallucination, Visual
Jamais Vu
Thinking Abnormal
Tremor
Dissociation
03-Apr-2012 09:37 AM Page: 448

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Fatigue
Hyperglycaemia
Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration
Depression Consumer Lariam (Mefloquine
Hallucination Health Hydrochloride) 250
Abnormal Dreams Professional Mg PS ORAL 250 MG 1 PER
Confusional State
WEEK ORAL
Feeling Abnormal
Risperdal
(Risperidone)
SS
Zyprexa (Olanzapine) SS
Valium (Diazepam) SS
Date:06/04/02ISR Number: 3943965-4Report Type:Periodic Company Report #255796 Age:37 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Muscular Weakness Consumer Lariam Tablets
Diarrhoea
(Mefloquine
Weight Decreased Hydrochloride) PS ORAL 1 DOSE FORM 1
Balance Disorder
PER WEEK ORAL
Panic Attack
Dizziness
Nerve Injury
Anxiety
Nausea
Date:06/04/02ISR Number: 3946386-3Report Type:Periodic Company Report #268911 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fatigue Consumer Lariam (Mefloquine
Hallucination Hydrochloride) PS ORAL 250 MG 1 PER
Dysgeusia
WEEK ORAL
Lethargy
Prempro (Estrogens
Insomnia
Conjugagted/Medroxyp
Depression
rogesterone
Suicidal Ideation Acetate) C
Fosamax (Alendronate
Sodium)
C
Date:06/10/02ISR Number: 3930038-XReport Type:Expedited (15-DaCompany Report #304145 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Guillain-Barre Syndrome Health Lariam PS Roche 4 TABLETS
Dyspnoea Professional TAKEN IN
TOTAL. 31 DAY

Date:06/10/02ISR Number: 3930229-8Report Type:Direct Company Report #CTU 169778 Age:47 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Behaviour Lariam 250mg Roche
Mania Laboratories PS Roche Laboratories ORAL 62.5MG WEEK
ORAL
03-Apr-2012 09:37 AM Page: 449

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/11/02ISR Number: 3931023-4Report Type:Expedited (15-DaCompany Report #314691 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Nightmare Mefloquine
Bipolar Disorder Hydrochloride PS Roche WEEKLY 8 DAY
Date:06/12/02ISR Number: 3931889-8Report Type:Expedited (15-DaCompany Report #269729 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viith Nerve Paralysis Lariam PS Roche 1 DAY
Paraesthesia
Date:06/13/02ISR Number: 3934018-XReport Type:Expedited (15-DaCompany Report #314691 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Paranoia Foreign Mefloquine
Mania Other Hydrochloride
Nightmare
(Mefloquine
Bipolar Disorder Hydrochloride) PS ORAL ORAL
Date:06/13/02ISR Number: 3934164-0Report Type:Expedited (15-DaCompany Report #304145 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Respiratory Disorder Foreign Lariam (Mefloquine
Pyrexia Health Hydrochloride) 250
Guillain-Barre Syndrome Professional Mg PS ORAL 250 MG 1 PER
Rash
WEEK ORAL
Date:06/17/02ISR Number: 3934814-9Report Type:Direct Company Report #CTU 170287 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Insomnia Lariam/Mefloquine
Hcl 250 Milligram
Tablets Hoffman La
Roche PS Hoffman La Roche ORAL 1 TABLE WEEK
ORAL
Date:06/17/02ISR Number: 3935025-3Report Type:Expedited (15-DaCompany Report #269729 Age:29 YR Gender:Female I/FU:F
Outcome
Other Serious
PT
Fatigue
Dizziness
Facial Nerve Disorder

Eye Irritation
Hypoaesthesia
Arteriosclerosis Coronary
Artery
Paraesthesia
Viith Nerve Paralysis
Diplopia
Headache
03-Apr-2012 09:37 AM Page: 450

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Trigeminal Nerve Disorder
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam (Mefloquine
Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG 1 PER
Other
WEEK ORAL
Date:06/18/02ISR Number: 3934117-2Report Type:Expedited (15-DaCompany Report #314691 Age:38 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Nightmare Mefloquine
Bipolar Disorder Hydrochloride PS Roche WEEKLY 8 DAY
Date:06/18/02ISR Number: 3934122-6Report Type:Expedited (15-DaCompany Report #314899 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disorientation Lariam PS Roche EVERY WEEK. 9 DAY
Initial or Prolonged Speech Disorder Valium SS Roche 1 DAY
Disability
Incontinence
Convulsion
Agitation
Drug Ineffective
Hallucination
Depression
Headache
Fatigue
Memory Impairment
Psychotic Disorder
Loss Of Libido
Paranoia
Hostility
Aggression
Gait Disturbance
Antisocial Behaviour
Date:06/20/02ISR Number: 3935868-6Report Type:Expedited (15-DaCompany Report #313825 Age:27 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Respiratory Failure Consumer Lariam PS Roche
Abnormal Behaviour
Fear
Asphyxia
Date:06/20/02ISR Number: 3937360-1Report Type:Expedited (15-DaCompany Report #314691 Age:38 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Bipolar Disorder Foreign Mefloquine
Nightmare Other Hydrochloride
Paranoia
(Mefloquine
Hydrochloride) PS ORAL ORAL
03-Apr-2012 09:37 AM Page: 451

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/20/02ISR Number: 3937925-7Report Type:Expedited (15-DaCompany Report #314899 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Other Lariam (Mefloquine
Initial or Prolonged Gait Disturbance Hydrochloride) 250
Disability Incoherent Mg PS ORAL 250 MG ORAL
Abnormal Behaviour Valium (Diazepam) SS INTRAVENOUS 2 PER ONE
Drug Ineffective
DOSE
Memory Impairment
INTRAVENOUS
Speech Disorder
Circulatory Collapse
Hallucination
Incontinence
Fatigue
Psychotic Disorder
Aggression
Antisocial Behaviour
Hypersomnia
Headache
Loss Of Libido
Paranoia
Agitation
Depression
Disorientation
Hostility
Date:06/20/02ISR Number: 3938627-3Report Type:Expedited (15-DaCompany Report #314899 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disorientation Consumer Lariam PS Roche EVERY WEEK. 9 DAY
Initial or Prolonged Drug Ineffective Valium SS Roche 1 DAY
Disability
Headache
Psychotic Disorder
Agitation
Speech Disorder
Memory Impairment
Hostility
Loss Of Libido
Circulatory Collapse
Hypersomnia
Paranoia
Gait Disturbance
Convulsion
Antisocial Behaviour
Incontinence
Hallucination
Fatigue
Depression
Aggression
Incoherent

Date:06/24/02ISR Number: 3937485-0Report Type:Expedited (15-DaCompany Report #315549 Age:52 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Anxiety
Delirium
Aggression
03-Apr-2012 09:37 AM Page: 452

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Agitation
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche 2 DAY
Date:06/24/02ISR Number: 3938733-3Report Type:Expedited (15-DaCompany Report #314899 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Gait Disturbance Other Lariam (Mefloquine
Initial or Prolonged Fatigue Hydrochloride) 250
Disability Loss Of Libido Mg PS ORAL 250 MG ORAL
Psychotic Disorder Valium (Diazepam) SS INTRAVENOUS 2 PER ONE
Incontinence
DOSE
Cognitive Disorder
INTRAVENOUS
Depression
Aggression
Speech Disorder
Antisocial Behaviour
Hypersomnia
Abnormal Behaviour
Drug Ineffective
Paranoia
Agitation
Communication Disorder
Disorientation
Hallucination
Headache
Hostility
Memory Impairment
Convulsion
Date:06/24/02ISR Number: 3939023-5Report Type:Expedited (15-DaCompany Report #313825 Age:27 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Fear Foreign Lariam (Mefloquine
Abnormal Behaviour Health Hydrochloride) PS
Respiratory Failure
Professional
Asphyxia
Other
Personality Change
Date:06/26/02ISR Number: 3940478-0Report Type:Expedited (15-DaCompany Report #315549 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Delirium Foreign Lariam (Mefloquine
Initial or Prolonged Anxiety Other Hydrochloride) PS ORAL 1 DOSE FORM 3
Agitation PER DAY ;
Aggression
ORAL

Date:07/01/02ISR Number: 3941764-0Report Type:Expedited (15-DaCompany Report #312685 Age:52 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nervous System Disorder Lariam PS Roche
Initial or Prolonged Loss Of Consciousness
03-Apr-2012 09:37 AM Page: 453

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/02/02ISR Number: 3943540-1Report Type:Direct Company Report #CTU 171531 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nausea Lariam, 250 Mg,
Thinking Abnormal Roche PS Roche 1 TABLET/WEEK
Hallucinations, Mixed
Diarrhoea
Decreased Appetite
Insomnia
Anxiety
Panic Attack
Tinnitus
Nightmare
Paraesthesia
Date:07/03/02ISR Number: 3942894-XReport Type:Expedited (15-DaCompany Report #316199 Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Papilloedema Lariam PS Roche
Date:07/03/02ISR Number: 3942896-3Report Type:Expedited (15-DaCompany Report #316127 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Oedema Lariam PS Roche 32 DAY
Prozac C 1/2 TABLET Q.
Date:07/03/02ISR Number: 3944277-5Report Type:Expedited (15-DaCompany Report #312685 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nervous System Disorder Foreign Lariam (Mefloquine
Initial or Prolonged Hunger Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Loss Of Consciousness Professional PER WEEK ORAL
Malaise
Date:07/08/02ISR Number: 3944365-3Report Type:Expedited (15-DaCompany Report #316149 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Optic Ischaemic Lariam PS Roche 48 DAY
Neuropathy
Date:07/08/02ISR Number: 3945803-2Report Type:Direct Company Report #CTU 171760 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Fatigue Lariam 250 Mg
Panic Attack
Roche Laboratories
Confusional State Inc. PS Roche Laboratories
Abnormal Dreams Inc. ORAL 1 WEEK ORAL
Paranoia
Anxiety
Insomnia
03-Apr-2012 09:37 AM Page: 454

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/10/02ISR Number: 3945975-XReport Type:Expedited (15-DaCompany Report #313891 Age: Gender:Not SpecifiI/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche 1 DAY
Date:07/11/02ISR Number: 3946728-9Report Type:Expedited (15-DaCompany Report #316885 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Transient Ischaemic Lariam PS Roche
Attack
Date:07/11/02ISR Number: 3946741-1Report Type:Direct Company Report #CTU 172130 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Lariam 250mg Roche PS Roche ORAL 250MG WEEKLY
Dizziness
ORAL
Date:07/12/02ISR Number: 3947476-1Report Type:Expedited (15-DaCompany Report #313825 Age:27 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Asphyxia Lariam PS Roche
Mood Altered
Fear
Death
Date:07/17/02ISR Number: 3949407-7Report Type:Direct Company Report #CTU 172441 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Headache Mefloquin 250mg PS ORAL 250MG ONE PER
Intervention to Feeling Of Body ORAL
Prevent Permanent
Impairment/Damage
Temperature Change
Palpitations
Influenza Like Illness
Paraesthesia
Hyperhidrosis
Fatigue
Disorientation
Eye Pain
Neck Pain
Tinnitus
Date:07/22/02ISR Number: 3951636-3Report Type:Direct Company Report #CTU 172653 Age:23 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Lariam 250mg Hoffman
Initial or Prolonged Nightmare Roche PS Hoffman Roche 2TAB ONCE PER
Sleep Disorder
Pain
Suicidal Ideation
03-Apr-2012 09:37 AM Page: 455

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/24/02ISR Number: 3952731-5Report Type:Expedited (15-DaCompany Report #317246 Age:21 YR Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Obsessive-Compulsive Lariam PS Roche WEEKLY
Disorder DOSING. 15 DAY
Restlessness
Anxiety
Delusional Disorder,
Persecutory Type
Date:07/25/02ISR Number: 3953195-8Report Type:Expedited (15-DaCompany Report #317246 Age:21 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusional Disorder, Lariam PS Roche WEEKLY
Persecutory Type DOSING. 15 DAY
Obsessive-Compulsive
Disorder
Restlessness
Anxiety
Date:07/26/02ISR Number: 3953701-3Report Type:Expedited (15-DaCompany Report #312621 Age:30 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viith Nerve Paralysis Lariam PS Roche 15 DAY
Paraesthesia Oral
Hypoaesthesia Oral
Neuritis
Date:07/26/02ISR Number: 3953703-7Report Type:Expedited (15-DaCompany Report #316035 Age:17 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam PS Roche 52 DAY
Irritability Contraceptive Pill C
Fatigue
Hallucination, Visual
Flashback
Nightmare
Date:07/30/02ISR Number: 3955307-9Report Type:Expedited (15-DaCompany Report #316127 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Oedema Lariam PS Roche 32 DAY
Prozac C 1/2 TABLET Q.

Date:07/30/02ISR Number: 3955636-9Report Type:Direct Company Report #CTU 173213 Age:22 YR Gender:Female I/FU:I
Outcome
PT
Fear
Anxiety
Insomnia
Paranoia
03-Apr-2012 09:37 AM Page: 456

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Euphoric Mood
Energy Increased
Report Source Product Role Manufacturer Route Dose Duration
Mefloquine 250 Mg PS Geneva Pharm Tech
Corp 250 MG X 1
Hepatitis A Vaccine C
Yellow Fever Vaccine C
Date:07/31/02ISR Number: 3955740-5Report Type:Expedited (15-DaCompany Report #263822 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Vision Blurred Health Lariam PS Roche 15 DAY
Cardiac Arrest Professional Malarone SS 4 DAY
Tinnitus
Movement Disorder
Grand Mal Convulsion
Dizziness
Deafness
Date:07/31/02ISR Number: 3956338-5Report Type:Direct Company Report #CTU 173279 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Mefloquine ( Lariam) PS ORAL WEEKLY ORAL 3 YR
Epilepsy Acetaminophen C
Aspirin
C
Date:08/02/02ISR Number: 3956916-3Report Type:Expedited (15-DaCompany Report #316127 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pruritus Lariam PS Roche 25 DAY
Oedema Peripheral Prozac C 1/2 TABLET Q.
Date:08/05/02ISR Number: 3957894-3Report Type:Direct Company Report #CTU 173530 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Lariam PS
Date:08/07/02ISR Number: 3959487-0Report Type:Direct Company Report #CTU 173717 Age: Gender:Male I/FU:I
Outcome
PT
Blood Pressure Increased
Depression
Suicidal Ideation

Thinking Abnormal
Anxiety
Chest Pain
Confusional State
Heart Rate Increased
Panic Attack
Fatigue
Feeling Abnormal
03-Apr-2012 09:37 AM Page: 457

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Mood Swings
Agitation
Cold Sweat Report Source Product Role Manufacturer Route Dose Duration
Disorientation Lariam PS 1 SERIES
Feeling Hot
Headache
Paranoia
Disturbance In Attention
Insomnia
Memory Impairment
Psychotic Disorder
Date:08/08/02ISR Number: 3959678-9Report Type:Expedited (15-DaCompany Report #318504 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Gastrointestinal Lariam PS Roche PATIENT
Initial or Prolonged Haemorrhage RECEIVED 6 OR
7 TABLETS IN
TOTAL.
Date:08/12/02ISR Number: 3960866-6Report Type:Expedited (15-DaCompany Report #316035 Age:17 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Irritability Lariam PS Roche 52 DAY
Depression Contraceptive Pill C
Nightmare
Flashback
Hallucination, Visual
Fatigue
Date:08/19/02ISR Number: 3963568-5Report Type:Expedited (15-DaCompany Report #319090 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicide Attempt Lariam PS Roche
Date:08/19/02ISR Number: 3963569-7Report Type:Expedited (15-DaCompany Report #319098 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chills Lariam PS Roche
Initial or Prolonged Crying
Vomiting
Hallucination
Asthenia
Chest Pain
Anxiety

Suicidal Ideation
03-Apr-2012 09:37 AM Page: 458

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/19/02ISR Number: 3963579-XReport Type:Expedited (15-DaCompany Report #319480 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Homicide Lariam PS Roche
Suicide Attempt
Physical Assault
Hypoxic-Ischaemic
Encephalopathy
Date:08/20/02ISR Number: 3964267-6Report Type:Direct Company Report #CTU 174573 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Emotional Distress Larium/Mefloquin PS ORAL 1 PER FOR TWO
Anxiety
ORAL
Mental Disorder
Date:08/20/02ISR Number: 3964533-4Report Type:Direct Company Report #CTU 174624 Age:70 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vision Blurred Lariam Tab 250 Mg Ud PS 250 MG Q WK 5 WK
Nitrostat
C
Date:08/21/02ISR Number: 3964552-8Report Type:Expedited (15-DaCompany Report #319597 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asphyxia Lariam PS Roche
Homicide
Feeling Abnormal
Aggression
Date:08/23/02ISR Number: 3965918-2Report Type:Direct Company Report #CTU 174896 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Mefloquine 250mg
Depression Roche PS Roche ORAL 250MG QWEEK
Panic Attack
ORAL
Malaria
Mental Disorder
Date:08/23/02ISR Number: 3965956-XReport Type:Direct Company Report #CTU 174911 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam Standard PS

Bipolar Disorder
Psychomotor Hyperactivity
Insomnia
Mania
03-Apr-2012 09:37 AM Page: 459

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/26/02ISR Number: 3966695-1Report Type:Direct Company Report #CTU 175006 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hypersensitivity Lariam Roche PS Roche ORAL 1 Q WEEK ORAL
Disability
Muscle Spasticity
Required
Tremor
Intervention to
Anaphylactic Reaction
Prevent Permanent
Impairment/Damage
Date:08/26/02ISR Number: 3966696-3Report Type:Direct Company Report #CTU 175007 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Asthenia Lariam PS AURICULAR
Intervention to Disorientation (OTIC) 1 WEEKLY
Prevent Permanent Insomnia AURICULAR
Impairment/Damage Dyspnoea
Headache
Vertigo
Vision Blurred
Anxiety
Dizziness
Date:08/26/02ISR Number: 3966794-4Report Type:Direct Company Report #CTU 175027 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Emotional Disorder Lariam PS 1X/WK
Confusional State
Crying
Mania
Panic Attack
Stress
Suicidal Ideation
Anxiety
Depression
Paranoia
Date:08/26/02ISR Number: 3966896-2Report Type:Direct Company Report #CTU 174984 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disorientation Lariam PS ORAL ORAL
Paranoia
Hypoaesthesia
Panic Attack
Confusional State

Date:08/26/02ISR Number: 3966913-XReport Type:Direct Company Report #CTU 174991 Age: Gender:Male I/FU:I
Outcome
Life-Threatening
Hospitalization -
Initial or Prolonged
PT
Psychomotor Skills
Impaired
Memory Impairment
Suicidal Ideation
03-Apr-2012 09:37 AM Page: 460

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depression
Disorientation
Report Source Product Role Manufacturer Route Dose Duration
Larium
PS
Date:08/27/02ISR Number: 3967147-5Report Type:Direct Company Report #CTU 175112 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Screaming Lariam 250 Mg Roche PS Roche ORAL 1 TABLE WEEK
Initial or Prolonged Fear ORAL
Hallucination
Nervous System Disorder
Hyperhidrosis
Feeling Cold
Nervousness
Poisoning
Depression
Crying
Anxiety
Flatulence
Panic Attack
Feeling Abnormal
Date:08/27/02ISR Number: 3967173-6Report Type:Direct Company Report #CTU 175102 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam
Anxiety Hoffman-Laroche PS Hoffman-Laroche ORAL 250MG WEEKLY
Paranoia
ORAL
Date:08/28/02ISR Number: 3967043-3Report Type:Expedited (15-DaCompany Report #264418 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pregnancy Lariam PS Roche
Apgar Score Low Quinine Sulfate C 24 HOUR
Premature Separation Of
PERIODS EVERY
Placenta 8 HOURS, 10
Caesarean Section
MG/KG.
Premature Baby TREATED 03 TO 25 DAY
Maternal Drugs Affecting
Foetus
Date:08/30/02ISR Number: 3969670-6Report Type:Direct Company Report #CTU 175355 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Paranoia Lariam Roche PS Roche ORAL 1/WEEK ORAL
Panic Reaction
03-Apr-2012 09:37 AM Page: 461

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/03/02ISR Number: 3970033-8Report Type:Direct Company Report #CTU 175541 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Mefloquine Hoffman
Paranoia Laroche PS Hoffman Laroche BUCCAL 250 MG ONCE A
Insomnia
WEEK BUCCAL
Hallucination
Activities Of Daily
Living Impaired
Date:09/05/02ISR Number: 3970808-5Report Type:Expedited (15-DaCompany Report #320492 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Depression Lariam PS Roche
Overdose
Completed Suicide
Date:09/05/02ISR Number: 3970809-7Report Type:Expedited (15-DaCompany Report #311320 Age:41 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blindness Health Lariam PS Roche 363 DAY
Visual Field Defect
Professional
Date:09/05/02ISR Number: 3970849-8Report Type:Direct Company Report #CTU 175737 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Abnormal Dreams Mefloquone PS ORAL STANDARD
Other Serious Suicidal Ideation WEEKLY ORAL
Date:09/05/02ISR Number: 3971375-2Report Type:Direct Company Report #CTU 175736 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disturbance In Attention Larium 250 Mg PS
Abnormal Behaviour
Fatigue
Insomnia
Psychomotor Hyperactivity
Nightmare
Date:09/06/02ISR Number: 3971323-5Report Type:Expedited (15-DaCompany Report #A0379543A Age:55 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Health Malarone PS Glaxo Wellcome ORAL 18 DAY

Tinnitus Professional Mefloquine SS ORAL 1 DAY
03-Apr-2012 09:37 AM Page: 462

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/06/02ISR Number: 3971398-3Report Type:Expedited (15-DaCompany Report #316149 Age:50 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Optic Ischaemic Health Lariam PS Roche 48 DAY
Neuropathy
Professional
Date:09/06/02ISR Number: 3971399-5Report Type:Expedited (15-DaCompany Report #319597 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anger Consumer Lariam PS Roche
Social Avoidant Behaviour
Nervousness
Homicide
Communication Disorder
Tremor
Incoherent
Aggression
Feeling Abnormal
Date:09/06/02ISR Number: 3971407-1Report Type:Expedited (15-DaCompany Report #320484 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Lariam PS Roche
Anger
Date:09/09/02ISR Number: 3974309-XReport Type:Expedited (15-DaCompany Report #02P-056-0198998-00 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myalgia Foreign Isoptine (Verapamil)
Initial or Prolonged Amyotrophy Health (Verapamil) PS ORAL 240 MG, PER
Red Blood Cell Professional ORAL
Sedimentation Rate Insuline Humalog SS
Increased Mefloquine SS ORAL 250 MG, 1 IN
Pain
1 WK, PER
Systemic Inflammatory
ORAL
Response Syndrome Perindopril SS ORAL 2 MG, PER
ORAL
Simvastatin SS ORAL PER ORAL
Insuline "Umuline" SS SUBCUTANEOUS SUBCUTANEOUS
Acetylsalicylic Acid SS ORAL PER ORAL
Date:09/10/02ISR Number: 3974021-7Report Type:Direct Company Report #CTU 176057 Age:37 YR Gender:Male I/FU:I
Outcome
Disability
PT
Paranoia

Fatigue
Hyperventilation
Agitation
Dizziness
Hallucination
Insomnia
Fear
Nightmare
03-Apr-2012 09:37 AM Page: 463

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Panic Disorder
Report Source Product Role Manufacturer Route Dose Duration
Lariam 250mg Roche PS Roche ORAL 1 TABLE ONCE
PER ORAL
Date:09/10/02ISR Number: 3974116-8Report Type:Direct Company Report #CTU 176039 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Unevaluable Event Lariam 250mg F
Hoffman-Laroche PS F Hoffman-Laroche ORAL 1 TABLE ONCE
A WEEK ORAL
Date:09/11/02ISR Number: 3974266-6Report Type:Expedited (15-DaCompany Report #PERI00202002217 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Red Blood Cell Foreign Coversyl
Initial or Prolonged Sedimentation Rate Health (Perindopril) PS ORAL 2 MG QD PO
Increased Professional Lariam (Mefloquine) SS ORAL 250 MG DAILY
Myalgia Other PO
Pain In Extremity
Kardegic
(Acetylsalicylate
Lysine) SS ORAL DAILY PO
Umuline (Insulin
Human Zinc
Suspension) SS SUBCUTANEOUS DAILY SC
Humalog (Insulin
Lispro) SS SUBCUTANEOUS DAILY SC
Lodales
(Simvastatin) SS DAILY
Isoptin (Verapamil
Hydrochloride) SS ORAL DAILY PO
Date:09/12/02ISR Number: 3975274-1Report Type:Direct Company Report #CTU 176271 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Lariam -Mefloaquin-
Fatigue 250 Mg. Roche PS Roche ORAL 250MG WEEKLY
Vertigo
ORAL
Tinnitus
Dysgraphia
Date:09/13/02ISR Number: 3975636-2Report Type:Direct Company Report #CTU 176356 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Insomnia Larium PS ORAL ONCE WEEK
Required Anxiety ORAL
Intervention to Paranoia Plaquenil C
Prevent Permanent Nervousness Ambien C
Impairment/Damage Biaxin C
03-Apr-2012 09:37 AM Page: 464

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/16/02ISR Number: 3975606-4Report Type:Expedited (15-DaCompany Report #321059 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Inflammation Lariam PS Roche 29 DAY
Initial or Prolonged Amyotrophy Lodales SS
Pain Coversyl SS
Pain In Extremity Kardegic SS FORMULATION
Myalgia
LYOPHILISED.
Red Blood Cell Umuline SS
Sedimentation Rate Isoptine SS
Increased Humalog C
Date:09/16/02ISR Number: 3976184-6Report Type:Direct Company Report #CTU 176452 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Aggression Mefloquine Hoffman
Hospitalization - Suicidal Ideation La Roche PS Hoffman La Roche ORAL BI-WEEKLY
Initial or Prolonged Homicidal Ideation ORAL
Other Serious
Hallucination
Required
Toxicity To Various
Intervention to
Agents
Prevent Permanent Psychotic Disorder
Impairment/Damage
Date:09/17/02ISR Number: 3977060-5Report Type:Direct Company Report #CTU 176592 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Alopecia Lariam PS ORAL ONCE WEEKLY
Dry Skin
ORAL
Vision Blurred
Feeling Abnormal
Headache
Dizziness
Swelling
Date:09/17/02ISR Number: 3977073-3Report Type:Direct Company Report #CTU 176590 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Palpitations Lariam 250mg Roche
Initial or Prolonged Illusion Lab PS Roche Lab ORAL ONCE WEEKLY
Other Serious Dyspnoea ORAL
Vertigo
Dizziness
Disorientation
Visual Impairment
Dysphagia
Headache

Anxiety
03-Apr-2012 09:37 AM Page: 465

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/18/02ISR Number: 3977706-1Report Type:Direct Company Report #CTU 176752 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hallucination Lariam PS Roche
Hospitalization - Neurosis Pharmaceuticals ONE PER
Initial or Prolonged Panic Attack
Suicidal Ideation
Night Sweats
Tachycardia
Insomnia
Muscle Spasms
Paranoia
Decreased Appetite
Psychotic Disorder
Thirst
Date:09/23/02ISR Number: 3978040-6Report Type:Expedited (15-DaCompany Report #320927 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dizziness Lariam PS Roche 25 DAY
Nausea Amlodipine C 143 DAY
Headache Bendrofluazide C 24 DAY
Vision Blurred
Sedation
Date:09/23/02ISR Number: 3978044-3Report Type:Expedited (15-DaCompany Report #320902 Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Feeling Abnormal Lariam PS Roche
Initial or Prolonged Cold Sweat
Hallucination
Aggression
Disorientation
Date:09/23/02ISR Number: 3979340-6Report Type:Direct Company Report #CTU 176999 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Delusion Lariam Laroche PS Laroche
Initial or Prolonged Performance Status
Disability
Decreased
Other Serious
Anxiety
Mental Disorder
Blood Pressure Increased
Suicidal Ideation
Abnormal Behaviour
Aggression
Anger

Divorced
Hallucination
Depression
Palpitations
03-Apr-2012 09:37 AM Page: 466

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/24/02ISR Number: 3978154-0Report Type:Expedited (15-DaCompany Report #321488 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Night Sweats Lariam PS Roche 43 DAY
Delirium
Nightmare
Heart Rate Increased
Date:09/26/02ISR Number: 3981417-6Report Type:Direct Company Report #CTU 177370 Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Agitation Larium - Roche PS Roche 1 TABLET
Initial or Prolonged Depression WEEKLY
Other Serious
Paraesthesia
Palpitations
Toxicity To Various
Agents
Anxiety
Hypertension
Nausea
Date:09/27/02ISR Number: 3982056-3Report Type:Direct Company Report #CTU 177430 Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Chills Lariam PS Roche ORAL 250MG WEEK
Intervention to Paraesthesia ORAL
Prevent Permanent Renal Pain Doxycycline C
Impairment/Damage Pollakiuria Bactrim C
Morbid Thoughts Ciprofloxacin C
Feeling Of Despair
Panic Attack
Insomnia
Sleep Disorder
Date:09/27/02ISR Number: 3985386-4Report Type:Expedited (15-DaCompany Report #321488 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Health Lariam (Mefloquine
Heart Rate Increased Professional Hydrochloride) PS ORAL ORAL
Night Sweats
Delirium
Date:10/01/02ISR Number: 3985463-8Report Type:Direct Company Report #CTU 177643 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Facial Pain Lariam PS ORAL WEEKLY ORAL
Dizziness
Microgestin-Birth
Nightmare Control- C
Disorientation
03-Apr-2012 09:37 AM Page: 467

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/03/02ISR Number: 3985611-XReport Type:Direct Company Report #CTU 177838 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disorientation Mefloquine PS 1 PILL WEEK
Depression
Mood Altered
Date:10/07/02ISR Number: 3984410-2Report Type:Expedited (15-DaCompany Report #A0379543A Age:55 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Malarone PS Glaxo Wellcome ORAL 18 DAY
Diarrhoea Mefloquine SS ORAL 1 DAY
Irritability Mvi C
Date:10/07/02ISR Number: 3984911-7Report Type:Expedited (15-DaCompany Report #305877 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Lung Infiltration Health Lariam PS Roche DESCRIBED AS
Dyspnoea Professional 3 TABLETS IN
THE MORNING,
2 IN THE
MIDDLE OF THE 1 DAY
Date:10/07/02ISR Number: 3984914-2Report Type:Expedited (15-DaCompany Report #321938 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vomiting Mefloquine
Nausea Hydrochloride PS Roche
Disturbance In Attention
Abnormal Dreams
Date:10/07/02ISR Number: 3984952-XReport Type:Expedited (15-DaCompany Report #316199 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Optic Neuritis Health Lariam PS Roche 366 DAY
Professional
Date:10/07/02ISR Number: 3984973-7Report Type:Expedited (15-DaCompany Report #319597 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Homicide Consumer Lariam PS Roche
Social Avoidant Behaviour
Dysphemia

Tremor
Aggression
Feeling Abnormal
Nervousness
Abnormal Behaviour
Incoherent
Anger
03-Apr-2012 09:37 AM Page: 468

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/07/02ISR Number: 3987080-2Report Type:Direct Company Report #CTU 178124 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Lariam- Roche Labs PS Roche Labs ORAL WEEKLY- 136
Myalgia
WKS ORAL
Fibromyalgia
Date:10/07/02ISR Number: 3987117-0Report Type:Direct Company Report #CTU 178129 Age:60 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abdominal Pain Lariam -Roche Labs PS Roche Labs ORAL WEEKLY
Tinnitus
-150WKS ORAL
Depression
Headache
Abnormal Dreams
Anxiety
Pruritus
Date:10/07/02ISR Number: 3990430-4Report Type:Direct Company Report #CTU 178059 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Headache Mefloquine
Panic Disorder
Hydrochloride 250mg
Abnormal Behaviour Geneva Pharm Tech PS Geneva Pharm Tech ONCE WEEKL
Abdominal Pain
Confusional State
Mood Swings
Emotional Disorder
Insomnia
Anxiety
Decreased Appetite
Date:10/08/02ISR Number: 3990489-4Report Type:Direct Company Report #CTU 178231 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aggression Larium PS 2 TABLETS 10
Vomiting
DAYS
Abnormal Behaviour
Malaise
Mood Swings
Date:10/09/02ISR Number: 3987337-5Report Type:Direct Company Report #CTU 178319 Age:41 YR Gender:Female I/FU:I
Outcome
Disability
PT
Mood Swings

Pulmonary Embolism
Back Pain
Chest Pain
Dyspepsia
Aggression
Dizziness
Stress
Depression
03-Apr-2012 09:37 AM Page: 469

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Feeling Abnormal
Headache
Sleep Disorder Report Source Product Role Manufacturer Route Dose Duration
Panic Attack Larium PS ORAL 1 WEEKLY ORAL
Oral Ulcer-Type
Products
C
Cimetidine
C
Warfarin
C
Date:10/10/02ISR Number: 3987531-3Report Type:Expedited (15-DaCompany Report #320484 Age:52 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Extrasystoles Consumer Lariam PS Roche 61 DAY
Initial or Prolonged Panic Attack
Insomnia
Vestibular Disorder
Hallucination
Suicidal Ideation
Cognitive Disorder
Depression
Toxicity To Various
Agents
Brain Injury
Tremor
Illusion
Nervous System Disorder
Hyperacusis
Anger
Date:10/11/02ISR Number: 3988282-1Report Type:Expedited (15-DaCompany Report #322910 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspnoea Lariam PS Roche
Gastrointestinal
Haemorrhage
Date:10/14/02ISR Number: 3989477-3Report Type:Expedited (15-DaCompany Report #265329 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Illusion Lariam PS Roche
Hallucination
Disturbance In Attention
Dysarthria
Panic Attack

Date:10/15/02ISR Number: 3989917-XReport Type:Expedited (15-DaCompany Report #323150 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Interaction Health Lariam PS Roche
Initial or Prolonged Psoas Sign Professional Previscan I
Coagulopathy
Haematoma
03-Apr-2012 09:37 AM Page: 470

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/15/02ISR Number: 3991717-1Report Type:Direct Company Report #CTU 178703 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Contusion Lariam Hoffman La
Required Decreased Appetite Roche PS Hoffman La Roche ORAL STANDARD ONCE
Intervention to Heart Rate Increased A WEEK ORAL
Prevent Permanent Tremor Cardizem Cd C
Impairment/Damage Chills Vioxx C
Syncope Centrum Silver C
Nausea
Hypertension
Hyperhidrosis
Date:10/16/02ISR Number: 3990823-5Report Type:Expedited (15-DaCompany Report #86887 Age:43 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Pain Consumer Lariam Tablets PS Roche 49 DAY
Suicidal Ideation
Myalgia
Arthropod Bite
Csf Protein Abnormal
Malaise
Angina Pectoris
Atrophy
Feeling Of Body
Temperature Change
Asthenia
Flushing
Convulsion
Tinnitus
Nervousness
Muscular Weakness
Sleep Disorder
Neck Pain
Peripheral Sensory
Neuropathy
Epistaxis
Fatigue
Date:10/17/02ISR Number: 3991243-XReport Type:Expedited (15-DaCompany Report #323291 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Respiratory Failure Lariam PS Roche 63 DAY
Maternal Drugs Affecting
Foetus
Microcephaly
Pregnancy

Date:10/17/02ISR Number: 3997443-7Report Type:Expedited (15-DaCompany Report #323150 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Coagulopathy Foreign Lariam (Mefloquine
Initial or Prolonged Drug Interaction Health Hydrochloride) PS ORAL ORAL
Muscle Haemorrhage Professional Previscan
(Fluindione) SS ORAL ORAL
03-Apr-2012 09:37 AM Page: 471

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/18/02ISR Number: 3992136-4Report Type:Expedited (15-DaCompany Report #200841 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Accommodation Disorder Health Lariam PS Roche CUMULATIVE
Initial or Prolonged Speech Disorder Professional DOSAGE= 750
Disability Dry Mouth MG 380 DAY
Dysphagia
Meningococcal
Paraesthesia Vaccine C 1 DAY
Emotional Disorder Flu Vaccine C 1 DAY
Panic Attack
Asthenia
Movement Disorder
Tinnitus
Vision Blurred
Gait Disturbance
Feeling Drunk
Malaise
Fall
Heterophoria
Tremor
Balance Disorder
Hallucination, Visual
Diarrhoea
Diplopia
Hydrocephalus
Arrhythmia
Somnolence
Fatigue
Hyperventilation
Nausea
Dyspnoea
Disturbance In Attention
Date:10/21/02ISR Number: 3993095-0Report Type:Expedited (15-DaCompany Report #305230 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Congenital Tongue Anomaly Lariam PS Roche 36 DAY
Cryptorchism
Maternal Drugs Affecting
Foetus
Date:10/22/02ISR Number: 3994346-9Report Type:Expedited (15-DaCompany Report #314899 Age: Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Incontinence
Paranoia
Speech Disorder
Antisocial Behaviour
Loss Of Libido

Communication Disorder
Reading Disorder
Depression
Memory Impairment
Incoherent
Circulatory Collapse
Hallucination
Disorientation
03-Apr-2012 09:37 AM Page: 472

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Psychotic Disorder
Gait Disturbance
Agitation Report Source Product Role Manufacturer Route Dose Duration
Convulsion Lariam PS Roche EVERY WEEK. 9 DAY
Hostility Valium SS Roche 1 DAY
Drug Ineffective
Aggression
Headache
Delusion
Fatigue
Mania
Confusional State
Date:10/22/02ISR Number: 3994559-6Report Type:Expedited (15-DaCompany Report #323614 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lung Infection Lariam PS Roche
Initial or Prolonged Hypoxia
Lung Disorder
Date:10/22/02ISR Number: 3994562-6Report Type:Expedited (15-DaCompany Report #323551 Age:13 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Haemorrhagic Lariam PS Roche
Date:10/23/02ISR Number: 3995061-8Report Type:Expedited (15-DaCompany Report #265329 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Balance Disorder Lariam PS Roche
Hallucinations, Mixed
Panic Attack
Illusion
Disturbance In Attention
Hallucination, Olfactory
Dysarthria
Date:10/24/02ISR Number: 3996343-6Report Type:Direct Company Report #CTU 179445 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Feeling Abnormal Lariam 250 Mg
Required Insomnia Mephaquin PS ORAL 1 PILL ONCE A
Intervention to Amnesia WEEK ORAL
Prevent Permanent
Impairment/Damage
Crying
Anger
Vertigo

Mood Swings
03-Apr-2012 09:37 AM Page: 473

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/25/02ISR Number: 3998338-5Report Type:Direct Company Report #CTU 179642 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspepsia Lariam 250 Mg
Depression
Mefloquin Mfr
-Hoffman La Roche PS Hoffman La Roche 250 MG EVERY
WEEK (ONE'S
A WEEK) 6 WK
Date:10/25/02ISR Number: 4000382-9Report Type:Direct Company Report #CTU 179617 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Feeling Abnormal Mefloquine (Lariam) PS ORAL 250 MG ONCE A
Other Serious Stress WEEK ORAL
Depression
Anxiety
Date:10/29/02ISR Number: 3998705-XReport Type:Expedited (15-DaCompany Report #323614 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoxia Lariam PS Roche
Initial or Prolonged Infection
Lung Disorder
Date:10/31/02ISR Number: 4000596-8Report Type:Expedited (15-DaCompany Report #323900 Age: Gender:Not SpecifiI/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Lariam PS Roche 549 DAY
Foetus
Abortion Spontaneous
Paternal Drugs Affecting
Foetus
Date:11/01/02ISR Number: 4003334-8Report Type:Direct Company Report #CTU 180174 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Nervousness
Lariam (Mefloquine
Nightmare Hydrochloride) PS ONCE A WEEK
Weight Decreased
Anxiety
Date:11/01/02ISR Number: 4003598-0Report Type:Direct Company Report #CTU 180150 Age:36 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Larium PS ORAL 1 PILL WEEK
Nausea
ORAL
03-Apr-2012 09:37 AM Page: 474

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/04/02ISR Number: 4002692-8Report Type:Expedited (15-DaCompany Report #324511 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Haemolytic Anaemia Lariam PS Roche
Initial or Prolonged
Date:11/06/02ISR Number: 4004677-4Report Type:Expedited (15-DaCompany Report #324735 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Gait Disturbance Lariam PS Roche 213 DAY
Visual Impairment
Tinnitus
Date:11/07/02ISR Number: 4005549-1Report Type:Direct Company Report #CTU 180546 Age:18 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paranoia Lariam La Roche PS La Roche ORAL 1 TABLE ONCE
Initial or Prolonged Psychotic Disorder A WEEK ORAL
Disability
Delusion
Required
Hallucination
Intervention to
Thinking Abnormal
Prevent Permanent
Impairment/Damage
Date:11/13/02ISR Number: 4012180-0Report Type:Expedited (15-DaCompany Report #321428 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Foreign Lariam (Mefloquine
Foetus Health Hydrochloride) 250
Abortion Spontaneous Professional Mg PS ORAL 250 MG 1 PER
Pregnancy
ONE DOSE ORAL
Date:11/13/02ISR Number: 4012181-2Report Type:Expedited (15-DaCompany Report #324511 Age:25 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Haemorrhage Foreign Lariam (Mefloquine
Initial or Prolonged Haemolytic Anaemia Health Hydrochloride) PS
Professional
Date:11/13/02ISR Number: 4012182-4Report Type:Expedited (15-DaCompany Report #323150 Age:48 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Muscle Haemorrhage Foreign Lariam (Mefloquine

Initial or Prolonged Pain Health Hydrochloride) PS ORAL ORAL
Flatulence Professional Previscan
Constipation (Fluindione) SS ORAL 1 DOSE FORM
Drug Interaction
Hypocoagulable State
Lovenox (Enoxaparin
Sodium)
C
DAILY ORAL
03-Apr-2012 09:37 AM Page: 475

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/13/02ISR Number: 4012183-6Report Type:Expedited (15-DaCompany Report #324949 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Foreign Lariam(Mefloquine
Initial or Prolonged Multiple Sclerosis Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Optic Neuritis Professional PER WEEK ORAL
Date:11/15/02ISR Number: 4011394-3Report Type:Direct Company Report #CTU 181033 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Asthenia Lariam (Mefloquin) PS ORAL 1X WK 1 WK
Hospitalization - Anxiety BEFOR ORAL; 1
Initial or Prolonged Blood Pressure Decreased X WK 4WKS AFT
Disability Psychotic Disorder ORAL
Congenital Anomaly Dizziness Prozac C
Required Chills Fludrocortizone C
Intervention to
Headache
Prevent Permanent Suicidal Ideation
Impairment/Damage
Date:11/18/02ISR Number: 4013350-8Report Type:Expedited (15-DaCompany Report #324949 Age:29 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Foreign Lariam (Mefloquine
Initial or Prolonged Optic Neuritis Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Professional
PER WEEK ORAL
Date:11/18/02ISR Number: 4013366-1Report Type:Expedited (15-DaCompany Report #321428 Age: Gender:Unknown I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Maternal Drugs Affecting Foreign Lariam (Mefloquine
Initial or Prolonged Foetus Health Hydrochloride) 250
Abortion Spontaneous Professional Mg PS ORAL 250 MG 1 PER
Pregnancy
ONE DOSE ORAL
Date:11/19/02ISR Number: 4014667-3Report Type:Expedited (15-DaCompany Report #325394 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicide Attempt Other Lariam PS ORAL ORAL
Suicidal Ideation
Homicidal Ideation
Paranoia
Confusional State
Depression
Hallucination

Date:11/19/02ISR Number: 4014668-5Report Type:Expedited (15-DaCompany Report #325416 Age:27 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Hallucination
Confusional State
03-Apr-2012 09:37 AM Page: 476

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Delusion
Anger
Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration
Tremor Other Lariam (Mefloquine
Hydrochloride) PS
Date:11/20/02ISR Number: 4012638-4Report Type:Direct Company Report #CTU 181421 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hallucination, Auditory Mefloquine (Lariam)
Other Serious Homicidal Ideation (Roche Pharm) PS Roche Pharm 2 DOSES OVER
Hypoaesthesia
2 WEEKS
Anxiety
Schizophrenia, Paranoid
Type
Suicidal Ideation
Depression
Psychotic Disorder
Restlessness
Depersonalisation
Date:11/20/02ISR Number: 4012681-5Report Type:Direct Company Report #CTU 181369 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Larium PS
Fear
Disorientation
Hallucination
Date:11/26/02ISR Number: 4017612-XReport Type:Expedited (15-DaCompany Report #324855 Age:68 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Aspartate Foreign Lariam (Mefloquine
Aminotransferase Other Hydrochloride) PS ORAL ORAL
Increased
Pneumonitis
Cerebral Atrophy
Gamma-Glutamyltransferase
Increased
Prothrombin Time
Prolonged
Alcohol Withdrawal
Syndrome
Haemoglobin Abnormal
Platelet Count Abnormal
Alanine Aminotransferase
Increased

Hyperhidrosis
Blood Potassium Abnormal
Blood Sodium Abnormal
Livedo Reticularis
Nosocomial Infection
Encephalopathy
Respiratory Alkalosis
Peripheral Coldness
03-Apr-2012 09:37 AM Page: 477

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/26/02ISR Number: 4018662-XReport Type:Expedited (15-DaCompany Report #325725 Age:43 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Multiple Sclerosis Foreign Lariam (Meloquine
Optic Neuritis Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Professional
Yellow Fever Vaccine
(Yellow Fever
Vaccine)
C
PER WEEK ORAL
Date:11/26/02ISR Number: 4018664-3Report Type:Expedited (15-DaCompany Report #323150 Age:48 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Gastrointestinal Motility Foreign Lariam(Mefloquine
Initial or Prolonged Disorder Health Hydrochloride) PS ORAL ORAL
Hypocoagulable State Professional Previsan
Flatulence (Fluindione) SS ORAL DOSE FORM
Pain
DAILY ORAL
Drug Interaction
Muscle Haemorrhage
Date:11/27/02ISR Number: 4019178-7Report Type:Expedited (15-DaCompany Report #304340 Age:15 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Bipolar Disorder Other Lariam (Mefloquine
Initial or Prolonged Hallucination Hydrochloride) 250
Disability Hemiparesis Mg PS ORAL 250 MG 1 PER
Myalgia
WEEK ORAL
Blindness
Depression
Paraesthesia
Depressed Level Of
Consciousness
Headache
Paranoia
Eye Swelling
Hypoaesthesia
Suicidal Ideation
Date:11/27/02ISR Number: 4019228-8Report Type:Expedited (15-DaCompany Report #325881 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Jaundice Foreign Lariam (Mefloquine
Erythema Multiforme Other Hydrochloride) PS ORAL 250 MG 1 PER
Arthralgia
Havrix (Hepatitis A
Vaccine)
C
WEEK ORAL

Date:12/06/02ISR Number: 4022746-XReport Type:Expedited (15-DaCompany Report #324949 Age:29 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Multiple Sclerosis
Headache
03-Apr-2012 09:37 AM Page: 478

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Optic Neuritis
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Lariam (Mefloquine
Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Professional
PER WEEK ORAL
Date:12/09/02ISR Number: 4020858-8Report Type:Direct Company Report #CTU 182353 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Personality Change Lariam - Mefloquine- PS
Pain
Abnormal Behaviour
Date:12/09/02ISR Number: 4020882-5Report Type:Direct Company Report #CTU 182327 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Lariam PS ORAL 250MG WEEKLY
ORAL
Date:12/16/02ISR Number: 4027039-2Report Type:Expedited (15-DaCompany Report #319597 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aggression Other Lariam (Mefloquine
Homicide Hydrochloride) 250
Anger Mg PS ORAL ORAL
Social Avoidant Behaviour
Tremor
Speech Disorder
Feeling Abnormal
Nervousness
Date:12/16/02ISR Number: 4027400-6Report Type:Expedited (15-DaCompany Report #324949 Age:29 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Foreign Lariam (Mefloquine
Initial or Prolonged Multiple Sclerosis Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Optic Neuritis Professional PER WEEK ORAL
Date:12/23/02ISR Number: 4028551-2Report Type:Direct Company Report #CTU 183235 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam 250mg Roche

Panic Reaction Labs. PS Roche Labs 1 TABLE
Toxicity To Various
WEEKLY
Agents
Confusional State
Irritability
03-Apr-2012 09:37 AM Page: 479

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/23/02ISR Number: 4028552-4Report Type:Direct Company Report #CTU 183236 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Lariam (Mefloqune)
Anxiety 250gm Roche Labs. PS Roche Labs ONE TABLE PER
Dizziness
WEEK
Nausea
Paranoia
Tinnitus
Vision Blurred
Toxicity To Various
Agents
Muscle Twitching
Muscle Spasms
Date:12/23/02ISR Number: 4028553-6Report Type:Direct Company Report #CTU 183237 Age:69 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Cerebral Atrophy Larium 250 Mg
Required Nausea Roche Lab PS Roche Lab ORAL 1 PER 7 WEEKS
Intervention to Balance Disorder ORAL
Prevent Permanent Dizziness
Impairment/Damage Syncope
Date:12/23/02ISR Number: 4033084-3Report Type:Expedited (15-DaCompany Report #327602 Age:47 YR Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Anticholinergic Syndrome Literature Mefloquine
Intervention to Health Hydrochloride PS
Prevent Permanent
Professional
Impairment/Damage
Date:12/23/02ISR Number: 4033392-6Report Type:Expedited (15-DaCompany Report #324949 Age:29 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Foreign Lariam (Mefloquine
Initial or Prolonged Optic Neuritis Health Hydrochloride) PS ORAL 1 DOSE FORM 1
Professional
PER WEEK ORAL
Date:12/26/02ISR Number: 4030737-8Report Type:Direct Company Report #CTU 183365 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Disorder Larium
Required Visual Impairment Unsure-Gov.'T Issue PS 1 PILL PER
Intervention to Diarrhoea WEEK

Prevent Permanent Vomiting Furamide C
Impairment/Damage Dizziness Metronidozol C
Insomnia Bactrim C
Nausea Fazygen C
Panic Attack
Anxiety
Hallucination
Skin Ulcer
03-Apr-2012 09:37 AM Page: 480

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/06/03ISR Number: 4039907-6Report Type:Expedited (15-DaCompany Report #323965 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nightmare Consumer Lariam (Mefloquine
Paraesthesia Hydrochloride) 250
Electrocardiogram T Wave Mg PS ORAL 250 MG 1 PER
Abnormal
WEEK ORAL
Agitation
Electrocardiogram
Abnormal
Fear
Hypotension
Panic Attack
Gastrointestinal Disorder
Abnormal Dreams
Convulsion
Diarrhoea
Anxiety
Conduction Disorder
Supraventricular
Tachycardia
Dyspepsia
Constipation
Dizziness
Gastrooesophageal Reflux
Disease
Insomnia
Restlessness
Chills
Tremor
Mental Disorder
Atrioventricular Block
First Degree
Choking Sensation
Nausea
Sensory Loss
Hypertension
Night Sweats
Vision Blurred
Eructation
Flushing
Palpitations
Supraventricular
Extrasystoles
Weight Decreased
Dysphagia
Date:01/08/03ISR Number: 4040684-3Report Type:Expedited (15-DaCompany Report #328238 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paresis Foreign Lariam (Mefloquine

Health Hydrochloride) 250
Professional Mg PS
Other
03-Apr-2012 09:37 AM Page: 481

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/14/03ISR Number: 4042880-8Report Type:Expedited (15-DaCompany Report #328748 Age:54 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Labyrinthitis Foreign Mefloquine
Bradyphrenia Literature Hydrochloride
Headache Health (Mefloquine
Hypercholesterolaemia Professional Hydrochloride) PS 250 MG 1
Clonic Convulsion
Cerivastatin
(Cerivastatin
Sodium)
C
PER WEEK
Date:01/14/03ISR Number: 4043507-1Report Type:Expedited (15-DaCompany Report #303888 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Panic Attack Foreign Lariam (Mefloquine
Required Visual Impairment Health Hydrochloride) PS ORAL 250 MG DAILY
Intervention to Agoraphobia Professional ORAL
Prevent Permanent Psychotic Disorder Other Chloroquine
Impairment/Damage Nervousness (Chloroquine) C
Date:01/16/03ISR Number: 4042779-7Report Type:Direct Company Report #CTU 184663 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Psychotic Disorder Lariam PS 2 TABLE
Hospitalization - Aggression
Initial or Prolonged
Required
Intervention to
Prevent Permanent
Impairment/Damage
Date:01/17/03ISR Number: 4043730-6Report Type:Direct Company Report #CTU 184788 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Panic Attack Lariam 250mg.#7
Paraesthesia
Roche? Not On Label
Eustachian Tube Disorder I Have Left PS Roche? ORAL 1-250 WEEK
Feeling Abnormal
ORAL
Hearing Impaired
Insomnia
Decreased Appetite
Dissociation
Tinnitus
Disturbance In Attention
Loss Of Consciousness
Anxiety

Fatigue
Suicidal Ideation
Asthenia
03-Apr-2012 09:37 AM Page: 482

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/21/03ISR Number: 4045508-6Report Type:Expedited (15-DaCompany Report #328238 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viith Nerve Paralysis Foreign Lariam (Mefloquine
Paresis Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG ORAL
Other
Havrix (Hepatitis A
Vaccine)
C
Date:01/21/03ISR Number: 4045971-0Report Type:Expedited (15-DaCompany Report #328238 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paresis Foreign Lariam (Mefloquine
Viith Nerve Paralysis Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG ORAL
Other
Havrix (Hepatitis A
Vaccine)
C
Date:01/23/03ISR Number: 4046538-0Report Type:Expedited (15-DaCompany Report #329521 Age:60 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Thrombocytopenia Foreign Lariam
Somnolence Health (Mefloquine
Haemolysis Professional Hydrochloride) PS ORAL 3 DOSE FORM
Renal Disorder
DAILY ORAL
Date:01/23/03ISR Number: 4046936-5Report Type:Expedited (15-DaCompany Report #325725 Age:43 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Optic Neuritis Foreign Lariam (Mefloquine
Initial or Prolonged Multiple Sclerosis Health Hydrochloride) PS ORAL 1 DOSE FORM
Professional
Yellow Fever Vaccine
(Yellow Fever
Vaccine)
C
1 PER WEEK
ORAL
Date:01/23/03ISR Number: 4046940-7Report Type:Expedited (15-DaCompany Report #312331 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Foreign Lariam (Mefloquine
Foetus Health Hydrochloride) PS ORAL 1 DOSE FORM
Intra-Uterine Death Professional 1 PER WEEK
Antepartum Haemorrhage
ORAL
Umbilical Cord
Trandate (Labetalol

Abnormality Hydrochloride) C
03-Apr-2012 09:37 AM Page: 483

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/23/03ISR Number: 4046951-1Report Type:Expedited (15-DaCompany Report #329423 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Renal Failure Foreign Lariam (Mefloquine
Initial or Prolonged Hypertension Health Hydrochloride) PS ORAL 1 DOSE FORM
Professional
Trandate (Labetalol
Hydrochloride)
C
1 PER WEEK
ORAL
Date:01/23/03ISR Number: 4046976-6Report Type:Expedited (15-DaCompany Report #329220 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Carpal Tunnel Syndrome Consumer Lariam (Mefloquine
Intervention to Diarrhoea Hydrochloride) PS ORAL 1 PER WEEK
Prevent Permanent Insomnia ORAL
Impairment/Damage Depression Adderall
Post-Traumatic Stress
(Amphetamine
Disorder
Aspartate/Amphetamin
Disturbance In Social
e
Behaviour
Sulfate/Dextroamphet C
Muscle Twitching
Chills
Vomiting
Hyperacusis
Disturbance In Attention
Fatigue
Memory Impairment
Nervousness
Restless Legs Syndrome
Paranoia
Date:01/26/03ISR Number: 4050195-7Report Type:Expedited (15-DaCompany Report #328612 Age:18 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cyanosis Foreign Lariam (Mefloquine
Fatigue Health Hydrochloride) PS ORAL 250 MG 1 PER
Convulsion Professional WEEK ORAL
Urinary Incontinence
Bcg Vaccine (Bcg
Disease Recurrence Vaccine) C
Muscle Rigidity
Date:01/27/03ISR Number: 4047938-5Report Type:Expedited (15-DaCompany Report #329220 Age:47 YR Gender:Male I/FU:F
Outcome
Required
Intervention to
PT
Diarrhoea
Vomiting

Prevent Permanent
Impairment/Damage
Fatigue
Paranoia
Depression
Disturbance In Attention
Hyperacusis
Muscle Twitching
Memory Impairment
Post-Traumatic Stress
03-Apr-2012 09:37 AM Page: 484

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorder
Restless Legs Syndrome
Chills
Insomnia Report Source Product Role Manufacturer Route Dose Duration
Nervousness Consumer Lariam (Mefloquine
Carpal Tunnel Syndrome Hydrochloride) PS ORAL 1 PER WEEK
ORAL
(Amphetamine
Aspartate/Amphetamin
e
Sulfate/Dextroamphet
amine
C
Adderall
C
Date:01/27/03ISR Number: 4048136-1Report Type:Expedited (15-DaCompany Report #328612 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Urinary Incontinence Foreign Lariam (Mefloquine
Convulsion Health Hydrochloride) 250
Syncope Professional Mg PS ORAL 250 MG 1 PER
Muscle Rigidity
Bcg Vaccine (Bcg
Vaccine)
C
WEEK ORAL
Date:01/27/03ISR Number: 4048137-3Report Type:Expedited (15-DaCompany Report #329947 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myoglobin Blood Increased Foreign Lariam (Mefloquine
Initial or Prolonged Heat Stroke Health Hydrochloride) PS ORAL 1 DOSE FORM
Hepatocellular Injury Professional 1 PER ONE
Blood Creatine
DOSE ORAL
Phosphokinase Increased
Date:01/27/03ISR Number: 4048138-5Report Type:Expedited (15-DaCompany Report #329796 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Erythema Foreign Lariam (Mefloquine
Initial or Prolonged Burning Sensation Health Hydrochloride) PS
Facial Pain
Professional
Mental Disorder
Tenderness
Emotional Disorder
Date:01/29/03ISR Number: 4050367-1Report Type:Expedited (15-DaCompany Report #324511 Age:25 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Convulsion Foreign Lariam (Mefloquine
Initial or Prolonged Headache Health Hydrochloride) PS ORAL 250 MG 1 PER
Transfusion Reaction Professional WEEK ORAL
Anaemia Haemolytic
Propecia
Autoimmune (Finasteride) C
Splenomegaly
03-Apr-2012 09:37 AM Page: 485

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/29/03ISR Number: 4050369-5Report Type:Expedited (15-DaCompany Report #309389 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Maternal Drugs Affecting Foreign Lariam (Mefloquine
Initial or Prolonged Foetus Health Hydrochloride) PS ORAL 250 MG 1 PER
Pregnancy Professional WEEK ORAL
Abortion Spontaneous Other Zinnat (Cefuroxime
Axetil Or Cefuroxime
Sodium/*Lidocaine
Hydrochloride) C
Date:01/30/03ISR Number: 4049529-9Report Type:Direct Company Report #CTU 185653 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Paranoia Larium PS
Psychotic Disorder
Date:02/03/03ISR Number: 4053696-0Report Type:Expedited (15-DaCompany Report #2003-102650-NL B0006-2003 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Syncope Bcg Vaccine PS
Convulsion Mefloquine SS 250 MG
Date:02/05/03ISR Number: 4052084-0Report Type:Direct Company Report #CTU 185987 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Syncope Mefloquine PS
Convulsion
Bacillus Calmette
Urinary Incontinence Guerin Vaccine C
Date:02/06/03ISR Number: 4055962-1Report Type:Expedited (15-DaCompany Report #329796 Age:19 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Emotional Disorder Foreign Lariam (Mefloquine
Initial or Prolonged Burning Sensation Health Hydrochloride) PS
Facial Pain
Professional
Mental Disorder
Erythema
Sensation Of Pressure
Tenderness
Date:02/07/03ISR Number: 4054267-2Report Type:Expedited (15-DaCompany Report #324949 Age:29 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Multiple Sclerosis Foreign Lariam (Mefloquine
Initial or Prolonged Blood Immunoglobulin G Health Hydrochloride) PS ORAL 1 DOSE FORM
Increased Professional 1 PER WEEK
Headache
ORAL
Optic Neuritis
Measles
03-Apr-2012 09:37 AM Page: 486

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/13/03ISR Number: 4056506-0Report Type:Direct Company Report #CTU 186611 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicide Attempt Mefloquine 250 Mg
Hospitalization - Overdose Geneva PS Geneva ORAL ONE WEEKLY
Initial or Prolonged
ORAL
Required Doxycycline C
Intervention to
Prevent Permanent
Impairment/Damage
Date:02/13/03ISR Number: 4057400-1Report Type:Expedited (15-DaCompany Report #328238 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Viith Nerve Paralysis Foreign Lariam (Mefloquine
Paresis Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG ORAL
Other
Havrix (Hepatitis A
Vaccine)
C
Date:02/13/03ISR Number: 4057959-4Report Type:Expedited (15-DaCompany Report #329220 Age:47 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Depression Consumer Lariam (Mefloquine
Intervention to Fatigue Hydrochloride) PS 1 PER WEEK
Prevent Permanent Insomnia Tramadol (Tramadol
Impairment/Damage Skin Discolouration Hydrochloride) C
Carpal Tunnel Syndrome
Indomethacin
Disturbance In Attention (Indomethacine) C
Emotional Disorder
Adderall
Stress
(Amphetamine
Suicidal Ideation
Aspartate/Amphetamin
Nightmare
e
Pollakiuria
Sulfate/Dextroamphen C
Weight Decreased
Hypersensitivity
Blood Cholesterol
Increased
Nausea
Nervousness
Pain In Extremity
Chills
Vomiting
Diarrhoea
Paranoia
Post-Traumatic Stress
Disorder
Vision Blurred
Anxiety

Headache
Memory Impairment
Muscle Twitching
Restless Legs Syndrome
03-Apr-2012 09:37 AM Page: 487

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/14/03ISR Number: 4056675-2Report Type:Direct Company Report #CTU 186682 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaise Larium PS ORAL 1/2 TABLE
Treatment Noncompliance
TWICE A WEEK
Depression
ORAL
Crying
Nightmare
Date:02/14/03ISR Number: 4060284-9Report Type:Expedited (15-DaCompany Report #329220 Age:46 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Stress Consumer Lariam (Mefloquine
Intervention to Vision Blurred Hydrochloride) PS ORAL 1 PER WEEK
Prevent Permanent Insomnia ORAL
Impairment/Damage Depression Tramadol (Tramadol
Headache Hydrochloride) C
Nausea
Indomethacin
Nervousness (Indomethacin) C
Chills
Adderall
Delusional Disorder,
(Amphetamine
Persecutory Type
Aspartate/Amphetamin
Post-Traumatic Stress
e
Disorder
Sulfate/Dextroamphet C
Suicidal Ideation
Emotional Disorder
Restless Legs Syndrome
Skin Disorder
Skin Papilloma
Blood Cholesterol
Increased
Diarrhoea
Paranoia
Memory Impairment
Pollakiuria
Disturbance In Attention
Anxiety
Carpal Tunnel Syndrome
Hyperacusis
Muscle Twitching
Nightmare
Pain In Extremity
Vomiting
Weight Decreased
Date:02/19/03ISR Number: 4059353-9Report Type:Expedited (15-DaCompany Report #329799 Age:16 YR Gender:Female I/FU:I
Outcome
Hospitalization -
PT
Headache

Initial or Prolonged
Disability
Nausea
Abdominal Distension
Middle Insomnia
Visual Impairment
Diarrhoea
Disorientation
Disturbance In Attention
Haemorrhage
03-Apr-2012 09:37 AM Page: 488

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Influenza Like Illness
Initial Insomnia
Oropharyngeal Pain Report Source Product Role Manufacturer Route Dose Duration
Pyrexia Consumer Lariam (Mefloquine
Constipation Health Hydrochloride) 250
Musculoskeletal Disorder Professional Mg PS ORAL 1 DOSE FORM
Dizziness
ORAL
Thinking Abnormal
Hepatitis A Vaccine
Dry Mouth
(Hepatitis A
Dry Skin Vaccine) C
Insomnia
Amnesia
Tinnitus
Abdominal Pain
Depression
Nervous System Disorder
Pruritus
Skin Depigmentation
Chronic Fatigue Syndrome
Orthostatic Hypotension
Date:02/20/03ISR Number: 4061246-8Report Type:Expedited (15-DaCompany Report #2003005986 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Drug Interaction Foreign Atorvastatin
Arrhythmia Health (Atorvastatin) PS
Myocardial Infarction Professional Mefloquine SS
Company
Representative
Date:02/24/03ISR Number: 4059792-6Report Type:Direct Company Report #CTU 187215 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Mefloquine Larium PS ORAL 1 PILL
Chapped Lips
ONCE A
Abnormal Dreams
ORAL
Feeling Of Body
Temperature Change
Influenza Like Illness
Rash
Flushing
Nightmare
Date:02/24/03ISR Number: 4064761-6Report Type:Expedited (15-DaCompany Report #2003005986 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Arrhythmia Foreign Atorvastatin

Drug Interaction Health (Atorvastatin) PS
Myocardial Infarction Professional Mefloquine SS
Company
Representative
03-Apr-2012 09:37 AM Page: 489

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/25/03ISR Number: 4062009-XReport Type:Direct Company Report #CTU 187388 Age:17 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Bipolar Disorder Lariam PS
Depression
Mental Impairment
Abnormal Behaviour
Anxiety
Date:02/25/03ISR Number: 4065847-2Report Type:Expedited (15-DaCompany Report #267379 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Foreign Lariam (Mefloquine
Maternal Drugs Affecting Health Hydrochloride) PS ORAL 250 MG ORAL
Foetus
Professional
Other
Date:02/25/03ISR Number: 4066502-5Report Type:Expedited (15-DaCompany Report #329799 Age:16 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chronic Fatigue Syndrome Consumer Lariam (Mefloquine
Initial or Prolonged Depression Health Hydrochloride) 250
Disability Dry Skin Professional Mg PS ORAL 1 DOSE FORM
Tinnitus
ORAL
Exercise Tolerance
Hepatitis A Vaccine
Decreased
(Hepatitis A
Abdominal Pain Vaccine) C
Disorientation
Dry Mouth
Skin Depigmentation
Nervous System Disorder
Amnesia
Disturbance In Attention
Nausea
Abdominal Distension
Oropharyngeal Pain
Constipation
Fatigue
Pyrexia
Syncope
Mental Impairment
Middle Insomnia
Diarrhoea
Headache
Insomnia
Orthostatic Hypotension
Pruritus
Heart Rate Decreased
Influenza Like Illness

Initial Insomnia
Haemorrhage
03-Apr-2012 09:37 AM Page: 490

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/26/03ISR Number: 4061186-4Report Type:Direct Company Report #CTU 187477 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam Roche PS Roche ORAL WEEK ORAL
Dyspepsia
Influenza Like Illness
Suicidal Ideation
Insomnia
Anxiety
Date:02/27/03ISR Number: 4067619-1Report Type:Expedited (15-DaCompany Report #329799 Age:16 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Consumer Lariam (Mefloquine
Initial or Prolonged Memory Impairment Health Hydrochloride) 250
Disability Nausea Professional Mg PS ORAL 1 DOSE FORM
Skin Depigmentation
ORAL
Dry Mouth
Hepatitis A Vaccine
Dry Skin
(Hepatitis A
Insomnia Vaccine) C
Orthostatic Hypotension
Oropharyngeal Pain
Fatigue
Constipation
Diarrhoea
Influenza Like Illness
Abdominal Pain
Dizziness
Syncope
Tinnitus
Nervous System Disorder
Sleep Disorder
Chronic Fatigue Syndrome
Depression
Abdominal Distension
Disorientation
Disturbance In Attention
Menorrhagia
Pruritus
Date:03/06/03ISR Number: 4071806-6Report Type:Expedited (15-DaCompany Report #332282 Age:63 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Memory Impairment Consumer Lariam (Mefloquine
Viith Nerve Paralysis Hydrochloride) 240
Visual Impairment Mg PS ORAL ORAL
Hypoaesthesia

Date:03/11/03ISR Number: 4069555-3Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0398888A Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Homicide Consumer Paxil PS Glaxosmithkline
Lariam
SS
03-Apr-2012 09:37 AM Page: 491

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/11/03ISR Number: 4074039-2Report Type:Expedited (15-DaCompany Report #324511 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Chromaturia Foreign Lariam (Mefloquine
Hospitalization - Decreased Appetite Health Hydrochloride) PS
Initial or Prolonged Heart Rate Increased Professional Propecia
Pallor Other (Finasteride) C
Asthenia
Anaemia Haemolytic
Autoimmune
Coombs Positive
Haemolytic Anaemia
Headache
Convulsion
Fatigue
Jaundice
Pyrexia
Splenomegaly
Date:03/11/03ISR Number: 4074044-6Report Type:Expedited (15-DaCompany Report #328238 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Viith Nerve Paralysis Foreign Lariam (Mefloquine
Paresis Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG ORAL
Other
Havrix (Hepatitis A
Vaccine)
C
Date:03/13/03ISR Number: 4074065-3Report Type:Direct Company Report #CTU 188642 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Lariam 250 Mg Roche PS Roche ORAL 250 MG WEEK
Initial or Prolonged Toxicity To Various ORAL
Disability
Agents
Suicidal Ideation
Aggression
Abnormal Behaviour
Paranoia
Hallucination
Psychotic Disorder
Confusional State
Date:03/14/03ISR Number: 4076565-9Report Type:Expedited (15-DaCompany Report #304340 Age:15 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Crying
Depression

Disability
Diplopia
Eye Swelling
Hemiplegia
Encephalitis
Mental Disorder Due To A
General Medical Condition
Sleep Disorder
Visual Field Defect
03-Apr-2012 09:37 AM Page: 492

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hallucination
Memory Impairment
Tinnitus Report Source Product Role Manufacturer Route Dose Duration
Bipolar I Disorder Other Lariam (Mefloquine
Blindness Hydrochloride) 250
Paranoia Mg PS ORAL 250 MG 1 PER
Intentional Self-Injury
WEEK ORAL
Vitreous Floaters
Papilloedema
Suicidal Ideation
Suicide Attempt
Arthralgia
Cognitive Disorder
Depressed Level Of
Consciousness
Mood Swings
Nervous System Disorder
Obsessive-Compulsive
Disorder
Date:03/14/03ISR Number: 4076957-8Report Type:Expedited (15-DaCompany Report #333205 Age:50 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Foreign Lariam (Mefloquine
Initial or Prolonged Insomnia Health Hydrochloride) PS ORAL ORAL
Bipolar I Disorder
Professional
Agitation
Crying
Date:03/17/03ISR Number: 4074480-8Report Type:Direct Company Report #CTU 188872 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Eye Disorder Lariam Peace Corps
Panic Attack Standard In PS ORAL 1 PILL WEEK
Fear
ORAL
Muscle Twitching Doxycyline C
Blepharospasm
Food Allergy
Hyperventilation
Dyskinesia
Fatigue
Feeling Abnormal
Grimacing
Vertigo
Date:03/18/03ISR Number: 4074965-4Report Type:Direct Company Report #CTU 188951 Age: Gender:Female I/FU:I

Outcome
Other Serious
PT
Dizziness
Myalgia
Fatigue
Hallucination
Tinnitus
Tremor
Sleep Terror
03-Apr-2012 09:37 AM Page: 493

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Suicidal Ideation
Depression
Nausea Report Source Product Role Manufacturer Route Dose Duration
Paranoia Mefloquin Generic
Nightmare For Hoffman-La
Hyperhidrosis Roche PS Hoffmann- La Roche ORAL 1 TABLE PER
WEEK ORAL
Date:03/19/03ISR Number: 4078912-0Report Type:Expedited (15-DaCompany Report #329521 Age:60 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Somnolence Foreign Lariam (Mefloquine
Initial or Prolonged General Physical Health Health Hydrochloride) PS ORAL 3 DOSE FORM
Deterioration Professional DAILY ORAL
Renal Disorder
Riamet (Coartem)
Haemolytic Anaemia
(Artemether/Lumefant
Thrombocytopenia rine) SS ORAL 6 DOSE FORM 1
PER 8 HOUR
ORAL
Date:03/21/03ISR Number: 4082093-7Report Type:Expedited (15-DaCompany Report #328748 Age:54 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Foreign Mefloquine
Dyskinesia Literature Hydrochloride
Headache Health (Mefloquine
Hypercholesterolaemia Professional Hydrochloride) PS 250 MG 1 PER
Clonic Convulsion
WEEK
Bradyphrenia
Shock
Cerivastatin
(Cerivastatin
Sodium)
C
Date:04/01/03ISR Number: 4082569-2Report Type:Expedited (15-DaCompany Report #CA-ROCHE-334734 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Electrocardiogram Qt Lariam PS Roche UNKNOWN THREE DOSES
Prolonged
WERE TAKEN BY
Hallucination
THE PATIENT.
Suicidal Ideation
Chloroquine
Paranoia Phosphate SS UNKNOWN
Toxicity To Various
Agents
Coordination Abnormal
Decreased Appetite

Date:04/01/03ISR Number: 4082624-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-328127 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche 30 DAY
03-Apr-2012 09:37 AM Page: 494

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/02/03ISR Number: 4088082-0Report Type:Expedited (15-DaCompany Report #328127 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pregnancy Consumer Lariam (Mefloquine
Abortion Spontaneous Hydrochloride) PS ORAL 250 MG 1 PER
Maternal Drugs Affecting
WEEK ORAL
Foetus
Date:04/04/03ISR Number: 4085178-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-320492 Age:22 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Lariam PS Roche UNKNOWN
Personality Change
Loss Of Consciousness
Intentional Overdose
Depression
Date:04/07/03ISR Number: 4088101-1Report Type:Direct Company Report #CTU 190308 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chest Pain Larium 250mg
Initial or Prolonged Anxiety Tablets Roche
Disability Palpitations Products PS Roche Products ORAL 1 TABLE
Dizziness
WEEKLY ORAL
Malaise Ventolin C
Chills Becotide C
Date:04/14/03ISR Number: 4090106-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-305025 Age:54 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Panic Disorder Mefloquine
Drug Withdrawal Syndrome Hydrochloride PS Roche ORAL 430 DAY
Drug Dependence
Date:04/14/03ISR Number: 4090111-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-313979 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam PS Roche ORAL
Anxiety
Drug Withdrawal Syndrome
Mood Altered
Date:04/15/03ISR Number: 4093685-3Report Type:Direct Company Report #CTU 190928 Age:24 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicidal Ideation Larium PS WEEKLY
Hospitalization - Depression
Initial or Prolonged
Disability
03-Apr-2012 09:37 AM Page: 495

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/18/03ISR Number: 4092995-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-336048 Age:6 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Lariam PS Roche ORAL
Initial or Prolonged Gastrointestinal
Infection
Weight Decreased
Diarrhoea
Date:04/22/03ISR Number: 4094866-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-333205 Age:50 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Lariam PS Roche ORAL 9 DAY
Initial or Prolonged Agitation
Bipolar I Disorder
Hallucination
Crying
Date:04/28/03ISR Number: 4098493-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-329220 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Lariam PS Roche ORAL
Post-Traumatic Stress Tramadol C ORAL
Disorder Indomethacin C ORAL
Tenosynovitis Adderall C ORAL
Insomnia
Surgical Procedure
Repeated
Paranoia
Disturbance In Attention
Memory Impairment
Vomiting
Muscle Twitching
Blood Cholesterol
Increased
Suicidal Ideation
Nausea
Restless Legs Syndrome
Libido Decreased
Skin Papilloma
Carpal Tunnel Syndrome
Nervousness
Chills
Nightmare
Hyperacusis
Headache
Pollakiuria
Migraine
Pain In Extremity

Loss Of Employment
Fatigue
Weight Decreased
Skin Discolouration
Visual Impairment
Stress
Depression
Vision Blurred
03-Apr-2012 09:37 AM Page: 496

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/01/03ISR Number: 4105493-5Report Type:Direct Company Report #CTU 192075 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Mefloquine 250 Mg
Palpitations
Geneva Pharm Tech
Supraventricular Corporation PS Geneva Pharm Tech
Extrasystoles Corporation PARENTERAL 250 MG Q
Mood Altered
WEEK
PARENTERAL
Date:05/02/03ISR Number: 4102404-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-336087 Age:71 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anosmia Lariam PS Roche ORAL
Ageusia
Date:05/06/03ISR Number: 4106524-9Report Type:Direct Company Report #CTU 192353 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Sinus Disorder Mefloquine PS
Dysphagia
Oropharyngeal Pain
Date:05/06/03ISR Number: 4106525-0Report Type:Direct Company Report #CTU 192354 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Mefloquine 250mg PS ORAL 250 MG PO
Loss Of Consciousness
WEEKLY
Affect Lability
Date:05/08/03ISR Number: 4105846-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-336087 Age:71 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anosmia Lariam PS Roche ORAL
Ageusia
Date:05/12/03ISR Number: 4107655-XReport Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Homicide Lariam PS Roche UNKNOWN
Paranoia
Hallucination, Auditory
Condition Aggravated

Hallucination, Olfactory
Mental Disorder
03-Apr-2012 09:37 AM Page: 497

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/12/03ISR Number: 4110899-4Report Type:Direct Company Report #CTU 192740 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Anxiety Lariam 250 Mg Per
Hospitalization - Fatigue Week Roche Usa PS Roche Usa ORAL 250 MG PER
Initial or Prolonged Suicidal Ideation WEEK ORAL
Disability
Other Serious
Night Sweats
Nightmare
Depression
Hallucination
Date:05/19/03ISR Number: 4111056-8Report Type:Expedited (15-DaCompany Report #SE-ROCHE-328238 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Viith Nerve Paralysis Lariam PS Roche ORAL 1 TABLET ONLY
TAKEN. 1 DAY
Havrix C INTRAMUSCULAR
Date:05/19/03ISR Number: 4111080-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-337777 Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Tachycardia Lariam PS Roche ORAL
Insomnia
Drowning
Anxiety
Date:05/19/03ISR Number: 4114514-5Report Type:Direct Company Report #CTU 193224 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Lariam Mefloquine
Required Panic Attack Hydrochloride 250mg
Intervention to Anxiety Tabs PS SEE IMAGE
Prevent Permanent Paranoia Omeprazole Magnesium C
Impairment/Damage Hallucination Losec C
Decreased Appetite
Emotional Disorder
Date:05/21/03ISR Number: 4113122-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-337388 Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hepatic Enzyme Increased Consumer Lariam PS Roche ORAL 2 DAY
Hospitalization - Psychotic Disorder Lariam SS Roche ORAL 1 DAY
Initial or Prolonged Clont SS ORAL 11 DAY
Lariam SS Roche ORAL 1 DAY

Date:05/28/03ISR Number: 4117382-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-329799 Age:16 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Psychotic Disorder
Abdominal Pain
Cognitive Disorder
03-Apr-2012 09:37 AM Page: 498

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depression
Diarrhoea
Dry Mouth Report Source Product Role Manufacturer Route Dose Duration
Pruritus Lariam PS Roche ORAL 1 TABLET
Mania
WEEKLY
Influenza Like Illness Hepatitis A Vaccine C
Nausea
Constipation
Headache
Disorientation
Initial Insomnia
Nervous System Disorder
Chronic Fatigue Syndrome
Menstruation Irregular
Dry Skin
Disturbance In Attention
Orthostatic Hypotension
Abdominal Distension
Amnesia
Heart Rate Decreased
Tinnitus
Skin Depigmentation
Exercise Tolerance
Decreased
Date:05/30/03ISR Number: 4187487-7Report Type:Periodic Company Report #255796 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nerve Injury Consumer Lariam (Mefloquine
Dizziness Health Hydrochloride) 250
Weight Decreased Professional Mg PS ORAL 1 DOSE FORM 1
Nausea
PER WEEK ORAL
Anxiety
Balance Disorder
Diarrhoea
Panic Attack
Vertigo
Muscular Weakness
Date:05/30/03ISR Number: 4187488-9Report Type:Periodic Company Report #312535 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Pressure Abnormal Consumer Lariam (Mefloquine
Initial or Prolonged Blood Pressure Increased Hydrochloride) 250
Weight Decreased Mg PS ORAL 250 MG 1 PER
Decreased Appetite
WEEK ORAL
Depression
Trandate (Labetalol
Tachycardia Hydrochloride) C
Anxiety

Suicidal Ideation
Bradycardia
Syncope
03-Apr-2012 09:37 AM Page: 499

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/30/03ISR Number: 4187489-0Report Type:Periodic Company Report #317591 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Health Lariam (Mefloquine
Initial or Prolonged Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:05/30/03ISR Number: 4187490-7Report Type:Periodic Company Report #322558 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Delusion Other Lariam (Mefloquine
Disability Depression Hydrochloride) 250
Anxiety Mg PS ORAL ORAL
Delusional Disorder,
Persecutory Type
Completed Suicide
Mood Swings
Confusional State
Headache
Date:05/30/03ISR Number: 4187491-9Report Type:Periodic Company Report #322574 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Feeling Cold Health Lariam (Mefloquine
Intervention to Confusional State Professional Hydrochloride) 250
Prevent Permanent Nausea Mg PS ORAL 250 MG 1 PER
Impairment/Damage Diarrhoea DAY ORAL
Medication Error
Date:05/30/03ISR Number: 4187492-0Report Type:Periodic Company Report #324697 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Consumer Lariam (Mefloquine
Weight Decreased Hydrochloride) 240
Suicidal Ideation Mg PS ORAL 240 MG 1 PER
1 WEEK ORAL
Date:05/30/03ISR Number: 4187493-2Report Type:Periodic Company Report #325385 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Other Lariam (Mefloquine
Initial or Prolonged Hallucination Hydrochloride) PS ORAL ORAL
Depression

Date:05/30/03ISR Number: 4187494-4Report Type:Periodic Company Report #327591 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Asthenia Literature Mefloquine
Health
Hydrochloride
Professional
(Mefloquine
03-Apr-2012 09:37 AM Page: 500

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride)
Pyridostigmine
(Pyridostigmine
Bromide)
PS
C
Date:05/30/03ISR Number: 4187495-6Report Type:Periodic Company Report #327601 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Asthenia Literature Mefloquine
Health
Hydrochloride
Professional
(Mefloquine
Hydrochloride) PS
Date:05/30/03ISR Number: 4187496-8Report Type:Periodic Company Report #329345 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Health Lariam (Mefloquine
Professional Hydrochloride) PS
Date:05/30/03ISR Number: 4188986-4Report Type:Periodic Company Report #329978 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Eye Irritation Consumer Lariam (Mefloquine
Initial or Prolonged Hallucination Health Hydrochloride) PS ORAL 1 DOSE FORM
Heart Rate Increased Professional 1 PER WEEK
Insomnia
ORAL
Nervousness
Ultran
Nightmare (Phenaglycodol) C
Dizziness
Lorazepam
Dry Mouth (Lorazepam) C
Dyspnoea
Oxycontin
Headache (Oxycodone) C
Psychotic Disorder
Unspecified
Tremor
Immunizations
Claustrophobia (Immunisation) C
Panic Attack
Effexor (Venlafaxine
Depression Hydrochloride) C
Agitation
Date:05/30/03ISR Number: 4188987-6Report Type:Periodic Company Report #332290 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Self Esteem Decreased Consumer Lariam (Mefloquine
Anxiety Hydrochloride) 250
Insomnia Mg PS ORAL ORAL 152 DAY
Dyspnoea

Chest Pain
Mood Swings
Suicide Attempt
Nervousness
Depression
03-Apr-2012 09:37 AM Page: 501

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/30/03ISR Number: 4188988-8Report Type:Periodic Company Report #332637 Age:2 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Petit Mal Epilepsy Health Lariam (Mefloquine
Convulsion Professional Hydrochloride) 250
Mg PS ORAL 0.25 DOSE
FORM 1 PER
WEEK ORAL
Date:05/30/03ISR Number: 4188989-XReport Type:Periodic Company Report #334655 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Acute Psychosis Health Lariam (Mefloquine
Initial or Prolonged Professional Hydrochloride) PS
Date:05/30/03ISR Number: 4188990-6Report Type:Periodic Company Report #335354 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaria Consumer Lariam (Mefloquine
Initial or Prolonged Abnormal Dreams Hydrochloride) 250
Hypotension Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/02/03ISR Number: 4120310-5Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Homicide Health Lariam PS Roche UNKNOWN 3 MON
Hallucination, Olfactory Professional Antidepressants Nos C
Flashback
Paranoia
Hallucination, Auditory
Date:06/03/03ISR Number: 4121733-0Report Type:Direct Company Report #CTU 194609 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Nausea Mefloquine 250 Mg
Hospitalization - Aggression Geneva PS Geneva 1 TABLET PER
Initial or Prolonged Paranoia WEEK
Disability Headache BEGINNING 1
Required Anxiety WK B/F
Intervention to Hallucination DEPARTURE AND
Prevent Permanent
Impairment/Damage
Oropharyngeal Pain
Tinnitus
Fatigue
Syncope

Skin Disorder
Confusional State
Dizziness
Mood Altered
Orthostatic Hypotension
Depression
Psychotic Disorder
Insomnia
03-Apr-2012 09:37 AM Page: 502

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/03/03ISR Number: 4122087-6Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041072A Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Intentional Overdose Halfan PS Glaxosmithkline ORAL 3000MG Single
Initial or Prolonged Alcohol Poisoning dose 1 DAY
Suicide Attempt Alcohol SS ORAL 1 DAY
Vomiting Lariam SS ORAL 1500MG Single
dose 1 DAY
Date:06/04/03ISR Number: 4122521-1Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination, Auditory Lariam PS Roche UNKNOWN 3 MON
Hallucination, Olfactory Antidepressants Nos C
Paranoia
Flashback
Homicide
Date:06/04/03ISR Number: 4122561-2Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0299754A Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Condition Aggravated Deroxat PS Glaxosmithkline ORAL 20MG Twice
Initial or Prolonged Overdose per day
Anxiety Lariam SS ORAL 250MG Unknown
Fear Prozac SS ORAL 36 DAY
Hallucination Lysanxia SS ORAL 36 DAY
Insomnia Xanax SS ORAL
Suicide Attempt
Depression
Nightmare
Date:06/04/03ISR Number: 4123059-8Report Type:Direct Company Report #CTU 194940 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Larium Roche PS Roche ORAL 250MG WEEKLY
Initial or Prolonged Depression ORAL
Required
Disturbance In Attention
Intervention to
Memory Impairment
Prevent Permanent
Impairment/Damage
Night Sweats
Suicidal Ideation
Insomnia
Date:06/05/03ISR Number: 4123097-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-339395 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Atrioventricular Block Lariam PS Roche ORAL
Complete Beta Blocker Nos C ORAL
03-Apr-2012 09:37 AM Page: 503

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/03ISR Number: 4123733-3Report Type:Direct Company Report #CTU 195063 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Disorder With Larium 250mg Roche PS Roche ORAL 250MG 1 PER
Initial or Prolonged Agoraphobia WEEK ORAL
Depression
Date:06/06/03ISR Number: 4123954-XReport Type:Expedited (15-DaCompany Report #CA-ROCHE-339135 Age:17 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Kawasaki'S Disease Lariam PS Roche ORAL
Cholestasis
Date:06/10/03ISR Number: 4125466-6Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Age:27 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination, Auditory Health Lariam PS Roche ORAL 3 MON
Paranoia Professional Flagyl C ORAL 8 DAY
Homicide Unknown Medication C ORAL
Hallucination, Olfactory Antidepressants Nos C
Flashback
Date:06/10/03ISR Number: 4125480-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-339481 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Meningism Consumer Lariam PS Roche ORAL 53 DAY
Initial or Prolonged Hepatitis Ibuprofene SS ORAL 7 DAY
Doliprane SS ORAL 7 DAY
Adepal C RECEIVED
TREATMENT FOR
SEVERAL
MONTHS
Date:06/10/03ISR Number: 4126187-6Report Type:Direct Company Report #CTU 195411 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Panic Reaction Larium Laroche PS Laroche ORAL 1 TABLE
Anxiety
WEEKLY ORAL
Paraesthesia
Depression
Dizziness
Distractibility
Neurotoxicity
Fatigue

Date:06/11/03ISR Number: 4126537-0Report Type:Expedited (15-DaCompany Report #SE-ROCHE-328238 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Viith Nerve Paralysis Consumer Lariam PS Roche ORAL 1 TABLET ONLY
TAKEN. 1 DAY
Havrix SS INTRAMUSCULAR 1 DAY
03-Apr-2012 09:37 AM Page: 504

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/13/03ISR Number: 4128467-7Report Type:Direct Company Report #CTU 195725 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Depression Lariam 250 Mg
Life-Threatening Asthenia Hoffman-Laroche,
Disability Sleep Apnoea Syndrome Inc. PS Hoffman-Laroche,
Other Serious Weight Increased Inc. ORAL 250 MG OVER 5
Required Panic Disorder ORAL
Intervention to Completed Suicide Phen/Fen SS ORAL OVER 9 ORAL
Prevent Permanent
Impairment/Damage
Date:06/23/03ISR Number: 4134248-0Report Type:Direct Company Report #CTU 196344 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Feeling Abnormal Lariam Roche PS Roche ORAL 1 TABLE ONCE
Hospitalization - Mental Disorder A WEEK ORAL
Initial or Prolonged Activities Of Daily
Disability
Living Impaired
Required
Intervention to
Prevent Permanent
Impairment/Damage
Date:06/24/03ISR Number: 4133560-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-336087 Age:71 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Ageusia Lariam PS Roche ORAL
Viral Infection
Anosmia
Date:06/26/03ISR Number: 4135803-4Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041072A Age:39 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicide Attempt Health Halfan PS Glaxosmithkline ORAL 3000MG Single
Initial or Prolonged Alcohol Poisoning Professional dose 1 DAY
Intentional Overdose Alcohol SS ORAL 1 DAY
Vomiting Lariam SS ORAL 1500MG Single
dose 1 DAY
Date:06/27/03ISR Number: 4136538-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-329799 Age:16 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Fatigue
Tinnitus

Disability
Diarrhoea
Dry Skin
Skin Depigmentation
Insomnia
Abdominal Distension
Nausea
Laboratory Test Abnormal
Disturbance In Attention
03-Apr-2012 09:37 AM Page: 505

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorientation
Malaise
Haemorrhage Report Source Product Role Manufacturer Route Dose Duration
Psychotic Disorder Lariam PS Roche ORAL 1 TABLET
Depression
WEEKLY
Headache Hepatitis A Vaccine C
Red Blood Cell
Sedimentation Rate
Increased
Amnesia
Exercise Tolerance
Decreased
Mania
C-Reactive Protein
Increased
Immunology Test Abnormal
Bipolar Disorder
Constipation
Abdominal Pain
Nervous System Disorder
Influenza Like Illness
Syncope
Heart Rate Decreased
Brain Scan Normal
Orthostatic Hypotension
Dry Mouth
Pyrexia
Initial Insomnia
Date:06/27/03ISR Number: 4137636-1Report Type:Direct Company Report #CTU 196820 Age:66 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Speech Disorder Lariam 250 Mg PS ORAL 1 TABLET BY
Initial or Prolonged Ear Pain MOUTH WEEKLY
Disability
Weight Decreased
Feeling Abnormal
Diplopia
Cerebrovascular Accident
Balance Disorder
Headache
Migraine
Nausea
Pain In Extremity
Vertigo
Vision Blurred
Lupus-Like Syndrome
Decreased Appetite
Asthenia
Confusional State
Gait Disturbance
Dizziness

Eye Disorder
Vomiting
Dysphemia
Arterial Occlusive
Disease
Arthralgia
03-Apr-2012 09:37 AM Page: 506

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/01/03ISR Number: 4138763-5Report Type:Expedited (15-DaCompany Report #KE-ROCHE-340706 Age:66 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Prothrombin Time Mefloquine
Initial or Prolonged Prolonged Hydrochloride PS Roche UNKNOWN DOSE REPORTED
Abdominal Distension
AS 250MG PER
Ascites
WEEK.
Blood Pressure Decreased Carvedilol C
Drug Interaction Betoptic Eye Drops C
Tachycardia Captoril C
Infectious Peritonitis Digoxin C
Cardiomegaly Warfarin I UNKNOWN
Abdominal Rebound
Tenderness
Anaemia
Gallop Rhythm Present
Date:07/01/03ISR Number: 4138771-4Report Type:Expedited (15-DaCompany Report #KE-ROCHE-340709 Age:63 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Prothrombin Time Mefloquine
Initial or Prolonged Prolonged Hydrochloride PS Roche UNKNOWN DOSE REPORTED
Oedema Peripheral
AS 250MG
Injury
WEEKLY.
Muscle Twitching Sotalol C
Confusional State Frusemide C REPORTED AS
Hypoglycaemia
GIVEN
Aggression
OCASIONALLY.
Haemorrhage Digoxin C
Blood Glucose Fluctuation Glibenclamide I Roche UNKNOWN
Cellulitis Chlorpropamide I UNKNOWN
Drug Interaction
Dermatitis Exfoliative
Blister
Retrograde Amnesia
Date:07/03/03ISR Number: 4140824-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-339743 Age:41 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Platelet Disorder Lariam PS Roche ORAL THE PATIENT
Contusion
WAS REPORTED
Menorrhagia
TO HAVE
RECEIVED
MEFLOQUINE
Lariam SS Roche ORAL
Lariam SS Roche ORAL

Date:07/07/03ISR Number: 4142181-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-341198 Age:75 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability C-Reactive Protein Lariam PS Roche ORAL
Increased
Arthropathy
Muscle Disorder
03-Apr-2012 09:37 AM Page: 507

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/07/03ISR Number: 4142198-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-341603 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Retinitis Pigmentosa Lariam PS Roche UNKNOWN
Date:07/07/03ISR Number: 4142200-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-341571 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Groin Pain Lariam PS Roche UNKNOWN 5 WK
Quadriplegia
Date:07/07/03ISR Number: 4142985-7Report Type:Direct Company Report #CTU 197286 Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Mefloquine 250
Initial or Prolonged Road Traffic Accident Lariam PS ORAL 1 WEEK ORAL
Lethargy
Depression
Date:07/07/03ISR Number: 4144312-8Report Type:Expedited (15-DaCompany Report #FRWYE193930JUN03 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatitis Health Adepal
Initial or Prolonged Cytolytic Hepatitis Professional (Levonorgestrel/Ethi
Antinuclear Antibody Other nyl Estradiol,
Positive Tablet, O) PS ORAL ORAL/SEVERAL
MONTHS
Lariam (Mefloquine,
0) SS ORAL 250 MG 1X PER
1 WK, ORAL 53 DAY
Doliprane
(Paracetamol)
C
Ibuprofen
(Ibuprofen)
C
Date:07/10/03ISR Number: 4144762-XReport Type:Direct Company Report #CTU 197662 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Viith Nerve Paralysis Mefloquine PS ORAL 250MG ORAL
Hepatitis A Vaccine C
Date:07/10/03ISR Number: 4147062-7Report Type:Expedited (15-DaCompany Report #FRWYE193930JUN03 Age:42 YR Gender:Female I/FU:F

Outcome
Hospitalization -
Initial or Prolonged
PT
Diarrhoea
Myalgia
Arthralgia
Hepatitis
Headache
Cytolytic Hepatitis
Antinuclear Antibody
03-Apr-2012 09:37 AM Page: 508

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Positive
Report Source Product Role Manufacturer Route Dose Duration
Health
Adepal
Professional
(Levonorgestrel/Ethi
Other
nyl Estradiol,
Tablet, 0) PS ORAL
Lariam (Mefloquine,
, 0) SS ORAL 250 MG 1X PER
1 WK 53 DAY
Date:07/11/03ISR Number: 4145359-8Report Type:Expedited (15-DaCompany Report #KE-ROCHE-340706 Age:66 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Peritoneal Haemorrhage Mefloquine
Initial or Prolonged Ascites Hydrochloride PS Roche UNKNOWN DOSE REPORTED
Infectious Peritonitis
AS 250MG PER
Blood Pressure Decreased
WEEK.
Prothrombin Time Carvedilol C
Prolonged Betoptic Eye Drops C
Cardiomegaly Captoril C
Anaemia Digoxin C
Gallop Rhythm Present Warfarin I UNKNOWN
Gastrointestinal
Haemorrhage
Drug Interaction
Tachycardia
Melaena
Date:07/14/03ISR Number: 4146493-9Report Type:Direct Company Report #CTU 197817 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delusion Larium PS
Memory Impairment
Social Avoidant Behaviour
Sensory Loss
Panic Attack
Visual Impairment
Speech Disorder
Crying
Depression
Poisoning
Hearing Impaired
Flat Affect
Emotional Disorder
Bipolar Disorder

Date:07/14/03ISR Number: 4148525-0Report Type:Expedited (15-DaCompany Report #200316652GDDC Age:63 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Drug Interaction
Aggression
Hyperhidrosis
Confusional State
Depressed Level Of
03-Apr-2012 09:37 AM Page: 509

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Consciousness
Hunger
Hypoglycaemia
Cellulitis Report Source Product Role Manufacturer Route Dose Duration
Fatigue Foreign Glibenclamide PS
Haemorrhage Literature Mefloquine
Irritability Health Hydrochloride SS 250 MG
Oedema Peripheral Professional Frusemide C
Muscle Twitching Other Sotalol C
Prothrombin Time Digoxin C
Prolonged
Mental Disorder
Blister
Retrograde Amnesia
Blood Glucose Fluctuation
Skin Graft
Injury
Dermatitis Exfoliative
Date:07/15/03ISR Number: 4147230-4Report Type:Direct Company Report #CTU 197900 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Chest Pain Mefloquine PS ORAL 250MG Q7D
Dyspnoea
ORAL
Hypoaesthesia
Conversion Disorder
Speech Disorder
Anxiety
Costochondritis
Date:07/15/03ISR Number: 4147241-9Report Type:Direct Company Report #CTU 197894 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diarrhoea Lariam PS ORAL 1 WEEKLY ORAL
Initial or Prolonged Eyelid Oedema
Local Swelling
Chest Discomfort
Nausea
Feeling Abnormal
Vision Blurred
Abdominal Discomfort
Abdominal Pain
Oedema Peripheral
Decreased Appetite
Rash
Swollen Tongue
Swelling Face

Date:07/15/03ISR Number: 4147253-5Report Type:Expedited (15-DaCompany Report #KE-ROCHE-308528 Age:66 YR Gender:Male I/FU:I
Outcome
Life-Threatening
Hospitalization -
Initial or Prolonged
PT
Drug Interaction
Prothrombin Time
Prolonged
Gallop Rhythm Present
Abdominal Rebound
03-Apr-2012 09:37 AM Page: 510

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Tenderness
Blood Pressure Decreased
Gastrointestinal
Haemorrhage Report Source Product Role Manufacturer Route Dose Duration
Ejection Fraction
Mefloquine
Decreased Hydrochloride PS Roche UNKNOWN
Infectious Peritonitis Carvedilol C
Anaemia Betoptic Eye Drops C
Congestive Cardiomyopathy Captopril C
Peritoneal Haemorrhage Digoxin C
Tachycardia Warfarin I UNKNOWN
Gastrointestinal Sounds
Abnormal
Abdominal Distension
Ascites
Cardiomegaly
Ileus
Date:07/16/03ISR Number: 4148165-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-339481 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Antinuclear Antibody Consumer Lariam PS Roche ORAL 53 DAY
Initial or Prolonged Positive Doliprane C ORAL 7 DAY
Hepatitis Adepal C RECEIVED
TREATMENT FOR
SEVERAL
MONTHS
Ibuprofene C ORAL 7 DAY
Date:07/17/03ISR Number: 4148786-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-342147 Age:9 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cerebrovascular Accident Lariam PS Roche UNKNOWN REPORTED AS
Initial or Prolonged
THREE-QUARTER
S OF A
TABLET.
Date:07/21/03ISR Number: 4150523-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-342003 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Pregnancy Lariam PS Roche UNKNOWN 40 DAY
Maternal Drugs Affecting Stamaril Unidose SS UNKNOWN 1 DAY
Foetus Librax SS Roche UNKNOWN TAKEN
Abortion Induced
OCCASIONALLY.
Foetal Disorder
Congenital Hydrocephalus

Date:07/22/03ISR Number: 4151451-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-336087 Age:71 YR Gender:Male I/FU:F
Outcome
Disability
PT
Cardiac Failure
Hyperlipidaemia
Viral Infection
Anosmia
03-Apr-2012 09:37 AM Page: 511

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Ageusia
Hypothyroidism
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL
Date:07/22/03ISR Number: 4151460-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-342003 Age:29 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Foetal Disorder Lariam PS Roche UNKNOWN 40 DAY
Lung Disorder Stamaril Unidose SS UNKNOWN 1 DAY
Maternal Drugs Affecting Librax SS Roche UNKNOWN TAKEN
Foetus
OCCASIONALLY.
Nervous System Disorder
Abortion Induced
Congenital Hydrocephalus
Metrorrhagia
Pregnancy
Dysplasia
Date:07/23/03ISR Number: 4152252-3Report Type:Direct Company Report #CTU 198498 Age:62 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Impaired Work Ability Mefloquine 250 Mg
Required Confusional State Roche PS Roche 1@ WEEK 10
Intervention to Arthritis WEEKS
Prevent Permanent
Impairment/Damage
Anxiety
Night Sweats
Hyperhidrosis
Insomnia
Depression
Hallucination, Auditory
Impaired Driving Ability
Date:07/24/03ISR Number: 4153323-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-339481 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatitis Lariam PS Roche ORAL 53 DAY
Initial or Prolonged Adepal SS ORAL RECEIVED
TREATMENT FOR
SEVERAL
MONTHS
Ibuprofene C ORAL 7 DAY
Doliprane C ORAL 7 DAY
Date:07/25/03ISR Number: 4154030-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-341571 Age:30 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paralysis Lariam PS Roche ORAL 36 DAY
Groin Pain
03-Apr-2012 09:37 AM Page: 512

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/25/03ISR Number: 4154884-5Report Type:Direct Company Report #CTU 198688 Age:34 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Restlessness Lariam = Mefloquine
Initial or Prolonged Rash 250 Mg PS 250MG 7 WEEKS
Heart Rate Increased
Dizziness
Anxiety
Confusional State
Date:07/28/03ISR Number: 4155347-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-324511 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Headache Lariam PS Roche ORAL THERAPY
Hospitalization - Convulsion DURATION
Initial or Prolonged Pyrexia REPORTED AS 5
Heart Rate Increased
MONTHS.
Splenomegaly Propecia C
Jaundice
Circulatory Collapse
Anaemia Haemolytic
Autoimmune
Date:07/28/03ISR Number: 4155373-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-342738 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pain In Extremity Lariam PS Roche ORAL
Headache
Date:07/30/03ISR Number: 4158822-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-329796 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Flushing Lariam PS Roche ORAL
Initial or Prolonged Emotional Distress
Disability
Facial Pain
Burning Sensation
Tenderness
Erythema
Date:07/31/03ISR Number: 4158590-2Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Age:27 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Flashback Lariam PS Roche ORAL 3 MON
Paranoia Flagyl C ORAL 8 DAY
Homicide Unknown Medication C ORAL

Hallucination, Auditory Antidepressants Nos C
Hallucination, Olfactory
03-Apr-2012 09:37 AM Page: 513

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/31/03ISR Number: 4158597-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-342869 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lymphocyte Morphology Lariam PS Roche ORAL 198 DAY
Initial or Prolonged Abnormal
Dermatitis Exfoliative
Pseudolymphoma
Lymphadenopathy
Date:07/31/03ISR Number: 4158599-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-343049 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatic Enzyme Increased Lariam PS Roche ORAL REPORTED AS 3
Initial or Prolonged Diarrhoea TABLETS EVERY
Hepatitis Cholestatic
8 HOURS, THEN
2 EVERY 8
HOURS, THEN 1 3 DAY
Di Antalvic C ORAL 1 DAY
Perfalgan C INTRAVENOUS 2 DAY
Date:08/04/03ISR Number: 4160446-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Lariam PS Roche ORAL
Hallucination, Visual
Vestibular Disorder
Headache
Hypertension
Confusional State
Depression
Memory Impairment
Dyspnoea
Skin Disorder
Gastrointestinal Disorder
Chronic Fatigue Syndrome
Mitral Valve Prolapse
Date:08/07/03ISR Number: 4163376-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-343702 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscle Spasms Lariam PS Roche ORAL
Date:08/11/03ISR Number: 4166680-3Report Type:Direct Company Report #CTU 199689 Age:31 YR Gender:Male I/FU:I
Outcome
PT

Other Serious
Required
Intervention to
Prevent Permanent
Impairment/Damage
Escherichia Infection
Anxiety
Disturbance In Attention
Paranoia
Thinking Abnormal
Diarrhoea
Insomnia
Vision Blurred
03-Apr-2012 09:37 AM Page: 514

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dizziness
Toxicity To Various
Agents Report Source Product Role Manufacturer Route Dose Duration
Headache Lariam 250 Mg
Vomiting Roche Labs Inc. Nj PS Roche Labs Inc. Nj ORAL 1 PILL 1 A
Abdominal Pain Upper
WEEK ORAL
Depression
Date:08/13/03ISR Number: 4166562-7Report Type:Expedited (15-DaCompany Report #AU-ROCHE-344285 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Arrhythmia Lariam PS Roche ORAL 22 DAY
Initial or Prolonged Supraventricular
Sinus Bradycardia
Date:08/13/03ISR Number: 4166567-6Report Type:Expedited (15-DaCompany Report #DE-ROCHE-341571 Age:30 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asthenia Lariam PS Roche ORAL 36 DAY
Paraesthesia
Groin Pain
Paralysis
Date:08/15/03ISR Number: 4169049-0Report Type:Direct Company Report #CTU 200038 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Anxiety Mefloquine PS ORAL 250 MG Q7D
Costochondritis
ORAL
Dyspnoea
Speech Disorder
Hypoaesthesia
Conversion Disorder
Chest Pain
Date:08/15/03ISR Number: 4169053-2Report Type:Direct Company Report #CTU 200041 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Oedema Peripheral Lariam PS ORAL 1 WEEKLY ORAL
Initial or Prolonged Abdominal Discomfort
Diarrhoea
Swollen Tongue
Eyelid Oedema
Feeling Abnormal
Nausea
Swelling Face

Rash
Local Swelling
Pain
Decreased Appetite
Chest Discomfort
Vision Blurred
03-Apr-2012 09:37 AM Page: 515

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/18/03ISR Number: 4171983-2Report Type:Direct Company Report #CTU 200182 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Larium - Mefloquin
Mental Disorder Roche PS Roche ORAL 250 MG, ORAL
Nervousness
WEEKLY
Abnormal Behaviour
Disturbance In Attention
Swollen Tongue
Irritability
Date:08/19/03ISR Number: 4169987-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-339743 Age:41 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Haemorrhage Lariam PS Roche ORAL THE PATIENT
Von Willebrand'S Disease
WAS REPORTED
TO HAVE
RECEIVED
MEFLOQUINE
Lariam SS Roche ORAL
Lariam SS Roche ORAL
Date:08/25/03ISR Number: 4177287-6Report Type:Expedited (15-DaCompany Report #2003034182 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Ineffective Foreign Doxycycline
Initial or Prolonged Dyspnoea Literature (Doxycycline) PS 100 MG
Other Serious Nausea Health (DAILY),
Paraesthesia Professional UNKNOWN
Productive Cough
Mefloquine
Hyperhidrosis (Mefloquine) SS
Medication Error
Fatigue
Pyrexia
Myalgia
Self-Medication
Insomnia
Oropharyngeal Pain
Sputum Discoloured
Malaria
Pharyngitis
Chills
Sleep Disorder
Decreased Appetite
Arthralgia
Headache
Lymphadenopathy

Date:08/27/03ISR Number: 4175954-1Report Type:Direct Company Report #CTU 200820 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Lariam PS ORAL 250 MG ORAL
Drug Abuser Marijuana C
03-Apr-2012 09:37 AM Page: 516

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/29/03ISR Number: 4176059-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-345390 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Fall Lariam PS Roche ORAL
Hallucination
Coordination Abnormal
Abnormal Behaviour
Balance Disorder
Confusional State
Date:09/02/03ISR Number: 4178742-5Report Type:Direct Company Report #CTU 201022 Age:16 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Emotional Disorder Mefloquin PS ORAL AS DIREC ORAL
Initial or Prolonged Anxiety Accutane C
Disturbance In Attention
Thinking Abnormal
Suicidal Ideation
Obsessive-Compulsive
Disorder
Confusional State
Dysgraphia
Attention
Deficit/Hyperactivity
Disorder
Binge Eating
Abnormal Dreams
Educational Problem
Bipolar Disorder
Date:09/04/03ISR Number: 4178977-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-343702 Age:17 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Overdose Lariam PS Roche ORAL
Muscle Spasms
Poisoning
Date:09/05/03ISR Number: 4180293-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-340171 Age:48 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Coordination Abnormal Lariam PS Roche ORAL 40 DAY
Initial or Prolonged Anxiety
Transient Ischaemic
Attack
Myalgia
Paraesthesia
Viith Nerve Paralysis

Neuromyopathy
03-Apr-2012 09:37 AM Page: 517

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/15/03ISR Number: 4185949-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-344428 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Lariam PS Roche ORAL 48 DAY
Nausea Trinordiol C ORAL
Gastroenteritis
Bacterial Infection
C-Reactive Protein
Increased
Decreased Appetite
Date:09/22/03ISR Number: 4190417-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-346816 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Disorder Lariam PS Roche ORAL
Initial or Prolonged Condition Aggravated
Date:09/22/03ISR Number: 4193952-9Report Type:Direct Company Report #CTU 202092 Age:34 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Fear Lariam 250 Mg Roche
Disability Abnormal Dreams Labs PS Roche Labs ORAL 1 WEEK ORAL
Ear Disorder Yellow Fever Shot C
Gastrointestinal Pain
Muscle Twitching
Panic Attack
Balance Disorder
Dyspepsia
Vestibular Disorder
Depressed Mood
Insomnia
Muscle Spasms
Muscular Weakness
Nausea
Depression
Dizziness
Motion Sickness
Pruritus
Somnambulism
Heart Rate Increased
Anxiety
Hypersensitivity
Irritable Bowel Syndrome
Date:09/23/03ISR Number: 4195373-1Report Type:Direct Company Report #CTU 2002273 Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Fear Lariam 250 Mg
Panic Attack Hoffmann-Laroche PS Hoffmann- Loroche ORAL 1 PILL WEEK
Dyspnoea
ORAL
Thinking Abnormal
Diamox-Acetazolamide C
03-Apr-2012 09:37 AM Page: 518

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/25/03ISR Number: 4196918-8Report Type:Direct Company Report #CTU 202631 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Selective Iga Larium (Mefloquine) PS Hoffman-La Roche ORAL 1 TAB WEEK
Immunodeficiency
ORAL
Sleep Disorder
Balance Disorder
Mood Swings
Vestibular Disorder
Post-Traumatic Stress
Disorder
Activities Of Daily
Living Impaired
Coordination Abnormal
Date:09/26/03ISR Number: 4197035-3Report Type:Direct Company Report #CTU 202661 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Balance Disorder Lariam -Mefloquine-
Activities Of Daily Hoffman-La Roche PS Hoffman-La Roche ORAL 1 TAB WEEK
Living Impaired
ORAL
Sleep Disorder
Coordination Abnormal
Vestibular Neuronitis
Mood Swings
Vestibular Disorder
Date:10/01/03ISR Number: 4199107-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-346816 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Disorder Lariam PS Roche ORAL
Initial or Prolonged
Date:10/02/03ISR Number: 4200052-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-347539 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Feeling Abnormal Mefloquine
Panic Reaction Hydrochloride PS Roche ORAL 1 DAY
Tremor
Hypoaesthesia
Vitreous Floaters
Date:10/02/03ISR Number: 4200058-9Report Type:Expedited (15-DaCompany Report #BE-ROCHE-347367 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Disability Dizziness Mefloquine
Speech Disorder Hydrochloride PS Roche ORAL
Coordination Abnormal
Nystagmus
03-Apr-2012 09:37 AM Page: 519

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/02/03ISR Number: 4200060-7Report Type:Expedited (15-DaCompany Report #CA-ROCHE-348024 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Creatine Lariam PS Roche ORAL
Initial or Prolonged Phosphokinase Echinacea C ORAL
Loss Of Consciousness
Vomiting
Nausea
Diarrhoea
Blood Lactate
Dehydrogenase Increased
Dehydration
Hepatic Enzyme Increased
Blood Creatine
Phosphokinase Increased
Myalgia
Date:10/03/03ISR Number: 4200906-2Report Type:Expedited (15-DaCompany Report #KR-ROCHE-347870 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dizziness Lariam PS Roche ORAL 4 DAY
Initial or Prolonged Visual Impairment
Nasal Congestion
Syncope
Date:10/08/03ISR Number: 4203837-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-347843 Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dehydration Lariam PS Roche UNKNOWN
Initial or Prolonged Blood Calcium Decreased
Blood Magnesium Decreased
Blood Parathyroid Hormone
Decreased
Oligodipsia
Date:10/10/03ISR Number: 4205951-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-348532 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pyrexia Lariam PS Roche ORAL
Nausea Lariam SS Roche ORAL
Metrorrhagia Microgynon C ORAL 17 DAY
Date:10/20/03ISR Number: 4212657-9Report Type:Direct Company Report #CTU 204129 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Completed Suicide Lariam Roche PS Roche ORAL ORAL
Physical Assault Prozak C
Abnormal Behaviour
Aggression
Thinking Abnormal
Anxiety
03-Apr-2012 09:37 AM Page: 520

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/21/03ISR Number: 4215201-5Report Type:Expedited (15-DaCompany Report #JP-ROCHE-348824 Age:71 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Haemolytic Anaemia Lariam PS Roche UNKNOWN
Initial or Prolonged Jaundice
Systemic Lupus
Erythematosus
Date:10/21/03ISR Number: 4215206-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-349152 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Rhabdomyolysis Lariam PS Roche UNKNOWN
Date:10/22/03ISR Number: 4215411-7Report Type:Direct Company Report #CTU 204278 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Diarrhoea
Mephaquin 275 Mg
Abnormal Dreams
Mefloquine
Psychiatric Symptom
Hydrichloride Mepha
Thinking Abnormal Ltd PS Mepha Ltd ORAL 1 TABLET 1/
Morbid Thoughts
WEEK ORAL
Anxiety
Date:10/23/03ISR Number: 4215803-6Report Type:Direct Company Report #CTU 204499 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Balance Disorder Lariam 250 Mg PS ORAL 250 MG Q WEEK
Nightmare
ORAL
Date:10/27/03ISR Number: 4218198-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-320492 Age:22 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Hypersomnia Lariam PS Roche UNKNOWN
Depression
Feeling Abnormal
Personality Change
Loss Of Consciousness
Overdose
Completed Suicide
Weight Increased
Sensory Disturbance
Tearfulness

Date:10/27/03ISR Number: 4218616-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-349710 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Drugs Affecting Lariam PS Roche ORAL
Foetus
Abortion Spontaneous
03-Apr-2012 09:37 AM Page: 521

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/28/03ISR Number: 4219696-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Age:40 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Antisocial Behaviour Lariam PS Roche ORAL EVERY WEEK. 9 DAY
Initial or Prolonged Convulsion Valium SS Roche INTRAVENOUS 1 DAY
Disability Headache Prozac C ORAL
Mania
Psychotic Disorder
Speech Disorder
Drug Ineffective
Blood Potassium Decreased
Incontinence
Memory Impairment
Delusion
Hostility
Confusional State
Hallucination
Disorientation
Aggression
Paranoia
Depression
Gait Disturbance
Agitation
Fatigue
Loss Of Libido
Date:10/30/03ISR Number: 4222386-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-257719 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Memory Impairment Lariam Tablets PS Roche ORAL SEVEN TABLETS
Suicidal Ideation
TAKEN IN
Hypertension
TOTAL.
Hallucination
Dissociative Disorder
Anxiety
Paranoia
Psychotic Disorder
Agoraphobia
Dizziness
Confusional State
Balance Disorder
Headache
Depression
Date:11/05/03ISR Number: 4237482-4Report Type:Expedited (15-DaCompany Report #12424925 Age:66 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Pressure Decreased Foreign Warfarin Sodium PS ORAL ORAL
Initial or Prolonged Infectious Peritonitis Literature Mefloquine

Tachycardia Health (Mefloquine Hcl) SS 250
Anaemia Professional MILLIGRAM, 1
Drug Interaction Other WEEK
Prothrombin Time
Captopril Tabs
Prolonged (Captopril) C
Ascites Digoxin (Digoxin) C
Carvedilol
(Carvedilol)
03-Apr-2012 09:37 AM Page: 522
C

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/10/03ISR Number: 4233982-1Report Type:Expedited (15-DaCompany Report #IE-ROCHE-350696 Age:23 MON Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Lariam PS Roche UNKNOWN 0.25 OF A
Initial or Prolonged Lower Respiratory Tract TABLET.
Infection Folic Acid C
Date:11/10/03ISR Number: 4233988-2Report Type:Expedited (15-DaCompany Report #IE-ROCHE-350774 Age:23 MON Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Lariam PS Roche UNKNOWN 0.25 OF A
Initial or Prolonged Lower Respiratory Tract TABLET.
Infection Folic Acid C
Date:11/12/03ISR Number: 4233947-XReport Type:Expedited (15-DaCompany Report #CA-ROCHE-348024 Age:40 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dehydration Lariam PS Roche ORAL
Initial or Prolonged Blood Creatine Echinacea C ORAL
Phosphokinase
Diarrhoea
Nausea
Vomiting
Blood Lactate
Dehydrogenase Increased
Loss Of Consciousness
Myalgia
Hepatitis
Hepatitis Viral
Date:11/14/03ISR Number: 4235630-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-351227 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viith Nerve Paralysis Lariam PS Roche ORAL 1 DAY
Vision Blurred
Dysgeusia
Product Quality Issue
Corneal Reflex Decreased
Eating Disorder
Date:11/17/03ISR Number: 4236524-XReport Type:Direct Company Report #CTU 206203 Age:35 YR Gender:Male I/FU:I
Outcome
Life-Threatening
PT
Abdominal Pain
Night Sweats

Depression
Suicidal Ideation
Nightmare
Homicidal Ideation
Fatigue
Insomnia
Overwork
Diarrhoea
03-Apr-2012 09:37 AM Page: 523

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Circadian Rhythm Sleep
Disorder
Report Source Product Role Manufacturer Route Dose Duration
Lariam Roche 250 Mg
Tablets PS Roche (1) 250 MG
TABLET 1X
WEEKLY X 5
WKS
Date:11/19/03ISR Number: 4237499-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-351387 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche ORAL
Maternal Drugs Affecting Stamaril Unidose C SUBCUTANEOUS 1 DAY
Foetus
Intra-Uterine Death
Date:11/21/03ISR Number: 4239347-0Report Type:Direct Company Report #CTU 206548 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Abasia Lariam 250 Mg Roche PS Roche ORAL 250 MG WEEKLY
Hospitalization - Photophobia ORAL
Initial or Prolonged Visual Field Defect
Disability
Bladder Disorder
Required
Feeling Abnormal
Intervention to
Hallucination, Auditory
Prevent Permanent
Impairment/Damage
Fall
Suicidal Ideation
Tremor
Anger
Anxiety
Visual Impairment
Insomnia
Aphasia
Panic Attack
Date:12/01/03ISR Number: 4243237-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-350389 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amnesia Lariam PS Roche UNKNOWN 3 DOSES TAKEN
Disorientation IN TOTAL. 24 DAY
Panic Attack
Date:12/01/03ISR Number: 4243240-7Report Type:Expedited (15-DaCompany Report #IE-ROCHE-350696 Age:23 MON Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Lariam PS Roche UNKNOWN 0.25 OF A
Initial or Prolonged Malaise TABLET.
Lower Respiratory Tract Penicillin V C ORAL DOSE
Infection
INCREASED TO
White Blood Cell Count
250MG BD.
Increased Cefotaxim C INTRAVENOUS 6 DAY
Dexamethasone C INTRAVENOUS 4MG TO 1 MG,
03-Apr-2012 09:37 AM Page: 524

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
QDS 2 DAY
Folic Acid C ORAL
Clarithromycin C ORAL 8 DAY
Date:12/01/03ISR Number: 4243244-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-350389 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disorientation Lariam PS Roche UNKNOWN 3 DOSES TAKEN
Panic Attack IN TOTAL. 24 DAY
Amnesia
Date:12/01/03ISR Number: 4243580-1Report Type:Expedited (15-DaCompany Report #IE-ROCHE-350774 Age:23 MON Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lower Respiratory Tract Lariam PS Roche ORAL 0.25 OF A
Initial or Prolonged Infection TABLET.
Malaise Penicillin V C ORAL
Pyrexia Clarithromycin C ORAL 8 DAY
White Blood Cell Count Folic Acid C ORAL
Increased Cefotaxime C INTRAVENOUS 8 DAY
Date:12/01/03ISR Number: 4243635-1Report Type:Expedited (15-DaCompany Report #IE-ROCHE-350774 Age:23 MON Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lower Respiratory Tract Lariam PS Roche ORAL 0.25 OF A
Initial or Prolonged Infection TABLET.
Pyrexia Penicillin V C ORAL
Malaise Clarithromycin C ORAL 8 DAY
White Blood Cell Count Folic Acid C ORAL
Increased Cefotaxime C INTRAVENOUS 8 DAY
Date:12/02/03ISR Number: 4244263-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-352392 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Homicidal Ideation Lariam PS Roche ORAL
Suicidal Ideation
Hallucination
Date:12/04/03ISR Number: 4245784-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-331974 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche UNKNOWN PATIENT TOOK
Maternal Drugs Affecting
3 TABLETS IN
Foetus TOTAL 3 WK

Alcohol Use Oral Contraceptive
Pregnancy On Oral Pill C ORAL
Contraceptive
03-Apr-2012 09:37 AM Page: 525

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/04/03ISR Number: 4245788-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-352436 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspnoea Lariam PS Roche UNKNOWN
Iiird Nerve Disorder
Hypoaesthesia
Paraesthesia
Date:12/08/03ISR Number: 4248397-XReport Type:Direct Company Report #CTU 207633 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Decreased Appetite Larium PS ORAL DAILY ORAL
Hyperhidrosis
Night Sweats
Asthenia
Heat Rash
Depression
Insomnia
Lethargy
Date:12/15/03ISR Number: 4251655-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-353732 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche ORAL 50 DAY
Pregnancy
Maternal Drugs Affecting
Foetus
Date:12/15/03ISR Number: 4252145-7Report Type:Direct Company Report #CTU 208025 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Panic Attack Mefloquine PS ORAL ONCE WEEK
Anxiety
ORAL
Birth Control Pill C
Cipro
C
Zovia
C
Date:12/18/03ISR Number: 4253973-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Age:40 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Paranoia
Disorientation
Blood Potassium Decreased
Vision Blurred
Memory Impairment

Hallucination
Psychotic Disorder
Incontinence
Disturbance In Attention
Hostility
Disability
Somnolence
Gait Disturbance
03-Apr-2012 09:37 AM Page: 526

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Fatigue
Circulatory Collapse
Delusion Report Source Product Role Manufacturer Route Dose Duration
Decreased Activity Consumer Lariam PS Roche ORAL EVERY WEEK. 9 DAY
Drug Ineffective Valium SS Roche INTRAVENOUS 1 DAY
Aggression Prozac C ORAL
Depression
Speech Disorder
Agitation
Headache
Antisocial Behaviour
Loss Of Libido
Confusional State
Mania
Convulsion
Date:12/18/03ISR Number: 4253974-6Report Type:Expedited (15-DaCompany Report #CA-ROCHE-348024 Age:40 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myalgia Health Lariam PS Roche ORAL
Initial or Prolonged Blood Creatine Professional Echinacea C ORAL
Phosphokinase
Dehydration
Hepatitis Viral
Loss Of Consciousness
Vomiting
Nausea
Hepatitis
Syncope
Diarrhoea
Date:12/22/03ISR Number: 4256133-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-354080 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Mefloquine
Loss Of Consciousness Hydrochloride PS Roche ORAL
Respiratory Arrest
Date:12/22/03ISR Number: 4256138-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-354423 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Biliary Colic Lariam PS Roche ORAL 1 DAY
Initial or Prolonged Cholecystitis
Date:12/23/03ISR Number: 4257040-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-352436 Age:30 YR Gender:Female I/FU:F

Outcome
Hospitalization -
Initial or Prolonged
PT
Feeling Cold
Muscle Rigidity
Protein C Increased
Iiird Nerve Disorder
Nervous System Disorder
Gait Disturbance
03-Apr-2012 09:37 AM Page: 527

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Injection Site
Anaesthesia
Dyspnoea Report Source Product Role Manufacturer Route Dose Duration
Paraesthesia Health Lariam PS Roche UNKNOWN
Chest Discomfort
Professional
Tremor
Diplopia
Painful Respiration
Hypoaesthesia
Cerebellar Syndrome
Date:01/05/04ISR Number: 4263391-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Paranoia Lariam PS Roche ORAL 23 TABLETS
Balance Disorder
DISPENSED.
Suicidal Ideation
Hallucination
Neuropathy Peripheral
Viiith Nerve Lesion
Visual Impairment
Tremor
Photophobia
Hepatic Failure
Panic Attack
Date:01/07/04ISR Number: 4265742-XReport Type:Expedited (15-DaCompany Report #GB-ROCHE-354080 Age:21 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Consumer Mefloquine
Respiratory Arrest Hydrochloride PS Roche ORAL
Loss Of Consciousness
Date:01/09/04ISR Number: 4268113-5Report Type:Direct Company Report #CTU 209610 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nightmare Mefloquin 250 Mg
Initial or Prolonged Tremor Lariam PS ORAL 1 WEEK ORAL
Disability
Depression
Anxiety
Convulsion
Date:01/12/04ISR Number: 4268779-XReport Type:Direct Company Report #CTU 209704 Age:54 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Depression Lariam PS ORAL ONE TIME ORAL
Initial or Prolonged Convulsion Antibiotic C
Anxiety Levaquen C
Reglan
C
Prevacid
C
03-Apr-2012 09:37 AM Page: 528

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/14/04ISR Number: 4271467-7Report Type:Direct Company Report #CTU 210092 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Feeling Abnormal Lariam Mefloquine
Sleep Disorder Roche PS Roche ORAL 1 WEEK ORAL
Hyperacusis
Stress
Depression
Anxiety
Emotional Disorder
Date:01/20/04ISR Number: 4274670-5Report Type:Direct Company Report #CTU 210400 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam PS WEEKLY
Panic Attack
Nightmare
Vertigo
Date:01/29/04ISR Number: 4281325-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-351227 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dysgeusia Consumer Lariam PS Roche ORAL 1 DAY
Viith Nerve Paralysis
Product Quality Issue
Vision Blurred
Lacrimation Increased
Date:01/30/04ISR Number: 4282938-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-357211 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Amnesia Mefloquine
Initial or Prolonged Hydrochloride PS Roche ORAL PATIENT TOOK
ONLY ONE DOSE
OF
MEFLOQUINE. 1 DAY
Date:02/02/04ISR Number: 4283667-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-357080 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dysphagia Lariam PS Roche UNKNOWN
Initial or Prolonged Urticaria

Date:02/04/04ISR Number: 4285179-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Age:40 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Hallucination
Mania
Psychotic Disorder
Speech Disorder
Confusional State
03-Apr-2012 09:37 AM Page: 529

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Blood Potassium Decreased
Hostility
Decreased Activity Report Source Product Role Manufacturer Route Dose Duration
Gait Disturbance Health Lariam PS Roche ORAL EVERY WEEK. 9 DAY
Antisocial Behaviour Professional Valium SS Roche INTRAVENOUS 1 DAY
Loss Of Libido Prozac C ORAL
Disturbance In Attention
Paranoia
Disorientation
Convulsion
Agitation
Fatigue
Aggression
Vision Blurred
Incontinence
Drug Ineffective
Headache
Depression
Memory Impairment
Delusion
Date:02/05/04ISR Number: 4286243-9Report Type:Direct Company Report #CTU 211605 Age:10 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Lariam 125 Mg/5ml. PS 1 TSP ONE
TIME PER WK
Methlaquine Tabs 250
Mg - Compounded SS
Date:02/06/04ISR Number: 4286779-0Report Type:Expedited (15-DaCompany Report #NL-ROCHE-348532 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Metrorrhagia Health Lariam PS Roche ORAL
Pyrexia Professional Lariam SS Roche ORAL
Nausea Microgynon 30 C ORAL 17 DAY
Date:02/06/04ISR Number: 4286781-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-355117 Age:21 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscle Spasms Lariam PS Roche ORAL 1 DAY
Mucosal Inflammation
Throat Irritation
Oropharyngeal Blistering
Palpitations
Dizziness

Date:02/12/04ISR Number: 4293681-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Age:40 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Hallucination
Depression
Gait Disturbance
Blood Potassium Decreased
03-Apr-2012 09:37 AM Page: 530

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Paranoia
Speech Disorder
Fatigue Report Source Product Role Manufacturer Route Dose Duration
Mania Health Lariam PS Roche ORAL EVERY WEEK. 9 DAY
Confusional State Professional Valium SS Roche INTRAVENOUS 1 DAY
Delusion Prozac C ORAL
Pyrexia
Muscle Rigidity
Disorientation
Hostility
Memory Impairment
Aggression
Headache
Psychotic Disorder
Convulsion
Loss Of Libido
Incontinence
Agitation
Antisocial Behaviour
Drug Ineffective
Date:02/12/04ISR Number: 4293695-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-354080 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Consumer Mefloquine
Loss Of Consciousness Hydrochloride PS Roche ORAL
Date:02/12/04ISR Number: 4294092-0Report Type:Direct Company Report #CTU 212123 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Anger Larium 250 Mg Roache
Aggression Pharmaceuticals PS Roache
Psychotic Disorder Pharmaceuticals ORAL 250 MG ,
Imprisonment
WEEKLY ORAL
Date:02/16/04ISR Number: 4295449-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-351227 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Viith Nerve Paralysis Consumer Lariam PS Roche ORAL 1 DAY
Dysgeusia
Date:02/16/04ISR Number: 4295459-7Report Type:Expedited (15-DaCompany Report #CA-ROCHE-358463 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Schizoaffective Disorder Lariam PS Roche ORAL

Mania
Psychotic Disorder
03-Apr-2012 09:37 AM Page: 531

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/24/04ISR Number: 4303509-4Report Type:Direct Company Report #CTU 213006 Age:69 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Abnormal Dreams Mefloquine Hcl 250
Intervention to Hallucination Mg Tab Geneva Pharm.
Prevent Permanent Anxiety Tech. Corp PS Geneva Pharm Tech.
Impairment/Damage Sleep Disorder Corp ORAL 1 A WEEK ORAL
Affect Lability Flomax C
Insomnia Proscar C
Decreased Appetite
Depression
Panic Attack
Date:02/26/04ISR Number: 4307492-7Report Type:Expedited (15-DaCompany Report #2003IC000217 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Intra-Uterine Death Foreign Librax
Congenital Anomaly Pregnancy Health (Chlordiazepoxide
Abortion Induced Professional Hydrochloride/Clidin
Foetal Malformation ium Bromide) PS TRANSPLACENTAL TRANSPLACENTA
Maternal Drugs Affecting
L
Foetus
Stamaril Amaril
Hydrocephalus
Vaccin (Generic
Foetal Disorder Unknown) SS TRANSPLACENTAL 1 FD;
Haemorrhage
TRANSPLACENTA
Foetal Malposition
L
Lariam (Mefloquine
Chlorhydrate)
(Generic Unknown) SS TRANSPLACENTAL TRANSPLANCENT
AL
Date:03/01/04ISR Number: 4308476-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-359452 Age:53 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Lymphadenopathy Consumer Lariam PS Roche ORAL DOSAGE
Initial or Prolonged Pulmonary Fibrosis REPORTED AS
Interstitial Lung Disease 1.1 AND 1.2
MG/L.
Unknown Medication C INTRAVENOUS DRUG REPORTED
AS CLAMOXIL. 3 DAY
Date:03/03/04ISR Number: 4310349-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-355117 Age:21 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscle Spasms Health Lariam PS Roche ORAL 1 DAY
Palpitations
Professional
Product Quality Issue

Medication Error
Mucosal Inflammation
Throat Irritation
Oropharyngeal Blistering
Dizziness
03-Apr-2012 09:37 AM Page: 532

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/03/04ISR Number: 4310471-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-351227 Age:55 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dysgeusia Health Lariam PS Roche ORAL 1 DAY
Vision Blurred
Professional
Face Oedema
Corneal Reflex Decreased
Viith Nerve Paralysis
Date:03/08/04ISR Number: 4313479-0Report Type:Expedited (15-DaCompany Report #CA-ROCHE-358463 Age:27 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mania Health Lariam PS Roche ORAL
Psychotic Disorder
Professional
Schizoaffective Disorder
Treatment Noncompliance
Date:03/09/04ISR Number: 4314313-5Report Type:Direct Company Report #CTU 214091 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Anxiety Lariam 250 Mg Roche PS Roche ORAL 500 MG WEEKLY
Hospitalization - Panic Attack ORAL, 1500 MG
Initial or Prolonged Malaria ONE TIME ORAL
Required Drug Ineffective Cipro C
Intervention to Major Depression Flagyl C
Prevent Permanent
Impairment/Damage
Date:03/11/04ISR Number: 4315538-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-351227 Age:55 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vision Blurred Lariam PS Roche ORAL 1 DAY
Dysgeusia
Viith Nerve Paralysis
Date:03/15/04ISR Number: 4317682-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Mitral Valve Prolapse
Depression
Viral Infection
Arthralgia
Constipation
Upper-Airway Cough
Syndrome

Hypertension
Angina Pectoris
Total Lung Capacity
Decreased
Somnolence
Bronchospasm
Low Density Lipoprotein
Increased
03-Apr-2012 09:37 AM Page: 533

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Exfoliative Rash
Dry Skin
Chest Discomfort Report Source Product Role Manufacturer Route Dose Duration
Vestibular Disorder Lariam PS Roche ORAL
Skin Disorder Zoloft C UNKNOWN
Bronchitis
Sinus Tachycardia
Blood Triglycerides
Increased
Dehydration
Blood Creatine
Phosphokinase Increased
Hallucination, Visual
Gastrointestinal Disorder
Diastolic Dysfunction
Cardiac Murmur
Dry Eye
Vitiligo
Blood Glucose Increased
Gastrooesophageal Reflux
Disease
Amnesia
Fatigue
Rash
Dry Mouth
Snoring
Anxiety
Headache
Angiotensin Converting
Enzyme Increased
Rhinitis
Dyspnoea
Weight Increased
Blood Cholesterol
Increased
Total Cholesterol/Hdl
Ratio Decreased
Diarrhoea
Oral Disorder
Insomnia
Confusional State
Ventricular Hypertrophy
Restrictive Pulmonary
Disease
Nocturia
Acrochordon
Date:03/16/04ISR Number: 4317812-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Anxiety

Ventricular Hypertrophy
Hypertension
Bronchitis
Cardiac Murmur
Dry Eye
Gastrooesophageal Reflux
Disease
Upper-Airway Cough
03-Apr-2012 09:37 AM Page: 534

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Syndrome
Amnesia
Skin Disorder
Fatigue Report Source Product Role Manufacturer Route Dose Duration
Somnolence Lariam PS Roche ORAL
Rash Zoloft C UNKNOWN
Weight Increased
Total Cholesterol/Hdl
Ratio Decreased
Dehydration
Oral Disorder
Vestibular Disorder
Angina Pectoris
Dry Mouth
Constipation
Rhinitis
Hallucination, Visual
Headache
Total Lung Capacity
Decreased
Sinus Tachycardia
Low Density Lipoprotein
Increased
Exfoliative Rash
Confusional State
Restrictive Pulmonary
Disease
Nocturia
Vitiligo
Angiotensin Converting
Enzyme Increased
Blood Glucose Increased
Hypersomnia
Mitral Valve Prolapse
Depression
Diastolic Dysfunction
Bronchospasm
Blood Cholesterol
Increased
Blood Triglycerides
Increased
Dry Skin
Chest Discomfort
Insomnia
Dyspnoea
Diarrhoea
Blood Creatine
Phosphokinase Increased
Snoring
Gastrointestinal Disorder
Viral Infection
Arthralgia
Acrochordon

Date:03/16/04ISR Number: 4317891-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Skin Disorder
Viral Infection
Bronchitis
03-Apr-2012 09:37 AM Page: 535

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Chest Discomfort
Angiotensin Converting
Enzyme Increased
Fundoscopy Abnormal
Body Temperature
Increased
Dyspnoea
Diastolic Dysfunction
Weight Increased
Blood Cholesterol
Increased
Dry Mouth
Vitiligo
Exercise Tolerance
Decreased
Nausea
Anxiety
Hypertension
Blood Triglycerides
Increased
Dehydration
Constipation
Rhinitis
Myalgia
Heart Sounds Abnormal
Occult Blood Positive
Exfoliative Rash
Dry Eye
Chronic Fatigue Syndrome
Hypersomnia
Rash
Low Density Lipoprotein
Increased
Upper-Airway Cough
Syndrome
Pain In Jaw
Chills
Mitral Valve Prolapse
Bronchospasm
Cardiac Murmur
Blood Glucose Increased
Insomnia
Tongue Coated
Listless
Neck Pain
Amnesia
Hallucination, Visual
Gastrointestinal Disorder
Fatigue
Angina Pectoris
Total Lung Capacity
Decreased
Somnolence

Diarrhoea
Dry Skin
Snoring
Nocturia
Oral Disorder
Upper Respiratory Tract
Infection
Impaired Work Ability
03-Apr-2012 09:37 AM Page: 536

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abdominal Tenderness
Confusional State
Vestibular Disorder Report Source Product Role Manufacturer Route Dose Duration
Depression Lariam PS Roche ORAL
Headache Zoloft C UNKNOWN
Ventricular Hypertrophy
Restrictive Pulmonary
Disease
Arthralgia
Sinus Tachycardia
Total Cholesterol/Hdl
Ratio Decreased
Blood Creatine
Phosphokinase Increased
Acrochordon
Gastrooesophageal Reflux
Disease
Drug Tolerance Decreased
Pyrexia
Injury
Date:03/18/04ISR Number: 4318870-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-321435 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Maternal Exposure During Consumer Lariam PS Roche 37 DAY
Initial or Prolonged Pregnancy Nivaquine SS 14 DAY
Premature Baby Quinine SS 6 DAY
Paludrine SS 14 DAY
Date:03/18/04ISR Number: 4318889-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-361697 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Premature Baby Consumer Lariam PS Roche 37 DAY
Initial or Prolonged Twin Pregnancy Nivaquine SS 14 DAY
Paludrine SS 14 DAY
Quinine SS 6 DAY
Date:03/23/04ISR Number: 4322410-3Report Type:Direct Company Report #CTU 215048 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Impaired Work Ability Larium Standard For
Activities Of Daily Malaria PS
Living Impaired
Depression

Date:03/29/04ISR Number: 4325789-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Fatigue
Rash
Constipation
Oral Disorder
Dyspnoea
03-Apr-2012 09:37 AM Page: 537

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Mitral Valve Prolapse
Total Lung Capacity
Decreased
Bronchospasm
Weight Increased
Chest Discomfort
Major Depression
Scratch
Chest X-Ray Abnormal
Vestibular Disorder
Blood Cholesterol
Increased
Dehydration
Blood Creatine
Phosphokinase Increased
Exfoliative Rash
Abnormal Dreams
Bipolar Disorder
Haemorrhoids
Balance Disorder
Affective Disorder
Confusional State
Restrictive Pulmonary
Disease
Blood Triglycerides
Increased
Low Density Lipoprotein
Increased
Diarrhoea
Dry Skin
Dry Eye
Vitiligo
Gastrooesophageal Reflux
Disease
Rhinitis
Clumsiness
Coordination Abnormal
Adjustment Disorder
Neck Pain
Ventricular Hypertrophy
Somnolence
Arthralgia
Cardiac Murmur
Blood Glucose Increased
Visual Impairment
Asthma
Hypersomnia
Wheezing
Sputum Abnormal
Oedema Peripheral
Skin Disorder
Diastolic Dysfunction
Acrochordon

Contusion
Upper Respiratory Tract
Infection
Dyspnoea Exertional
Depression
Hypertension
Angina Pectoris
Bronchitis
03-Apr-2012 09:37 AM Page: 538

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sinus Tachycardia
Total Cholesterol/Hdl
Ratio Decreased Report Source Product Role Manufacturer Route Dose Duration
Snoring Consumer Lariam PS Roche ORAL
Angiotensin Converting Zoloft C UNKNOWN
Enzyme Increased
Adjustment Disorder With
Depressed Mood
Body Temperature
Increased
Amnesia
Hallucination, Visual
Anxiety
Gastrointestinal Disorder
Headache
Viral Infection
Dry Mouth
Nocturia
Upper-Airway Cough
Syndrome
Insomnia
Memory Impairment
Date:04/05/04ISR Number: 4332092-2Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-362924 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Psoriasis Lariam PS Roche ORAL 15 DAY
Date:04/08/04ISR Number: 4334985-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-360920 Age:41 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Muscular Weakness Lariam PS Roche ORAL 2 DAY
Myalgia Lariam SS Roche ORAL
Blood Creatine
Phosphokinase Increased
Blood Lactate
Dehydrogenase Increased
Balance Disorder
Insomnia
Vertigo
Hypertension
Fall
Date:04/21/04ISR Number: 4343035-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Dyspnoea

Mitral Valve Prolapse
Hypertension
Somnolence
Cardiac Murmur
Blood Cholesterol
Increased
Blood Triglycerides
Increased
03-Apr-2012 09:37 AM Page: 539

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Upper-Airway Cough
Syndrome
Insomnia
Affective Disorder
Depression
Headache
Ventricular Hypertrophy
Diastolic Dysfunction
Bronchitis
Dehydration
Dry Skin
Bipolar Disorder
Major Depression
Restrictive Pulmonary
Disease
Viral Infection
Total Cholesterol/Hdl
Ratio Decreased
Exfoliative Rash
Nocturia
Vitiligo
Visual Impairment
Abnormal Dreams
Coordination Abnormal
Adjustment Disorder With
Depressed Mood
Adjustment Disorder
Hallucination, Visual
Gastrointestinal Disorder
Fatigue
Blood Creatine
Phosphokinase Increased
Gastrooesophageal Reflux
Disease
Balance Disorder
Hypersomnia
Anxiety
Bronchospasm
Diarrhoea
Memory Impairment
Angina Pectoris
Sleep Apnoea Syndrome
Rash
Weight Increased
Dry Eye
Oral Disorder
Blood Glucose Increased
Rhinitis
Contusion
Amnesia
Vestibular Disorder
Arthralgia
Low Density Lipoprotein

Increased
Constipation
Acrochordon
Clumsiness
Haemorrhoids
Scratch
Confusional State
Skin Disorder
03-Apr-2012 09:37 AM Page: 540

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Total Lung Capacity
Decreased
Sinus Tachycardia Report Source Product Role Manufacturer Route Dose Duration
Dry Mouth Consumer Lariam PS Roche ORAL
Snoring Zoloft C UNKNOWN
Chest Discomfort
Angiotensin Converting
Enzyme Increased
Asthma
Date:04/21/04ISR Number: 4344421-4Report Type:Direct Company Report #CTU 217021 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anger Mefloquine 250 Mg PS ORAL 250 MG Q WK
Headache PO 2 MON
Myalgia
Mood Swings
Date:04/26/04ISR Number: 4347305-0Report Type:Direct Company Report #CTU 217365 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Tachycardia Mefloquine Lariam PS ORAL ONE TAB
Intervention to Heart Rate Irregular WEEKLY ORAL
Prevent Permanent Extrasystoles
Impairment/Damage
Date:04/27/04ISR Number: 4348517-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-365129 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mania Lariam PS Roche ORAL
Initial or Prolonged Psychotic Disorder
Date:04/27/04ISR Number: 4349105-4Report Type:Direct Company Report #CTU 217446 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gait Disturbance Lariam 250 Mg
Eating Disorder Hoffmann-La Roche PS Hoffmann-La Roche ORAL 1 TABLET
Muscle Spasms
WEEKLY ORAL
Dizziness
Date:04/30/04ISR Number: 4351518-1Report Type:Direct Company Report #CTU 217725 Age:60 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Loss Of Consciousness Mefloquine 250mg
Initial or Prolonged Geneva PS Geneva 1 PER WEEK
Minocycline 200mg SS 200MG FIRST
DAY, 100MG
AFTER
03-Apr-2012 09:37 AM Page: 541

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/03/04ISR Number: 4351449-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-328967 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Congenital Anomaly Lariam PS Roche 1 DAY
Hypospadias
Testicular Atrophy
Testicular Disorder
Maternal Drugs Affecting
Foetus
Date:05/12/04ISR Number: 4357189-2Report Type:Direct Company Report #CTU 218492 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Lariam 250 Mg Roche PS Roche ORAL 1 PILL PER WK
Required Fear ORAL
Intervention to
Thinking Abnormal
Prevent Permanent
Impairment/Damage
Mental Disorder
Malaise
Feeling Abnormal
Confusional State
Date:05/14/04ISR Number: 4358415-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Vestibular Disorder
Rash
Weight Increased
Diarrhoea
Chest Discomfort
Blood Glucose Increased
Clumsiness
Haemorrhoids
Schizoaffective Disorder
Sleep Apnoea Syndrome
Bronchospasm
Total Cholesterol/Hdl
Ratio Decreased
Blood Creatine
Phosphokinase Increased
Exfoliative Rash
Angiotensin Converting
Enzyme Increased
Rhinitis
Balance Disorder
Psychotic Disorder
Anxiety
Headache
Restrictive Pulmonary
Disease

Viral Infection
Arthralgia
Bronchitis
Sinus Tachycardia
Constipation
Upper-Airway Cough
Syndrome
Asthma
03-Apr-2012 09:37 AM Page: 542

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Adjustment Disorder With
Depressed Mood
Fatigue Report Source Product Role Manufacturer Route Dose Duration
Total Lung Capacity Consumer Lariam PS Roche ORAL
Decreased Zoloft C UNKNOWN
Cardiac Murmur
Blood Cholesterol
Increased
Low Density Lipoprotein
Increased
Oral Disorder
Vitiligo
Contusion
Memory Impairment
Confusional State
Gastrointestinal Disorder
Depression
Snoring
Bipolar Disorder
Major Depression
Hypertension
Dry Mouth
Gastrooesophageal Reflux
Disease
Visual Impairment
Abnormal Dreams
Scratch
Amnesia
Dyspnoea
Mitral Valve Prolapse
Skin Disorder
Angina Pectoris
Blood Triglycerides
Increased
Dry Skin
Coordination Abnormal
Affective Disorder
Ventricular Hypertrophy
Diastolic Dysfunction
Somnolence
Dehydration
Dry Eye
Nocturia
Acrochordon
Insomnia
Date:05/14/04ISR Number: 4358421-1Report Type:Expedited (15-DaCompany Report #CH-ROCHE-357220 Age:61 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blindness Unilateral Lariam PS Roche ORAL DOSAGE
Initial or Prolonged Vitreous Haemorrhage REGIMEN

Lariam SS Roche ORAL
REPORTED AS
250 MG.
03-Apr-2012 09:37 AM Page: 543

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/14/04ISR Number: 4358430-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-367059 Age:69 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Glaucoma Lariam PS Roche ORAL
Arrhythmia
Date:05/14/04ISR Number: 4358440-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-367058 Age:81 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Glaucoma Lariam PS Roche ORAL
Silent Myocardial
Infarction
Date:05/24/04ISR Number: 4363710-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Disorientation Lariam PS Roche ORAL
Insomnia
Vertigo
Diarrhoea
Vestibular Disorder
Chest Pain
Night Sweats
Agitation
Anxiety Disorder
Fatigue
Psychotic Disorder
Nightmare
Amnesia
Tinnitus
Vomiting
Memory Impairment
Nausea
Mood Swings
Date:05/27/04ISR Number: 4366518-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Age:40 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Paranoia
Depression
Delusion
Speech Disorder
Confusional State
Aggression
Blood Potassium Decreased
Agitation
Antisocial Behaviour

Drug Ineffective
Muscle Rigidity
Disorientation
Convulsion
Loss Of Libido
Psychotic Disorder
Gait Disturbance
Incontinence
03-Apr-2012 09:37 AM Page: 544

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Memory Impairment
Mania
Pyrexia Report Source Product Role Manufacturer Route Dose Duration
Hallucination Health Lariam PS Roche ORAL EVERY WEEK. 9 DAY
Hostility Professional Valium SS Roche INTRAVENOUS 1 DAY
Fatigue Prozac C ORAL
Headache
Date:05/27/04ISR Number: 4366535-5Report Type:Expedited (15-DaCompany Report #CA-ROCHE-368340 Age:17 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Urinary Incontinence Lariam PS Roche ORAL 58 DAY
Panic Reaction
Dizziness
Date:05/27/04ISR Number: 4367724-6Report Type:Periodic Company Report #262840 Age:34 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Cold Sweat Health Lariam (Mefloquine
Heart Rate Irregular Professional Hydrochloride) 250
Depression Other Mg PS ORAL 1 DOSE FROM 1
Tinnitus
PER WEEK ORAL
Abdominal Distension
Weight Decreased
Acrophobia
Heart Rate Increased
Diarrhoea
Dyspnoea
Disturbance In Attention
Anxiety
Panic Attack
Motion Sickness
Hypersensitivity
Phobia Of Flying
Suicidal Ideation
Dizziness
Self Esteem Decreased
Photophobia
Burning Sensation
Paraesthesia
Nausea
Abdominal Pain
Rash
Vestibular Disorder
Faeces Discoloured
Phobia
Claustrophobia
Disorientation
Balance Disorder

Emotional Distress
Flatulence
Constipation
Insomnia
Headache
Irritable Bowel Syndrome
03-Apr-2012 09:37 AM Page: 545

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/27/04ISR Number: 4367725-8Report Type:Periodic Company Report #350185 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Tinnitus Health Lariam (Mefloquine
Anxiety Professional Hydrochloride) 250
Dizziness Mg PS ORAL 250 MG, 1 PER
Psychotic Disorder
WEEK ORAL
Insomnia
Tremor
Confusional State
Abnormal Behaviour
Head Discomfort
Date:05/27/04ISR Number: 4367728-3Report Type:Periodic Company Report #354441 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Arrhythmia Consumer Lariam (Mefloquine
Death Other Hydrochloride) 250
Adverse Event Mg PS ORAL ORAL
Date:05/27/04ISR Number: 4367729-5Report Type:Periodic Company Report #358251 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Health Lariam (Mefloquine
Initial or Prolonged Professional Hydrochloride) 250
Mg PS ORAL ORAL
Propranolol
(Propranolol
Hydrochloride) C
Date:05/27/04ISR Number: 4367731-3Report Type:Periodic Company Report #358470 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Health Lariam (Mefloquine
Obsessive Thoughts Professional Hydrochloride) 250
Panic Attack Mg PS ORAL ORAL
Anxiety
Date:05/27/04ISR Number: 4367732-5Report Type:Periodic Company Report #360727 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Health Lariam (Mefloquine
Anxiety Professional Hydrochloride) 250
Mg PS ORAL ORAL

Date:05/27/04ISR Number: 4367733-7Report Type:Periodic Company Report #361035 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Social Avoidant Behaviour Health Lariam (Mefloquine
Anger Professional Hydrochloride) 250
Paranoia Mg PS ORAL ORAL
03-Apr-2012 09:37 AM Page: 546

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/27/04ISR Number: 4367734-9Report Type:Periodic Company Report #361644 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Reactive Psychosis Health Lariam (Mefloquine
Initial or Prolonged Professional Hydrochloride) 250
Mg PS ORAL 250 MG ORAL
Malarone
(Atovaquone/Chlorogu
anide Hydrochloride) SS ORAL ORAL
Date:05/27/04ISR Number: 4367735-0Report Type:Periodic Company Report #361850 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Deafness Health Lariam (Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL 1 PER WEEK
ORAL
Date:05/27/04ISR Number: 4367736-2Report Type:Periodic Company Report #362309 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Adverse Event Health Lariam (Mefloquine
Completed Suicide Professional Hydrochloride) 250
Mg PS ORAL ORAL
Date:05/27/04ISR Number: 4367737-4Report Type:Periodic Company Report #336177 Age:40 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Oral Disorder
Toxicity To Various
Agents
Hyperventilation
Dizziness
Vision Blurred
Insomnia
Mood Altered
Dyspnoea
Abnormal Dreams
Heart Rate Increased
Panic Attack
Hyperhidrosis
Fatigue
Blood Pressure Increased
Adverse Event
Headache
Paraesthesia
Agitation

Vertigo
Decreased Activity
Erythema
Chest Discomfort
Balance Disorder
Lichen Planus
Disturbance In Attention
Nightmare
03-Apr-2012 09:37 AM Page: 547

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Anxiety
Panic Disorder
Depression Report Source Product Role Manufacturer Route Dose Duration
Consumer
Lariam (Mefloquine
Health Hydrochloride) 250
Professional Mg PS ORAL 250 MG ORAL
Other
Date:05/27/04ISR Number: 4367738-6Report Type:Periodic Company Report #339621 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicidal Ideation Consumer Lariam (Mefloquine
Initial or Prolonged Confusional State Hydrochloride) 250
Disability Night Sweats Mg PS ORAL 250 MG 1 PER
Adverse Event
WEEK ORAL
Anxiety
Disturbance In Attention
Depression
Palpitations
Date:05/27/04ISR Number: 4367739-8Report Type:Periodic Company Report #339943 Age:15 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Consumer Lariam (Mefloquine
Hydrochloride) PS
Date:05/27/04ISR Number: 4367740-4Report Type:Periodic Company Report #342838 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Tinnitus Other Lariam (Mefloquine
Hydrochloride) 250
Mg PS ORAL 1 DOSE FORM 1
PER WEEK ORAL
Date:05/27/04ISR Number: 4367741-6Report Type:Periodic Company Report #343641 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Adverse Event Literature Mefloquine
Initial or Prolonged Psychotic Disorder Health Hydrochloride
Professional
(Mefloquine
Hydrochloride) PS 250 MG 1 PER
WEEK
Oral Contraceptive
Nos (Oral
Contraceptive Nos)
C

Date:05/27/04ISR Number: 4367744-1Report Type:Periodic Company Report #344143 Age:42 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Anxiety
Suicidal Ideation
03-Apr-2012 09:37 AM Page: 548

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Emotional Disorder
Insomnia
Report Source Product Role Manufacturer Route Dose Duration
Consumer
Lariam (Mefloquine
Hydrochloride) 250
Mg PS ORAL 1 DOSE FOR 1
PER WEEK ORAL
Liquibid
(Guaifenesin)
C
Flonase (Fluticasone
Propionate)
C
Zyrtec (Cetirizine
Hydrochloride) C
Date:05/27/04ISR Number: 4367745-3Report Type:Periodic Company Report #346923 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Chills Consumer Lariam (Mefloquine
Suicidal Ideation Health Hydrochloride) PS ORAL ORAL
Weight Decreased
Professional
Depression
Decreased Appetite
Fatigue
Hyperhidrosis
Adverse Event
Date:05/27/04ISR Number: 4367746-5Report Type:Periodic Company Report #347625 Age:64 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Consumer Lariam (Mefloquine
Vomiting Hydrochloride) PS ORAL ORAL
Neuropathy Peripheral
Chloroquine
Dizziness (Chloroquine) C
Headache
Nitroglycerine
(Nitroglycerin) C
Premarin (Estrogens,
Conjugated)
C
Fansidar
(Pyrimethamine/Sulfa
doxine)
C
Date:05/27/04ISR Number: 4367747-7Report Type:Periodic Company Report #348770 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abdominal Discomfort Consumer Lariam (Mefloquine
Initial or Prolonged Insomnia Hydrochloride) PS ORAL ORAL
Hallucination

Fatigue
Dyspepsia
Myalgia
03-Apr-2012 09:37 AM Page: 549

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/27/04ISR Number: 4367748-9Report Type:Periodic Company Report #350183 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tremor Health Lariam (Mefloquine
Fatigue Professional Hydrochloride) PS ORAL ORAL
Convulsion
Muscle Twitching
Dizziness
Adverse Event
Date:06/01/04ISR Number: 4367871-9Report Type:Direct Company Report #CTU 219805 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicide Attempt Lariam 250 Mg Roche
Disability Abnormal Behaviour Pharmaceuticals PS Roche
Required Depression Pharmaceuticals ORAL ONE-1- PER
Intervention to Fall DAY ORAL
Prevent Permanent
Impairment/Damage
Vision Blurred
Suicidal Ideation
Amnesia
Balance Disorder
Date:06/08/04ISR Number: 4374191-5Report Type:Direct Company Report #CTU 220327 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Balance Disorder Larium PS 2 TAB
Vertigo
Date:06/08/04ISR Number: 4374192-7Report Type:Direct Company Report #CTU 220326 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Balance Disorder Larium PS 2 TAB
Vertigo
Date:06/08/04ISR Number: 4374195-2Report Type:Direct Company Report #CTU 220324 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Balance Disorder Larium PS 2 TAB
Vertigo
Date:06/08/04ISR Number: 4374199-XReport Type:Direct Company Report #CTU 220323 Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Disability Balance Disorder Larium PS 2 TAB
Vertigo
03-Apr-2012 09:37 AM Page: 550

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/08/04ISR Number: 4374203-9Report Type:Direct Company Report #CTU 220322 Age:45 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Vertigo Larium PS 2 TAB
Balance Disorder
Date:06/08/04ISR Number: 4374205-2Report Type:Direct Company Report #CTU 220321 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Vertigo Larium PS 2 TABS
Balance Disorder
Date:06/09/04ISR Number: 4375988-8Report Type:Direct Company Report #CTU 220405 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Rash Larium-Mefloquin-
Standard Pills PS ORAL 1 PILL DAILY
ORAL
Date:06/09/04ISR Number: 4376006-8Report Type:Direct Company Report #CTU 220398 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Aggression Lariam PS WEEKLY 2/03->
Physical Assault 12/03
Incoherent
Psychotic Disorder
Completed Suicide
Date:06/15/04ISR Number: 4377670-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-369567 Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Heat Stroke Lariam PS Roche ORAL
Disorientation Omeprazole C ORAL
Tremor Risperdal C ORAL
Dehydration
Cerebral Ventricle
Dilatation
Normal Pressure
Hydrocephalus
Date:06/21/04ISR Number: 4381191-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age: Gender:Male I/FU:F
Outcome
PT

Disability
Hepatic Failure
Cranial Nerve Disorder
Balance Disorder
Nausea
Amnesia
Incontinence
Aggression
Disturbance In Attention
03-Apr-2012 09:37 AM Page: 551

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Photosensitivity Reaction
Paranoia
Visual Field Defect Report Source Product Role Manufacturer Route Dose Duration
Depression Consumer Lariam PS Roche ORAL 23 TABLETS
Photophobia
DISPENSED.
Panic Attack
Suicidal Ideation
Visual Impairment
Vestibular Disorder
Hallucination
Insomnia
Diarrhoea
Anger
Tremor
Vomiting
Toxicity To Various
Agents
Date:06/29/04ISR Number: 4386462-7Report Type:Expedited (15-DaCompany Report #CH-ROCHE-371304 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Lariam PS Roche ORAL 29 DAY
Initial or Prolonged Urinary Incontinence
Disability
Asthenia
Eosinophilia
Date:06/29/04ISR Number: 4386466-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-371475 Age:57 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dementia Lariam PS Roche ORAL
Date:07/07/04ISR Number: 4391114-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-372586 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicide Attempt Lariam PS Roche ORAL
Disability
Homicide
Brain Injury
Aggression
Date:07/12/04ISR Number: 4394587-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-372726 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Sarcoidosis Lariam PS Roche ORAL
Initial or Prolonged Pulmonary Oedema
Left Ventricular Failure

Myocarditis
03-Apr-2012 09:37 AM Page: 552

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/13/04ISR Number: 4395807-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-371475 Age:58 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Health Lariam PS Roche ORAL
Cognitive Disorder
Professional
Cerebral Disorder
Delusion
Dementia
Date:08/02/04ISR Number: 4413078-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Age:34 YR Gender:Male I/FU:F
Outcome
Disability
PT
Suicidal Ideation
Heart Rate Irregular
Disorientation
Balance Disorder
Phobia
Generalised Anxiety
Disorder
Abdominal Distension
Constipation
Anxiety
Panic Attack
Vestibular Disorder
Fatigue
Abdominal Discomfort
House Dust Allergy
Hyperventilation
Depression
Rash
Dyspnoea
Headache
Irritable Bowel Syndrome
Acrophobia
Claustrophobia
Migraine
Heart Rate Increased
Nausea
Diarrhoea
Hypersensitivity
Tinnitus
Self Esteem Decreased
Photophobia
Melanocytic Naevus
Body Tinea
Bronchospasm
Emotional Distress
Paraesthesia
Phobia Of Flying
Abdominal Pain
Disturbance In Attention

Weight Decreased
Dizziness
Insomnia
Motion Sickness
Sensory Integrative
Dysfunction
Flatulence
Lipoma
03-Apr-2012 09:37 AM Page: 553

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Injury
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL THE PATIENT
HAD TAKEN 4-5
TABLETS OF
MEFLOQUINE IN
TOTAL. 5 WK
Date:08/03/04ISR Number: 4414927-8Report Type:Direct Company Report #CTU 224121 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Convulsion Mefloquine 250 Mg
Hospitalization - Bradycardia Geneva Pharm Tech /
Initial or Prolonged Atrioventricular Block Sandoz PS Geneva Pharm Tech /
Required Complete Sandoz ORAL 1 PILL WEEK
Intervention to
ORAL
Prevent Permanent
Impairment/Damage
Date:08/05/04ISR Number: 4416339-XReport Type:Expedited (15-DaCompany Report #CH-ROCHE-371304 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Urinary Incontinence Lariam PS Roche ORAL 29 DAY
Initial or Prolonged Fatigue
Disability
Eosinophilia
Asthenia
Date:08/10/04ISR Number: 4422188-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-376379 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cerebellar Syndrome Lariam PS Roche ORAL 60 DAY
Initial or Prolonged Coordination Abnormal
Date:08/10/04ISR Number: 4422192-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-319597 Age:36 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Lariam PS Roche ORAL TAKEN WEEKLY 99 DAY
Anger
Social Avoidant Behaviour
Communication Disorder
Tremor
Mood Altered
Disorientation
Nervousness

Feeling Abnormal
Psychotic Disorder
Aggression
Abnormal Behaviour
03-Apr-2012 09:37 AM Page: 554

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/10/04ISR Number: 4424148-0Report Type:Direct Company Report #CTU 224675 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amnesia Lariam 250 Mg PS 1 A WK
Mefloquine (Hci)
Roche Labs SS Roche Labs
Date:08/16/04ISR Number: 4426723-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-308521 Age:12 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Lariam PS Roche ORAL 23 DAY
Initial or Prolonged Vomiting
Malaise
Sleep Disorder
Muscle Twitching
Headache
Abdominal Pain
Balance Disorder
Date:08/16/04ISR Number: 4426725-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-369567 Age:54 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Cerebral Ventricle Health Lariam PS Roche ORAL 21 DAY
Dilatation Professional Omeprazole C ORAL
Fatigue L-Thyroxine C ORAL
Disorientation Risperdal C ORAL INCREASED TO
Affect Lability
1 MG DAILY
Heat Stroke FROM 07-15
Tremor MAY 2004.
Hydrocephalus
Dehydration
Date:08/20/04ISR Number: 4429680-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377653 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Brain Oedema Lariam PS Roche UNKNOWN
Initial or Prolonged
Date:08/20/04ISR Number: 4430060-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-377087 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anger Lariam PS Roche ORAL
Homicide

Date:08/20/04ISR Number: 4430095-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-377090 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Homicide Lariam PS Roche ORAL
Anger
03-Apr-2012 09:37 AM Page: 555

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/20/04ISR Number: 4430108-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-377096 Age:33 YR Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anger Lariam PS Roche ORAL
Homicide
Date:08/23/04ISR Number: 4430901-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-377100 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Injury Lariam PS Roche ORAL
Anger
Physical Assault
Date:08/23/04ISR Number: 4430909-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377775 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Macular Degeneration Lariam PS Roche ORAL
Initial or Prolonged Befizal C ORAL
Date:08/27/04ISR Number: 4435139-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Age:34 YR Gender:Male I/FU:F
Outcome
Disability
PT
Sleep Disorder Due To
General Medical
Condition, Hypersomnia
Type
Suicidal Ideation
Disorientation
Headache
Weight Decreased
Fear
Injury
Nausea
Balance Disorder
Vestibular Disorder
Cold Sweat
Body Tinea
Emotional Distress
Anxiety
Abdominal Pain
Hypersensitivity
Self Esteem Decreased
Disturbance In Attention
Photophobia
Gastrointestinal Pain
Adjustment Disorder With
Anxiety

Motion Sickness
Diarrhoea
Paraesthesia
Dyspnoea
Bronchospasm
Dizziness
Heart Rate Irregular
Acrophobia
03-Apr-2012 09:37 AM Page: 556

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Claustrophobia
Adjustment Disorder
Self Esteem Inflated Report Source Product Role Manufacturer Route Dose Duration
Impetigo Health Lariam PS Roche ORAL THE PATIENT
Adjustment Disorder With Professional HAD TAKEN 4-5
Depressed Mood
TABLETS OF
Insomnia
MEFLOQUINE IN
Panic Attack TOTAL. 5 WK
Tinnitus
Phobia
Rash
Irritable Bowel Syndrome
Generalised Anxiety
Disorder
Sensory Integrative
Dysfunction
Fatigue
Sleep Disorder
Melanocytic Naevus
Lipoma
Mood Disorder Due To A
General Medical Condition
Heart Rate Increased
Depression
Phobia Of Flying
Migraine
Lactose Intolerance
Cognitive Disorder
Date:08/27/04ISR Number: 4435146-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-369567 Age:54 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Fatigue Health Lariam PS Roche ORAL 21 DAY
Dehydration Professional Omeprazole C ORAL
Tremor L-Thyroxine C ORAL
Hydrocephalus Risperdal C ORAL INCREASED TO
Affect Lability
1 MG DAILY
Disorientation FROM 07-15
Cerebral Ventricle MAY 2004.
Dilatation
Date:09/02/04ISR Number: 4441050-9Report Type:Direct Company Report #CTU 226240 Age: Gender:Female I/FU:I
Outcome
Life-Threatening
Disability
PT
Nausea
Fear
Thinking Abnormal
Blood Pressure Decreased
Suicidal Ideation

Dizziness
Sleep Terror
Heart Rate Increased
Stress
Fatigue
Nightmare
Decreased Appetite
Depression
03-Apr-2012 09:37 AM Page: 557

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Panic Reaction
Chest Pain
Hypoaesthesia Report Source Product Role Manufacturer Route Dose Duration
Carpal Tunnel Syndrome Lariam PS 250 MG ONCE
Cold Sweat WEEKLY 2
Anxiety
DOSES
Dyspnoea Antibiotic C
Feeling Abnormal
Confusional State
Vertigo
Date:09/03/04ISR Number: 4443505-XReport Type:Direct Company Report #CTU 226320 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Feeling Abnormal Lariam PS ORAL ONE WEEK ORAL
Intervention to
Tremor
Prevent Permanent Nightmare
Impairment/Damage Dizziness
Disorientation
Date:09/07/04ISR Number: 4441862-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-378987 Age:73 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Disorientation Lariam PS Roche ORAL TAKEN
Malaise
INTERMITTENTL
Vomiting
Y
Cardiac Failure
Diarrhoea
Headache
Asthenia
Dyspnoea
Date:09/08/04ISR Number: 4447144-6Report Type:Direct Company Report #CTU 226602 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Hallucination Mefloquine PS ORAL PO 250 MG QWK
Social Avoidant Behaviour
Fall
Date:09/08/04ISR Number: 4447208-7Report Type:Direct Company Report #CTU 226584 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicide Attempt Lariam PS ORAL ONCE A WEEK
Depression
ORAL

Date:09/09/04ISR Number: 4444958-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-379100 Age: Gender:Male I/FU:I
Outcome
Other Serious
PT
Insomnia
Eating Disorder
Schizophrenia, Paranoid
03-Apr-2012 09:37 AM Page: 558

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Type
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL
Date:09/09/04ISR Number: 4444960-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377653 Age:22 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Health Lariam PS Roche ORAL 15 DAY
Initial or Prolonged Brain Oedema Professional
Headache
Vomiting
Vertigo
Date:09/09/04ISR Number: 4448491-4Report Type:Direct Company Report #CTU 226761 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Larium PS ORAL 1 A DAY ORAL
Required
Feeling Abnormal
Intervention to
Insomnia
Prevent Permanent Headache
Impairment/Damage Suicidal Ideation
Anxiety
Anger
Date:09/13/04ISR Number: 4449499-5Report Type:Direct Company Report #CTU 226923 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Insomnia Lariam PS ORAL TWICE A WEEK
Hospitalization - Anxiety ORAL
Initial or Prolonged Hypertension Doxycycline C
Nightmare
Panic Attack
Suicidal Ideation
Tinnitus
Date:09/14/04ISR Number: 4449511-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377992 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Lactate Lariam PS Roche UNKNOWN 4 DAY
Initial or Prolonged Dehydrogenase Increased
Aspartate
Aminotransferase
Increased
Blood Creatine

Phosphokinase Increased
Alanine Aminotransferase
Increased
Confusional State
Nausea
03-Apr-2012 09:37 AM Page: 559

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/15/04ISR Number: 4449981-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377992 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Delirium Health Lariam PS Roche UNKNOWN 4 DAY
Initial or Prolonged Confusional State Professional
Nausea
Alanine Aminotransferase
Increased
Blood Lactate
Dehydrogenase Increased
Blood Creatine
Phosphokinase Increased
Aspartate
Aminotransferase
Increased
Date:09/15/04ISR Number: 4450070-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-377992 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Confusional State Lariam PS Roche UNKNOWN 4 DAY
Initial or Prolonged Blood Lactate
Dehydrogenase Increased
Delirium
Pyrexia
Alanine Aminotransferase
Increased
Aspartate
Aminotransferase
Increased
Gastroenteritis
Blood Creatine
Phosphokinase Increased
Nausea
Date:09/16/04ISR Number: 4451065-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377992 Age:42 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Lactate Health Lariam PS Roche UNKNOWN 4 DAY
Initial or Prolonged Dehydrogenase Increased Professional
Alanine Aminotransferase
Increased
Confusional State
Aspartate
Aminotransferase
Increased
Gastroenteritis
Blood Creatine
Phosphokinase Increased
Delirium

Date:09/16/04ISR Number: 4451425-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-377992 Age:42 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Nausea
Delirium
03-Apr-2012 09:37 AM Page: 560

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Aspartate
Aminotransferase
Increased Report Source Product Role Manufacturer Route Dose Duration
Confusional State Health Lariam PS Roche UNKNOWN 4 DAY
Blood Creatine
Professional
Phosphokinase Increased
Blood Lactate
Dehydrogenase Increased
Alanine Aminotransferase
Increased
Date:09/16/04ISR Number: 4451447-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-380221 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psychiatric Symptom Lariam PS Roche ORAL
Brain Stem Syndrome
Suicidal Ideation
Date:09/17/04ISR Number: 4452279-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Age:34 YR Gender:Male I/FU:F
Outcome
Disability
PT
Bronchospasm
Dizziness
Heart Rate Irregular
Rash
Disturbance In Attention
Headache
Acrophobia
Lactose Intolerance
Burning Sensation
Anxiety
Heart Rate Increased
Motion Sickness
Hypersensitivity
Phobia Of Flying
Claustrophobia
Migraine
Back Pain
Nasal Congestion
Injury
Sleep Disorder Due To
General Medical
Condition, Hypersomnia
Type
Insomnia
Panic Attack
Amnesia
Body Tinea
Emotional Distress

Paraesthesia
Irritable Bowel Syndrome
Weight Decreased
Haemorrhoids
Vitreous Floaters
Mood Disorder Due To A
General Medical Condition
Disorientation
03-Apr-2012 09:37 AM Page: 561

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Vestibular Disorder
Throat Irritation
Hypoaesthesia Report Source Product Role Manufacturer Route Dose Duration
Constipation Lariam PS Roche ORAL THE PATIENT
Cold Sweat HAD TAKEN 4-5
Impetigo
TABLETS OF
Lipoma
MEFLOQUINE IN
Hyperventilation TOTAL. 5 WK
Adjustment Disorder With Vaccine C OTHER 1 DAY
Depressed Mood
Nausea
Dyspnoea
Self Esteem Decreased
Photophobia
Flatulence
Adjustment Disorder With
Anxiety
Suicidal Ideation
Tinnitus
Balance Disorder
Phobia
Generalised Anxiety
Disorder
Sensory Integrative
Dysfunction
Fatigue
Musculoskeletal Stiffness
Abdominal Distension
Abdominal Pain Lower
Gait Disturbance
Abdominal Discomfort
Abdominal Symptom
Sinus Bradycardia
Abdominal Pain
Diarrhoea
Depression
Sleep Disorder
Neck Pain
Condition Aggravated
Abdominal Pain Upper
Melanocytic Naevus
Panic Disorder
Date:09/17/04ISR Number: 4452299-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-376379 Age:37 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cerebellar Syndrome Lariam PS Roche ORAL 60 DAY
Initial or Prolonged Coordination Abnormal

Date:09/17/04ISR Number: 4452312-3Report Type:Expedited (15-DaCompany Report #IE-ROCHE-379920 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Lariam PS Roche ORAL
Dyskinesia
Grand Mal Convulsion
Muscle Twitching
03-Apr-2012 09:37 AM Page: 562

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/20/04ISR Number: 4453827-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-377423 Age:63 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cardiac Failure Lariam PS Roche ORAL
Initial or Prolonged Electrocardiogram Toprol Xl C
Abnormal
Cerebrovascular Accident
Date:09/20/04ISR Number: 4453925-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-377423 Age:63 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Electrocardiogram Health Lariam PS Roche ORAL
Initial or Prolonged Abnormal Professional Toprol Xl C
Cerebrovascular Accident
Cardiac Failure
Date:09/20/04ISR Number: 4454571-XReport Type:Direct Company Report #CTU 227503 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Fatigue Lariam (Mefloquine
Intervention to Headache Hydrochloride) PS Roche 1 TABLET PER
Prevent Permanent Insomnia WEEK FOR 7
Impairment/Damage Anxiety WEEKS
Feeling Of Body
Temperature Change
Disturbance In Attention
Paraesthesia
Paranoia
Balance Disorder
Heart Rate Irregular
Hyperhidrosis
Chills
Depression
Panic Reaction
Alanine Aminotransferase
Increased
Date:09/21/04ISR Number: 4454933-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Mitral Valve Prolapse
Arthralgia
Diarrhoea
Dry Eye
Constipation
Upper-Airway Cough
Syndrome

Rhinitis
Visual Impairment
Adjustment Disorder With
Depressed Mood
Schizoaffective Disorder
Confusional State
Angina Pectoris
Sleep Apnoea Syndrome
03-Apr-2012 09:37 AM Page: 563

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Rash
Bronchitis
Total Cholesterol/Hdl
Ratio Decreased
Blood Creatine
Phosphokinase Increased
Dry Skin
Blood Glucose Increased
Scratch
Headache
Weight Increased
Cardiac Murmur
Abnormal Dreams
Skin Disorder
Fatigue
Hypertension
Bronchospasm
Nocturia
Vitiligo
Angiotensin Converting
Enzyme Increased
Gastrooesophageal Reflux
Disease
Asthma
Affective Disorder
Depression
Sinus Tachycardia
Blood Triglycerides
Increased
Low Density Lipoprotein
Increased
Dehydration
Dry Mouth
Chest Discomfort
Balance Disorder
Amnesia
Diastolic Dysfunction
Somnolence
Blood Cholesterol
Increased
Exfoliative Rash
Snoring
Acrochordon
Major Depression
Psychotic Disorder
Ventricular Hypertrophy
Viral Infection
Oral Disorder
Insomnia
Bipolar Disorder
Haemorrhoids
Coordination Abnormal
Memory Impairment

Anxiety
Dyspnoea
Vestibular Disorder
Gastrointestinal Disorder
Total Lung Capacity
Decreased
Restrictive Pulmonary
Disease
03-Apr-2012 09:37 AM Page: 564

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Clumsiness
Contusion
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL
Zoloft C UNKNOWN
Date:09/22/04ISR Number: 4459307-4Report Type:Direct Company Report #CTU 227806 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Paranoia Mefloquine PS ORAL 250 MG Q7D
Intervention to Toxicity To Various ORAL
Prevent Permanent
Impairment/Damage
Agents
Vertigo
Tremor
Vision Blurred
Headache
Medication Error
Date:09/29/04ISR Number: 4462210-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-380927 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Mefloquine
Neurotoxicity Hydrochloride PS Roche ORAL SINGLE DOSE
Diplopia
TAKEN.
Beclomethasone C RESPIRATORY
(INHALATION)
Typhim Vi C INTRAMUSCULAR 1 DAY
Date:09/30/04ISR Number: 4463201-2Report Type:Expedited (15-DaCompany Report #IE-ROCHE-379920 Age:25 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscle Twitching Health Lariam PS Roche ORAL
Grand Mal Convulsion
Professional
Visual Impairment
Dyskinesia
Fall
Date:10/01/04ISR Number: 4464169-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-381273 Age:61 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Gastrointestinal Disorder Lariam PS Roche ORAL 2 DAY
Initial or Prolonged Diarrhoea Aspirine C ORAL
Confusional State
Psychotic Disorder
Disorientation

Delirium
03-Apr-2012 09:37 AM Page: 565

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/04/04ISR Number: 4465047-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-381273 Age:61 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Gastrointestinal Disorder Lariam PS Roche ORAL 2 DAY
Initial or Prolonged Fatigue Aspirine C ORAL
Diarrhoea
Psychotic Disorder
Delirium
Disorientation
Confusional State
Date:10/08/04ISR Number: 4469780-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-381674 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Foetal Malformation Lariam PS Roche UNKNOWN
Abortion Induced
Maternal Exposure During
Pregnancy
Date:10/08/04ISR Number: 4469794-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-382257 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Complex Regional Pain Lariam PS Roche ORAL
Syndrome Lariam SS Roche ORAL
Date:10/12/04ISR Number: 4471713-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Bronchospasm
Gastrooesophageal Reflux
Disease
Adjustment Disorder With
Depressed Mood
Depression
Bronchitis
Total Cholesterol/Hdl
Ratio Decreased
Snoring
Nocturia
Clumsiness
Tremor
Confusional State
Dyspnoea
Headache
Rash
Blood Cholesterol
Increased

Blood Triglycerides
Increased
Chest Discomfort
Oral Disorder
Insomnia
Abnormal Dreams
Coordination Abnormal
Amnesia
03-Apr-2012 09:37 AM Page: 566

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Diastolic Dysfunction
Arthralgia
Sinus Tachycardia Report Source Product Role Manufacturer Route Dose Duration
Low Density Lipoprotein Consumer Lariam PS Roche ORAL
Increased Zoloft C UNKNOWN
Blood Creatine
Phosphokinase Increased
Vitiligo
Bipolar Disorder
Contusion
Aggression
Anxiety
Skin Disorder
Gastrointestinal Disorder
Angina Pectoris
Sleep Apnoea Syndrome
Dry Mouth
Constipation
Angiotensin Converting
Enzyme Increased
Major Depression
Affective Disorder
Psychotic Disorder
Hypertension
Viral Infection
Dry Eye
Acrochordon
Upper-Airway Cough
Syndrome
Scratch
Vestibular Disorder
Mitral Valve Prolapse
Restrictive Pulmonary
Disease
Somnolence
Weight Increased
Cardiac Murmur
Dehydration
Exfoliative Rash
Dry Skin
Blood Glucose Increased
Balance Disorder
Schizoaffective Disorder
Fatigue
Ventricular Hypertrophy
Total Lung Capacity
Decreased
Diarrhoea
Rhinitis
Visual Impairment
Asthma
Haemorrhoids
Memory Impairment

Date:10/12/04ISR Number: 4471726-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-377775 Age:49 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Macular Degeneration Health Lariam PS Roche ORAL 4 MON
Professional Befizal C ORAL
03-Apr-2012 09:37 AM Page: 567

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/12/04ISR Number: 4471734-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-382418 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abdominal Pain Upper Lariam PS Roche UNKNOWN
Nausea
Full Blood Count Abnormal
Oropharyngeal Pain
Lymphocyte Count
Increased
Fatigue
Date:10/12/04ISR Number: 4472797-6Report Type:Direct Company Report #CTU 229406 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Palpitations Lariam 750mg
Tremor Mefloquine PS ORAL 1 WEEK ORAL
Date:10/15/04ISR Number: 4475448-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-382481 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Balance Disorder Lariam PS Roche ORAL
Anxiety
Malaria
Hallucination, Auditory
Psychotic Disorder
Homicide
Hallucination
Date:10/19/04ISR Number: 4478306-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-383127 Age:15 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Toxicity To Various Lariam PS Roche ORAL
Agents
Aphasia
Date:10/19/04ISR Number: 4480777-XReport Type:Direct Company Report #CTU 229949 Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Medication Error Mefloquine (Lariam)
- 250 Mgs -Sandoz PS Sandoz 1 DAILY W/
SUPPER - X 23
Date:10/26/04ISR Number: 4486473-7Report Type:Direct Company Report #CTU 230455 Age: Gender:Female I/FU:I

Outcome
Disability
PT
Asthenia
Dyspnoea
Flatulence
Eructation
Chest Pain
Morbid Thoughts
03-Apr-2012 09:37 AM Page: 568

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Palpitations
Nausea
Dyspepsia Report Source Product Role Manufacturer Route Dose Duration
Dizziness Larium 250 Mg La
Tremor Roche PS La Roche ORAL 1 TABLET
Condition Aggravated
ONCE A WEEK
Panic Attack
ORAL
Eye Disorder Protonix C
Hiatus Hernia
Feeling Abnormal
Date:10/27/04ISR Number: 4487799-3Report Type:Direct Company Report #CTU 230523 Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Anxiety Lariam PS
Hospitalization - Depression
Initial or Prolonged Convulsion
Mental Disorder
Date:10/28/04ISR Number: 4488116-5Report Type:Expedited (15-DaCompany Report #IE-ROCHE-379920 Age:25 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Muscle Twitching Health Lariam PS Roche ORAL
Visual Impairment
Professional
Grand Mal Convulsion
Date:10/28/04ISR Number: 4491873-5Report Type:Direct Company Report #CTU 230702 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Insomnia Larium One Tablet
Impaired Work Ability Per Week Roche PS Roche ORAL 1 TABLET
Headache WEEK ORAL
Dizziness
Depression
Vision Blurred
Suicidal Ideation
Date:10/29/04ISR Number: 4489101-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-384026 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Homicide Lariam PS Roche INTRAMUSCULAR
Medication Error

Date:11/02/04ISR Number: 4490702-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-372726 Age:32 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Sarcoidosis
Pulmonary Oedema
Pericardial Disease
Myocarditis
Myocardial Infarction
03-Apr-2012 09:37 AM Page: 569

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Left Ventricular Failure
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL 41 DAY
Date:11/04/04ISR Number: 4494141-0Report Type:Direct Company Report #CTU 231293 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Mood Swings Lariam Probably 250
Intervention to Fatigue Mg Tablet PS ORAL 250 MG WEEKLY
Prevent Permanent Feeling Abnormal ORAL
Impairment/Damage Tension
Crying
Impaired Work Ability
Depression
Hypersomnia
Date:11/04/04ISR Number: 4494371-8Report Type:Direct Company Report #CTU 231346 Age:14 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Aphasia Mefloquine (Lariam) PS ORAL 250 MG PO
Other Serious Catatonia EVERY WEEK
Required
Toxicity To Various
Intervention to
Agents
Prevent Permanent
Impairment/Damage
Panic Attack
Amnesia
Thinking Abnormal
Anxiety
Psychotic Disorder
Antisocial Behaviour
Pyrexia
Date:11/11/04ISR Number: 4499163-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-381674 Age:31 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Maternal Exposure During Lariam PS Roche UNKNOWN
Pregnancy
Abortion Induced
Foetal Malformation
Date:11/12/04ISR Number: 4500146-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age: Gender:Male I/FU:I
Outcome
Disability
PT
Insomnia
Mood Swings

Balance Disorder
Toxicity To Various
Agents
Aggression
Abnormal Behaviour
Agitation
Disturbance In Attention
Memory Impairment
03-Apr-2012 09:37 AM Page: 570

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Suicidal Ideation
Coordination Abnormal
Visual Impairment Report Source Product Role Manufacturer Route Dose Duration
Hallucination, Visual Lariam PS Roche ORAL
Depression
Anxiety
Vertigo
Date:11/15/04ISR Number: 4501752-2Report Type:Direct Company Report #CTU 232000 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Coordination Abnormal Lariam - Mefloquine
Disability Weight Decreased - 1 Tablet 250mg
Required Paranoia Roche PS Roche ORAL 250MG ONCE
Intervention to Self Esteem Decreased WEEKLY ORAL
Prevent Permanent
Impairment/Damage
Hypoaesthesia
Tinnitus
Nausea
Panic Attack
Thinking Abnormal
Decreased Interest
Erectile Dysfunction
Fear
Headache
Tremor
Pain
Disturbance In Attention
Loss Of Libido
Suicidal Ideation
Muscle Twitching
Decreased Appetite
Hyperhidrosis
Amnesia
Feeling Abnormal
Sensory Disturbance
Major Depression
Temperature Regulation
Disorder
Nightmare
Functional
Gastrointestinal Disorder
Chills
Autism
Emotional Disorder
Date:11/16/04ISR Number: 4502163-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-361839 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Exposure During Lariam PS Roche ORAL

Pregnancy
Ectopic Pregnancy
Abortion Spontaneous
03-Apr-2012 09:37 AM Page: 571

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/19/04ISR Number: 4512858-6Report Type:Direct Company Report #CTU 232457 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tremor Larium 250 Mg Tabs PS 1 Q WEEK
Palpitations
Feeling Abnormal
Feeling Jittery
Anxiety
Date:11/22/04ISR Number: 4506772-XReport Type:Expedited (15-DaCompany Report #GB-ROCHE-385961 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - General Physical Health Lariam PS Roche UNKNOWN
Initial or Prolonged Deterioration
Joint Dislocation
Balance Disorder
Upper Limb Fracture
Fall
Decreased Appetite
Insomnia
Date:11/23/04ISR Number: 4507897-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-377423 Age:63 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cerebrovascular Accident Lariam PS Roche ORAL
Initial or Prolonged Electrocardiogram Toprol Xl C
Abnormal
Cardiac Failure
Date:11/23/04ISR Number: 4507908-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-386256 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Photosensitivity Reaction Lariam PS Roche ORAL
Initial or Prolonged Malaise
Feeling Abnormal
Suicidal Ideation
Depression
Date:11/29/04ISR Number: 4512071-2Report Type:Expedited (15-DaCompany Report #DE-ROCHE-382481 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Homicide Lariam PS Roche ORAL TAKEN WEEKLY. 316 DAY
Malaria
Psychotic Disorder
Anxiety

Hallucination, Auditory
Hallucination
Balance Disorder
03-Apr-2012 09:37 AM Page: 572

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/29/04ISR Number: 4512170-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-386651 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Blindness Lariam PS Roche ORAL
Date:11/29/04ISR Number: 4512180-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-386791 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Retinopathy Lariam PS Roche ORAL 1 MON
Initial or Prolonged Lariam SS Roche ORAL 1 MON
Lariam SS Roche ORAL UNKNOWN
DURATION.
Lariam SS Roche ORAL 1 MON
Date:12/08/04ISR Number: 4521121-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-386256 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Toxicity To Various Lariam PS Roche ORAL
Initial or Prolonged Agents
Suicidal Ideation
Depression
Feeling Abnormal
Anxiety
Photosensitivity Reaction
Malaise
Fear
Negative Thoughts
Date:12/13/04ISR Number: 4525226-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Tremor
Vomiting
Vestibular Disorder
Tinnitus
Muscle Twitching
Photophobia
Visual Field Defect
Nausea
Aggression
Disturbance In Attention
Anxiety
Insomnia
Jaundice
Hallucination
Depression
Amnesia

Photosensitivity Reaction
Toxicity To Various
Agents
Irritability
Endolymphatic Hydrops
Hepatic Failure
Cranial Nerve Disorder
Visual Impairment
03-Apr-2012 09:37 AM Page: 573

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Diarrhoea
Suicidal Ideation
Asthenia Report Source Product Role Manufacturer Route Dose Duration
Obsessive Thoughts Lariam PS Roche ORAL 23 TABLETS
Depressed Level Of
DISPENSED.
Consciousness Sudafed C
Paranoia
Incontinence
General Symptom
Cough
Mood Swings
Balance Disorder
Panic Attack
Anger
Post-Traumatic Stress
Disorder
Migraine
Date:12/15/04ISR Number: 4530035-XReport Type:Direct Company Report #CTU 234381 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Insomnia Mefloquine 250mg
Disability Panic Attack Sandoz PS Sandoz ORAL 250MG PER
Anxiety WEEK ORAL
Hallucination
Suicidal Ideation
Night Sweats
Depression
Delusion
Date:12/22/04ISR Number: 4535059-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-388966 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Lariam PS Roche ORAL
Initial or Prolonged Tardive Dyskinesia Zyprexa SS ORAL
Date:12/23/04ISR Number: 4536778-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-384854 Age:37 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Insomnia
Paraesthesia
Skin Disorder
Hyperhidrosis
Fatigue
Disorientation
Liver Function Test
Abnormal

Disturbance In Attention
Agitation
Vertigo
Diarrhoea
Paranoia
Chills
Back Pain
Anxiety
03-Apr-2012 09:37 AM Page: 574

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Panic Attack
Depression
Heart Rate Increased Report Source Product Role Manufacturer Route Dose Duration
Heart Rate Irregular Lariam PS Roche ORAL 3-4 PILLS
Mood Swings WERE TAKEN. 43 DAY
Balance Disorder
Date:01/03/05ISR Number: 4544470-7Report Type:Direct Company Report #CTU 235515 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Headache Lariam 250 Mg PS ORAL 1 PILL WEEK
Disability Hallucination ORAL
Balance Disorder
Disturbance In Attention
Sleep Disorder
Impaired Work Ability
Dizziness
Confusional State
Memory Impairment
Homicidal Ideation
Thinking Abnormal
Mania
Motion Sickness
Suicidal Ideation
Heart Rate Irregular
Depression
Nightmare
Panic Attack
Night Sweats
Self Esteem Decreased
Date:01/05/05ISR Number: 4544789-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Diarrhoea
Hepatic Failure
Nausea
Disturbance In Attention
Photosensitivity Reaction
Jaundice
Cranial Nerve Disorder
Visual Field Defect
Insomnia
General Symptom
Obsessive Thoughts
Depressed Level Of
Consciousness
Post-Traumatic Stress
Disorder

Migraine
Paranoia
Depression
Amnesia
Vestibular Disorder
Anxiety
Tinnitus
Irritability
03-Apr-2012 09:37 AM Page: 575

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Muscle Twitching
Photophobia
Tremor Report Source Product Role Manufacturer Route Dose Duration
Vomiting Lariam PS Roche ORAL 23 TABLETS
Anger
DISPENSED.
Asthenia Sudafed C
Endolymphatic Hydrops
Panic Attack
Aggression
Mood Swings
Hallucination
Balance Disorder
Incontinence
Toxicity To Various
Agents
Visual Impairment
Suicidal Ideation
Cough
Date:01/06/05ISR Number: 4546225-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-390293 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pneumonitis Lariam PS Roche UNKNOWN
Date:01/07/05ISR Number: 4547388-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-386651 Age:23 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Blindness Lariam PS Roche ORAL
Date:01/07/05ISR Number: 4547393-2Report Type:Expedited (15-DaCompany Report #KR-ROCHE-389876 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatitis Acute Lariam PS Roche ORAL DOSAGE
Initial or Prolonged
REGIMEN:
1T/WEEK
Lariam SS Roche ORAL DOSAGE
REGIMEN:
1T/WEEK
Date:01/10/05ISR Number: 4549486-2Report Type:Direct Company Report #CTU 236012 Age:55 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Multiple Allergies Lariam 250 Mg Roche PS Roche ORAL 1 WEEK ORAL
Hallucination
Nightmare

Headache
Diarrhoea
03-Apr-2012 09:37 AM Page: 576

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/11/05ISR Number: 4549536-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-390682 Age:59 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Panic Attack Lariam PS Roche UNKNOWN
Hospitalization - Anxiety
Initial or Prolonged Hyperhidrosis
Atrial Fibrillation
Heart Rate Increased
Fluid Retention
Palpitations
Date:01/12/05ISR Number: 4550163-2Report Type:Expedited (15-DaCompany Report #KR-ROCHE-389876 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Product Quality Issue Consumer Lariam PS Roche ORAL DOSAGE
Initial or Prolonged Hepatitis Acute REGIMEN:
1T/WEEK
Lariam SS Roche ORAL DOSAGE
REGIMEN:
1T/WEEK
Date:01/14/05ISR Number: 4552774-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-319597 Age:33 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Disorientation Lariam PS Roche ORAL TAKEN WEEKLY 99 DAY
Abnormal Behaviour Primaquine Phosphate C ORAL 15 DAY
Social Avoidant Behaviour
Psychotic Disorder
Feeling Abnormal
Anger
Communication Disorder
Tremor
Mood Altered
Completed Suicide
Aggression
Nervousness
Date:01/14/05ISR Number: 4552794-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-391105 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Oligohydramnios Lariam PS Roche UNKNOWN 38 DAY
Initial or Prolonged Abortion Induced Lysine
Congenital Anomaly Premature Rupture Of Acetylsalicylate SS UNKNOWN 36 DAY
Membranes
Talipes
Maternal Exposure During
Pregnancy

Date:01/14/05ISR Number: 4552795-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Age: Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
03-Apr-2012 09:37 AM Page: 577

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disability
PT Report Source Product Role Manufacturer Route Dose Duration
Self Esteem Decreased Lariam PS Roche UNKNOWN
Depression
Anxiety Disorder
Panic Attack
Mood Swings
Memory Impairment
Psychotic Disorder
Suicidal Ideation
Amnesia
Mental Disorder
Date:01/14/05ISR Number: 4553803-7Report Type:Direct Company Report #CTU 236752 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Mefloquine (Larium) PS 1 TIME A WEEK 10 WK
Pregnancy
Maternal Drugs Affecting
Foetus
Hypervigilance
Amnesia
Hallucination
Date:01/19/05ISR Number: 4555880-6Report Type:Expedited (15-DaCompany Report #FR-ROCHE-386791 Age:58 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Retinopathy Lariam PS Roche ORAL 1 MON
Initial or Prolonged Lariam SS Roche ORAL 1 MON
Lariam SS Roche ORAL UNKNOWN
DURATION.
Lariam SS Roche ORAL 1 MON
Date:01/24/05ISR Number: 4559263-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Cough
Mood Swings
Migraine
Endolymphatic Hydrops
Jaw Disorder
Gilbert'S Syndrome
Hyperacusis
Visual Impairment
Tremor
Obsessive Thoughts

Lacrimation Increased
Mania
Visual Field Defect
Balance Disorder
Diarrhoea
Aggression
Anger
Jaundice
03-Apr-2012 09:37 AM Page: 578

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Post-Traumatic Stress
Disorder
Incontinence Report Source Product Role Manufacturer Route Dose Duration
Vestibular Disorder Lariam PS Roche ORAL 23 TABLETS
General Symptom
DISPENSED.
Depressed Level Of Sudafed C
Consciousness
Confusional State
Dysarthria
Abnormal Dreams
Hallucination
Cranial Nerve Disorder
Photosensitivity Reaction
Toxicity To Various
Agents
Decreased Appetite
Paranoia
Nausea
Disturbance In Attention
Suicidal Ideation
Irritability
Thirst
Cognitive Disorder
Gait Disturbance
Dysphemia
Hepatic Failure
Photophobia
Panic Attack
Insomnia
Depression
Amnesia
Anxiety
Tinnitus
Tardive Dyskinesia
Vomiting
Asthenia
Muscle Twitching
Motor Dysfunction
Conduction Disorder
Date:01/24/05ISR Number: 4560679-0Report Type:Direct Company Report #CTU 237716 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Atrial Fibrillation Lariam PS ORAL 1 PER WEEK
Initial or Prolonged Nausea FIVE WEEKS
Panic Attack
ORAL
Chest Pain
Disturbance In Attention
Cardiac Disorder
Anxiety
Arrhythmia

Heart Rate Increased
Dizziness
03-Apr-2012 09:37 AM Page: 579

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/25/05ISR Number: 4560377-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Age:34 YR Gender:Male I/FU:F
Outcome
Disability
PT
Motion Sickness
Hypersensitivity
Irritable Bowel Syndrome
Phobia Of Flying
Claustrophobia
Bronchospasm
Mood Disorder Due To A
General Medical Condition
Balance Disorder
Migraine
Musculoskeletal Stiffness
Adjustment Disorder With
Anxiety
Suicidal Ideation
Sinus Bradycardia
Dyspnoea
Disturbance In Attention
Vestibular Disorder
Photophobia
Sensory Integrative
Dysfunction
Throat Irritation
Nasal Congestion
Vertigo
Dizziness
Heart Rate Increased
Tinnitus
Self Esteem Decreased
Acrophobia
Fatigue
Sleep Disorder
Neck Pain
Hypoaesthesia
Amnesia
Insomnia
Diarrhoea
Paraesthesia
Disorientation
Headache
Abdominal Pain Lower
Adjustment Disorder With
Depressed Mood
Abdominal Pain
Generalised Anxiety
Disorder
Lactose Intolerance
Abdominal Distension
Emotional Distress
Anxiety
Nausea

Panic Attack
Depression
Weight Decreased
Back Pain
Sleep Disorder Due To
General Medical
Condition, Hypersomnia
Type
03-Apr-2012 09:37 AM Page: 580

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Heart Rate Irregular
Rash
Phobia Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL THE PATIENT
HAD TAKEN 4-5
TABLETS OF
MEFLOQUINE IN
TOTAL. 21 DAY
Vaccine C OTHER 1 DAY
Date:01/27/05ISR Number: 4562580-5Report Type:Expedited (15-DaCompany Report #CH-ROCHE-392759 Age:62 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatocellular Injury Lariam PS Roche ORAL 6 WK
Initial or Prolonged Decreased Appetite Activelle C ORAL DOSE DURATION
Gamma-Glutamyltransferase
WAS REPORTED
Increased
AS LONG TERM.
Nausea Alcacyl C ORAL
Abdominal Pain Upper Selipran C ORAL DOSE DURATION
Jaundice
WAS REPORTED
Pyrexia
AS LONG TERM.
Date:01/27/05ISR Number: 4562583-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-386791 Age:58 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Retinopathy Lariam PS Roche ORAL 1 MON
Initial or Prolonged Lariam SS Roche ORAL 1 MON
Lariam SS Roche ORAL UNKNOWN
DURATION.
Lariam SS Roche ORAL 1 MON
Date:01/27/05ISR Number: 4562585-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disturbance In Attention Lariam PS Roche ORAL
Initial or Prolonged Grand Mal Convulsion
Amnesia
Date:01/27/05ISR Number: 4570256-3Report Type:Direct Company Report #CTU 238338 Age:45 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Lariam 250 Mg Nsn
Depression 6505-00-Foh-3872 PS F.Hoffman-La Roche
Abnormal Dreams Ltd WEEKLY
Stress

Date:01/28/05ISR Number: 4564224-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-392922 Age:50 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anaemia Lariam PS Roche ORAL
Initial or Prolonged Thrombocytopenia
03-Apr-2012 09:37 AM Page: 581

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/31/05ISR Number: 4575489-8Report Type:Direct Company Report #CTU 238692 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam PS ORAL WEEKLY
Feeling Abnormal
ORAL
Anxiety
Date:02/01/05ISR Number: 4567071-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-393160 Age:6 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Respiratory Arrest Lariam PS Roche ORAL
Initial or Prolonged Convulsion
Date:02/01/05ISR Number: 4567072-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-393292 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypothyroidism Lariam PS Roche ORAL
Autoimmune Thyroiditis
Date:02/04/05ISR Number: 4570324-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Incontinence
Amnesia
Endolymphatic Hydrops
Abnormal Dreams
Hyperacusis
Tremor
Insomnia
Photosensitivity Reaction
General Symptom
Depressed Level Of
Consciousness
Dysarthria
Motor Dysfunction
Hallucination
Cranial Nerve Disorder
Anxiety
Obsessive Thoughts
Gait Disturbance
Visual Field Defect
Balance Disorder
Panic Attack
Vestibular Disorder
Migraine
Thirst
Tardive Dyskinesia

Conduction Disorder
Paranoia
Photophobia
Nausea
Aggression
Suicidal Ideation
Tinnitus
Post-Traumatic Stress
03-Apr-2012 09:37 AM Page: 582

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorder
Decreased Appetite
Lacrimation Increased
Hepatic Failure Report Source Product Role Manufacturer Route Dose Duration
Diarrhoea Lariam PS Roche ORAL 23 TABLETS
Disturbance In Attention
DISPENSED.
Toxicity To Various Sudafed C
Agents
Mood Swings
Dysphemia
Visual Impairment
Vomiting
Anger
Asthenia
Cough
Jaundice
Confusional State
Mania
Gilbert'S Syndrome
Depression
Irritability
Muscle Twitching
Jaw Disorder
Cognitive Disorder
Date:02/04/05ISR Number: 4570348-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-393292 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Autoimmune Thyroiditis Lariam PS Roche ORAL
Hypothyroidism
Date:02/04/05ISR Number: 4570355-6Report Type:Expedited (15-DaCompany Report #CA-ROCHE-393893 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypotrichosis Lariam PS Roche ORAL 15 DAY
Hallucination Vivotif "Berna" C ORAL
White Blood Cell Count Dukoral C ORAL
Decreased
Vomiting
Loss Of Consciousness
Fatigue
Somnolence
Panic Attack
Dizziness
Date:02/07/05ISR Number: 4571642-8Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12841631 Age:59 YR Gender:Female I/FU:I
Outcome
PT

Hospitalization -
Initial or Prolonged
Nausea
Transaminases Increased
Prothrombin Time
Prolonged
Chromaturia
Jaundice Cholestatic
Hepatitis A Antibody
Positive
03-Apr-2012 09:37 AM Page: 583

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abdominal Pain
Report Source Product Role Manufacturer Route Dose Duration
Selipran Tabs PS Bristol-Myers Squibb
Company
ORAL
Activella SS ORAL
Lariam SS ORAL
Date:02/07/05ISR Number: 4571701-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-384854 Age:37 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Consumer Lariam PS Roche ORAL 3-4 PILLS
Mood Swings WERE TAKEN. 43 DAY
Fatigue
Panic Attack
Chills
Depression
Agitation
Liver Function Test
Abnormal
Heart Rate Increased
Anxiety
Paranoia
Hyperhidrosis
Disorientation
Disturbance In Attention
Back Pain
Balance Disorder
Vertigo
Paraesthesia
Cold Sweat
Skin Disorder
Feeling Abnormal
Heart Rate Irregular
Insomnia
Alanine Aminotransferase
Increased
Date:02/09/05ISR Number: 4578673-2Report Type:Direct Company Report #CTU 239959 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disturbance In Attention Lariam 250mg
Dizziness Roxane PS Roxane ORAL 1 WEEKLY
Memory Impairment
ORAL
Anxiety
Date:02/10/05ISR Number: 4577110-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-319597 Age:33 YR Gender:Male I/FU:F

Outcome
Death
PT
Completed Suicide
Tremor
Brain Oedema
Aggression
Nervousness
Abnormal Behaviour
03-Apr-2012 09:37 AM Page: 584

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Psychotic Disorder
Asphyxia
Stress Report Source Product Role Manufacturer Route Dose Duration
Mood Altered Lariam PS Roche ORAL TAKEN WEEKLY 99 DAY
Homicide Primaquine Phosphate C ORAL 15 DAY
Disorientation
Incoherent
Communication Disorder
Dysphemia
Social Avoidant Behaviour
Pulmonary Congestion
Feeling Abnormal
Anger
Marital Problem
Date:02/10/05ISR Number: 4577145-9Report Type:Expedited (15-DaCompany Report #DK-ROCHE-394266 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nervousness Lariam PS Roche ORAL
Mental Impairment
Petit Mal Epilepsy
Date:02/10/05ISR Number: 4577147-2Report Type:Expedited (15-DaCompany Report #CH-ROCHE-394176 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Transaminases Increased Lariam PS Roche ORAL 45 DAY
Initial or Prolonged Abdominal Pain Selipran SS ORAL
Jaundice Cholestatic Activelle SS ORAL FREQUENCY
Nausea
REPORTED AS
Chromaturia
"AS
Prothrombin Time
NECESSARY"
Prolonged
Date:02/10/05ISR Number: 4577157-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-394348 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Disturbance In Attention Lariam PS Roche ORAL DOSAGE
Palpitations
REGIMEN
Paraesthesia REPORTED AS 1
Sleep Disorder TABLET WEEKLY 15 DAY
Dizziness
Restlessness
Date:02/15/05ISR Number: 4586918-8Report Type:Direct Company Report #CTU 240367 Age:27 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Lariam
Nausea Roche PS Roche
Dizziness
03-Apr-2012 09:37 AM Page: 585

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/16/05ISR Number: 4584087-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Balance Disorder
Diarrhoea
Muscle Twitching
Endolymphatic Hydrops
Tardive Dyskinesia
Lacrimation Increased
Dysphemia
Conduction Disorder
Hallucination
Cranial Nerve Disorder
Tremor
Toxicity To Various
Agents
Obsessive Thoughts
Post-Traumatic Stress
Disorder
Gait Disturbance
Abnormal Dreams
Neuropathy Peripheral
Hepatic Failure
Visual Field Defect
Insomnia
Anger
Depression
Vestibular Disorder
Photosensitivity Reaction
Depressed Level Of
Consciousness
Visual Impairment
Amnesia
Hyperacusis
Paranoia
Panic Attack
Incontinence
Asthenia
Cough
Tinnitus
Jaundice
Dysarthria
Motor Dysfunction
Photophobia
Nausea
Aggression
Anxiety
General Symptom
Migraine
Jaw Disorder
Cognitive Disorder
Mania
Viiith Nerve Lesion

Vomiting
Suicidal Ideation
Irritability
Disturbance In Attention
Mood Swings
Decreased Appetite
Thirst
Confusional State
03-Apr-2012 09:37 AM Page: 586

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Gilbert'S Syndrome
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL 23 TABLETS
DISPENSED.
Sudafed
C
Date:02/17/05ISR Number: 4586792-XReport Type:Direct Company Report #CTU 240711 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Lariam PS 1 TABLET 10
Phobia
DAYS??
Panic Attack
Suicidal Ideation
Personality Change
Gastric Disorder
Crying
Anxiety
Paranoia
Date:02/23/05ISR Number: 4589655-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-390682 Age:59 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Anxiety Lariam PS Roche UNKNOWN
Hospitalization - Palpitations
Initial or Prolonged Weight Increased
Foot Fracture
Panic Attack
Heart Rate Increased
Fluid Retention
Balance Disorder
Atrial Fibrillation
Hyperhidrosis
Date:03/04/05ISR Number: 4598556-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-381724 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche ORAL
Maternal Exposure During
Pregnancy
Date:03/04/05ISR Number: 4599949-9Report Type:Direct Company Report #CTU 242097 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Delirium Mefloquine 250 Mg PS ORAL 250 MG QWEEK

Initial or Prolonged Thinking Abnormal ORAL
Hallucination
03-Apr-2012 09:37 AM Page: 587

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/09/05ISR Number: 4603011-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-397065 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Toxicity To Various Lariam PS Roche ORAL FREQUENCY
Agents
STATED AS
Dizziness WEEKLY. 47 DAY
Psychotic Disorder
Hearing Impaired
Visual Impairment
Tinnitus
Panic Attack
Anxiety
Depression
Confusional State
Mood Swings
Paranoia
Insomnia
Date:03/10/05ISR Number: 4603890-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Sinus Tachycardia
Blood Cholesterol
Increased
Snoring
Constipation
Blood Glucose Increased
Upper-Airway Cough
Syndrome
Visual Impairment
Psychotic Disorder
Amnesia
Dry Mouth
Angiotensin Converting
Enzyme Increased
Bipolar Disorder
Scratch
Schizoaffective Disorder
Depression
Fatigue
Headache
Restrictive Pulmonary
Disease
Somnolence
Viral Infection
Bronchospasm
Total Cholesterol/Hdl
Ratio Decreased
Diarrhoea
Dehydration
Nocturia

Gastrooesophageal Reflux
Disease
Confusional State
Anxiety
Bronchitis
Weight Increased
Exfoliative Rash
Acrochordon
03-Apr-2012 09:37 AM Page: 588

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Asthma
Major Depression
Aggression Report Source Product Role Manufacturer Route Dose Duration
Skin Disorder Lariam PS Roche ORAL
Gastrointestinal Disorder Zoloft C UNKNOWN
Diastolic Dysfunction
Total Lung Capacity
Decreased
Dry Eye
Balance Disorder
Vestibular Disorder
Hypertension
Angina Pectoris
Arthralgia
Low Density Lipoprotein
Increased
Dry Skin
Chest Discomfort
Vitiligo
Haemorrhoids
Contusion
Affective Disorder
Dyspnoea
Sleep Apnoea Syndrome
Rash
Cardiac Murmur
Blood Triglycerides
Increased
Blood Creatine
Phosphokinase Increased
Rhinitis
Adjustment Disorder With
Depressed Mood
Memory Impairment
Tremor
Mitral Valve Prolapse
Ventricular Hypertrophy
Oral Disorder
Insomnia
Clumsiness
Abnormal Dreams
Coordination Abnormal
Date:03/10/05ISR Number: 4603962-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-397276 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Furuncle Lariam PS Roche ORAL
Initial or Prolonged

Date:03/11/05ISR Number: 4606008-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Hepatic Failure
Hallucination
Tremor
Insomnia
Thirst
03-Apr-2012 09:37 AM Page: 589

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dysphemia
Abnormal Dreams
Tooth Discolouration
Gastroenteritis
Incontinence
Aggression
Suicidal Ideation
Irritability
Atrial Fibrillation
Antisocial Behaviour
Amnesia
Asthenia
Mood Swings
Depressed Level Of
Consciousness
Decreased Appetite
Cognitive Disorder
Lacrimation Increased
Viiith Nerve Lesion
Nervous System Disorder
Cranial Nerve Disorder
Balance Disorder
Nausea
Cough
Tinnitus
Jaw Disorder
Confusional State
Gilbert'S Syndrome
Memory Impairment
Visual Impairment
Depression
General Symptom
Obsessive Thoughts
Post-Traumatic Stress
Disorder
Endolymphatic Hydrops
Dysarthria
Photophobia
Panic Attack
Toxicity To Various
Agents
Muscle Twitching
Tardive Dyskinesia
Gait Disturbance
Hyperacusis
Creutzfeldt-Jakob Disease
Paranoia
Diarrhoea
Vestibular Disorder
Anxiety
Jaundice
Migraine
Motor Dysfunction

Conduction Disorder
Hepato-Lenticular
Degeneration
Metal Poisoning
Visual Field Defect
Vomiting
Anger
Disturbance In Attention
03-Apr-2012 09:37 AM Page: 590

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Photosensitivity Reaction
Mania
Alcohol Poisoning Report Source Product Role Manufacturer Route Dose Duration
Rash Pruritic Lariam PS Roche ORAL 23 TABLETS
DISPENSED.
Sudafed
C
Date:03/16/05ISR Number: 4610613-XReport Type:Expedited (15-DaCompany Report #004337 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asthenia Consumer Mefloquine
Dizziness
Hydrochloride
Myalgia
(Mefloquine
Pyrexia
Hydrochloride)
Gait Disturbance Tablet, 250 Mg PS ORAL SEE IMAGE 30 DAY
Aphasia
Toprol Xl
(Metoprolol
Succinate)
C
Zoloft (Sertraline
Hydrochloride) C
Date:03/16/05ISR Number: 4612641-7Report Type:Direct Company Report #CTU 243413 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Aggression Mefloquine-Lariam- PS ORAL 1 WEEK ORAL
Hospitalization - Self Injurious Behaviour
Initial or Prolonged Feeling Of Despair
Disturbance In Social
Behaviour
Thinking Abnormal
Anxiety
Mental Disorder
Emotional Disorder
Psychotic Disorder
Abnormal Behaviour
Suicidal Ideation
Multiple Injuries
Date:03/21/05ISR Number: 4613947-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Fatigue
Total Lung Capacity
Decreased
Abnormal Dreams
Asthma
Haemorrhoids

Contusion
Psychotic Disorder
Amnesia
Vestibular Disorder
Gastrointestinal Disorder
Headache
Somnolence
Chest Discomfort
03-Apr-2012 09:37 AM Page: 591

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Rhinitis
Insomnia
Balance Disorder
Adjustment Disorder With
Depressed Mood
Major Depression
Dyspnoea
Mitral Valve Prolapse
Hypertension
Arthralgia
Weight Increased
Cardiac Murmur
Sinus Tachycardia
Blood Creatine
Phosphokinase Increased
Bipolar Disorder
Memory Impairment
Tremor
Depression
Restrictive Pulmonary
Disease
Bronchitis
Bronchospasm
Dry Eye
Blood Glucose Increased
Schizoaffective Disorder
Angina Pectoris
Blood Cholesterol
Increased
Blood Triglycerides
Increased
Low Density Lipoprotein
Increased
Total Cholesterol/Hdl
Ratio Decreased
Diarrhoea
Constipation
Acrochordon
Coordination Abnormal
Affective Disorder
Aggression
Rash
Dehydration
Dry Skin
Oral Disorder
Vitiligo
Angiotensin Converting
Enzyme Increased
Gastrooesophageal Reflux
Disease
Scratch
Anxiety
Skin Disorder

Diastolic Dysfunction
Exfoliative Rash
Nocturia
Clumsiness
Visual Impairment
Confusional State
Ventricular Hypertrophy
Sleep Apnoea Syndrome
03-Apr-2012 09:37 AM Page: 592

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Viral Infection
Dry Mouth
Snoring Report Source Product Role Manufacturer Route Dose Duration
Upper-Airway Cough Lariam PS Roche ORAL
Syndrome Zoloft C UNKNOWN
Date:03/21/05ISR Number: 4613968-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Grand Mal Convulsion Lariam PS Roche ORAL
Initial or Prolonged Disturbance In Attention
Amnesia
Date:03/22/05ISR Number: 4620246-7Report Type:Direct Company Report #CTU 243980 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dizziness Mefloquine PS ORAL 1 WEEK ORAL
Anxiety
Depressed Mood
Nausea
Date:03/23/05ISR Number: 4617079-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Dyspnoea
Hypertension
Restrictive Pulmonary
Disease
Somnolence
Bronchitis
Total Cholesterol/Hdl
Ratio Decreased
Exfoliative Rash
Snoring
Vitiligo
Rhinitis
Insomnia
Adjustment Disorder With
Depressed Mood
Major Depression
Psychotic Disorder
Body Temperature
Increased
Wheezing
Rectal Haemorrhage
Depression
Angina Pectoris

Total Lung Capacity
Decreased
Sleep Apnoea Syndrome
Dry Mouth
Oral Disorder
Aggression
Cough
Sarcoidosis
03-Apr-2012 09:37 AM Page: 593

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Amnesia
Vestibular Disorder
Fatigue
Arthralgia
Rash
Low Density Lipoprotein
Increased
Dehydration
Upper-Airway Cough
Syndrome
Asthma
Scratch
Tremor
Productive Cough
Photosensitivity Reaction
Anxiety
Weight Increased
Blood Glucose Increased
Visual Impairment
Peripheral Sensory
Neuropathy
Exercise Tolerance
Decreased
Sinusitis
Confusional State
Mitral Valve Prolapse
Blood Cholesterol
Increased
Diarrhoea
Chest Discomfort
Constipation
Angiotensin Converting
Enzyme Increased
Nervous System Disorder
Skin Disorder
Headache
Ventricular Hypertrophy
Diastolic Dysfunction
Bronchospasm
Blood Triglycerides
Increased
Dry Skin
Acrochordon
Contusion
Schizoaffective Disorder
Listless
Upper Respiratory Tract
Infection
Oedema
Jaw Disorder
Gastrointestinal Disorder
Cardiac Murmur
Blood Creatine

Phosphokinase Increased
Dry Eye
Nocturia
Gastrooesophageal Reflux
Disease
Haemorrhoids
Affective Disorder
Eye Pruritus
03-Apr-2012 09:37 AM Page: 594

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Lacrimation Increased
Viral Infection
Sinus Tachycardia Report Source Product Role Manufacturer Route Dose Duration
Clumsiness Lariam PS Roche ORAL
Abnormal Dreams Zoloft C UNKNOWN
Bipolar Disorder
Balance Disorder
Coordination Abnormal
Memory Impairment
Sputum Discoloured
Myalgia
Sjogren'S Syndrome
Embolism Arterial
Discomfort
Nasal Congestion
Date:03/23/05ISR Number: 4617081-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Cranial Nerve Disorder
Insomnia
Disturbance In Attention
Vestibular Disorder
Cough
Irritability
Cognitive Disorder
Hyperacusis
Dizziness
Weight Decreased
Psychiatric Symptom
Nightmare
Antisocial Behaviour
Incontinence
Aggression
Obsessive Thoughts
Muscle Twitching
Thirst
Gait Disturbance
Motor Dysfunction
Gilbert'S Syndrome
Electrocardiogram St-T
Change
Tooth Discolouration
Stress
Upper Respiratory Tract
Infection
Tremor
Anger
Depressed Level Of
Consciousness
Dysarthria

Fatigue
Electroencephalogram
Abnormal
Hepatic Failure
Hallucination
Visual Field Defect
Nausea
Jaundice
03-Apr-2012 09:37 AM Page: 595

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Tearfulness
Acoustic Neuritis
Vomiting Report Source Product Role Manufacturer Route Dose Duration
Suicidal Ideation Lariam PS Roche ORAL 23 TABLETS
Anxiety
DISPENSED.
General Symptom Sudafed C
Tinnitus
Post-Traumatic Stress
Disorder
Endolymphatic Hydrops
Decreased Appetite
Abnormal Dreams
Reading Disorder
Tic
Panic Attack
Toxicity To Various
Agents
Mania
Vertigo
Narcissistic Personality
Disorder
Paranoia
Photophobia
Diarrhoea
Depression
Mood Swings
Jaw Disorder
Tardive Dyskinesia
Lacrimation Increased
Confusional State
Dysphemia
Visual Impairment
Balance Disorder
Amnesia
Photosensitivity Reaction
Asthenia
Migraine
Conduction Disorder
Bipolar Disorder
Gastroenteritis
Hyporeflexia
Feeling Abnormal
Date:03/24/05ISR Number: 4617721-8Report Type:Expedited (15-DaCompany Report #CA-ROCHE-398664 Age:57 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pancreatitis Lariam PS Roche ORAL 3 DOSES TAKEN
Date:03/24/05ISR Number: 4617730-9Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398996 Age:30 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche ORAL TOTAL OF 7-8
Maternal Exposure During
250 MG
Pregnancy
TABLETS WERE
TAKEN
03-Apr-2012 09:37 AM Page: 596

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/24/05ISR Number: 4617734-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-399038 Age:61 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Feeling Abnormal Lariam PS Roche UNKNOWN
Dermatitis Exfoliative
Vision Blurred
Dry Skin
Vomiting
Date:03/30/05ISR Number: 4622495-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-257719 Age:32 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dizziness Lariam Tablets PS Roche ORAL SEVEN TABLETS
Visual Impairment
TAKEN IN
Panic Attack
TOTAL.
Muscle Twitching
Insomnia
Anxiety
Agoraphobia
Confusional State
Hepatocellular Injury
Hallucination
Aggression
Nervous System Disorder
Suicidal Ideation
Paranoia
Psychotic Disorder
Hypertension
Dissociative Disorder
Tremor
Mood Swings
Fatigue
Pyrexia
Headache
Feeling Abnormal
Immune System Disorder
Amnesia
Balance Disorder
Depression
Myalgia
Date:03/31/05ISR Number: 4623912-2Report Type:Expedited (15-DaCompany Report #CA-ROCHE-393893 Age:22 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Loss Of Consciousness Lariam PS Roche ORAL 15 DAY
Dizziness Vivotif "Berna" C ORAL
Vomiting Dukoral C ORAL
Somnolence
Panic Attack

Hallucination
Fatigue
White Blood Cell Count
Decreased
Hypotrichosis
03-Apr-2012 09:37 AM Page: 597

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/01/05ISR Number: 4625199-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Mitral Valve Prolapse
Diastolic Dysfunction
Bronchitis
Blood Triglycerides
Increased
Blood Creatine
Phosphokinase Increased
Exfoliative Rash
Balance Disorder
Sinusitis
Amnesia
Anxiety
Sinus Tachycardia
Diarrhoea
Nocturia
Vitiligo
Gastrooesophageal Reflux
Disease
Haemorrhoids
Psychotic Disorder
Gastrointestinal Disorder
Ventricular Hypertrophy
Hypertension
Restrictive Pulmonary
Disease
Dry Skin
Angiotensin Converting
Enzyme Increased
Bipolar Disorder
Major Depression
Contusion
Aggression
Depression
Oral Disorder
Fatigue
Angina Pectoris
Total Lung Capacity
Decreased
Viral Infection
Rash
Blood Cholesterol
Increased
Dehydration
Dry Mouth
Insomnia
Visual Impairment
Scratch
Memory Impairment
Affective Disorder
Tremor

Confusional State
Dyspnoea
Somnolence
Bronchospasm
Cardiac Murmur
Snoring
Chest Discomfort
Constipation
03-Apr-2012 09:37 AM Page: 598

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Acrochordon
Blood Glucose Increased
Headache Report Source Product Role Manufacturer Route Dose Duration
Sleep Apnoea Syndrome Lariam PS Roche ORAL
Arthralgia Zoloft C UNKNOWN
Weight Increased
Low Density Lipoprotein
Increased
Total Cholesterol/Hdl
Ratio Decreased
Clumsiness
Asthma
Adjustment Disorder With
Depressed Mood
Vestibular Disorder
Skin Disorder
Dry Eye
Upper-Airway Cough
Syndrome
Rhinitis
Abnormal Dreams
Coordination Abnormal
Schizoaffective Disorder
Date:04/01/05ISR Number: 4625201-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Paranoia
Hallucination
Depression
Anxiety
Obsessive Thoughts
Jaw Disorder
Gait Disturbance
Abnormal Dreams
Cranial Nerve Disorder
Panic Attack
Incontinence
Cough
Irritability
Depressed Level Of
Consciousness
Tardive Dyskinesia
Motor Dysfunction
Gilbert'S Syndrome
Amnesia
General Symptom
Muscle Twitching
Mood Swings
Migraine
Hepatic Failure

Tremor
Diarrhoea
Aggression
Vestibular Disorder
Photosensitivity Reaction
Tinnitus
Lacrimation Increased
Dysarthria
03-Apr-2012 09:37 AM Page: 599

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Conduction Disorder
Hyperacusis
Photophobia Report Source Product Role Manufacturer Route Dose Duration
Disturbance In Attention Lariam PS Roche ORAL 23 TABLETS
Visual Impairment
DISPENSED.
Visual Field Defect Sudafed C
Balance Disorder
Anger
Endolymphatic Hydrops
Decreased Appetite
Mania
Insomnia
Jaundice
Cognitive Disorder
Nausea
Vomiting
Toxicity To Various
Agents
Suicidal Ideation
Asthenia
Post-Traumatic Stress
Disorder
Thirst
Confusional State
Dysphemia
Date:04/04/05ISR Number: 4626282-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-399129 Age:63 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Contusion Lariam PS Roche ORAL 250 MG
International Normalised
RECEIVED
Ratio Increased
WEEKLY.
Cefaclor SS ORAL 5 DAY
Warfarin SS ORAL
Date:04/08/05ISR Number: 4630752-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-399038 Age:61 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dermatitis Exfoliative Lariam PS Roche ORAL 20 DAY
Dry Skin
Feeling Abnormal
Vision Blurred
Vomiting
Sensory Disturbance
Date:04/11/05ISR Number: 4632263-1Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398996 Age:29 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche ORAL TOTAL OF 7-8
Maternal Exposure During
250 MG
Pregnancy
TABLETS WERE
Ultrasound Antenatal
TAKEN
Screen Abnormal Trinordiol C ORAL
Vaginal Haemorrhage
03-Apr-2012 09:37 AM Page: 600

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/11/05ISR Number: 4657678-7Report Type:Periodic Company Report #GXBR2005US00443 Age:51 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nausea Consumer Mefloquine Hcl
Initial or Prolonged Tinnitus Tablets
Convulsion
(Ngx)(Mefloquine)
Dizziness Tablet PS ORAL 250 MG, QW,
ORAL; 500
MG, QW
Valium (Diazepam) C
Vicodin (Hydrocodone
Bitartrate,
Paracetamol)
C
Date:04/11/05ISR Number: 4657680-5Report Type:Periodic Company Report #GXBR2005US00448 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dizziness Postural Consumer Mefloquine Hcl
Asthenia
Tablets
Loss Of Consciousness
(Ngx)(Mefloquine)
Palpitations Tablet PS ORAL 250 MG, QW,
Disturbance In Attention
ORAL
Tremor
Cipro (Ciprofloxacin
Hydrochloride) C
Date:04/18/05ISR Number: 4637881-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Confusional State
Depression
Headache
Bronchospasm
Diarrhoea
Chest Discomfort
Angiotensin Converting
Enzyme Increased
Bronchitis
Weight Increased
Cardiac Murmur
Sinus Tachycardia
Blood Triglycerides
Increased
Low Density Lipoprotein
Increased
Nocturia
Vitiligo
Upper-Airway Cough
Syndrome
Abnormal Dreams

Coordination Abnormal
Major Depression
Aggression
Amnesia
Gastrointestinal Disorder
Hypertension
Dry Skin
Snoring
03-Apr-2012 09:37 AM Page: 601

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Acrochordon
Insomnia
Anxiety Report Source Product Role Manufacturer Route Dose Duration
Dyspnoea Lariam PS Roche ORAL
Vestibular Disorder Zoloft C UNKNOWN
Mitral Valve Prolapse
Skin Disorder
Angina Pectoris
Restrictive Pulmonary
Disease
Rhinitis
Bipolar Disorder
Contusion
Schizoaffective Disorder
Somnolence
Rash
Dehydration
Dry Eye
Blood Glucose Increased
Asthma
Haemorrhoids
Affective Disorder
Total Cholesterol/Hdl
Ratio Decreased
Exfoliative Rash
Dry Mouth
Scratch
Tremor
Ventricular Hypertrophy
Sleep Apnoea Syndrome
Viral Infection
Arthralgia
Oral Disorder
Gastrooesophageal Reflux
Disease
Clumsiness
Balance Disorder
Adjustment Disorder With
Depressed Mood
Psychotic Disorder
Fatigue
Diastolic Dysfunction
Total Lung Capacity
Decreased
Blood Cholesterol
Increased
Blood Creatine
Phosphokinase Increased
Constipation
Visual Impairment
Memory Impairment

Date:04/18/05ISR Number: 4638885-6Report Type:Direct Company Report #CTU 246445 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Sleep Talking Mefloquine PS
Abnormal Behaviour
03-Apr-2012 09:37 AM Page: 602

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/25/05ISR Number: 4644025-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Diarrhoea Lariam PS Roche ORAL 23 TABLETS
Toxicity To Various
DISPENSED.
Agents Sudafed C
Irritability
Obsessive Thoughts
Migraine
Endolymphatic Hydrops
Thirst
Hepatic Failure
Gilbert'S Syndrome
Hyperacusis
Visual Field Defect
Balance Disorder
Vomiting
Asthenia
Muscle Twitching
Post-Traumatic Stress
Disorder
Dysphemia
Mania
Cranial Nerve Disorder
Tremor
Nausea
Suicidal Ideation
Motor Dysfunction
Photophobia
Anger
Depressed Level Of
Consciousness
Tardive Dyskinesia
Gait Disturbance
Hallucination
Insomnia
Photosensitivity Reaction
Anxiety
Tinnitus
Decreased Appetite
Jaw Disorder
Confusional State
Dysarthria
Abnormal Dreams
Incontinence
Aggression
Amnesia
Vestibular Disorder
General Symptom
Cough
Jaundice
Mood Swings
Cognitive Disorder

Conduction Disorder
Paranoia
Visual Impairment
Panic Attack
Disturbance In Attention
Depression
Lacrimation Increased
03-Apr-2012 09:37 AM Page: 603

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/26/05ISR Number: 4645005-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Vomiting Lariam PS Roche ORAL
Blood Pressure Increased Imodium C
Chest Pain Compazine C ON 18 APR
Depression
2001, THERAPY
Rash
REPORTED AS
Photophobia
TWICE DAILY.
Phonophobia Antibiotics Nos C
Insomnia Ambien C
Nightmare Prednisone C BY TAPER.
Vertigo Valium C ON 18 APR
Tinnitus
2001, THERAPY
Inner Ear Disorder
REPORTED AS:
Vision Blurred
AS NEEDED.
Disturbance In Attention Phenergan C
Hypoaesthesia Biaxin C
Blood Urea Increased Advil C
Gait Disturbance Bactrim C
Amnesia Antivert C
Dizziness
Eye Pain
Pain Of Skin
Abnormal Dreams
Anxiety Disorder
Memory Impairment
Headache
Nystagmus
Irritable Bowel Syndrome
Neutrophil Count
Increased
Lymphocyte Count
Decreased
Epididymitis
Nausea
Fatigue
Psychotic Disorder
Testicular Pain
Diarrhoea
Disorientation
Vestibular Disorder
Colitis
Monocyte Count Increased
Night Sweats
Agitation
Mood Swings
Abdominal Pain
Nervousness
Pain
Enteritis

Date:04/28/05ISR Number: 4647479-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-319597 Age:33 YR Gender:Male I/FU:F
Outcome
Death
PT
Completed Suicide
Incoherent
Feeling Abnormal
Aggression
03-Apr-2012 09:37 AM Page: 604

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abnormal Behaviour
Homicide
Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration
Social Avoidant Behaviour Lariam PS Roche ORAL TAKEN WEEKLY 99 DAY
Disorientation Primaquine Phosphate C ORAL 15 DAY
Pulmonary Congestion
Asphyxia
Communication Disorder
Mood Altered
Dysphemia
Anger
Tremor
Nervousness
Brain Oedema
Date:04/28/05ISR Number: 4647505-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-385961 Age:70 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Insomnia Lariam PS Roche ORAL
Initial or Prolonged Neuropathy Peripheral
Disability
Limb Deformity
General Physical Health
Deterioration
Joint Dislocation
Upper Limb Fracture
Fall
Balance Disorder
Decreased Appetite
Date:04/28/05ISR Number: 4647549-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-402425 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatocellular Injury Lariam PS Roche ORAL 3 YR
Liver Function Test Alcohol SS UNKNOWN
Abnormal
Date:04/28/05ISR Number: 4647735-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-402089 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Epilepsy Lariam PS Roche UNKNOWN 5 MON
Anxiety
Nightmare
Date:04/28/05ISR Number: 4649734-4Report Type:Direct Company Report #CTU 247330 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Nervous System Disorder Lariam Standard
Disability Cognitive Disorder Hoffman Laroche PS Hoffman Laroche ORAL 1 PILL
Required Toxicity To Various WEEKLY ORAL
Intervention to Agents Namenda C
Prevent Permanent Vestibular Disorder Paxil C
Impairment/Damage Depakote C
Benzodiazapines C
03-Apr-2012 09:37 AM Page: 605

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sleeping Pills
C
Date:05/02/05ISR Number: 4649996-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Mitral Valve Prolapse
Viral Infection
Blood Creatine
Phosphokinase Increased
Exfoliative Rash
Oral Disorder
Gastrooesophageal Reflux
Disease
Insomnia
Schizoaffective Disorder
Confusional State
Headache
Hypertension
Rash
Dry Mouth
Clumsiness
Coordination Abnormal
Memory Impairment
Restrictive Pulmonary
Disease
Bronchitis
Cardiac Murmur
Sinus Tachycardia
Dry Eye
Blood Glucose Increased
Adjustment Disorder With
Depressed Mood
Depression
Diastolic Dysfunction
Somnolence
Blood Triglycerides
Increased
Low Density Lipoprotein
Increased
Dehydration
Rhinitis
Haemorrhoids
Balance Disorder
Aggression
Angina Pectoris
Total Lung Capacity
Decreased
Diarrhoea
Dry Skin
Visual Impairment
Abnormal Dreams

Scratch
Amnesia
Vestibular Disorder
Gastrointestinal Disorder
Fatigue
Sleep Apnoea Syndrome
Arthralgia
Weight Increased
03-Apr-2012 09:37 AM Page: 606

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Blood Cholesterol
Increased
Vitiligo Report Source Product Role Manufacturer Route Dose Duration
Acrochordon Lariam PS Roche ORAL
Angiotensin Converting Zoloft C UNKNOWN
Enzyme Increased
Upper-Airway Cough
Syndrome
Asthma
Skin Disorder
Ventricular Hypertrophy
Bronchospasm
Nocturia
Bipolar Disorder
Major Depression
Psychotic Disorder
Anxiety
Dyspnoea
Total Cholesterol/Hdl
Ratio Decreased
Snoring
Chest Discomfort
Constipation
Contusion
Affective Disorder
Tremor
Date:05/10/05ISR Number: 4657892-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Hepatic Failure
Visual Impairment
Panic Attack
Insomnia
Nausea
Depression
Photosensitivity Reaction
Anxiety
Cough
Depressed Level Of
Consciousness
Cognitive Disorder
Dysarthria
Dysphemia
Tearfulness
Hallucination
Photophobia
Vomiting
Muscle Twitching
Jaw Disorder
Lacrimation Increased

Tinnitus
Irritability
Endolymphatic Hydrops
Gilbert'S Syndrome
Nervous System Disorder
Weight Decreased
Deafness
Toxicity To Various
03-Apr-2012 09:37 AM Page: 607

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Agents
General Symptom
Post-Traumatic Stress
Disorder Report Source Product Role Manufacturer Route Dose Duration
Thirst Lariam PS Roche ORAL 23 TABLETS
Confusional State
DISPENSED.
Gait Disturbance Sudafed C
Gastroenteritis
Electroencephalogram
Abnormal
Migraine
Decreased Appetite
Conduction Disorder
Dizziness
Sensory Disturbance
Paranoia
Tremor
Incontinence
Disturbance In Attention
Amnesia
Tardive Dyskinesia
Abnormal Dreams
Water Pollution
Stress
Chest Pain
Balance Disorder
Aggression
Anger
Vestibular Disorder
Asthenia
Mania
Viiith Nerve Lesion
Nystagmus
Hepato-Lenticular
Degeneration
Creutzfeldt-Jakob Disease
Sinus Tachycardia
Cranial Nerve Disorder
Visual Field Defect
Diarrhoea
Suicidal Ideation
Obsessive Thoughts
Jaundice
Mood Swings
Motor Dysfunction
Hyperacusis
Respiratory Disorder
Blood Bilirubin Increased
Tooth Discolouration
Accidental Exposure
Binocular Eye Movement
Disorder
Disorientation
Metal Poisoning

Date:05/13/05ISR Number: 4661718-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Anxiety
Depression
03-Apr-2012 09:37 AM Page: 608

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Headache
Arthralgia
Bronchitis
Total Cholesterol/Hdl
Ratio Decreased
Dry Eye
Insomnia
Asthma
Ventricular Hypertrophy
Diastolic Dysfunction
Restrictive Pulmonary
Disease
Sleep Apnoea Syndrome
Diarrhoea
Dry Skin
Constipation
Angiotensin Converting
Enzyme Increased
Balance Disorder
Memory Impairment
Psychotic Disorder
Mitral Valve Prolapse
Somnolence
Viral Infection
Gastrooesophageal Reflux
Disease
Upper-Airway Cough
Syndrome
Abnormal Dreams
Bipolar Disorder
Aggression
Dyspnoea
Snoring
Acrochordon
Blood Glucose Increased
Scratch
Amnesia
Vestibular Disorder
Skin Disorder
Angina Pectoris
Weight Increased
Exfoliative Rash
Dry Mouth
Rhinitis
Haemorrhoids
Rash
Sinus Tachycardia
Visual Impairment
Affective Disorder
Confusional State
Total Lung Capacity
Decreased
Cardiac Murmur

Blood Triglycerides
Increased
Blood Creatine
Phosphokinase Increased
Coordination Abnormal
Adjustment Disorder With
Depressed Mood
Tremor
03-Apr-2012 09:37 AM Page: 609

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Gastrointestinal Disorder
Fatigue
Hypertension Report Source Product Role Manufacturer Route Dose Duration
Bronchospasm Lariam PS Roche ORAL
Blood Cholesterol Zoloft C UNKNOWN
Increased
Low Density Lipoprotein
Increased
Dehydration
Nocturia
Chest Discomfort
Oral Disorder
Vitiligo
Clumsiness
Major Depression
Contusion
Schizoaffective Disorder
Date:05/13/05ISR Number: 4662475-2Report Type:Direct Company Report #CTU 248485 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Idiopathic Larium 250 Mg PS ORAL 250 MG
Hospitalization - Thrombocytopenic Purpura WEEKLY ORAL
Initial or Prolonged
Disability
Date:05/16/05ISR Number: 4662466-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome
Disability
PT
Agitation
Vertigo
Disorientation
Dizziness
Nervousness
Paraesthesia
Migraine Without Aura
Diarrhoea
Mood Swings
Chest Pain
Nystagmus
Testicular Pain
Sinus Disorder
Low Density Lipoprotein
Increased
Night Sweats
Anxiety Disorder
Memory Impairment
Amnesia
Asthenia

Cluster Headache
Weight Increased
Vomiting
Insomnia
Psychotic Disorder
Inner Ear Disorder
Abdominal Pain
Rash
03-Apr-2012 09:37 AM Page: 610

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pain Of Skin
Blood Pressure Increased
Balance Disorder Report Source Product Role Manufacturer Route Dose Duration
Upper Respiratory Tract Lariam PS Roche ORAL
Infection Imodium C
Nightmare Compazine C ON 18 APR
Irritable Bowel Syndrome
2001, THERAPY
Disturbance In Attention
REPORTED AS
Eye Pain
TWICE DAILY.
Phonophobia Antibiotics Nos C
Blood Cholesterol Ambien C
Increased Prednisone C BY TAPER.
Pharyngitis Streptococcal Valium C ON 18 APR
Fatigue
2001, THERAPY
Headache
REPORTED AS:
Photophobia
AS NEEDED.
Abnormal Dreams Phenergan C
Blood Urea Increased Biaxin C
Nausea Advil C
Vestibular Disorder Bactrim C
Vision Blurred Antivert C
Depression
Colitis
Hypoaesthesia
Viral Labyrinthitis
Blood Triglycerides
Increased
Toxicity To Various
Agents
Tinnitus
Epididymitis
Date:05/17/05ISR Number: 4663595-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-403695 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Ineffective Lariam PS Roche ORAL
Malaria
Date:05/18/05ISR Number: 4664622-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-384854 Age:37 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Feeling Abnormal
Cold Sweat
Liver Function Test
Abnormal
Chills
Disorientation
Agitation
Fatigue

Skin Disorder
Vertigo
Heart Rate Increased
Hyperhidrosis
Anxiety
Depression
Back Pain
Heart Rate Irregular
03-Apr-2012 09:37 AM Page: 611

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Paranoia
Diarrhoea
Insomnia Report Source Product Role Manufacturer Route Dose Duration
Mood Swings Lariam PS Roche ORAL 3-4 PILLS
Paraesthesia WERE TAKEN. 43 DAY
Panic Attack
Disturbance In Attention
Balance Disorder
Date:05/19/05ISR Number: 4666042-6Report Type:Expedited (15-DaCompany Report #CH-ROCHE-334363 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dyspnoea Lariam PS Roche ORAL
Headache
Memory Impairment
Fatigue
Asthenia
Tachycardia
Apathy
Dizziness
Date:05/19/05ISR Number: 4666059-1Report Type:Expedited (15-DaCompany Report #NO-ROCHE-404116 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fatigue Lariam PS Roche ORAL 22 DAY
Dyspnoea
Atrioventricular Block
Complete
Dizziness
Atrioventricular Block
Date:05/19/05ISR Number: 4667441-9Report Type:Direct Company Report #CTU 249136 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Mental Disorder Mefloquine
Disability Injury Unknown Unknown PS ORAL
Other Serious Ill-Defined Disorder 2OR3XDAILY
ORAL
Mefloquine
Stronger Than First
Dose Unknown SS ORAL STRONGER
SAME ORAL
Date:05/27/05ISR Number: 4676616-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-405127 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Speech Disorder Lariam PS Roche ORAL STARTED AFTER
Initial or Prolonged Loss Of Consciousness VERAPAMIL.
Blood Pressure Increased Lariam SS Roche ORAL
Paraesthesia Verapamil SS Roche UNKNOWN STARTED
BEFORE
MEFLOQUINE
(LARIAM).
03-Apr-2012 09:37 AM Page: 612

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Verapamil SS Roche UNKNOWN
Aspirin
C
Simvastatin
C
Date:06/02/05ISR Number: 4682080-1Report Type:Periodic Company Report #379157 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Weight Decreased Consumer Lariam (Mefloquine
Anxiety Hydrochloride) PS ORAL ORAL
Paranoia
Fear
Date:06/02/05ISR Number: 4682082-5Report Type:Periodic Company Report #379218 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Consumer Lariam (Mefloquine
Hydrochloride) PS ORAL ORAL
Date:06/02/05ISR Number: 4682085-0Report Type:Periodic Company Report #380190 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Diarrhoea Other Lariam (Mefloquine
Paranoia Hydrochloride) 250
Fatigue Mg PS ORAL 1 DOSE FORM 1
Depression
PER WEEK ORAL
Aggression
Agitation
Delusion
Headache
Completed Suicide
Night Sweats
Mood Swings
Insomnia
Date:06/02/05ISR Number: 4682086-2Report Type:Periodic Company Report #380226 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anger Other Lariam (Mefloquine
Nightmare Hydrochloride) 250
Abdominal Pain Upper Mg PS ORAL 250 MG 1 PER
Dizziness
WEEK ORAL
Fear
Panic Attack
Diarrhoea
Physical Assault

Nausea
03-Apr-2012 09:37 AM Page: 613

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/02/05ISR Number: 4682088-6Report Type:Periodic Company Report #380311 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Anger Other Lariam (Mefloquine
Psychotic Disorder Hydrochloride) 250
Panic Attack Mg PS ORAL ORAL
Completed Suicide
Diarrhoea
Physical Abuse
Rash
Date:06/02/05ISR Number: 4682089-8Report Type:Periodic Company Report #384553 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Amnesia Health Lariam (Mefloquine
Headache Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/02/05ISR Number: 4682090-4Report Type:Periodic Company Report #386934 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Health Lariam (Mefloquine
Hallucination Professional Hydrochloride) 250
Anxiety Mg PS ORAL ORAL
Date:06/02/05ISR Number: 4682091-6Report Type:Periodic Company Report #395642 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Other Lariam (Mefloquine
Imprisonment Hydrochloride) PS ORAL ORAL 213 DAY
Paranoia
Anxiety
Theft
Date:06/02/05ISR Number: 4682156-9Report Type:Periodic Company Report #369650 Age:49 YR Gender:Male I/FU:I
Outcome
Death
PT
Agitation
Mood Swings
Tinnitus
Disorientation
Self Esteem Decreased
Hostility
Fear

Completed Suicide
Wound
Fatigue
Abnormal Dreams
Memory Impairment
Speech Disorder
Communication Disorder
Emotional Distress
03-Apr-2012 09:37 AM Page: 614

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sleep Apnoea Syndrome
Report Source Product Role Manufacturer Route Dose Duration
Other
Lariam (Mefloquine
Hydrochloride) 250
Mg PS ORAL ORAL
Date:06/02/05ISR Number: 4682159-4Report Type:Periodic Company Report #370361 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Other Lariam (Mefloquine
Hydrochloride) 250
Mg PS ORAL ORAL
Date:06/02/05ISR Number: 4682161-2Report Type:Periodic Company Report #370897 Age:63 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypersensitivity Health Lariam (Mefloquine
Urticaria Professional Hydrochloride) PS ORAL 1 PER WEEK
Rash
ORAL
Pruritus
Date:06/02/05ISR Number: 4682163-6Report Type:Periodic Company Report #372533 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Attack Other Lariam (Mefloquine
Initial or Prolonged Hydrochloride) 250
Mg PS ORAL ORAL
Date:06/02/05ISR Number: 4682166-1Report Type:Periodic Company Report #372536 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Other Lariam (Mefloquine
Physical Assault Hydrochloride) 250
Mg PS ORAL ORAL
Date:06/02/05ISR Number: 4682167-3Report Type:Periodic Company Report #372585 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Other Lariam (Mefloquine
Hydrochloride) 250
Mg PS ORAL ORAL

Date:06/02/05ISR Number: 4682176-4Report Type:Periodic Company Report #374396 Age: Gender:Unknown I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Deafness Health Lariam (Mefloquine
Professional Hydrochloride) 250
Mg PS ORAL ORAL
03-Apr-2012 09:37 AM Page: 615

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/02/05ISR Number: 4682196-XReport Type:Periodic Company Report #378593 Age:15 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Urticaria Health Lariam (Mefloquine
Professional Hydrochloride) PS ORAL 1 DOSE FORM 1
PER 1 WEEK
ORAL
Date:06/02/05ISR Number: 4684026-9Report Type:Periodic Company Report #395651 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Mood Swings Other Lariam (Mefloquine
Deafness Hydrochloride) 250
Tinnitus Mg PS ORAL 250 MG 1 PER
Fatigue
WEEK ORAL
Completed Suicide
Depression
Psychotic Disorder
Agitation
Date:06/02/05ISR Number: 4684027-0Report Type:Periodic Company Report #398558 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Consumer Lariam (Mefloquine
Disturbance In Attention Hydrochloride) PS ORAL ORAL
Amnesia
Anxiety
Date:06/02/05ISR Number: 4684029-4Report Type:Periodic Company Report #400091 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Nightmare Other Lariam (Mefloquine
Injury Hydrochloride) PS ORAL ORAL
Sleep Disorder
Personality Change
Completed Suicide
Weight Decreased
Depression
Date:06/03/05ISR Number: 4681183-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome
Disability
PT
Nausea
Diarrhoea
Mood Swings

Vision Blurred
Enteritis Infectious
Lymphocyte Count
Decreased
Blood Triglycerides
Increased
Streptococcal Infection
Mucous Membrane Disorder
03-Apr-2012 09:37 AM Page: 616

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Night Sweats
Photophobia
Blood Pressure Increased Report Source Product Role Manufacturer Route Dose Duration
Epididymitis Lariam PS Roche ORAL
Amnesia Imodium C
Headache Compazine C ON 18 APR
Psychotic Disorder
2001, THERAPY
Nystagmus
REPORTED AS
Testicular Pain
TWICE DAILY.
Dizziness Antibiotics Nos C
Eye Pain Ambien C
Colitis Prednisone C BY TAPER.
Rash Valium C ON 18 APR
Abnormal Dreams
2001, THERAPY
Vertigo
REPORTED AS:
Chest Pain
AS NEEDED.
Depression Phenergan C
Agitation Biaxin C
Insomnia Advil C
Anxiety Disorder Bactrim C
Memory Impairment Antivert C
Vestibular Disorder
Inner Ear Disorder
Nervousness
Pain Of Skin
Blood Cholesterol
Increased
Low Density Lipoprotein
Increased
Vomiting
Fatigue
Abdominal Pain
Disturbance In Attention
Phonophobia
Blood Urea Increased
Viral Labyrinthitis
Balance Disorder
Posture Abnormal
Nightmare
Disorientation
Hypoaesthesia
Monocyte Count Increased
Upper Respiratory Tract
Infection
Tinnitus
Irritable Bowel Syndrome
Paraesthesia
Burning Sensation
Neutrophil Count
Increased
Nuclear Magnetic
Resonance Imaging
Abnormal

Activities Of Daily
Living Impaired
03-Apr-2012 09:37 AM Page: 617

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/03/05ISR Number: 4681185-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Vestibular Disorder
Hypertension
Sinus Tachycardia
Low Density Lipoprotein
Increased
Dry Mouth
Constipation
Upper-Airway Cough
Syndrome
Asthma
Haemorrhoids
Affective Disorder
Productive Cough
Cough
Electrocardiogram T Wave
Abnormal
Pharyngeal Disorder
Weight Decreased
Rectal Haemorrhage
Anal Fissure
Road Traffic Accident
Bronchitis
Blood Cholesterol
Increased
Exfoliative Rash
Major Depression
Musculoskeletal
Discomfort
Mental Status Changes
Hallucination, Auditory
Sinusitis
Amnesia
Anxiety
Dyspnoea
Restrictive Pulmonary
Disease
Sleep Apnoea Syndrome
Bronchospasm
Insomnia
Abnormal Dreams
Bipolar Disorder
Coordination Abnormal
Body Temperature
Increased
Sputum Discoloured
Myalgia
Collagen-Vascular Disease
Fatigue
Total Lung Capacity
Decreased

Arthralgia
Blood Creatine
Phosphokinase Increased
Oral Disorder
Gastrooesophageal Reflux
Disease
Scratch
Contusion
03-Apr-2012 09:37 AM Page: 618

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Exercise Tolerance
Decreased
Sleep Disorder Report Source Product Role Manufacturer Route Dose Duration
Jaw Disorder Lariam PS Roche ORAL
Rectal Neoplasm Zoloft C UNKNOWN
Anhedonia
Psychomotor Hyperactivity
Cognitive Disorder
Post-Traumatic Neck
Syndrome
Skin Disorder
Gastrointestinal Disorder
Angina Pectoris
Total Cholesterol/Hdl
Ratio Decreased
Diarrhoea
Snoring
Acrochordon
Angiotensin Converting
Enzyme Increased
Blood Glucose Increased
Memory Impairment
Aggression
Erythema
Mitral Valve Prolapse
Diastolic Dysfunction
Dry Skin
Chest Discomfort
Vitiligo
Visual Impairment
Adjustment Disorder With
Depressed Mood
Oedema
Ventricular Hypertrophy
Rash
Weight Increased
Cardiac Murmur
Blood Triglycerides
Increased
Rhinitis
Balance Disorder
Schizoaffective Disorder
Upper Respiratory Tract
Infection
Colitis
Feelings Of Worthlessness
Confusional State
Depression
Headache
Somnolence
Viral Infection
Dehydration
Dry Eye

Nocturia
Clumsiness
Psychotic Disorder
Tremor
Wheezing
Blood Pressure Diastolic
Increased
03-Apr-2012 09:37 AM Page: 619

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/03/05ISR Number: 4681187-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Visual Field Defect
Suicidal Ideation
Cough
Muscle Twitching
Mood Swings
Confusional State
Hyperacusis
Mental Disorder
Eye Movement Disorder
Dizziness
Cranial Nerve Disorder
Anger
General Symptom
Endolymphatic Hydrops
Thirst
Gilbert'S Syndrome
Conduction Disorder
Tearfulness
Sensory Disturbance
Creutzfeldt-Jakob Disease
Anxiety Disorder
Energy Increased
Paranoia
Insomnia
Depression
Vestibular Disorder
Photosensitivity Reaction
Depressed Level Of
Consciousness
Migraine
Gait Disturbance
Dysphemia
Nervous System Disorder
Antisocial Behaviour
Narcissistic Personality
Disorder
Hepatic Failure
Panic Attack
Nausea
Disturbance In Attention
Tardive Dyskinesia
Respiratory Disorder
Blood Bilirubin Increased
Hepato-Lenticular
Degeneration
Abnormal Behaviour
Photophobia
Vomiting
Aggression
Tinnitus

Mania
Water Pollution
Binocular Eye Movement
Disorder
Rapid Eye Movements Sleep
Abnormal
Electrocardiogram St-T
Change
03-Apr-2012 09:37 AM Page: 620

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hallucination
Balance Disorder
Toxicity To Various Report Source Product Role Manufacturer Route Dose Duration
Agents Lariam PS Roche ORAL 23 TABLETS
Asthenia
DISPENSED.
Obsessive Thoughts Sudafed C
Jaundice
Post-Traumatic Stress
Disorder
Amyotrophic Lateral
Sclerosis
Electroencephalogram
Abnormal
Hyporeflexia
Electrocardiogram
Abnormal
Tic
Incontinence
Amnesia
Anxiety
Irritability
Lacrimation Increased
Motor Dysfunction
Abnormal Dreams
Tooth Discolouration
Affective Disorder
Metal Poisoning
Visual Impairment
Tremor
Diarrhoea
Decreased Appetite
Jaw Disorder
Cognitive Disorder
Dysarthria
Weight Decreased
Gastroenteritis
Date:06/08/05ISR Number: 4687515-6Report Type:Direct Company Report #CTU 250678 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Affect Lability Lariam PS ORAL ONE TABLET
Aggression WEEK ORAL
Date:06/17/05ISR Number: 4692525-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-407146 Age:64 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vertigo Lariam PS Roche ORAL 29 DAY
Initial or Prolonged Fall Xalacom SS TOPICAL
Glycosylated Haemoglobin Fenofibrate SS ORAL

Increased Captopril SS Roche ORAL
Vision Blurred
Atrioventricular Block
Bradycardia
03-Apr-2012 09:37 AM Page: 621

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/17/05ISR Number: 4693517-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Age:34 YR Gender:Male I/FU:F
Outcome
Disability
PT
Abdominal Pain
Dyspnoea
Headache
Acrophobia
Sensory Integrative
Dysfunction
Neck Pain
Vertigo
Insomnia
Panic Attack
Generalised Anxiety
Disorder
Sleep Disorder
Dizziness
Motion Sickness
Vestibular Disorder
Photophobia
Weight Decreased
Adjustment Disorder With
Anxiety
Sinus Bradycardia
Migraine
Fatigue
Lactose Intolerance
Abdominal Distension
Hypoaesthesia
Emotional Distress
Diarrhoea
Disorientation
Self Esteem Decreased
Disturbance In Attention
Phobia
Claustrophobia
Back Pain
Nasal Congestion
Abdominal Pain Lower
Bronchospasm
Anxiety
Heart Rate Increased
Nausea
Rash
Adjustment Disorder With
Depressed Mood
Heart Rate Irregular
Irritable Bowel Syndrome
Phobia Of Flying
Musculoskeletal Stiffness
Amnesia
Sleep Disorder Due To
General Medical

Condition, Hypersomnia
Type
Mood Disorder Due To A
General Medical Condition
Suicidal Ideation
Depression
Paraesthesia
Hypersensitivity
03-Apr-2012 09:37 AM Page: 622

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Tinnitus
Balance Disorder
Throat Irritation Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL THE PATIENT
HAD TAKEN 4-5
TABLETS OF
MEFLOQUINE IN
TOTAL. 21 DAY
Vaccine C OTHER 1 DAY
Date:06/17/05ISR Number: 4693518-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Incontinence
Diarrhoea
Post-Traumatic Stress
Disorder
Endolymphatic Hydrops
Thirst
Dysarthria
Hyperacusis
Hepatic Failure
Paranoia
Amnesia
Muscle Twitching
Lacrimation Increased
Gait Disturbance
Visual Impairment
Tremor
Obsessive Thoughts
Motor Dysfunction
Photophobia
Insomnia
Vomiting
Vestibular Disorder
Photosensitivity Reaction
Suicidal Ideation
Depressed Level Of
Consciousness
Confusional State
Nausea
Anxiety
Tardive Dyskinesia
Abnormal Dreams
Conduction Disorder
Hallucination
Panic Attack
Aggression
Cough
Cognitive Disorder
Cranial Nerve Disorder

Visual Field Defect
Balance Disorder
Anger
Disturbance In Attention
Asthenia
General Symptom
Tinnitus
Jaundice
03-Apr-2012 09:37 AM Page: 623

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dysphemia
Gilbert'S Syndrome
Depression Report Source Product Role Manufacturer Route Dose Duration
Toxicity To Various Lariam PS Roche ORAL 23 TABLETS
Agents
DISPENSED.
Irritability Sudafed C
Mood Swings
Migraine
Decreased Appetite
Jaw Disorder
Mania
Date:06/17/05ISR Number: 4693539-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-389470 Age:12 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Personality Disorder Lariam PS Roche ORAL
Initial or Prolonged Psychomotor Retardation
Adjustment Disorder
Tinnitus
Bipolar I Disorder
Psychotic Disorder
Hearing Impaired
Hallucination, Auditory
Depression
Suicidal Ideation
Major Depression
Insomnia
Anxiety
Headache
Decreased Appetite
Suicide Attempt
Autonomic Nervous System
Imbalance
Agitation
Date:06/20/05ISR Number: 4694445-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Abnormal Behaviour
Vertigo
Bronchospasm
Productive Cough
Chest Discomfort
Headache
Hyperhidrosis
Cognitive Disorder
Attention
Deficit/Hyperactivity
Disorder

Respiratory Rate
Increased
Convulsion
Nocturia
Myalgia
Eosinophilia
Arthralgia
Disturbance In Attention
03-Apr-2012 09:37 AM Page: 624

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hallucination, Visual
Major Depression
Generalised Anxiety
Disorder
Fall
Decreased Activity
Dehydration
Musculoskeletal Stiffness
Tinnitus
Agitation
Mood Swings
Depression
Fatigue
Joint Dislocation
Psychiatric Symptom
Hypoaesthesia
Ventricular Extrasystoles
Bacterial Infection
Dizziness
Visual Impairment
Asthenia
Respiratory Disorder
Meniscus Lesion
Asthma
Oxygen Saturation
Decreased
Coronary Artery Disease
Homicidal Ideation
Hiatus Hernia
Panic Attack
Haemophilus Infection
Palpitations
Anxiety
Balance Disorder
Suicidal Ideation
Selective Iga
Immunodeficiency
Cranial Nerve Disorder
Dysthymic Disorder
Bundle Branch Block Right
Eye Movement Disorder
Contusion
Rhinitis Allergic
Insomnia
Memory Impairment
Panic Disorder
Hypertension
Psychotic Disorder
Self-Injurious Ideation
Musculoskeletal Pain
Mitral Valve
Calcification
Humerus Fracture

Gait Disturbance
Ulna Fracture
Aggression
Dyspnoea
Sleep Apnoea Syndrome
Tremor
Mitral Valve Incompetence
Exostosis
03-Apr-2012 09:37 AM Page: 625

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Weight Decreased
Nystagmus
Ligament Sprain Report Source Product Role Manufacturer Route Dose Duration
Pyrexia Lariam PS Roche ORAL
Rash Papular Primaquine C
Weight Increased Cipro C
Deafness
Coordination Abnormal
Upper Respiratory Tract
Infection
Blood Pressure Increased
Chest Pain
Post-Traumatic Stress
Disorder
Thinking Abnormal
Toxicity To Various
Agents
Antinuclear Antibody
Positive
Rheumatoid Factor
Increased
Ill-Defined Disorder
Amnesia
Snoring
Nightmare
Date:06/23/05ISR Number: 4698813-4Report Type:Expedited (15-DaCompany Report #05-06-1067 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Speech Disorder Foreign Verapamil Hcl Er
Initial or Prolonged Blood Pressure Increased Other -Ipi PS Ipi
Paraesthesia Lariam SS ORAL ORAL
Aspirin
C
Simvastatin
C
Date:06/24/05ISR Number: 4699090-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-405127 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paraesthesia Lariam PS Roche ORAL STARTED AFTER
Initial or Prolonged Speech Disorder VERAPAMIL.
Loss Of Consciousness Lariam SS Roche ORAL
Blood Pressure Increased Verapamil SS Roche UNKNOWN STARTED
BEFORE
MEFLOQUINE
(LARIAM).
Verapamil SS Roche UNKNOWN
Aspirin
C
Simvastatin
C

Date:06/27/05ISR Number: 4700390-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Sleep Apnoea Syndrome
Dehydration
Rhinitis
03-Apr-2012 09:37 AM Page: 626

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Clumsiness
Upper Respiratory Tract
Infection
Listless
Dyspnoea Exertional
Adjustment Disorder
Anxiety
Dyspnoea
Vestibular Disorder
Somnolence
Nocturia
Blood Glucose Increased
Memory Impairment
Psychotic Disorder
Gastrointestinal Disorder
Ventricular Hypertrophy
Arthralgia
Weight Increased
Blood Triglycerides
Increased
Total Cholesterol/Hdl
Ratio Decreased
Upper-Airway Cough
Syndrome
Aggression
Psychomotor Hyperactivity
Confusional State
Diastolic Dysfunction
Viral Infection
Insomnia
Visual Impairment
Adjustment Disorder With
Depressed Mood
Contusion
Schizoaffective Disorder
Condition Aggravated
Rectal Haemorrhage
Skin Disorder
Fatigue
Total Lung Capacity
Decreased
Blood Cholesterol
Increased
Dry Skin
Snoring
Acrochordon
Abnormal Dreams
Affective Disorder
Tremor
Multiple Allergies
Depression
Headache
Bronchospasm

Diarrhoea
Exfoliative Rash
Bipolar Disorder
Scratch
Neck Pain
Drug Intolerance
Amnesia
Mitral Valve Prolapse
03-Apr-2012 09:37 AM Page: 627

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Cardiac Murmur
Sinus Tachycardia
Low Density Lipoprotein Report Source Product Role Manufacturer Route Dose Duration
Increased Lariam PS Roche ORAL
Dry Mouth Zoloft C UNKNOWN
Chest Discomfort
Angiotensin Converting
Enzyme Increased
Balance Disorder
Nausea
Hypertension
Angina Pectoris
Restrictive Pulmonary
Disease
Rash
Bronchitis
Blood Creatine
Phosphokinase Increased
Dry Eye
Constipation
Oral Disorder
Vitiligo
Gastrooesophageal Reflux
Disease
Asthma
Haemorrhoids
Coordination Abnormal
Major Depression
Date:06/28/05ISR Number: 4701483-XReport Type:Expedited (15-DaCompany Report #SE-ROCHE-407993 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Lariam PS Roche ORAL 9 DAY
Visual Impairment Lexinor C
Amnesia
Date:06/28/05ISR Number: 4702207-2Report Type:Direct Company Report #CTU 252039 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam Roche PS Roche
Memory Impairment
Headache
Dizziness
Date:06/29/05ISR Number: 4702966-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-408409 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Asthenia Lariam PS Roche ORAL THE PATIENT
Initial or Prolonged Hyponatraemia TOOK JUST ONE
Feeling Drunk
DOSE OF THREE
Psychotic Disorder
TABLETS AT
Fatigue
ONCE.
03-Apr-2012 09:37 AM Page: 628

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/05/05ISR Number: 4706612-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Photophobia
Vestibular Disorder
Suicidal Ideation
Confusional State
Motor Dysfunction
Abnormal Dreams
Gastroenteritis
Impulsive Behaviour
Hallucination
Tinnitus
Irritability
Thirst
Hyperacusis
Paranoia
Tremor
Nausea
Vomiting
Anger
Muscle Twitching
Amnesia
Photosensitivity Reaction
Toxicity To Various
Agents
Cranial Nerve Disorder
Balance Disorder
Panic Attack
Mood Swings
Migraine
Dysarthria
Hepatic Failure
Aggression
Anxiety
Asthenia
Gait Disturbance
Tooth Discolouration
Ear Infection
Visual Impairment
Diarrhoea
Depression
General Symptom
Cough
Obsessive Thoughts
Depressed Level Of
Consciousness
Jaw Disorder
Tardive Dyskinesia
Lacrimation Increased
Dysphemia
Mania
Conduction Disorder

Visual Field Defect
Insomnia
Incontinence
Disturbance In Attention
Jaundice
Post-Traumatic Stress
Disorder
Endolymphatic Hydrops
03-Apr-2012 09:37 AM Page: 629

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Decreased Appetite
Cognitive Disorder
Gilbert'S Syndrome Report Source Product Role Manufacturer Route Dose Duration
Electrocardiogram St-T Lariam PS Roche ORAL 23 TABLETS
Change
DISPENSED.
Attention Sudafed C
Deficit/Hyperactivity
Disorder
Daydreaming
Date:07/08/05ISR Number: 4711571-XReport Type:Direct Company Report #CTU 252820 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Mefloquine PS 250 MG Q WEEK
Required
Intervention to
Prevent Permanent
Impairment/Damage
Date:07/12/05ISR Number: 4712969-6Report Type:Direct Company Report #CTU 253019 Age:7 MON Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Petechiae Mefloquine 250 Mg
Haematochezia Tab PS ORAL 1/8 TAB WEEK
Platelet Count Decreased
ORAL
Bactrim
C
Date:07/13/05ISR Number: 4713176-3Report Type:Direct Company Report #CTU 253105 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Mefloquine PS 250 MG Q
Depression
WEEKLY
Tri-Sprintec
C
Luvox
C
Date:07/13/05ISR Number: 4713437-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-402425 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Liver Function Test Lariam PS Roche ORAL 3 YR
Abnormal Alcohol SS UNKNOWN
Hepatocellular Injury
Alcohol Use

Date:07/14/05ISR Number: 4714346-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Age: Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Initial Insomnia
Disturbance In Attention
Amoebiasis
Coordination Abnormal
Hypersomnia
03-Apr-2012 09:37 AM Page: 630

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Erectile Dysfunction
Social Avoidant Behaviour
Judgement Impaired Report Source Product Role Manufacturer Route Dose Duration
Bradycardia Lariam PS Roche UNKNOWN
Self Esteem Decreased Diazepam C
Generalised Anxiety Lorazepam C
Disorder Seroquel C
Mood Swings Gabapentin C
Suicidal Ideation Effexor Xr C
Fatigue
Crying
Somatisation Disorder
Varicocele
Hypotension
Mitral Valve Prolapse
Libido Decreased
Amnesia
Inadequate Diet
Psychomotor Retardation
Scrotal Varicose Veins
Memory Impairment
Mental Disorder
Palpitations
Restlessness
Aphasia
Dysarthria
Blood Pressure Increased
Viral Infection
Major Depression
Psychotic Disorder
Terminal Insomnia
Adjustment Disorder
Panic Attack
Self Injurious Behaviour
Anhedonia
Feeling Jittery
Flat Affect
Date:07/14/05ISR Number: 4714347-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Hepatic Failure
Cranial Nerve Disorder
Visual Impairment
Tremor
Photosensitivity Reaction
Asthenia
Endolymphatic Hydrops
Tardive Dyskinesia
Motor Dysfunction
Hyperacusis

Hallucination
Insomnia
Vomiting
Anxiety
Cough
Confusional State
Panic Attack
Depression
03-Apr-2012 09:37 AM Page: 631

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Post-Traumatic Stress
Disorder
Dysphemia Report Source Product Role Manufacturer Route Dose Duration
Gilbert'S Syndrome Lariam PS Roche ORAL 23 TABLETS
Balance Disorder
DISPENSED.
Aggression Sudafed C
Amnesia
Vestibular Disorder
Jaw Disorder
Gait Disturbance
Paranoia
Nausea
Anger
Muscle Twitching
Mood Swings
Migraine
Lacrimation Increased
Irritability
Depressed Level Of
Consciousness
Thirst
Photophobia
Disturbance In Attention
Toxicity To Various
Agents
Suicidal Ideation
General Symptom
Obsessive Thoughts
Cognitive Disorder
Dysarthria
Conduction Disorder
Visual Field Defect
Incontinence
Diarrhoea
Tinnitus
Jaundice
Decreased Appetite
Mania
Abnormal Dreams
Bipolar Disorder
Date:07/15/05ISR Number: 4715449-7Report Type:Direct Company Report #CTU 253311 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicidal Ideation Lariam PS ORAL ORAL
Initial or Prolonged Screaming
Required
Depression
Intervention to
Aggression
Prevent Permanent Abnormal Behaviour
Impairment/Damage

Date:07/18/05ISR Number: 4718297-7Report Type:Direct Company Report #CTU 253463 Age:28 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
Disability
03-Apr-2012 09:37 AM Page: 632

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Other Serious
Required
Intervention to PT Report Source Product Role Manufacturer Route Dose Duration
Prevent Permanent Depression Larium La Roche PS La Roche ORAL 1
Impairment/Damage Sensory Loss WEEKLY ORAL
Anxiety
Brain Injury
Muscle Twitching
Monoplegia
Tremor
Date:07/18/05ISR Number: 4718303-XReport Type:Direct Company Report #CTU 253466 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Tinnitus Mefloquine Unknown
Influenza Like Illness Generic PS ORAL 1 PER WEEK
Fatigue
9 WEEKS
Diarrhoea
ORAL
Abdominal Pain Upper Gingko Biloba C
Emotional Disorder Lexapro C
Reading Disorder
Pain
Anxiety
Weight Decreased
Abdominal Distension
Pyrexia
Flatulence
Disturbance In Attention
Amnesia
Myoclonus
Dyspepsia
Malaise
Visual Impairment
Dizziness
Feeling Abnormal
Educational Problem
Stress
Depression
Cognitive Disorder
Date:07/21/05ISR Number: 4723398-3Report Type:Direct Company Report #CTU 253857 Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Drug Dependence Lariam Weekly Sr
Other Serious Eye Pain Roche PS Roche ORAL 1 WEEKLY ORAL
Mood Swings Verapamil C
Headache

Date:07/22/05ISR Number: 4722019-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome
Disability
PT
Insomnia
Fatigue
Tinnitus
Psychotic Disorder
03-Apr-2012 09:37 AM Page: 633

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Testicular Pain
Irritable Bowel Syndrome
Eye Pain Report Source Product Role Manufacturer Route Dose Duration
Mood Swings Lariam PS Roche ORAL
Anxiety Disorder Imodium C
Abdominal Pain Compazine C ON 18 APR
Photophobia
2001, THERAPY
Nightmare
REPORTED AS
Nystagmus
TWICE DAILY.
Inner Ear Disorder Antibiotics Nos C
Pain Of Skin Ambien C
Vomiting Prednisone C BY TAPER.
Rash Valium C ON 18 APR
Nervousness
2001, THERAPY
Phonophobia
REPORTED AS:
Night Sweats
AS NEEDED.
Agitation Phenergan C
Nausea Biaxin C
Vertigo Advil C
Headache Bactrim C
Hypoaesthesia Antivert C
Blood Pressure Increased
Memory Impairment
Vestibular Disorder
Chest Pain
Colitis
Disorientation
Dizziness
Diarrhoea
Amnesia
Vision Blurred
Depression
Disturbance In Attention
Date:07/28/05ISR Number: 4727555-1Report Type:Direct Company Report #CTU 254655 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam Unsure
Required Lethargy Roche PS Roche ORAL DAILY ORAL
Intervention to Hallucination Birth Control Pills C
Prevent Permanent
Impairment/Damage
Depression
Paranoia
Nightmare
Date:08/02/05ISR Number: 4731828-6Report Type:Direct Company Report #CTU 255169 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Lariam PS ORAL 1 WEEK
Motion Sickness
ORAL

Dizziness
Mood Altered
Circadian Rhythm Sleep
Disorder
Abnormal Dreams
Anger
Insomnia
Depression
03-Apr-2012 09:37 AM Page: 634

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/03/05ISR Number: 4734187-8Report Type:Direct Company Report #CTU 255326 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Congenital Anomaly Mefloquine 250mg
Other Serious Pregnancy Qweek PS 250MG Q WEEK
Anencephaly
X 100 WKS
Hallucination
Mefloquine 1250mg
Maternal Drugs Affecting Stat Dose SS 1250 MG STAT
Foetus
X 1 DOSE
Date:08/04/05ISR Number: 4734436-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-397065 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Lariam PS Roche ORAL FREQUENCY
Initial or Prolonged Panic Disorder STATED AS
Disability Paraesthesia WEEKLY. 47 DAY
Anxiety Disorder
Ear Pain
Decreased Appetite
Tinnitus
Chills
Headache
Mood Swings
Depression
Diarrhoea
Skin Disorder
Paranoia
Dizziness
Hearing Impaired
Panic Attack
Abdominal Pain
Hyperhidrosis
Fatigue
Toxicity To Various
Agents
Confusional State
Memory Impairment
Arthralgia
Insomnia
Visual Impairment
Chest Pain
Agitation
Myalgia
Date:08/17/05ISR Number: 4746842-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome
Disability
PT
Insomnia
Disorientation

Vestibular Disorder
Nystagmus
Dizziness
Pain Of Skin
Agitation
Fatigue
Amnesia
Eye Pain
03-Apr-2012 09:37 AM Page: 635

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Rash
Headache
Chest Pain Report Source Product Role Manufacturer Route Dose Duration
Irritable Bowel Syndrome Lariam PS Roche ORAL
Nightmare Imodium C
Tinnitus Compazine C ON 18 APR
Disturbance In Attention
2001, THERAPY
Hypoaesthesia
REPORTED AS
Memory Impairment
TWICE DAILY.
Vertigo Antibiotics Nos C
Psychotic Disorder Ambien C
Inner Ear Disorder Prednisone C BY TAPER.
Abdominal Pain Valium C ON 18 APR
Enteritis Infectious
2001, THERAPY
Night Sweats
REPORTED AS:
Nausea
AS NEEDED.
Diarrhoea Phenergan C
Vision Blurred Biaxin C
Nervousness Advil C
Vomiting Bactrim C
Mood Swings Antivert C
Testicular Pain
Depression
Colitis
Phonophobia
Blood Pressure Increased
Anxiety Disorder
Photophobia
Date:08/22/05ISR Number: 4749682-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-414147 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nausea Lariam PS Roche ORAL 1 DAY
Disturbance In Attention Nitrofurantoin C ORAL
Vision Blurred
Dizziness
Paraesthesia
Disorientation
Date:08/23/05ISR Number: 4750604-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-408409 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hyponatraemia Lariam PS Roche ORAL THE PATIENT
Initial or Prolonged Asthenia TOOK JUST ONE
Psychotic Disorder
DOSE OF THREE
Fatigue
TABLETS AT
Blood Creatine
ONCE.
Phosphokinase Increased
Feeling Drunk

Date:08/26/05ISR Number: 4754048-8Report Type:Expedited (15-DaCompany Report #2005-BP-13941RO Age:20 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Nausea
Electrocardiogram Qt
03-Apr-2012 09:37 AM Page: 636

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Prolonged
Paraesthesia
Headache
Dizziness Report Source Product Role Manufacturer Route Dose Duration
Depressed Level Of Literature Mefloquine
Consciousness Health (Mefloquine) PS ORAL 240 MG ONCE
Hypotension Professional WEEKLY (250
MG, 1 IN 1
WK), PO
Date:08/29/05ISR Number: 4754920-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nausea Lariam PS Roche ORAL
Memory Impairment Imodium C
Nystagmus Compazine C ON 18 APR
Irritable Bowel Syndrome
2001, THERAPY
Rash
REPORTED AS
Vomiting
TWICE DAILY.
Headache Antibiotics Nos C
Abdominal Pain Ambien C
Night Sweats Prednisone C BY TAPER.
Disorientation Valium C ON 18 APR
Vestibular Disorder
2001, THERAPY
Disturbance In Attention
REPORTED AS:
Eye Pain
AS NEEDED.
Colitis Phenergan C
Blood Pressure Increased Biaxin C
Mood Swings Advil C
Insomnia Bactrim C
Nightmare Antivert C
Agitation
Anxiety Disorder
Depression
Amnesia
Tinnitus
Inner Ear Disorder
Testicular Pain
Hypoaesthesia
Nervousness
Phonophobia
Diarrhoea
Fatigue
Chest Pain
Vision Blurred
Photophobia
Pain Of Skin
Vertigo
Psychotic Disorder
Dizziness

Date:08/29/05ISR Number: 4754954-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Age:42 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Amnesia
Stress
Grand Mal Convulsion
Fatigue
03-Apr-2012 09:37 AM Page: 637

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Headache
Disturbance In Attention
Palpitations Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL
Lexinor C ORAL
Malarone C ORAL
Date:08/30/05ISR Number: 4756595-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-415094 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Fall Lariam PS Roche ORAL THE PATIENT
Hospitalization - Foaming At Mouth DID NOT TAKE
Initial or Prolonged Coma ANY OTHER
Postictal State DRUGS. 1 DAY
Loss Of Consciousness
Date:08/31/05ISR Number: 4759812-7Report Type:Direct Company Report #CTU 257313 Age:21 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Legal Problem Lariam 250 Mg
Other Serious Abnormal Behaviour Hoffman Laroche PS Hoffman Laroche BUCCAL 250 MG 1/WEEK
Stress BUCCAL 6 WK
Treatment Noncompliance
Mania
Nervousness
Economic Problem
Insomnia
Heart Rate Increased
Bipolar Disorder
Loss Of Employment
Educational Problem
Depression
Date:09/02/05ISR Number: 4763450-XReport Type:Expedited (15-DaCompany Report #2005-BP-14576RO Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insulinoma Literature Mefloquine
Hypoglycaemia Health (Mefloquine) PS ONCE/WEEK
Insulin C-Peptide
Professional
Increased
Neuroglycopenia
Blood Insulin Increased
Date:09/06/05ISR Number: 4762148-1Report Type:Direct Company Report #CTU 257623 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Anxiety Mefloquine 250 Mg
Hospitalization - Feeling Abnormal Sandoz PS Sandoz ORAL 1 TABLET -250
Initial or Prolonged Abnormal Behaviour MG ONCE A
Required Homicidal Ideation WEEK PO
Intervention to
Creutzfeldt-Jakob Disease
Prevent Permanent Hallucination, Visual
Impairment/Damage Self Injurious Behaviour
03-Apr-2012 09:37 AM Page: 638

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/08/05ISR Number: 4763724-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-415971 Age:61 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Amyotrophy Lariam PS Roche ORAL
Respiratory Failure Engerix B SS INTRAMUSCULAR THE PATIENT
Amyotrophic Lateral
RECEIVED
Sclerosis
THREE
Upper Motor Neurone
INJECTIONS IN
Lesion 1995 (MARCH, 189 DAY
Date:09/09/05ISR Number: 4764962-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-415763 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Panic Reaction Lariam PS Roche ORAL
Disturbance In Attention Dpt C
Psychotic Disorder
Hepatitis
Depression Vaccination C
Date:09/14/05ISR Number: 4768435-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Gastrointestinal Disorder
Arthralgia
Blood Triglycerides
Increased
Diarrhoea
Dry Mouth
Nocturia
Gastrooesophageal Reflux
Disease
Visual Impairment
Abnormal Dreams
Major Depression
Scratch
Anxiety
Hypertension
Diastolic Dysfunction
Angina Pectoris
Somnolence
Viral Infection
Cardiac Murmur
Haemorrhoids
Memory Impairment
Vestibular Disorder
Depression
Headache
Sleep Apnoea Syndrome
Bronchospasm
Ventricular Hypertrophy

Exfoliative Rash
Dry Skin
Contusion
Schizoaffective Disorder
Tremor
Mitral Valve Prolapse
Fatigue
Restrictive Pulmonary
03-Apr-2012 09:37 AM Page: 639

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disease
Snoring
Constipation
Oral Disorder Report Source Product Role Manufacturer Route Dose Duration
Bipolar Disorder Lariam PS Roche ORAL
Skin Disorder Zoloft C UNKNOWN
Sinus Tachycardia
Low Density Lipoprotein
Increased
Vitiligo
Rhinitis
Balance Disorder
Coordination Abnormal
Affective Disorder
Amnesia
Confusional State
Blood Cholesterol
Increased
Dehydration
Angiotensin Converting
Enzyme Increased
Insomnia
Clumsiness
Adjustment Disorder With
Depressed Mood
Psychotic Disorder
Aggression
Dyspnoea
Total Lung Capacity
Decreased
Rash
Bronchitis
Weight Increased
Total Cholesterol/Hdl
Ratio Decreased
Blood Creatine
Phosphokinase Increased
Dry Eye
Chest Discomfort
Acrochordon
Blood Glucose Increased
Upper-Airway Cough
Syndrome
Asthma
Date:09/14/05ISR Number: 4770717-8Report Type:Direct Company Report #CTU 258158 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Nightmare Mefloquine PS ONCE A WEEK
Completed Suicide
Depression

Date:09/15/05ISR Number: 4770906-2Report Type:Expedited (15-DaCompany Report #SE-ROCHE-407993 Age:42 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Visual Impairment
Convulsion
Disturbance In Attention
03-Apr-2012 09:37 AM Page: 640

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Amnesia
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL 9 DAY
Lexinor
C
Date:09/22/05ISR Number: 4778888-4Report Type:Expedited (15-DaCompany Report #343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Vestibular Disorder
Bipolar Disorder
Major Depression
Schizoaffective Disorder
Arthralgia
Blood Triglycerides
Increased
Diarrhoea
Acrochordon
Peripheral Sensory
Neuropathy
Exercise Tolerance
Decreased
Hypersensitivity
Upper Respiratory Tract
Infection
Somnolence
Contusion
Viral Infection
Bronchospasm
Blood Creatine
Phosphokinase Increased
Exfoliative Rash
Productive Cough
Cough
Blood Pressure Systolic
Increased
Allergy To Animal
Neck Pain
Drug Tolerance Decreased
Dyspnoea Exertional
Dyspnoea
Fatigue
Diastolic Dysfunction
Affective Disorder
Blood Cholesterol
Increased
Snoring
Vitiligo
Rhinitis
Sleep Apnoea Syndrome
Spirometry Abnormal

Adjustment Disorder
Scratch
Bronchitis
Weight Increased
Dry Mouth
Insomnia
Pyrexia
Listless
03-Apr-2012 09:37 AM Page: 641

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Electrocardiogram T Wave
Abnormal
Amnesia Report Source Product Role Manufacturer Route Dose Duration
Depression Consumer Lariam (Mefloquine
Ventricular Hypertrophy Other Hydrochloride) 250
Abnormal Dreams Mg PS ORAL 250 MG 1 PER
Sinus Tachycardia
1 WEEK ORAL
Dry Skin
Zoloft (Sertraline
Nocturia Hydrochloride) C
Sputum Discoloured
Total Cholesterol/Hdl
Ratio Increased
Restlessness
Confusional State
Skin Disorder
Gastrointestinal Disorder
Headache
Clumsiness
Asthma
Coordination Abnormal
Depressive Symptom
Low Density Lipoprotein
Increased
Dry Eye
Blood Glucose Increased
Upper-Airway Cough
Syndrome
Haemorrhoids
Aggression
Wheezing
Allergy Test Positive
Mitral Valve Prolapse
Hypertension
Angina Pectoris
Visual Impairment
Balance Disorder
Psychotic Disorder
Rash
Dehydration
Chest Discomfort
Myalgia
Chest X-Ray Abnormal
Mycotic Allergy
Anxiety
Lung Disorder
Memory Impairment
Cardiac Murmur
Constipation
Angiotensin Converting
Enzyme Increased
Gastrooesophageal Reflux
Disease
Tremor

Nervous System Disorder
03-Apr-2012 09:37 AM Page: 642

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/26/05ISR Number: 4778694-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-384854 Age:37 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Lariam PS Roche ORAL 3-4 PILLS
Panic Attack WERE TAKEN. 43 DAY
Balance Disorder
Paranoia
Insomnia
Disorientation
Feeling Abnormal
Fatigue
Liver Function Test
Abnormal
Heart Rate Increased
Hyperhidrosis
Depression
Disturbance In Attention
Cold Sweat
Vertigo
Alcohol Use
Mood Swings
Alanine Aminotransferase
Increased
Heart Rate Irregular
Diarrhoea
Chills
Anxiety
Skin Disorder
Back Pain
Agitation
Date:09/26/05ISR Number: 4778714-3Report Type:Expedited (15-DaCompany Report #SE-ROCHE-407993 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Lariam PS Roche ORAL 9 DAY
Cerebral Disorder Lexinor C
Visual Impairment
Disturbance In Attention
Amnesia
Fatigue
Date:09/30/05ISR Number: 4784739-4Report Type:Expedited (15-DaCompany Report #IT-ROCHE-418516 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Anxiety Lariam PS Roche ORAL 29 DAY
Panic Attack
Dyspnoea
Crying

Date:09/30/05ISR Number: 4784747-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-418484 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Lung Disorder Lariam PS Roche ORAL
Hypoxia
03-Apr-2012 09:37 AM Page: 643

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/05/05ISR Number: 4795220-0Report Type:Direct Company Report #CTU 259799 Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Nightmare Lariam PS 1 PILL /WK
Congenital Anomaly Paranoia
Required
Anxiety
Intervention to
Suicide Attempt
Prevent Permanent
Impairment/Damage
Date:10/07/05ISR Number: 4791872-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Generalised Anxiety Lariam PS Roche UNKNOWN
Initial or Prolonged Disorder
Disability
Panic Attack
Suicidal Ideation
Mood Swings
Memory Impairment
Mental Disorder
Amnesia
Self-Medication
Self Esteem Decreased
Major Depression
Date:10/11/05ISR Number: 4794427-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-419662 Age:4 MON Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Cardiac Arrest Lariam PS Roche ORAL FREQUENCY:
Convulsion
WEEKLY.
Haemolytic Uraemic Immunizations C SUBCUTANEOUS FIRST AND
Syndrome
SECOND SERIES
Vomiting
OF CHILDHOOD
IMMUNIZATIONS
NOS.
Date:10/11/05ISR Number: 4794488-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Vertigo
Visual Impairment
Panic Disorder
Major Depression
Generalised Anxiety
Disorder
Meniscus Lesion
Tremor

Cognitive Disorder
Dysthymic Disorder
Exostosis
Nocturia
Agitation
Balance Disorder
Ill-Defined Disorder
Fall
03-Apr-2012 09:37 AM Page: 644

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Attention
Deficit/Hyperactivity
Disorder
Insomnia
Memory Impairment
Fatigue
Dyspnoea
Cranial Nerve Disorder
Toxicity To Various
Agents
Bundle Branch Block Right
Respiratory Rate
Increased
Contusion
Antinuclear Antibody
Positive
Eosinophilia
Aggression
Mitral Valve Incompetence
Eye Movement Disorder
Ligament Sprain
Pyrexia
Suicidal Ideation
Asthenia
Chest Pain
Hypertension
Psychiatric Symptom
Musculoskeletal Pain
Decreased Activity
Humerus Fracture
Weight Decreased
Rhinitis Allergic
Ventricular Extrasystoles
Abnormal Behaviour
Mood Swings
Depression
Hallucination, Visual
Headache
Sleep Apnoea Syndrome
Self-Injurious Ideation
Dehydration
Myalgia
Disturbance In Attention
Selective Iga
Immunodeficiency
Bronchospasm
Chest Discomfort
Joint Dislocation
Post-Traumatic Stress
Disorder
Hyperhidrosis
Homicidal Ideation
Oxygen Saturation

Decreased
Convulsion
Rheumatoid Factor
Increased
Anxiety
Productive Cough
Psychotic Disorder
Asthma
03-Apr-2012 09:37 AM Page: 645

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Thinking Abnormal
Mitral Valve
Calcification Report Source Product Role Manufacturer Route Dose Duration
Hypoaesthesia Lariam PS Roche ORAL
Nystagmus Primaquine C
Rash Papular Cipro C
Date:10/11/05ISR Number: 4794512-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Visual Impairment
Dyspnoea
Generalised Anxiety
Disorder
Decreased Activity
Respiratory Rate
Increased
Rhinitis Allergic
Mood Swings
Bronchospasm
Chest Discomfort
Chest Pain
Self-Injurious Ideation
Cognitive Disorder
Humerus Fracture
Hypoaesthesia
Vertigo
Hypertension
Fall
Thinking Abnormal
Bundle Branch Block Right
Oxygen Saturation
Decreased
Rash Papular
Ventricular Extrasystoles
Asthenia
Cranial Nerve Disorder
Tremor
Homicidal Ideation
Toxicity To Various
Agents
Nocturia
Eosinophilia
Anxiety
Suicidal Ideation
Selective Iga
Immunodeficiency
Major Depression
Mitral Valve
Calcification
Antinuclear Antibody

Positive
Pyrexia
Insomnia
Memory Impairment
Balance Disorder
Fatigue
Ill-Defined Disorder
Sleep Apnoea Syndrome
03-Apr-2012 09:37 AM Page: 646

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Psychotic Disorder
Post-Traumatic Stress
Disorder Report Source Product Role Manufacturer Route Dose Duration
Musculoskeletal Pain Lariam PS Roche ORAL
Dysthymic Disorder Primaquine C
Dehydration Cipro C
Weight Decreased
Nystagmus
Eye Movement Disorder
Rheumatoid Factor
Increased
Abnormal Behaviour
Aggression
Agitation
Disturbance In Attention
Productive Cough
Headache
Panic Disorder
Joint Dislocation
Psychiatric Symptom
Hyperhidrosis
Mitral Valve Incompetence
Exostosis
Attention
Deficit/Hyperactivity
Disorder
Convulsion
Contusion
Myalgia
Depression
Hallucination, Visual
Meniscus Lesion
Asthma
Ligament Sprain
Date:10/13/05ISR Number: 4797132-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Hepatic Failure
Cranial Nerve Disorder
Tremor
Insomnia
Disturbance In Attention
Tinnitus
Migraine
Dysarthria
Dysphemia
Syncope
Self-Injurious Ideation
Visual Impairment
Photophobia

Visual Field Defect
Aggression
Amnesia
Photosensitivity Reaction
Post-Traumatic Stress
Disorder
Cognitive Disorder
Gilbert'S Syndrome
03-Apr-2012 09:37 AM Page: 647

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abnormal Dreams
Dizziness
Sleep Disorder Report Source Product Role Manufacturer Route Dose Duration
Psychomotor Hyperactivity Lariam PS Roche ORAL 23 TABLETS
Panic Attack
DISPENSED.
Nausea Sudafed C
Vestibular Disorder
Toxicity To Various
Agents
Muscle Twitching
Mood Swings
Thirst
Neck Pain
Homicidal Ideation
Abnormal Behaviour
Attention
Deficit/Hyperactivity
Disorder
Vomiting
Depression
Suicidal Ideation
Asthenia
Cough
Confusional State
Mania
Fatigue
Dehydration
Obsessive Thoughts
Depressed Level Of
Consciousness
Endolymphatic Hydrops
Jaw Disorder
Tardive Dyskinesia
Gait Disturbance
Road Traffic Accident
Stress
Atrial Fibrillation
Anger
General Symptom
Bipolar Disorder
Hypoaesthesia
Memory Impairment
Alcohol Poisoning
Hallucination
Balance Disorder
Incontinence
Anxiety
Jaundice
Conduction Disorder
Hyperacusis
Pain In Extremity
Paranoia
Diarrhoea

Irritability
Decreased Appetite
Lacrimation Increased
Motor Dysfunction
Feeling Abnormal
03-Apr-2012 09:37 AM Page: 648

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/13/05ISR Number: 4799799-4Report Type:Direct Company Report #CTU 260561 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Mefloquine
Required Feeling Hot Lariam PS ORAL PO
Intervention to
Pruritus
Prevent Permanent
Impairment/Damage
Pyrexia
Headache
Loss Of Consciousness
Feeling Abnormal
Burning Sensation
Date:10/18/05ISR Number: 4801794-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002297 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicidal Ideation Imodium PS ORAL
Initial or Prolonged Overdose Gelonida SS ORAL
Talvosilen SS ORAL
Lariam SS ORAL 16 tablets.
Talvosilen SS ORAL
Gelonida SS ORAL
Ibuprofen SS ORAL 20 tablets.
Date:10/18/05ISR Number: 4804112-XReport Type:Direct Company Report #CTU 260897 Age:55 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Paranoia Mefloquine 250mg
Required Hallucination Geneva PS Geneva 1 EVERY WEEK
Intervention to Anxiety White Sidel: Gp 118 C
Prevent Permanent Suicidal Ideation
Impairment/Damage
Date:10/21/05ISR Number: 4805756-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-407993 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Lariam PS Roche ORAL 9 DAY
Amnesia Lexinor C
Visual Impairment
Date:10/21/05ISR Number: 4805757-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-420600 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Chills Lariam PS Roche ORAL
Joint Swelling
Erythema

Dyspnoea
Arrhythmia
03-Apr-2012 09:37 AM Page: 649

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/21/05ISR Number: 4805773-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-420097 Age:4 MON Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Hypothyroidism Lariam PS Roche UNKNOWN
Congenital Anomaly Delayed Fontanelle
Closure
Haemolytic Uraemic
Syndrome
Skin Discolouration
Pallor
Plagiocephaly
Penis Disorder
Developmental Delay
Vomiting
Maternal Exposure During
Pregnancy
Date:10/21/05ISR Number: 4805981-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Disturbance In Attention
Amnesia
Endolymphatic Hydrops
Conduction Disorder
Paranoia
Hallucination
Cranial Nerve Disorder
Tremor
Aggression
Anger
Vestibular Disorder
Irritability
Dysphemia
Ototoxicity
Panic Attack
Toxicity To Various
Agents
Suicidal Ideation
Anxiety
Mood Swings
Post-Traumatic Stress
Disorder
Gait Disturbance
Bipolar Disorder
Tinnitus
Obsessive Thoughts
Jaundice
Muscle Twitching
Cognitive Disorder
Syncope
Hepatic Failure

Vomiting
Depression
Depressed Level Of
Consciousness
Thirst
Confusional State
Dysarthria
Motor Dysfunction
03-Apr-2012 09:37 AM Page: 650

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abnormal Dreams
Photophobia
Visual Field Defect Report Source Product Role Manufacturer Route Dose Duration
Balance Disorder Lariam PS Roche ORAL 23 TABLETS
Insomnia
DISPENSED.
Asthenia Sudafed C
Cough
Jaw Disorder
Tardive Dyskinesia
Hyperacusis
Incontinence
Diarrhoea
Photosensitivity Reaction
General Symptom
Migraine
Gilbert'S Syndrome
Visual Impairment
Nausea
Decreased Appetite
Lacrimation Increased
Mania
Homicidal Ideation
Date:10/21/05ISR Number: 4806101-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-419686 Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Leukopenia Lariam PS Roche ORAL DOSING
Initial or Prolonged Neutropenia REGIMEN
Thrombocytopenia REPORTED AS 3
Hepatic Enzyme Increased TABLETS, 2
TABLETS THEN 2 DAY
Date:10/21/05ISR Number: 4806107-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-419662 Age:4 MON Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Haemolytic Uraemic Lariam PS Roche ORAL FREQUENCY:
Syndrome
WEEKLY.
Convulsion Immunizations C SUBCUTANEOUS FIRST AND
Vomiting
SECOND SERIES
Cardiac Arrest
OF CHILDHOOD
IMMUNIZATIONS
NOS.
Date:10/25/05ISR Number: 4811091-8Report Type:Expedited (15-DaCompany Report #385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
PT
Aggression

Initial or Prolonged
Disability
Toxicity To Various
Agents
Chest Discomfort
Wheezing
Rhinitis Allergic
Abnormal Behaviour
Hallucination, Visual
Snoring
03-Apr-2012 09:37 AM Page: 651

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Bundle Branch Block Right
Generalised Anxiety
Disorder Report Source Product Role Manufacturer Route Dose Duration
Amnesia Other Lariam (Mefloquine
Coordination Abnormal Hydrochloride) PS ORAL ORAL
Palpitations
Primaquine
Nocturia
(Primaquine
Chest Pain Phosphate) C
Asthma
Cipro (Ciprofloxacin
Joint Stiffness Hydrochloride) C
Mood Swings
Weight Increased
Agitation
Vertigo
Balance Disorder
Dyspnoea
Pulmonary Function
Challenge Test Abnormal
Troponin Increased
Arthralgia
Decreased Activity
Chondroplasty
Occupational Exposure To
Air Contaminants
Insomnia
Disturbance In Attention
Suicidal Ideation
Headache
Fatigue
Hyperhidrosis
Tremor
Morbid Thoughts
Deafness
Anxiety
Poor Quality Drug
Administered
Cough
Blood Potassium Decreased
Loose Body In Joint
Rash Papular
Musculoskeletal Pain
Tinnitus
Depression
Visual Impairment
Myalgia
Acute Coronary Syndrome
Coronary Artery Disease
Meniscus Removal
Pyrexia
Hypervigilance

Date:10/28/05ISR Number: 4814893-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Abnormal Behaviour
Mood Swings
Cranial Nerve Disorder
Joint Dislocation
Post-Traumatic Stress
03-Apr-2012 09:37 AM Page: 652

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorder
Asthma
Nystagmus
Suicidal Ideation
Selective Iga
Immunodeficiency
Headache
Panic Disorder
Hypertension
Generalised Anxiety
Disorder
Self-Injurious Ideation
Fall
Mitral Valve Incompetence
Dehydration
Weight Decreased
Convulsion
Eye Movement Disorder
Disturbance In Attention
Vertigo
Hallucination, Visual
Asthenia
Bronchospasm
Chest Discomfort
Major Depression
Decreased Activity
Humerus Fracture
Hypoaesthesia
Ligament Sprain
Rheumatoid Factor
Increased
Memory Impairment
Depression
Productive Cough
Chest Pain
Toxicity To Various
Agents
Exostosis
Antinuclear Antibody
Positive
Pyrexia
Balance Disorder
Ill-Defined Disorder
Sleep Apnoea Syndrome
Psychiatric Symptom
Cognitive Disorder
Bundle Branch Block Right
Contusion
Agitation
Anxiety
Psychotic Disorder
Meniscus Lesion
Thinking Abnormal
Homicidal Ideation

Mitral Valve
Calcification
Respiratory Rate
Increased
Myalgia
Rash Papular
Insomnia
Fatigue
03-Apr-2012 09:37 AM Page: 653

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dyspnoea
Hyperhidrosis
Tremor Report Source Product Role Manufacturer Route Dose Duration
Dysthymic Disorder Lariam PS Roche ORAL
Oxygen Saturation Primaquine C
Decreased Cipro C
Rhinitis Allergic
Eosinophilia
Ventricular Extrasystoles
Aggression
Visual Impairment
Musculoskeletal Pain
Attention
Deficit/Hyperactivity
Disorder
Nocturia
Date:11/02/05ISR Number: 4818003-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Grand Mal Convulsion Lariam PS Roche ORAL 9 DAY
Initial or Prolonged Palpitations Lexinor C ORAL
Amnesia Malarone C ORAL
Visual Impairment
Fatigue
Disturbance In Attention
Headache
Date:11/02/05ISR Number: 4818006-7Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Age:38 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Balance Disorder Lariam PS Roche ORAL 15 DAY
Initial or Prolonged Tinnitus
Disability
Nystagmus
Hearing Impaired
Dizziness
Vertigo
Diarrhoea
Nausea
Date:11/03/05ISR Number: 4821792-3Report Type:Expedited (15-DaCompany Report #385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Disturbance In Attention
Memory Impairment
Toxicity To Various
Agents

Mood Swings
Bronchopneumonia
Nocturia
Arthralgia
Musculoskeletal Stiffness
Sputum Culture
Joint Dislocation
Vestibular Disorder
03-Apr-2012 09:37 AM Page: 654

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Cognitive Disorder
Agitation
Depression
Vertigo
Visual Impairment
Hallucination, Visual
Asthenia
Dizziness
Loss Of Libido
Convulsion
Dissociation
Meniscus Lesion
Respiratory Fume
Inhalation Disorder
Selective Iga
Immunodeficiency
Haemarthrosis
Homicidal Ideation
Insomnia
Stress
Hiatus Hernia
Dysthymic Disorder
Dehydration
Palpitations
Rash Papular
Bronchial Hyperreactivity
Exostosis
Amnesia
Coordination Abnormal
Tinnitus
Gait Disturbance
Mucosal Inflammation
Hypervigilance
Eye Movement Disorder
Sleep Apnoea Syndrome
Mitral Valve
Calcification
Electroencephalogram
Abnormal
Nightmare
Balance Disorder
Electrocardiogram St
Segment Depression
Panic Attack
Accident
Decreased Appetite
Intentional Self-Injury
Nystagmus
Derealisation
Hypertension
Rheumatoid Factor
Increased
Rhinitis Allergic

Myalgia
Marital Problem
Medication Error
Chondropathy
Fatigue
Self-Medication
Electrocardiogram St
Segment Abnormal
03-Apr-2012 09:37 AM Page: 655

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Headache
Blood Pressure Increased
Paranoia Report Source Product Role Manufacturer Route Dose Duration
Contusion Other Lariam
Blood Potassium Decreased
(Mefloquine
Acute Coronary Syndrome Hydrochloride) PS ORAL ORAL
Asthma
Primaquine
Nodule
(Primaquine
Bacterial Infection Phosphate) C
Haemophilus Infection
Cipro
Mitral Valve Incompetence
(Ciprofloxacin
Tremor Hydrochloride) C
Eosinophilia
Hallucination
Suicidal Ideation
Product Quality Issue
Fall
Deafness
Chronic Sinusitis
Physical Assault
Weight Decreased
Respiratory Rate
Increased
Oxygen Saturation
Decreased
Ventricular Extrasystoles
Joint Lock
Humerus Fracture
Ototoxicity
Aggression
Anxiety
Poor Quality Drug
Administered
Productive Cough
Hypoaesthesia
Ligament Sprain
Antinuclear Antibody
Positive
Weight Increased
Bundle Branch Block Right
Post-Traumatic Stress
Disorder
Hyperhidrosis
Emotional Disorder
Impulsive Behaviour
Abnormal Dreams
Date:11/04/05ISR Number: 4820968-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
PT
Disturbance In Attention

Initial or Prolonged
Disability
Vertigo
Asthenia
Chest Pain
Major Depression
Toxicity To Various
Agents
Convulsion
Nocturia
03-Apr-2012 09:37 AM Page: 656

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Coordination Abnormal
Electrocardiogram St
Segment Depression
Panic Attack
Skin Mass
Productive Cough
Chest Discomfort
Hypertension
Psychotic Disorder
Homicidal Ideation
Oxygen Saturation
Decreased
Dizziness
Haemarthrosis
Decreased Appetite
Priapism
Weight Increased
Snoring
Agitation
Selective Iga
Immunodeficiency
Meniscus Lesion
Mitral Valve Incompetence
Ventricular Extrasystoles
Electrocardiogram Qrs
Complex Prolonged
Disease Recurrence
Partner Stress
Libido Decreased
Paranoia
Dissociation
Derealisation
Acute Coronary Syndrome
Insomnia
Sleep Apnoea Syndrome
Joint Dislocation
Generalised Anxiety
Disorder
Post-Traumatic Stress
Disorder
Decreased Activity
Asthma
Dehydration
Nystagmus
Eye Movement Disorder
Ligament Sprain
Hyperkeratosis
Tinnitus
Gait Disturbance
Sputum Culture Positive
Bronchial Hyperreactivity
Nightmare
Loss Of Consciousness

Arthralgia
Musculoskeletal Stiffness
Abnormal Behaviour
Visual Impairment
Hallucination, Visual
Balance Disorder
Suicidal Ideation
Cranial Nerve Disorder
03-Apr-2012 09:37 AM Page: 657

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Tremor
Mitral Valve
Calcification
Respiratory Rate
Increased
Antinuclear Antibody
Positive
Rhinitis Allergic
Rash Papular
Eosinophilia
Electrocardiogram T Wave
Abnormal
Bronchopneumonia
Mood Altered
Deafness
Emotional Disorder
Blood Pressure Increased
Bronchospasm
Headache
Panic Disorder
Self-Injurious Ideation
Fall
Musculoskeletal Pain
Hyperhidrosis
Thinking Abnormal
Bundle Branch Block Right
Exostosis
Hypoaesthesia
Contusion
Pyrexia
Bacterial Infection
Amnesia
Apathy
Aggression
Anxiety
Memory Impairment
Fatigue
Ill-Defined Disorder
Dyspnoea
Psychiatric Symptom
Cognitive Disorder
Dysthymic Disorder
Attention
Deficit/Hyperactivity
Disorder
Rheumatoid Factor
Increased
Myalgia
Chronic Sinusitis
Upper Respiratory Tract
Infection
Vestibular Disorder
Injury

Palpitations
Wheezing
Blood Potassium Decreased
Tongue Disorder
Mood Swings
Depression
Humerus Fracture
Weight Decreased
03-Apr-2012 09:37 AM Page: 658

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hiatus Hernia
Mucous Membrane Disorder
Haemophilus Infection Report Source Product Role Manufacturer Route Dose Duration
Hypervigilance Lariam PS Roche ORAL
Respiratory Fume Primaquine C
Inhalation Disorder Cipro C
Feeling Abnormal
Date:11/09/05ISR Number: 4823715-XReport Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Age:38 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Tinnitus Lariam PS Roche ORAL TAKEN ON 22
Initial or Prolonged Diarrhoea FEB, 01 MAR
Hearing Impaired
AND 08 MAR
Nausea 2005. 15 DAY
Vertigo
Dizziness
Nystagmus
Balance Disorder
Date:11/11/05ISR Number: 4826347-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-354748 Age:44 YR Gender:Male I/FU:F
Outcome
Disability
PT
Hepatic Failure
Tremor
Diarrhoea
Disturbance In Attention
Toxicity To Various
Agents
Post-Traumatic Stress
Disorder
Decreased Appetite
Mania
Hallucination
Visual Field Defect
Nausea
Depressed Level Of
Consciousness
Ototoxicity
Conduction Disorder
Hyperacusis
Balance Disorder
Incontinence
General Symptom
Cough
Migraine
Tardive Dyskinesia
Vestibular Disorder
Suicidal Ideation

Tinnitus
Irritability
Muscle Twitching
Confusional State
Cranial Nerve Disorder
Insomnia
Photosensitivity Reaction
Anxiety
03-Apr-2012 09:37 AM Page: 659

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Asthenia
Obsessive Thoughts
Yellow Skin Report Source Product Role Manufacturer Route Dose Duration
Lacrimation Increased Lariam PS Roche ORAL 23 TABLETS
Paranoia
DISPENSED.
Photophobia Sudafed C
Aggression
Amnesia
Jaw Disorder
Cognitive Disorder
Motor Dysfunction
Dysphemia
Visual Impairment
Panic Attack
Anger
Depression
Thirst
Gait Disturbance
Gilbert'S Syndrome
Abnormal Dreams
Syncope
Vomiting
Mood Swings
Endolymphatic Hydrops
Dysarthria
Bipolar Disorder
Date:11/11/05ISR Number: 4826351-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Insomnia
Aggression
Sleep Apnoea Syndrome
Fall
Decreased Activity
Dysthymic Disorder
Humerus Fracture
Respiratory Rate
Increased
Rash Papular
Memory Impairment
Mood Swings
Visual Impairment
Selective Iga
Immunodeficiency
Major Depression
Generalised Anxiety
Disorder
Post-Traumatic Stress
Disorder
Musculoskeletal Pain

Antinuclear Antibody
Positive
Myalgia
Abnormal Behaviour
Asthenia
Hypoaesthesia
Rhinitis Allergic
Depression
03-Apr-2012 09:37 AM Page: 660

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Bronchial Hyperreactivity
Chest Pain
Asthma Report Source Product Role Manufacturer Route Dose Duration
Homicidal Ideation Lariam PS Roche ORAL
Dehydration Primaquine C
Ligament Sprain Cipro C
Contusion
Ventricular Extrasystoles
Balance Disorder
Ill-Defined Disorder
Chest Discomfort
Cranial Nerve Disorder
Hypertension
Psychotic Disorder
Convulsion
Nystagmus
Anxiety
Disturbance In Attention
Hallucination, Visual
Suicidal Ideation
Productive Cough
Dyspnoea
Psychiatric Symptom
Tremor
Thinking Abnormal
Cognitive Disorder
Attention
Deficit/Hyperactivity
Disorder
Nocturia
Vertigo
Fatigue
Headache
Panic Disorder
Meniscus Lesion
Hyperhidrosis
Mitral Valve
Calcification
Weight Decreased
Eye Movement Disorder
Pyrexia
Agitation
Joint Dislocation
Self-Injurious Ideation
Toxicity To Various
Agents
Bundle Branch Block Right
Mitral Valve Incompetence
Exostosis
Oxygen Saturation
Decreased
Rheumatoid Factor
Increased

Eosinophilia
03-Apr-2012 09:37 AM Page: 661

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/14/05ISR Number: 4827825-2Report Type:Direct Company Report #CTU 262994 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Feeling Abnormal Lariam-Mefloquine-
Disturbance In Attention Roche PS Roche ORAL 1 PILL PER
Impaired Driving Ability
WEEK 11 WEEKS
Visual Impairment
PO
Raynaud'S Phenomenon
Generalised Anxiety
Disorder
Fatigue
Suicidal Ideation
Panic Attack
Tremor
Abdominal Pain Upper
Nervousness
Thinking Abnormal
Date:11/14/05ISR Number: 4827832-XReport Type:Direct Company Report #CTU 262979 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nausea Lariam PS ORAL ONE PILL ONCE
Required Weight Decreased WEEKLY PO
Intervention to
Depression
Prevent Permanent
Impairment/Damage
Anxiety
Nightmare
Hallucination
Skin Discomfort
Social Avoidant Behaviour
Paranoia
Date:11/14/05ISR Number: 4832250-4Report Type:Expedited (15-DaCompany Report #385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Abnormal Behaviour
Agitation
Anxiety
Disturbance In Attention
Hallucination, Visual
Bronchopneumonia
Acquired Diaphragmatic
Eventration
Electrocardiogram
Repolarisation
Abnormality
Tinnitus
Mitral Valve Incompetence
Electroencephalogram
Abnormal

Nightmare
Dysthymic Disorder
Priapism
Paranoia
Nystagmus
Rheumatoid Factor
Increased
Snoring
03-Apr-2012 09:37 AM Page: 662

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Bundle Branch Block Right
Aggression
Mood Swings
Depression
Electrocardiogram St
Segment Abnormal
Cardiac Stress Test
Abnormal
Deafness
Inflammation
Sputum Culture Positive
Marital Problem
Attention
Deficit/Hyperactivity
Disorder
Visual Field Defect
Impulsive Behaviour
Abnormal Dreams
Weight Increased
Chest Pain
Coronary Artery Disease
Generalised Anxiety
Disorder
Pyrexia
Rash
Joint Crepitation
Arthroscopy
Gait Disturbance
Major Depression
Apathy
Respiratory Rate
Increased
Convulsion
Dissociation
Cognitive Disorder
Vital Functions Abnormal
Tongue Disorder
Musculoskeletal Pain
Musculoskeletal Stiffness
Insomnia
Chondroplasty
Fatigue
Pain
Headache
Panic Attack
Rapid Eye Movements Sleep
Abnormal
Hyperhidrosis
Accident
Libido Decreased
Eye Movement Disorder
Hypertension
Memory Impairment

Chest Discomfort
Self-Medication
Stress
Dizziness
Emotional Disorder
Joint Dislocation
Exostosis
Humerus Fracture
03-Apr-2012 09:37 AM Page: 663

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Eosinophilia
Psychomotor Skills
Impaired
Loss Of Consciousness
Palpitations
Wheezing
Rhinitis Allergic
Acute Coronary Syndrome
Thinking Abnormal
Speech Disorder
Asthma
Poor Quality Drug
Administered
Vertigo
Coordination Abnormal
Fall
Bronchial Hyperreactivity
Haemarthrosis
Post-Traumatic Stress
Disorder
Tremor
Divorced
Physical Assault
Weight Decreased
Hypervigilance
Derealisation
Ventricular Extrasystoles
Contusion
Antinuclear Antibody
Positive
Cough
Nocturia
Myalgia
Visual Impairment
Suicidal Ideation
Mental Disorder
Dyspnoea
Mood Altered
Hiatus Hernia
Chronic Sinusitis
Haemophilus Infection
Bacterial Infection
Selective Iga
Immunodeficiency
Vestibular Disorder
Amnesia
Decreased Appetite
Feeling Abnormal
Psychiatric Symptom
Heart Rate Decreased
Hypoaesthesia
Meniscus Lesion
Blood Potassium Increased

Rash Papular
Balance Disorder
Toxicity To Various
Agents
Productive Cough
Respiratory Tract
Infection
Sleep Apnoea Syndrome
03-Apr-2012 09:37 AM Page: 664

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Mitral Valve
Calcification
Mental Retardation Report Source Product Role Manufacturer Route Dose Duration
Dehydration Other Lariam (Mefloquine
Self-Injurious Ideation Hydrochloride) 250
Ligament Sprain Mg PS ORAL ORAL
Movement Disorder
Primaquine
Eye Disorder
(Primaquine
Drug Ineffective Phosphate) C
Arthralgia
Cipro (Ciprofloxacin
Joint Lock Hydrochloride) C
Date:11/15/05ISR Number: 4828508-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Generalised Anxiety Lariam PS Roche UNKNOWN
Initial or Prolonged Disorder
Disability
Mental Disorder
Major Depression
Self Esteem Decreased
Panic Attack
Amnesia
Suicidal Ideation
Mood Swings
Memory Impairment
Date:11/17/05ISR Number: 4832517-XReport Type:Direct Company Report #CTU 263333 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Lariam Laroche PS Laroche ORAL 1 PILL WEEKLY
Required Insomnia PO
Intervention to
Panic Attack
Prevent Permanent
Impairment/Damage
Heart Rate Increased
Depression
Feeling Of Despair
Suicidal Ideation
Date:11/21/05ISR Number: 4833061-6Report Type:Expedited (15-DaCompany Report #FR-ROCHE-415971 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Upper Motor Neurone Lariam PS Roche ORAL
Lesion Engerix B SS INTRAMUSCULAR THE PATIENT
Amyotrophy
RECEIVED
THREE
INJECTIONS IN
1995 (MARCH, 189 DAY

Date:11/21/05ISR Number: 4835576-3Report Type:Expedited (15-DaCompany Report #385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Abnormal Behaviour
Major Depression
Weight Increased
03-Apr-2012 09:37 AM Page: 665

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Snoring
Musculoskeletal Stiffness
Sputum Culture Positive
Exostosis
Insomnia
Disturbance In Attention
Vertigo
Affective Disorder
Bronchial Hyperreactivity
Hyperhidrosis
Dehydration
Hypoaesthesia
Hypertension
Electrocardiogram St
Segment Depression
Marital Problem
Occupational Exposure To
Dust
Occupational Exposure To
Toxic Agent
Agitation
Memory Impairment
Visual Impairment
Tinnitus
Chronic Sinusitis
Nightmare
Chest Discomfort
Blood Pressure Increased
Heart Rate Decreased
Posterior Capsule Rupture
Rheumatoid Factor
Increased
Bronchopneumonia
Accident At Work
Mood Swings
Depression
Mental Disorder
Disease Recurrence
Haemorrhage
Homicidal Ideation
Loss Of Consciousness
Myalgia
Asthma
Rash
Decreased Activity
Poor Quality Drug
Administered
Haemophilus Infection
Suicidal Ideation
Dizziness
Fall
Gait Disturbance
Sleep Apnoea Syndrome

Mitral Valve
Calcification
Electroencephalogram
Abnormal
Post-Traumatic Stress
Disorder
Vision Blurred
Ventricular Extrasystoles
03-Apr-2012 09:37 AM Page: 666

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Tongue Injury
Hiatus Hernia
Product Quality Issue Report Source Product Role Manufacturer Route Dose Duration
Electrocardiogram Other Lariam (Mefloquine
Repolarisation Hydrochloride) 250
Abnormality Mg PS ORAL ORAL
Generalised Anxiety
Primaquine
Disorder
(Primaquine
Deafness Phosphate) C
Joint Dislocation
Cipro (Ciprofloxacin
Cognitive Disorder Hydrochloride) C
Amnesia
Convulsion
Contusion
Coronary Artery Disease
Self-Medication
Stress
Electrocardiogram St
Segment Abnormal
Humerus Fracture
Hallucination, Visual
Balance Disorder
Coordination Abnormal
Toxicity To Various
Agents
Headache
Selective Iga
Immunodeficiency
Mitral Valve Incompetence
Vestibular Disorder
Dysthymic Disorder
Pain
Fatigue
Acute Coronary Syndrome
Aggression
Panic Attack
Upper Respiratory Tract
Infection
Emotional Disorder
Tremor
Eosinophilia
Weight Decreased
Antinuclear Antibody
Positive
Rhinitis Allergic
Bundle Branch Block Right
Haemarthrosis
Date:11/28/05ISR Number: 4837942-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-424819 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Psychotic Disorder Lariam PS Roche ORAL
03-Apr-2012 09:37 AM Page: 667

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/28/05ISR Number: 4837946-6Report Type:Expedited (15-DaCompany Report #HU-ROCHE-424837 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Mefloquine
Initial or Prolonged Persecutory Delusion Hydrochloride PS Roche UNKNOWN TOTAL DOSE
Hallucination, Auditory REPORTED AS 2
TABLETS ( 1
TABLET = 250
MG OF ACTIVE
Date:11/28/05ISR Number: 4837983-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-411818 Age:15 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Creatine Lariam PS Roche ORAL 28 DAY
Phosphokinase Increased Ritonavir C ORAL
Epzicom C ORAL
Fosamprenavir C ORAL
Date:11/29/05ISR Number: 4839920-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-425462 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aphasia Lariam PS Roche UNKNOWN
Catatonia
Psychotic Disorder
Date:12/02/05ISR Number: 4844064-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Selective Iga
Immunodeficiency
Chest Discomfort
Sleep Apnoea Syndrome
Meniscus Lesion
Decreased Activity
Mitral Valve
Calcification
Mitral Valve Incompetence
Dehydration
Contusion
Rash Papular
Bronchopneumonia
Visual Acuity Reduced
Haemarthrosis
Aggression
Anxiety
Depression
Suicidal Ideation

Productive Cough
Ill-Defined Disorder
Headache
Joint Dislocation
Hyperhidrosis
Nystagmus
Stress
Dizziness
03-Apr-2012 09:37 AM Page: 668

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Bacterial Infection
Emotional Disorder
Amnesia
Hypervigilance
Snoring
Somnolence
Agitation
Hallucination, Visual
Dyspnoea
Chest Pain
Weight Decreased
Ventricular Extrasystoles
Deafness
Gait Disturbance
Electroencephalogram
Abnormal
Mental Impairment
Vision Blurred
Loss Of Consciousness
Paranoia
Hypertension
Tremor
Exostosis
Convulsion
Hypoaesthesia
Electrocardiogram St
Segment Abnormal
Vestibular Disorder
Impulsive Behaviour
Drug Effect Decreased
Memory Impairment
Mood Swings
Visual Impairment
Balance Disorder
Asthenia
Self-Injurious Ideation
Musculoskeletal Pain
Asthma
Bundle Branch Block Right
Humerus Fracture
Attention
Deficit/Hyperactivity
Disorder
Conduction Disorder
Upper Respiratory Tract
Infection
Rapid Eye Movements Sleep
Abnormal
Priapism
Palpitations
Acute Coronary Syndrome
Abnormal Behaviour
Insomnia

Panic Disorder
Psychotic Disorder
Major Depression
Generalised Anxiety
Disorder
Fall
Respiratory Rate
Increased
03-Apr-2012 09:37 AM Page: 669

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Rheumatoid Factor
Increased
Myalgia Report Source Product Role Manufacturer Route Dose Duration
Injury Lariam PS Roche ORAL
Marital Problem Primaquine C
Derealisation Cipro C
Rash
Bronchial Hyperreactivity
Cranial Nerve Disorder
Psychiatric Symptom
Thinking Abnormal
Cognitive Disorder
Homicidal Ideation
Dysthymic Disorder
Toxicity To Various
Agents
Antinuclear Antibody
Positive
Rhinitis Allergic
Eosinophilia
Acquired Diaphragmatic
Eventration
Cardiac Stress Test
Abnormal
Panic Attack
Chronic Sinusitis
Dissociative Disorder
Disturbance In Attention
Vertigo
Fatigue
Post-Traumatic Stress
Disorder
Oxygen Saturation
Decreased
Eye Movement Disorder
Ligament Sprain
Nocturia
Pyrexia
Hyperkeratosis
Hiatus Hernia
Tinnitus
Haemophilus Infection
Nightmare
Musculoskeletal Stiffness
Date:12/02/05ISR Number: 4844102-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Vestibular Disorder
Dry Eye
Dry Mouth

Gastrooesophageal Reflux
Disease
Abnormal Dreams
Bipolar Disorder
Balance Disorder
Confusional State
Anxiety
Diastolic Dysfunction
03-Apr-2012 09:37 AM Page: 670

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Blood Cholesterol
Increased
Blood Triglycerides
Increased
Memory Impairment
Upper Respiratory Tract
Infection
Bursitis
Gastrointestinal Disorder
Angina Pectoris
Dehydration
Snoring
Oral Disorder
Acrochordon
Visual Impairment
Scratch
Contusion
Joint Dislocation
Colitis
Mitral Valve Prolapse
Restrictive Pulmonary
Disease
Bronchitis
Diarrhoea
Blood Creatine
Phosphokinase Increased
Nocturia
Major Depression
Amnesia
Skin Disorder
Ventricular Hypertrophy
Dry Skin
Clumsiness
Tinnitus
Dyspnoea
Depression
Total Lung Capacity
Decreased
Bronchospasm
Cardiac Murmur
Sinus Tachycardia
Chest Discomfort
Constipation
Angiotensin Converting
Enzyme Increased
Blood Glucose Increased
Upper-Airway Cough
Syndrome
Haemorrhoids
Adjustment Disorder With
Depressed Mood
Affective Disorder
Psychotic Disorder

Schizoaffective Disorder
Tremor
Aggression
Headache
Hypertension
Rash
Low Density Lipoprotein
Increased
03-Apr-2012 09:37 AM Page: 671

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Total Cholesterol/Hdl
Ratio Decreased
Rhinitis Report Source Product Role Manufacturer Route Dose Duration
Asthma Lariam PS Roche ORAL A TOTAL OF 6
Coordination Abnormal
TABLETS WERE
Adjustment Disorder
INGESTED.
Anhedonia Zoloft C UNKNOWN
Intervertebral Disc
Degeneration
Fatigue
Somnolence
Sleep Apnoea Syndrome
Viral Infection
Arthralgia
Weight Increased
Exfoliative Rash
Vitiligo
Insomnia
Date:12/02/05ISR Number: 4844105-XReport Type:Expedited (15-DaCompany Report #GB-ROCHE-425626 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Confusional State Lariam PS Roche ORAL 56 DAY
Asthma
Dizziness
Date:12/12/05ISR Number: 4851571-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-419686 Age:38 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Thrombocytopenia Lariam PS Roche ORAL DOSING
Initial or Prolonged Leukopenia REGIMEN
Neutropenia REPORTED AS 3
Hepatic Enzyme Increased TABLETS, 2
Hyperthermia TABLETS THEN 2 DAY
Imovane
C
Date:12/12/05ISR Number: 4851573-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Somnolence
Sleep Apnoea Syndrome
Viral Infection
Bronchitis
Vitiligo
Angiotensin Converting
Enzyme Increased
Coordination Abnormal

Memory Impairment
Schizoaffective Disorder
Vision Blurred
Myalgia
Anxiety
Ventricular Hypertrophy
Total Lung Capacity
Decreased
03-Apr-2012 09:37 AM Page: 672

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Bronchospasm
Chest Discomfort
Insomnia
Major Depression
Paraesthesia
Confusional State
Skin Disorder
Upper-Airway Cough
Syndrome
Asthma
Bipolar Disorder
Haemorrhoids
Psychotic Disorder
Mitral Valve Prolapse
Angina Pectoris
Restrictive Pulmonary
Disease
Arthralgia
Rash
Weight Increased
Sinus Tachycardia
Low Density Lipoprotein
Increased
Snoring
Oral Disorder
Abnormal Dreams
Adjustment Disorder With
Depressed Mood
Amnesia
Fatigue
Total Cholesterol/Hdl
Ratio Decreased
Diarrhoea
Blood Creatine
Phosphokinase Increased
Constipation
Scratch
Affective Disorder
Aggression
Tinnitus
Self Esteem Decreased
Gastrointestinal Disorder
Depression
Diastolic Dysfunction
Blood Triglycerides
Increased
Exfoliative Rash
Dry Eye
Acrochordon
Gastrooesophageal Reflux
Disease
Hypersensitivity
Dyspnoea

Headache
Dehydration
Dry Mouth
Nocturia
Rhinitis
Contusion
Cold Sweat
Vestibular Disorder
03-Apr-2012 09:37 AM Page: 673

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hypertension
Cardiac Murmur
Blood Cholesterol Report Source Product Role Manufacturer Route Dose Duration
Increased Lariam PS Roche ORAL A TOTAL OF 6
Dry Skin
TABLETS WERE
Blood Glucose Increased
INGESTED.
Clumsiness Zoloft C UNKNOWN
Visual Impairment
Balance Disorder
Tremor
Dizziness
Date:12/12/05ISR Number: 4851582-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-427130 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paralysis Lariam PS Roche UNKNOWN
Date:12/12/05ISR Number: 4853723-4Report Type:Expedited (15-DaCompany Report #343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Angina Pectoris
Somnolence
Bipolar Disorder
Weight Increased
Sinus Tachycardia
Dry Skin
Chest Discomfort
Blood Glucose Increased
Myalgia
Feelings Of Worthlessness
Hallucination, Visual
Sinusitis
Amnesia
Dyspnoea
Headache
Balance Disorder
Scratch
Contusion
Constipation
Tremor
Peripheral Sensory
Neuropathy
Sjogren'S Syndrome
Confusional State
Skin Disorder
Hypertension
Clumsiness
Asthma
Psychotic Disorder

Bronchitis
Blood Cholesterol
Increased
Blood Triglycerides
Increased
Low Density Lipoprotein
Increased
Exfoliative Rash
03-Apr-2012 09:37 AM Page: 674

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dry Mouth
Snoring
Aggression
Pharyngeal Disorder
Chronic Fatigue Syndrome
Obesity
Restrictive Pulmonary
Disease
Colitis
Mental Status Changes
Intervertebral Disc
Degeneration
Bursitis
Cold Sweat
Dizziness
Anxiety
Gastrointestinal Disorder
Ventricular Hypertrophy
Lung Disorder
Adjustment Disorder
Depressive Symptom
Schizoaffective Disorder
Rash
Cardiac Murmur
Diarrhoea
Upper-Airway Cough
Syndrome
Listless
Sinus Disorder
Anal Neoplasm
Anhedonia
Tendonitis
Fatigue
Visual Impairment
Coordination Abnormal
Arthralgia
Acrochordon
Anal Fissure
Psychomotor Hyperactivity
Nightmare
Photosensitivity Reaction
Asthenia
Diplopia
Disorientation
Vestibular Disorder
Mitral Valve Prolapse
Abnormal Dreams
Affective Disorder
Total Cholesterol/Hdl
Ratio Increased
Dry Eye
Nocturia
Insomnia

Sleep Apnoea Syndrome
Haemorrhoids
Dyspnoea Exertional
Rectal Haemorrhage
Feeling Guilty
Disturbance In Attention
Hallucination, Auditory
Paraesthesia
03-Apr-2012 09:37 AM Page: 675

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Vision Blurred
Self Esteem Decreased
Major Depression Report Source Product Role Manufacturer Route Dose Duration
Bronchospasm Consumer Lariam (Mefloquine
Dehydration Other Hydrochloride) 250
Blood Creatine Mg PS ORAL 250 MG 1 PER
Phosphokinase Increased
1 WEEK ORAL
Vitiligo
Zoloft (Sertraline
Gastrooesophageal Reflux Hydrochloride) C
Disease
Neck Pain
Bronchial Hyperreactivity
Collagen-Vascular Disease
Road Traffic Accident
Musculoskeletal Stiffness
Post-Traumatic Neck
Syndrome
Cognitive Disorder
Depression
Diastolic Dysfunction
Memory Impairment
Viral Infection
Angiotensin Converting
Enzyme Increased
Rhinitis
Upper Respiratory Tract
Infection
Pain In Jaw
Weight Decreased
Tinnitus
Hyperhidrosis
Date:12/12/05ISR Number: 4853725-8Report Type:Expedited (15-DaCompany Report #385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Amnesia
Coordination Abnormal
Productive Cough
Tinnitus
Sputum Culture Positive
Mitral Valve
Calcification
Dysthymic Disorder
Weight Decreased
Social Avoidant Behaviour
Self-Injurious Ideation
Paranoia
Derealisation
Contusion
Wheezing
Rash

Arthralgia
Agitation
Disturbance In Attention
Loose Body In Joint
Bronchopneumonia
Self-Medication
Electrocardiogram St
Segment Abnormal
03-Apr-2012 09:37 AM Page: 676

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Fall
Selective Iga
Immunodeficiency
Electroencephalogram
Abnormal
Homicidal Ideation
Apathy
Psychiatric Symptom
Ligament Sprain
Coronary Artery Disease
Vertigo
Injury
Hiatus Hernia
Gait Disturbance
Condition Aggravated
Chronic Sinusitis
Mental Impairment
Emotional Disorder
Post-Traumatic Stress
Disorder
Tremor
Eosinophilia
Thinking Abnormal
Hypertension
Physical Assault
Decreased Appetite
Eye Movement Disorder
Meniscus Lesion
Weight Increased
Rhinitis Allergic
Chest Pain
Blood Potassium Decreased
Acute Coronary Syndrome
Speech Disorder
Asthma
Arthropathy
Insomnia
Toxicity To Various
Agents
Mood Altered
Dizziness
Sleep Apnoea Syndrome
Vestibular Disorder
Occupational Exposure To
Noise
Visual Field Defect
Cognitive Disorder
Accident
Convulsion
Nystagmus
Dissociation
Anxiety Disorder
Nocturia

Non-Cardiac Chest Pain
Generalised Anxiety
Disorder
Suicidal Ideation
Poor Quality Drug
Administered
Mental Disorder
Unevaluable Event
03-Apr-2012 09:37 AM Page: 677

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Chest Discomfort
Bronchial Hyperreactivity
Mitral Valve Incompetence
Humerus Fracture
Hyperhidrosis
Hypoaesthesia
Eye Disorder
No Therapeutic Response
Cough
Myalgia
Joint Lock
Decreased Activity
Aggression
Visual Impairment
Hallucination, Visual
Product Quality Issue
Stress
Acquired Diaphragmatic
Eventration
Headache
Haemophilus Infection
Haemarthrosis
Occupational Exposure To
Toxic Agent
Loss Of Consciousness
Occupational Exposure To
Dust
Psychotic Disorder
Impaired Work Ability
Oxygen Saturation
Decreased
Rheumatoid Factor
Increased
Hallucination, Auditory
Blood Creatine
Phosphokinase Mb Normal
Pyrexia
Musculoskeletal Pain
Abnormal Behaviour
Anxiety
Mood Swings
Depression
Balance Disorder
Fatigue
Electrocardiogram St
Segment Depression
Exercise Test Abnormal
Deafness
Bacterial Test Positive
Exostosis
Divorced
Nightmare
Loss Of Libido

Priapism
Respiratory Rate
Increased
Panic Disorder
Snoring
Tongue Disorder
Chondropathy
Dyspnoea
03-Apr-2012 09:37 AM Page: 678

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Panic Attack
Joint Dislocation
Marital Problem Report Source Product Role Manufacturer Route Dose Duration
Occupational Exposure To Other Lariam (Mefloquine
Air Contaminants Hydrochloride) 250
Dehydration Mg PS ORAL ORAL
Major Depression
Primaquine
Palpitations
(Primaquine
Hypervigilance Phosphate) C
Ventricular Extrasystoles
Cipro (Ciprofloxacin
Antinuclear Antibody Hydrochloride) C
Positive
Pulmonary Function
Challenge Test Abnormal
Bundle Branch Block Right
Rash Papular
Feeling Abnormal
Musculoskeletal Stiffness
Upper Respiratory Tract
Infection
Date:12/13/05ISR Number: 4852051-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-427130 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asthenia Lariam PS Roche UNKNOWN
Paresis
Hypokinesia
Date:12/14/05ISR Number: 4853197-3Report Type:Expedited (15-DaCompany Report #JP-ROCHE-426965 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cyanosis Lariam PS Roche UNKNOWN PATIENT TOOK
Initial or Prolonged Dyspnoea FOUR DOSES. 21 DAY
Pneumonia
Red Blood Cell
Sedimentation Rate
Increased
C-Reactive Protein
Increased
Sinus Tachycardia
Blood Lactate
Dehydrogenase Increased
Respiratory Failure
Date:12/16/05ISR Number: 4855695-5Report Type:Expedited (15-DaCompany Report #CA-ROCHE-427697 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Irritability Mefloquine
Personality Disorder Hydrochloride PS Roche ORAL 3 WK
Logorrhoea Doxycycline C ORAL
Aggression
Insomnia
Thinking Abnormal
Neurosis
Cognitive Disorder
03-Apr-2012 09:37 AM Page: 679

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/16/05ISR Number: 4855703-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-427620 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaise Lariam PS Roche UNKNOWN 6 WK
Chest Pain Malarone C
Dizziness Typhoid Vaccine C ORAL
Tinnitus
Diphtheria And
Insomnia Tetanus Vaccine C
Fatigue Hepatitis A Vaccine C
Nausea Hepatitis B Vaccine C
Paraesthesia
Hypoaesthesia
Palpitations
Upper Respiratory Tract
Infection
Hypertension
Date:12/19/05ISR Number: 4864051-5Report Type:Direct Company Report #CTU 265337 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Insomnia Mefloquine (Lariam) PS ONCE PER WEEK
Agitation
Thinking Abnormal
Memory Impairment
Arthralgia
Neck Pain
Rash
Pruritus
Confusional State
Headache
Fatigue
Myalgia
Skin Disorder
Skin Lesion
Anxiety
Date:12/22/05ISR Number: 4864524-5Report Type:Expedited (15-DaCompany Report #IT-ROCHE-426078 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatitis Acute Lariam PS Roche ORAL 62 DAY
Date:12/22/05ISR Number: 4867674-2Report Type:Direct Company Report #CTU 265598 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Mental Disorder Lariam 150 Mg.
Other Serious Stress Not Sure Hoffman
Required Feeling Abnormal Laroche, Inc. PS Hoffman Laroche, Inc ORAL 1 PILL EVERY

Intervention to Self Injurious Behaviour WEEK PO
Prevent Permanent Paranoia
Impairment/Damage
03-Apr-2012 09:37 AM Page: 680

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/23/05ISR Number: 4865446-6Report Type:Expedited (15-DaCompany Report #AU-ROCHE-428550 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paranoia Mefloquine
Initial or Prolonged Agitation Hydrochloride PS Roche ORAL ONE DAY
Illusion TREATMENT. 1 DAY
Date:12/23/05ISR Number: 4865465-XReport Type:Expedited (15-DaCompany Report #CH-ROCHE-428290 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - General Physical Health Mefloquine
Initial or Prolonged Deterioration Hydrochloride PS Roche UNKNOWN RECEIVED A
Pulmonary Toxicity
TOTAL DOSE OF
Blood Pressure Decreased
Diffuse Alveolar Damage
1500MG OF
MEFLOQUINE
OVER 24 HOURS
Paracetamol
C
Halofantrine C FOR 48 HOURS
Date:12/23/05ISR Number: 4865509-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-420600 Age:40 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Inflammation Lariam PS Roche ORAL
Joint Swelling
Arrhythmia
Erythema
Chills
Dyspnoea
Date:12/28/05ISR Number: 4867307-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-407146 Age:64 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vision Blurred Lariam PS Roche ORAL 29 DAY
Initial or Prolonged Vertigo Xalacom SS TOPICAL
Atrioventricular Block Fenofibrate SS ORAL
Complete Captopril SS Roche ORAL
Fall
Atrioventricular Block
Date:12/28/05ISR Number: 4867316-6Report Type:Expedited (15-DaCompany Report #AU-ROCHE-429059 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Exposure During Lariam PS Roche ORAL 29 DAY
Pregnancy
Abortion Spontaneous

Date:12/28/05ISR Number: 4867318-XReport Type:Expedited (15-DaCompany Report #AU-ROCHE-429052 Age:42 YR Gender: I/FU:I
Outcome
Other Serious
PT
Oropharyngeal Pain
Nausea
03-Apr-2012 09:37 AM Page: 681

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dizziness
Hallucination
Vomiting Report Source Product Role Manufacturer Route Dose Duration
Dysphagia Lariam PS Roche ORAL 41 DAY
Mouth Ulceration Unspecified Drug C REPORTED AS
Pruritus
ADT.
Gastrooesophageal Reflux Havrix C
Disease
Date:12/28/05ISR Number: 4870956-1Report Type:Expedited (15-DaCompany Report #343474 Age:42 YR Gender:Male I/FU:F
Outcome
Disability
PT
Chest X-Ray Abnormal
Exercise Tolerance
Decreased
Impaired Work Ability
Palatal Disorder
Feelings Of Worthlessness
Sinusitis
Asthenia
Treatment Noncompliance
Hyperhidrosis
Amnesia
Gastrointestinal Disorder
Hypertension
Diastolic Dysfunction
Psychotic Disorder
Bronchospasm
Cardiac Murmur
Sinus Tachycardia
Aggression
Drug Intolerance
Collagen-Vascular Disease
Blood Triglycerides
Abnormal
Low Density Lipoprotein
Abnormal
Weight Decreased
Feeling Guilty
Cognitive Disorder
Dislocation Of Vertebra
Intervertebral Disc
Degeneration
Spinal X-Ray Abnormal
Vision Blurred
Injury
Restrictive Pulmonary
Disease
Bipolar Disorder
Blood Cholesterol
Increased

Rhinitis
Blood Cholesterol
Abnormal
Total Cholesterol/Hdl
Ratio Abnormal
Pharyngeal Disorder
Oxygen Saturation
Decreased
03-Apr-2012 09:37 AM Page: 682

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Weight Loss Poor
Drug Effect Decreased
Paraesthesia
Diplopia
Vestibular Disorder
Clumsiness
Asthma
Adjustment Disorder With
Depressed Mood
Schizoaffective Disorder
Diarrhoea
Insomnia
Hyperacusis
Nocturia
Jaw Disorder
Neoplasm
Musculoskeletal Pain
Post-Traumatic Neck
Syndrome
Rhinitis Perennial
Self Esteem Decreased
Headache
Angina Pectoris
Hypersomnia
Coordination Abnormal
Arthralgia
Bronchitis
Dehydration
Dry Skin
Dry Mouth
Upper-Airway Cough
Syndrome
Neck Pain
Listless
Disturbance In Attention
Cervical Spine Flattening
Tinnitus
Confusional State
Fatigue
Visual Impairment
Affective Disorder
Memory Impairment
Viral Infection
Rash
Vitiligo
Acrochordon
Angiotensin Converting
Enzyme Increased
Blood Glucose Increased
Gastrooesophageal Reflux
Disease
Sleep Apnoea Syndrome
Haemorrhoids

Oedema
Obesity
Myalgia
Rectal Haemorrhage
Colitis
Psychomotor Hyperactivity
Mental Status Changes
Nightmare
03-Apr-2012 09:37 AM Page: 683

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Musculoskeletal Stiffness
Brain Stem Auditory
Evoked Response Abnormal Report Source Product Role Manufacturer Route Dose Duration
Photosensitivity Reaction Consumer Lariam (Mefloquine
Cold Sweat Other Hydrochloride) 250
Multiple Allergies Mg PS ORAL 250 MG, 1 PER
Ventricular Hypertrophy
1 WEEK, ORAL
Scratch
Zoloft (Sertraline
Low Density Lipoprotein Hydrochloride) C
Increased
Chest Discomfort
Upper Respiratory Tract
Infection
Exercise Lack Of
Lung Neoplasm
Pulmonary Granuloma
Nausea
Anhedonia
Dizziness
Anxiety
Mitral Valve Prolapse
Depression
Abnormal Dreams
Condition Aggravated
Balance Disorder
Major Depression
Contusion
Snoring
Constipation
Tremor
Embolism Arterial
Musculoskeletal
Discomfort
Hallucinations, Mixed
Road Traffic Accident
Disorientation
Skin Disorder
Weight Increased
Blood Triglycerides
Increased
Total Cholesterol/Hdl
Ratio Decreased
Blood Creatine
Phosphokinase Increased
Exfoliative Rash
Dry Eye
Gastrointestinal Tract
Mucosal Discolouration
Date:01/04/06ISR Number: 4871979-9Report Type:Expedited (15-DaCompany Report #ZM-ROCHE-430119 Age:28 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nephrotic Syndrome Mefloquine
Initial or Prolonged Hydrochloride PS Roche ORAL 3 DAY
03-Apr-2012 09:37 AM Page: 684

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/05/06ISR Number: 4873359-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-429867 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pericardial Effusion Lariam PS Roche ORAL
Hypersensitivity
Arrhythmia
Myocarditis
Asthenia
Date:01/10/06ISR Number: 4876923-6Report Type:Expedited (15-DaCompany Report #DE-ROCHE-430544 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Lactate Lariam PS Roche UNKNOWN
Initial or Prolonged Dehydrogenase Increased Valette C ORAL
Jaundice
Blood Alkaline
Phosphatase Increased
Pyrexia
Epigastric Discomfort
Gallbladder Oedema
Hiatus Hernia
Cholecystitis Acute
Transaminases Increased
Ocular Icterus
Date:01/11/06ISR Number: 4879688-7Report Type:Expedited (15-DaCompany Report #2005-BP-21825RO Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dysphoria Foreign Mefloquine
Initial or Prolonged Nausea Literature (Mefloquine) PS ORAL 250 MG/WEEK X
Treatment Noncompliance Health 8 WEEKS (250
Dry Mouth Professional MG), PO
Weight Decreased
Alprazolam
Anxiety (Alprazolam) C
Asthenia
Fluoxetine
Tremor (Fluoxetine) C
Sleep Disorder
Depression
Agitation
Date:01/16/06ISR Number: 4881711-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-386256 Age:23 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Depression
Fear
Nervousness
Suicidal Ideation

Malaise
Paranoia
Toxicity To Various
Agents
Anxiety
Skin Odour Abnormal
Photosensitivity Reaction
Photophobia
03-Apr-2012 09:37 AM Page: 685

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Epistaxis
Abnormal Dreams
Feeling Abnormal Report Source Product Role Manufacturer Route Dose Duration
Lethargy Lariam PS Roche ORAL
Marijuana SS ORAL
Date:01/20/06ISR Number: 4889556-2Report Type:Direct Company Report #CTU 267348 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Panic Disorder Lariam 250 Mg Barr
Anxiety Laboratories, Inc. PS Barr Laboratories,
Inc. ORAL ONE 250 MG
PILL ONCE A
WEEK PO
Date:01/23/06ISR Number: 4891871-3Report Type:Expedited (15-DaCompany Report #430544 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hiatus Hernia Foreign Lariam (Mefloquine
Initial or Prolonged Cholecystitis Acute Literature Hydrochloride) PS
Health
Professional
Valette
(Dienogest/Ethinyl
Estradiol)
C
Date:01/24/06ISR Number: 4890014-XReport Type:Expedited (15-DaCompany Report #DK-ROCHE-430861 Age:34 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypoaesthesia Lariam PS Roche ORAL ORDINARY
White Blood Cell Count
GROWN-UP
Decreased
PROPHYLACTIC
Blood Thyroid Stimulating
LARIAM DOSIS.
Hormone Increased
Leukopenia
Date:01/24/06ISR Number: 4891009-2Report Type:Direct Company Report #CTU 267616 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dizziness Lariam PS ORAL 1 PER WEEK
Initial or Prolonged Heart Rate Irregular FIVE WEEKS PO
Panic Attack
Atrial Fibrillation
Chest Pain
Nausea
Anxiety

Date:01/26/06ISR Number: 4892620-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Age:42 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Illogical Thinking
Grand Mal Convulsion
Amnesia
03-Apr-2012 09:37 AM Page: 686

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disturbance In Attention
Headache
Visual Impairment Report Source Product Role Manufacturer Route Dose Duration
Palpitations Lariam PS Roche ORAL 9 DAY
Brain Injury Lexinor C ORAL
Fatigue Malarone C ORAL
Date:01/27/06ISR Number: 4894727-5Report Type:Direct Company Report #CTU 267976 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam PS 1 PILL PER
Required Paranoia WEEK
Intervention to
Weight Increased
Prevent Permanent Heart Rate Increased
Impairment/Damage Hypertension
Date:01/30/06ISR Number: 4895159-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002297 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicidal Ideation Imodium PS ORAL
Initial or Prolonged Overdose Gelonida SS ORAL
Liver Function Test Talvosilen SS ORAL
Abnormal Lariam SS ORAL 16 tablets.
Somnolence Talvosilen SS ORAL
Gelonida SS ORAL
Ibuprofen SS ORAL 20 tablets.
Date:01/30/06ISR Number: 4895544-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-426242 Age:10 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nightmare Lariam PS Roche UNKNOWN 25 DAY
Initial or Prolonged Syncope
Malaise
Urinary Incontinence
Visual Impairment
Date:01/31/06ISR Number: 4896641-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-418484 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Lung Disorder Lariam PS Roche ORAL
Date:02/01/06ISR Number: 4897778-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002297 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Suicidal Ideation Imodium PS ORAL
Initial or Prolonged Liver Function Test Gelonida SS ORAL
Abnormal Talvosilen SS ORAL
Somnolence Lariam SS ORAL 16 tablets.
Overdose Talvosilen SS ORAL
Gelonida SS ORAL
Ibuprofen SS ORAL 20 tablets.
03-Apr-2012 09:37 AM Page: 687

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/01/06ISR Number: 4898042-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mood Swings Lariam PS Roche UNKNOWN
Initial or Prolonged Amnesia
Disability
Self-Medication
Feeling Guilty
Memory Impairment
Suicidal Ideation
Fatigue
Mental Disorder
Major Depression
Generalised Anxiety
Disorder
Anxiety
Nervousness
Self Esteem Decreased
Decreased Interest
Panic Attack
Social Phobia
Disturbance In Attention
Date:02/02/06ISR Number: 4899221-3Report Type:Expedited (15-DaCompany Report #AU-ROCHE-433139 Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Lariam PS Roche ORAL 15 DAY
Initial or Prolonged Dizziness
Haemolytic Anaemia
Headache
Nausea
Myalgia
Cardiac Murmur
Alopecia
Date:02/03/06ISR Number: 4900280-XReport Type:Expedited (15-DaCompany Report #SE-ROCHE-392506 Age:42 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Palpitations Lariam PS Roche ORAL 9 DAY
Initial or Prolonged Visual Impairment Lexinor C ORAL
Grand Mal Convulsion Malarone C ORAL
Amnesia
Disturbance In Attention
Headache
Feeling Abnormal
Fatigue
Cerebral Disorder

Date:02/09/06ISR Number: 4909064-XReport Type:Direct Company Report #CTU 269215 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Deafness Mefloquine 250 Mg
Intervention to Generic PS ORAL 250 MG 3 X
Prevent Permanent WITHIN' 5
Impairment/Damage
DAYS PO
03-Apr-2012 09:37 AM Page: 688

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/10/06ISR Number: 4910665-3Report Type:Direct Company Report #USP 57779 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Drug Dispensing Error Lariam PS Roche TABLET
Medication Error Zaroxolyn SS Cell Tech TABLET
Wrong Drug Administered
Date:02/15/06ISR Number: 4912780-7Report Type:Expedited (15-DaCompany Report #SE-ROCHE-433848 Age:73 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nephropathy Toxic Lariam PS Roche ORAL 8 WK
Initial or Prolonged
Date:02/15/06ISR Number: 4912790-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome
Disability
PT
Insomnia
Nightmare
Irritable Bowel Syndrome
Disturbance In Attention
Pharyngitis Streptococcal
Rash
Phonophobia
Blood Pressure Increased
Epididymitis
Agitation
Dizziness
Mood Swings
Anxiety Disorder
Fatigue
Vertigo
Nystagmus
Inner Ear Disorder
Eye Pain
Pain Of Skin
Night Sweats
Nausea
Diarrhoea
Amnesia
Abdominal Pain
Testicular Pain
Depression
Colitis
Hypoaesthesia
Nervousness
Activities Of Daily
Living Impaired
Vomiting
Disorientation

Psychotic Disorder
Memory Impairment
Headache
Vestibular Disorder
Chest Pain
Tinnitus
Vision Blurred
Photophobia
03-Apr-2012 09:37 AM Page: 689

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Upper Respiratory Tract
Infection
Weight Increased Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL
Imodium
C
Compazine C ON 18 APR
2001, THERAPY
REPORTED AS
TWICE DAILY.
Antibiotics Nos C
Ambien
C
Prednisone C BY TAPER.
Valium C ON 18 APR
2001, THERAPY
REPORTED AS:
AS NEEDED.
Phenergan
C
Biaxin
C
Advil
C
Bactrim
C
Antivert
C
Date:02/16/06ISR Number: 4914041-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-359452 Age:53 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Respiratory Failure Lariam PS Roche ORAL DOSAGE
Initial or Prolonged Pulmonary Fibrosis REPORTED AS
Lung Disorder 1.1 AND 1.2
Toxicity To Various
MG/L.
Agents Unknown Medication C INTRAVENOUS DRUG REPORTED
AS CLAMOXIL. 3 DAY
Date:02/17/06ISR Number: 4915831-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-435505 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Restlessness Lariam PS Roche ORAL 22 DAY
Anxiety
Chest Discomfort
Depression
Panic Attack
Date:02/17/06ISR Number: 4920328-6Report Type:Expedited (15-DaCompany Report #GXKR2006IT00866 Age:56 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Vision Blurred
Leukocytosis
Thrombotic

Thrombocytopenic Purpura
Anaemia
Neutrophil Count
Increased
Confusional State
Ocular Icterus
Anisocytosis
Myalgia
03-Apr-2012 09:37 AM Page: 690

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Lethargy
Decreased Appetite
Low Density Lipoprotein Report Source Product Role Manufacturer Route Dose Duration
Increased Foreign Mefloquine
Plasmapheresis Literature (Ngx)(Mefloquine)
Asthenia Health Tablet PS 250 MG,QW
Professional
Date:02/20/06ISR Number: 4916768-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-424819 Age:40 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psychotic Disorder Lariam PS Roche ORAL
Alcohol Use
Stress
Anxiety
Persecutory Delusion
Date:02/23/06ISR Number: 4920624-2Report Type:Expedited (15-DaCompany Report #SE-ROCHE-436796 Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Trisomy 21 Lariam PS Roche ORAL
Maternal Exposure During
Pregnancy
Date:02/24/06ISR Number: 4922524-0Report Type:Expedited (15-DaCompany Report #IT-ROCHE-436175 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Gastrointestinal Lariam PS Roche ORAL 36 DAY
Haemorrhage
Thrombocytopenia
Headache
Vomiting
Cerebral Haemorrhage
Coma
Date:02/27/06ISR Number: 4924436-5Report Type:Expedited (15-DaCompany Report #ZM-ROCHE-430119 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nephrotic Syndrome Mefloquine
Initial or Prolonged Abdominal Distension Hydrochloride PS Roche ORAL 3 DAY
Glucose Urine Present
Respiratory Rate
Increased

Date:02/28/06ISR Number: 4928936-3Report Type:Direct Company Report #CTU 270859 Age:22 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Anxiety
Mental Disorder
Panic Attack
Hyperhidrosis
03-Apr-2012 09:37 AM Page: 691

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Fear
Palpitations
Dyspnoea Report Source Product Role Manufacturer Route Dose Duration
Thinking Abnormal
Larium/Mefloquine
Hallucination Roche PS Roche ORAL ONE PILL
Diarrhoea
ONCE PER WEEK
Feeling Abnormal
PO
Date:03/06/06ISR Number: 4933631-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-432400 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Sleep Disorder Lariam PS Roche UNKNOWN
Initial or Prolonged Dyspnoea Exertional Lariam SS Roche UNKNOWN 25 DAY
Tachycardia
Anxiety
Hyperventilation
Neurosis
Anaemia
Malaise
Histrionic Personality
Disorder
Asthenia
Vertigo
Conversion Disorder
Date:03/06/06ISR Number: 4933637-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-436796 Age:38 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Trisomy 21 Lariam PS Roche ORAL
Abortion
Maternal Exposure During
Pregnancy
Date:03/06/06ISR Number: 4933650-4Report Type:Expedited (15-DaCompany Report #DK-ROCHE-430861 Age:34 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Sensory Disturbance Lariam PS Roche ORAL ORDINARY
Monocyte Count Abnormal
GROWN-UP
Neutrophil Count Abnormal
PROPHYLACTIC
White Blood Cell Count
LARIAM DOSIS.
Decreased
Hypoaesthesia
Blood Thyroid Stimulating
Hormone Increased
Abortion
Alanine Aminotransferase
Abnormal

Lymphocyte Count Abnormal
Leukopenia
03-Apr-2012 09:37 AM Page: 692

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/09/06ISR Number: 4937024-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Anxiety
Panic Disorder
Major Depression
Psychiatric Symptom
Fall
Toxicity To Various
Agents
Convulsion
Nocturia
Insomnia
Disturbance In Attention
Selective Iga
Immunodeficiency
Fatigue
Ill-Defined Disorder
Chest Discomfort
Joint Dislocation
Respiratory Rate
Increased
Rheumatoid Factor
Increased
Dizziness
Abnormal Behaviour
Memory Impairment
Hyperhidrosis
Tremor
Bundle Branch Block Right
Exostosis
Hypoaesthesia
Myalgia
Mood Swings
Visual Impairment
Hallucination, Visual
Dyspnoea
Post-Traumatic Stress
Disorder
Decreased Activity
Antinuclear Antibody
Positive
Rhinitis Allergic
Ventricular Extrasystoles
Balance Disorder
Asthenia
Chest Pain
Psychotic Disorder
Generalised Anxiety
Disorder
Mitral Valve
Calcification
Dehydration

Weight Decreased
Oxygen Saturation
Decreased
Eye Movement Disorder
Eosinophilia
Coordination Abnormal
Mood Altered
Aggression
03-Apr-2012 09:37 AM Page: 693

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Suicidal Ideation
Sleep Apnoea Syndrome
Meniscus Lesion Report Source Product Role Manufacturer Route Dose Duration
Thinking Abnormal Lariam PS Roche ORAL
Dysthymic Disorder Primaquine C
Attention Cipro C
Deficit/Hyperactivity
Disorder
Ligament Sprain
Rash Papular
Cervical Vertebral
Fracture
Bronchopneumonia
Agitation
Depression
Bronchial Hyperreactivity
Productive Cough
Cranial Nerve Disorder
Hypertension
Self-Injurious Ideation
Cognitive Disorder
Mitral Valve Incompetence
Humerus Fracture
Contusion
Pyrexia
Tinnitus
Vertigo
Headache
Musculoskeletal Pain
Asthma
Homicidal Ideation
Nystagmus
Upper Respiratory Tract
Infection
Date:03/09/06ISR Number: 4988015-6Report Type:Periodic Company Report #GXBR2005US01407 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Back Pain Consumer Mefloquine Hcl
Initial or Prolonged Panic Attack Tablets
Hypoaesthesia
(Ngx)(Mefloquine)
Neck Pain Tablet PS ORAL 250 MG, QW,
Asthenia
ORAL
Headache Motrin (Ibuprofen) C
Dysphemia
Muscle Spasms
Tremor
Disturbance In Attention
Anxiety

Date:03/09/06ISR Number: 4988019-3Report Type:Periodic Company Report #GXBR2005US00770 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Platelet Count Decreased Consumer Mefloquine Hcl
Initial or Prolonged
Tablets
(Ngx)(Mefloquine)
Tablet PS OPHTHALMIC 250 MG QW,
03-Apr-2012 09:37 AM Page: 694

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Z-Pak (Azithromycin) C
Prednisone
(Prednisone)
C
Albuterol
(Salbutamol)
C
Advair Diskus
(Fluticasone
Propionate,
Salmeterol
Xinafoate)
C
ORAL
Date:03/13/06ISR Number: 4941688-6Report Type:Expedited (15-DaCompany Report #SE-ROCHE-435563 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Arthropod Bite Lariam PS Roche ORAL 56 DAY
Initial or Prolonged Headache
Depressed Mood
Sleep Disorder
Hyperaesthesia
Date:03/14/06ISR Number: 4943232-6Report Type:Expedited (15-DaCompany Report #DK-ROCHE-430861 Age:34 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Blood Thyroid Stimulating Lariam PS Roche ORAL ORDINARY
Hormone Increased
GROWN-UP
Leukopenia
PROPHYLACTIC
Hypoaesthesia
LARIAM DOSIS.
White Blood Cell Count
Decreased
Hypothyroidism
Date:03/14/06ISR Number: 4943235-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-424819 Age:40 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psychotic Disorder Lariam PS Roche ORAL
Delusion
Confusional State
Persecutory Delusion
Anxiety
Date:03/14/06ISR Number: 4943292-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-391660 Age: Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Suicidal Ideation
Mental Disorder

Disability
Generalised Anxiety
Disorder
Major Depression
Feeling Guilty
Panic Attack
Amnesia
Self Esteem Decreased
Mood Swings
03-Apr-2012 09:37 AM Page: 695

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Memory Impairment
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche UNKNOWN
Date:03/15/06ISR Number: 4944593-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-439267 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anhedonia Lariam PS Roche UNKNOWN
Initial or Prolonged Pain
Disability
Cognitive Disorder
Injury
Mental Disorder
Date:03/20/06ISR Number: 4948316-4Report Type:Expedited (15-DaCompany Report #IT-ROCHE-439289 Age:56 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Thrombotic Mefloquine
Initial or Prolonged Thrombocytopenic Purpura Hydrochloride PS Roche ORAL
Asthenia
Pyrexia
Vision Blurred
Confusional State
Decreased Appetite
Myalgia
Lethargy
Date:03/20/06ISR Number: 4948344-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Agitation
Mood Swings
Depression
Asthenia
Headache
Post-Traumatic Stress
Disorder
Meniscus Lesion
Attention
Deficit/Hyperactivity
Disorder
Suicidal Ideation
Productive Cough
Decreased Activity
Dysthymic Disorder
Bundle Branch Block Right
Eye Movement Disorder

Contusion
Anxiety
Bronchial Hyperreactivity
Thinking Abnormal
Brain Stem Syndrome
Memory Impairment
Ill-Defined Disorder
Dyspnoea
03-Apr-2012 09:37 AM Page: 696

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Chest Discomfort
Hypertension
Psychiatric Symptom Report Source Product Role Manufacturer Route Dose Duration
Musculoskeletal Pain Lariam PS Roche ORAL
Homicidal Ideation Primaquine C
Convulsion Cipro C
Rheumatoid Factor
Increased
Nocturia
Pyrexia
Rash Papular
Abnormal Behaviour
Aggression
Selective Iga
Immunodeficiency
Cranial Nerve Disorder
Joint Dislocation
Generalised Anxiety
Disorder
Asthma
Cognitive Disorder
Mitral Valve Incompetence
Humerus Fracture
Dehydration
Weight Decreased
Respiratory Rate
Increased
Antinuclear Antibody
Positive
Rhinitis Allergic
Hallucination, Visual
Balance Disorder
Fatigue
Panic Disorder
Self-Injurious Ideation
Oxygen Saturation
Decreased
Nystagmus
Eosinophilia
Insomnia
Visual Impairment
Chest Pain
Hyperhidrosis
Tremor
Craniocerebral Injury
Toxicity To Various
Agents
Hypoaesthesia
Disturbance In Attention
Vertigo
Sleep Apnoea Syndrome
Psychotic Disorder
Major Depression

Fall
Mitral Valve
Calcification
Exostosis
Ligament Sprain
Myalgia
Ventricular Extrasystoles
03-Apr-2012 09:37 AM Page: 697

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/24/06ISR Number: 4958844-3Report Type:Expedited (15-DaCompany Report #385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Hypoaesthesia
Humerus Fracture
Mitral Valve Incompetence
Mitral Valve
Calcification
Aggression
Meniscus Lesion
Major Depression
Panic Disorder
Chest Pain
Visual Impairment
Memory Impairment
Abnormal Behaviour
Cough
Angina Pectoris
Joint Lock
Deafness
Anger
Upper Respiratory Tract
Infection
Eructation
Abdominal Pain Upper
Mucous Stools
Exostosis
Homicidal Ideation
Post-Traumatic Stress
Disorder
Joint Dislocation
Vestibular Function Test
Abnormal
Headache
Balance Disorder
Snoring
Speech Disorder
Joint Crepitation
Diarrhoea
Rash Macular
Pyrexia
Myalgia
Rhinitis Allergic
Ligament Sprain
Convulsion
Hypertension
Sleep Apnoea Syndrome
Productive Cough
Poor Quality Drug
Administered
Weight Increased
Thinking Abnormal
Sedation

Tongue Eruption
Arthralgia
Rectal Haemorrhage
Eosinophilia
Nystagmus
Hyperhidrosis
Fatigue
Selective Iga
03-Apr-2012 09:37 AM Page: 698

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Immunodeficiency
Suicidal Ideation
Agitation
Insomnia
Family Stress
Nausea
Ventricular Extrasystoles
Tremor
Nocturia
Antinuclear Antibody
Positive
Bundle Branch Block Right
Dysthymic Disorder
Dyspnoea
Asthenia
Coordination Abnormal
Vertigo
Derealisation
Exposure To Toxic Agent
Wheezing
Occupational Problem
Environmental
Chondroplasty
Musculoskeletal Stiffness
Breath Odour
Injury
Attention
Deficit/Hyperactivity
Disorder
Weight Decreased
Generalised Anxiety
Disorder
Chest Discomfort
Pulmonary Congestion
Bronchial Hyperreactivity
Hallucination, Visual
Disturbance In Attention
Acute Coronary Syndrome
Psychiatric Symptom
Tinnitus
Hypervigilance
Impaired Work Ability
Constipation
Decreased Activity
Rash Papular
Oxygen Saturation
Decreased
Respiratory Rate
Increased
Dehydration
Toxicity To Various
Agents
Impulsive Behaviour
Self-Injurious Ideation

Anxiety Disorder
Depression
Mood Swings
Anxiety
Dissociative Disorder
Palpitations
Dizziness
Brain Stem Syndrome
03-Apr-2012 09:37 AM Page: 699

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Visual Field Defect
Rheumatoid Factor
Increased Report Source Product Role Manufacturer Route Dose Duration
Contusion Other Lariam (Mefloquine
Eye Movement Disorder Hydrochloride) 250mg PS ORAL ORAL
Cognitive Disorder
Primaquine
Asthma
(Primaquine
Musculoskeletal Pain Phosphate) C
Fall
Cirpo (Ciprofloxacin
Psychotic Disorder Hydrochloride) C
Priapism
Paranoia
Blood Potassium Decreased
Emotional Distress
Dyspepsia
Abdominal Distension
Date:03/24/06ISR Number: 4958848-0Report Type:Expedited (15-DaCompany Report #385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Agitation
Product Quality Issue
Hyperkeratosis
Coronary Artery Disease
Headache
Dizziness
Joint Dislocation
Choking
Weight Decreased
Meniscus Lesion
Respiratory Fume
Inhalation Disorder
Acute Coronary Syndrome
Disturbance In Attention
Visual Impairment
Loose Body In Joint
Fall
Humerus Fracture
Divorced
Accident
Hypertension
Weight Increased
Rhinitis Allergic
Bundle Branch Block Right
Arthralgia
Anxiety
Suicidal Ideation
Chondroplasty
Electrocardiogram T Wave
Abnormal
Chest X-Ray Abnormal

Haemophilus Infection
Sleep Apnoea Syndrome
Visual Field Defect
Eosinophilia
Cognitive Disorder
Exposure To Noise
Priapism
Ventricular Extrasystoles
03-Apr-2012 09:37 AM Page: 700

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Palpitations
Snoring
Abnormal Behaviour
Aggression
Vertigo
Hallucination, Visual
Toxicity To Various
Agents
Poor Quality Drug
Administered
Stress
Hiatus Hernia
Electrocardiogram St
Segment Depression
Upper Respiratory Tract
Infection
Mitral Valve
Calcification
Nightmare
Ligament Sprain
Nocturia
Blood Creatine
Phosphokinase Increased
Psychiatric Symptom
Insomnia
Mood Swings
Depression
Cardiac Stress Test
Abnormal
Panic Attack
Tinnitus
Bacteraemia
Selective Iga
Immunodeficiency
Marital Problem
Exostosis
Post-Traumatic Stress
Disorder
Vestibular Disorder
Hyperhidrosis
Abnormal Dreams
Nystagmus
Blood Potassium Decreased
Asthma
Rash
Fatigue
Mood Altered
Chronic Sinusitis
Rapid Eye Movements Sleep
Abnormal
Mitral Valve Incompetence
Electroencephalogram
Abnormal

Emotional Disorder
Homicidal Ideation
Performance Fear
Loss Of Consciousness
Eye Movement Disorder
Memory Impairment
Balance Disorder
Coordination Abnormal
03-Apr-2012 09:37 AM Page: 701

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Haemarthrosis
Impulsive Behaviour
Dysthymic Disorder Report Source Product Role Manufacturer Route Dose Duration
Dehydration Other Lariam (Mefloquine
Paranoia Hydrochloride) 250
Derealisation Mg PS ORAL ORAL
Contusion
Primaquine
Antinuclear Antibody
(Primaquine
Positive Phosphate) C
Rheumatoid Factor
Cipro (Ciprofloxacin
Increased Hydrochloride) C
Chest Pain
Musculoskeletal Stiffness
Hypervigilance
Meniscus Removal
Conduction Disorder
Pneumonia
Deafness
Bronchial Hyperreactivity
Tremor
Blood Pressure Increased
Physical Assault
Convulsion
Hypoaesthesia
Myalgia
Date:04/03/06ISR Number: 4960823-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-427130 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Neuralgic Amyotrophy Lariam PS Roche UNKNOWN FOR FIVE TO
Initial or Prolonged Paresis SIX WEEKS,
BEGINNING THE
END OF AUGUST
2005.
Date:04/10/06ISR Number: 4968399-5Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-06P-151-0329756-00 Age:59 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Paresis Klaricid Film-Coated
Hepatic Cyst Tablets PS ORAL 5 DAY
Paraesthesia Mefloquine SS
Mefloquine
SS
Mefloquine SS ORAL
Klaricid Film-Coated
Tablets SS 5 DAY
Melisec
C
Thyorsian
C
Yecueine
C
Pepermint
C

Salvia C
Clavulin C ORAL 500 MG/125 MG
03-Apr-2012 09:37 AM Page: 702

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/11/06ISR Number: 4969270-5Report Type:Expedited (15-DaCompany Report #CH-ROCHE-442702 Age:57 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Paresis Lariam PS Roche ORAL
Hepatic Cyst Lariam SS Roche ORAL TAKEN 6
Drug Interaction
CAPSULES OF
Paraesthesia 250 MG IN 3
Confusional State
DAYS
Drug Level Decreased (SELF-MEDICAT 4 DAY
Fatigue Lariam SS Roche ORAL
Augmentin C ORAL STRENGHTH
REPORTED AS
500 MG/ 125
MG. FILM
COATED 6 DAY
Klacid I ORAL FILM COATED
TABLETS. 6 DAY
Date:04/13/06ISR Number: 4973397-1Report Type:Direct Company Report #CTU 274136 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Attack Mefloquine (Unknown
Initial or Prolonged Manuf.) PS ORAL 250 MG
WEEKLY P.O.
Date:04/14/06ISR Number: 4973077-2Report Type:Expedited (15-DaCompany Report #CA-ROCHE-443261 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Mefloquine
Delusion Hydrochloride PS Roche UNKNOWN 3 WK
Paranoia Cipralex C UNKNOWN
Depression Clonazepam C UNKNOWN
Risperdal C UNKNOWN
Date:04/18/06ISR Number: 4976519-1Report Type:Direct Company Report #CTU 274487 Age:41 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Anxiety Mefloquine 250mg
Other Serious Dyspnoea Barr Laboratories, PS Barr Laboratories BUCCAL 250MG ONCE A
Insomnia
WEEK BUCCAL
Chest Discomfort
Date:04/18/06ISR Number: 4976726-8Report Type:Direct Company Report #CTU 274491 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Panic Attack Mefloquine
Hallucination
Hydrochloride Tablet
Tinnitus
250 Mg
Nightmare Sandoz, Inc PS Sandoz, Inc ORAL 1/4 TABLET
Anxiety
ONCE WEEKLY
PO
03-Apr-2012 09:37 AM Page: 703

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/21/06ISR Number: 4979539-6Report Type:Expedited (15-DaCompany Report #NG-ROCHE-444178 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Confusional State Lariam PS Roche UNKNOWN
Initial or Prolonged Hypersensitivity
Disorientation
Incoherent
Date:04/21/06ISR Number: 4979606-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-444160 Age:76 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Retinal Artery Occlusion Lariam PS Roche ORAL 29 DAY
Unspecified
Medication C ORAL
Norflex C ORAL
Voltarol C INTRAMUSCULAR
Simvastatin C ORAL
Date:04/24/06ISR Number: 4980521-3Report Type:Expedited (15-DaCompany Report #SE-ROCHE-444010 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Lariam PS Roche UNKNOWN
Initial or Prolonged Oedema Peripheral
Nausea
Cold Sweat
Fatigue
Date:04/25/06ISR Number: 4982322-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Abnormal Behaviour
Visual Impairment
Suicidal Ideation
Selective Iga
Immunodeficiency
Cranial Nerve Disorder
Joint Dislocation
Hyperhidrosis
Thinking Abnormal
Eosinophilia
Ventricular Extrasystoles
Hypervigilance
Ill-Defined Disorder
Psychiatric Symptom
Cognitive Disorder
Dysthymic Disorder
Oxygen Saturation

Decreased
Antinuclear Antibody
Positive
Mood Swings
Depression
Hallucination, Visual
Chest Pain
Decreased Activity
03-Apr-2012 09:37 AM Page: 704

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Respiratory Rate
Increased
Ligament Sprain Report Source Product Role Manufacturer Route Dose Duration
Nocturia Lariam PS Roche ORAL
Anxiety Primaquine C
Fatigue Cipro C
Major Depression
Generalised Anxiety
Disorder
Toxicity To Various
Agents
Bundle Branch Block Right
Exostosis
Dehydration
Convulsion
Eye Movement Disorder
Insomnia
Memory Impairment
Vertigo
Productive Cough
Mitral Valve
Calcification
Nystagmus
Disturbance In Attention
Dyspnoea
Hypertension
Meniscus Lesion
Fall
Tremor
Homicidal Ideation
Craniocerebral Injury
Mitral Valve Incompetence
Attention
Deficit/Hyperactivity
Disorder
Contusion
Myalgia
Agitation
Balance Disorder
Chest Discomfort
Headache
Panic Disorder
Sleep Apnoea Syndrome
Psychotic Disorder
Post-Traumatic Stress
Disorder
Musculoskeletal Pain
Asthma
Humerus Fracture
Weight Decreased
Aggression
Asthenia
Bronchial Hyperreactivity

Self-Injurious Ideation
Hypoaesthesia
Rheumatoid Factor
Increased
Rhinitis Allergic
Pyrexia
Rash Papular
03-Apr-2012 09:37 AM Page: 705

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/28/06ISR Number: 4990843-8Report Type:Expedited (15-DaCompany Report #GXKR2006IN02239 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Areflexia Foreign Mefloquine (Ngx)
Other Serious Abasia Literature (Mefloquine) PS ORAL SEE IMAGE 1 DAY
Dysgraphia Health Chloroquine C
Polyneuropathy
Professional
Rash Erythematous
Other
Hypokinesia
Hypotonia
Neuropathy Peripheral
Date:04/28/06ISR Number: 4991115-8Report Type:Expedited (15-DaCompany Report #GXKR2006IN01102 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Asthenia Foreign Mefloquine (Ngx)
Polyneuropathy Literature (Mefloquine) PS 1000 MG
Dermatitis
Infected Skin Ulcer
Health
Professional
Other
Date:05/01/06ISR Number: 4989706-3Report Type:Expedited (15-DaCompany Report #007178 Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Confusional State Consumer Mefloquine
Heart Rate Increased
Hydrochloride
Decreased Appetite
(Mefloquine
Suicidal Ideation
Hydrochloride)
Disturbance In Attention Tablet, 250mg PS ORAL 1 TABLET,
Anxiety
WEEKLY, ORAL
Prenatal Vitamins
(Ascorbic Acid,
Vitamin D Nos,
Minerals Nos,
Vitamins B Nos, C
Date:05/08/06ISR Number: 4995548-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-329897 Age:30 YR Gender:Female I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Suicide Attempt
Depression
Paraesthesia
Respiratory Disorder
Panic Attack
Dysthymic Disorder
Heart Rate Increased
Intentional Self-Injury

Fatigue
Fear
Claustrophobia
Chest Pain
Nightmare
Headache
Mood Swings
Mental Impairment
03-Apr-2012 09:37 AM Page: 706

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Gastrointestinal Disorder
Overdose
Anxiety Report Source Product Role Manufacturer Route Dose Duration
Insomnia Lariam PS Roche ORAL TAKEN TWO
DOSES IN
TOTAL. 8 DAY
Prozac C ORAL
Trazodone C ORAL
Date:05/11/06ISR Number: 4999408-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-446876 Age:65 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Renal Failure Acute Lariam PS Roche ORAL 1 DOSE
Initial or Prolonged Dialysis WEEKLY. 6 DAY
Lasilix C ORAL
Solupred C ORAL 3 DOSES
DAILY.
Renitec C ORAL
Neoral C ORAL
Mopral C ORAL ONE DOSE
DAILY.
Date:05/11/06ISR Number: 4999413-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-446907 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Chest Pain Lariam PS Roche ORAL 1 DAY
Initial or Prolonged Syncope Cilest C ORAL
Blood Pressure Decreased
Myalgia
Musculoskeletal Stiffness
Loss Of Consciousness
Date:05/16/06ISR Number: 5004582-0Report Type:Direct Company Report #CTU 276678 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Mefloquine
Anxiety
Hydrochloride 250 Mg
Mood Altered Roche Laboratories PS Roche Laboratories ORAL 1 TABLET ONCE
Paranoia
A WEEK PO
Nausea
Date:05/18/06ISR Number: 5005520-7Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Age:38 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nystagmus Lariam PS Roche ORAL TAKEN ON 22

Initial or Prolonged Balance Disorder FEB, 01 MAR
Disability Diarrhoea AND 08 MAR
Tinnitus 2005. 15 DAY
Hearing Impaired
Vertigo
Dizziness
Nausea
03-Apr-2012 09:37 AM Page: 707

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/24/06ISR Number: 5009780-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-444178 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Lariam PS Roche ORAL 15 DAY
Initial or Prolonged Confusional State
Disability
Incoherent
Hypersensitivity
Depression
Disorientation
Date:05/24/06ISR Number: 5011972-9Report Type:Expedited (15-DaCompany Report #2006-BP-05361RO Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Infected Skin Ulcer Foreign Mefloquine
Polyneuropathy Literature (Mefloquine) PS ORAL 1000 MG
Dermatitis Health COURSE, PO
Skin Ulcer
Professional
Date:05/24/06ISR Number: 5011974-2Report Type:Expedited (15-DaCompany Report #2006-BP-05360RO Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Polyneuropathy Foreign Mefloquine
Hypotonia Literature (Mefloquine) PS ORAL 1000 MG DAY
Hypoaesthesia Health 1, 500 MG DAY
Rash Erythematous Professional 2, PO
Dysstasia
Abasia
Burning Sensation
Muscular Weakness
Asthenia
Activities Of Daily
Living Impaired
Paraesthesia
Arthropathy
Areflexia
Date:05/26/06ISR Number: 5013961-7Report Type:Direct Company Report #CTU 277654 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam -Mefloquine- PS ORAL ONCE A WEEK
Nightmare
PO
Feeling Abnormal
Fear
Mental Disorder
Depression
Suicidal Ideation
Mental Impairment

Thinking Abnormal
Malaise
03-Apr-2012 09:37 AM Page: 708

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/30/06ISR Number: 5013837-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-448428 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Umbilical Malformation Lariam PS Roche ORAL
Initial or Prolonged Maternal Exposure During
Congenital Anomaly Pregnancy
Abortion Induced
Date:05/31/06ISR Number: 5014899-1Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Age:38 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nystagmus Lariam PS Roche ORAL TAKEN ON 22
Initial or Prolonged Tinnitus FEB, 01 MAR
Disability Balance Disorder AND 08 MAR
Diarrhoea 2005. 15 DAY
Deafness Unilateral
Nausea
Hearing Impaired
Dizziness
Vertigo
Vestibular Neuronitis
Date:05/31/06ISR Number: 5014941-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-441981 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Irritable Bowel Syndrome Lariam PS Roche UNKNOWN
Personality Change
Depression
Date:06/01/06ISR Number: 5015586-6Report Type:Expedited (15-DaCompany Report #SE-ROCHE-449547 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Umbilical Malformation Lariam PS Roche ORAL
Initial or Prolonged Abortion
Maternal Exposure During
Pregnancy
Pregnancy
Date:06/01/06ISR Number: 5036335-1Report Type:Periodic Company Report #402101 Age:36 YR Gender:Male I/FU:I
Outcome
Death
PT
Headache
Decreased Appetite
Chills
Abdominal Pain Upper

Pyrexia
Diarrhoea
Anuria
Respiratory Rate
Increased
Psychiatric Symptom
Eye Disorder
Vomiting
03-Apr-2012 09:37 AM Page: 709

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Local Swelling
Nausea
Oropharyngeal Pain Report Source Product Role Manufacturer Route Dose Duration
Ear Congestion Consumer Lariam (Mefloquine
Balance Disorder Hydrochloride) PS ORAL ORAL
Ear Disorder
Dizziness
Malaria
Cough
Swelling Face
Date:06/01/06ISR Number: 5036336-3Report Type:Periodic Company Report #409218 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Loss Of Consciousness Consumer Lariam (Mefloquine
Insomnia Hydrochloride) 250
Vision Blurred Mg PS ORAL ORAL
Amnesia
Depression
Mental Impairment
Disturbance In Attention
Suicidal Ideation
Balance Disorder
Date:06/01/06ISR Number: 5036337-5Report Type:Periodic Company Report #411025 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Attack Consumer Lariam (Mefloquine
Initial or Prolonged Anxiety Hydrochloride) 250
Mg PS ORAL ORAL 30 DAY
Date:06/01/06ISR Number: 5036338-7Report Type:Periodic Company Report #412629 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Panic Attack Health Lariam (Mefloquine
Depression Professional Hydrochloride) 250
Paranoia Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Birth Control Pills
Nos (Oral
Contraceptive Nos) C
Albuterol
(Albuterol)
C
Lexapro
(Escitalopram) C

Date:06/01/06ISR Number: 5036339-9Report Type:Periodic Company Report #425065 Age:22 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Suicidal Ideation
Memory Impairment
Enuresis
Emotional Disorder
03-Apr-2012 09:37 AM Page: 710

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Joint Injury
Disorientation
Alcohol Intolerance Report Source Product Role Manufacturer Route Dose Duration
Anxiety Consumer Lariam (Mefloquine
Depression Hydrochloride) 250
Neurological Examination Mg PS ORAL 250 MG 1 PER
Abnormal
WEEK ORAL
Panic Attack
Coordination Abnormal
Abnormal Dreams
Paranoia
Date:06/01/06ISR Number: 5036340-5Report Type:Periodic Company Report #426777 Age:49 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Health Lariam (Mefloquine
Initial or Prolonged Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/01/06ISR Number: 5036341-7Report Type:Periodic Company Report #427138 Age:69 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicidal Ideation Health Lariam (Mefloquine
Required Depression Professional Hydrochloride) 250
Intervention to Mg PS ORAL 1 PER WEEK
Prevent Permanent
Impairment/Damage
Antidepressant Nos
(Antidepressant Nos) C
ORAL
Date:06/01/06ISR Number: 5036342-9Report Type:Periodic Company Report #428956 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Consumer Lariam (Mefloquine
Initial or Prolonged Health Hydrochloride) PS ORAL ORAL
Professional
Birth Control Pills
Nos (Oral
Contraceptive Nos) C
Date:06/01/06ISR Number: 5036343-0Report Type:Periodic Company Report #336177 Age:40 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Lichen Planus
Headache
Suicidal Ideation

Hyperhidrosis
Anhedonia
Tinnitus
Groin Pain
Haematuria
Vestibular Disorder
Oral Disorder
Heart Rate Increased
03-Apr-2012 09:37 AM Page: 711

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Paraesthesia
Nightmare
Blood Pressure Increased Report Source Product Role Manufacturer Route Dose Duration
Hyperventilation Consumer Lariam (Mefloquine
Depression Health Hydrochloride) 250
Major Depression Professional Mg PS ORAL 250 MG ORAL
Dysuria
Other
Rash Papular
Vision Blurred
Insomnia
Mood Altered
Nystagmus
Urethritis
Dyspnoea
Toxicity To Various
Agents
Chest Discomfort
Depressed Mood
Agoraphobia
Pain In Extremity
Agitation
Panic Disorder
Epicondylitis
Disturbance In Attention
Vertigo
Balance Disorder
Panic Attack
Anxiety
Erythema
Dizziness
Fatigue
Decreased Activity
Decreased Interest
Vitreous Floaters
Activities Of Daily
Living Impaired
Date:06/01/06ISR Number: 5036344-2Report Type:Periodic Company Report #369650 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Other Lariam (Mefloquine
Fatigue Hydrochloride) 250
Hostility Mg PS ORAL ORAL
Sleep Apnoea Syndrome
Inderal
Abnormal Dreams (Propranolol) C
Memory Impairment
Cimetidine
Disorientation (Cimetidine) C
Communication Disorder Xanax (Alprazolam) C
Emotional Distress
Dysarthria
Gun Shot Wound

Mood Swings
Agitation
Self Esteem Decreased
Tinnitus
Fear
03-Apr-2012 09:37 AM Page: 712

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/06ISR Number: 5036345-4Report Type:Periodic Company Report #380190 Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Paranoia Other Lariam (Mefloquine
Night Sweats Hydrochloride) 250
Fatigue Mg PS ORAL 1 DOSE FORM 1
Gun Shot Wound
PER WEEK ORAL
Post-Traumatic Stress
Disorder
Social Avoidant Behaviour
Delusion
Diarrhoea
Sleep Disorder
Emotional Disorder
Poor Quality Sleep
Completed Suicide
Insomnia
Agitation
Depression
Mood Swings
Headache
Aggression
Date:06/01/06ISR Number: 5036346-6Report Type:Periodic Company Report #384553 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Amnesia Health Lariam (Mefloquine
Headache Professional Hydrochloride) 250
Mg PS ORAL 250 MG 1 PER
WEEK ORAL
Date:06/01/06ISR Number: 5036347-8Report Type:Periodic Company Report #395651 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Psychotic Disorder Other Lariam (Mefloquine
Back Pain Hydrochloride) 250
Depression Mg PS ORAL 250 MG 1 PER
Agitation
WEEK ORAL
Rash
Glucosamine
Pyrexia (Glucosamine) C
Paraesthesia
Chondroitin
Hypoaesthesia
(Chondroitin
Headache Sulfate) C
Tinnitus
Celebrex (Celecoxib) C
Fatigue
Cough
Myalgia
Diarrhoea
Mood Swings

Anger
Completed Suicide
Deafness
Arthralgia
Asthenia
Spousal Abuse
Panic Attack
03-Apr-2012 09:37 AM Page: 713

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/06ISR Number: 5036348-XReport Type:Periodic Company Report #398411 Age:10 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Sleep Disorder Health Lariam (Mefloquine
Mood Swings Professional Hydrochloride) 250
Insomnia Mg PS ORAL 1 PER WEEK
ORAL
Date:06/06/06ISR Number: 5019015-8Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0426071A Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Ineffective Malarone PS Glaxosmithkline ORAL 3 DAY
Initial or Prolonged Hallucination Lariam SS ORAL 2250MG per
Major Depression
day
Date:06/06/06ISR Number: 5019336-9Report Type:Expedited (15-DaCompany Report #SE-ROCHE-448488 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Angioedema Lariam PS Roche ORAL 2 MON
Date:06/09/06ISR Number: 5022485-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-450157 Age:43 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pericarditis Lariam PS Roche ORAL REPORTED AS
Initial or Prolonged Ventricular Extrasystoles 250 MG AT
Myocardial Infarction TOTAL. 1 DAY
Sinus Tachycardia Mediator 150 SS ORAL 726 DAY
Myocarditis Havrix C INTRAMUSCULAR 1 DOSE. 1 DAY
Extrasystoles Rabipur C INTRAMUSCULAR 1 DOSE. 1 DAY
Date:06/15/06ISR Number: 5026560-8Report Type:Expedited (15-DaCompany Report #CH-ROCHE-308974 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pulmonary Toxicity Mefloquine
Initial or Prolonged Toxicity To Various Hydrochloride PS Roche UNKNOWN
Agents
Diffuse Alveolar Damage
Date:06/16/06ISR Number: 5027852-9Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Age:38 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dizziness Lariam PS Roche ORAL TAKEN ON 22
Initial or Prolonged Vertigo FEB, 01 MAR

Disability Balance Disorder AND 08 MAR
Nausea 2005. 15 DAY
Tinnitus
Diarrhoea
Nystagmus
Hearing Impaired
03-Apr-2012 09:37 AM Page: 714

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/16/06ISR Number: 5027885-2Report Type:Expedited (15-DaCompany Report #SE-ROCHE-449547 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Maternal Exposure During Lariam PS Roche ORAL
Initial or Prolonged Pregnancy
Abortion
Umbilical Malformation
Date:06/20/06ISR Number: 5030269-4Report Type:Expedited (15-DaCompany Report #CH-ROCHE-428290 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypoxia Mefloquine
Initial or Prolonged Haemoglobin Decreased Hydrochloride PS Roche UNKNOWN RECEIVED A
Diarrhoea
TOTAL DOSE OF
Lung Infiltration
1500MG OF
Pulmonary Toxicity
MEFLOQUINE
Blood Pressure Decreased
OVER 24 HOURS
General Physical Health Paracetamol C
Deterioration Halofantrine C FOR 48 HOURS
Diffuse Alveolar Damage
Date:06/20/06ISR Number: 5032579-3Report Type:Direct Company Report #CTU 279190 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Simple Partial Seizures Mefloquine (Lariam) PS Sandoz ORAL 250 MG ONE
Muscle Spasms
TIME DOSE PO
Sleep Disorder
Paraesthesia
Sensory Loss
Depression
Abnormal Sensation In Eye
Dizziness
Auricular Swelling
Hypoaesthesia
Disorientation
Paranoia
Anxiety
Asthenia
Fatigue
Menstrual Disorder
Oropharyngeal Pain
Nervous System Disorder
Mood Swings
Confusional State
Intracranial Pressure
Increased
Feeling Cold
Anhidrosis
Blindness

Date:06/20/06ISR Number: 5032742-1Report Type:Direct Company Report #CTU 279122 Age:25 YR Gender:Male I/FU:I
Outcome
Life-Threatening
Hospitalization -
03-Apr-2012 09:37 AM Page: 715

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Initial or Prolonged
Required
Intervention to
Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration
Impairment/Damage Dysarthria Lariam Roche PS Roche 250 MG WEEKLY
Hallucination
Confusional State
Toxicity To Various
Agents
Disturbance In Attention
Fatigue
Insomnia
Dizziness
Suicidal Ideation
Date:06/22/06ISR Number: 5033028-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Abnormal Behaviour
Disturbance In Attention
Productive Cough
Ill-Defined Disorder
Tremor
Oxygen Saturation
Decreased
Hypoaesthesia
Mucous Stools
Rectal Haemorrhage
Balance Disorder
Bronchial Hyperreactivity
Headache
Sleep Apnoea Syndrome
Musculoskeletal Pain
Hyperhidrosis
Dysthymic Disorder
Rheumatoid Factor
Increased
Rash Papular
Eosinophilia
Paranoia
Hypervigilance
Breath Odour
Nausea
Aggression
Psychiatric Symptom
Decreased Activity
Convulsion
Dissociative Disorder
Hypoacusis
Dyspepsia
Insomnia
Depression

Selective Iga
Immunodeficiency
Fatigue
Asthenia
Chest Discomfort
Chest Pain
Psychotic Disorder
Self-Injurious Ideation
03-Apr-2012 09:37 AM Page: 716

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Meniscus Lesion
Thinking Abnormal
Homicidal Ideation
Mitral Valve Incompetence
Dehydration
Attention
Deficit/Hyperactivity
Disorder
Contusion
Antinuclear Antibody
Positive
Derealisation
Product Contamination
Palpitations
Somnolence
Dizziness
Tinnitus
Emotional Disorder
Eructation
Anxiety
Memory Impairment
Hallucination, Visual
Hypertension
Fall
Asthma
Weight Decreased
Nystagmus
Eye Movement Disorder
Ligament Sprain
Coordination Abnormal
Vestibular Disorder
Weight Increased
Snoring
Coronary Artery Disease
Non-Cardiac Chest Pain
Angina Pectoris
Visual Impairment
Dyspnoea
Cranial Nerve Disorder
Joint Dislocation
Cognitive Disorder
Craniocerebral Injury
Humerus Fracture
Pyrexia
Product Quality Issue
Abdominal Pain Upper
Photophobia
Agitation
Mood Swings
Generalised Anxiety
Disorder
Post-Traumatic Stress
Disorder

Bundle Branch Block Right
Exostosis
Rhinitis Allergic
Nocturia
Heart Rate Decreased
Rash
Vertigo
Suicidal Ideation
03-Apr-2012 09:37 AM Page: 717

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Panic Disorder
Major Depression
Toxicity To Various Report Source Product Role Manufacturer Route Dose Duration
Agents Lariam PS Roche ORAL
Mitral Valve Primaquine C
Calcification Cipro C
Myalgia
Ventricular Extrasystoles
Eye Disorder
Merycism
Upper Respiratory Tract
Infection
Abdominal Distension
Gastrointestinal Motility
Disorder
Date:06/30/06ISR Number: 5040526-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-452577 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Lariam PS Roche UNKNOWN
Suicidal Ideation
Date:07/10/06ISR Number: 5046420-6Report Type:Expedited (15-DaCompany Report #ZM-ROCHE-453365 Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Blood Creatinine Mefloquine
Hospitalization - Increased Hydrochloride PS Roche ORAL 1 DAY
Initial or Prolonged Nephrotic Syndrome
Date:07/10/06ISR Number: 5048049-2Report Type:Direct Company Report #CTU 280300 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Generalised Anxiety Larium Don'T
Disorder
Know
Malaise Hoffman-Laroche PS Hoffman-Laroche 1 PILL
Emotional Disorder
WEEKLY
Palpitations
Feeling Abnormal
Heart Rate Increased
Date:07/17/06ISR Number: 5052750-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-450157 Age:43 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myocardial Infarction Lariam PS Roche ORAL REPORTED AS
Initial or Prolonged Supraventricular 250 MG AS

Extrasystoles TOTAL. 1 DAY
Sinus Tachycardia Mediator 150 SS ORAL 726 DAY
Pericarditis Havrix C INTRAMUSCULAR FORM:
Ventricular Extrasystoles
INJECTABLE
SOLUTION. 1 DAY
Rabipur C INTRAMUSCULAR 1 DAY
03-Apr-2012 09:37 AM Page: 718

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/18/06ISR Number: 5053702-0Report Type:Expedited (15-DaCompany Report #SE-ROCHE-454148 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspnoea Lariam PS Roche ORAL 8 DAY
Angioedema
Anxiety
Date:07/18/06ISR Number: 5054159-6Report Type:Expedited (15-DaCompany Report #CA-ROCHE-454857 Age:48 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nodular Vasculitis Lariam PS Roche ORAL
Synthroid
C
Date:07/24/06ISR Number: 5059676-0Report Type:Expedited (15-DaCompany Report #SE-ROCHE-454148 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam PS Roche ORAL 8 DAY
Angioedema
Dyspnoea
Sensation Of Foreign Body
Date:07/31/06ISR Number: 5065746-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-451414 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Asthenia Lariam PS Roche ORAL
Nausea Lariam SS Roche ORAL
Oropharyngeal Pain Lariam SS Roche ORAL
Mood Swings Artesunate C ORAL
Anxiety Chloroquine C ORAL
Abdominal Discomfort Doxycycline C 3 DAY
Depression
Confusional State
Thinking Abnormal
Abdominal Pain
Diarrhoea
Musculoskeletal Pain
Tremor
Feeling Abnormal
Amnesia
Disease Recurrence
Fatigue
Myalgia
Bedridden
Date:08/11/06ISR Number: 5078369-7Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0426071A Age:28 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Ineffective Malarone PS Glaxosmithkline ORAL 2TAB Three
Initial or Prolonged Hallucination times per day 3 DAY
Disability Insomnia Lariam SS Other ORAL 1250MG per
Major Depression day 1 DAY
Rohypnol SS Other ORAL 5MG Per day 3 WK
Ciflox C Other UNKNOWN 8 DAY
03-Apr-2012 09:37 AM Page: 719

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/14/06ISR Number: 5079426-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-452577 Age:62 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Psychiatric Symptom Lariam PS Roche ORAL 29 DAY
Anxiety Teoptic C OPHTHALMIC
Suicidal Ideation
Depression
Panic Attack
Date:08/17/06ISR Number: 5082526-3Report Type:Expedited (15-DaCompany Report #SE-ROCHE-454148 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspnoea Lariam PS Roche ORAL 8 DAY
Angioedema
Sensation Of Foreign Body
Anxiety
Date:08/22/06ISR Number: 5087940-8Report Type:Direct Company Report #CTU 283391 Age:70 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Rash Mefloquine PS ORAL PO
Initial or Prolonged Duodenitis Chloroquine SS ORAL PO
Decreased Appetite Pravachol C
Leukocytoclastic Loratidine C
Vasculitis Plavix C
Infection Lotrel C
Nonspecific Reaction Toprol C
Asthenia Nitroglycerin Patch C
Gastritis Aspirin C
Date:08/23/06ISR Number: 5088480-2Report Type:Direct Company Report #CTU 283589 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Lariam (Mefloquine) PS 250 MG 1
Vertigo
TABLET WEEKLY
Sleep Disorder
Abnormal Dreams
Suicidal Ideation
Insomnia
Paranoia
Anger
Affect Lability
Panic Attack
Tinnitus
Anxiety
Depression
Headache

Dizziness
03-Apr-2012 09:37 AM Page: 720

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/25/06ISR Number: 5088864-2Report Type:Expedited (15-DaCompany Report #BE-ROCHE-460045 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pneumonitis Mefloquine
Initial or Prolonged Hydrochloride PS Roche UNKNOWN
Mefloquine
Hydrochloride SS Roche UNKNOWN
Bisoprolol Fumarate C REPORTED AS
CHRONIC
MEDICAITON.
Ciprofibratum C REPORTED AS
CHRONIC
MEDICAITON.
Aspirin C REPORTED AS:
CHRONIC
MEDICATION -
LOW DOSE
ASPIRIN.
Date:08/28/06ISR Number: 5093449-8Report Type:Expedited (15-DaCompany Report #2006-BP-09661RO Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disinhibition Foreign Mefloquine
Initial or Prolonged Hallucination, Visual Literature (Mefloquine) PS 250 MG PER
Other Serious Delusion Health WEEK (250
Delusion Of Grandeur Professional MG), PO 2 WK
Insomnia
Persecutory Delusion
Delusion Of Reference
Mania
Psychotic Disorder
Date:08/31/06ISR Number: 5094068-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-459650 Age:39 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Parkinson'S Disease Lariam PS Roche ORAL
Date:09/05/06ISR Number: 5096297-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-461700 Age:43 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anaemia Lariam PS Roche ORAL
Initial or Prolonged Anxiety
Confusional State
Psychotic Disorder
Insomnia
Abnormal Behaviour
Liver Disorder

Date:09/06/06ISR Number: 5097232-9Report Type:Expedited (15-DaCompany Report #SE-ROCHE-461385 Age:11 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Iron Deficiency Lariam PS Roche ORAL DOSAGE
Leukopenia
REGIMEN
03-Apr-2012 09:37 AM Page: 721

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
REPORTED AS
3/4 TABLET.
Date:09/07/06ISR Number: 5098825-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-461020 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Thrombosis Lariam PS Roche ORAL 24 DAY
Initial or Prolonged
Date:09/08/06ISR Number: 5099741-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-461579 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Delusion Mefloquine
Initial or Prolonged Hypomania Hydrochloride PS Roche ORAL 57 DAY
Insomnia Salbutamol C
Agitation Betnovate C TOPICAL
Tearfulness
Delusional Disorder,
Persecutory Type
Date:09/08/06ISR Number: 5099758-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-461827 Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Renal Failure Acute Lariam PS Roche ORAL 8 DAY
Initial or Prolonged Ecchymosis Ciprofloxacine SS ORAL 15 DAY
Headache Flagyl SS ORAL 15 DAY
Tendon Disorder Paracetamol C
Urinary Tract Infection Polygynax C
Vaginal Infection Solubacter C
Vertigo
Rash
Date:09/08/06ISR Number: 5099759-2Report Type:Expedited (15-DaCompany Report #GB-ROCHE-461998 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Renal Dysplasia Lariam PS Roche TRANSPLACENTAL
Pregnancy Alcohol C
Maternal Exposure During
Pregnancy
Date:09/11/06ISR Number: 5104007-0Report Type:Expedited (15-DaCompany Report #GXKR2006BE05415 Age:60 YR Gender:Female I/FU:I
Outcome
Hospitalization -
PT
Respiratory Distress

Initial or Prolonged
Interstitial Lung Disease
Leukocytosis
Hypoxia
Cyanosis
Myalgia
Headache
Rales
Blood Lactate
03-Apr-2012 09:37 AM Page: 722

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dehydrogenase Increased
Tachycardia
Report Source Product Role Manufacturer Route Dose Duration
Foreign
Mefloquine
Literature (Ngx)(Mefloquine) PS 250 MG, QW
Health Bisoprolol Fumarate C
Professional Ciprofibrate C
Other
Aspirine
(Acetylsalicylic
Acid)
C
Date:09/12/06ISR Number: 5102387-3Report Type:Expedited (15-DaCompany Report #FR-AVENTIS-200613012FR Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Renal Failure Acute Flagyl "Aventis" PS Aventis
Initial or Prolonged Ecchymosis Pharmaceuticals Inc. ORAL
Rash Papular Lariam SS ORAL
Pruritus Ciprofloxacine SS ORAL
Vertigo Morphine C
Chills Motilium C
Tendon Disorder Di-Antalvic C
Abdominal Pain Lower Spasfon C
Urinary Tract Infection Polygynax C
Vaginal Infection Solubacter C
Headache
Date:09/15/06ISR Number: 5105797-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-462646 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Exposure During Lariam PS Roche ORAL
Pregnancy
Abortion Spontaneous
Date:09/19/06ISR Number: 5108165-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-443462 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diarrhoea Lariam PS Roche UNKNOWN 4 TABLETS IN
Initial or Prolonged Vomiting TOTAL.
Fatigue
Disturbance In Attention
Vertigo
Visual Impairment
Date:09/20/06ISR Number: 5109127-2Report Type:Expedited (15-DaCompany Report #ZM-ROCHE-453365 Age:28 YR Gender:Male I/FU:I

Outcome
Life-Threatening
Hospitalization -
Initial or Prolonged
PT
Blood Creatinine
Increased
Nephrotic Syndrome
Oedema Peripheral
Blood Albumin Decreased
Blood Sodium Decreased
Abdominal Distension
03-Apr-2012 09:37 AM Page: 723

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Blood Potassium Decreased
Body Temperature
Decreased Report Source Product Role Manufacturer Route Dose Duration
Respiratory Rate
Mefloquine
Increased Hydrochloride PS Roche ORAL 1 DAY
Date:09/20/06ISR Number: 5109459-8Report Type:Expedited (15-DaCompany Report #BE-ROXANE LABORATORIES, INC-2006-BP-10708RO Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Mefloquine PS Roxane Laboratories,
Initial or Prolonged Leukocytosis Inc. ORAL 250 mg x 1
Headache
dose
Hypoxia Bisoprolol Fumarate C
Pneumonitis Ciprofibratum C
Dyspnoea Aspirin C
C-Reactive Protein
Increased
Cough
Chills
Tachycardia
Blood Lactate
Dehydrogenase Increased
Cyanosis
Myalgia
Date:09/20/06ISR Number: 5109460-4Report Type:Expedited (15-DaCompany Report #FR-ROXANE LABORATORIES, INC-2006-BP-10993RO Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Contusion Mefloquine PS Roxane Laboratories,
Malaria Inc. 48 HR
Mental Disorder
Proguanil-Chloroquin
Wound e SS 3 MON
Drug Ineffective
Completed Suicide
Haemothorax
Date:09/20/06ISR Number: 5112513-8Report Type:Direct Company Report #CTU 285351 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Incontinence Lariam PS
Grand Mal Convulsion
Tongue Biting
Date:09/28/06ISR Number: 5118014-5Report Type:Direct Company Report #CTU 285895 Age:28 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Mefloquine Roche PS Roche ORAL ONE TABLET
Initial or Prolonged
ONCE A WEEK
PO
03-Apr-2012 09:37 AM Page: 724

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/29/06ISR Number: 5117526-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-447408 Age:44 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vomiting Lariam PS Roche ORAL
Coordination Abnormal
Anaesthetic
Asthenia Medication C REPORTED AS
Tachycardia
ANAESTHESIA,
Dizziness
LOCAL.
Nausea
Hypertension
Hot Flush
Date:10/09/06ISR Number: 5122975-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-465214 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Myalgia Lariam PS Roche ORAL
Monoplegia
Pain
Date:10/10/06ISR Number: 5123787-1Report Type:Expedited (15-DaCompany Report #FR-AVENTIS-200613012FR Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vertigo Flagyl "Aventis" PS Aventis
Initial or Prolonged Rash Papular Pharmaceuticals Inc. ORAL
Headache Lariam SS ORAL
Leukocytosis Ciprofloxacine SS ORAL
Ecchymosis Morphine C
Chills Motilium C
Urinary Tract Infection Diantalvic C
Renal Failure Acute Spasfon C
Tendon Disorder Polygynax C
Gamma-Glutamyltransferase Solubacter C
Increased
Muscle Spasms
Pruritus
Date:10/16/06ISR Number: 5127772-5Report Type:Expedited (15-DaCompany Report #ZM-ROCHE-430119 Age:28 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Nephrotic Syndrome Mefloquine
Hospitalization - Blood Creatinine Hydrochloride PS Roche ORAL 3 DAY
Initial or Prolonged Increased
Date:10/16/06ISR Number: 5127780-4Report Type:Expedited (15-DaCompany Report #ZM-ROCHE-453365 Age:28 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Blood Creatinine Mefloquine
Hospitalization - Increased Hydrochloride PS Roche ORAL 1 DAY
Initial or Prolonged Nephrotic Syndrome
Respiratory Rate
Increased
03-Apr-2012 09:37 AM Page: 725

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/17/06ISR Number: 5128708-3Report Type:Expedited (15-DaCompany Report #FR-AVENTIS-200613012FR Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Constipation Flagyl PS Aventis
Initial or Prolonged Chills Pharmaceuticals Inc. ORAL
Gamma-Glutamyltransferase Lariam SS ORAL
Increased Ciprofloxacine SS ORAL
Muscle Spasms Morphine C
Rash Papular Motilium C
Vertigo Diantalvic C
Headache Spasfon C
Pain Polygynax C
Renal Failure Acute Solubacter C
Pruritus
Abdominal Pain
Tendon Disorder
Ecchymosis
Leukocytosis
Date:10/18/06ISR Number: 5129717-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-466784 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tongue Ulceration Lariam PS Roche ORAL
Pharyngeal Ulceration
Oropharyngeal Pain
Inflammation
Oral Administration
Complication
Date:10/23/06ISR Number: 5132543-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-461827 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Prurigo Lariam PS Roche ORAL FIRST TABLET
Initial or Prolonged Urinary Tract Infection ON 17 JUL
Rash Papular
2006, SECOND
Constipation TABLET ON 24
Rash Erythematous JUL 2006. 8 DAY
Renal Failure Acute Ciprofloxacine SS ORAL 15 DAY
Vertigo Flagyl SS ORAL 15 DAY
Abdominal Pain Paracetamol C
Headache Polygynax C
Ecchymosis Solubacter C
Date:10/24/06ISR Number: 5133707-1Report Type:Expedited (15-DaCompany Report #IT-ROCHE-467032 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatic Failure Mefloquine

Initial or Prolonged Hepatomegaly Hydrochloride PS Roche UNKNOWN TREATMENT
Hepatic Steatosis
INTERRUPTED
AFTER THE 5TH
WEEK
03-Apr-2012 09:37 AM Page: 726

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/30/06ISR Number: 5138679-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-459650 Age:39 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Parkinsonism Lariam PS Roche ORAL
Date:10/30/06ISR Number: 5138717-6Report Type:Expedited (15-DaCompany Report #NL-ROCHE-467834 Age:59 YR Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypertensive Crisis Lariam PS Roche ORAL 1 DAY
Initial or Prolonged Metoprolol Tartrate C ORAL
Simvastatin C ORAL
Coversyl Plus C ORAL STRENGTH
REPORTED AS
4/1,25 MG.
Date:10/30/06ISR Number: 5138723-1Report Type:Expedited (15-DaCompany Report #RU-ROCHE-467843 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gamma-Glutamyltransferase Lariam PS Roche ORAL ONCE ONE
Increased TABLET OF 250
MG. 1 DAY
Date:11/06/06ISR Number: 5144153-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457439 Age:3 MON Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Lariam PS Roche ORAL 1 DAY
Initial or Prolonged Haematocrit Decreased
Respiratory Disorder
Vomiting
Salivary Hypersecretion
Haemoglobin Decreased
Date:11/14/06ISR Number: 5158996-9Report Type:Expedited (15-DaCompany Report #D0045516A Age:43 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Drug Ineffective Foreign Malarone PS ORAL ORAL
Hospitalization - Depressed Level Of Literature Sodium Artesunate
Initial or Prolonged Consciousness Health (Sodium Artesunate) SS ORAL PER DAY ORAL
Cerebral Malaria
Professional
Psychiatric Symptom
Other
Myoclonic Epilepsy
Date:11/22/06ISR Number: 5156058-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-447408 Age:43 YR Gender:Female I/FU:F

Outcome
Other Serious
PT
Tachycardia
Asthenia
Dizziness
Hypertension
Hot Flush
Vomiting
03-Apr-2012 09:37 AM Page: 727

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Coordination Abnormal
Nausea
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL
Femoston C TAKEN FOR
YEARS.
Jodetten
C
Anaesthetic
Medication C REPORTED AS
ANAESTHESIA,
LOCAL.
Date:11/22/06ISR Number: 5157901-9Report Type:Direct Company Report #CTU 289911 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam 250 Mg
Panic Attack (Weekly) Roche PS Roche ORAL 250 MG ONCE
Insomnia
WEEKLY ORALLY
Depression
Date:11/24/06ISR Number: 5156951-6Report Type:Expedited (15-DaCompany Report #NL-ROCHE-467834 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypertensive Crisis Lariam PS Roche ORAL 1 DAY
Initial or Prolonged Malignant Hypertension Cosopt C OTHER ROUTE
REPORTED AS
OCULAR AND
FORM REPORTED
AS EYEDROPS.
Simvastatin C ORAL
Coversyl Plus C ORAL STRENGTH
REPORTED AS
4/1,25 MG.
Selokeen C ORAL
Date:11/27/06ISR Number: 5165169-2Report Type:Expedited (15-DaCompany Report #GXKR2006SG07387 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Contusion Foreign Mefloquine (Ngx)
Rectal Haemorrhage Literature (Mefloquine) Unknown PS QW
Platelet Count Increased Health
Professional
Other
Date:11/28/06ISR Number: 5159052-6Report Type:Expedited (15-DaCompany Report #SG-ROXANE LABORATORIES, INC-2006-BP-13605RO Age:46 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Platelet Count Increased Mefloquine PS Roxane Laboratories,
Contusion Inc. once weekly x
Rectal Haemorrhage 3 weeks 3 WK
03-Apr-2012 09:37 AM Page: 728

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/01/06ISR Number: 5162883-XReport Type:Expedited (15-DaCompany Report #113217 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatomegaly Lariam Tablets PS Roche ORAL
Initial or Prolonged Toxicity To Various
Agents
Metabolic Disorder
Nausea
Nervousness
Diarrhoea
Abdominal Distension
Depression
Vomiting
Alcohol Use
Weight Decreased
Dehydration
Hepatic Steatosis
Decreased Appetite
Gastroenteritis
Gravitational Oedema
Hepatic Failure
Date:12/04/06ISR Number: 5163420-6Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457439 Age:3 MON Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Haematocrit Decreased Lariam PS Roche ORAL 1 DAY
Initial or Prolonged Platelet Count Increased
Fatigue
Convulsion
Respiratory Disorder
Haemoglobin Decreased
Vomiting
Dyspnoea
Salivary Hypersecretion
Date:12/08/06ISR Number: 5168390-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-472987 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Torticollis Lariam PS Roche UNKNOWN
Laryngeal Disorder
Date:12/11/06ISR Number: 5175373-5Report Type:Direct Company Report #CTU 291283 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Restlessness Lariam Roche PS Roche THREE PILLS
Required Tinnitus OF 250 MG ONE
Intervention to Fatigue A WEEK 3 WK

Prevent Permanent
Impairment/Damage
Mood Swings
03-Apr-2012 09:37 AM Page: 729

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/14/06ISR Number: 5174215-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-474014 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vasculitis Lariam PS Roche UNKNOWN
Initial or Prolonged Human Ehrlichiosis
Creatinine Renal
Clearance Increased
Nephritis
Date:12/18/06ISR Number: 5177195-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-474927 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Aplasia Lariam PS Roche ORAL 72 DAY
Maternal Exposure During
Pregnancy
Abortion Induced
Foetal Malformation
Date:12/19/06ISR Number: 5179370-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-98097 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Depression Lariam Tablets PS Roche ORAL
Femur Fracture
Completed Suicide
Skull Fracture
Abnormal Behaviour
Fall
Multiple Injuries
Facial Bones Fracture
Aortic Rupture
Date:12/19/06ISR Number: 5179424-3Report Type:Expedited (15-DaCompany Report #CA-ROCHE-940804124001 Age:23 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Hallucination Lariam PS Roche ORAL
Life-Threatening Completed Suicide Alcohol C ORAL
Date:12/19/06ISR Number: 5191295-8Report Type:Direct Company Report #CTU 291816 Age:42 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Hallucination
Insomnia
Rapid Eye Movements Sleep
Abnormal
Hyperhidrosis

Crying
Nausea
Nightmare
Emotional Disorder
Hypoaesthesia
Myocardial Infarction
Decreased Appetite
Paranoia
03-Apr-2012 09:37 AM Page: 730

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Paraesthesia
Dizziness
Report Source Product Role Manufacturer Route Dose Duration
Mefloquine 250 Mg
Sandoz PS Sandoz ORAL 1 TABLET
WEEKLY PO
Date:12/21/06ISR Number: 5188158-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-447408 Age:43 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypertension Lariam PS Roche ORAL
Hot Flush Femoston C ORAL DRUG NAME
Coordination Abnormal
REPORTED AS
Nausea
FEMOSTON
Vomiting
2/10. TAKEN
Tachycardia
FOR YEARS.
Asthenia Jodetten C ORAL DRUG NAME
Dizziness
REPORTED AS
JODETTEN
DEPOT. DOSAGE
REGIMEN
Anaesthetic
Medication C REPORTED AS
ANAESTHESIA,
LOCAL.
Date:01/02/07ISR Number: 5195733-6Report Type:Expedited (15-DaCompany Report #FR-ROCHE-472987 Age:40 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Laryngeal Disorder Lariam PS Roche UNKNOWN
Dystonia
Torticollis
Speech Disorder
Date:01/03/07ISR Number: 5199854-3Report Type:Direct Company Report #CTU 292560 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Asthenia Larium PS
Intervention to
Depression
Prevent Permanent Hypothyroidism
Impairment/Damage Lethargy
Fatigue
Mental Disorder
Date:01/09/07ISR Number: 5202168-6Report Type:Expedited (15-DaCompany Report #IT-ROCHE-476898 Age:44 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Angioedema Lariam PS Roche ORAL 52 DAY
Initial or Prolonged Urticaria Amoxicilline SS ORAL 7 DAY
03-Apr-2012 09:37 AM Page: 731

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/09/07ISR Number: 5203930-6Report Type:Direct Company Report #CTU 292996 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Larium PS ORAL 1 TABLET ONCE
Initial or Prolonged Paranoia DAILY ORALLY 8 DAY
Other Serious
Delusion
Convulsion
Loss Of Proprioception
Heart Rate Increased
Panic Attack
Psychotic Disorder
Date:01/11/07ISR Number: 5208350-6Report Type:Direct Company Report #CTU 293144 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Balance Disorder Lariam 250mg Roche PS Roche ORAL 250 MG WEEKLY
Hospitalization - Anxiety PO 3 WK
Initial or Prolonged Fatigue Travel C
Other Serious
Brain Injury
Required
Hallucination
Intervention to
Panic Attack
Prevent Permanent
Impairment/Damage
Insomnia
Impaired Work Ability
Aphasia
Suicidal Ideation
Psychiatric Symptom
Feeling Of Body
Temperature Change
Cold Sweat
Psychotic Disorder
Vestibular Neuronitis
Dizziness
Chills
Headache
Disturbance In Attention
Depression
Neurotoxicity
Convulsion
Date:01/17/07ISR Number: 5210481-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-477655 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vestibular Disorder Lariam PS Roche UNKNOWN THE PATIENT
Initial or Prolonged Convulsion REPORTED
Psychotic Disorder
TAKING THREE
Nightmare
LARIAM
Hallucination
"PILLS" IN
Suicidal Ideation
Thinking Abnormal

Aggression
Insomnia
03-Apr-2012 09:37 AM Page: 732

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/17/07ISR Number: 5211569-1Report Type:Direct Company Report #CTU 293643 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Night Blindness Mefloquine 250 Mg
Maculopathy Roche PS Roche ORAL 250 MG PO QWK
Visual Acuity Reduced
PO
Colour Blindness Erythromycin C
Scotoma
Date:01/19/07ISR Number: 5213113-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-478024 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Rectal Haemorrhage Lariam PS Roche ORAL
Initial or Prolonged Diarrhoea Lariam SS Roche ORAL
Anisocytosis Tenstaten C ORAL
Poikilocytosis
Microcytic Anaemia
Blood Potassium Decreased
Diarrhoea Infectious
Date:01/25/07ISR Number: 5219034-2Report Type:Expedited (15-DaCompany Report #NO-ROCHE-398212 Age:38 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diarrhoea Lariam PS Roche ORAL TAKEN ON 22
Initial or Prolonged Tinnitus FEB, 01 MAR
Disability Hearing Impaired AND 08 MAR
Vertigo 2005. 15 DAY
Balance Disorder
Nausea
Dizziness
Nystagmus
Date:01/26/07ISR Number: 5221301-3Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-477672 Age:34 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Dry Eye Lariam PS Roche ORAL
Hospitalization - Corneal Scar
Initial or Prolonged Stevens-Johnson Syndrome
Disability
Date:01/29/07ISR Number: 5224770-8Report Type:Direct Company Report #CTU 294509 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Wound Secretion Larium PS ORAL 1 TABLET ONCE
Initial or Prolonged Rash DAILY ORALLY 9 DAY

Other Serious
Menstruation Irregular
03-Apr-2012 09:37 AM Page: 733

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/30/07ISR Number: 5223920-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Age:34 YR Gender:Male I/FU:F
Outcome
Disability
PT
Nausea
Depression
Paraesthesia
Disorientation
Dyspnoea
Irritable Bowel Syndrome
Lactose Intolerance
Lipoma
Haemorrhoids
Vitreous Floaters
Bronchial Hyperreactivity
Anxiety
Panic Attack
Rash
Hypersensitivity
Generalised Anxiety
Disorder
Musculoskeletal Stiffness
Amnesia
Eye Movement Disorder
Treatment Noncompliance
Food Allergy
Melanocytic Naevus
Dizziness
Motion Sickness
Tinnitus
Self Esteem Decreased
Disturbance In Attention
Headache
Neck Pain
Abdominal Pain Lower
Vertigo
Sleep Disorder Due To
General Medical
Condition, Hypersomnia
Type
Heart Rate Increased
Abdominal Pain
Diarrhoea
Photophobia
Acrophobia
Throat Irritation
Rhinitis Allergic
Mental Disorder
Adjustment Disorder With
Anxiety
Mood Disorder Due To A
General Medical Condition
Insomnia
Balance Disorder

Abdominal Distension
Condition Aggravated
Gilbert'S Syndrome
Infection Parasitic
Emotional Distress
Suicidal Ideation
Heart Rate Irregular
Burning Sensation
03-Apr-2012 09:37 AM Page: 734

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Injury
Palpitations
Sinus Bradycardia Report Source Product Role Manufacturer Route Dose Duration
Vestibular Disorder Lariam PS Roche ORAL THE PATIENT
Weight Decreased HAD TAKEN 4-5
Phobia Of Flying
TABLETS OF
Phobia
MEFLOQUINE IN
Migraine TOTAL. 21 DAY
Blood Bilirubin Increased Vaccine C OTHER 1 DAY
Impetigo
Abdominal Pain Upper
Adjustment Disorder With
Depressed Mood
Claustrophobia
Sensory Integrative
Dysfunction
Fatigue
Sleep Disorder
Back Pain
Nasal Congestion
Hypoaesthesia
Gait Disturbance
Visual Impairment
Date:01/30/07ISR Number: 5225876-XReport Type:Direct Company Report #CTU 294564 Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Palpitations Mefloquine Hcl 250
Panic Attack Mg PS ORAL 1 WEEKLY
Fear
PO
Dyspnoea
Date:01/30/07ISR Number: 5225886-2Report Type:Direct Company Report #CTU 294589 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Lariam-Mefloquine
Initial or Prolonged Vomiting Hcl- Sandoz Or Roche PS Sandoz Or Roche ORAL 250MG ONCE A
Other Serious Nausea WEEK PO (2
Anxiety
DOSES ONLY)
Feeling Abnormal
Hypophagia
Heart Rate Increased
Malaise
Insomnia
Palpitations
Chills

Date:02/16/07ISR Number: 5239696-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Age:36 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Vertigo
Sleep Disorder
Disturbance In Attention
Cardiovascular Disorder
Mental Disorder
03-Apr-2012 09:37 AM Page: 735

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Malaise
Headache
Coordination Abnormal Report Source Product Role Manufacturer Route Dose Duration
Fatigue Lariam PS Roche UNKNOWN DOSAGE
Anxiety
REGIMEN
Oedema Peripheral
REPORTED AS
Formication
FOUR TABS IN
Asthenia
TOTAL.
Abnormal Dreams
Paraesthesia
Tinnitus
Depression
Tachycardia
Feeling Abnormal
Muscle Twitching
Night Sweats
Date:02/16/07ISR Number: 5239744-0Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-477672 Age:34 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Dry Eye Lariam PS Roche ORAL
Hospitalization - Corneal Scar
Initial or Prolonged Stevens-Johnson Syndrome
Disability
Date:02/20/07ISR Number: 5243672-4Report Type:Direct Company Report #CTU 296345 Age:47 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Middle Insomnia Mefloquine Std ? PS ORAL STD 1/ WEEK
Sensitivity Of Teeth
PO
Condition Aggravated
Fatigue
Date:02/21/07ISR Number: 5242741-2Report Type:Expedited (15-DaCompany Report #GB-ROCHE-482808 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Renal Failure Acute Lariam PS Roche UNKNOWN
Initial or Prolonged Lariam SS Roche UNKNOWN
Lariam SS Roche UNKNOWN
Lariam SS Roche UNKNOWN
Date:02/28/07ISR Number: 5252267-8Report Type:Direct Company Report #CTU 296837 Age:23 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Panic Attack Larium Mefloquine

Dizziness Roche PS Roche ORAL ONE PILL
Paranoia
-250MG- PER
Abnormal Dreams WEEK PO 10 MON
Hallucination
Anxiety
Heart Rate Increased
Insomnia
Motion Sickness
03-Apr-2012 09:37 AM Page: 736

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/02/07ISR Number: 5254139-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-483909 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Lariam PS Roche ORAL 1 DAY
Initial or Prolonged Delirium
Aggression
Date:03/02/07ISR Number: 5256250-8Report Type:Direct Company Report #CTU 297137 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Lariam PS Barr Laboratories,
Initial or Prolonged Inc. ORAL 1 PILL 1/WEEK
PO
Date:03/06/07ISR Number: 5256605-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Age:40 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Lariam PS Roche ORAL EVERY WEEK. 9 DAY
Initial or Prolonged Antisocial Behaviour Valium SS Roche INTRAVENOUS 1 DAY
Disability Muscle Rigidity Prozac C ORAL
Speech Disorder
Agitation
Memory Impairment
Depression
Gait Disturbance
Blood Potassium Decreased
Paranoia
Convulsion
Hostility
Headache
Hallucination
Incontinence
Confusional State
Delusion
Disorientation
Fatigue
Loss Of Libido
Drug Ineffective
Aggression
Mania
Pyrexia
Date:03/06/07ISR Number: 5258866-1Report Type:Direct Company Report #CTU 297362 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Lariam PS
Anxiety

Depression
Nightmare
03-Apr-2012 09:37 AM Page: 737

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/08/07ISR Number: 5258961-7Report Type:Expedited (15-DaCompany Report #SE-ROCHE-485061 Age:3 MON Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Increased Upper Airway Lariam PS Roche ORAL 1 DAY
Secretion
Respiratory Arrest
Erythema
Anaphylactic Reaction
Bronchospasm
Date:03/09/07ISR Number: 5260861-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Age:36 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vertigo Lariam PS Roche UNKNOWN DOSAGE
Initial or Prolonged Disturbance In Attention REGIMEN
Abnormal Dreams
REPORTED AS
Headache
FOUR TABS IN
Tachycardia TOTAL. 22 DAY
Feeling Abnormal
Agitation
Coordination Abnormal
Fatigue
Oedema Peripheral
Cardiovascular Disorder
Anxiety
Depression
Formication
Asthenia
Sleep Disorder
Muscle Twitching
Malaise
Mental Disorder
Paraesthesia
Night Sweats
Tinnitus
Date:03/16/07ISR Number: 5267373-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-485061 Age:3 MON Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Bronchospasm Lariam PS Roche ORAL 1 DAY
Erythema
Respiratory Arrest
Anaphylactic Reaction
Increased Upper Airway
Secretion
Respiratory Disorder

Date:03/19/07ISR Number: 5269055-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Age:36 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Febrile Infection
Disturbance In Attention
Fatigue
Malaise
Formication
03-Apr-2012 09:37 AM Page: 738

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Vertigo
Oedema Peripheral
Dyspepsia Report Source Product Role Manufacturer Route Dose Duration
Headache Lariam PS Roche UNKNOWN DOSAGE
Depression
REGIMEN
Tachycardia
REPORTED AS
Asthenia
FOUR TABS IN
Muscle Twitching TOTAL. WEEKLY 22 DAY
Agitation
Paraesthesia
Feeling Abnormal
Abnormal Dreams
Night Sweats
Cardiovascular Disorder
Anxiety
Tinnitus
Sleep Disorder
Coordination Abnormal
Mental Disorder
Date:03/27/07ISR Number: 5277512-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-485061 Age:3 MON Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Bronchospasm Lariam PS Roche ORAL TWO DOSES,
Respiratory Depression
THE FIRST
Increased Bronchial
DOSE WAS
Secretion SPITTED OUT. 1 DAY
Increased Upper Airway
Secretion
Respiratory Arrest
Respiratory Disorder
Erythema
Anaphylactic Reaction
Date:03/27/07ISR Number: 5277551-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-488026 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cardiac Arrest Lariam PS Roche UNKNOWN
Electrocardiogram Qt Sudafed C
Prolonged
Date:03/29/07ISR Number: 5280375-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-487625 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Homicide Mefloquine
Confusional State Hydrochloride PS Roche UNKNOWN

Date:03/30/07ISR Number: 5281849-2Report Type:Expedited (15-DaCompany Report #SE-ROCHE-488539 Age:2 MON Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyspnoea Lariam PS Roche ORAL REPORTED
Initial or Prolonged Increased Bronchial DOSAGE
Secretion
REGIMEN:
03-Apr-2012 09:37 AM Page: 739

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
62.MG1 MG 1. 1 DAY
Date:04/03/07ISR Number: 5284325-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-439267 Age:14 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Disorder Lariam PS Roche UNKNOWN
Initial or Prolonged Encephalopathy
Disability
Panic Attack
Cognitive Disorder
Speech Disorder
Anxiety Disorder
Depression
Date:04/03/07ISR Number: 5284692-3Report Type:Expedited (15-DaCompany Report #CA-ROCHE-489380 Age:43 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Toxicity To Various Lariam PS Roche UNKNOWN 18 MON
Agents
Maculopathy
Date:04/05/07ISR Number: 5288333-0Report Type:Expedited (15-DaCompany Report #SE-ROCHE-490181 Age:4 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Pulmonary Fibrosis Lariam PS Roche ORAL DOSAGE
Hospitalization - Respiratory Failure REGIMEN
Initial or Prolonged Cough REPORTED AS
Inflammation 75MGW MG W. 7 WK
Alveolitis Lariam SS Roche ORAL
Infection
Fatigue
Rash
Weight Decreased
Pyrexia
Depressed Level Of
Consciousness
Date:04/05/07ISR Number: 5288700-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-490463 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Road Traffic Accident Lariam PS Roche ORAL
Hyperhidrosis Laroxyl SS Roche ORAL
Malaise Laroxyl SS Roche ORAL
Dry Mouth
Asthenia

Date:04/05/07ISR Number: 5288710-8Report Type:Expedited (15-DaCompany Report #KR-ROCHE-490940 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Myocardial Infarction Lariam PS Roche UNKNOWN 4 WK
03-Apr-2012 09:37 AM Page: 740

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/06/07ISR Number: 5289566-XReport Type:Expedited (15-DaCompany Report #SE-ROCHE-488539 Age:61 DY Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Increased Bronchial Lariam PS Roche ORAL REPORTED
Initial or Prolonged Secretion DOSAGE
Dyspnoea
REGIMEN:
62.MG1 MG 1. 1 DAY
Date:04/11/07ISR Number: 5299140-7Report Type:Direct Company Report #CTU 300388 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Lariam, 250mg,
Initial or Prolonged Impaired Work Ability Hoffman-Laroche PS Hoffman-Laroche 250 MG ONCE
Disability Bipolar I Disorder WEEKLY
Discomfort
Date:04/12/07ISR Number: 5294969-3Report Type:Expedited (15-DaCompany Report #KR-ROCHE-490940 Age:40 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Myocardial Infarction Lariam PS Roche UNKNOWN 4 WK
Date:04/13/07ISR Number: 5296357-2Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Age:36 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Formication Lariam PS Roche UNKNOWN DOSAGE
Initial or Prolonged Abnormal Dreams REGIMEN
Disturbance In Attention
REPORTED AS
Cardiovascular Disorder
FOUR TABS IN
Fatigue TOTAL. WEEKLY 22 DAY
Agitation
Depression
Sleep Disorder
Headache
Anxiety
Tinnitus
Paraesthesia
Feeling Abnormal
Mental Disorder
Oedema Peripheral
Tachycardia
Muscle Twitching
Night Sweats
Malaise
Febrile Infection
Coordination Abnormal
Dyspepsia
Asthenia

Vertigo
03-Apr-2012 09:37 AM Page: 741

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/13/07ISR Number: 5296514-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-488026 Age:41 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Cardiac Arrest Lariam PS Roche ORAL DOSE: 250 MG
Hospitalization - Electrocardiogram Qt EVERY WEEK
Initial or Prolonged Prolonged Pseudoephedrine SS ORAL
Date:04/13/07ISR Number: 5300366-4Report Type:Direct Company Report #CTU 300636 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Abnormal Dreams Lariam PS
Adverse Drug Reaction
Suicidal Ideation
Hallucination
Completed Suicide
Depression
Date:04/16/07ISR Number: 5297609-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-477655 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vestibular Disorder Lariam PS Roche UNKNOWN THE PATIENT
Initial or Prolonged Nightmare REPORTED
Convulsion
TAKING THREE
Psychotic Disorder
LARIAM
Aggression
"PILLS" IN
Thinking Abnormal
Insomnia
Suicidal Ideation
Hallucination
Date:04/16/07ISR Number: 5297627-4Report Type:Expedited (15-DaCompany Report #SE-ROCHE-490181 Age:226 WK Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Infection Lariam PS Roche ORAL DOSAGE
Hospitalization - Interstitial Lung Disease REGIMEN
Initial or Prolonged Weight Decreased REPORTED AS
Pulmonary Fibrosis 75MGW MG W. 7 WK
Inflammation Lariam SS Roche ORAL
Respiratory Failure
Rash
Pyrexia
Depressed Level Of
Consciousness
Fatigue
Alveolitis
Cough

Date:04/30/07ISR Number: 5311573-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-490463 Age:46 YR Gender:Male I/FU:F
Outcome
Death
PT
Road Traffic Accident
Hyperhidrosis
Dry Mouth
03-Apr-2012 09:37 AM Page: 742

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Asthenia
Drug Interaction
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL
Laroxyl I Roche ORAL
Date:04/30/07ISR Number: 5312051-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-439267 Age:14 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Disorder Lariam PS Roche UNKNOWN
Initial or Prolonged Cognitive Disorder
Disability
Encephalopathy
Other Serious
Suicidal Ideation
Depression
Speech Disorder
Psychotic Disorder
Panic Attack
Anxiety Disorder
Date:04/30/07ISR Number: 5312244-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome
Disability
PT
Agitation
Nightmare
Vertigo
Chest Pain
Tinnitus
Nervousness
Photophobia
Phonophobia
Amnesia
Testicular Pain
Disturbance In Attention
Rash
Blood Pressure Increased
Dizziness
Irritable Bowel Syndrome
Nausea
Mood Swings
Fatigue
Psychotic Disorder
Diarrhoea
Memory Impairment
Disorientation
Headache
Abdominal Pain
Eye Pain
Pain Of Skin
Night Sweats

Vomiting
Anxiety Disorder
Nystagmus
Inner Ear Disorder
Depression
Insomnia
Vision Blurred
Vestibular Disorder
03-Apr-2012 09:37 AM Page: 743

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hypoaesthesia
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL
Imodium
C
Compazine C ON 18 APR
2001, THERAPY
REPORTED AS
TWICE DAILY.
Antibiotics Nos C
Ambien
C
Prednisone C BY TAPER.
Valium C ON 18 APR
2001, THERAPY
REPORTED AS:
AS NEEDED.
Phenergan
C
Biaxin
C
Advil
C
Bactrim
C
Antivert
C
Date:04/30/07ISR Number: 5316669-3Report Type:Direct Company Report #CTU 301881 Age:64 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Fatigue
Mefloquine 250mg
Photophobia Geneva Pharm PS Geneva Pharm ORAL ONE TAB
Malaise
WEEKLY PRIO,
Dizziness
10 DAYS AFTER
Disorientation
LEA PO
Vision Blurred
Headache
Circadian Rhythm Sleep
Disorder
Nausea
Date:05/02/07ISR Number: 5317809-2Report Type:Direct Company Report #CTU 302172 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Confusional State Mefloquine (Lariam) PS Roche ORAL 1 TABLET ONCE
Other Serious Hallucination PO
Required
Amnesia
Intervention to
Anxiety
Prevent Permanent Panic Attack
Impairment/Damage
Date:05/03/07ISR Number: 5316001-5Report Type:Expedited (15-DaCompany Report #KR-ROCHE-490940 Age:40 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Arteriosclerosis Coronary Lariam PS Roche UNKNOWN 4 WK
Artery
Cardiomegaly
Myocardial Infarction
03-Apr-2012 09:37 AM Page: 744

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/07/07ISR Number: 5318027-4Report Type:Expedited (15-DaCompany Report #KR-ROCHE-490940 Age:40 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Myocardial Infarction Lariam PS Roche UNKNOWN 4 WK
Arteriosclerosis Coronary
Artery
Cardiomegaly
Date:05/09/07ISR Number: 5320400-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Age:36 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abnormal Dreams Lariam PS Roche UNKNOWN DOSAGE
Initial or Prolonged Agitation REGIMEN
Other Serious Dyspepsia REPORTED AS
Headache
FOUR TABS IN
Asthenia
TOTAL. WEEKLY
Mental Disorder
Depression
Formication
Feeling Abnormal
Sleep Disorder
Fatigue
Oedema Peripheral
Coordination Abnormal
Night Sweats
Anxiety
Tachycardia
Tinnitus
Muscle Twitching
Upper Respiratory Tract
Infection
Pyrexia
Paraesthesia
Disturbance In Attention
Vertigo
Cardiovascular Disorder
Malaise
Date:05/11/07ISR Number: 5322571-3Report Type:Expedited (15-DaCompany Report #KR-ROCHE-490940 Age:40 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Myocardial Infarction Lariam PS Roche UNKNOWN 4 WK
Cardiomegaly
Arteriosclerosis Coronary
Artery
Date:05/14/07ISR Number: 5323676-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-490463 Age:46 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Hyperhidrosis Lariam PS Roche ORAL
Drug Interaction Laroxyl I Roche ORAL
Road Traffic Accident
Asthenia
Dry Mouth
03-Apr-2012 09:37 AM Page: 745

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/16/07ISR Number: 5326183-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-497219 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cardiac Disorder Lariam PS Roche ORAL 37 DAY
Hypothyroidism Typhoid Vaccine C 1 DAY
Grand Mal Convulsion Yellow Fever Vaccine C 1 DAY
Hepatitis A Vaccine C 1 DAY
Levothyroxine C ORAL
Date:05/18/07ISR Number: 5328482-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-489574 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Vertigo Lariam PS Roche ORAL
Cognitive Disorder Trinordiol C DOSAGE
Amnesia
REGIMEN
Anxiety REPORTED AS 1
Hearing Impaired
DOSE ONCE A
Muscle Spasms
DAY.
Hallucination
Palpitations
Tremor
Disturbance In Attention
Nausea
Nightmare
Dyspnoea
Date:05/21/07ISR Number: 5330072-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Age:36 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Lariam PS Roche UNKNOWN DOSAGE
Initial or Prolonged Tachycardia REGIMEN
Other Serious Coordination Abnormal REPORTED AS
Mental Disorder
FOUR TABS IN
Night Sweats
TOTAL. WEEKLY
Paraesthesia
Oedema Peripheral
Upper Respiratory Tract
Infection
Agitation
Dyspepsia
Disturbance In Attention
Pyrexia
Headache
Vertigo
Muscle Twitching
Anxiety
Depression
Abnormal Dreams
Formication

Sleep Disorder
Malaise
Asthenia
Tinnitus
Feeling Abnormal
Cardiovascular Disorder
03-Apr-2012 09:37 AM Page: 746

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/29/07ISR Number: 5336930-6Report Type:Expedited (15-DaCompany Report #IT-ROCHE-498140 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Renal Failure Lariam PS Roche ORAL
Hospitalization - Thrombotic
Initial or Prolonged Thrombocytopenic Purpura
Date:05/31/07ISR Number: 5343858-4Report Type:Direct Company Report #CTU 304366 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Lariam 250mg Roche PS Roche ORAL 1 TABLET
Insomnia
WEEKLY PO
Condition Aggravated
Anxiety
Memory Impairment
Impaired Work Ability
Amnesia
Paraesthesia
Vision Blurred
Influenza Like Illness
Mood Altered
Disturbance In Attention
Date:05/31/07ISR Number: 5356549-0Report Type:Periodic Company Report #329978 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Attack Consumer Lariam (Mefloquine
Initial or Prolonged Agitation Health Hydrochloride) 250
Dry Mouth Professional Mg PS ORAL 1 DOSE FORM 1
Suicidal Ideation Other PER WEEK ORAL
Depression
Ultran
Dizziness (Phenaglycodol) C
Fatigue
Lorazepam
Dyspnoea (Lorazepam) C
Abnormal Dreams
Unspecified
Headache
Immunizations
Nervousness (Immunisation) C
Hallucination
Effexor (Venlafaxine
Mood Swings Hydrochloride) C
Tremor
Eye Irritation
Nightmare
Heart Rate Increased
Claustrophobia
Memory Impairment
Disturbance In Attention
Balance Disorder
Psychotic Disorder
Insomnia

Date:05/31/07ISR Number: 5356550-7Report Type:Periodic Company Report #444908 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Consumer Lariam (Mefloquine
Initial or Prolonged Other Hydrochloride) PS
03-Apr-2012 09:37 AM Page: 747

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/31/07ISR Number: 5356551-9Report Type:Periodic Company Report #452842 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Neurotoxicity Consumer Lariam (Mefloquine
Fatigue Other Hydrochloride) 250
Simple Partial Seizures Mg PS ORAL 250 MG 1 PER
Abdominal Pain
ONE DOSE ORAL
Asthenia
Date:05/31/07ISR Number: 5356552-0Report Type:Periodic Company Report #466044 Age:10 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Disorder Literature Lariam (Mefloquine
Health Hydrochloride) PS ORAL 250 MG ORAL
Professional
Other
Date:05/31/07ISR Number: 5356553-2Report Type:Periodic Company Report #466080 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Other Lariam (Mefloquine
Initial or Prolonged Hydrochloride) 250
Mg
PS
Prozac (Fluoxetine) C
Date:05/31/07ISR Number: 5356554-4Report Type:Periodic Company Report #466103 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Consumer Lariam (Mefloquine
Initial or Prolonged Other Hydrochloride) 250
Mg
PS
Date:05/31/07ISR Number: 5356555-6Report Type:Periodic Company Report #467434 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Other Lariam (Mefloquine
Hydrochloride) 250
Mg
PS
Date:05/31/07ISR Number: 5356556-8Report Type:Periodic Company Report #469321 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Ineffective Literature Mefloquine

Initial or Prolonged Plasmodium Falciparum Health Hydrochloride
Infection Professional (Mefloquine
Other Hydrochloride) PS ORAL 250 MG 1 PER
1 WEEK ORAL
03-Apr-2012 09:37 AM Page: 748

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/31/07ISR Number: 5356557-XReport Type:Periodic Company Report #484946 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaise Consumer Lariam (Mefloquine
Initial or Prolonged Psychotic Disorder Other Hydrochloride) PS
Date:05/31/07ISR Number: 5356558-1Report Type:Periodic Company Report #487913 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Consumer Mefloquine
Depression Other Hydrochloride
Headache
(Mefloquine
Speech Disorder Hydrochloride) 250
Disturbance In Attention Mg PS ORAL 250 MG 1 PER
Hypoaesthesia
Memory Impairment
Zithromax
(Azithromycin)
C
WEEK ORAL
Date:05/31/07ISR Number: 5356559-3Report Type:Periodic Company Report #336177 Age:40 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Rash Papular
Disturbance In Attention
Groin Pain
Panic Attack
Oral Disorder
Agitation
Decreased Activity
Hyperventilation
Nystagmus
Major Depression
Chest Discomfort
Insomnia
Depressed Mood
Tinnitus
Vitreous Floaters
Blood Bilirubin Increased
Dyspnoea
Paraesthesia
Blood Pressure Increased
Blood Pressure
Agoraphobia
Dysuria
Blood Creatinine
Increased
Palpitations
Anxiety
Lichen Planus
Dizziness

Headache
Hyperhidrosis
Nightmare
Fatigue
Balance Disorder
Decreased Interest
Decreased Appetite
Anhedonia
03-Apr-2012 09:37 AM Page: 749

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pain In Extremity
Haematuria
Heart Rate Increased Report Source Product Role Manufacturer Route Dose Duration
Erythema Consumer Lariam (Mefloquine
Mood Altered Health Hydrochloride) 250
Depression Professional Mg PS ORAL 250 MG ORAL
Epicondylitis
Other
Toxicity To Various
Agents
Vision Blurred
Vertigo
Panic Disorder
Urethritis
Date:05/31/07ISR Number: 5356560-XReport Type:Periodic Company Report #428956 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Consumer Lariam (Mefloquine
Initial or Prolonged Health Hydrochloride) PS ORAL ORAL
Professional
Other
Birth Control Pills
Nos (Oral
Contraceptives Nos)
C
Date:06/04/07ISR Number: 5344208-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-499416 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maculopathy Lariam PS Roche UNKNOWN 6 MON
Visual Acuity Reduced
Date:06/05/07ISR Number: 5345982-9Report Type:Expedited (15-DaCompany Report #AU-ROCHE-499414 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hepatitis Fulminant Lariam PS Roche UNKNOWN
Date:06/05/07ISR Number: 5345983-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Age:36 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Other Serious
PT
Upper Respiratory Tract
Infection
Malaise
Agitation
Anxiety
Paraesthesia
Feeling Abnormal
Vertigo

Disturbance In Attention
Pyrexia
Dyspepsia
Asthenia
Depression
Tachycardia
Tinnitus
Formication
03-Apr-2012 09:37 AM Page: 750

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Coordination Abnormal
Night Sweats
Cardiovascular Disorder Report Source Product Role Manufacturer Route Dose Duration
Abnormal Dreams Lariam PS Roche UNKNOWN DOSAGE
Headache
REGIMEN
Sleep Disorder
REPORTED AS
Fatigue
FOUR TABS IN
Muscle Twitching
TOTAL. WEEKLY
Mental Disorder
Oedema Peripheral
Date:06/06/07ISR Number: 5347841-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-497864 Age:23 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amenorrhoea Lariam PS Roche ORAL
Date:06/06/07ISR Number: 5347843-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-500150 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amenorrhoea Lariam PS Roche ORAL
Date:06/06/07ISR Number: 5350805-8Report Type:Direct Company Report #CTU 304987 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Mefloquine PS ORAL 1 PILL EVERY
Required Paranoia 7 DAYS PO
Intervention to
Panic Attack
Prevent Permanent
Impairment/Damage
Nightmare
Anxiety
Weight Decreased
Tremor
Crying
Insomnia
Date:06/08/07ISR Number: 5351021-6Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Age:27 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Lariam PS Roche ORAL 3 MON
Hallucination, Olfactory Flagyl C ORAL
Hallucination, Auditory Unknown Medication C ORAL
Hallucination Antidepressants Nos C
Homicide
Flashback

Date:06/13/07ISR Number: 5355886-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-497864 Age:23 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amenorrhoea Lariam PS Roche ORAL
Lariam SS Roche ORAL 3 MON
03-Apr-2012 09:37 AM Page: 751

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/13/07ISR Number: 5355888-7Report Type:Expedited (15-DaCompany Report #AU-ROCHE-499414 Age:24 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Vomiting Lariam PS Roche ORAL
Hepatitis Fulminant Rabies Vaccine C
Hepatic Failure Typhoid Vaccine C
Diarrhoea Levlen Ed C
Tetanus Vaccine C
Date:06/18/07ISR Number: 5362132-3Report Type:Direct Company Report #USP 59046 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Drug Dispensing Error Lariam PS TABLET
Medication Error Malarone SS Glaxosmithkline TABLET
Date:06/19/07ISR Number: 5362230-4Report Type:Expedited (15-DaCompany Report #IT-ROCHE-501993 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Disorder Lariam PS Roche ORAL
Initial or Prolonged
Date:06/20/07ISR Number: 5363677-2Report Type:Expedited (15-DaCompany Report #ES-ROCHE-502414 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatitis Toxic Mefloquine
Hydrochloride PS Roche UNKNOWN
Hepatitis B Vaccine C
Date:06/22/07ISR Number: 5367205-7Report Type:Expedited (15-DaCompany Report #SE-ROCHE-498551 Age:20 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diplopia Lariam PS Roche ORAL THE PATIENT
Initial or Prolonged Headache TOOK A TOTAL
Neuropathy Peripheral
OF TWO
TABLETS.
REPORTED 1 DAY
Malarone SS ORAL FORM: FILM
COATED (FC)
TABLETS. 5 WK
Unspecified Drug SS UNKNOWN 1 DAY
Lexinor SS ORAL FORM FILM
COATED (FC)
TABLETS. 1 DAY

Date:06/22/07ISR Number: 5367210-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Age:36 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Other Serious
PT
Dyspepsia
Muscle Twitching
Paraesthesia
Formication
03-Apr-2012 09:37 AM Page: 752

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Oedema Peripheral
Sleep Disorder
Upper Respiratory Tract Report Source Product Role Manufacturer Route Dose Duration
Infection Lariam PS Roche UNKNOWN DOSAGE
Headache
REGIMEN
Fatigue
REPORTED AS
Night Sweats
FOUR TABS IN
Malaise
TOTAL. WEEKLY
Agitation
Abnormal Dreams
Tinnitus
Asthenia
Feeling Abnormal
Coordination Abnormal
Pyrexia
Tachycardia
Disturbance In Attention
Anxiety
Depression
Vertigo
Mental Disorder
Cardiovascular Disorder
Date:06/25/07ISR Number: 5369184-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-502756 Age:51 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Amyotrophic Lateral Lariam PS Roche ORAL REPORTED AS
Initial or Prolonged Sclerosis TAKEN 5
Paraneoplastic Syndrome
WEEKLY DOSES
Vitamin E
C
Alpha Lipoic Acid C
Vitamins Nos
C
Co-Enzyme
C
Rilutek
C
Vitamin C
C
Date:06/25/07ISR Number: 5370250-9Report Type:Direct Company Report #CTU 306401 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Medication Error Mercaptopurine 50mg
Intervention to Intercepted Drug Tab-Roxane PS Roxane
Prevent Permanent Dispensing Error Mefloquine 250mg Tab
Impairment/Damage Roxane SS Roxane
Date:06/29/07ISR Number: 5374239-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-262840 Age:34 YR Gender:Male I/FU:F
Outcome
PT

Disability
Adjustment Disorder With
Anxiety
Photophobia
Phobia
Generalised Anxiety
Disorder
Hypoaesthesia
Amnesia
03-Apr-2012 09:37 AM Page: 753

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Anxiety
Panic Attack
Diarrhoea Report Source Product Role Manufacturer Route Dose Duration
Self Esteem Decreased Lariam PS Roche ORAL THE PATIENT
Headache HAD TAKEN 4-5
Acrophobia
TABLETS OF
Heart Rate Increased
MEFLOQUINE IN
Insomnia TOTAL. 21 DAY
Hypersensitivity Vaccine C OTHER 1 DAY
Musculoskeletal Stiffness
Bronchial Hyperreactivity
Mood Disorder Due To A
General Medical Condition
Dizziness
Paraesthesia
Suicidal Ideation
Abdominal Pain
Heart Rate Irregular
Tinnitus
Disturbance In Attention
Balance Disorder
Vestibular Disorder
Weight Decreased
Lactose Intolerance
Throat Irritation
Nausea
Motion Sickness
Depression
Disorientation
Dyspnoea
Irritable Bowel Syndrome
Phobia Of Flying
Migraine
Nasal Congestion
Sleep Disorder Due To
General Medical
Condition, Hypersomnia
Type
Adjustment Disorder With
Depressed Mood
Sinus Bradycardia
Rash
Sensory Integrative
Dysfunction
Fatigue
Neck Pain
Abdominal Distension
Abdominal Pain Lower
Vertigo
Emotional Distress
Claustrophobia
Sleep Disorder
Back Pain

Date:06/29/07ISR Number: 5374266-8Report Type:Expedited (15-DaCompany Report #IE-ROCHE-337440 Age:27 YR Gender:Male I/FU:F
Outcome
Other Serious
PT
Flashback
Hallucination
03-Apr-2012 09:37 AM Page: 754

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hallucination, Auditory
Homicide
Hallucination, Olfactory Report Source Product Role Manufacturer Route Dose Duration
Paranoia Lariam PS Roche ORAL 3 MON
Flagyl C ORAL
Unknown Medication C ORAL
Antidepressants Nos C
Date:06/29/07ISR Number: 5374267-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Diarrhoea Lariam PS Roche ORAL
Memory Impairment Imodium C
Vestibular Disorder Compazine C ON 18 APR
Nystagmus
2001, THERAPY
Abdominal Pain
REPORTED AS
Phonophobia
TWICE DAILY.
Insomnia Antibiotics Nos C
Vertigo Ambien C
Depression Prednisone C BY TAPER.
Eye Pain Valium C ON 18 APR
Nightmare
2001, THERAPY
Tinnitus
REPORTED AS:
Psychotic Disorder
AS NEEDED.
Agitation Phenergan C
Vomiting Biaxin C
Headache Advil C
Inner Ear Disorder Bactrim C
Photophobia Antivert C
Anxiety Disorder
Dizziness
Irritable Bowel Syndrome
Rash
Pain Of Skin
Blood Pressure Increased
Mood Swings
Disorientation
Amnesia
Nervousness
Night Sweats
Nausea
Fatigue
Chest Pain
Testicular Pain
Vision Blurred
Disturbance In Attention
Hypoaesthesia
Date:06/29/07ISR Number: 5374285-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-314899 Age:40 YR Gender:Female I/FU:F

Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Incontinence
Drug Ineffective
Hostility
Headache
Muscle Rigidity
Agitation
03-Apr-2012 09:37 AM Page: 755

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Mania
Psychotic Disorder
Disorientation Report Source Product Role Manufacturer Route Dose Duration
Loss Of Libido Lariam PS Roche ORAL EVERY WEEK. 9 DAY
Confusional State Valium SS Roche INTRAVENOUS 1 DAY
Delusion Prozac C ORAL
Hallucination
Paranoia
Convulsion
Pyrexia
Gait Disturbance
Speech Disorder
Fatigue
Antisocial Behaviour
Aggression
Blood Potassium Decreased
Depression
Memory Impairment
Date:07/03/07ISR Number: 5377491-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-498551 Age:20 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diplopia Lariam PS Roche ORAL THE PATIENT
Initial or Prolonged Neuropathy Peripheral TOOK A TOTAL
Headache
OF TWO
TABLETS.
REPORTED 1 DAY
Malarone SS ORAL FORM: FILM
COATED (FC)
TABLETS. 5 WK
Unspecified Drug SS UNKNOWN 1 DAY
Lexinor SS ORAL FORM FILM
COATED (FC)
TABLETS. 5 DAY
Date:07/09/07ISR Number: 5381827-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-505274 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Torsade De Pointes Lariam PS Roche ORAL
Initial or Prolonged Electrocardiogram Qt Meningococcal
Prolonged Vaccine C
Hepatyrix
C
Revaxis
C
Warfarin
C
Ramipril
C
Date:07/09/07ISR Number: 5382114-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-502756 Age:51 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Amyotrophic Lateral Lariam PS Roche ORAL REPORTED AS
Initial or Prolonged Sclerosis TAKEN 5
Paraneoplastic Syndrome
WEEKLY DOSES
Vitamin E
C
Alpha Lipoic Acid C
Vitamins Nos
C
03-Apr-2012 09:37 AM Page: 756

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Co-Enzyme
Rilutek
Vitamin C
C
C
C
Date:07/09/07ISR Number: 5385345-3Report Type:Direct Company Report #CTU 307608 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Mefloquine 250 Mg
Dizziness Barr Laboratories PS Barr Laboratories ORAL ONCE PER WEEK
Mood Swings
PO
Sleep Disorder
Irritability
Insomnia
Date:07/10/07ISR Number: 5386284-4Report Type:Direct Company Report #CTU 307650 Age:28 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Lariam -Mefloquine- PS ORAL 1 TABLET PO
Convulsion
Asthenia
Nervous System Disorder
Paraesthesia
Muscle Spasms
Muscle Twitching
Hypoaesthesia
Date:07/13/07ISR Number: 5390014-XReport Type:Expedited (15-DaCompany Report #GXKR2007TR05543 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Parkinsonism Foreign Mefloquine PS
Literature
Health
Professional
Other
Date:07/16/07ISR Number: 5387788-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-503881 Age:41 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam PS Roche UNKNOWN REPORTED THAT
Tremor
PATIENT TOOK
Ill-Defined Disorder
3 DOSES.
Abnormal Dreams Allegra C ORAL
Pyrexia Wellbutrin C ORAL REPORTED AS
Fatigue
150-450MG.
Sleep Disorder
Unspecified

Mental Disorder Medication C ORAL
Ativan C ORAL
Lexapro C ORAL
03-Apr-2012 09:37 AM Page: 757

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/16/07ISR Number: 5388059-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-54240 Age:52 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Lariam PS Roche ORAL 27 DAY
Initial or Prolonged Visual Impairment Pizotifen I UNKNOWN
Chest Pain
Panic Attack
Fatigue
Head Discomfort
Drug Interaction
Nausea
Date:07/16/07ISR Number: 5388628-6Report Type:Expedited (15-DaCompany Report #CA-ROXANE LABORATORIES, INC-2007-BP-17394RO Age:43 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maculopathy Mefloquine PS Roxane Laboratories,
Retinal Pigmentation Inc. ORAL 1 YR
Date:07/16/07ISR Number: 5388633-XReport Type:Expedited (15-DaCompany Report #TR-ROXANE LABORATORIES, INC-2007-BP-17147RO Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Parkinsonism Mefloquine PS Roxane Laboratories,
Inc.
ORAL
Date:07/17/07ISR Number: 5389111-4Report Type:Expedited (15-DaCompany Report #NL-ROCHE-505944 Age:4 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Grand Mal Convulsion Lariam PS Roche ORAL
Hospitalization -
Initial or Prolonged
Date:07/17/07ISR Number: 5392183-4Report Type:Direct Company Report #CTU 308140 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Myalgia Mefloquine 250 Mg PS ORAL 1 ONCE A WEEK
Intervention to Tendonitis PO
Prevent Permanent Swelling
Impairment/Damage Pain In Extremity
Date:07/23/07ISR Number: 5397614-1Report Type:Direct Company Report #CTU 308660 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Infection Larium Hoffman La

Hospitalization - Tongue Disorder Roche PS Hoffman La Roche ORAL 1 TABLET ONCE
Initial or Prolonged Partial Seizures A WEEK PO
Other Serious
Swollen Tongue
Required
Epilepsy
Intervention to
Prevent Permanent
Impairment/Damage
03-Apr-2012 09:37 AM Page: 758

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/26/07ISR Number: 5397579-2Report Type:Expedited (15-DaCompany Report #NL-ROCHE-507469 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Diarrhoea Lariam PS Roche ORAL
Nightmare Microgynon C ORAL DOSAGE
Psychotic Disorder
REGIMEN
Disturbance In Attention
REPORTED AS
Bone Pain 1X/1
CYCLICAL.
Hepatitis A
Vaccine/Hepatitis B
Vaccine
C
Date:07/27/07ISR Number: 5399351-6Report Type:Expedited (15-DaCompany Report #NL-ROCHE-507408 Age:29 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Depression Lariam PS Roche ORAL
Completed Suicide
Date:07/30/07ISR Number: 5400247-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-477655 Age:33 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cognitive Disorder Lariam PS Roche UNKNOWN THE PATIENT
Initial or Prolonged Memory Impairment REPORTED
Disability Insomnia TAKING THREE
Other Serious Nightmare LARIAM
Suicidal Ideation
"PILLS" IN
Convulsion Ibuprofen C
Flight Of Ideas Birth Control Pill C DRUG NAME
Aggression
REPORTED AS:
Visual Impairment
BCP (TYPE
Vestibular Disorder
UNKNOWN)
Psychotic Disorder Tylenol C
Hallucination
Date:07/30/07ISR Number: 5402419-9Report Type:Direct Company Report #CTU 309170 Age:32 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Mood Altered
Memory Impairment
Headache
Feeling Abnormal
Thinking Abnormal
Confusional State
Dizziness
Disturbance In Attention
Affect Lability

Anxiety
Amnesia
Depression
Motor Dysfunction
Social Avoidant Behaviour
Mood Swings
Anger
Paranoia
03-Apr-2012 09:37 AM Page: 759

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Irritability
Violence-Related Symptom
Crying Report Source Product Role Manufacturer Route Dose Duration
Mefloquine (Lariam) PS
1 TABLET
WEEKLY
Date:07/30/07ISR Number: 5402425-4Report Type:Direct Company Report #CTU 309171 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disturbance In Attention Lariam Roche PS Roche ORAL 1 ONCE A WEEK
Hallucination, Olfactory
PO
Dizziness
Vertigo
Depression
Mania
Mood Altered
Fatigue
Nausea
Hallucination, Auditory
Vomiting
Date:08/03/07ISR Number: 5405080-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-489574 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Lariam PS Roche ORAL FIRST INTAKE
Other Serious Amnesia (ONE TABLET)
Vertigo
ON 19 FEB
Muscle Spasms
2007, SECOND
Asthenia
INTAKE (ONE
Cognitive Disorder Trinordiol C DOSAGE
Disturbance In Attention
REGIMEN
Palpitations REPORTED AS 1
Nightmare
DOSE ONCE A
Hallucination
DAY.
Tremor
Hearing Impaired
Nausea
Dyspnoea
Date:08/03/07ISR Number: 5405240-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-508756 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cerebellar Ataxia Lariam PS Roche ORAL FIRST THREE
Initial or Prolonged
TABLETS, THEN
SIX HOURS
LATER TWO
TABLETS, THEN

Date:08/09/07ISR Number: 5409796-3Report Type:Expedited (15-DaCompany Report #NL-ROCHE-509467 Age:59 YR Gender:Male I/FU:I
Outcome
Life-Threatening
Hospitalization -
03-Apr-2012 09:37 AM Page: 760

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Initial or Prolonged
PT Report Source Product Role Manufacturer Route Dose Duration
Orthostatic Hypotension Lariam PS Roche ORAL
Coma Fortzaar SS ORAL
Blood Pressure Decreased Doxazosine SS ORAL DOSAGE
Syncope
REGIMEN: 2 DD
Hyperhidrosis
4 MG.
Tremor
Bradycardia
Date:08/10/07ISR Number: 5411289-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-510074 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depression Lariam PS Roche UNKNOWN TOTAL OF
Initial or Prolonged Headache THREE
Vomiting
TABLETS.
Social Phobia
SECOND TABLET
Tinnitus
TAKEN IN
Paraesthesia
Nausea
Gastrointestinal Disorder
Panic Attack
Anxiety
Hyperhidrosis
Sensation Of Foreign Body
Date:08/21/07ISR Number: 5420894-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-511983 Age:65 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Gynaecomastia Lariam PS Roche ORAL
Date:08/22/07ISR Number: 5424395-5Report Type:Expedited (15-DaCompany Report #6036499 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Coma Health Lariam (250 Mg),
Hospitalization - Blood Pressure Decreased Professional Tablet PS 250 MG (250
Initial or Prolonged Syncope Other MG 1 IN 1 WK) 35 DAY
Loss Of Consciousness
Fortzaar (Tablet)
Bradycardia
Drug Interaction
(Hydrochlorothiazide
, Losartan
Potassium) SS 1 DOSAGE
FORMS, 1 D)
Doxazosin Tablets 4
Mg (4 Mg Tablet)
(Doxazosin) SS ORAL 8 MG (4 MG, 2
IN 1 D), ORAL 97
197 DAY
DAY

Date:08/22/07ISR Number: 5424727-8Report Type:Direct Company Report #CTU 311097 Age: Gender:Female I/FU:I
Outcome
Disability
PT
Dizziness
Memory Impairment
03-Apr-2012 09:37 AM Page: 761

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Bruxism
Abdominal Pain Upper
Insomnia Report Source Product Role Manufacturer Route Dose Duration
Anxiety
Lariam (Mefloquine
Hallucination Hcl 250 Mg) PS 250 MG 1 X
Fatigue
WEEK
Depression
Paranoia
Chills
Disturbance In Attention
Vision Blurred
Panic Attack
Diarrhoea
Mood Swings
Suicidal Ideation
Date:08/24/07ISR Number: 5425148-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-511718 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Delinquency Lariam PS Roche UNKNOWN
Schizophrenia
Date:08/24/07ISR Number: 5425388-4Report Type:Expedited (15-DaCompany Report #DE-ROXANE LABORATORIES, INC-2007-DE-04938GD Age:56 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vomiting Morphine PS Roxane Laboratories,
Initial or Prolonged Toxicity To Various Inc.
Agents Codeine SS Roxane Laboratories,
Abdominal Pain
Inc.
Citalopram
SS
Diclofenac
SS
Mefloquine SS Roxane Laboratories,
Inc.
Zopiclone
SS
Fluoxetine
SS
Lansoprazole
SS
Penbutolol
SS
Rabeprazole
SS
Senna Preparation SS
Simeticone
SS
Paracetamol
SS
Amitriptyline
SS
Date:08/24/07ISR Number: 5427445-5Report Type:Direct Company Report #CTU 311343 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dizziness Mefloquine PS ORAL 250 MG ONCE A

Fear WEEK PO
Impaired Work Ability
Anxiety
Fatigue
Vertigo
03-Apr-2012 09:37 AM Page: 762

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/27/07ISR Number: 5429208-3Report Type:Direct Company Report #CTU 311464 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Chest Pain Mefloquine 250 Mg PS ORAL 250MG ONCE A
Initial Insomnia
WEEK PO
Fear
Panic Reaction
Palpitations
Heart Rate Decreased
Date:08/28/07ISR Number: 5435071-7Report Type:Direct Company Report #CTU 311536 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Urticaria
Mefloquine 7 Tablets
Rash Pruritic Hoffman-Laroche PS Hoffman-Laroche ORAL 1 TABLET ONCE
A WEEK PO
Date:08/29/07ISR Number: 5429063-1Report Type:Periodic Company Report #A0655132A Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Drug Dispensing Error Malarone PS Glaxosmithkline UNKNOWN 1TAB Per day
Lariam SS UNKNOWN 250MG Unknown
Date:08/30/07ISR Number: 5431010-3Report Type:Expedited (15-DaCompany Report #B0485142A Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paraesthesia Malarone PS Glaxosmithkline 33 DAY
Initial or Prolonged Headache Lexinor SS Glaxosmithkline 5 DAY
Malaria Lariam SS 2TAB Single
Diplopia
dose
Diarrhoea
Abdominal Discomfort
Dehydration
Facial Paresis
Neuropathy Peripheral
Date:08/30/07ISR Number: 5441851-4Report Type:Direct Company Report #CTU 311703 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Accident Laiam Roche PS Roche ORAL 1 WEEKLY PO
Hospitalization -
Initial or Prolonged
Other Serious
Required
Intervention to

Prevent Permanent
Impairment/Damage
03-Apr-2012 09:37 AM Page: 763

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/04/07ISR Number: 5442028-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-511983 Age:65 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Gynaecomastia Lariam PS Roche ORAL
Esomeprazole
C
Date:09/06/07ISR Number: 5444869-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-509667 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vomiting Lariam PS Roche ORAL
Abdominal Pain Engerix B SS INTRAMUSCULAR DRUG NAME
Myalgia
REPORTED AS
C-Reactive Protein ENGERIX B 10.
Increased
INDICATION
Pyrexia
REPORTED AS
Cytolytic Hepatitis
Date:09/10/07ISR Number: 5447630-6Report Type:Expedited (15-DaCompany Report #BE-ROCHE-514773 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatitis Lariam PS Roche UNKNOWN
Date:09/11/07ISR Number: 5449004-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-515132 Age:75 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Red Blood Cell Lariam PS Roche ORAL 1 DAY
Sedimentation Rate
Increased
Polymyalgia Rheumatica
Date:09/11/07ISR Number: 5449013-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome
Disability
PT
Vestibular Disorder
Chest Pain
Testicular Pain
Diarrhoea
Anxiety Disorder
Fatigue
Vision Blurred
Hypoaesthesia
Insomnia
Psychotic Disorder
Nystagmus
Inner Ear Disorder

Phonophobia
Nausea
Memory Impairment
Nightmare
Amnesia
Tinnitus
Disturbance In Attention
Eye Pain
03-Apr-2012 09:37 AM Page: 764

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Rash
Nervousness
Deafness Report Source Product Role Manufacturer Route Dose Duration
Night Sweats Lariam PS Roche ORAL
Agitation Imodium C
Vertigo Compazine C ON 18 APR
Headache
2001, THERAPY
Depression
REPORTED AS
Photophobia
TWICE DAILY.
Pain Of Skin Antibiotics Nos C
Mood Swings Ambien C
Disorientation Prednisone C BY TAPER.
Dizziness Valium C ON 18 APR
Vomiting
2001, THERAPY
Abdominal Pain
REPORTED AS:
Irritable Bowel Syndrome
AS NEEDED.
Blood Pressure Increased Phenergan C
Biaxin
C
Advil
C
Bactrim
C
Antivert
C
Date:09/12/07ISR Number: 5452321-1Report Type:Direct Company Report #CTU 312582 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mental Disorder Mefloquine 250 Mg
Anxiety Geneva PS Geneva ORAL 250 MG WEEKLY
Panic Attack
PO DOSE TAKEN
Impaired Driving Ability
Date:09/13/07ISR Number: 5451462-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome
Disability
PT
Vomiting
Insomnia
Vertigo
Abdominal Pain
Dizziness
Vision Blurred
Hypoaesthesia
Phonophobia
Blood Pressure Increased
Amnesia
Irritable Bowel Syndrome
Depression
Agitation
Vestibular Disorder
Nystagmus
Inner Ear Disorder

Testicular Pain
Rash
Photophobia
Deafness
Diarrhoea
Chest Pain
Memory Impairment
Eye Pain
03-Apr-2012 09:37 AM Page: 765

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nausea
Mood Swings
Nightmare Report Source Product Role Manufacturer Route Dose Duration
Anxiety Disorder Lariam PS Roche ORAL
Disturbance In Attention Imodium C
Nervousness Compazine C ON 18 APR
Pain Of Skin
2001, THERAPY
Fatigue
REPORTED AS
Disorientation
TWICE DAILY.
Headache Antibiotics Nos C
Tinnitus Ambien C
Night Sweats Prednisone C BY TAPER.
Psychotic Disorder Valium C ON 18 APR
2001, THERAPY
REPORTED AS:
AS NEEDED.
Phenergan
C
Biaxin
C
Advil
C
Bactrim
C
Antivert
C
Date:09/14/07ISR Number: 5452778-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-503881 Age:41 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Ill-Defined Disorder Lariam PS Roche UNKNOWN REPORTED THAT
Sleep Disorder
PATIENT TOOK
Pyrexia
3 DOSES.
Fatigue Allegra C ORAL
Tremor Wellbutrin C ORAL REPORTED AS
Abnormal Dreams
150-450MG.
Mental Disorder
Unspecified
Depression Medication C ORAL
Ativan C ORAL
Lexapro C ORAL
Date:09/14/07ISR Number: 5452940-2Report Type:Expedited (15-DaCompany Report #NL-ROCHE-509467 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Blood Pressure Decreased Lariam PS Roche ORAL
Hospitalization - Syncope Fortzaar SS ORAL
Initial or Prolonged Orthostatic Hypotension Doxazosine SS ORAL DOSAGE
Hyperhidrosis
REGIMEN: 2 DD
Tremor
4 MG.
Bradycardia
Date:09/17/07ISR Number: 5453931-8Report Type:Expedited (15-DaCompany Report #AU-ROCHE-499414 Age:24 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hepatitis Fulminant Lariam PS Roche ORAL ONE DOSE
Hepatic Failure
WEEKLY.
Jaundice Rabies Vaccine C
Diarrhoea Typhoid Vaccine C
Vomiting Levlen Ed C ORAL ONE DOSE.
Tetanus Vaccine C
03-Apr-2012 09:37 AM Page: 766

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/18/07ISR Number: 5460867-5Report Type:Expedited (15-DaCompany Report #6036499 Age:59 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Syncope Foreign Doxazosin PS ORAL 8 MG (4 MG, 2
Hospitalization - Blood Pressure Decreased Health IN 1 D) ORAL 97 DAY
Initial or Prolonged Bradycardia Professional Fortzaar
Other
(Hydrochlorothiazide
, Losartan
Potassium) SS 1 DOSAGE
FORMS (1
DOSAGE FORMS,
1 IN 1 D) 197 DAY
Lariam SS 250 MG (250
MG, 1 IN 1
WK) 35 DAY
Date:09/24/07ISR Number: 5465671-XReport Type:Expedited (15-DaCompany Report #JP-ROCHE-518961 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Optic Neuritis Mefloquine
Hydrochloride PS Roche UNKNOWN
Date:09/24/07ISR Number: 5465673-3Report Type:Expedited (15-DaCompany Report #JP-ROCHE-518962 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Lung Neoplasm Malignant Mefloquine
Hydrochloride PS Roche UNKNOWN
Date:09/24/07ISR Number: 5465676-9Report Type:Expedited (15-DaCompany Report #JP-ROCHE-518963 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Glomerulonephritis Mefloquine
Proliferative Hydrochloride PS Roche UNKNOWN
Date:09/28/07ISR Number: 5471134-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome
Disability
PT
Vomiting
Mood Swings
Memory Impairment
Amnesia
Testicular Pain
Irritable Bowel Syndrome
Disturbance In Attention
Eye Pain

Tinnitus
Nervousness
Photophobia
Brain Stem Syndrome
Anxiety Disorder
Nystagmus
Dizziness
Hypoaesthesia
03-Apr-2012 09:37 AM Page: 767

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorientation
Vision Blurred
Nightmare Report Source Product Role Manufacturer Route Dose Duration
Fatigue Lariam PS Roche ORAL
Headache Imodium C
Inner Ear Disorder Compazine C ON 18 APR
Night Sweats
2001, THERAPY
Nausea
REPORTED AS
Abdominal Pain
TWICE DAILY.
Depression Antibiotics Nos C
Deafness Ambien C
Agitation Prednisone C BY TAPER.
Insomnia Valium C ON 18 APR
Vertigo
2001, THERAPY
Vestibular Disorder
REPORTED AS:
Phonophobia
AS NEEDED.
Pain Of Skin Phenergan C
Blood Pressure Increased Biaxin C
Diarrhoea Advil C
Chest Pain Bactrim C
Psychotic Disorder Antivert C
Rash
Paraesthesia
Date:09/28/07ISR Number: 5471155-5Report Type:Expedited (15-DaCompany Report #ES-ROCHE-519121 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tumour Marker Increased Lariam PS Roche UNKNOWN
Date:10/02/07ISR Number: 5474876-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-521722 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Frequent Bowel Movements Mefloquine
Mood Swings Hydrochloride PS Roche ORAL 40 DAY
Abnormal Dreams Unspecified Drug C
Alice In Wonderland Nicotine C TRANSDERMAL DOSING AMOUNT
Syndrome
Clumsiness
AND FREQUENCY
REPORTED AS:
21 MG 24
HOURS 7 DAY
Date:10/02/07ISR Number: 5476961-9Report Type:Direct Company Report #CTU 314199 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Paraesthesia
Mefloquine
Hydrochloride 250
Mg Sandoz, Inc. PS Sandoz, Inc. ORAL 1 TABLET

WEEKLY PO
03-Apr-2012 09:37 AM Page: 768

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/02/07ISR Number: 5477024-9Report Type:Direct Company Report #CTU 314251 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Initial Insomnia Lariam Unknown Roche
Initial or Prolonged Paralysis Pharmaceuticals PS ORAL ONCE PER WEEK
Other Serious Feeling Abnormal PO
Dyspnoea
Abnormal Dreams
Headache
Paraesthesia
Fear
Immobile
Disturbance In Attention
Date:10/02/07ISR Number: 5477059-6Report Type:Direct Company Report #CTU 314240 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fear Mefloquine 250mg Hcl PS ORAL 252MG TWICE
Nightmare
PO
Feeling Abnormal
Date:10/05/07ISR Number: 5478471-1Report Type:Expedited (15-DaCompany Report #DK-ROCHE-521810 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Arrhythmia Lariam PS Roche UNKNOWN
Date:10/05/07ISR Number: 5478472-3Report Type:Expedited (15-DaCompany Report #ES-ROCHE-519121 Age:56 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tumour Marker Test Lariam PS Roche ORAL
Date:10/05/07ISR Number: 5478473-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-521263 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Brachial Plexus Injury Lariam PS Roche ORAL
Joint Dislocation Microgynon C ORAL
Grand Mal Convulsion
Date:10/05/07ISR Number: 5478475-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-510074 Age:32 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Nausea
Tachycardia

Depression
Vomiting
Hypertension
Disorientation
Paraesthesia
Hyperhidrosis
Gastrointestinal Disorder
Panic Attack
03-Apr-2012 09:37 AM Page: 769

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Tinnitus
Social Phobia
Headache Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL TOTAL OF
THREE
TABLETS.
SECOND TABLET
TAKEN IN
Date:10/18/07ISR Number: 5490518-5Report Type:Direct Company Report #CTU 315637 Age:28 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hallucination Lariam 250 Mg, Roche PS Roche ORAL 250 MG ONE
Anxiety
TAB Q WK PO
Panic Attack Xanax C
Date:10/23/07ISR Number: 5493377-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-525623 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Feeling Abnormal Lariam PS Roche UNKNOWN
Initial or Prolonged
Date:10/23/07ISR Number: 5494663-XReport Type:Direct Company Report #CTU 316116 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicidal Ideation Mefloquine PS 1 PER WEEK
Fear
Depression
Date:10/23/07ISR Number: 5496173-2Report Type:Direct Company Report #CTU 316106 Age:18 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Sleep Disorder Lariam PS
Panic Attack
Decompression Sickness
Memory Impairment
Depression
Insomnia
Blindness
Disturbance In Attention
Malaise
Unevaluable Event
Vertigo
Dreamy State
Hypoaesthesia

Suicidal Ideation
Thinking Abnormal
Feeling Abnormal
Confusional State
Somnolence
03-Apr-2012 09:37 AM Page: 770

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/24/07ISR Number: 5494720-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Anxiety
Asthenia
Chest Pain
Generalised Anxiety
Disorder
Self-Injurious Ideation
Mitral Valve
Calcification
Humerus Fracture
Oxygen Saturation
Decreased
Rheumatoid Factor
Increased
Pyrexia
Rash Papular
Aggression
Memory Impairment
Vertigo
Dyspnoea
Cranial Nerve Disorder
Asthma
Homicidal Ideation
Dehydration
Convulsion
Abnormal Behaviour
Agitation
Joint Dislocation
Post-Traumatic Stress
Disorder
Tremor
Cognitive Disorder
Toxicity To Various
Agents
Contusion
Antinuclear Antibody
Positive
Ventricular Extrasystoles
Productive Cough
Ill-Defined Disorder
Psychotic Disorder
Attention
Deficit/Hyperactivity
Disorder
Nocturia
Mood Swings
Fatigue
Bronchial Hyperreactivity
Headache
Sleep Apnoea Syndrome
Major Depression

Meniscus Lesion
Violence-Related Symptom
Craniocerebral Injury
Bundle Branch Block Right
Ligament Sprain
Myalgia
Eosinophilia
Visual Impairment
03-Apr-2012 09:37 AM Page: 771

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hallucination, Visual
Chest Discomfort
Decreased Activity Report Source Product Role Manufacturer Route Dose Duration
Thinking Abnormal Lariam PS Roche ORAL
Dysthymic Disorder Primaquine C
Rhinitis Allergic Cipro C
Insomnia
Disturbance In Attention
Depression
Suicidal Ideation
Selective Iga
Immunodeficiency
Hypertension
Hyperhidrosis
Eye Movement Disorder
Balance Disorder
Panic Disorder
Fall
Musculoskeletal Pain
Mitral Valve Incompetence
Exostosis
Weight Decreased
Respiratory Rate
Increased
Hypoaesthesia
Nystagmus
Date:10/25/07ISR Number: 5497070-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-525623 Age:39 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Feeling Abnormal Lariam PS Roche UNKNOWN
Initial or Prolonged
Date:10/25/07ISR Number: 5498506-XReport Type:Direct Company Report #CTU 316349 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Sleep Terror
Mefloquine 250mg
Depression
Tabs Mepha
Syncope Switzerland PS Mepha Switzerland ORAL ONE TABLET
Insomnia
WEEKLY TWO
Vertigo
YEARS PO
Abnormal Dreams
Primaquine 15 Mg
Alopecia Tabs Pharm Chem SS Pharm Chem ORAL 2 TABLETS
Confusional State
DAILY 1X14
DAYS PO
Date:10/30/07ISR Number: 5503946-6Report Type:Direct Company Report #CTU 316659 Age:52 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Attack Artequin -Artesimine
Initial or Prolonged Asthenia 200+Meflouquin 600mg PS ORAL ONE
Other Serious Palpitations ARTESIMINE+
Flushing
ONE
Dizziness
MEFLOUQUIN
Hypoaesthesia
DAILY PO
03-Apr-2012 09:37 AM Page: 772

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/01/07ISR Number: 5504026-6Report Type:Expedited (15-DaCompany Report #FR-ROCHE-499416 Age:46 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maculopathy Lariam PS Roche UNKNOWN 6 MON
Date:11/05/07ISR Number: 5506648-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Aggression
Memory Impairment
Mood Swings
Ill-Defined Disorder
Cranial Nerve Disorder
Hypertension
Cognitive Disorder
Mitral Valve Incompetence
Ligament Sprain
Antinuclear Antibody
Positive
Rheumatoid Factor
Increased
Pyrexia
Brain Stem Syndrome
Anger
Abdominal Distension
Haematochezia
Mood Altered
Depression
Balance Disorder
Generalised Anxiety
Disorder
Meniscus Lesion
Dysthymic Disorder
Craniocerebral Injury
Weight Decreased
Convulsion
Anxiety Disorder
Loose Body In Joint
Diarrhoea
Abdominal Pain Upper
Dyspnoea
Headache
Sleep Apnoea Syndrome
Musculoskeletal Pain
Bundle Branch Block Right
Exostosis
Nystagmus
Contusion
Blood Potassium Decreased
Rash
Merycism

Dyspepsia
Eructation
Abnormal Behaviour
Visual Impairment
Selective Iga
Immunodeficiency
Fatigue
Chest Discomfort
03-Apr-2012 09:37 AM Page: 773

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Chest Pain
Impulsive Behaviour
Acute Coronary Syndrome
Upper Respiratory Tract
Infection
Vertigo
Hallucination, Visual
Asthenia
Panic Disorder
Fall
Tremor
Thinking Abnormal
Toxicity To Various
Agents
Attention
Deficit/Hyperactivity
Disorder
Respiratory Rate
Increased
Eye Movement Disorder
Nocturia
Rash Papular
Coordination Abnormal
Wheezing
Snoring
Vestibular Disorder
Deafness
Hypervigilance
Emotional Disorder
Mucous Membrane Disorder
Constipation
Mucous Stools
Nightmare
Insomnia
Agitation
Anxiety
Post-Traumatic Stress
Disorder
Asthma
Humerus Fracture
Dehydration
Hypoaesthesia
Myalgia
Eosinophilia
Ventricular Extrasystoles
Injury
Visual Field Defect
Priapism
No Therapeutic Response
Tongue Disorder
Dizziness
Family Stress
Nausea

Disturbance In Attention
Bronchial Hyperreactivity
Joint Dislocation
Psychotic Disorder
Self-Injurious Ideation
Hyperhidrosis
Homicidal Ideation
Mitral Valve
03-Apr-2012 09:37 AM Page: 774

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Calcification
Rhinitis Allergic
Palpitations
Tinnitus Report Source Product Role Manufacturer Route Dose Duration
Hydrocephalus Lariam PS Roche ORAL
Suicidal Ideation Primaquine C
Productive Cough Cipro C
Major Depression
Decreased Activity
Oxygen Saturation
Decreased
Joint Range Of Motion
Decreased
Breath Odour
Date:11/08/07ISR Number: 5512218-5Report Type:Direct Company Report #CTU 317413 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Panic Attack Mefloquine 250 Mg PS 1 TABLET ONCE
Decreased Appetite A WEEK FOR 5
Pyrexia
ONE PILL PER
Tremor WEEK 5 WK
Feeling Abnormal
Nervousness
Sleep Disorder
Influenza Like Illness
Palpitations
Date:11/14/07ISR Number: 5516163-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome
Disability
PT
Anxiety Disorder
Psychotic Disorder
Insomnia
Amnesia
Vestibular Disorder
Nystagmus
Eye Pain
Rash
Mood Swings
Tinnitus
Disturbance In Attention
Dizziness
Irritable Bowel Syndrome
Hypoaesthesia
Night Sweats
Vision Blurred
Nervousness
Pain Of Skin
Blood Pressure Increased

Brain Stem Syndrome
Vomiting
Memory Impairment
Vertigo
Headache
Phonophobia
Paraesthesia
Nausea
03-Apr-2012 09:37 AM Page: 775

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorientation
Chest Pain
Agitation Report Source Product Role Manufacturer Route Dose Duration
Diarrhoea Lariam PS Roche ORAL
Nightmare Imodium C
Fatigue Compazine C ON 18 APR
Inner Ear Disorder
2001, THERAPY
Abdominal Pain
REPORTED AS
Testicular Pain
TWICE DAILY.
Depression Antibiotics Nos C
Photophobia Ambien C
Deafness Prednisone C BY TAPER.
Valium C ON 18 APR
2001, THERAPY
REPORTED AS:
AS NEEDED.
Phenergan
C
Biaxin
C
Advil
C
Bactrim
C
Antivert
C
Date:11/15/07ISR Number: 5518385-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-472986 Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nervousness Lariam PS Roche ORAL PATIENT TOOK
Agitation
ONLY ONE DOSE
Hallucination Wellbutrin SS ORAL FORM: SR
Anxiety
TABLET
Depersonalisation
Date:11/15/07ISR Number: 5518594-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-529910 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypotonia Mefloquine
Convulsion Hydrochloride PS Roche UNKNOWN
1 Drug Suspected SS INTRAMUSCULAR FREQUENCY
REPORTED:
FIRST DOSE 1 DAY
Fansidar
C
Date:11/19/07ISR Number: 5521627-XReport Type:Direct Company Report #CTU 318163 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Chills Lariam PS
Intervention to
Diarrhoea
Prevent Permanent Depression

Impairment/Damage
Thinking Abnormal
Dyspnoea
Panic Attack
03-Apr-2012 09:37 AM Page: 776

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/19/07ISR Number: 5525171-5Report Type:Direct Company Report #CTU 318215 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mental Disorder Larium 250 Mg Roche PS Roche ORAL 250 MG ONCE
Adverse Drug Reaction
PER WEEK PO
Dizziness
Paranoia
Anxiety
Date:11/20/07ISR Number: 5522092-9Report Type:Expedited (15-DaCompany Report #CA-ROCHE-529910 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Mefloquine
Hypotonia Hydrochloride PS Roche UNKNOWN
1 Drug Suspected SS INTRAMUSCULAR FREQUENCY
REPORTED:
FIRST DOSE 1 DAY
Fansidar
C
Date:11/23/07ISR Number: 5524616-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Agitation
Depression
Bronchial Hyperreactivity
Hypertension
Psychotic Disorder
Decreased Activity
Dysthymic Disorder
Nystagmus
Rheumatoid Factor
Increased
Pyrexia
Insomnia
Fatigue
Dyspnoea
Fall
Cognitive Disorder
Bundle Branch Block Right
Dehydration
Hypoaesthesia
Disturbance In Attention
Aggression
Ill-Defined Disorder
Joint Dislocation
Post-Traumatic Stress
Disorder
Violence-Related Symptom
Eye Movement Disorder

Ligament Sprain
Antinuclear Antibody
Positive
Rash Papular
Abnormal Behaviour
Selective Iga
Immunodeficiency
Asthenia
03-Apr-2012 09:37 AM Page: 777

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Major Depression
Generalised Anxiety
Disorder Report Source Product Role Manufacturer Route Dose Duration
Self-Injurious Ideation Lariam PS Roche ORAL
Musculoskeletal Pain Primaquine C
Hyperhidrosis Cipro C
Mitral Valve Incompetence
Oxygen Saturation
Decreased
Convulsion
Balance Disorder
Suicidal Ideation
Productive Cough
Headache
Panic Disorder
Tremor
Thinking Abnormal
Mitral Valve
Calcification
Exostosis
Weight Decreased
Myalgia
Memory Impairment
Visual Impairment
Hallucination, Visual
Asthma
Homicidal Ideation
Toxicity To Various
Agents
Humerus Fracture
Attention
Deficit/Hyperactivity
Disorder
Respiratory Rate
Increased
Contusion
Rhinitis Allergic
Eosinophilia
Mood Swings
Chest Pain
Cranial Nerve Disorder
Nocturia
Anxiety
Vertigo
Chest Discomfort
Sleep Apnoea Syndrome
Meniscus Lesion
Craniocerebral Injury
Ventricular Extrasystoles
Date:11/26/07ISR Number: 5525274-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-525623 Age:39 YR Gender:Female I/FU:F

Outcome
Hospitalization -
Initial or Prolonged
PT
Feeling Abnormal
Dizziness
Paraesthesia
Sleep Disorder
Headache
Mental Disorder
03-Apr-2012 09:37 AM Page: 778

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pain In Extremity
Anxiety
Paraesthesia Oral Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche UNKNOWN
Date:11/28/07ISR Number: 5527945-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-529962 Age:40 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche UNKNOWN ON AN
UNSPECIFIED
DATE, THE
PATIENT
RECEIVED 4TH
Date:12/03/07ISR Number: 5531862-2Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-532847 Age:66 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Adverse Drug Reaction Lariam PS Roche ORAL
Hospitalization - Interstitial Lung Disease
Initial or Prolonged Respiratory Failure
C-Reactive Protein
Increased
Overdose
Laboratory Test Abnormal
Date:12/04/07ISR Number: 5533285-9Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-532847 Age:66 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Overdose Lariam PS Roche ORAL
Hospitalization - Adverse Drug Reaction
Initial or Prolonged Respiratory Failure
Interstitial Lung Disease
Date:12/10/07ISR Number: 5541933-2Report Type:Expedited (15-DaCompany Report #NL-ROCHE-505944 Age:4 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Status Epilepticus Lariam PS Roche ORAL
Hospitalization -
Initial or Prolonged
Date:12/10/07ISR Number: 5542551-2Report Type:Expedited (15-DaCompany Report #TW-SANOFI-SYNTHELABO-A01200713585 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Serious Hypotension Chloroquine PS UNKNOWN UNK
Mefloquine SS UNKNOWN UNK
03-Apr-2012 09:37 AM Page: 779

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/12/07ISR Number: 5551451-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-534849 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Insomnia Lariam PS Roche ORAL DOSAGE
Anxiety
REGIMEN
Dyspnoea REPORTED AS 1
Congestive Cardiomyopathy
DOSE PER WEEK
Date:12/12/07ISR Number: 5564269-2Report Type:Expedited (15-DaCompany Report #GXKR2007GR10354 Age:67 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Malaise Foreign Mefloquine
Initial or Prolonged Eosinophilic Pneumonia Literature (Ngx)(Mefloquine)
Blood Lactate Health Unknown PS ORAL 250 MG, QW,
Dehydrogenase Increased Professional ORAL 84 DAY
Pulmonary Toxicity
Ketoconazole
Hypoxia
(Ngx)(Ketoconazole)
Tachycardia Unknown SS TOPICAL TOPICAL
Normochromic Normocytic
Anaemia
Date:12/14/07ISR Number: 5558149-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-535633 Age:67 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspnoea Exertional Lariam PS Roche UNKNOWN
Lung Infiltration
Pyrexia
Eosinophilic Pneumonia
Eosinophilia
Date:12/19/07ISR Number: 5566578-XReport Type:Expedited (15-DaCompany Report #GB-ROCHE-535633 Age:67 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Eosinophilic Pneumonia Lariam PS Roche UNKNOWN
Date:12/19/07ISR Number: 5571067-2Report Type:Expedited (15-DaCompany Report #021668 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cognitive Disorder Other Mefloquine
Mental Disorder
Hydrochloride(Mefloq
Pain
uine Hydrochloride)
Tablet, 250mg
PS

Date:12/21/07ISR Number: 5571533-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-537148 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Eye Pain Lariam PS Roche UNKNOWN
Nausea
Paralysis
Vertigo
Headache
03-Apr-2012 09:37 AM Page: 780

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/27/07ISR Number: 5574447-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-385293 Age:45 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Disability
PT
Disturbance In Attention
Aggression
Psychotic Disorder
Major Depression
Hyperhidrosis
Attention
Deficit/Hyperactivity
Disorder
Ligament Sprain
Depression
Fatigue
Productive Cough
Chest Pain
Sleep Apnoea Syndrome
Joint Dislocation
Mitral Valve Incompetence
Convulsion
Hypoaesthesia
Contusion
Rheumatoid Factor
Increased
Nocturia
Abnormal Behaviour
Mood Swings
Visual Impairment
Suicidal Ideation
Bronchial Hyperreactivity
Panic Disorder
Post-Traumatic Stress
Disorder
Meniscus Lesion
Cognitive Disorder
Homicidal Ideation
Dysthymic Disorder
Toxicity To Various
Agents
Humerus Fracture
Dehydration
Respiratory Rate
Increased
Antinuclear Antibody
Positive
Myalgia
Hallucination, Visual
Balance Disorder
Selective Iga
Immunodeficiency
Chest Discomfort
Asthma
Rhinitis Allergic

Pyrexia
Violence-Related Symptom
Fall
Exostosis
Ventricular Extrasystoles
Dyspnoea
Tremor
Thinking Abnormal
03-Apr-2012 09:37 AM Page: 781

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Oxygen Saturation
Decreased
Rash Papular Report Source Product Role Manufacturer Route Dose Duration
Insomnia Lariam PS Roche ORAL
Agitation Primaquine C
Anxiety Cipro C
Memory Impairment
Vertigo
Asthenia
Generalised Anxiety
Disorder
Musculoskeletal Pain
Craniocerebral Injury
Mitral Valve
Calcification
Eosinophilia
Ill-Defined Disorder
Headache
Cranial Nerve Disorder
Hypertension
Self-Injurious Ideation
Decreased Activity
Bundle Branch Block Right
Weight Decreased
Nystagmus
Eye Movement Disorder
Date:01/03/08ISR Number: 5581533-1Report Type:Direct Company Report #CTU 321532 Age:39 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hyperventilation Larium ? Hoffman La
Initial or Prolonged Anxiety Roche PS Hoffman La Roche ORAL 1 PER WEEK PO
Other Serious
Thinking Abnormal
Required
Toxicity To Various
Intervention to
Agents
Prevent Permanent
Impairment/Damage
Poor Quality Sleep
Stress
Dehydration
Panic Attack
Initial Insomnia
Chest Discomfort
Heart Rate Increased
Fear
Palpitations
Dyspnoea
Impaired Work Ability
Middle Insomnia
Alcohol Use

Date:01/11/08ISR Number: 5588505-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-415971 Age:61 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Amyotrophy Lariam PS Roche ORAL
Upper Motor Neurone Engerix B SS INTRAMUSCULAR FORM:
Lesion
INHALATION
SOLUTION, THE
PATIENT
03-Apr-2012 09:37 AM Page: 782

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
RECEIVED
Date:01/14/08ISR Number: 5592903-XReport Type:Direct Company Report #CTU 322500 Age:36 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Feeling Abnormal Lariam PS ORAL ONCE PER WEEK
Fear
PO
Psychotic Disorder
Anxiety
Date:01/14/08ISR Number: 5593124-7Report Type:Direct Company Report #CTU 322421 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Road Traffic Accident Mefloquine PS ORAL 250MG QWEEK
Vertigo Positional
PO
Date:01/15/08ISR Number: 5593239-3Report Type:Direct Company Report #CTU 322557 Age:38 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mood Swings Lariam PS ORAL 1/WEEK PO
Panic Disorder
Anxiety
Toxicity To Various
Agents
Fear
Date:01/16/08ISR Number: 5593525-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-535633 Age:67 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Eosinophilic Pneumonia Mefloquine
Initial or Prolonged Hydrochloride PS Roche ORAL 84 DAY
Ketoconazole SS TOPICAL SHAMPOO
Ketoconazole SS TOPICAL SHAMPOO
Date:01/22/08ISR Number: 5601165-6Report Type:Direct Company Report #CTU 322950 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Lariam PS
Required
Mental Disorder
Intervention to
Insomnia
Prevent Permanent Mood Altered
Impairment/Damage Anxiety
Migraine
Visual Impairment

Date:01/29/08ISR Number: 5605775-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-537148 Age: Gender:Male I/FU:F
Outcome
Other Serious
PT
Headache
Vertigo
03-Apr-2012 09:37 AM Page: 783

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nausea
Eye Pain
Paralysis Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche UNKNOWN
Date:01/30/08ISR Number: 5609148-7Report Type:Direct Company Report #CTU 323900 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Myalgia Mefloquine 250mg PS ONCE WEEKLY
Hypoaesthesia
Dizziness
Impaired Work Ability
Arthralgia
Date:02/05/08ISR Number: 5618668-0Report Type:Direct Company Report #CTU 324564 Age:42 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Tinnitus Mefloquine Hcl 250mg
Initial or Prolonged Insomnia Sandoz PS Sandoz ORAL 1 TABLET ONCE
Anxiety
A WEEK PO
Palpitations
Sinus Tachycardia
Date:02/07/08ISR Number: 5618791-0Report Type:Expedited (15-DaCompany Report #AU-ROCHE-543953 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paranoia Lariam PS Roche UNKNOWN
Initial or Prolonged Depression
Mania
Date:02/07/08ISR Number: 5618980-5Report Type:Expedited (15-DaCompany Report #GR-BOEHRINGER INGELHEIM GMBH, GERMANY-2008-BP-01668RAge:67 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Mefloquine PS Boehringer Ingelheim
Initial or Prolonged Eosinophilic Pneumonia Gmbh, Germany ORAL 12 WK
Normochromic Normocytic Ketoconazole SS TOPICAL
Anaemia
Tachypnoea
Red Blood Cell
Sedimentation Rate
Increased
Blood Lactate
Dehydrogenase Increased
Eosinophilia
Tachycardia

C-Reactive Protein
Increased
Hypoxia
03-Apr-2012 09:37 AM Page: 784

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/11/08ISR Number: 5622046-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Tinnitus Lariam PS Roche ORAL
Other Serious Testicular Pain Imodium C
Photophobia Compazine C ON 18 APR
Night Sweats
2001, THERAPY
Mood Swings
REPORTED AS
Fatigue
TWICE DAILY.
Chest Pain Antibiotics Nos C
Vision Blurred Ambien C
Disturbance In Attention Prednisone C BY TAPER.
Diarrhoea Valium C ON 18 APR
Diabetes Mellitus
2001, THERAPY
Deafness
REPORTED AS:
Disorientation
AS NEEDED.
Vestibular Disorder Phenergan C
Irritable Bowel Syndrome Biaxin C
Eye Pain Advil C
Hypoaesthesia Bactrim C
Vertigo Antivert C
Psychotic Disorder
Nystagmus
Blood Triglycerides
Increased
Agitation
Nausea
Insomnia
Nightmare
Amnesia
Headache
Abdominal Pain
Dizziness
Depression
Blood Pressure Increased
Memory Impairment
Inner Ear Disorder
Rash
Nervousness
Phonophobia
Paraesthesia
Brain Stem Syndrome
Vomiting
Anxiety Disorder
Pain Of Skin
Date:02/19/08ISR Number: 5630886-4Report Type:Expedited (15-DaCompany Report #CH-ROCHE-435016 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Cerebral Ventricle Lariam PS Roche TRANSPLACENTAL INDICATION
Other Serious Dilatation DRUG ACTING

Premature Baby ON OTHER
Foetal Growth Restriction
BLOOD
Maternal Exposure During PROTOZOA 15 DAY
Pregnancy Eltroxin C
Stilnox C REPORTED
FREQUENCY 2
TOTAL. 3 DAY
03-Apr-2012 09:37 AM Page: 785

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/19/08ISR Number: 5636737-6Report Type:Direct Company Report #CTU 326092 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Lariam 250 Mg
Deafness Unilateral Roche PS Roche ORAL 250 MG ONCE
Tinnitus
WEEKLY PO
Crying
(ONE DOSE)
Klonopin
C
Wellbutrin
C
Lamictal
C
Date:02/25/08ISR Number: 5637134-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-548290 Age:30 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Liver Function Test Lariam PS Roche ORAL
Abnormal Imodium SS ORAL
Suicidal Ideation Imodium SS ORAL
Overdose Talvosilen SS ORAL
Somnolence Gelonida SS ORAL
Ibuprofen SS Roche ORAL
Ibuprofen SS Roche ORAL
Talvosilen SS ORAL
Lariam SS Roche ORAL
Gelonida SS ORAL
Date:02/25/08ISR Number: 5637136-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548278 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Homicide Lariam PS Roche UNKNOWN
Other Serious
Completed Suicide
Date:02/25/08ISR Number: 5637320-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548228 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Death Lariam PS Roche UNKNOWN
Other Serious
Suicide Attempt
Date:02/25/08ISR Number: 5637331-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548255 Age:55 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cardiovascular Lariam PS Roche ORAL
Insufficiency Doxam C
Depression
Suicidal Ideation

Date:03/07/08ISR Number: 5655519-2Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548290 Age:30 YR Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Somnolence
Liver Function Test
Abnormal
03-Apr-2012 09:37 AM Page: 786

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Suicidal Ideation
Overdose
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL
Talvosilen SS ORAL DRUG REPORTED
AS "PANADEINE
CO"
Ibuprofen SS Roche ORAL
Imodium SS ORAL DRUG REPORTED
AS
"LOPERAMIDE
HYDROCHLORIDE
"
Gelonida SS ORAL DRUG REPORTED
AS "PANADEINE
CO"
Date:03/07/08ISR Number: 5655523-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548255 Age:55 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Lariam PS Roche ORAL
Depression Doxam C
Cardiovascular
Insufficiency
Date:03/11/08ISR Number: 5659980-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-550654 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Amyotrophic Lateral Lariam PS Roche ORAL DOSE
Initial or Prolonged Sclerosis REPORTED: 1
COURSE
Date:03/12/08ISR Number: 5661506-0Report Type:Expedited (15-DaCompany Report #IT-ROCHE-550893 Age:73 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Abdominal Distension Lariam PS Roche ORAL
Initial or Prolonged Dyspnoea
Oedema Peripheral
Date:03/12/08ISR Number: 5661510-2Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548228 Age: Gender: I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Death Lariam PS Roche UNKNOWN
Other Serious
Suicide Attempt

Date:03/13/08ISR Number: 5662678-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-548278 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Homicide Lariam PS Roche UNKNOWN
Other Serious
Completed Suicide
03-Apr-2012 09:37 AM Page: 787

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/21/08ISR Number: 5676118-2Report Type:Expedited (15-DaCompany Report #CA-ROCHE-940804124001 Age:23 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Hallucination Lariam PS Roche ORAL
Life-Threatening Completed Suicide Alcohol C ORAL
Date:03/28/08ISR Number: 5685018-3Report Type:Expedited (15-DaCompany Report #CH-ROCHE-84542 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Nasopharyngitis Lariam Tablets PS Roche ORAL
Death Flunitrazepam C UNKNOWN
Neo-Citran C ORAL
Date:03/28/08ISR Number: 5685028-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-94161 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Death Lariam Tablets PS Roche ORAL
Indapamide SS UNKNOWN
Date:03/28/08ISR Number: 5685058-4Report Type:Expedited (15-DaCompany Report #NL-ROCHE-104818 Age:67 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Malaise Lariam PS Roche ORAL
Death
Nausea
Date:03/31/08ISR Number: 5688792-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-550654 Age:62 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Amyotrophic Lateral Lariam PS Roche ORAL DOSE
Hospitalization - Sclerosis REPORTED: 1
Initial or Prolonged
COURSE
(COMMON)
Date:03/31/08ISR Number: 5688827-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-305523 Age:68 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Death Lariam PS Roche ORAL
Mental Disorder Lodoz SS ORAL
Date:03/31/08ISR Number: 5689149-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-940400336001 Age:27 YR Gender:Male I/FU:I

Outcome
Death
Other Serious
PT
Drug Interaction
Foot Fracture
Death
Epilepsy
Depression
Accidental Death
03-Apr-2012 09:37 AM Page: 788

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Drowning
Abnormal Behaviour
Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration
Hallucination Lariam PS Roche ORAL
Carbamazepine C ORAL
Valproate I ORAL
Date:04/01/08ISR Number: 5690471-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-354441 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Death Lariam PS Roche ORAL
Other Serious
Arrhythmia
Date:04/01/08ISR Number: 5693443-XReport Type:Direct Company Report #CTU 330870 Age:58 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Larium 250 Mg Tablet PS ORAL 250 MG ONCE
Initial or Prolonged Chest Pain WEEKLY ORAL
Flight Of Ideas
Delusion
Agitation
Psychotic Disorder
Confusional State
Altered State Of
Consciousness
Feeling Abnormal
Claustrophobia
Date:04/03/08ISR Number: 5694409-6Report Type:Direct Company Report #CTU 331148 Age:64 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Mefloquine 250 Mg PS 1 TABLET 1
Dry Mouth
PER WEEK
Asthenia
Blood Cholesterol
Increased
Balance Disorder
Hypotension
Product Quality Issue
Dizziness
Date:04/04/08ISR Number: 5694932-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-531067 Age: Gender:Male I/FU:F
Outcome
Disability
PT
Stress At Work

Anxiety
Tachycardia
Sensory Disturbance
Compulsions
Heart Rate Irregular
Depression
Psychosomatic Disease
Irritability
03-Apr-2012 09:37 AM Page: 789

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Muscle Twitching
Panic Attack
Restlessness Report Source Product Role Manufacturer Route Dose Duration
Nervous System Disorder Lariam PS Roche ORAL
Self Esteem Decreased
Affect Lability
Cardiovascular Disorder
Tremor
Sleep Disorder
Personality Change
Tachyarrhythmia
Date:04/07/08ISR Number: 5696150-2Report Type:Expedited (15-DaCompany Report #DE-ROCHE-555182 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Atrial Septal Defect Lariam PS Roche ORAL 3 MON
Date:04/07/08ISR Number: 5699102-1Report Type:Direct Company Report #CTU 331512 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Insomnia Mefloquine Hcl 250
Other Serious Anxiety Mg Sandoz PS Sandoz ORAL 250 MG 1 A
Balance Disorder
WEEK PO
Hallucination
Paranoia
Nightmare
Dizziness
Suicidal Ideation
Date:04/10/08ISR Number: 5700060-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-550654 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Amyotrophic Lateral Lariam PS Roche ORAL DOSE
Hospitalization - Sclerosis REPORTED: 1
Initial or Prolonged
COURSE
(COMMON)
Date:04/10/08ISR Number: 5702450-XReport Type:Direct Company Report #CTU 331896 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Psychiatric Symptom Lariam 250 Mg PS BUCCAL 8 WEEKLY
Intervention to Neurological Symptom BUCCAL 8 WK
Prevent Permanent
Impairment/Damage

Date:04/18/08ISR Number: 5709774-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Age: Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Other Serious
PT
Abnormal Dreams
Vertigo
Depression
03-Apr-2012 09:37 AM Page: 790

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Headache
Fatigue
Tinnitus Report Source Product Role Manufacturer Route Dose Duration
Tachycardia Lariam PS Roche UNKNOWN DOSAGE
Dyspepsia
REGIMEN
Formication
REPORTED AS
Oedema Peripheral
FOUR TABS IN
Unevaluable Event
TOTAL. WEEKLY
Malaise
Paraesthesia
Sleep Disorder
Disturbance In Attention
Anxiety
Pyrexia
Coordination Abnormal
Muscle Twitching
Cardiovascular Disorder
Upper Respiratory Tract
Infection
Agitation
Asthenia
Feeling Abnormal
Mental Disorder
Night Sweats
Date:04/22/08ISR Number: 5712570-1Report Type:Expedited (15-DaCompany Report #GB-AVENTIS-200811608EU Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Death Indapamide PS Aventis
Pharmaceuticals Inc. ORAL
dose: UNK
Lariam
/00813001/ SS ORAL dose: UNK
Date:04/22/08ISR Number: 5716351-4Report Type:Expedited (15-DaCompany Report #2008S1005710 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Death Foreign Indapamide
Health (Indapamide) PS
Professional Lariam /00813001/
Other (Mefloquine) SS ORAL ORAL
Date:04/25/08ISR Number: 5717904-XReport Type:Expedited (15-DaCompany Report #GB-ABBOTT-98P-167-0078100-00 Age:27 YR Gender:Male I/FU:I
Outcome
Death
PT
Depression
Social Avoidant Behaviour

Foot Fracture
Psychotic Disorder
Fatigue
Abnormal Behaviour
Epilepsy
Drowning
Drug Level Below
Therapeutic
03-Apr-2012 09:37 AM Page: 791

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Drug Interaction
Report Source Product Role Manufacturer Route Dose Duration
Valproate Sodium PS ORAL
Valproate Sodium SS ORAL Dose
increased
Valproate Sodium SS ORAL 600 mg daily
Valproate Sodium SS
Carbamazepine C ORAL
Carbamazepine C ORAL Dose tapered
Carbamazepine C ORAL Dose tapered
Mefloquine I ORAL 250 mg weekly
Date:04/29/08ISR Number: 5721785-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-560669 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypomania Lariam PS Roche ORAL
Initial or Prolonged Abnormal Behaviour Fortzaar C ORAL
Fortzaar C ORAL
Date:04/30/08ISR Number: 5724928-5Report Type:Direct Company Report #CTU 334288 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Liver Disorder Mefloquine PS
Initial or Prolonged
Date:05/05/08ISR Number: 5731287-0Report Type:Expedited (15-DaCompany Report #2008S1005710 Age:60 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Death Health Indapamide
Professional (Indapamide) PS
Other Lariam /00813001/
(Mefloquine) SS ORAL ORAL
Date:05/07/08ISR Number: 5730460-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-561917 Age:42 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Rhabdomyolysis Lariam PS Roche ORAL
Initial or Prolonged Pancreatitis Acute Xanax C
Areflexia
Pericarditis
Date:05/08/08ISR Number: 5731765-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age: Gender:Male I/FU:F

Outcome
Disability
Other Serious
PT
Nausea
Insomnia
Irritable Bowel Syndrome
Nervousness
Blood Pressure Increased
Disorientation
03-Apr-2012 09:37 AM Page: 792

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Amnesia
Nystagmus
Blood Triglycerides Report Source Product Role Manufacturer Route Dose Duration
Increased Lariam PS Roche ORAL
Toxicity To Various Bactrim C
Agents Imodium C
Agitation Compazine C ON 18 APR
Anxiety Disorder
2001, THERAPY
Eye Pain
REPORTED AS
Rash
TWICE DAILY.
Memory Impairment Antibiotics Nos C
Headache Ambien C
Vestibular Disorder Prednisone C BY TAPER.
Photophobia Valium C ON 18 APR
Paraesthesia
2001, THERAPY
Fatigue
REPORTED AS:
Tinnitus
AS NEEDED.
Inner Ear Disorder Phenergan C
Dizziness Biaxin C
Disturbance In Attention Advil C
Hypoaesthesia Bactrim C
Phonophobia Antivert C
Brain Stem Syndrome
Diarrhoea
Night Sweats
Mood Swings
Vertigo
Chest Pain
Psychotic Disorder
Testicular Pain
Depression
Vomiting
Nightmare
Diabetes Mellitus
Abdominal Pain
Vision Blurred
Pain Of Skin
Deafness
Date:05/12/08ISR Number: 5735434-6Report Type:Expedited (15-DaCompany Report #SE-ROCHE-560756 Age:69 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious International Normalised Lariam PS Roche ORAL THERAPY START
Ratio Increased
AND STOP DATE
REPORTED AS
2008, DOSAGE
REGIMEN: DD
Waran SS ORAL DOSAGE
REGIMEN
REPORTED AS D
D

Date:05/14/08ISR Number: 5737157-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-367621 Age: Gender:Male I/FU:F
Outcome
Disability
Other Serious
PT
Vertigo
Blood Triglycerides
03-Apr-2012 09:37 AM Page: 793

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Increased
Vision Blurred
Rash
Nausea Report Source Product Role Manufacturer Route Dose Duration
Mood Swings Lariam PS Roche ORAL
Insomnia Bactrim C
Amnesia Imodium C
Depression Compazine C ON 18 APR
Blood Pressure Increased
2001, THERAPY
Paraesthesia
REPORTED AS
Diarrhoea
TWICE DAILY.
Vestibular Disorder Antibiotics Nos C
Psychotic Disorder Ambien C
Diabetes Mellitus Prednisone C BY TAPER.
Nervousness Valium C ON 18 APR
Fatigue
2001, THERAPY
Photophobia
REPORTED AS:
Pain Of Skin
AS NEEDED.
Toxicity To Various Phenergan C
Agents Biaxin C
Vomiting Advil C
Nightmare Bactrim C
Testicular Pain Antivert C
Dizziness
Hypoaesthesia
Phonophobia
Anxiety Disorder
Disorientation
Chest Pain
Nystagmus
Inner Ear Disorder
Abdominal Pain
Irritable Bowel Syndrome
Disturbance In Attention
Eye Pain
Night Sweats
Agitation
Headache
Tinnitus
Deafness
Brain Stem Syndrome
Memory Impairment
Date:05/14/08ISR Number: 5742047-9Report Type:Direct Company Report #CTU 336553 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Vertigo Lariam -Mefloquin- PS ORAL 1 PILL ONCE A
Initial or Prolonged Nausea WEEK PO
Required
Hallucination
Intervention to
Headache
Prevent Permanent
Impairment/Damage

Date:05/29/08ISR Number: 5752217-1Report Type:Expedited (15-DaCompany Report #NL-ROCHE-566208 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Respiratory Distress Lariam PS Roche ORAL
Initial or Prolonged Cyanosis
03-Apr-2012 09:37 AM Page: 794

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/02/08ISR Number: 5755389-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-566032 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Poisoning Lariam PS Roche UNKNOWN
Sexual Abuse
Unknown
Benzodiazepines SS UNKNOWN
Date:06/02/08ISR Number: 5758017-0Report Type:Direct Company Report #CTU 338594 Age:55 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Weight Decreased Lariam 250 Mg
Aggression Roche PS Roche ORAL 250 MG
Insomnia
WEEKLY PO
Date:06/03/08ISR Number: 5757295-1Report Type:Expedited (15-DaCompany Report #ZA-ROCHE-566339 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatic Steatosis Mefloquine
Hydrochloride PS Roche UNKNOWN
Date:06/03/08ISR Number: 5757344-0Report Type:Expedited (15-DaCompany Report #SE-ROCHE-566343 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nightmare Lariam PS Roche UNKNOWN
Initial or Prolonged Hallucination, Visual
Other Serious
Psychotic Disorder
Incoherent
Date:06/04/08ISR Number: 5758918-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-564714 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disturbance In Attention Lariam PS Roche ORAL
Herpes Zoster Lariam C DOSING
Dizziness
FREQUENCY
Memory Impairment REPORTED AS 6
Altered Visual Depth TABLETS IN 2
Perception
DAYS.
Balance Disorder
Colour Blindness
Date:06/04/08ISR Number: 5765655-8Report Type:Periodic Company Report #493511 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Suicide Attempt Other Lariam (Mefloquine
Completed Suicide Hydrochloride) PS
Suicidal Ideation
03-Apr-2012 09:37 AM Page: 795

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/04/08ISR Number: 5765660-1Report Type:Periodic Company Report #512701 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Consumer Lariam (Mefloquine
Company Hydrochloride) PS
Representative
Other
Date:06/04/08ISR Number: 5765665-0Report Type:Periodic Company Report #534035 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicidal Ideation Consumer Lariam (Mefloquine
Disturbance In Attention Other Hydrochloride) PS
Panic Attack
Anxiety
Abnormal Dreams
Aggression
Depression
Date:06/04/08ISR Number: 5765670-4Report Type:Periodic Company Report #543330 Age:82 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Medication Error Literature Lariam (Mefloquine
Overdose Health Hydrochloride) PS 250 MG DAILY 61 DAY
Agitation
Professional
Confusional State
Other
Ataxia
Dizziness
Speech Disorder
Deafness
Date:06/04/08ISR Number: 5765673-XReport Type:Periodic Company Report #543771 Age:53 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nausea Literature Lariam (Mefloquine
Paraesthesia Health Hydrochloride) PS 250 MG DAILY
Overdose
Professional
Asthenia
Other
Depression
Medication Error
Disorientation
Fatigue
Date:06/04/08ISR Number: 5765685-6Report Type:Periodic Company Report #543808 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mental Disorder Consumer Lariam (Mefloquine
Other Hydrochloride) PS
03-Apr-2012 09:37 AM Page: 796

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/11/08ISR Number: 5767227-8Report Type:Direct Company Report #CTU 339638 Age:25 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Mefloquine Malaris E PS
Nightmare
Date:06/12/08ISR Number: 5766736-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-569094 Age:48 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Lariam PS Roche UNKNOWN
Other Serious
Delusion
Date:06/13/08ISR Number: 5773271-7Report Type:Direct Company Report #CTU 339922 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Confusional State Lariam Hydrochloride
Intervention to Hallucination Hoffman-Laroche
Prevent Permanent Adverse Drug Reaction -Roche- PS Hoffman-Laroche
Impairment/Damage Psychotic Disorder -Roche- ORAL WEEKLY PO
Mania
Depression
Thinking Abnormal
Suicidal Ideation
Date:06/17/08ISR Number: 5775289-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-569005 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Rhabdomyolysis Lariam PS Roche ORAL
Initial or Prolonged Xanax C
Date:06/17/08ISR Number: 5776506-XReport Type:Direct Company Report #CTU 340311 Age:46 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicidal Ideation Larium PS ONE TABLET
Hospitalization - Mental Disorder WEEKLY
Initial or Prolonged Panic Attack
Date:06/18/08ISR Number: 5778564-5Report Type:Direct Company Report #CTU 340511 Age:21 YR Gender:Male I/FU:I
Outcome
Life-Threatening
Other Serious
Required
PT
Anxiety
Insomnia
Paranoia

Intervention to
Prevent Permanent
Impairment/Damage
Attention
Deficit/Hyperactivity
Disorder
Anger
Fatigue
Mood Swings
Suicidal Ideation
Aggression
03-Apr-2012 09:37 AM Page: 797

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depression
Phobia
Nervous System Disorder Report Source Product Role Manufacturer Route Dose Duration
Brain Injury Lariam Roche PS Roche ORAL 1 PILL ONCE
PO
Date:06/23/08ISR Number: 5781458-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-569094 Age:48 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Delusion Lariam PS Roche UNKNOWN
Other Serious
Completed Suicide
Date:06/23/08ISR Number: 5786900-9Report Type:Direct Company Report #CTU 340905 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Mefloquine Taken
Suicidal Ideation Once A Wk X 2 Doses PS ORAL 250MG WEEKLY
Abnormal Dreams
PO
Anxiety Albendazole C
Cipro
C
Date:06/30/08ISR Number: 5794845-3Report Type:Expedited (15-DaCompany Report #SE-ROCHE-566343 Age:27 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Incoherent Lariam PS Roche UNKNOWN
Initial or Prolonged Nightmare Malarone C
Other Serious Psychotic Disorder Malarone C
Hallucination, Visual
Date:07/02/08ISR Number: 5798235-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-570689 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Ineffective Lariam PS Roche UNKNOWN
Date:07/03/08ISR Number: 5800412-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-570689 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Ineffective Lariam PS Roche UNKNOWN
Date:07/07/08ISR Number: 5801506-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-572343 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cognitive Disorder Lariam PS Roche UNKNOWN
03-Apr-2012 09:37 AM Page: 798

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/08/08ISR Number: 5802953-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-573267 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pulmonary Oedema Lariam PS Roche ORAL
Pulmonary Fibrosis Lariam SS Roche ORAL
Pneumonia
Dyspnoea
Date:07/10/08ISR Number: 5806523-2Report Type:Expedited (15-DaCompany Report #US-BOEHRINGER INGELHEIM GMBH, GERMANY-2008-BP-10301RAge:63 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - White Blood Cell Count Mefloquine PS Boehringer Ingelheim
Initial or Prolonged Increased Gmbh, Germany 5 WK
Antipsychotic Drug Level Eskalith Cr SS
Increased Eskalith Cr SS
Mania Lunesta SS
Quetiapine
C
Quetiapine
C
Date:07/14/08ISR Number: 5809717-5Report Type:Direct Company Report #CTU 343343 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Anxiety Larium La Roche PS La Roche ORAL 1 TABLET
Muscle Twitching
WEEKLY PO
Malaise
Pain
Depression
Nerve Injury
Date:07/15/08ISR Number: 5810454-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-531067 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Depression Lariam PS Roche ORAL
Tachycardia
Affect Lability
Stress At Work
Anxiety
Restlessness
Nervous System Disorder
Panic Attack
Muscle Twitching
Cardiovascular Disorder
Tremor
Sleep Disorder
Compulsions
Irritability
Heart Rate Irregular

Psychosomatic Disease
Sensory Disturbance
Self Esteem Decreased
Personality Change
Tachyarrhythmia
03-Apr-2012 09:37 AM Page: 799

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/21/08ISR Number: 5816593-3Report Type:Expedited (15-DaCompany Report #NL-ROCHE-575244 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Renal Failure Lariam PS Roche ORAL
Hepatic Failure
Date:07/22/08ISR Number: 5821277-1Report Type:Direct Company Report #CTU 344228 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Activities Of Daily Lariam Roche PS Roche THREE PILLS
Living Impaired
Depression
Anxiety
Insomnia
Disorientation
Crying
Hallucination
Date:07/23/08ISR Number: 5822351-6Report Type:Direct Company Report #CTU 344345 Age:33 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Grand Mal Convulsion Mefloquine 250mg PS
Hospitalization - Upper Limb Fracture
Initial or Prolonged
Required
Intervention to
Prevent Permanent
Impairment/Damage
Date:07/25/08ISR Number: 5823376-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-314664 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Lariam PS Roche ORAL
Other Serious
Job Dissatisfaction
Depression
Restlessness
Nervous System Disorder
Tremor
Panic Attack
Affect Lability
Palpitations
Sleep Disorder
Compulsions
Irritability
Sensory Disturbance
Self Esteem Decreased
Peripheral Vascular

Disorder
Muscle Twitching
Personality Change
Arrhythmia
Heart Rate Irregular
Tachycardia
Psychosomatic Disease
03-Apr-2012 09:37 AM Page: 800

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/28/08ISR Number: 5824289-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-576460 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cytolytic Hepatitis Lariam PS Roche ORAL DOSE: 15
Initial or Prolonged MG/KG THEN 20
MG/KG EIGHT
HOURS LATER
Date:07/31/08ISR Number: 5832404-4Report Type:Direct Company Report #CTU 345127 Age:46 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Restlessness Lariam/Mefloquine
Hospitalization - Memory Impairment N/A N/A PS BUCCAL 60 ONE PER
Initial or Prolonged Confusional State DAY BUCCAL
Disability
Visual Impairment
Other Serious
Tinnitus
Required
Anxiety
Intervention to
Palpitations
Prevent Permanent
Impairment/Damage
Dyspepsia
Rash
Asthma
Dyspnoea
Mood Altered
Oedema
Bone Disorder
Hypertension
Tachycardia
Muscular Weakness
Back Disorder
Depression
Myalgia
Muscle Spasms
Arthralgia
Suicidal Ideation
Urticaria
Hypersensitivity
Fatigue
Date:08/07/08ISR Number: 5841157-5Report Type:Direct Company Report #CTU 345741 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Anger Mefloquine Once A
Hospitalization - Impaired Work Ability Week Dose PS ORAL ONCE A WEEK
Initial or Prolonged Aggression PO
Other Serious
Suicidal Ideation
Required
Bipolar Disorder
Intervention to
Activities Of Daily
Prevent Permanent Living Impaired
Impairment/Damage Mental Disorder

Hallucination
Confusional State
Feeling Abnormal
03-Apr-2012 09:37 AM Page: 801

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/12/08ISR Number: 5842265-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-578606 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Atrial Fibrillation Lariam PS Roche UNKNOWN 3 WK
Ventricular Tachycardia
Sinus Arrhythmia
Date:08/19/08ISR Number: 5849623-3Report Type:Expedited (15-DaCompany Report #GB-ROCHE-580275 Age:4 MON Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Crying Lariam PS Roche ORAL REPORTED AS
Dyspnoea
MEFLOQUINE
GIVEN
'CRUSHED IN
WATER' 1 DAY
Date:08/22/08ISR Number: 5853999-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-581040 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypersensitivity Lariam PS Roche UNKNOWN
Amnesia
General Physical Health
Deterioration
Tachycardia
Date:08/22/08ISR Number: 5854000-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-529962 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS Roche UNKNOWN ON AN
UNSPECIFIED
DATE, THE
PATIENT
RECEIVED 4TH 8 WK
Date:08/29/08ISR Number: 5864202-XReport Type:Expedited (15-DaCompany Report #US-ROCHE-582167 Age:11 MON Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Sepsis Mefloquine
Hospitalization - Chronic Granulomatous Hydrochloride PS Roche UNKNOWN DRUG NAME
Initial or Prolonged Disease REPORTED AS
Multi-Organ Failure
MEFLOQUINE
Bronchopulmonary
Immunoglobulin
Aspergillosis Injectable SS INTRAMUSCULAR DRUG NAME
Pyrexia
REPORTED AS
IMMUNOGLOBULI

03-Apr-2012 09:37 AM Page: 802
N

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/29/08ISR Number: 5864210-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-582044 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Mefloquine
Initial or Prolonged Visual Field Defect Hydrochloride PS Roche UNKNOWN
Restlessness
Diarrhoea
Insomnia
Decreased Appetite
Date:08/29/08ISR Number: 5867094-8Report Type:Direct Company Report #CTU 347996 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Panic Attack Lariam PS 1 PILL 1 PER
Other Serious Ear Pain WEEK
Loss Of Consciousness
Depression
Anxiety
Psychotic Disorder
Hallucination
Headache
Insomnia
Arthralgia
Neck Pain
Mood Swings
Confusional State
Myalgia
Fatigue
Paranoia
Dizziness
Memory Impairment
Date:09/02/08ISR Number: 5868957-XReport Type:Direct Company Report #CTU 348060 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Affect Lability Meflouquine PS ORAL PO 1 WK
Feeling Of Despair
Crying
Cold Sweat
Emotional Disorder
Early Retirement
Insomnia
Marital Problem
Depression
Impaired Work Ability
Suicidal Ideation
Disturbance In Attention
Muscle Disorder
Divorced

Date:09/03/08ISR Number: 5868533-9Report Type:Expedited (15-DaCompany Report #US-ROCHE-582804 Age:24 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Post-Traumatic Stress
Disorder
03-Apr-2012 09:37 AM Page: 803

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Amnesia
Physical Assault
Sexual Abuse Report Source Product Role Manufacturer Route Dose Duration
Theft Lariam PS Roche UNKNOWN
Date:09/08/08ISR Number: 5873719-3Report Type:Expedited (15-DaCompany Report #CH-ROCHE-583994 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Obsessive-Compulsive Lariam PS Roche ORAL
Disorder
Date:09/08/08ISR Number: 5874972-2Report Type:Direct Company Report #CTU 348811 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Disturbance In Attention Mefloquine Hci 250
Intervention to Amnesia Mg Tablets Barr
Prevent Permanent Aphasia Laboratories Inc. PS Barr Laboratories
Impairment/Damage Depression Inc. ORAL 1 TABLET ONCE
Thinking Abnormal
A WEEK PO
Date:09/08/08ISR Number: 5876479-5Report Type:Direct Company Report #CTU 348925 Age:18 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Mefloquine 250 Mg PS ORAL 250MG WEEKLY
Initial or Prolonged Abnormal Behaviour PO
Belligerence
Paranoia
Date:09/10/08ISR Number: 5880016-9Report Type:Direct Company Report #CTU 349175 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Mefloquine PS ORAL 1 TABLET
Initial or Prolonged Vomiting WEEKLY PO
Other Serious Nightmare Macrobid C
Required Nausea Dramamine C
Intervention to Feeling Abnormal Seasonique C
Prevent Permanent Suicidal Ideation Ambien Cr C
Impairment/Damage Fear
Frequent Bowel Movements
Impaired Work Ability
Dizziness
Gastroenteritis
Panic Attack
Abnormal Behaviour
Retching

Anxiety
Delusion
Mental Disorder
Pyrexia
03-Apr-2012 09:37 AM Page: 804

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/15/08ISR Number: 5883994-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-585370 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gamma-Glutamyltransferase Lariam PS Roche UNKNOWN DOSE REPORTED
Increased
AS 250 MG/WEE
Date:09/19/08ISR Number: 5889257-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-581040 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amnesia Lariam PS Roche UNKNOWN
Incorrect Dose
Administered
Tachycardia
Hypersensitivity
Unresponsive To Stimuli
General Physical Health
Deterioration
Date:09/22/08ISR Number: 5891587-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-586516 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Lariam PS Roche UNKNOWN
Nausea
Euphoric Mood
Vomiting
Persecutory Delusion
Pyrexia
Date:09/29/08ISR Number: 5901813-7Report Type:Expedited (15-DaCompany Report #CA-ROCHE-319480 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Suicide Attempt Lariam PS Roche ORAL
Other Serious
Physical Assault
Homicide
Amnesia
Date:09/30/08ISR Number: 5904319-4Report Type:Direct Company Report #CTU 351238 Age:22 YR Gender:Female I/FU:I
Outcome
Life-Threatening
Hospitalization -
Initial or Prolonged
Required
Intervention to
Prevent Permanent
PT
Activities Of Daily
Living Impaired
Suicidal Ideation
Abnormal Dreams
Discomfort
Sleep Disorder

Impairment/Damage
Metamorphopsia
Nervousness
Panic Attack
Malaise
Stress
Feeling Hot
Tension
Pyrexia
03-Apr-2012 09:37 AM Page: 805

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Anxiety
Balance Disorder
Malaria Report Source Product Role Manufacturer Route Dose Duration
Hallucination
Lariam -Mefloquine-
Tremor 250mg Roche/Lariam PS Roche/Lariam ORAL 250MG 1/WEEK
Eating Disorder
PO
Ill-Defined Disorder
Hypochondriasis
Psychotic Disorder
Insomnia
Hypoaesthesia
Paraesthesia
Mental Disorder
Paranoia
Depression
Morbid Thoughts
Asthenia
Feeling Abnormal
Dyskinesia
Date:10/03/08ISR Number: 5907741-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-581040 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious General Physical Health Lariam PS Roche UNKNOWN
Deterioration
Hypersensitivity
Tachycardia
Amnesia
Date:10/09/08ISR Number: 5914065-9Report Type:Expedited (15-DaCompany Report #SE-ROCHE-588873 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Atrial Fibrillation Lariam PS Roche UNKNOWN
Initial or Prolonged
Date:10/16/08ISR Number: 5920895-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-590200 Age:59 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Shock Lariam PS Roche UNKNOWN
Hospitalization - Acute Respiratory Failure
Initial or Prolonged Pulmonary Toxicity
Disability
Date:10/24/08ISR Number: 5929861-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-587928 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Polyneuropathy Lariam PS Roche UNKNOWN 'PATIENT TOOK
Initial or Prolonged Spinal Column Stenosis FOUR TABLETS
Other Serious IN TOTAL'. 4 WK
03-Apr-2012 09:37 AM Page: 806

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/30/08ISR Number: 5939669-9Report Type:Direct Company Report #CTU 354413 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Dreams Mefloquine Hcl 250mg PS ORAL 250MG 1 PILL
Confusional State
PER WEEK PO
Panic Attack
Paranoia
Nightmare
Depression
Heart Rate Increased
Disturbance In Attention
Dizziness
Flushing
Nonspecific Reaction
Impaired Driving Ability
Date:11/07/08ISR Number: 5945298-3Report Type:Expedited (15-DaCompany Report #NL-ROCHE-594401 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Lariam PS Roche ORAL
Initial or Prolonged Psychotic Disorder
Tongue Disorder
Dizziness
Date:11/12/08ISR Number: 5951184-5Report Type:Direct Company Report #CTU 355843 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Metabolic Disorder Lariam-Mefloquine-
Intervention to Bronchitis Hoffman Laroche PS Hoffman Laroche ORAL 250MG WEEKLY
Prevent Permanent Anxiety PO
Impairment/Damage Panic Attack
Hallucination, Auditory
Pneumonitis
Overdose
Vestibular Disorder
Balance Disorder
Date:11/13/08ISR Number: 5955004-4Report Type:Direct Company Report #CTU 356027 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myalgia Lariam 250mg R PS R ORAL 250MG WEEKLY
Initial or Prolonged Dyspnoea PO
Diarrhoea
Anxiety
Vomiting
Dyspepsia
Pulmonary Embolism

Insomnia
Chest Pain
03-Apr-2012 09:37 AM Page: 807

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/19/08ISR Number: 5961252-XReport Type:Expedited (15-DaCompany Report #08-001813 Age:26 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Level Increased Foreign Doryx (Doxycycline)
Vomiting Literature Capsule, 100mg PS ORAL 100 MG, BID,
Cinchonism Health ORAL
Tinnitus Professional Mefloquine
Headache (Mefloquine) SS ORAL 500 MG, ORAL
Pyrexia
Quinine
Nausea
Hydrochloride
Deafness
(Quinine
Parasite Blood Test Hydrochloride) SS INTRAVENOUS 600 MG, QID,
Positive
INTRAVENOUS
Erythema
Flushing
Date:11/20/08ISR Number: 5960089-5Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Lariam PS Roche ORAL FREQUENCY
Initial or Prolonged Dehydration REPORTED:
Gastrointestinal
1X/WEEK.
Bacterial Infection Lariam SS Roche ORAL
Date:11/24/08ISR Number: 5963991-3Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2008-RO-00257RO Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hospitalisation Mefloquine PS Roxane Laboratories,
Initial or Prolonged Drug Prescribing Error Inc. 47 DAY
Other Serious
Date:11/25/08ISR Number: 5966467-2Report Type:Expedited (15-DaCompany Report #NL-ROCHE-594401 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Lariam PS Roche ORAL
Initial or Prolonged Psychotic Disorder
Dizziness
Tongue Disorder
Date:11/26/08ISR Number: 5972754-4Report Type:Direct Company Report #CTU 357480 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Panic Attack Lariam PS
Intervention to
Feeling Abnormal
Prevent Permanent Claustrophobia

Impairment/Damage
03-Apr-2012 09:37 AM Page: 808

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/02/08ISR Number: 5976051-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-575286 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Disorder Lariam PS Roche ORAL
Initial or Prolonged Headache Arthritis Medication
Disability Confusional State Nos C
Other Serious Conversion Disorder Naproxen C ORAL
Weight Decreased Hctz C ORAL
Arthralgia Paxil C
Depression Tramadol C ORAL
Dysphagia Aspirin C ORAL
Dyspnoea Exertional Heparin C
Agitation Ativan C FREQUENCY: 1
Deafness
MG Q.H.S
Suicidal Ideation Seroquel C
Scab Unknown Bp Medicine C
Poor Quality Sleep Enalapril C ORAL
Constipation
Mania
Chest Pain
Date:12/02/08ISR Number: 5976068-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-598858 Age:71 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Attack Lariam PS Roche UNKNOWN
Initial or Prolonged Psychotic Disorder Fosamax C
Other Serious
Depression
Choking Sensation
Paranoia
Dehydration
Swollen Tongue
Fall
Date:12/08/08ISR Number: 5983945-0Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Gastrointestinal Lariam PS Roche ORAL FREQUENCY
Initial or Prolonged Bacterial Infection REPORTED:
Anxiety
1X/WEEK.
Lariam SS Roche ORAL
Date:12/10/08ISR Number: 5993287-5Report Type:Direct Company Report #CTU 358888 Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paraesthesia Oral Mefloquine Hcl 250
Pain In Extremity
Mg Tablesan Sandoz,
Paraesthesia Inc PS Sandoz, Inc ORAL ONE WEEKLY PO

Mass
Headache
Neck Pain
Burning Sensation
03-Apr-2012 09:37 AM Page: 809

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/11/08ISR Number: 5999479-3Report Type:Direct Company Report #CTU 358964 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Convulsion Lariam PS ORAL WEEKLY MOUTH
Dilantin
C
Date:12/12/08ISR Number: 5995867-XReport Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2008-RO-00369RO Age:4 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Interstitial Lung Disease Mefloquine PS Roxane Laboratories,
Hospitalization - Pulmonary Fibrosis Inc.
Initial or Prolonged Rash Immunoglobulins C
Pyrexia Corticosteroids C
Fatigue Antibiotics C
Weight Decreased Corticosteroids C
Date:12/18/08ISR Number: 6011449-8Report Type:Expedited (15-DaCompany Report #IE-ROCHE-313825 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Fear Lariam PS Roche UNKNOWN
Other Serious
Completed Suicide
Persecutory Delusion
Mood Altered
Paranoia
Date:12/18/08ISR Number: 6011699-0Report Type:Expedited (15-DaCompany Report #CH-ROCHE-890100204001 Age:70 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Pneumonia Aspiration Lariam PS Roche ORAL
Other Serious Shock Quinine C INTRAVENOUS
Cerebral Malaria
Pulmonary Oedema
Date:12/18/08ISR Number: 6011707-7Report Type:Expedited (15-DaCompany Report #CA-ROCHE-900800054001 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Disease Progression Lariam PS Roche ORAL
Life-Threatening Lariam SS Roche ORAL
Hospitalization - Diclazuril C ORAL
Initial or Prolonged Somatostatin C SUBCUTANEOUS
Disability Spiramycin C INTRAVENOUS
Date:01/15/09ISR Number: 6043585-4Report Type:Direct Company Report #CTU 362740 Age:14 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Tinnitus Lariam-Mefloquine-
Initial or Prolonged Vision Blurred 250 Mg Roche
Required Rash Pharmaceuticals PS Roche
Intervention to Psychotic Disorder Pharmaceuticals ORAL 250 MG ONCE A
Prevent Permanent Aggression WEEK PO
Impairment/Damage
03-Apr-2012 09:37 AM Page: 810

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/26/09ISR Number: 6051859-6Report Type:Expedited (15-DaCompany Report #DE-ROCHE-581040 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious General Physical Health Lariam PS Roche ORAL
Deterioration
Tachycardia
Hypersensitivity
Amnesia
Date:01/26/09ISR Number: 6057433-XReport Type:Direct Company Report #CTU 363921 Age:34 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Fear Mefloquine 250mg
Anxiety Sandoz, Inc. PS Sandoz, Inc. ORAL 1 TABLET PER
Nausea WEEK PO 7 WK
Tinnitus
Syncope
Headache
Diarrhoea
Dizziness
Date:01/28/09ISR Number: 6055070-4Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Gastrointestinal Lariam PS Roche ORAL FREQUENCY
Initial or Prolonged Bacterial Infection REPORTED:
Road Traffic Accident
1X/WEEK.
Anxiety Lariam SS Roche ORAL
Lariam SS Roche ORAL
Date:01/30/09ISR Number: 6059290-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-609832 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Renal Failure Acute Lariam PS Roche ORAL DRUG
Initial or Prolonged Syncope WITHDRAWN
Rhabdomyolysis
Date:02/02/09ISR Number: 6061512-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-611253 Age:74 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Alanine Aminotransferase Lariam PS Roche ORAL
Initial or Prolonged Increased
Gamma-Glutamyltransferase
Increased
Abdominal Pain Upper

Drug Prescribing Error
Nausea
Medication Error
Bradycardia
Vertigo
03-Apr-2012 09:37 AM Page: 811

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/02/09ISR Number: 6065717-4Report Type:Expedited (15-DaCompany Report #A03200803370 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Burkholderia Cepacia Literature Chloroquine -
Hospitalization - Complex Infection Health Unknown - Unit Dose
Initial or Prolonged Lung Infiltration Professional : Unknown PS
Blood Culture Positive
Mefloquine - Unknown
Granuloma - Unit Dose :
Pneumonitis Unknown SS
Pyrexia
Aspergillosis
Date:02/09/09ISR Number: 6073845-2Report Type:Direct Company Report #CTU 365767 Age:41 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Panic Attack Mefloquine PS ORAL 1 TABLET PER
Initial or Prolonged Amnesia WEEK PO
Required
Suicidal Ideation
Intervention to
Drug Ineffective
Prevent Permanent
Impairment/Damage
Insomnia
Hypomania
Thinking Abnormal
Anxiety
Disturbance In Attention
Depressed Level Of
Consciousness
Impaired Work Ability
Date:02/13/09ISR Number: 6077926-9Report Type:Expedited (15-DaCompany Report #IE-ROCHE-497032 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amnesia Lariam PS Roche ORAL DRUG REPORTED
AS: LARIAM
250 MG
TABLETS
Date:02/17/09ISR Number: 6080007-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-613148 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pre-Eclampsia Lariam PS Roche ORAL
Initial or Prolonged Maternal Exposure During Typhim Vi SS UNKNOWN
Pregnancy Stamaril Unidose SS UNKNOWN DRUG: STAMRIL
Caesarean Section Havrix SS INTRAMUSCULAR
Date:02/25/09ISR Number: 6097639-7Report Type:Direct Company Report #CTU 367568 Age: Gender:Female I/FU:I

Outcome
Other Serious
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Fear
Paraesthesia
Palpitations
Hypoaesthesia
Tremor
Panic Attack
03-Apr-2012 09:37 AM Page: 812

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Insomnia
Report Source Product Role Manufacturer Route Dose Duration
Lariam/Mefloquine PS ORAL 1 WEEKLY PO 3 WK
Date:03/02/09ISR Number: 6098995-6Report Type:Expedited (15-DaCompany Report #DE-ROCHE-581040 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tachycardia Lariam PS Roche ORAL
General Physical Health
Deterioration
Amnesia
Urticaria
Date:03/03/09ISR Number: 6102926-XReport Type:Direct Company Report #CTU 367987 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Mefloquine PS ORAL 250 MG WEEKLY
Oesophageal Ulcer
PO
Date:03/13/09ISR Number: 6115524-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-619054 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Memory Impairment Lariam PS Roche ORAL
Speech Disorder
Confusional State
Cognitive Disorder
Unresponsive To Stimuli
Date:03/16/09ISR Number: 6119261-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-621179 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aggression Lariam PS Roche UNKNOWN FORM: PILL
Disorientation
Mefloquine
Vestibular Disorder Hydrochloride SS Roche UNKNOWN FORM: PILL
Anger
Hallucination
Date:03/16/09ISR Number: 6119262-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-621169 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Self Injurious Behaviour Lariam PS Roche UNKNOWN FORM: PILL

Date:03/17/09ISR Number: 6124514-1Report Type:Direct Company Report #CTU 369854 Age:64 YR Gender:Female I/FU:I
Outcome
PT
Dizziness
Insomnia
Nausea
03-Apr-2012 09:37 AM Page: 813

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Medication Error
Disorientation
Abnormal Dreams Report Source Product Role Manufacturer Route Dose Duration
Sinusitis
Mefloquine Hcl 250mg
Lethargy Sandoz PS Sandoz ORAL ONE TABLET
Wrong Drug Administered
DAILY PO
Date:03/18/09ISR Number: 6123298-0Report Type:Expedited (15-DaCompany Report #SK-ROCHE-619440 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Disseminated Mefloquine
Intravascular Coagulation Hydrochloride PS Roche INTRAVENOUS
Thrombocytopenia Klimicin SS INTRAVENOUS
Date:03/19/09ISR Number: 6124240-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-620677 Age:38 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lariam PS Roche UNKNOWN
Memory Impairment
Brain Injury
Fear
Convulsion
Date:03/19/09ISR Number: 6124241-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-620680 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Weight Decreased Lariam PS Roche UNKNOWN
Malaise
Tremor
Date:03/27/09ISR Number: 6134700-2Report Type:Expedited (15-DaCompany Report #FR-ROCHE-622237 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Pressure Increased Lariam PS Roche UNKNOWN
Initial or Prolonged Gastritis
Other Serious
Vestibular Neuronitis
Dehydration
Date:03/31/09ISR Number: 6142028-XReport Type:Direct Company Report #CTU 371475 Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Lariam 250mg Sandoz PS Sandoz ORAL 11 WEEKLY PO
Insomnia Lariam C

Anxiety
Activities Of Daily
Living Impaired
Drug Dependence
Palpitations
Asthenia
03-Apr-2012 09:37 AM Page: 814

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/07/09ISR Number: 6145878-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-457571 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dyspepsia Lariam PS Roche UNKNOWN DOSAGE
Initial or Prolonged Paraesthesia REGIMEN
Other Serious Feeling Abnormal REPORTED AS
Sleep Disorder
FOUR TABS IN
Asthenia
TOTAL. WEEKLY
Vertigo
Mental Disorder
Formication
Abnormal Dreams
Fatigue
Oedema Peripheral
Anxiety
Headache
Cardiovascular Disorder
Unevaluable Event
Depression
Pyrexia
Muscle Twitching
Malaise
Upper Respiratory Tract
Infection
Coordination Abnormal
Night Sweats
Agitation
Tachycardia
Tinnitus
Disturbance In Attention
Date:04/10/09ISR Number: 6155267-9Report Type:Direct Company Report #CTU 373056 Age:54 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Skin Burning Sensation Lariam/Mefloquine
Intervention to Diarrhoea 250 Mg Roche PS Roche ORAL 250 MG ONCE A
Prevent Permanent Tinnitus WEEK PO
Impairment/Damage Pyrexia
Tremor
Dizziness
Anxiety
Date:04/14/09ISR Number: 6154073-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-622237 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Blood Pressure Increased Lariam PS Roche ORAL
Initial or Prolonged Gastritis
Other Serious
Vestibular Neuronitis
Dehydration

Date:04/14/09ISR Number: 6157667-XReport Type:Direct Company Report #CTU 373296 Age:55 YR Gender:Male I/FU:I
Outcome
Life-Threatening
Other Serious
03-Apr-2012 09:37 AM Page: 815

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Required
Intervention to
Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration
Impairment/Damage Tinnitus Mefloquine (Lariam) PS Roche Laboratories ORAL 250 MG WEEKLY
Judgement Impaired
PO
Toxicity To Various
Agents
Confusional State
Disorientation
Brain Injury
Stress
Fatigue
Asthenia
Anhedonia
Burning Sensation
Anxiety
Hair Colour Changes
Sexual Dysfunction
Paraesthesia
Dizziness
Balance Disorder
Muscle Twitching
Muscle Contractions
Involuntary
Insomnia
Neuralgia
Sleep Apnoea Syndrome
Nervous System Disorder
Myalgia
Mental Disorder
Emotional Disorder
Date:04/16/09ISR Number: 6156743-5Report Type:Expedited (15-DaCompany Report #US-ROCHE-625513 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Expired Drug Administered Lariam PS Roche UNKNOWN
Initial or Prolonged Malaria
Date:04/24/09ISR Number: 6166557-8Report Type:Expedited (15-DaCompany Report #FI-ROCHE-627019 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Loss Of Consciousness Lariam PS Roche ORAL
Initial or Prolonged Convulsion Primaspan C ORAL
Simvastatin C ORAL
Cozaar Comp C ORAL STRENGTH
REPORTED AS
100MG/25MG.
DRUG
REPORTED:

Date:04/28/09ISR Number: 6171274-4Report Type:Direct Company Report #CTU 374910 Age: Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
03-Apr-2012 09:37 AM Page: 816

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Required
Intervention to
Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration
Impairment/Damage Abnormal Dreams Lariam 250 Mg Roche PS Roche ORAL 250 MG WEEKLY
Depression
PO, 3-4 DOSES
Insomnia Risperdal C
Hypophagia Claritin C
Weight Decreased Periactin C
Psychomotor Retardation Wellbutrin C
Dyspnoea Ambien C
Panic Attack Klonopin C
Date:05/07/09ISR Number: 6182450-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-620677 Age:38 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Brain Injury Lariam PS Roche UNKNOWN
Anxiety
Fear
Convulsion
Memory Impairment
Date:05/12/09ISR Number: 6189598-3Report Type:Direct Company Report #CTU 376748 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Crying Mefloquine 250 Mg PS ORAL 250 MG WEEKY
Nightmare
PO
Insomnia
Hypervigilance
Agitation
Dyspnoea
Paranoia
Unevaluable Event
Anxiety
Date:05/18/09ISR Number: 6193521-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-631390 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Nightmare Lariam PS Roche ORAL
Initial or Prolonged Insomnia Imovane C
Mania Xanax C
Weight Decreased Laroxyl C
Rivotril
C
Rohypnol
C
Tercian
C
Stilnox
C
Lysanxia
C

Date:06/02/09ISR Number: 6211453-0Report Type:Expedited (15-DaCompany Report #CH-ROCHE-635186 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Optic Atrophy Lariam PS Roche ORAL
03-Apr-2012 09:37 AM Page: 817

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/03/09ISR Number: 6219428-2Report Type:Periodic Company Report #563556 Age:63 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Literature Mefloquine
Initial or Prolonged Mania Health Hydrochloride
Professional
(Mefloquine
Other Hydrochloride) PS
Lunesta
(Eszopiclone)
C
Eskalith Cr (Lithium
Nos)
C
Date:06/03/09ISR Number: 6219439-7Report Type:Periodic Company Report #591140 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Completed Suicide Other Lariam (Mefloquine
Psychogenic Pain Disorder Hydrochloride) PS
Abdominal Pain Upper
Date:06/03/09ISR Number: 6219441-5Report Type:Periodic Company Report #610871 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mania Health Lariam (Mefloquine
Initial or Prolonged Professional Hydrochloride) PS
Other
Date:06/05/09ISR Number: 6219220-9Report Type:Direct Company Report #CTU 379716 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Grand Mal Convulsion Mefloquine 250 Mg
Unk PS ORAL 250 MG ONCE
PO
Date:06/12/09ISR Number: 6226710-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-636293 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Methaemoglobinaemia Mefloquine
Dyspnoea Hydrochloride PS Roche UNKNOWN
Cyanosis Primaquine SS UNKNOWN
Hypoxia
Date:06/15/09ISR Number: 6233305-2Report Type:Direct Company Report #CTU 380628 Age:20 YR Gender:Male I/FU:I

Outcome
Hospitalization -
Initial or Prolonged
Disability
Other Serious
PT
Anxiety
Mood Altered
Aggression
Alcohol Use
Panic Attack
Sinus Arrhythmia
Memory Impairment
03-Apr-2012 09:37 AM Page: 818

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nightmare
Supraventricular
Extrasystoles Report Source Product Role Manufacturer Route Dose Duration
Depression
Mefloquine
Tinnitus Hydrochloride PS 023/047
Psychotic Behaviour Larium SS
Paranoia Prolixin C
Agitation Paxil C
Ear Pain Navane C
Date:06/23/09ISR Number: 6241720-6Report Type:Expedited (15-DaCompany Report #JP-ROCHE-493929 Age:54 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Urinary Tract Infection Mefloquine
Initial or Prolonged Haemolytic Anaemia Hydrochloride PS Roche ORAL
Other Serious Nervous System Disorder Artesunate C INTRAVENOUS
Date:06/23/09ISR Number: 6241739-5Report Type:Expedited (15-DaCompany Report #ES-ROCHE-502414 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatitis Toxic Mefloquine
Erythema Hydrochloride PS Roche UNKNOWN
Skin Exfoliation Hepatitis B Vaccine C
Date:06/30/09ISR Number: 6250672-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-619054 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Cognitive Disorder Lariam PS Roche ORAL
Initial or Prolonged Dizziness
Other Serious
Fatigue
Aphasia
Dissociation
Upper Respiratory Tract
Infection
Delusion
Headache
Hyperhidrosis
Unresponsive To Stimuli
Skin Disorder
Sleep Disorder
Date:07/22/09ISR Number: 6276324-2Report Type:Expedited (15-DaCompany Report #FI-ROCHE-643178 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abdominal Pain Lariam PS Roche ORAL

Throat Irritation
Product Quality Issue
Fatigue
Decreased Appetite
03-Apr-2012 09:37 AM Page: 819

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/06/09ISR Number: 6301233-XReport Type:Direct Company Report #CTU 387916 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abdominal Pain Upper Mefloquine PS Sandoz 250 MG 1 X
Nausea
DAY
Flatulence
Date:09/03/09ISR Number: 6339884-9Report Type:Expedited (15-DaCompany Report #FI-ROCHE-643178 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abdominal Pain Lariam PS Roche ORAL
Fatigue
Throat Irritation
Decreased Appetite
Product Quality Issue
Date:09/04/09ISR Number: 6341111-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-654282 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Constipation Lariam PS Roche UNKNOWN
Initial or Prolonged
Date:09/11/09ISR Number: 6356543-7Report Type:Direct Company Report #CTU 391604 Age:49 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Headache Mefloquine PS ORAL 1 WHITE PILL
Intervention to Affective Disorder 50 PULSE PO
Prevent Permanent Insomnia YES
Impairment/Damage Post-Traumatic Stress Lariam SS YES
Disorder
Dizziness
Arthralgia
Tinnitus
Photosensitivity Reaction
Date:09/18/09ISR Number: 6361469-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-653396 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Sopor Lariam PS Roche ORAL
Initial or Prolonged
Date:10/02/09ISR Number: 6386657-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-654282 Age:22 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Rash Lariam PS Roche UNKNOWN
Initial or Prolonged Constipation
03-Apr-2012 09:37 AM Page: 820

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/05/09ISR Number: 6387922-XReport Type:Expedited (15-DaCompany Report #DK-ROCHE-658792 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Amenorrhoea Lariam PS Roche ORAL THE FIRST
Acne
PERIOD OF
TREATMENT WAS
TWO YEARS
AGO.
Lariam SS Roche ORAL FREQUENCY:
QWK (PER
WEEK).
Date:10/13/09ISR Number: 6401872-1Report Type:Direct Company Report #CTU 394752 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Insomnia Mefloquine PS ORAL 1 PILL 1 TIME
Heart Rate Increased
PER WEEK PO
Activities Of Daily
Living Impaired
Mental Disorder
Fear
Panic Attack
Anxiety
Hypersomnia
Date:10/15/09ISR Number: 6402365-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-448387 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Suicidal Ideation Lariam PS Roche UNKNOWN
Post Concussion Syndrome Cymbalta C
Date:10/26/09ISR Number: 6413276-6Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Gastrointestinal Lariam PS Roche ORAL FREQUENCY
Initial or Prolonged Bacterial Infection REPORTED:
Other Serious Road Traffic Accident 1X/WEEK.
Toxicity To Various Lariam SS Roche ORAL
Agents Lariam SS Roche ORAL
Thermal Burn
Delirium
Psychotic Disorder
Panic Attack
Contusion
Anxiety
Dehydration
Fear

Date:10/28/09ISR Number: 6417569-8Report Type:Expedited (15-DaCompany Report #FR-ROCHE-662936 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pancreatitis Lariam PS Roche ORAL
Initial or Prolonged
03-Apr-2012 09:37 AM Page: 821

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/16/09ISR Number: 6441094-1Report Type:Expedited (15-DaCompany Report #KR-ROCHE-667927 Age:57 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Plasmodium Falciparum Mefloquine
Infection Hydrochloride PS Roche UNKNOWN
Date:11/27/09ISR Number: 6458750-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-669990 Age:16 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Narcolepsy Lariam PS Roche UNKNOWN
Somnolence Vaccines Nos C
Date:12/01/09ISR Number: 6464251-7Report Type:Periodic Company Report #US-ROXANE LABORATORIES, INC.-2009-RO-01199RO Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Nausea Mefloquine PS Roxane Laboratories,
Anxiety
Inc.
Depression
Date:12/03/09ISR Number: 6468605-4Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Lariam PS Roche ORAL FREQUENCY
Initial or Prolonged Gastrointestinal REPORTED:
Other Serious Bacterial Infection 1X/WEEK.
Road Traffic Accident Lariam SS Roche ORAL
Psychotic Disorder Lariam SS Roche ORAL
Date:12/04/09ISR Number: 6476837-4Report Type:Direct Company Report #CTU 400853 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Epistaxis Foreign Mefloquine Mephaquin
8 Lactab Mepha PS Mepha ORAL 250 MG ONCE A
WEEK PO
Lantus Insulin C
Date:12/17/09ISR Number: 6503113-3Report Type:Expedited (15-DaCompany Report #CH-ROCHE-673621 Age:64 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Immune Reconstitution Lariam PS Roche ORAL
Initial or Prolonged Syndrome Kaletra SS ORAL
Confusional State Remeron SS ORAL
Hallucination Truvada SS ORAL

Keppra C ORAL
Benerva C ORAL
Bactrim C ORAL
03-Apr-2012 09:37 AM Page: 822

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/17/09ISR Number: 6504148-7Report Type:Expedited (15-DaCompany Report #IN-ROXANE LABORATORIES, INC.-2009-RO-01259RO Age:11 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Mefloquine PS Roxane Laboratories,
Initial or Prolonged Mania Inc. ORAL
Artesunate SS PARENTERAL
Artesunate SS PARENTERAL
Artesunate SS PARENTERAL
Primaquine
SS
Risperidone
C
Risperidone
C
Date:12/18/09ISR Number: 6506374-XReport Type:Expedited (15-DaCompany Report #CH-ABBOTT-09P-151-0613387-00 Age:64 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Kaletra Tablets
Initial or Prolonged Aggression 200mg/50mg PS ORAL 2 doses of
Other Serious Cognitive Disorder 200mg/50mg
Frontotemporal Dementia
daily
Abnormal Behaviour Mefloquine SS ORAL
Incoherent Truvada SS ORAL 245mg/200mg
Apraxia
daily
Persecutory Delusion Mefloquine SS 250mg weekly
Nervous System Disorder Mirtazapine SS ORAL
Grand Mal Convulsion Levetiracetam C ORAL
Confusional State Thiamine Hcl C ORAL
Disturbance In Attention
Sulfamethoxazole And
Immune Reconstitution Trimethoprim C ORAL 1 dose 3
Syndrome
times per
Progressive Multifocal
week
Leukoencephalopathy
Visual Impairment
Date:12/21/09ISR Number: 6509110-6Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-09P-151-0613387-00 Age:64 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Kaletra Tablets
Initial or Prolonged Cognitive Disorder 200mg/50mg PS ORAL 2 doses of
Other Serious Mental Impairment 200mg/50mg
Nervous System Disorder
daily
Neurologic Neglect Mefloquine SS ORAL
Syndrome Truvada SS ORAL 245mg/200mg
Progressive Multifocal
daily
Leukoencephalopathy Mefloquine SS 250mg weekly
Aggression Mirtazapine SS ORAL
Persecutory Delusion Levetiracetam C ORAL
Immune Reconstitution Thiamine Hcl C ORAL
Syndrome
Sulfamethoxazole And
Incoherent Trimethoprim C ORAL 1 dose 3

Apraxia times per
Disturbance In Attention
week
Confusional State
Mental Disorder
Abnormal Behaviour
Grand Mal Convulsion
03-Apr-2012 09:37 AM Page: 823

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/22/09ISR Number: 6522734-5Report Type:Expedited (15-DaCompany Report #2009SP040553 Age:64 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Grand Mal Convulsion Foreign Remeron
Initial or Prolonged Visual Impairment Health (Mirtazapine)
Other Serious Thinking Abnormal Professional (Mirtazapine) PS ORAL 30 MG;QD;PO
Electroencephalogram
Truvada (Truvada
Abnormal 01778501/) SS ORAL 1 DF;QD;PO
Incoherent
Kaletra (Kaletra
Hallucination 015066501/) SS ORAL 2 DF; BID; PO
Attention
Lariam (Mefloquine)
Deficit/Hyperactivity (Mefloquine) SS ORAL 250 MG;QD;PO;
Disorder
250 MG;QW;PO
Nervous System Disorder Keppra (Con.) C
Progressive Multifocal Benerva (Con.) C
Leukoencephalopathy Bactrim /00086101/
Abnormal Behaviour (Con.) C
Confusional State
Persecutory Delusion
Psychomotor Hyperactivity
Jc Virus Test Positive
Hallucination, Visual
Aggression
Apraxia
Immune Reconstitution
Syndrome
Date:12/23/09ISR Number: 6518124-1Report Type:Direct Company Report #CTU 402582 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Lariam Unknown PS ORAL 1/WEEK PO
Sleep Disorder
Suicidal Ideation
Date:12/30/09ISR Number: 6521464-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-676934 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pancreatitis Lariam PS Roche UNKNOWN TAKEN FOR 4
Erectile Dysfunction
WEEKS
Date:12/31/09ISR Number: 6524131-5Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-09P-151-0613387-00 Age:64 YR Gender:Male I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
Other Serious
PT
Cognitive Disorder
Nervous System Disorder
Abnormal Behaviour
Incoherent

Persecutory Delusion
Confusional State
Mental Impairment
Immune Reconstitution
Syndrome
Grand Mal Convulsion
Progressive Multifocal
Leukoencephalopathy
03-Apr-2012 09:37 AM Page: 824

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hallucination
Aggression
Neurologic Neglect Report Source Product Role Manufacturer Route Dose Duration
Syndrome
Kaletra Tablets
Apraxia 200mg/50mg PS ORAL 2 doses of
Mental Disorder
200mg/50mg
Disturbance In Attention
daily
Mefloquine SS ORAL
Truvada SS ORAL 245mg/200mg
daily
Mefloquine SS 250mg weekly
Mirtazapine SS ORAL
Levetiracetam C ORAL
Thiamine Hcl C ORAL
Sulfamethoxazole And
Trimethoprim C ORAL 1 dose 3
times per
week
Date:01/12/10ISR Number: 6537985-3Report Type:Direct Company Report #CTU 404434 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Mefloquine PS Sandoz ORAL 250 MG 1/WEEK
Emotional Disorder
PO
Psychomotor Hyperactivity
Anxiety
Fear
Feeling Of Despair
Insomnia
Thinking Abnormal
Date:01/13/10ISR Number: 6535336-1Report Type:Expedited (15-DaCompany Report #NZ-ROCHE-678722 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mucosal Ulceration Lariam PS Roche ORAL FREQUENCY
Initial or Prolonged Asthenia REPORTED AS
Agitation
ONCE.
Confusional State
Nausea
Date:01/19/10ISR Number: 6541581-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-679518 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Psychotic Disorder Lariam PS Roche UNKNOWN

Date:01/25/10ISR Number: 6549089-4Report Type:Expedited (15-DaCompany Report #NG-ROCHE-679647 Age:6 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Intravascular Haemolysis Mefloquine
Initial or Prolonged Hydrochloride PS Roche ORAL
Artesunate SS ORAL
03-Apr-2012 09:37 AM Page: 825

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/02/10ISR Number: 6567143-8Report Type:Expedited (15-DaCompany Report #CH-SANOFI-AVENTIS-2010SA005048 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Sudden Death Lantus PS SUBCUTANEOUS
Mephaquin SS ORAL
Humalog SS SUBCUTANEOUS
Date:02/03/10ISR Number: 6569558-0Report Type:Direct Company Report #CTU 407019 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Nervous System Disorder Lariam (Mefloquine)
Other Serious Suicidal Ideation Roche + Us Army PS Roche ORAL ONE PILL ONCE
Affective Disorder
ORAL
Insomnia
Mental Disorder
Major Depression
Anxiety Disorder
Fatigue
Date:02/17/10ISR Number: 6585163-4Report Type:Expedited (15-DaCompany Report #NL-ROCHE-685113 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mental Disorder Lariam PS Roche ORAL
Anxiety Lariam SS Roche ORAL
Date:02/18/10ISR Number: 6588357-7Report Type:Expedited (15-DaCompany Report #PT-ROCHE-684767 Age:57 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Interaction Mefloquine
Initial or Prolonged Atrioventricular Block Hydrochloride PS Roche ORAL
Bisoprolol I UNKNOWN
Date:02/19/10ISR Number: 6590405-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-679518 Age:20 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Lariam PS Roche ORAL REPORTED AS
Initial or Prolonged
LARIAM TABL.
DOSE REPORTED
AS 250 MGW
Date:03/02/10ISR Number: 6610332-4Report Type:Expedited (15-DaCompany Report #GXKR2010DE02231 Age:74 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Pancytopenia Mirtazapine (Ngx) PS ORAL UNK 70 DAY
Initial or Prolonged
Lariam
/Aut/ SS ORAL 250 mg, QD 65 DAY
Acetylsalicylic Acid
(Ngx) SS ORAL 100 mg, QD
Karvea
C
Actrapid Human C
03-Apr-2012 09:37 AM Page: 826

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Calcilac Kt
C
Digitoxin
C
Prednisolon
C
Spironolactone C
Iscover I ORAL 75 mg, QD
Torem I ORAL 10 mg, QD
Pantozol I ORAL 40 mg, BID
Date:03/02/10ISR Number: 6612109-2Report Type:Direct Company Report #CTU 410025 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Psychotic Disorder Lariam -Mefloquine-
Intervention to Insomnia Hoffman-Laroche PS Hoffman-Laroche ORAL WEEKLY PO
Prevent Permanent
Impairment/Damage
Date:03/03/10ISR Number: 6611774-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-676934 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Erectile Dysfunction Lariam PS Roche UNKNOWN TAKEN FOR 4
Pancreatitis
WEEKS
Date:03/03/10ISR Number: 6611852-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-687965 Age:74 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pancytopenia Lariam PS Roche ORAL
Initial or Prolonged Calcilac Kt C ORAL FORM:
CHEWABLE
TABLET
Karvea C ORAL FORM:FILM
COATED TABLET
Digitoxin C ORAL
Prednisolon C ORAL
Spironolactone C ORAL
Actrapid C SUBCUTANEOUS FORM:INJECTIO
N
Acetylsalicylic Acid I
ORAL
Pantozol I ORAL FORM:
GASTRO-RESIST
ANT TABLET
Mirtazapin I ORAL
Torem I Roche ORAL
Iscover I ORAL FORM:FILM
COATED TABLET

Date:03/05/10ISR Number: 6616241-9Report Type:Expedited (15-DaCompany Report #GXKR2010PT02277 Age:57 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Bisoprolol (Ngx) PS Novartis Sector:
Initial or Prolonged Drug Interaction Generics UNKNOWN 5 mg/day
Atrioventricular Block Mefloquine (Ngx) I ORAL 250 mg, QW
Bradycardia
Presyncope
03-Apr-2012 09:37 AM Page: 827

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/08/10ISR Number: 6627028-5Report Type:Expedited (15-DaCompany Report #2010SP012262 Age:74 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pancytopenia Foreign Mirtazapine
Initial or Prolonged Rhonchi Health (Mirtazapine
Pyrexia Professional /01293201/) PS ORAL 15 MG;BID;PO
Endocarditis Other Pantozol
C-Reactive Protein
(Pantoprazole
Increased Sodium) SS ORAL 40 MG;BID;PO
Drug Interaction
Acetylsalicylic Acid
(Acetylsalicylic
Acid / 00002701/) SS ORAL 100 MG;QD;PO
Torem
(Torasemide) SS ORAL 10 MG;QD;PO
Lariam
(Mefloquine) SS ORAL 250 MG;QW;PO
Iscover
(Clopidogrel
Sulfate) SS ORAL 75 MG;QD;PO
Prednisolon
C
Digitoxin
C
Calcilac Kt
C
Spironolactone C
Karvea
C
Actrapid
C
Date:03/09/10ISR Number: 6621540-0Report Type:Expedited (15-DaCompany Report #DE-WYE-H13829710 Age:74 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Interaction Iscover PS Bristol-Myers Squibb ORAL
Initial or Prolonged Pancytopenia Acetylsalicylic Acid SS Unknown ORAL
Torem SS Boehringer Mannheim
Gmbh
ORAL
Calcilac C Jenapharm Gmbh ORAL
Actrapid Human C Novo Industri A/S SUBCUTANEOUS df-4/12/8
Karvea C Bristol-Myers Squibb ORAL
Spironolactone C Unknown ORAL
Prednisolone C Unknown ORAL
Digitoxin C Unknown ORAL
Pantozol I Wyeth
Pharmaceuticals Inc.
Mirtazapine I Unknown ORAL 70 DAY
Pantozol I Wyeth
Pharmaceuticals Inc. ORAL
Lariam I Hoffman-La Roche,
Inc. ORAL 65 DAY
Date:03/10/10ISR Number: 6624728-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-689118 Age:48 YR Gender:Female I/FU:I

Outcome
Life-Threatening
Hospitalization -
Initial or Prolonged
PT
Supraventricular
Tachycardia
Sleep Disorder
Impaired Driving Ability
Bradycardia
Nausea
03-Apr-2012 09:37 AM Page: 828

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorientation
Palpitations
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL ACTION TAKEN:
WITHDRAWN.
Date:03/11/10ISR Number: 6631204-5Report Type:Expedited (15-DaCompany Report #DE-MYLANLABS-2010S1003362 Age:74 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pancytopenia Mirtazapin PS ORAL Dosis je
Initial or Prolonged Drug Interaction Applikation:
15/30 mg
Karvea C ORAL
Spironolactone C ORAL
Calcilac Kt C ORAL 1 Df= 500mg
Calcium
Carbonate +
400IU
Colecalcifero
Digitoxin C ORAL
Actrapid C SUBCUTANEOUS Dosis je
Applikation:
4/12/8 IU
Prednisolon C ORAL
Torem /01036501/ I ORAL
Acetylsalicylic Acid I
ORAL
Pantozol I ORAL
Lariam I ORAL
Iscover I ORAL
Date:03/11/10ISR Number: 6631205-7Report Type:Expedited (15-DaCompany Report #DE-MYLANLABS-2010S1003362 Age:74 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Drug Interaction Mirtazapin PS Alphapharm ORAL Dosis je
Initial or Prolonged Pancytopenia Applikation:
15/30 mg
Karvea C ORAL
Spironolactone C ORAL
Calcilac Kt C ORAL 1 Df= 500mg
Calcium
Carbonate +
400IU
Colecalcifero
Digitoxin C ORAL
Actrapid C SUBCUTANEOUS Dosis je
Applikation:
4/12/8 IU
Prednisolon C ORAL
Torem /01036501/ I ORAL

Acetylsalicylic Acid I ORAL
Pantozol I ORAL
Lariam I ORAL
Iscover I ORAL
03-Apr-2012 09:37 AM Page: 829

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/15/10ISR Number: 6640138-1Report Type:Expedited (15-DaCompany Report #AUR-APL-2010-00611 Age:74 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Foreign Mirtazapine
Initial or Prolonged Pancytopenia Health Film-Coated Tablet PS ORAL 15/30MG, BID,
Endocarditis Professional ORAL
Other Pantoprazole SS ORAL 40MG-ORAL
Acetylsalicylic Acid SS ORAL 100MG-ORAL
Torsemide (Torem) SS ORAL 10MG-ORAL
Mefloquine (Lariam)
Tablet SS ORAL 250MG,
WEEKLY, ORAL
Clopidogrel Sulfate
(Iscover) SS ORAL 75MG-ORAL
Prednisolone
C
Digitoxin
C
Calcium Carbonate C
Spironolactone C
Karvea (Irbesartan) C
Actrapid (Insulin
Human)
C
Date:03/17/10ISR Number: 6638812-6Report Type:Expedited (15-DaCompany Report #PT-MYLANLABS-2010S1003533 Age:57 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Atrioventricular Block Bisoprolol PS UNKNOWN
Initial or Prolonged Second Degree Bisoprolol I UNKNOWN
Other Serious Drug Interaction Mefloquine I ORAL
Bisoprolol I UNKNOWN
Date:03/19/10ISR Number: 6642420-0Report Type:Expedited (15-DaCompany Report #US-ROCHE-72710 Age:82 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Deafness Lariam PS Roche ORAL TOTAL DOSE OF
Other Serious Dizziness 15250 MG 61 DAY
Overdose Cardizem C
Abasia Propoxyphene C
Respiratory Disorder Desyrel C
Ataxia Ultram C
Speech Disorder Depakote C ORAL
Bundle Branch Block Apresoline C
Medication Error
Asthenia
Agitation
Confusional State
Alanine Aminotransferase
Increased

Date:03/23/10ISR Number: 6646722-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-676934 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Overdose Lariam PS Roche ORAL
Erectile Dysfunction
Pancreatitis
03-Apr-2012 09:37 AM Page: 830

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/24/10ISR Number: 6648322-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-691204 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mental Disorder Lariam PS Roche UNKNOWN INDICATION
Initial or Prolonged Face Injury REPORTED AS
Ill-Defined Disorder
ANTI MALARIA
Limb Injury
Abdominal Distension
Renal Disorder
Proteinuria
Date:03/26/10ISR Number: 6656270-2Report Type:Direct Company Report #CTU 413026 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Aphasia Mefloquine Larium PS ORAL 1 PILL ONCE A
Hospitalization - Educational Problem WEEK PO
Initial or Prolonged
Other Serious
Palpitations
Confusional State
Arrhythmia
Metamorphopsia
Insomnia
Disorientation
Lung Disorder
Thinking Abnormal
Impaired Work Ability
Amnesia
Paranoia
Suicidal Ideation
Dizziness
Paraesthesia
Hypersomnia
Abnormal Dreams
Tremor
Hallucination
Convulsion
Malaise
Dyspnoea
Fatigue
Abasia
Date:03/26/10ISR Number: 6656273-8Report Type:Direct Company Report #CTU 413007 Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dyspnoea Mefloquine Hcl 250mg
Hallucination Roxane PS Roxane ORAL 1-250 TABLET
Confusional State WEEKLY PO, 1
Decreased Appetite
TABLET PER
Personality Change
WEEK
Crying

Abnormal Behaviour
Paranoia
Heart Rate Irregular
Speech Disorder
03-Apr-2012 09:37 AM Page: 831

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/30/10ISR Number: 6657893-7Report Type:Expedited (15-DaCompany Report #IT-ROCHE-692416 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anaemia Lariam PS Roche ORAL
Initial or Prolonged Malaria
Date:03/31/10ISR Number: 6667768-5Report Type:Expedited (15-DaCompany Report #AUR-APL-2010-00715 Age:57 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Atrioventricular Block Foreign Bisoprolol PS 5 MG, DAILY,
Initial or Prolonged First Degree Literature UNK
Other Serious Fatigue Health Mefloquine SS ORAL 250 MG,
Presyncope Professional WEEKLY, ORAL
Sinus Bradycardia
Drug Interaction
Date:04/08/10ISR Number: 6673219-7Report Type:Periodic Company Report #US-ROXANE LABORATORIES, INC.-2010-RO-00351RO Age:19 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hallucination Mefloquine PS Roxane Laboratories,
Paranoia Inc. ORAL
Dyspnoea Multivitamin C
Depression Nasocort C
Tinnitus Vyvanse C
Speech Disorder Fexofenadine C
Anxiety
Nightmare
Cognitive Disorder
Abdominal Pain Upper
Fatigue
Decreased Appetite
Memory Impairment
Personality Change
Date:04/19/10ISR Number: 6686484-7Report Type:Expedited (15-DaCompany Report #SE-ROCHE-695381 Age:18 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Angioedema Lariam PS Roche ORAL
Dimor
C
Date:04/27/10ISR Number: 6701288-4Report Type:Expedited (15-DaCompany Report #2010040047 Age:74 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pancytopenia Foreign Torem (Torasemide PS ORAL 10 MG (10 MG
Initial or Prolonged Poikilocytosis Health 1 IN 1D),

Haemoglobin Decreased Professional ORAL
Anisocytosis
Mirtazapine
Endocarditis (Mirtazapine) SS ORAL 5 MG (5MG, 1
Pulmonary Congestion
IN 1 D), ORAL
Pantozol
(Pantoprazole) SS 40 MG (40 MG,
1 IN 1 D),
ORAL
03-Apr-2012 09:37 AM Page: 832

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Acetysalicylic Acid
(Acetysalicylic
Acid) SS ORAL 100 MG (100
MG, 1 IN 1
D), ORAL
Lariam (Mefloquine) SS ORAL 35.7143 MG
(250 MG, 1 IN
1 WK), ORAL
Iscover
(Clopidogrel) SS ORAL 75 MG (75 MG,
1 IN 1 D),
ORAL
Prednisolon
(Prednisolone) C
Digitoxin
(Digitoxin)
C
Karvea (Irbesartan) C
Calcilac Kt (Calcium
Carbonate)
C
Spironolactone
(Spironolactone) C
Actrapid (Insulin) C
Date:05/03/10ISR Number: 6707157-8Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2010-RO-00351RO Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Fatigue Mefloquine PS Roxane Laboratories,
Initial or Prolonged Contusion Inc. ORAL
Hallucination Allegra C
Paranoia Nasocort C
Tinnitus Multivitamin C
Abdominal Pain Upper Vyvanse C
Depression Fexofenadine C
Personality Change
Dyspnoea
Cognitive Disorder
Decreased Appetite
Speech Disorder
Nightmare
Anxiety
Memory Impairment
Sleep Disorder
Date:05/11/10ISR Number: 6720485-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-569005 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Rhabdomyolysis Lariam PS Roche ORAL
Initial or Prolonged Xanax C

Date:05/12/10ISR Number: 6722843-1Report Type:Direct Company Report #CTU 418008 Age:25 YR Gender:Female I/FU:I
Outcome
PT
Palpitations
Panic Attack
Paranoia
03-Apr-2012 09:37 AM Page: 833

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nightmare
Suicidal Ideation
Dizziness Report Source Product Role Manufacturer Route Dose Duration
Confusional State
Mefloquine 250 Mg
Coordination Abnormal Mepha / Switzerland PS Mepha / Switzerland ORAL 250 MG 1 X
Cold Sweat
WEEK PO
Depression
Disturbance In Attention
Date:05/13/10ISR Number: 6723578-1Report Type:Expedited (15-DaCompany Report #DE-ROCHE-687965 Age:74 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pancytopenia Lariam PS Roche ORAL
Initial or Prolonged Calcilac Kt C ORAL FORM:
CHEWABLE
TABLET
Karvea C ORAL FORM:FILM
COATED TABLET
Digitoxin C ORAL
Prednisolon C ORAL
Spironolactone C ORAL
Actrapid C SUBCUTANEOUS FORM:INJECTIO
N
Acetylsalicylic Acid I
ORAL
Pantozol I ORAL FORM:
GASTRO-RESIST
ANT TABLET
Mirtazapin I ORAL
Torem I Roche ORAL
Iscover I ORAL FORM:FILM
COATED TABLET
Date:05/14/10ISR Number: 6726252-0Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2010-RO-00351RO Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Mefloquine PS Roxane Laboratories,
Initial or Prolonged Insomnia Inc. ORAL
Sleep Disorder Allegra C
Hallucination Nasocort C
Fatigue Multivitamin C
Speech Disorder Vyvanse C
Abnormal Dreams Fexofenadine C
Sinusitis
Contusion
Paranoia
Cognitive Disorder
Tachycardia
Nightmare
Dyspnoea

Abdominal Pain Upper
Tinnitus
Memory Impairment
Disturbance In Attention
Decreased Appetite
Personality Change
Depression
03-Apr-2012 09:37 AM Page: 834

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/10ISR Number: 6750020-7Report Type:Expedited (15-DaCompany Report #GXKR2010DE02231 Age:74 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Leukopenia Prednisolone (Ngx) PS Novartis Sector:
Initial or Prolonged Pyrexia Generics ORAL 5 mg, QD
Mirtazapine (Ngx) SS ORAL UNK 70 DAY
Lariam
/Aut/ SS ORAL 250 mg, QD 69 DAY
Calcilac Kt
C
Digitoxin
C
Spironolactone C
Acetylsalicylic Acid C ORAL 100 mg, QD
Actrapid Human C
Karvea
C
Torem I ORAL 10 mg, QD
Pantozol I ORAL 40 mg, BID
Iscover I ORAL 75 mg, QD
Date:06/03/10ISR Number: 6769667-7Report Type:Expedited (15-DaCompany Report #2010SP012262 Age:74 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Myelodysplastic Syndrome Foreign Mirtazapine
Initial or Prolonged Drug Interaction Health (Mirtazapine
Endocarditis Professional /01293201/) PS ORAL 15 MG; BID;
Leukopenia Other PO
Pyrexia
Pantozol
Rhonchi
(Pantoprazole
Erythema Infectiosum Sodium) SS ORAL 40 MG; BID;
PO
Torem (Torasemide) SS ORAL 10 MG; QD; PO
Iscover (Clopidogrel
Sulfate) (75 Mg) SS ORAL 75 MG; QD; PO
Lariam (Mefloquine) SS ORAL 250 MG; QW;
PO
Prednisolon
(Prednisolone) SS ORAL 5 MG; QD; PO
Acetylsalicylic Acid
(Other Mfr)
(Acetylsalicylic
Acid /00002701/) SS ORAL 100 MG; QD;
PO
Digitoxin
C
Calcilac Kt
C
Spironolactone C
Karvea
C
Actrapid
C
Date:06/10/10ISR Number: 6764578-5Report Type:Expedited (15-DaCompany Report #DE-MYLANLABS-2010S1003362 Age:74 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pyrexia Mirtazapin PS Alphapharm ORAL Dosis je
Initial or Prolonged Leukopenia Applikation:
15/30 mg
Torem /01036501/ SS ORAL
Lariam SS ORAL
Prednisolon SS ORAL
03-Apr-2012 09:37 AM Page: 835

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pantozol SS ORAL
Spironolactone C ORAL
Calcilac Kt C ORAL 1 Df= 500mg
Calcium
Carbonate +
400IU
Colecalcifero
Digitoxin C ORAL
Acetylsalicylic Acid C
ORAL
Karvea C ORAL
Actrapid C SUBCUTANEOUS Dosis je
Applikation:
4/12/8 IU
Iscover I ORAL
Date:06/10/10ISR Number: 6764579-7Report Type:Expedited (15-DaCompany Report #DE-MYLANLABS-2010S1003362 Age:74 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Leukopenia Mirtazapin PS ORAL Dosis je
Initial or Prolonged Pyrexia Applikation:
15/30 mg
Torem /01036501/ SS ORAL
Lariam SS ORAL
Prednisolon SS ORAL
Pantozol SS ORAL
Spironolactone C ORAL
Calcilac Kt C ORAL 1 Df= 500mg
Calcium
Carbonate +
400IU
Colecalcifero
Digitoxin C ORAL
Acetylsalicylic Acid C
ORAL
Karvea C ORAL
Actrapid C SUBCUTANEOUS Dosis je
Applikation:
4/12/8 IU
Iscover I ORAL
Date:06/15/10ISR Number: 6769769-5Report Type:Expedited (15-DaCompany Report #IT-ROCHE-708290 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Plasmodium Falciparum Lariam PS Roche ORAL ROUTE: OS
Initial or Prolonged Infection FREQUENCY:
Anaemia
WEEKLY
Date:06/15/10ISR Number: 6775329-2Report Type:Direct Company Report #CTU 421259 Age:42 YR Gender:Female I/FU:I

Outcome
Life-Threatening
Other Serious
PT
Menstrual Disorder
Multiple Allergies
Condition Aggravated
Fatigue
Depression
Memory Impairment
03-Apr-2012 09:37 AM Page: 836

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Balance Disorder
Mood Swings
Feeling Of Body Report Source Product Role Manufacturer Route Dose Duration
Temperature Change Mefloquine Tab 250
Vertigo Mg Sandoz Inc PS Sandoz TAB 250 MG 1
Headache
TABLET WEEKLY
Pyrexia
Insomnia
Muscle Spasms
Abnormal Dreams
Panic Attack
Dizziness
Disorientation
Disturbance In Attention
Arthralgia
Coordination Abnormal
Cold Sweat
Confusional State
Date:06/16/10ISR Number: 6771209-7Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2010-RO-00351RO Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Sleep Disorder Mefloquine PS Roxane Laboratories,
Initial or Prolonged Memory Impairment Inc. ORAL
Abdominal Pain Upper Allegra C
Depression Nasocort C
Abnormal Dreams Multivitamin C
Cognitive Disorder Vyvanse C
Sinusitis Fexofenadine C
Dyspnoea
Speech Disorder
Hallucination
Nightmare
Anxiety
Decreased Appetite
Personality Change
Fatigue
Paranoia
Insomnia
Tachycardia
Tinnitus
Contusion
Disturbance In Attention
Date:06/16/10ISR Number: 6781696-6Report Type:Expedited (15-DaCompany Report #AUR-APL-2010-00611 Age:74 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anaemia Foreign Mirtazapine
Initial or Prolonged Drug Interaction Health Film-Coated Tablet PS ORAL 15/30 MG,

Pancytopenia Professional BID, ORAL
Pyrexia Other Pantoprazole SS ORAL 40MG - ORAL
Prednisolone SS ORAL 5MG - DAILY -
ORAL
Torem SS ORAL 10 MG - ORAL
Mefloquine (Lariam)
Tablet SS ORAL 250MG,
WEEKLY, ORAL
03-Apr-2012 09:37 AM Page: 837

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Iscover SS ORAL 75MG - ORAL
Acetylsalicylic Acid C
Digitoxin
C
Calcium Carbonate C
Spironolactone C
Karvea (Irbesartan) C
Actrapid (Insulin
Human)
C
Date:07/06/10ISR Number: 6817110-1Report Type:Expedited (15-DaCompany Report #ES-ROCHE-711590 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Tinnitus Lariam PS Roche UNKNOWN
Visual Impairment
Hangover
Nervousness
Hair Disorder
Insomnia
Date:07/19/10ISR Number: 6856560-4Report Type:Expedited (15-DaCompany Report #NO-ROCHE-714994 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dissociation Lariam PS Roche ORAL
Initial or Prolonged Anxiety
Delusion
Psychotic Disorder
Date:07/22/10ISR Number: 6866191-8Report Type:Expedited (15-DaCompany Report #ES-ROXANE LABORATORIES, INC.-2010-RO-00865RO Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mania Mefloquine PS Roxane Laboratories,
Initial or Prolonged
Inc.
Date:08/06/10ISR Number: 6914038-3Report Type:Direct Company Report #CTU 426167 Age:24 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Confusional State Mefloquine PS ORAL 250MG 1/WK
Chest Pain
ORAL
Anxiety Primaquine SS ORAL 15MG 2/DAY
Paraesthesia
ORAL
Palpitations
Hyperhidrosis
Dyspnoea
Dizziness

Date:08/20/10ISR Number: 6937750-9Report Type:Direct Company Report #CTU 427536 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Mefloquine Hcl 250
Abnormal Dreams Mg Barr Laboratories PS Barr Laboratories
03-Apr-2012 09:37 AM Page: 838

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/31/10ISR Number: 6958591-2Report Type:Expedited (15-DaCompany Report #IT-ROCHE-723784 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Convulsion Lariam PS Roche ORAL
Initial or Prolonged Amnesia
Vomiting
Incontinence
Date:09/09/10ISR Number: 6974608-3Report Type:Direct Company Report #CTU 429157 Age:32 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Paranoia Mefloquine (Lariam) PS
Initial or Prolonged Suicidal Ideation
Other Serious
Abnormal Dreams
Delusion
Insomnia
Anxiety
Tachycardia
Date:09/14/10ISR Number: 6980311-6Report Type:Expedited (15-DaCompany Report #IT-ROCHE-723784 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Incontinence Lariam PS Roche ORAL
Initial or Prolonged Amnesia
Convulsion
Vomiting
Date:09/17/10ISR Number: 6992598-4Report Type:Expedited (15-DaCompany Report #CI-ROCHE-726684 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatorenal Failure Mefloquine
Initial or Prolonged Hydrochloride PS Roche ORAL
Date:09/17/10ISR Number: 6992643-6Report Type:Expedited (15-DaCompany Report #CI-ROCHE-727703 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatorenal Failure Mefloquine
Initial or Prolonged Hydrochloride PS Roche ORAL
Date:09/17/10ISR Number: 6992649-7Report Type:Expedited (15-DaCompany Report #CI-ROCHE-727701 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatorenal Failure Mefloquine

Initial or Prolonged Hydrochloride PS Roche ORAL
03-Apr-2012 09:37 AM Page: 839

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/17/10ISR Number: 6992650-3Report Type:Expedited (15-DaCompany Report #CI-ROCHE-727705 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatorenal Failure Mefloquine
Initial or Prolonged Hydrochloride PS Roche ORAL
Date:09/17/10ISR Number: 6992651-5Report Type:Expedited (15-DaCompany Report #CI-ROCHE-727704 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatorenal Failure Mefloquine
Initial or Prolonged Hydrochloride PS Roche ORAL
Date:09/17/10ISR Number: 6992653-9Report Type:Expedited (15-DaCompany Report #CI-ROCHE-727706 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatorenal Failure Mefloquine
Initial or Prolonged Hydrochloride PS Roche ORAL
Date:09/20/10ISR Number: 7001509-7Report Type:Expedited (15-DaCompany Report #CI-ROCHE-727702 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hepatorenal Failure Mefloquine
Initial or Prolonged Hydrochloride PS Roche ORAL
Date:10/07/10ISR Number: 7032717-7Report Type:Expedited (15-DaCompany Report #NL-ROCHE-730731 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Mefloquine
Hydrochloride PS Roche ORAL
Date:10/08/10ISR Number: 7035053-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-730882 Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Postural Orthostatic Mefloquine
Initial or Prolonged Tachycardia Syndrome Hydrochloride PS Roche UNKNOWN
Other Serious
Diarrhoea
Date:10/19/10ISR Number: 7051782-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-732598 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Lariam PS Roche UNKNOWN

Drug Ineffective
03-Apr-2012 09:37 AM Page: 840

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/20/10ISR Number: 7053655-XReport Type:Expedited (15-DaCompany Report #IT-ROCHE-734492 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Interstitial Lung Disease Lariam PS Roche ORAL ROUTE: OS,
Initial or Prolonged Hypereosinophilic FREQUENCY:
Syndrome
TOTAL
Date:10/22/10ISR Number: 7056933-3Report Type:Periodic Company Report #US-ROXANE LABORATORIES, INC.-2010-RO-01393RO Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Histamine Intolerance Mefloquine PS Roxane Laboratories,
Inc.
ORAL
Date:10/25/10ISR Number: 7060713-2Report Type:Expedited (15-DaCompany Report #IT-ROCHE-734492 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Interstitial Lung Disease Lariam PS Roche ORAL ROUTE: OS,
Initial or Prolonged Hypereosinophilic FREQUENCY:
Syndrome
TOTAL
Date:10/27/10ISR Number: 7064702-3Report Type:Expedited (15-DaCompany Report #DE-ROCHE-227783 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Microcephaly Lariam PS Roche TRANSPLACENTAL
Other Serious
Congenital Oesophageal
Anomaly
Developmental Delay
Hypertension
Date:10/27/10ISR Number: 7064703-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-244148 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Klinefelter'S Syndrome Lariam PS Roche ORAL 4 WK
Talipes
Maternal Drugs Affecting
Foetus
Abortion Induced
Date:10/27/10ISR Number: 7064711-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-308888 Age:27 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Encephalocele Mefloquine
Hydrochloride PS Roche ORAL

Date:10/27/10ISR Number: 7064715-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-49139 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Hypoglycaemia Lariam PS Roche ORAL
Other Serious Death Ranitidine C
03-Apr-2012 09:37 AM Page: 841

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Cotrimoxazole
Ketoconazole
Penicillin
C
C
C
Date:10/27/10ISR Number: 7064718-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-57420 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Congenital Hip Deformity Lariam PS Roche TRANSPLACENTAL
Jaundice Neonatal
Imminent Abortion
Date:10/27/10ISR Number: 7064969-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-950400276001 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Ankyloglossia Congenital Lariam PS Roche
Date:10/27/10ISR Number: 7068288-9Report Type:Direct Company Report #CTU 433646 Age:31 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Restlessness Lariam 250mg PS Roche ORAL 1 PILL ONCE
Nightmare
PER WEEK PO
Hallucination
Product Quality Issue
Hyperacusis
Tremor
Abnormal Dreams
Heart Rate Irregular
Date:10/28/10ISR Number: 7069237-XReport Type:Expedited (15-DaCompany Report #GB-ROXANE LABORATORIES, INC.-2010-RO-01414RO Age:44 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diarrhoea Mefloquine PS Roxane Laboratories,
Initial or Prolonged Leukocytosis Inc.
Other Serious
Postural Orthostatic
Tachycardia Syndrome
Blood Urine Present
Nitrite Urine Present
Protein Urine Present
Date:10/29/10ISR Number: 7074206-XReport Type:Expedited (15-DaCompany Report #NL-ROCHE-735888 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Maternal Exposure During Lariam PS Roche ORAL

Pregnancy Lariam SS Roche ORAL
Haemorrhage
Abortion Missed
03-Apr-2012 09:37 AM Page: 842

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/05/10ISR Number: 7090977-0Report Type:Direct Company Report #CTU 434769 Age:40 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Completed Suicide Mefloquine (Lariam) PS Roche ORAL ONE A WEEK PO 8 MON
Initial or Prolonged Product Quality Issue
Required
Intervention to
Prevent Permanent
Impairment/Damage
Date:11/09/10ISR Number: 7091146-0Report Type:Expedited (15-DaCompany Report #GB-ROCHE-730882 Age:44 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Leukocytosis Mefloquine
Initial or Prolonged Postural Orthostatic Hydrochloride PS Roche UNKNOWN
Other Serious
Tachycardia Syndrome
Palpitations
Diarrhoea
Chest Discomfort
Dizziness
Sinus Tachycardia
Lethargy
Respiratory Alkalosis
Hyperhidrosis
Fibrin D Dimer Increased
Date:11/11/10ISR Number: 7107348-0Report Type:Direct Company Report #CTU 435243 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Sleep Terror Mefloquine PS
Initial or Prolonged Convulsion
Date:11/22/10ISR Number: 7116028-7Report Type:Expedited (15-DaCompany Report #DE-ROCHE-732598 Age:26 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Malaria Lariam PS Roche UNKNOWN
Drug Ineffective
Date:12/03/10ISR Number: 7134773-4Report Type:Expedited (15-DaCompany Report #DE-ROCHE-744914 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Initial Insomnia Lariam PS Roche UNKNOWN
Psychotic Disorder
Depressed Mood
Muscle Contractions

Involuntary
Ill-Defined Disorder
03-Apr-2012 09:37 AM Page: 843

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/23/10ISR Number: 7191336-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-748952 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Lariam PS Roche ORAL
Gait Disturbance
Tremor
Dizziness
Peripheral Paralysis
Balance Disorder
Loss Of Consciousness
Muscular Weakness
Drug Dispensing Error
Memory Impairment
Coordination Abnormal
Insomnia
Date:12/27/10ISR Number: 7197996-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-749160 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Delusion Of Grandeur Lariam PS Roche ORAL
Initial or Prolonged Hallucination, Auditory
Hallucinations, Mixed
Date:12/29/10ISR Number: 7201753-XReport Type:Expedited (15-DaCompany Report #IT-ROCHE-750196 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Partial Seizures Lariam PS Roche ORAL FREQUENCY:
Initial or Prolonged Status Epilepticus WEEKLY.
Date:12/29/10ISR Number: 7206059-0Report Type:Direct Company Report #CTU 439781 Age:35 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Mefloquine (Lariam) PS Roche 1 TABLET ONCE
Initial or Prolonged Intentional Self-Injury A WEEK 3 WK
Required
Anxiety
Intervention to
Depression
Prevent Permanent Thermal Burn
Impairment/Damage Paranoia
Date:01/03/11ISR Number: 7207222-5Report Type:Expedited (15-DaCompany Report #IT-ROCHE-750196 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Partial Seizures Lariam PS Roche ORAL FREQUENCY:
Initial or Prolonged Status Epilepticus WEEKLY.

Date:01/13/11ISR Number: 7224924-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-752549 Age:39 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Confusional State
Agitation
Ataxia
03-Apr-2012 09:37 AM Page: 844

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Urinary Incontinence
Amnesia
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS Roche ORAL
Date:01/14/11ISR Number: 7227043-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-102721 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Congenital Hearing Lariam Tablets PS Roche
Disorder Vitamins C
Date:01/14/11ISR Number: 7227050-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-59906 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Dermatitis Atopic Lariam Tablets PS Roche TRANSPLACENTAL
Premature Baby Paludrine C
Duphaston
C
Yellow Fever Vaccine C
Havrix
C
Hepatitis B Vaccine C
Nivaquine
C
Typhim Vi
C
Date:01/14/11ISR Number: 7227158-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-753136 Age:26 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Cholestasis Of Pregnancy Lariam PS Roche ORAL FREQUENCY:
WEEKLY
Paludrine
C
Duphaston C ORAL
Yellow Fever Vaccine C
SUBCUTANEOUS
Havrix C SUBCUTANEOUS
Hepatitis B Vaccine C SUBCUTANEOUS
Nivaquine C ORAL
Typhim Vi
C
Date:01/14/11ISR Number: 7235027-8Report Type:Direct Company Report #CTU 441318 Age:42 MON Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Convulsion Mefloquine PS ORAL 1 ML ONCE A
WEEK PO 8 WK
Date:01/19/11ISR Number: 7241581-2Report Type:Direct Company Report #CTU 441981 Age:54 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Rash Pruritic Mefloquine Hcl 250
Photosensitivity Reaction Mg Tablets PS ORAL 1 TABLET (250
MG) ONCE/WEEK
ORAL (047)
03-Apr-2012 09:37 AM Page: 845

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/31/11ISR Number: 7265091-1Report Type:Expedited (15-DaCompany Report #ZA-SANOFI-AVENTIS-2011SA003745 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pneumonia Ketek PS ORAL
Malaria Mefliam SS UNKNOWN
Malaise Puricos C UNKNOWN
Drug Interaction
Date:02/03/11ISR Number: 7280060-3Report Type:Direct Company Report #CTU 443409 Age:43 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aggression Mefloquine PS Safeway Pharmacy ORAL 250 MG 1 PER
Product Label Issue
WEEK PO
Influenza Like Illness
Date:02/09/11ISR Number: 7292937-3Report Type:Direct Company Report #CTU 443925 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Insomnia Larium PS ORAL 3 LARGE PILLS
Intervention to Panic Attack 3 TIMES A DAY
Prevent Permanent Arthralgia PO 2 WK
Impairment/Damage Myalgia
Self Esteem Decreased
Paranoia
Disturbance In Attention
Thinking Abnormal
Date:02/10/11ISR Number: 7285069-1Report Type:Expedited (15-DaCompany Report #ZA-SANOFI-AVENTIS-2011SA003745 Age:50 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Interaction Ketek PS ORAL
Malaise Puricos C UNKNOWN
Malaria Panafcort C UNKNOWN
Theophen C UNKNOWN
Mefliam I UNKNOWN
Date:02/10/11ISR Number: 7285336-1Report Type:Expedited (15-DaCompany Report #GB-ROCHE-753520 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Weight Decreased Lariam PS Roche UNKNOWN
Initial or Prolonged Depression
Mental Disorder

Date:02/25/11ISR Number: 7327952-4Report Type:Direct Company Report #CTU 445472 Age:61 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Dizziness
Hyperhidrosis
Asthenia
Depression
Nausea
03-Apr-2012 09:37 AM Page: 846

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Paraesthesia
Chest Pain
Flushing Report Source Product Role Manufacturer Route Dose Duration
Bradycardia Mefloquine PS West Ward ORAL 250MG ONCE
Headache
WEEKLY ORAL
12/31, 1/7,
1/14, 1/21
Lisinopril
C
Date:02/25/11ISR Number: 7328807-1Report Type:Direct Company Report #CTU 445536 Age:22 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anxiety Lariam PS Hoffman La Roche ORAL 250MG WEEKLY
Initial or Prolonged Insomnia PO
Other Serious
Hallucination, Auditory
Vomiting
Nausea
Weight Decreased
Depression
Date:03/03/11ISR Number: 7328619-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-218344 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Haemangioma Lariam Tablets PS Roche ORAL
Date:03/04/11ISR Number: 7332509-5Report Type:Expedited (15-DaCompany Report #IE-ROCHE-763058 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nerve Injury Lariam PS Roche UNKNOWN FREQUENCY:
Nerve Root Injury
WEEKLY
Cervical
Speech Disorder
Balance Disorder
Depression
Tremor
Gait Disturbance
Date:03/10/11ISR Number: 7343777-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-107875 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Hypotonia Neonatal Lariam PS Roche
Vision Abnormal Neonatal
Dysmorphism
Mental Retardation
Developmental Delay

Microcephaly
Body Height Above Normal
03-Apr-2012 09:37 AM Page: 847

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/10/11ISR Number: 7344412-5Report Type:Expedited (15-DaCompany Report #DE-ROCHE-940321069001 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Bradycardia Neonatal Lariam PS Roche 3 WK
Neonatal Asphyxia
Hyporeflexia
Hyperbilirubinaemia
Neonatal
Small For Dates Baby
Caesarean Section
Maternal Drugs Affecting
Foetus
Respiratory Disorder
Neonatal
Cyanosis Neonatal
Hypotonia Neonatal
Date:03/14/11ISR Number: 7349953-2Report Type:Expedited (15-DaCompany Report #CA-ROCHE-764134 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Gait Disturbance Lariam PS Roche UNKNOWN DURATION: 23
Diarrhoea
DAYS
Vertigo Advil C
Date:03/23/11ISR Number: 7369129-2Report Type:Expedited (15-DaCompany Report #GB-ROCHE-753520 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Depressed Mood Lariam PS Roche ORAL 4 TABLETS
Initial or Prolonged Weight Decreased DISPENSED
Other Serious
Major Depression
Insomnia
Date:03/28/11ISR Number: 7377882-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-767499 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anaphylactic Reaction Mefloquine
Initial or Prolonged Hydrochloride PS Roche UNKNOWN DRUG:
MEFLOQUINE
Date:03/30/11ISR Number: 7383944-0Report Type:Expedited (15-DaCompany Report #FR-PFIZER INC-2011065249 Age:58 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pancytopenia Zithromax PS Pfizer, Inc. ORAL UNK 3 DAY
Initial or Prolonged Lariam SS ORAL 250 mg,
weekly

Tilcotil C 20 mg, 1x/day
Inipomp C 20 mg, 1x/day
Actonel C 75 mg twice
monthly
03-Apr-2012 09:37 AM Page: 848

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/11/11ISR Number: 7405879-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-769860 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Pancytopenia Lariam PS Roche ORAL
Initial or Prolonged Zithromax SS ORAL
Tilcotil
C
Inipomp
C
Actonel
C
Date:04/12/11ISR Number: 7409148-0Report Type:Expedited (15-DaCompany Report #IE-ROCHE-769610 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hallucination Lariam PS Roche UNKNOWN
Paranoia
Suicidal Ideation
Psychotic Disorder
Suicide Attempt
Anxiety
Depression
Date:04/13/11ISR Number: 7412305-0Report Type:Expedited (15-DaCompany Report #FI-ROCHE-770160 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychotic Disorder Lariam PS Roche ORAL
Initial or Prolonged
Date:04/18/11ISR Number: 7420609-0Report Type:Expedited (15-DaCompany Report #IE-ROCHE-241671 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dizziness Lariam PS Roche ORAL
Other Serious
Suicidal Ideation
Arthralgia
Nightmare
Palpitations
Depression
Vestibular Disorder
Myalgia
Alcohol Intolerance
Insomnia
Fatigue
Visual Impairment
Anxiety Disorder
Dry Throat
Tinnitus
Nausea
Hypotension
Restlessness

Vertigo
03-Apr-2012 09:37 AM Page: 849

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/18/11ISR Number: 7420818-0Report Type:Expedited (15-DaCompany Report #IE-ROCHE-769921 Age:43 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mood Swings Lariam PS Roche UNKNOWN
Skin Disorder
Suicidal Ideation
Abnormal Behaviour
Fatigue
Insomnia
Aggression
Depression
Weight Decreased
Memory Impairment
Acne
Date:04/20/11ISR Number: 7425453-6Report Type:Periodic Company Report #US-ROXANE LABORATORIES, INC.-2011-RO-00514RO Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Insomnia Mefloquine PS Roxane Laboratories,
Decreased Interest Inc. ORAL
Libido Decreased Lexapro C 20 mg
Depressive Symptom
Disturbance In Attention
Asthenia
Chills
Anxiety
Tearfulness
Date:04/25/11ISR Number: 7442461-XReport Type:Direct Company Report #CTU 451598 Age:34 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Confusional State Mefloquine PS ORAL WEEKLY PO
Initial or Prolonged Tinnitus
Mood Swings
Toxicity To Various
Agents
Cardiac Disorder
Chest Discomfort
Abnormal Dreams
Anxiety
Depression
Insomnia
Abnormal Behaviour
Date:04/26/11ISR Number: 7444804-XReport Type:Direct Company Report #CTU 451780 Age:20 YR Gender:Female I/FU:I
Outcome
PT

Other Serious
Balance Disorder
Neurotoxicity
Fatigue
Panic Attack
Disturbance In Attention
Anxiety
Vertigo
Cognitive Disorder
03-Apr-2012 09:37 AM Page: 850

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depression
Report Source Product Role Manufacturer Route Dose Duration
Lariam 250 Mg/Tablet
Mefloquine PS ORAL 1 TABLET
WEEKLY PO
Date:05/02/11ISR Number: 7451500-1Report Type:Expedited (15-DaCompany Report #FR-ROXANE LABORATORIES, INC.-2006-BP-10993RO Age:27 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Malaria Mefloquine PS Roxane Laboratories,
Hospitalization - Drug Ineffective Inc. 48 HR
Initial or Prolonged Completed Suicide Proguanil-Chloroquin
e SS 3 MON
Date:05/04/11ISR Number: 7458831-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-774347 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hypoaesthesia Lariam PS Roche ORAL TAKEN FOR
Drug Level Increased
MANY YEARS
Abdominal Discomfort
FOR TIME
PERIODS OF
6-12 WEEKS
Date:05/10/11ISR Number: 7477508-8Report Type:Direct Company Report #CTU 453058 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Pruritus Mefloquine 250 Mg
Nausea
Unknown -Given By
Impetigo Peace Corps- PS ORAL 250 MG WEEKLY
Headache
PO
Rash
Insomnia
Bacterial Infection
Stomatitis
Mood Swings
Diarrhoea
Pollakiuria
Malaise
Feeling Jittery
Cough
Lethargy
Dizziness
Depression

Date:06/08/11ISR Number: 7531752-XReport Type:Expedited (15-DaCompany Report #IE-ROCHE-709959 Age: Gender:Male I/FU:I
Outcome
Other Serious
PT
Chest Pain
Headache
Fatigue
Hallucination
Diarrhoea
03-Apr-2012 09:37 AM Page: 851

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Renal Pain
Depression
Abdominal Pain Upper Report Source Product Role Manufacturer Route Dose Duration
Joint Swelling Lariam PS Roche UNKNOWN DOSE AND
Muscle Spasms
FREQUENCY NOT
Oedema Peripheral
PROVIDED.
Insomnia
Mental Disorder
Anxiety
Myalgia
Date:06/09/11ISR Number: 7536782-XReport Type:Expedited (15-DaCompany Report #IE-ROCHE-769921 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abnormal Behaviour Lariam PS Roche UNKNOWN
Fatigue
Acne
Arthralgia
Anxiety
Insomnia
Mood Swings
Suicidal Ideation
Depression
Aggression
Memory Impairment
Weight Decreased
Skin Disorder
Date:06/09/11ISR Number: 7537009-5Report Type:Expedited (15-DaCompany Report #PHHY2011BE48648 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Lamivudine PS 15 mg/day
Drug Interaction Atazanavir SS 300 mg/day
Dyspnoea Tenofovir SS 300 mg/day
Palpitations Ritonavir I 100 mg/day
Asthenia Mefloquine I Novartis Sector:
Neurotoxicity Generics 1 DF, QW
Dizziness (starting 2
weeks before
departure)
Date:06/21/11ISR Number: 7560277-0Report Type:Expedited (15-DaCompany Report #BE-ROXANE LABORATORIES, INC.-2011-RO-00817RO Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Phobia Of Flying Mefloquine PS Roxane Laboratories,
Inc.
Ritonavir SS 100 mg

Atazanavir SS 300 mg
Tenofovir SS 300 mg
Lamivudine SS 150 mg
03-Apr-2012 09:37 AM Page: 852

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/21/11ISR Number: 7563471-8Report Type:Direct Company Report #CTU 457120 Age:33 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Larium -Mefloquine
Insomnia
Hydrochloride
Psychotic Disorder
Standard Dose
Fear Generic? PS ORAL WEEKLY PO
Depression
Date:06/22/11ISR Number: 7570018-9Report Type:Direct Company Report #CTU 457416 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Fear Lariam PS 1 TABLET 1
Disability Confusional State PER WEEK
Negative Thoughts Melfloquine SS
Anxiety
Hallucination
Depression
Disturbance In Attention
Completed Suicide
Educational Problem
Date:06/23/11ISR Number: 7568415-0Report Type:Expedited (15-DaCompany Report #CA-ROCHE-782365 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Lariam PS Roche ORAL
Aggression
Psychotic Behaviour
Physical Assault
Paranoia
Suicidal Ideation
Date:06/28/11ISR Number: 7579274-4Report Type:Expedited (15-DaCompany Report #BE-ABBOTT-11P-013-0731972-00 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Asthenia Ritonavir PS
Palpitations Tenofovir C
Anxiety Doxycycline C
Neurotoxicity Lamivudine C
Drug Interaction Atazanavir C
Dizziness Mefloquine I
Dyspnoea
Date:07/11/11ISR Number: 7602716-2Report Type:Direct Company Report #CTU 458772 Age:61 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nightmare Mefloquine I Don'T
Middle Insomnia Remeber PS ORAL 1 TABLET ONCE
A WEEK PO
03-Apr-2012 09:37 AM Page: 853

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/22/11ISR Number: 7629066-2Report Type:Direct Company Report #US-FDA-7629066 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Nightmare Lariam PS ORAL 250 mg
Anxiety
Disturbance In Attention
Depression
Suicidal Ideation
Tinnitus
Date:07/22/11ISR Number: 7629067-4Report Type:Direct Company Report #US-FDA-7629067 Age:40 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hallucination Lariam PS 1 pill per
Initial or Prolonged Sleep Disorder week
Other Serious
Tachycardia
Acute Stress Disorder
Panic Attack
Bipolar I Disorder
Insomnia
Date:07/22/11ISR Number: 7629077-7Report Type:Direct Company Report #US-FDA-7629077 Age:25 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Discomfort Mefloquine/Larium PS ORAL unknown
Initial or Prolonged Anxiety
Disability
Somnolence
Other Serious
Sleep Terror
Balance Disorder
Fatigue
Restlessness
Depression
Coordination Abnormal
Nausea
Abnormal Behaviour
Suicidal Ideation
Headache
Sleep Disorder
Memory Impairment
Mood Altered
Confusional State
Decreased Appetite
Diarrhoea
Paranoia
Mental Status Changes
Abdominal Pain Upper
Myalgia
Cognitive Disorder

Date:07/22/11ISR Number: 7629089-3Report Type:Direct Company Report #US-FDA-7629089 Age: Gender:Male I/FU:I
Outcome
Life-Threatening
Other Serious
PT
Sleep Disorder
Affective Disorder
Impaired Work Ability
03-Apr-2012 09:37 AM Page: 854

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Neurotoxicity
Paranoia
Major Depression Report Source Product Role Manufacturer Route Dose Duration
Aggression Mefloquine -Lariam- PS
Suicidal Ideation
Date:07/22/11ISR Number: 7629092-3Report Type:Direct Company Report #US-FDA-7629092 Age:37 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Memory Impairment Mefloquine -Lariam- PS
Paranoia
Mental Disorder
Anxiety
Restlessness
Balance Disorder
Tinnitus
Dyspnoea
Depression
Hypoaesthesia
Paraesthesia
Fatigue
Mood Altered
Confusional State
Alopecia
Influenza Like Illness
Coordination Abnormal
Suicidal Ideation
Date:07/25/11ISR Number: 7632099-3Report Type:Direct Company Report #US-FDA-7632099 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Insomnia Lariam PS
Mental Disorder
Emotional Disorder
Disturbance In Attention
Anger
Date:07/25/11ISR Number: 7632140-8Report Type:Direct Company Report #US-FDA-7632140 Age:37 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anxiety Mefloquine PS ORAL 1
Chest Discomfort
Palpitations
Dizziness

Date:07/26/11ISR Number: 7638848-2Report Type:Direct Company Report #CTU 460126 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Required Mental Disorder Mefloquin Lariam PS
Intervention to
Emotional Disorder
Prevent Permanent Insomnia
Impairment/Damage Vision Blurred
Anger
03-Apr-2012 09:37 AM Page: 855

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/27/11ISR Number: 7638325-9Report Type:Direct Company Report #US-FDA-7638325 Age:50 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Mefloquine PS ORAL 1 pill
Myocardial Infarction
Amnesia
Anxiety
Insomnia
Confusional State
Visual Impairment
Weight Decreased
Date:08/02/11ISR Number: 7652942-1Report Type:Direct Company Report #CTU 460602 Age:44 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Vestibular Disorder Lariam 250 Mg
Hospitalization - (Mefloquine) PS ORAL 250 MG WEEKLY
Initial or Prolonged
ORAL
Disability
Date:08/03/11ISR Number: 7653623-0Report Type:Direct Company Report #US-FDA-7653623 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Amnesia Mefloquin PS ORAL 250mg 6 WK
Hospitalization - Muscle Spasms
Initial or Prolonged Deafness
Other Serious
Aphasia
Dissociation
Paranoia
Emotional Poverty
Confusional State
Vision Blurred
Feeling Abnormal
Insomnia
Psychotic Disorder
Hallucinations, Mixed
Speech Disorder
Personality Change
Mood Swings
Delirium
Balance Disorder
Depression
Date:08/04/11ISR Number: 7656076-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-792894 Age:62 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anaemia Lariam PS Roche ORAL LARIAM TABL

Initial or Prolonged
250 MG
Bricanyl
C
Pulmicort
C
Behepan
C
Entocort C ENTOCORT
PROLONGED-REL
EASE CAPSULE,
HARD
03-Apr-2012 09:37 AM Page: 856

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Kalcipos-D C KALCIPOS-D
CHEWABLE TABL
Date:09/08/11ISR Number: 7737052-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-787194 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Disease Progression Lariam PS Roche ORAL
Initial or Prolonged Muscular Weakness
Date:09/19/11ISR Number: 7759394-1Report Type:Expedited (15-DaCompany Report #SE-ROCHE-792894 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anaemia Lariam PS Roche ORAL DOSE: 2
Initial or Prolonged TABLETS (500
MG) IN 14 DAY
INTERVALS.
Bricanyl
C
Pulmicort
C
Behepan
C
Entocort C ENTOCORT
PROLONGED-REL
EASE CAPSULE,
HARD
Kalcipos-D C KALCIPOS-D
CHEWABLE TABL
Date:09/23/11ISR Number: 7774722-9Report Type:Expedited (15-DaCompany Report #SE-ROCHE-803592 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Diarrhoea Lariam PS Roche UNKNOWN
Initial or Prolonged Cardiac Fibrillation Malarone SS UNKNOWN
Photopsia
Nightmare
Hypoaesthesia
Date:10/06/11ISR Number: 7799537-7Report Type:Direct Company Report #US-FDA-7799537 Age:24 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Brain Stem Syndrome Mefloquine PS ORAL 250mg
Hospitalization - Mood Altered
Initial or Prolonged Hallucinations, Mixed
Other Serious
Personality Change
Psychotic Disorder

Date:10/14/11ISR Number: 7815089-7Report Type:Direct Company Report #US-FDA-7815089 Age:25 YR Gender:Female I/FU:I
Outcome
Life-Threatening
PT
Personality Change
Insomnia
Fatigue
Depression
03-Apr-2012 09:37 AM Page: 857

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pyrexia
Rash
Hepatitis Report Source Product Role Manufacturer Route Dose Duration
Mefloquine PS 25mg
Date:10/19/11ISR Number: 7825961-XReport Type:Expedited (15-DaCompany Report #IE-ROCHE-1005156 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Anger Lariam PS UNKNOWN
Personality Change
Suicidal Ideation
Amnesia
Anxiety
Paranoia
Date:10/31/11ISR Number: 7875822-5Report Type:Expedited (15-DaCompany Report #SE-ROCHE-1007641 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Atrial Fibrillation Lariam PS
Date:10/31/11ISR Number: 7875861-4Report Type:Expedited (15-DaCompany Report #CA-ROCHE-782365 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Aggression Lariam PS ORAL
Other Serious
Paranoia
Depression
Psychotic Behaviour
Suicidal Ideation
Physical Assault
Date:11/04/11ISR Number: 7893372-7Report Type:Expedited (15-DaCompany Report #SE-ROCHE-1007641 Age:35 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Atrial Fibrillation Lariam PS ORAL
Date:11/04/11ISR Number: 7893376-4Report Type:Expedited (15-DaCompany Report #US-ROCHE-1008551 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hip Arthroplasty Lariam PS UNKNOWN
Initial or Prolonged Nervous System Disorder Norco SS UNKNOWN

Date:11/11/11ISR Number: 7910386-9Report Type:Expedited (15-DaCompany Report #NL-ROCHE-596597 Age: Gender:Female I/FU:F
Outcome
Life-Threatening
Hospitalization -
Initial or Prolonged
Other Serious
PT
Rash
Hyperaesthesia
Dizziness
Anxiety
Gastrointestinal
03-Apr-2012 09:37 AM Page: 858

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Bacterial Infection
Road Traffic Accident
Sleep Disorder
Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration
Lariam PS ORAL
Lariam SS ORAL
Lariam SS ORAL
Date:11/16/11ISR Number: 7917500-XReport Type:Expedited (15-DaCompany Report #MA-ROCHE-1012968 Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Mania Mefloquine PS
Psychotic Behaviour
Date:11/21/11ISR Number: 7931978-7Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2011-RO-01656RO Age:73 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Immune Reconstitution Prednisone PS Roxane Laboratories,
Life-Threatening Syndrome Inc. 10 mg
Other Serious Jc Virus Infection Hydroxychloroquine
Progressive Multifocal Sulfate SS
Leukoencephalopathy Rituximab SS
Leflunomide
SS
Prednisone SS Roxane Laboratories,
Inc.
2.5 mg
Mefloquine SS Roxane Laboratories,
Inc.
Date:11/21/11ISR Number: 7932129-5Report Type:Expedited (15-DaCompany Report #US-ROXANE LABORATORIES, INC.-2011-RO-01657RO Age:72 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Death Jc Virus Infection Methotrexate PS Roxane Laboratories,
Other Serious Lymphopenia Inc.
Progressive Multifocal Mirtazapine SS
Leukoencephalopathy Etanercept SS
Adalimumab
SS
Mefloquine SS Roxane Laboratories,
Inc.
Rituximab
SS
Date:11/29/11ISR Number: 7945806-7Report Type:Expedited (15-DaCompany Report #BE-ROCHE-1014123 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS
Pregnancy Of Partner

Date:11/29/11ISR Number: 7946293-5Report Type:Expedited (15-DaCompany Report #NO-ROCHE-714994 Age: Gender:Female I/FU:F
Outcome
Hospitalization -
Initial or Prolonged
PT
Dissociation
Psychotic Disorder
Delusion
03-Apr-2012 09:37 AM Page: 859

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Anxiety
Report Source Product Role Manufacturer Route Dose Duration
Lariam PS ORAL
Date:11/30/11ISR Number: 7949244-2Report Type:Expedited (15-DaCompany Report #BE-ROCHE-1014127 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abortion Spontaneous Lariam PS
Maternal Exposure During
Pregnancy
Date:12/21/11ISR Number: 7997595-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-1022627 Age:20 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Headache Lariam PS ORAL
Dizziness
White Blood Cell Count
Increased
Pyrexia
Loss Of Consciousness
Date:12/22/11ISR Number: 8003452-3Report Type:Direct Company Report #US-FDA-8003452 Age:36 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Sleep Disorder Mefloquine PS 250 mg
Anxiety
Balance Disorder
Migraine
Nightmare
Depression
Date:12/22/11ISR Number: 8003453-5Report Type:Direct Company Report #US-FDA-8003453 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Suicidal Ideation Mefloquine / Lariam PS ORAL 250 mg.
Somnambulism
Nightmare
Confusional State
Dizziness
Anger
Loss Of Consciousness
Fall

Date:12/22/11ISR Number: 8003460-2Report Type:Direct Company Report #US-FDA-8003460 Age:44 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Dysarthria
Amnesia
Photophobia
Balance Disorder
03-Apr-2012 09:37 AM Page: 860

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Tremor
Tinnitus
Nausea Report Source Product Role Manufacturer Route Dose Duration
Dizziness Postural Lariam PS ORAL 250mg
Date:12/22/11ISR Number: 8003461-4Report Type:Direct Company Report #US-FDA-8003461 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Sleep Disorder Lariam PS
Balance Disorder
Irritability
Mood Swings
Date:12/22/11ISR Number: 8011342-5Report Type:Expedited (15-DaCompany Report #2011P1014269 Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Delusion Of Grandeur Foreign Mefloquine (No Pref.
Initial or Prolonged Mania Literature Name) PS 250 MG;QW
Hallucination
Health
Restlessness
Professional
Hypomania
Delusion
Logorrhoea
Hallucination, Auditory
Neuropsychiatric Syndrome
Flight Of Ideas
Date:12/23/11ISR Number: 8004849-8Report Type:Direct Company Report #US-FDA-8004849 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Balance Disorder Lariam PS ORAL 1 pill
Memory Impairment
Tinnitus
Anxiety
Fatigue
Tremor
Disturbance In Attention
Date:12/23/11ISR Number: 8004850-4Report Type:Direct Company Report #US-FDA-8004850 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Mefloquine PS ORAL unknown
Paranoia
Anger
Anxiety

Gastrointestinal Disorder
Bipolar Disorder
Post-Traumatic Stress
Disorder
03-Apr-2012 09:37 AM Page: 861

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/23/11ISR Number: 8004866-8Report Type:Direct Company Report #US-FDA-8004866 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Unevaluable Event Lariam PS
Date:12/23/11ISR Number: 8004874-7Report Type:Direct Company Report #US-FDA-8004874 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Anxiety Larium PS One tablet
Post-Traumatic Stress
Disorder
Depression
Panic Attack
Migraine
Nightmare
Date:12/23/11ISR Number: 8004883-8Report Type:Direct Company Report #US-FDA-8004883 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Congenital Anomaly Urticaria Mefloquine PS ORAL 250mg
Other Serious
Rash
Arthralgia
Tinnitus
Diarrhoea
Sleep Disorder
Date:12/23/11ISR Number: 8004893-0Report Type:Direct Company Report #US-FDA-8004893 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Tinnitus Mefloquin Lariam PS ORAL 1 weekly
Arthralgia
Nightmare
Balance Disorder
Paranoia
Loss Of Consciousness
Anxiety
Date:12/23/11ISR Number: 8005563-5Report Type:Expedited (15-DaCompany Report #GB-ROCHE-1023903 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Ineffective Lariam PS UNKNOWN
Malaria

Date:12/27/11ISR Number: 8011243-2Report Type:Direct Company Report #US-FDA-8011243 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Poor Quality Sleep
Mefloquine
Disturbance In Attention
Hydrochoride
Insomnia -Lariam- PS ORAL 250 mg
03-Apr-2012 09:37 AM Page: 862

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/27/11ISR Number: 8011244-4Report Type:Direct Company Report #US-FDA-8011244 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Nightmare Lariam PS ORAL 1 YR
Insomnia
Anger
Mood Swings
Bipolar Disorder
Malaise
Date:12/27/11ISR Number: 8011247-XReport Type:Direct Company Report #US-FDA-8011247 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Emotional Disorder Mefloquine PS ORAL 1 x 250mg
Depression
pill
Abnormal Behaviour
Sleep Disorder
Mental Disorder
Apnoea
Anxiety
Date:12/27/11ISR Number: 8011256-0Report Type:Direct Company Report #US-FDA-8011256 Age:19 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Paranoia Lariam PS ORAL 250mg
Hypervigilance
Anxiety
Nightmare
Tinnitus
Date:12/27/11ISR Number: 8011262-6Report Type:Direct Company Report #US-FDA-8011262 Age:22 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Hallucination Lariam PS ORAL 20mg
Hospitalization - Insomnia
Initial or Prolonged Mental Disorder
Abnormal Dreams
Bipolar Disorder
Cold Sweat
Major Depression
Date:12/27/11ISR Number: 8011265-1Report Type:Direct Company Report #US-FDA-8011265 Age:41 YR Gender:Female I/FU:I
Outcome
Other Serious
PT
Anxiety Disorder

Compulsions
Dizziness
Obsessive Thoughts
Asthenia
Tachycardia
Irritability
Panic Attack
Major Depression
03-Apr-2012 09:37 AM Page: 863

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abnormal Dreams
Nightmare
Report Source Product Role Manufacturer Route Dose Duration
Mefloquine PS BUCCAL 250MG
Date:12/27/11ISR Number: 8011270-5Report Type:Direct Company Report #US-FDA-8011270 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Insomnia Lariam PS ORAL 1pill
Hospitalization - Aphasia
Initial or Prolonged Neuropathy Peripheral
Brain Injury
Convulsion
Vestibular Neuronitis
Hyperacusis
Amnesia
Major Depression
Photophobia
Date:12/27/11ISR Number: 8011277-8Report Type:Direct Company Report #US-FDA-8011277 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Mood Altered Mefloquine PS ORAL unknown
Initial or Prolonged Depression
Other Serious
Personality Change
Weight Decreased
Psychotic Disorder
Decreased Appetite
Date:12/27/11ISR Number: 8011281-XReport Type:Direct Company Report #US-FDA-8011281 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Balance Disorder Mefloquine PS ORAL
Mental Disorder
Dizziness
Nervous System Disorder
Date:12/27/11ISR Number: 8011290-0Report Type:Direct Company Report #US-FDA-8011290 Age:32 YR Gender:Male I/FU:I
Outcome
Other Serious
PT
Mood Swings
Agoraphobia
Depression
Dizziness
Disturbance In Attention

Memory Impairment
Post-Traumatic Stress
Disorder
Tinnitus
Balance Disorder
Arthralgia
Irritability
Hyperhidrosis
03-Apr-2012 09:37 AM Page: 864

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Neck Pain
Heart Rate Increased
Sleep Disorder Report Source Product Role Manufacturer Route Dose Duration
Anxiety Lariam PS ORAL One pill
Nightmare
Multiple Allergies
Migraine
Date:12/28/11ISR Number: 8011094-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-1023903 Age: Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Drug Dose Omission Lariam PS UNKNOWN
Malaria
Date:12/29/11ISR Number: 8013268-XReport Type:Direct Company Report #US-FDA-8013268 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Larium PS
Anger
Postpartum Stress
Disorder
Date:12/29/11ISR Number: 8014072-9Report Type:Expedited (15-DaCompany Report #DE-ROCHE-1026064 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Abdominal Discomfort Lariam PS TRANSPLACENTAL
Maternal Drugs Affecting
Foetus
Date:12/30/11ISR Number: 8016015-0Report Type:Direct Company Report #US-FDA-8016015 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Major Depression Lariam PS ORAL megadose
Suicidal Ideation
Sleep Disorder
Fatigue
Anxiety
Affective Disorder
Date:01/02/12ISR Number: 8017322-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-1022627 Age:20 YR Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Dizziness Lariam PS ORAL

Initial or Prolonged
Other Serious
Nausea
Pyrexia
White Blood Cell Count
Increased
Somnolence
Headache
Loss Of Consciousness
03-Apr-2012 09:37 AM Page: 865

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/03/12ISR Number: 8018678-2Report Type:Direct Company Report #US-FDA-8018678 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Vertigo Lariam PS
Gastric Ulcer Haemorrhage
Night Sweats
Mood Swings
Depression
Date:01/06/12ISR Number: 8027763-0Report Type:Direct Company Report #US-FDA-8027763 Age:43 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Coordination Abnormal Lariam PS ORAL 250mg
Social Problem
Balance Disorder
Psychotic Disorder
Hallucination, Visual
Nightmare
Abnormal Dreams
Product Quality Issue
Sleep Disorder
Diplopia
Poor Quality Drug
Administered
Product Contamination
Brain Injury
Emotional Poverty
Date:01/09/12ISR Number: 8030390-2Report Type:Direct Company Report #US-FDA-8030390 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Anxiety Lariam PS
Depression
Anger
Date:01/09/12ISR Number: 8030431-2Report Type:Direct Company Report #US-FDA-8030431 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Tinnitus Lariam PS
Other Serious
Amnesia
Balance Disorder
Anger
Homicidal Ideation
Depression
Somnambulism

Date:01/09/12ISR Number: 8030434-8Report Type:Direct Company Report #US-FDA-8030434 Age: Gender:Male I/FU:I
Outcome
Life-Threatening
Other Serious
PT
Somnambulism
Tinnitus
Homicidal Ideation
Balance Disorder
03-Apr-2012 09:37 AM Page: 866

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Anger
Depression
Amnesia Report Source Product Role Manufacturer Route Dose Duration
Mefoquine
PS
Date:01/10/12ISR Number: 8035586-1Report Type:Direct Company Report #CTU 468507 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Tinnitus Mefloquine 250 Mg
Disability Skin Infection Generic PS ORAL 250 MG WEEKLY
Loss Of Employment
ORAL
Anxiety Doxycycline C
Neuropsychiatric Syndrome Otc Analgesics C
Depression Lindane C
Headache
Bismuth
Dizziness Subsalicylate C
Visual Impairment Erythromycin C
Paraesthesia Primaquine C
Insomnia
Malaise
Pruritus
Date:01/17/12ISR Number: 8048956-2Report Type:Expedited (15-DaCompany Report #PHHY2012MA001757 Age:31 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Delirium Mefloquine PS Novartis Sector:
Initial or Prolonged Agitation Generics 250 mg, QW
Other Serious
Hallucination, Auditory
Mood Altered
Psychomotor Hyperactivity
Logorrhoea
Date:01/17/12ISR Number: 8048957-4Report Type:Expedited (15-DaCompany Report #PHHY2012MA002356 Age:27 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Mefloquine PS Novartis Sector:
Initial or Prolonged Suicidal Ideation Generics 250 mg, QW
Other Serious
Depressive Symptom
Anxiety
Personality Disorder
Vertigo
Psychotic Disorder
Insomnia
Persecutory Delusion
Hallucination, Auditory
Depression
Poisoning

Delirium
Social Avoidant Behaviour
03-Apr-2012 09:37 AM Page: 867

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/17/12ISR Number: 8050687-XReport Type:Direct Company Report #US-FDA-8050687 Age:45 MON Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Visual Impairment Mefloquine PS ORAL 250mg
Hospitalization - Deafness
Initial or Prolonged Tinnitus
Aggression
Muscle Spasms
Arthralgia
Oedema Peripheral
Pain In Extremity
Insomnia
Suicidal Ideation
Paraesthesia
Abdominal Pain
Diarrhoea
Headache
Musculoskeletal Pain
Paranoia
Depression
Asthenia
Malaise
Nausea
Anxiety
Vision Blurred
Dry Eye
Mood Swings
Pruritus
Date:01/17/12ISR Number: 8050698-4Report Type:Direct Company Report #US-FDA-8050698 Age:21 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Hepatic Pain Mefloquine PS ORAL 250mg
Ear Discomfort
Panic Attack
Insomnia
Chills
Tinnitus
Amnesia
Glare
Emotional Disorder
Anger
Lentigo
Tremor
Photophobia
Ear Pain
Fatigue
Night Sweats
Deafness
Migraine With Aura
Paraesthesia

Depression
03-Apr-2012 09:37 AM Page: 868

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/17/12ISR Number: 8050756-4Report Type:Direct Company Report #US-FDA-8050756 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Nervous System Disorder Larium PS ORAL 250
Visual Impairment
Gastrointestinal Disorder
Date:01/17/12ISR Number: 8050758-8Report Type:Direct Company Report #US-FDA-8050758 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Depression Lariam PS
Fibromyalgia
Anger
Sensory Disturbance
Nightmare
Myalgia
Irritable Bowel Syndrome
Multiple Allergies
Insomnia
Paranoia
Arthralgia
Date:01/19/12ISR Number: 8058416-0Report Type:Direct Company Report #CTU 469002 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Fear Mefloquine - Larian
Disability Insomnia - La Roche PS La Roche ORAL 1X PER WEEK
Other Serious Vertigo ORAL
Required
Pain In Extremity
Intervention to
Panic Reaction
Prevent Permanent
Impairment/Damage
Suicidal Ideation
Muscular Weakness
Feeling Abnormal
Headache
Chest Pain
Dyspnoea
Depression
Anxiety
Nightmare
Euphoric Mood
Palpitations
Date:01/24/12ISR Number: 8066421-3Report Type:Direct Company Report #US-FDA-8066421 Age:20 YR Gender:Male I/FU:I
Outcome
Life-Threatening
Other Serious
PT
Hallucination
Anger

Mood Swings
Suicidal Ideation
Aggression
Irritability
Partner Stress
Mental Disorder
Personality Change
Insomnia
03-Apr-2012 09:37 AM Page: 869

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depression
Balance Disorder
Report Source Product Role Manufacturer Route Dose Duration
Mefloquine
PS
Date:01/24/12ISR Number: 8067510-XReport Type:Expedited (15-DaCompany Report #AU-ROCHE-1032915 Age: Gender: I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Aplastic Anaemia Lariam PS
Date:01/30/12ISR Number: 8082004-3Report Type:Expedited (15-DaCompany Report #PHHY2012MA001757 Age:31 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Psychomotor Hyperactivity Mefloquine PS Novartis Sector:
Initial or Prolonged Hallucination, Auditory Generics 250 mg, QW
Other Serious
Restlessness
Agitation
Delirium
Logorrhoea
Flight Of Ideas
Mood Altered
Date:01/30/12ISR Number: 8082017-1Report Type:Expedited (15-DaCompany Report #PHHY2012MA002356 Age:27 YR Gender:Male I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Social Avoidant Behaviour Mefloquine PS Novartis Sector:
Initial or Prolonged Emotional Disorder Generics 250 mg, QW
Other Serious
Persecutory Delusion
Depression
Anxiety
Poisoning
Dizziness
Insomnia
Hallucination, Auditory
Headache
Withdrawal Syndrome
Psychotic Disorder
Depressive Symptom
Delirium
Suicidal Ideation
Date:02/01/12ISR Number: 8183412-2Report Type:Periodic Company Report #286078USA Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Glossodynia Health Mefloquine

Swollen Tongue Professional Hydrochloride Tablet
250mg (Mefloquine)
PS
03-Apr-2012 09:37 AM Page: 870

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/10/12ISR Number: 8128421-4Report Type:Expedited (15-DaCompany Report #GB-ROCHE-1034260 Age:50 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Skin Disorder Lariam PS ORAL
Asthenia
Migraine
Dyspnoea
Alopecia
Headache
Lethargy
Dizziness
Tearfulness
Date:02/13/12ISR Number: 8133825-XReport Type:Direct Company Report #US-FDA-8133825 Age:35 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Vestibular Disorder Mefloquine PS ORAL 1 pill
Hospitalization - Dizziness
Initial or Prolonged Aggression
Other Serious
Insomnia
Cognitive Disorder
Brain Injury
Suicidal Ideation
Affective Disorder
Impaired Work Ability
Convulsion
Psychotic Disorder
Date:02/15/12ISR Number: 8138119-4Report Type:Direct Company Report #US-FDA-8138119 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious No Adverse Event Mefloquine Hcl PS ORAL 250 mg
Doxycycline C ORAL
Date:02/17/12ISR Number: 8143978-5Report Type:Direct Company Report #US-FDA-8143978 Age:29 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Abnormal Dreams Mefloquine PS 1 pill 8 MON
Panic Attack
Confusional State
Insomnia
Palpitations
Pain
Nightmare
Memory Impairment

Date:02/17/12ISR Number: 8144002-0Report Type:Direct Company Report #US-FDA-8144002 Age:29 YR Gender:Male I/FU:I
Outcome
PT
Nightmare
Memory Impairment
Abnormal Dreams
Pain
03-Apr-2012 09:37 AM Page: 871

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Confusional State
Insomnia
Panic Attack Report Source Product Role Manufacturer Route Dose Duration
Palpitations Mefloquine PS 1 pill 8 MON
Date:02/17/12ISR Number: 8144507-2Report Type:Expedited (15-DaCompany Report #FI-ROCHE-1037088 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Anxiety Lariam PS ORAL
Hospitalization - Mood Swings
Initial or Prolonged Hostility
Psychotic Disorder
Suicidal Ideation
Restlessness
Depression
Hallucination
Agitation
Fear Of Disease
Confusional State
Panic Disorder
Date:02/21/12ISR Number: 8152664-7Report Type:Expedited (15-DaCompany Report #PHHY2012US011789 Age:48 YR Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Polyneuropathy Mefloquine PS Novartis Sector:
Allodynia Generics 250 mg,
Insomnia
ONCE/SINGLE
Depression Mefloquine SS Novartis Sector:
Drug Hypersensitivity Generics 250 mg,
Neuropathy Peripheral
ONCE/SINGLE
Pain In Extremity Mefloquine SS Novartis Sector:
Pyrexia Generics 250 mg,
Neck Pain
ONCE/SINGLE
Facial Pain Mefloquine SS Novartis Sector:
Paraesthesia Generics 250 mg,
Hypoaesthesia
ONCE/SINGLE
Burning Sensation Naproxen Sodium C 550 mg, BID
Gabapentin C 300 mg, UNK
Ibuprofen C 600 mg, TID
Acetaminophen
W/Oxycodone C 2 DF, QHS as
needed
Gabapentin C 600 mg, TID
Zolpidem Tartrate C 10 mg, QHS
Esomeprazole
Magnesium C 40 mg, daily

Date:02/23/12ISR Number: 8160310-1Report Type:Direct Company Report #US-FDA-8160310 Age:20 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Quality Of Life Decreased Lariam PS ORAL one pill
03-Apr-2012 09:37 AM Page: 872

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/24/12ISR Number: 8162503-6Report Type:Direct Company Report #US-FDA-8162503 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Other Serious Depression Mefloquine PS
Headache
Insomnia
Hallucination
Suicidal Behaviour
Dizziness
Abnormal Dreams
Abnormal Behaviour
Anxiety
Date:02/28/12ISR Number: 8170623-5Report Type:Expedited (15-DaCompany Report #NO-ROCHE-1042181 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Disability Dizziness Lariam PS ORAL
Deafness
Disability
Tinnitus
Date:03/06/12ISR Number: 8187252-XReport Type:Expedited (15-DaCompany Report #DE-ROCHE-769644 Age:52 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Hypertension Lariam PS UNKNOWN DAILY DOSE 1.
Initial or Prolonged Nausea TOTAL TABLETS
Disability Dizziness ADMINISTERED:
Sinoatrial Block 245
Cardiac Pacemaker
Insertion
Sinus Arrest
Date:03/15/12ISR Number: 8212057-0Report Type:Expedited (15-DaCompany Report #DE-ROCHE-1046709 Age: Gender:Female I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anaphylactic Shock Lariam PS ORAL
Initial or Prolonged
Date:03/22/12ISR Number: 8227789-8Report Type:Expedited (15-DaCompany Report #DE-ROCHE-1046709 Age: Gender:Female I/FU:F
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Anaphylactic Shock Lariam PS ORAL
Initial or Prolonged

Date:03/23/12ISR Number: 8231170-5Report Type:Direct Company Report #US-FDA-8231170 Age:25 YR Gender:Male I/FU:I
Outcome
Hospitalization -
Initial or Prolonged
PT
Nausea
Depressed Level Of
Consciousness
Fear
03-Apr-2012 09:37 AM Page: 873

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Grand Mal Convulsion
Visual Impairment
Vomiting Report Source Product Role Manufacturer Route Dose Duration
Fatigue Mefloquine PS
Amnesia
Asthenia
Abasia
Vision Blurred
Anxiety
Headache
Date:03/23/12ISR Number: 8231209-7Report Type:Direct Company Report #US-FDA-8231209 Age:23 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Road Traffic Accident Larium PS ORAL 1 tablet 15 MON
Initial or Prolonged Drug Dependence
Psychotic Disorder
Feeling Abnormal
Date:03/23/12ISR Number: 8231220-6Report Type:Direct Company Report #US-FDA-8231220 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Panic Attack Lariam PS
Sleep Disorder
Feeling Abnormal
Date:03/27/12ISR Number: 8237197-1Report Type:Direct Company Report #US-FDA-8237197 Age:32 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Amnesia Lariam PS ORAL 250mg
Tinnitus
Irritable Bowel Syndrome
Date:03/27/12ISR Number: 8237261-7Report Type:Direct Company Report #US-FDA-8237261 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Life-Threatening Sleep Disorder Larium Or Mefloquine PS
Other Serious
Nightmare
Post-Traumatic Stress
Disorder
Suicidal Ideation
Depression

Date:03/27/12ISR Number: 8237273-3Report Type:Direct Company Report #US-FDA-8237273 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Hospitalization - Headache Mefloquin PS ORAL 15-25 mg
Initial or Prolonged Hyperhidrosis
Other Serious
Tremor
Memory Impairment
03-Apr-2012 09:37 AM Page: 874

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/28/12ISR Number: 8240288-2Report Type:Direct Company Report #US-FDA-8240288 Age:30 YR Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Amnesia Lariam/Mefloquine PS ORAL 250 mg
Vertigo
Tinnitus
Suicidal Ideation
Tremor
Abnormal Dreams
Sleep Disorder
Date:03/28/12ISR Number: 8240324-3Report Type:Direct Company Report #US-FDA-8240324 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Unevaluable Event Larium PS ORAL 1 pill
Date:03/28/12ISR Number: 8240330-9Report Type:Direct Company Report #US-FDA-8240330 Age: Gender:Male I/FU:I
Outcome PT Report Source Product Role Manufacturer Route Dose Duration
Abnormal Dreams Mefloquine PS ORAL Dont remember
Anxiety

03-Apr-2012 09:37 AM Page: 875

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Summary report for FOI selections:
Selection by inexact search of active ingredient:
MEFLOQUINE%
Selection by inexact search of Tradename/Verbatim:
LARIAM%
Total number of reports: 3,384
From: 01-NOV-1997 To: 03-APR-2012

03-Apr-2012 09:37 AM Page: 876