Diagnosis and Management of Infantile Hemangioma

Table 24. Adverse effects in case series of propranolol to treat IH
Intervention
* Oral Propranolol
1-1.5 mg/kg/day
Oral Propranolol
2-2.1 mg/kg/day
Harm/Adverse Event
Number of
Studies (#
Participants
With
Harm/Total
Participants)
Reported
Rates
Across
Studies
Decrease in heart rate and blood pressure 171 1 (89/89) 100%
Elevation of liver enzymes (ALT, AST) 171 1 (5/89) 6%
Hypoglycemia 171 1 (4/89) 4.5%
Anorexia 155 1 (1/35) 3%
Diarrhea 153,189 2 (6/114) 3%-12%
Asymptomatic hypotension 153 1 (1/60) 2%
Nausea 171 1 (2/89) 2%
Cold extremities 171 1 (1/89) 1%
Restless sleep 171 1 (1/89) 1%
**Hypotension 18,167,168,173,190,191,194,199,200,202,205 11 (89/944) 0.4%-62%
ECG changes 167 1 (7/25) 28%
Bradycardia 151,167,168,173,190,191,199 7 (51/577) 0.8%-38%
Nausea/Vomiting/Diarrhea 151,153,162,175,178,179,181,190-193 12 (37/1048) 0.4%-24%
Cold extremities 151,163,178,180,193,200,202 7 (17/626) 1%-10%
Sleep disturbance/Light sleep 153,162,165,167,179,190-193,203 10 (88/729) 3%-29%
Behavioral changes 162,167,175,178,193,200 6 (13/531) 0.5%-10.8%
Respiratory
10 (35/725) 2%-10%
symptoms/Asthma/Dyspnea 151,162,163,165,178,180,190,192,194
Fatigue/Somnolence 165,167,173,176,180,201 6 (15/289) 1%-25.9%
Fever 162 1 (2/30) 7%
Gross motor abnormalities 175 1 (13/188) 7%
***Hypoglycemia 168,173,191,194,202 5 (14/328) 2%-6.8%
Cutaneous symptoms/Rash 153,176,180 3 (5/172) 2%-5%
Gastroesophageal issues 180,194 2 (3/99) 2.3%-4%
Sweating 18,176 2 (2/85) 2%-4%
Constipation 151,202 2 (3/186) 0.8%-3%
Respiratory tract infection 162 1 (1/30) 3%
Skin atrophy 156 1 (2/50) 3%
Seizure 170 1 (1/45) 2%
Agranulocytosis 163 1 (1/97) 1%
Cyanotic breath-holding spells 183,184 1 (1/71) 1%
Low body temperature 163 1 (1/97) 1%
Stridor 183,184 1 (1/71) 1%
Bronchospasm 168,193,203 3 (3/337) 0.4%-2.7%
Worsening of ulceration 190 1 (4/250) 1.6%
Peripheral cyanosis 190 1 (2/250) 0.8%
Oral Propranolol
† Sleep disturbances/Nightmares 158,164,166 3 (14/99) 3%-23%
3-3.3 mg/kg/day Transient asymptomatic hypotension 158,164 2 (7/66) 3%-17%
Daytime drowsiness 164 1 (6/35) 17%
Benign infections 164 1 (4/35) 11%
Digestive symptoms 164 1 (3/35) 9%
Constipation 152 1 (2/30) 7%
Tachypnea 152 1 (2/30) 7%
Irritability 164 1 (2/35) 6%
Cold extremities 152,166 2 (2/66) 3%
Esophageal reflux 158,166 2 (2/64) 3%
Poor weight gain 164 1 (1/35) 3%
Decreased appetite 164 1 (1/35) 3%
Bradycardia 164 1 (1/35) 3%
Hypoglycemia 152 1 (1/30) 3%
Increased appetite 164 1 (1/35) 3%
Shortness of breath on activity 164 1 (1/35) 3%
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