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Diagnosis and Management of Infantile Hemangioma

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Table 24. Adverse effects in case series <strong>of</strong> propranolol to treat IH (continued)<br />

Number <strong>of</strong><br />

Studies (#<br />

Intervention<br />

Harm/Adverse Event<br />

Participants<br />

With Harm/Total<br />

Participants)<br />

Oral Propranolol 2-3<br />

mg/kg/day<br />

†† Oral Propranolol 1-4<br />

mg/kg/day<br />

Topical Propranolol 0.5-3%<br />

Reported<br />

Rates<br />

Across<br />

Studies<br />

Cold extremities 16,172 2 (64/206) 3%-36%<br />

Nocturnal restlessness 172 1 (39/174) 22%<br />

Daytime sleepiness/Inactivity 172 1 (28/174) 16%<br />

Gastrointestinal symptoms 172 1 (12/174) 7%<br />

Agitation 16 1 (2/32) 6%<br />

Insomnia 16 1 (2/32) 6%<br />

Restlessness/Increased daytime activity 172 1 (9/174) 5%<br />

Hypotension 16,172 2 (7/206) 3%<br />

Asthma/Wheezing 16,172 2 (18/206) 3%<br />

Nightmares 16 1 (1/32) 3%<br />

Sweating 16 1 (1/32) 3%<br />

Feeding difficulties 172 1 (3/174) 2%<br />

Ulceration (onset/worsening) 172 1 (4/174) 2%<br />

Breath holding spells 172 1 (2/174) 1%<br />

Somnolence 185,195 2 (5/83) 6%-6.7%<br />

Hypoglycemia 185 1 (1/53) 2%<br />

Hypotension 185 1 (1/53) 2%<br />

Pr<strong>of</strong>ound mottling <strong>of</strong> extremities 185 1 (1/53) 2%<br />

Severe bradycardia 185 1 (1/53) 2%<br />

Cold extremities 195 1 (3/30) 10%<br />

Bronchospasm 195 1 (3/30) 10%<br />

Transaminase increase 195 1 (1/30) 3.3%<br />

Skin changes (redness, rash, itching, 2 (9/249) 1.96%-4%<br />

erosion, eczema) 197,198,204<br />

Ulceration 204 1 (5/148) 3%<br />

63

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