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Aldara

Aldara Adverse Reactions

imiquimod

Manufacturer:

iNova

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
In controlled clinical trials, the most frequently reported adverse reactions were those of local skin and application site reactions. Some patients also reported systemic reactions. These reactions were usually mild to moderate in intensity; however, severe reactions were reported with 3 times a week application. These reactions were more frequent and more intense with daily application than with 3 times a week application. Overall, in clinical studies applying Aldara 3 times a week, 1.2% (4/327) of the patients discontinued due to local skin/application site reactions.
Reported adverse events in 273 patients treated with Aldara applied 3 times a week are presented at frequencies of: Very common (≥1/10) and common (≥1/100 and <1/10).
Application Site Disorders: Wart Site Reactions: Very common: Erythema, erosion, excoriation/flaking, oedema, itching, burning. Common: Induration, ulceration, scabbing, vesicle, pain, soreness, burning, irritation, pain, hypopigmentation, itching, rash, sensitivity, soreness, stinging, tenderness.
Remote Site Reactions: Common: Bleeding, burning, itching, pain, tenderness, tinea cruris.
Body as a Whole: Common: Influenza symptom, fatigue, fever, fungal infection.
Central and Peripheral Nervous System: Common: Headache.
Digestive System: Common: Diarrhoea.
Musculo-Skeletal System: Common: Myalgia.
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