Aldara 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 three times a week application. These reactions were more frequent and more intense with daily application than with three times a week application. Overall, in clinical studies applying Aldara Cream 5% w/w three 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 Cream 5% w/w applied three times a week are presented at frequencies of: Very common ≥ 1/10 (10%); Common ≥ 1/100 (1%) and < 1/10 (10%).
Application Site: Wart Site: 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: common: bleeding, burning, itching, pain, tenderness, tinea cruris.
Body as a whole: Common: influenza symptoms, fatigue, fever, fungal infection.
Central and Peripheral Nervous System: Common: headache.
Digestive System: Common: diarrhoea.
Musculo-Skeletal System: Common: myalgia.