Aldara Adverse Reactions





Agencia Lei Va Hong
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 the 3 times a week application clinical studies, 1.2% (4/327) of the patients discontinued due to local skin/application site reactions. The incidence and severity of local skin reactions during controlled clinical trials are shown in Table 2.

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Remote site skin reactions were also reported in female and male patients treated 3 times a week with imiquimod 5% cream. The severe remote site skin reactions reported for females were erythema (3%), ulceration (2%) and edema (1%); and for males, erosion (2%), and erythema, edema, induration and excoriation/flaking (each 1%).
Adverse events judged to be probably or possibly related to Aldara reported by >5% of patients are listed in Table 3. Also included are soreness, influenza-like symptoms and myalgia. (See Table 3.)

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Adverse events judged to be possibly or probably related to Aldara and reported by >1% of patients include:
Application Site Disorders: Wart Site Reactions: Burning, hypopigmentation, irritation, itching, pain, rash, sensitivity, soreness, stinging, tenderness. Remote Site Reactions: Bleeding, burning, itching, pain, tenderness, tinea cruris.
Body as a Whole: Fatigue, fever, influenza-like symptoms.
Central and Peripheral Nervous System Disorders: Headache.
Gastrointestinal System Disorders: Diarrhea.
Musculoskeletal System Disorders: Myalgia.
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