Aldara疣定寧

Aldara Adverse Reactions

imiquimod

Manufacturer:

iNova

Distributor:

Zuellig
/
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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