"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
During clinical trials, the most frequently reported adverse event in the BenzaClin (clindamycin and benzoyl peroxide) treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the BenzaClin (clindamycin and benzoyl peroxide) and vehicle groups.
Local Adverse Events - all causalities in > /= 1% of patients
n = 420
n = 168
|Application site reaction||13 (3%)||1 ( < 1%)|
|Dry skin||50 (12%)||10 (6%)|
|Pruritus||8 (2%)||1 ( < 1%)|
|Erythema||6 (1%)||1 ( < 1%)|
The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.
Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the BenzaClin (clindamycin and benzoyl peroxide) Side Effects Center for a complete guide to possible side effects
Last reviewed on RxList: 7/7/2009
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