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Drug Information for Clindamycin Phosphate and Benzoyl Peroxide (Mylan Pharmaceuticals Inc.): ADVERSE REACTIONS
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During clinical trials, the most frequently reported adverse event in the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% and vehicle groups.
Local Adverse Events - all causalities in >/= 1% of patients Clindamycin Phosphate and BenzoylPeroxide Gel, 1%/5%n = 420 Vehiclen = 168 Application Site Reaction 13 (3%) 1 (< 1%) Dry Skin 50 (12%) 10 (6%) Pruritis 8 (2%) 1 (< 1%) Peeling 9 (2%) - Erythema 6 (1%) 1 (< 1%) Sunburn 5 (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.
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