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Drug Information

Drug Information for Clindamycin Phosphate and Benzoyl Peroxide (Mylan Pharmaceuticals Inc.): ADVERSE REACTIONS

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.

Drug Information Provided by National Library of Medicine (NLM).

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