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 = 420Vehiclen = 168
    Application Site Reaction13 (3%)1 (< 1%)
    Dry Skin50 (12%)10 (6%)
    Pruritis8 (2%)1 (< 1%)
    Peeling9 (2%)-
    Erythema6 (1%)1 (< 1%)
    Sunburn5 (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).