The incidence of adverse events occurring in ≥1% of the patients in clinical studies comparing Evoclin and its vehicle is presented below:
Selected Adverse Events Occurring in ≥1% of Subjects
|Adverse Event||Number (%) of Subjects|
|Evoclin Foam||Vehicle Foam|
|N = 439||N = 154|
|Headache||12 (3%)||1 (1%)|
|Application site burning||27 (6%)||14 (9%)|
|Application site pruritus||5 (1%)||5 (3%)|
|Application site dryness||4 (1%)||5 (3%)|
|Application site reaction,not otherwise specified||3 (1%)||4 (3%)|
In a contact sensitization study, none of the 203 subjects developed evidence of allergic contact sensitization to Evoclin.
Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally.
Cases of diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS). Abdominal pain and gastrointestinal disturbances, as well as gramnegative folliculitis, have also been reported in association with the use of topical formulations of clindamycin.