Evoclin Side Effects

Please note - some side effects for Evoclin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Evoclin - for the Consumer

Evoclin Foam

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Evoclin Foam:

Burning sensation on treated areas; dry or itchy skin; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood or mucus in stools; severe or persistent diarrhea; stomach cramps or pain; swelling, redness, burning, or peeling of your skin.

Evoclin Side Effects - for the Professional

Evoclin

The incidence of adverse events occurring in ≥1% of the patients in clinical studies comparing Evoclin and its vehicle is presented below:

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. Abdominal pain and gastrointestinal disturbances, as well as gramnegative folliculitis, have also been reported in association with the use of topical formulations of clindamycin.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included diarrhea in patients treated with topical clindamycin (less than 0.1% incidence), although in most cases it resolved despite continued therapy. Bloody diarrhea and colitis (including pseudomembranous colitis) have been reported rarely with topical clindamycin. In general, these cases involved extemporaneously prepared solutions of clindamycin hydrochloride. Rarely, heartburn, nausea, vomiting, constipation, and abdominal pain have been reported during vaginal use of clindamycin cream. Gastrointestinal disturbances have also been reported with the use of topical clindamycin.

Clindamycin has not been shown to have significant effects on colon flora. In one study, Clostridium difficile was detected in the stool of 4 of 19 patients receiving topical clindamycin for eight weeks. No Clostridium difficile was detected in the stool of patients receiving placebo. However, the difference was not statistically significant. Diarrhea was not reported in any patient.

Local

Local side effects have been frequently reported with the use of topical clindamycin. These have included transient drying, followed by erythema, burning, peeling, and itching. Contact dermatitis has been reported infrequently. Oiliness or oily skin has also been reported.

The foam, gel, and lotion formulations are less drying than the solution formulation, which contains alcohol.

Genitourinary

Genitourinary side effects have included vulvar irritation during use of vaginal clindamycin cream. Yeast overgrowth resulting in the development of fungal vaginitis has been reported. Symptomatic vaginal candida infection has also been reported in approximately 10% of women treated with intravaginal clindamycin.

Nervous system

Nervous system side effects have been reported rarely. Headache, dizziness, and vertigo have been reported with the use of clindamycin vaginal cream.

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