Evoclin (Clindamycin Phosphate Topical) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO EVOCLIN

Possible Evoclin side effects / adverse reactions in 15 year old female

Reported by a consumer/non-health professional from United States on 2007-04-12

Patient: 15 year old female weighing 52.6 kg (115.8 pounds)

Reactions: Enteritis, Gastritis

Adverse event resulted in: hospitalization

Suspect drug(s):
Evoclin

Other drugs received by patient: Synthroid

Possible Evoclin side effects / adverse reactions in 15 year old female

Reported by a physician from United States on 2007-04-24

Patient: 15 year old female weighing 52.6 kg (115.8 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Enteritis, Gastritis

Adverse event resulted in: hospitalization

Suspect drug(s):
Evoclin

Other drugs received by patient: Synthroid

Possible Evoclin side effects / adverse reactions in 49 year old female

Reported by a physician from United States on 2007-10-02

Patient: 49 year old female weighing 90.3 kg (198.6 pounds)

Reactions: Diarrhoea Haemorrhagic

Suspect drug(s):
Evoclin