Duac (Clindamycin Phosphate / Benzoyl Peroxide) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

During clinical trials, all patients were graded for facial erythema, peeling, burning, and dryness on the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The percentage of patients that had symptoms present before treatment (at baseline) and during treatment were as follows:

Local reactions with use of Duac^® Topical Gel % of patients using Duac^® Topical Gel with symptom present Combined results from 5 studies (n=397)

	Before Treatment (Baseline)			During Treatment
	Mild	Moderate	Severe	Mild	Moderate	Severe
Erythema	28%	3%	0	26%	5%	0
Peeling	6%	<1%	0	17%	2%	0
Burning	3%	<1%	0	5%	<1%	0
Dryness	6%	<1%	0	15%	1%	0

(Percentages derived by # subjects with symptom score/# enrolled Duac^® Topical Gel subjects, n = 397).

Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in post-marketing use with Duac^® Topical Gel. 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 a drug exposure.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO DUAC

Possible Duac side effects / adverse reactions in 36 year old female

Reported by a physician from United States on 2007-03-30

Patient: 36 year old female

Reactions: Disease Recurrence, Crohn's Disease

Suspect drug(s):
Duac

Possible Duac side effects / adverse reactions in 17 year old female

Reported by a individual with unspecified qualification from Ireland on 2007-04-12

Patient: 17 year old female

Reactions: Hypersensitivity, Wound Secretion

Adverse event resulted in: hospitalization

Suspect drug(s):
Duac

Possible Duac side effects / adverse reactions in 29 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2007-05-18

Patient: 29 year old female

Reactions: Dermatitis Allergic, Adverse Drug Reaction

Adverse event resulted in: disablity

Suspect drug(s):
Duac

Other drugs received by patient: Erythromycin