Benzamycin (Erythromycin / Benzoyl Peroxide Topical) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

During clinical trials, 550 acne patients were studied. Of these patients, 236 were treated with Benzamycin ® Pak. The most frequently reported adverse event considered at least possibly related was dry skin (7.6%) as compared to Vehicle (3.9%). Application site reactions (stinging, burning sensation, tingling, erythema) were reported in 2.5% of patients versus 1.3% for Vehicle patients. Blepharitis, pruritus and photosensitivity reactions were reported in <2% of patients who used the dual pouch product.

	Treatment Group Summaries Number of Patients (%)
COSTART Term	Benzamycin® Pak   N = 236	Benzamycin ® Pak Vehicle N = 153	Benzamycin® Topical Gel   N = 121	Benzamycin® Topical Gel Vehicle   N = 40
DRY SKIN	18 (7.6%)	6 (3.9%)	6 (5.0%)	0
APPLICATION SITE REACTION (stinging, erythema, and burning)	6 (2.5%)	2 (1.3%)	1 (0.8%)	0
BLEPHARITIS	4 (1.7%)	1 (0.7%)	0	1 (2.5%)
PRURITUS	4 (1.7%)	2 (1.3%)	3 (2.5%)	0
PHOTOSENSITIVITY REACTION (Sunburn, stinging with sun exposure)	3 (1.3%)	0	0	0
PEELING	1 (0.5%)	1 (0.7%)	0	0

REPORTS OF SUSPECTED BENZAMYCIN SIDE EFFECTS / ADVERSE REACTIONS

Possible Benzamycin side effects / adverse reactions in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: 69 year old female

Reactions: Rosacea, Erythema, Thermal Burn

Suspect drug(s):
Benzamycin