Benzaclin (Clindamycin Phosphate Topical Gel) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

During clinical trials, the most frequently reported adverse event in the BenzaClin treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the BenzaClin and vehicle groups.

Local Adverse Events - all causalities in >/= 1% of patients

	BenzaClin	Vehicle
	n = 420	n = 168
Application site reaction	13 (3%)	1 (<1%)
Dry skin	50 (12%)	10 (6%)
Pruritus	8 (2%)	1 (<1%)
Peeling	9 (2%)	-
Erythema	6 (1%)	1 (<1%)
Sunburn	5 (1%)	-

The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.

Hypersensitivity/allergic reactions (including facial swelling and urticaria) have been reported in post-marketing use with BenzaClin 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 drug exposure.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO BENZACLIN

Possible Benzaclin side effects / adverse reactions in 24 year old female

Reported by a physician from United States on 2007-03-12

Patient: 24 year old female weighing 56.7 kg (124.7 pounds)

Reactions: LIP Swelling, Hypoaesthesia Oral, Syncope, Dizziness, Enterocolitis, Muscle Spasms

Suspect drug(s):
Differin
    Dosage: 1 app qd tp
    Indication: Acne
    Start date: 2007-02-02
    End date: 2007-02-04

Benzaclin
    Start date: 2007-02-02
    End date: 2007-02-05

Other drugs received by patient: Lexapro; Yasmin