Tretinoinside effects

Most common adverse reactions were skin irritation, skin burning, erythema, peeling, dryness, itching, and dermatitis. To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. RETIN-A MICRO, 0.1% The safety of RETIN-A MICRO, 0.1% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 1 and 2). A total of 347 subjects with acne vulgaris were treated in Studies 1 and 2 in which 172 subjects received RETIN-A MICRO, 0.1% and 175 subjects received vehicle, applied topically once daily in the evening, for 12 weeks. Mean age was 19 years (range 11-40) and 55% were female. RETIN-A MICRO is not approved for use in pediatric patients younger than 12 years of age. In Studies 1 and 2, subjects treated with RETIN-A MICRO, 0.1% had increased cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching that peaked during the initial two weeks of therapy and decreased thereafter, compared to those treated with vehicle. During the 12-week treatment period, no more than 3% of RETIN-A MICRO, 0.1%-treated subjects had cutaneous irritation scores indicative of severe cutaneous irritation and 6% (14/224) of RETIN-A MICRO 0.1%-treated subjects discontinued treatment due to cutaneous irritation. Of these 14 subjects, four had severe cutaneous irritation after 3 to 5 days of treatment, with blistering in one subject. RETIN-A MICRO, 0.04% The safety of RETIN-A MICRO, 0.04% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 3 and 4). A total of 451 subjects with acne vulgaris were treated in Studies 3 and 4 in which 225 subjects received RETIN-A MICRO, 0.04% and 226 subjects received vehicle, applied once daily in the evening, for 12 weeks. Mean age was 19 years (range 11-49) and 57% were female. RETIN-A MICRO is not approved for use in pediatric patients younger than 12 years of age. In Studies 3 and 4, subjects treated with RETIN-A MICRO, 0.04% had increased cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching that peaked during the initial two weeks of therapy and decreased thereafter, compared to those treated with vehicle. Approximately half of the 225 subjects in the RETIN-A MICRO, 0.04%-treated group had cutaneous irritation at Week 2. Of the subjects who experienced cutaneous irritation, most had signs or symptoms that were mild in severity (severity was ranked on a 4-point ordinal scale: 0=none, 1=mild, 2=moderate, and 3=severe). Less than 10% of RETIN-A MICRO, 0.04%-treated subjects experienced moderate cutaneous irritation, and none had severe cutaneous irritation at Week 2. In Studies 3 and 4, during the 12-week treatment period, the majority of RETIN-A MICRO, 0.04%-treated subjects experienced cutaneous irritation (mild, moderate, or severe), of which, 1% (2/225) of subjects had cutaneous irritation scores indicative of a severe irritation and 1.3% (3/225) of subjects discontinued treatment due to cutaneous irritation, which included dryness in one subject and peeling and urticaria in another. RETIN-A MICRO, 0.04% and 0.1% In a double-blind trial, 156 subjects with acne vulgaris were treated for 12-weeks with RETIN-A MICRO 0.04% (n=78) or 0.1% (n=78) topically once daily. In this trial, the most frequently reported adverse events affected the skin and subcutaneous tissue (15% in the 0.04% group, and 21% in the 0.1% group). The most prevalent events in the 0.04% group were skin irritation (6%); and in the 0.1% group, skin burning (8%), erythema (5%), skin irritation (4%), and dermatitis (4%). In this trial, 63% of the adverse events were of mild intensity, and 34% were of moderate intensity.

6.2 Postmarketing

Experience The following adverse reactions have been identified during post-approval use of RETIN-A MICRO and other topical tretinoin products. 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:

Hyper- or hypopigmentation has been reported with repeated application of tretinoin.