Tretinoin
Generic: TRETINOIN
Basic Information
Manufacturer
Obagi Cosmeceuticals LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
c5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b
Indications & Usage
1 INDICATIONS AND USAGE Tretinoin Gel is indicated for topical treatment of acne vulgaris.
Tretinoin Gel is a retinoid indicated for topical treatment of acne vulgaris.
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Tretinoin Gel is a retinoid indicated for topical treatment of acne vulgaris.
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Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥5%) with Tretinoin Gel are dry skin, peeling/scaling/flaking skin, skin burning sensation, and erythema.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Obagi Cosmeceuticals LLC at 1-800-636-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under prescribing 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.
In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Tretinoin Gel [see Clinical Studies (14) ] .In these studies, 50% of the subjects who were treated with Tretinoin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions.
In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related.
There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups.
Selected adverse reactions that occurred in at least 1% of subjects in the two trials combined are shown in Table 1 (below).
Most skin-related adverse reactions first appear during the first two weeks of treatment with Tretinoin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment.
In some subjects, the skin-related adverse reactions persist throughout the treatment period.
Table 1: Number of Subjects with Selected Adverse Reactions (Occurring in at Least 1% of Subjects) Event Tretinoin Gel (n = 674) Vehicle Gel (n = 487) Dry Skin 109 (16%) 8 (2%) Peeling/Scaling/Flaking Skin 78 (12%) 7 (1%) Skin Burning Sensation 53 (8%) 8 (2%) Erythema 47 (7%) 1 (<1%) Pruritus 11 (2%) 3 (1%) Pain of Skin 7 (1%) 0 (0%) Sunburn 7 (1%) 3 (1%) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Tretinoin 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.
Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Obagi Cosmeceuticals LLC at 1-800-636-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under prescribing 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.
In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Tretinoin Gel [see Clinical Studies (14) ] .In these studies, 50% of the subjects who were treated with Tretinoin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions.
In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related.
There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups.
Selected adverse reactions that occurred in at least 1% of subjects in the two trials combined are shown in Table 1 (below).
Most skin-related adverse reactions first appear during the first two weeks of treatment with Tretinoin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment.
In some subjects, the skin-related adverse reactions persist throughout the treatment period.
Table 1: Number of Subjects with Selected Adverse Reactions (Occurring in at Least 1% of Subjects) Event Tretinoin Gel (n = 674) Vehicle Gel (n = 487) Dry Skin 109 (16%) 8 (2%) Peeling/Scaling/Flaking Skin 78 (12%) 7 (1%) Skin Burning Sensation 53 (8%) 8 (2%) Erythema 47 (7%) 1 (<1%) Pruritus 11 (2%) 3 (1%) Pain of Skin 7 (1%) 0 (0%) Sunburn 7 (1%) 3 (1%) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Tretinoin 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.
Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin.