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Renova (Tretinoin) - Side Effects and Adverse Reactions



(See WARNINGS and PRECAUTIONS sections.)

In double-blind, vehicle-controlled studies involving 339 patients who applied RENOVA® (tretinoin cream) 0.02% to their faces, adverse reactions associated with the use of RENOVA® (tretinoin cream) 0.02% were limited primarily to the skin. Almost all patients reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus. In 32% of all study patients, skin irritation was reported that was severe, led to temporary discontinuation of RENOVA® (tretinoin cream) 0.02%, or led to the use of a mild topical corticosteroid. About 7% of patients using RENOVA® (tretinoin cream) 0.02%, compared to less than 1% of the control patients, had sufficiently severe local irritation to warrant short-term use of mild topical corticosteroids to alleviate local irritation. About 4% of patients had to discontinue use of RENOVA® (tretinoin cream) 0.02% because of adverse reactions.

Approximately 2% of spontaneous post-marketing adverse even reporting for RENOVA® (tretinoin cream) 0.05% were for skin hypo- or hyperpigmentation. Other spontaneously reported adverse events for RENOVA® (tretinoin cream) 0.05% predominantly appear to be local reactions similar to those seen in clinical trials.

Drug label data at the top of this Page last updated: 2014-08-18

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