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.
Read the Renova 0.02% (tretinoin cream) Side Effects Center for a complete guide to possible side effects
Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetic with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with RENOVA® (tretinoin cream) 0.02% because they may increase irritation with RENOVA® (tretinoin cream) 0.02%.
RENOVA® (tretinoin cream) 0.02% should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Last reviewed on RxList: 6/27/2014
This monograph has been modified to include the generic and brand name in many instances.
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