In double-blind, vehicle-controlled studies involving 179 patients who applied RENOVA (tretinoin emollient cream 0.05%) 0.05% to their face, adverse reactions associated with the use of RENOVA (tretinoin emollient cream 0.05%) 0.05% were limited primarily to the skin. During these trials, 4% of patients had to discontinue use of RENOVA (tretinoin emollient cream 0.05%) 0.05% because of adverse reactions. These discontinuations were due to skin irritation or related cutaneous adverse reactions.
Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy with RENOVA (tretinoin emollient cream 0.05%) 0.05%. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. In most patients the dryness, peeling, and redness recurred after an initial (24 week) decline.
In spontaneous post-marketing adverse event reporting for RENOVA (tretinoin emollient cream 0.05%) 0.05%, approximately 2% of those were for skin hypo- or hyperpigmentation. Other spontaneously reported adverse events predominantly appear to be local reactions similar to those seen in clinical trials.
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Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics 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 emollient cream 0.05%) because they may increase irritation with RENOVA (tretinoin emollient cream 0.05%) .
RENOVA (tretinoin emollient cream 0.05%) 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: 12/10/2008
This monograph has been modified to include the generic and brand name in many instances.
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