ADVERSE REACTIONS:
(See WARNINGS and PRECAUTIONS sections.)
In double-blind, vehicle-controlled studies involving 339 patients who applied RENOVA 0.02% to their faces, adverse reactions associated with the use of RENOVA 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 0.02%, or led to use of a mild topical corticosteroid. About 7% of patients using RENOVA 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 because of adverse reactions.
Approximately 2% of spontaneous post-marketing adverse event reporting for RENOVA 0.05% were for skin hypo- or hyperpigmentation. Other spontaneously reported adverse events for RENOVA 0.05% predominantly appear to be local reactions similar to those seen in clinical trials.
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