RENOVA SIDE EFFECTS

SIDE EFFECTS

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.

SRC: NLM .