Renova Side Effects

Please note - some side effects for Renova may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Renova - for the consumer

Renova Emollient Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Renova Emollient Cream:

Burning; dry skin; itching; peeling; redness; stinging or warmth at application site; unusual sensitivity to wind and cold.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering, crusting, swelling, or excessive redness of the skin; changes in skin color.

For the professional

Renova

In double-blind, vehicle-controlled studies involving 179 patients who applied Renova to their face, adverse reactions associated with the use of Renova were limited primarily to the skin. During these trials, 4% of patients had to discontinue use of Renova 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. 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.

Renova Cream

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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