Avage Side Effects

Please note - some side effects for Avage 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 Avage - for the Consumer

Avage 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 Avage Cream:

Burning; dry skin; irritation; itching; peeling; redness; scaling; skin inflammation; skin pain; stinging.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or prolonged itching, burning, redness, or peeling; sunburn; swelling of the skin, hands, or feet; swelling or cracking around the mouth; worsening of psoriasis.

Avage Side Effects - for the Professional

Avage

In human dermal safety studies, tazarotene 0.05% and 0.1% creams did not induce allergic contact sensitization, phototoxicity or photoallergy.

The most frequent treatment-related adverse reactions (≥5%) reported during the clinical trials with Avage® (TAZAROTENE) Cream 0.1% in the treatment of facial fine wrinkling, mottled hypo- and hyperpigmentation, and benign facial lentigines were limited to the skin. Those occurring in >10%, in descending order, included: desquamation, erythema, burning sensation, and dry skin. Events occurring in ≥1% to ≤10% of patients, in descending order included: skin irritation, pruritus, irritant contact dermatitis, stinging, acne, rash or cheilitis. Common adverse events observed in the clinical trials are presented in the following table:

A few patients reported adverse events at Week 0; however, for patients who were treated with Avage® the highest number of new reports for each adverse event was at Week 2.

When combining data from the two pivotal studies, 5.3% of patients in the tazarotene cream group and 0.9% of patients in the vehicle group discontinued due to adverse events.

Overall, 20/567 (3.5%) patients in the Avage® (TAZAROTENE) Cream 0.1% group and 16/564 (2.8%) patients in the vehicle group reported adverse events (including edema, irritation, and inflammation) directly related to the eye or eyelid. The majority of these conditions were mild.

Side Effects by Body System

Dermatologic

Dermatologic side effects in up to 10% to 30% of patients include pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, desquamation, dry skin, and skin pain. Side effects in up to 1% to 10% include rash, irritant contact dermatitis, skin inflammation, fissuring, bleeding, localized edema, and skin discoloration. Psoriasis worsening and sun induced erythema have also been reported.

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