Avage

Avage

Avage Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Avage (tazarotene) Cream, 0.1% is used to treat plaque psoriasis (psoriasis with scaly patches) and to treat facial acne. The Avage brand of tazarotene cream is used to reduce the appearance of fine wrinkles on the face, mottled light and dark skin patches on the face, and benign facial lentigines (noncancerous freckles). It is a compound similar to vitamin A. Common side effects include skin burning, warmth, stinging, tingling, itching, redness, swelling, dryness, peeling, or irritation.

Apply a pea-sized dose of Avage Cream once a day at bedtime to lightly cover the entire face including the eyelids if desired. Remove makeup before applying Avage. Facial moisturizers may be used as desired. Avage Cream may interact with hiazide diuretics, antibiotics, phenothiazines, other topical products with a strong drying effect, products with high concentrations of alcohol, astringents, spices, peel of lime, medicated soaps or shampoos, permanent wave solutions, electrolysis, chemical hair removers or waxes, or other products that might dry or irritate the skin. Tell your doctor all medications and supplements you use. Avage Cream should not be used during pregnancy. It may harm a fetus. Women should have a negative pregnancy test within 2 weeks prior to starting this drug. Consult your doctor about using birth control. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Avage (tazarotene) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Avage in Detail - Patient Information: Side Effects

Serious side effects are not likely to occur. Stop using tazarotene topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives).

You may experience some skin burning, warmth, stinging, tingling, itching, redness, swelling, dryness, peeling, or irritation while using tazarotene topical. If these side effects are excessive, talk to your doctor. You may need a lower dose or less frequent applications of tazarotene topical.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Avage (Tazarotene) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Avage FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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:

TABLE OF ADVERSE EVENTS SEEN IN CLINICAL TRIALS WITH AVAGE® (TAZAROTENE) Cream 0.1% 

Adverse Event AVAGE ®
N=567
Vehicle
N=564
Desquamation 40% 3%
Erythema 34% 3%
BurningSensation 26% <1%
DrySkin 16% 3%
Irritation Skin 10% 1%
Pruritus 10% 1%
Irritant Contact Dermatitis 8% 1%
Stinging 3% <1%
Acne 3% 3%
Rash 3% 1%
Cheilitis 1% 0%

A few patients reported adverse events at Week 0; however, for patients who were treated with AVAGE® (tazarotene) 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.

Read the entire FDA prescribing information for Avage (Tazarotene) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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