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Avage (Tazarotene) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 (greater than or equal to 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 greater than 10%, in descending order, included: desquamation, erythema, burning sensation, and dry skin. Events occurring in greater than or equal to 1% to less than or equal 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%
Burning Sensation 26% <1%
Dry Skin 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® 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.



REPORTS OF SUSPECTED AVAGE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Avage. The information is not vetted and should not be considered as verified clinical evidence.

Possible Avage side effects / adverse reactions in 44 year old female

Reported by a consumer/non-health professional from United States on 2012-02-17

Patient: 44 year old female

Reactions: Drug Ineffective, Skin Disorder

Suspect drug(s):
Avage

Avage
    Indication: Skin Disorder

Avage
    Dosage: 1 application applied topically to the forehead and cheeks
    Administration route: Topical
    Indication: Pigmentation Disorder



See index of all Avage side effect reports >>

Drug label data at the top of this Page last updated: 2012-01-31

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