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
|
