FABIOR SIDE EFFECTS
- Generic Name: tazarotene
- Brand Name: Fabior
- Drug Class: Acne Agents, Topical, Antipsoriatics, Topical, Retinoid-like Agents, Topical
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data reflect exposure to FABIOR Foam in 744 subjects with acne vulgaris. Subjects were aged 12 to 45 years and were treated once daily in the evening for 12 weeks. Adverse reactions reported in ≥ 1% of subjects treated with FABIOR Foam are presented in Table 1. Most adverse reactions were mild to moderate in severity. Severe adverse reactions represented 3.0% of the subjects treated. Overall, 2.7% (20/744) of subjects discontinued FABIOR Foam because of local skin reactions.
Table 1. Incidence of Adverse Reactions in ≥1 % of Subjects Treated with FABIOR Foam
| FABIOR Foam N = 744 |
Vehicle Foam N = 741 |
|
| Patients with any adverse reaction, n (%) | 163 (22) | 19 (3) |
| Application site irritation | 107 (14) | 9 (1) |
| Application site dryness | 50 (7) | 8 (1) |
| Application site erythema | 48 (6) | 3 (<1) |
| Application site exfoliation | 44 (6) | 3 (<1) |
| Application site pain | 9 (1) | 0 |
| Application site photosensitivity (including sunburn) | 8 (1) | 3 (<1) |
| Application site pruritus | 7 (1) | 3 (<1) |
| Application site dermatitis | 6 (1) | 1 (<1) |
Additional adverse reactions that were reported in <1% of subjects treated with FABIOR Foam included application site reactions (including discoloration, discomfort, edema, rash, and swelling), dermatitis, impetigo, and pruritus.
Local skin reactions, dryness, erythema, and peeling actively assessed by the investigator and burning/stinging and itching reported by the subject were evaluated at baseline, during treatment, and end of treatment. During the 12 weeks of treatment, each local skin reaction peaked at Week 2 and gradually reduced thereafter with the continued use of FABIOR Foam.
SRC: NLM .