"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
Fabior Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
- skin irritation
- skin discoloration, and
- skin sensitivity to sunlight.
The foam is flammable.
Dosed in 0.1% (strength is 1mg/g) foam, patients should apply a thin layer to the entire affected areas of the face and/or upper trunk once daily in the evening, avoiding the eyes, lips, and mucous membranes. Be sure to wash hands after application. Fabior may interact with benzoyl peroxide, or other medications or cosmetics that have a drying effect on the skin. Tell your doctor all medications and supplements you use. Fabior may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient should be apprised of the potential hazard to the fetus. Females of child-bearing potential should be warned of the potential risk and use adequate birth control measures when Fabior is used. It is not known whether this drug is excreted in human milk. The safe use of Fabior during lactation or in children under 12 years old has not been established. A decision should be made whether to discontinue breastfeeding or to discontinue Fabior therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Our Fabior 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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Fabior FDA Prescribing Information: 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, 2.6% (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
N = 744
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.
Read the entire FDA prescribing information for Fabior (Tazarotene)
Additional Fabior Information
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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