Fabior Side Effects Center

Last updated on RxList: 8/3/2022
Fabior Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Fabior?

Fabior (tazarotene) is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

What Are Side Effects of Fabior?

Common side effects of Fabior are application site reactions including:

  • skin irritation
  • dryness
  • peeling
  • redness
  • pain
  • itching
  • swelling
  • burning
  • stinging
  • skin discoloration, and
  • skin sensitivity to sunlight.

The foam is flammable.

Fabior may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • severe redness, irritation, and peeling at the application site, and
  • severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Fabior?

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.

What Drugs, Substances, or Supplements Interact with Fabior?

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 During Pregnancy and Breastfeeding

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.

Additional Information

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.

QUESTION

Acne is the result of an allergy. See Answer
Fabior Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using tazarotene topical and call your doctor at once if you have:

  • severe skin irritation (pain, dryness, flaking, peeling, burning, stinging, itching) after applying the medicine;
  • blistering or peeling skin;
  • severe redness or discomfort; or
  • swelling, warmth, oozing, or other signs of skin infection.

Common side effects may include:

  • dry, scaly, or peeling skin;
  • skin pain, redness or burning; or
  • itching or other irritation of treated skin.

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.

SLIDESHOW

Skin Health: 15 Tips for Clear Skin See Slideshow
Fabior Professional 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, 2.7% (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 irritation107 (14)9 (1)
Application site dryness50 (7)8 (1)
Application site erythema48 (6)3 (<1)
Application site exfoliation44 (6)3 (<1)
Application site pain9 (1)0
Application site photosensitivity (including sunburn)8 (1)3 (<1)
Application site pruritus7 (1)3 (<1)
Application site dermatitis6 (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)

© Fabior Patient Information is supplied by Cerner Multum, Inc. and Fabior Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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