Drug Details
Drug Name(s) FABIORFDA
Application No. (NDA) 202428
Active Ingredient(s) TAZAROTENE
Company STIEFEL LABS
INCOriginal Approval or
Tentative Approval Date May 11, 2012
Chemical Type3 New dosage form
Review ClassificationS Standard review drug
Drug Name(s) FABIORFDA
Application No. (NDA) 202428
Active Ingredient(s) TAZAROTENE
Company STIEFEL LABS
INCOriginal Approval or
Tentative Approval Date May 11, 2012
Chemical Type3 New dosage form
Review ClassificationS Standard review drug
- USES:
- Tazarotene is used to treat psoriasis or acne. It is a retinoid product related to Vitamin A. It works by affecting the growth of skin cells.
- The foam form of this medication is only approved for use on acne.
How to use Fabior topicalRead the Patient Information Leaflet if available from your pharmacist before you start using tazarotene and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
This medication is for use on the skin only. Wash and dry your hands before applying the medication. If you are treating acne, clean and dry the affected area. If you are treating psoriasis, make sure the skin is dry before applying the medication. Apply a thin film of the medication to the affected area and gently rub in as directed by your doctor, usually once a day in the evening. The dosage is based on your medical condition and response to treatment.
If you are using the foam form of this medication, shake the can before each use. The foam is flammable. Avoid smoking or going near an open flame while applying the medication.
Avoid getting this medication in your eyes,mouth, or vagina or on your eyelids or lips. If this happens, rinse with plenty of water.
Do not cover, bandage, or wrap the area. Do not apply this medication to normal, healthy skin. Also, do not apply this medication to skin that is cut, scraped, sunburned, or affected by eczema.
After applying the medication, wash your hand sunless you are using this medication to treat the hands. If you are using this medication on your hands, do not touch your eyes with your hands.
If you are also using a moisturizing cream or lotion, apply it at least 1 hour before applying this medication. If you are using the foam form of this medication, you may use a moisturizing cream or lotion as needed.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.
Do not use large amounts or apply this medication more often, or use for longer than prescribed. Your condition will not improve faster, and your risk of side effects will increase.
Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.
Tell your doctor if you do not get better or if you get worse after several weeks of treatment.
Side Effects
Itching, redness, irritation, burning/stinging, scaling, dry skin, or pain at application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: severe redness/irritation/peeling at application site.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Itching, redness, irritation, burning/stinging, scaling, dry skin, or pain at application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: severe redness/irritation/peeling at application site.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
- Precautions
- Before using tazarotene, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such asisotretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other skin conditions (such as eczema, sunburn, sun sensitivity).
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen (at least SPF 15) daily, and wear protective clothing when outdoors. Wait until your skin has completely recovered from a sunburn before using this medication. Weather extremes such as wind or cold may also be irritating to the skin.
Avoid electrolysis, waxing, and chemical depilatories for hair removal on the treated areas while using this product.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. Before starting this medication, women who could become pregnant should have a negative pregnancy test result within the last 2 weeks. This medication should be started during a normal menstrual period.
Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.