Tazarotene

Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARɣ, but shows relative selectivity for RARβ, and RARɣ and may modify gene expression.

• TAZORAC ® Cream 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. ( 1.1 ) TAZORAC Cream 0.1% is indicated for the topical treatment of acne vulgaris.ICD-10: L40.9, L70.0

• TAZORAC Cream is contraindicated in: Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] .contraindicated

Apply a thin layer of TAZORAC Cream only to the affected area once daily in the evening. ( 2.1 , 2.2 ) Not for ophthalmic, oral, or intravaginal use. ( 2.2 ) If contact with eyes occurs, rinse thoroughly with water. ( 2.2 ) 2.1 Important Administration Instructions TAZORAC Cream is for topical use only. TAZORAC Cream is not for ophthalmic, oral, or intravaginal use. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precaution ( 5.2 )] . Wash hands thoroughly after application. 2.2 Psoriasis It is recommended that treatment starts with TAZORAC Cream, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Apply a thin film (2 mg/cm 2 ) of TAZORAC Cream once per day, in the evening, to cover only the psoriatic lesions. If a bath or shower is taken prior to application, the skin should be dry before applying the cream. If emollients are used, they should be applied at least an hour before application of TAZORAC Cream. Because unaffected skin may be more susceptible to irritation, application of TAZORAC Cream to these areas should be carefully avoided. 2.3 Acne Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm 2 ) of TAZORAC Cream 0.1% once per day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area. Use effective sunscreens and wear protective clothing while using TAZORAC Cream [see Warnings and Precaution ( 5.3 )] .

Embryofetal Toxicity: TAZORAC Cream contains tazarotene, which is a teratogenic substance. TAZORAC Cream is contraindicated in pregnancy. Females of child-bearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use an effective method of contraception during treatment. ( 5.1 ) Local Irritation: Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, discontinue until the integrity of the skin has been restored, or reduce dosing interval, or in the case of psoriasis, may switch to the lower concentration. TAZORAC Cream should not be used on eczematous skin, as it may cause severe irritation. ( 5.2 ) Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. TAZORAC Cream should be administered with caution if the patient is also taking drugs known to be photosensitizers. ( 5.3 ) 5.1 Embryofetal Toxicity Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated. In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in orally treated animals. Although there may be less systemic exposure in the treatment of acne of the face alone due to less surface area for application, tazarotene is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans [see Clinical Pharmacology ( 12.3 )] .

The following serious adverse reactions are discussed in more detail in other sections of the labeling: Embryofetal toxicity [see Warnings and Precautions ( 5.1 )] Photosensitivity and Risk of Sunburn [see Warnings and Precautions ( 5.3 )] Plaque psoriasis: Most common adverse reactions occurring in 10 to 23% of patients are pruritus, erythema, and burning. ( 6.1 ) Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, dry skin, erythema, and burning sensation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In human dermal safety trials, TAZORAC Cream, 0.05% and 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy. Psoriasis The most frequent adverse reactions reported with TAZORAC Cream, 0.05% and 0.1% occurring in 10 to 23% of subjects, in descending order, included pruritus, erythema, and burning. Reactions occurring in greater than 1 to less than 10% of subjects, in descending order, included irritation, desquamation, stinging, contact dermatitis, dermatitis, eczema, worsening of psoriasis, skin pain, rash, hypertriglyceridemia, dry skin, skin inflammation, and peripheral edema.

8.1 Pregnancy Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, TAZORAC Cream may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from TAZORAC Cream during pregnancy; therefore, TAZORAC Cream should be discontinued as soon as pregnancy is recognized [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )]. Limited case reports of pregnancy in females enrolled in clinical trials for TAZORAC Cream have not established a clear association with tazarotene and major birth defects or miscarriage risk. Because the exact timing and extent of exposure in relation to the gestational age are not certain, the significance of these findings is unknown. In animal reproduction studies with pregnant rats, tazarotene dosed topically during organogenesis at 2 times the maximum systemic exposure in subjects treated with the maximum recommended human dose (MRHD) of tazarotene cream, 0.1% resulted in reduced fetal body weights and reduced skeletal ossification.

Metabolism

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Little parent compound could be detected in the plasma.

Excessive topical use of TAZORAC Cream, 0.05% and 0.1% may lead to marked redness, peeling, or discomfort [see Warnings and Precautions ( 5.2 )] . TAZORAC Cream, 0.05% and 0.1% are not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.

• Jun 13, 1997NDANDA020600Almirall
• Sep 29, 2000NDANDA021184Almirall
• May 11, 2012NDANDA202428Mayne Pharma
• Apr 3, 2017ANDAANDA208258Sun Pharma Canada
• Dec 22, 2017ANDAANDA208662Cosette
• Apr 25, 2019NDANDA209354Bausch
• Dec 18, 2019NDANDA211882Bausch
• Sep 13, 2022ANDAANDA214136Cosette

1. 1Drug Ineffective1219.0%
2. 2Erythema906.7%
3. 3Psoriasis886.6%
4. 4Skin Exfoliation846.3%
5. 5Off Label Use836.2%
6. 6Pruritus785.8%
7. 7Pain725.4%
8. 8Rash725.4%
9. 9Headache685.1%
10. 10Application Site Erythema533.9%
11. 11Application Site Pain483.6%
12. 12Diarrhoea463.4%
13. 13Dry Skin463.4%
14. 14Nausea453.4%
15. 15Acne423.1%

The 10 most recently updated of 62 ClinicalTrials.gov registrations naming Tazarotene as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Duobrii Treatment of Acne Keloidalis Nuchae (AKN)
  Terminated · Phase 3 · Interventional · 15 enrolled · Icahn School of Medicine at Mount Sinai
  NCT05608499updated 2025-11-04
• Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF
  Completed · Phase 2 · Interventional · 35 enrolled · GRI Bio Operations, Inc.
  NCT06331624updated 2025-10-30
• Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults
  Completed · Phase 3 · Interventional · 21 enrolled · Austin Institute for Clinical Research
  NCT05203315updated 2024-07-19
• Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions
  Terminated · Phase 2 · Interventional · 8 enrolled · Dana-Farber Cancer Institute
  NCT04071756updated 2024-02-07
• Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis
  Completed · Phase 4 · Interventional · 10 enrolled · Dermatology Consulting Services, PLLC
  NCT06042647updated 2023-11-18
• A Demonstration of the Hair and Scalp Benefits of Duobrii in Scalp Psoriasis
  Completed · Phase 4 · Interventional · 20 enrolled · Dermatology Consulting Services, PLLC
  NCT05872256updated 2023-11-18
• Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis
  Completed · Phase 4 · Interventional · 22 enrolled · Icahn School of Medicine at Mount Sinai
  NCT04720105updated 2023-10-27
• Comparison Of Efficacy Of Tazarotene 0.045% Vs Halobetasol Propionate 0.01% Lotion For Treatment of Scalp Psoriasis
  Completed · Interventional · 90 enrolled · Jinnah Postgraduate Medical Centre
  NCT06015152updated 2023-08-29
• Tazarotene 0.045% Lotion for Treating PIE and PIH in Subjects With Acne
  Completed · Phase 4 · Interventional · 20 enrolled · Dr. Emmy Graber
  NCT05704114updated 2023-01-30
• Excimer Laser With Topical Agents in Psoriasis Vulgaris
  Unknown · Phase 4 · Interventional · 30 enrolled · Assiut University
  NCT05555797updated 2022-10-18

Frequently asked questions

How does Tazarotene work?

Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARɣ, but shows relative selectivity for RARβ, and RARɣ and may modify gene expression.

What is Tazarotene used for?

According to FDA labeling, Tazarotene carries indications including: TAZORAC ® Cream 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. ( 1.1 ) TAZORAC Cream 0.1% is indicated for the topical treatment of acne vulgaris.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tazarotene?

Tazarotene is classified as Other antipsoriatics for topical use, Retinoid, Immunologic and Biological Factor Interactions, Receptor Interactions, Cellular Division Phase Alteration, Cellular Growth Phase Arrest, Decreased Immunologically Active Molecule Activity, Decreased Transcription to RNA.

What are the brand names for Tazarotene?

Tazarotene is marketed under brand names including Arazlo, Duobrii, Fabior, Tazorac.

What are the contraindications for Tazarotene?

Tazarotene labeling lists contraindications including: TAZORAC Cream is contraindicated in: Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] .. Always consult the full prescribing information and a clinician.