Prescription medicine
Tazarotene Brand names: Tazorac, Arazlo, Fabior, Trilitas
Tazarotene (Arazlo) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $6.11 per gram (Tazarotene 0.1% gel) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the tazarotene FDA label on DailyMed (effective November 13, 2025, Almirall, LLC); the NDA 20600 record on Drugs@FDA; every tazarotene label on DailyMed.
Highlights of the record
FDA label of November 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTAZORAC ® Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement.
Forms and strengths
- 0.05 mg/g
- 0.1 mg/g
- 0.45 mg/g
- 0.5 mg/g
- 1 mg/g
Gel; cream; aerosol (foam); lotion.
On the market
- Earliest approval on file
- June 13, 1997 Tazorac, Chartwell Rx; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first April 3, 2017; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 7 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- May 11, 2038 Arazlo lotion; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $6.11 per gram Tazarotene 0.1% gel
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2018 0 Class I among all firms' recalls; latest March 21, 2018
- FAERS reports
- 1,167 through July 30, 2026
What is tazarotene used for?
From the label: indications and usageTAZORAC ® Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. ( 1.1 ) TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. ( 1.2 ) Limitations of Use The safety of TAZORAC Gel use on more than 20% body surface area has not been established. […]
Conditions named in the indications of tazarotene's FDA labels, with every medicine labeled for each:
From other tazarotene labelsPsoriasis: Plaque Psoriasis TAZORAC® (tazarotene) Gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.
Acne: Acne Vulgaris TAZORAC (tazarotene) Gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity.
FDA pharmacologic class: Retinoid.
Source: FDA drug label (Tazorac), NDA020600 (Chartwell Rx), as published by Almirall, LLC, effective November 13, 2025 (SPL set 4e4e4b81-420e-4492-8a74-80b692a80057), via openFDA; the full label on DailyMed
What does the patient leaflet for tazarotene say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TAZORAC Gel?TAZORAC Gel may cause birth defects if used during pregnancy. Females must not be pregnant when they start using TAZORAC Gel or become pregnant during treatment with TAZORAC Gel. For females who can become pregnant: Your doctor will order a pregnancy test for you within 2 weeks before you begin treatment with TAZORAC Gel to be sure that you are not pregnant. Your doctor will decide when to do the test. Begin treatment with TAZORAC Gel during a normal menstrual period. Use an effective form of birth control during treatment with TAZORAC Gel. Talk with your doctor about birth control options that may be used to prevent pregnancy during treatment with TAZORAC Gel. Stop using TAZORAC Gel and tell your doctor right away if you become pregnant while using TAZORAC Gel.
From the patient leaflet: What should I avoid while using TAZORAC Gel?Avoid sunlight, including sunlamps, during treatment with TAZORAC Gel. TAZORAC Gel can make you more sensitive to the sun, and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get a sunburn during treatment with TAZORAC Gel. If you get a sunburn, do not use TAZORAC Gel until your sunburn is healed. Avoid using cosmetics or topical medicines that may make your skin more sensitive to sunlight or make your skin dry. Avoid using TAZORAC Gel on unaffected skin or skin with eczema because it may cause severe irritation.
From the patient leaflet: How should I store TAZORAC Gel?Store TAZORAC Gel at 68°F to 77°F (20°C to 25°C). Keep TAZORAC Gel and all medicines out of the reach of children.
Source: FDA drug label (Tazorac), NDA020600 (Chartwell Rx), as published by Almirall, LLC, effective November 13, 2025 (SPL set 4e4e4b81-420e-4492-8a74-80b692a80057), via openFDA; the full label on DailyMed
Is there a generic for tazarotene (Arazlo)?
The FDA approved the first generic tazarotene on April 3, 2017. 10 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tazarotene from 7 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 3 patents for Arazlo lotion, the last expiring on May 11, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1997 earliest approval on file
- 2017 first generic approved
- 2038 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tazarotene (Arazlo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.11 per gram (Tazarotene 0.1% gel), down 26% from $8.25 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tazarotene 0.1% gel (generic)
- Fabior 0.1% foam (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tazarotene 0.05% cream | Generic | $7.48 per gram | n/a | -23% |
| Tazarotene 0.05% gel | Generic | $5.31 per gram | n/a | -29% |
| Tazarotene 0.1% cream | Generic | $1.92 per gram | n/a | -17% |
| Tazarotene 0.1% gel | Generic | $6.11 per gram | n/a | -26% |
| Fabior 0.1% foam | Brand | $12.32 per gram | n/a | -1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tazarotene been recalled?
The FDA's Enforcement Report lists 1 recall naming tazarotene since 2018: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 21, 2018 | Class III | Mayne Pharma Inc | Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tazarotene label say about other medicines?
The tazarotene label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Benzoyl peroxide | drug interactions | Concomitant use with oxidizing agents, such as benzoyl peroxide, may cause degradation of tazarotene and may reduce the clinical efficacy of tazarotene. |
| Chorionic gonadotropin | warnings and precautions | A negative serum or urine result for pregnancy test having a sensitivity down to at least 25 mIU/mL for human chorionic gonadotropin (hCG) should be obtained within 2 weeks prior to therapy with FABIOR Foam, which should begin during a normal menstrual period for females of childbearing potential. |
| Norethindrone | drug interactions | In a trial of 27 healthy female subjects between the ages of 20–55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD C max and AUC 0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and … |
Source: FDA drug label (Tazorac), NDA020600 (Chartwell Rx), as published by Almirall, LLC, effective November 13, 2025 (SPL set 4e4e4b81-420e-4492-8a74-80b692a80057), via openFDA; the full label on DailyMed
What do FAERS reports show for tazarotene?
The FDA Adverse Event Reporting System holds 1,167 reports that list tazarotene among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 167 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tazarotene?
17 other medicines are given the same way (topical) and in the same FDA class as tazarotene or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tretinoin | Acne | 19 labelers | $0.506 per gram 0.025% cream | No current entry |
| Adapalene | Acne | 34 labelers | $0.504 per gram 0.3% gel | No current entry |
| Adapalene and benzoyl peroxide | Acne | 11 labelers | $0.626 per gram 0.3-2.5% | No current entry |
| Clindamycin and tretinoin | Acne | 3 labelers | $3.91 per gram 1.2%-0.025% | No current entry |
| Benzoyl peroxide and tretinoin | Acne | none listed | $31.66 per gram 0.1%-3% cream pump | No current entry |
| Adapalene and benzoyl peroxide and clindamycin | Acne | none listed | n/a | No current entry |
| Trifarotene | Acne | none listed | $16.36 per gram 0.005% cream | No current entry |
| Salicylic acid | Acne, Psoriasis | none listed | $0.102 per patch Callus removers patch | No current entry |
Every medicine labeled for the same conditions as tazarotene
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tazarotene compare with medicines for the same use?
4 side-by-side pages set tazarotene beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tazarotene
- 17 medicines for the same use
- Other retinoids
- the pharmacologic class, with prices and generics
- Tazarotene side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other