Prescription medicine
Bexarotene Brand names: Targretin
Bexarotene (Targretin) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 7 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the bexarotene FDA label on DailyMed (effective April 30, 2020, Bausch Health US, LLC); the NDA 21055 record on Drugs@FDA; every bexarotene label on DailyMed.
Highlights of the record
FDA label of April 30, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
BIRTH DEFECTS.
TARGRETIN is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. TARGRETIN must not be administered to a pregnant woman. ( 8.1 ) WARNING: BIRTH DEFECTS See full prescribing information for complete boxed warning. TARGRETIN is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. TARGRETIN must not be administered to a pregnant woman.
Used for
From the label: indications and usageTARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
Forms and strengths
- 75 mg
- 1 g/100g
- 10 mg/g
Liquid-filled capsule; capsule; gel.
On the market
- Earliest approval on file
- December 29, 1999 Targretin, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first August 12, 2014; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 7 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest July 29, 2019
- FAERS reports
- 1,309 through July 30, 2026
What is bexarotene used for?
From the label: indications and usageTARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. TARGRETIN (bexarotene) is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
Conditions named in the indications of bexarotene's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Retinoid.
Source: FDA drug label (Targretin), Bausch Health US, LLC, effective April 30, 2020 (SPL set 1d056725-0576-4338-8089-6336e768ccdc), via openFDA; the full label on DailyMed
What does the patient leaflet for bexarotene 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 TARGRETIN?TARGRETIN can cause serious side effects, including major birth defects to an unborn baby, if taken during pregnancy. For females who can become pregnant: • You should avoid becoming pregnant during treatment with TARGRETIN. • Do not take TARGRETIN if you are pregnant or plan to become pregnant. • Your healthcare provider will do a pregnancy test, within 1 week before you start TARGRETIN, and each month during treatment with TARGRETIN to make sure that you are not pregnant. • You must use two effective forms of birth control together starting 1 month before you begin treatment with TARGRETIN, during treatment, and for 1 month after stopping TARGRETIN. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used with TARGRETIN. At least one of the forms of birth control that you choose should not contain hormones. Talk to your healthcare provider about what forms of birth control may be right for you during treatment with TARGRETIN. • You should start taking TARGRETIN on the second or third day of a normal menstrual period. Follow your healthcare provider’s instructions about when to start TARGRETIN. • Call your healthcare provider right away, if you become pregnant or think that you are pregnant during treatment with TARGRETIN, and for 1 month after you stop taking TARGRETIN. For males: • You must use a condom with female partners who are pregnant, might be pregnant, or who are able to become pregnant, during treatment with TARGRETIN and for at least 1 month after your last dose.
From the patient leaflet: What should I avoid while taking TARGRETIN?Limit your exposure to sunlight and artificial types of sunlight. TARGRETIN can make your skin more sensitive to sunlight and you can get sunburn. • Limit the amount of vitamin A that you take during treatment with TARGRETIN. Large doses of vitamin A may cause side effects that are similar to side effects that can happen in people who take TARGRETIN.
From the patient leaflet: How should I store TARGRETIN?Store TARGRETIN between 36° to 77°F (2° to 25°C). • Store the TARGRETIN bottle away from light, heat, and humidity. • The capsules should not be taken after the expiration date printed on the bottle. Keep TARGRETIN and all medicines out of the reach of children.
Source: FDA drug label (Targretin), Bausch Health US, LLC, effective April 30, 2020 (SPL set 1d056725-0576-4338-8089-6336e768ccdc), via openFDA; the full label on DailyMed
Is there a generic for bexarotene (Targretin)?
The FDA approved the first generic bexarotene on August 12, 2014. 9 generic applications are approved; 7 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 bexarotene from 7 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2014 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has bexarotene been recalled?
The FDA's Enforcement Report lists 1 recall naming bexarotene since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 29, 2019 | Class II | Upsher Smith Laboratories, Inc. | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bexarotene label say about other medicines?
The bexarotene label names 7 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 |
|---|---|---|
| Atorvastatin | warnings and precautions | Atorvastatin was used in 48% (73/152) of patients with CTCL. |
| Chorionic gonadotropin | contraindications | A negative pregnancy test (e.g., serum beta-human chorionic gonadotropin, beta-HCG) with a sensitivity of at least 50 mIU/L should be obtained within one week prior to Targretin gel therapy, and the pregnancy test must be repeated at monthly intervals while the patient remains on Targretin gel. |
| Erythromycin | drug interactions | On the basis of the metabolism of bexarotene by cytochrome P450 3A4, concomitant ketoconazole, itraconazole, erythromycin and grapefruit juice could increase bexarotene plasma concentrations. |
| Gemfibrozil | drug interactions | DRUG INTERACTIONS Effect of Other Drugs on TARGRETIN Gemfibrozil: Concomitant administration of TARGRETIN and gemfibrozil resulted in increases in plasma concentrations of bexarotene. |
| Itraconazole | drug interactions | On the basis of the metabolism of bexarotene by cytochrome P450 3A4, concomitant ketoconazole, itraconazole, erythromycin and grapefruit juice could increase bexarotene plasma concentrations. |
| Ketoconazole | drug interactions | On the basis of the metabolism of bexarotene by cytochrome P450 3A4, concomitant ketoconazole, itraconazole, erythromycin and grapefruit juice could increase bexarotene plasma concentrations. |
| Vitamin a | warnings and precautions | Because of the relationship of bexarotene to vitamin A, patients should be advised to limit vitamin A supplements to avoid potential additive toxic effects. |
Source: FDA drug label (Targretin), Bausch Health US, LLC, effective April 30, 2020 (SPL set 1d056725-0576-4338-8089-6336e768ccdc), via openFDA; the full label on DailyMed
What do FAERS reports show for bexarotene?
The FDA Adverse Event Reporting System holds 1,309 reports that list bexarotene among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 247 are coded as a death and 389 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 bexarotene?
37 other medicines are given the same way (oral) and in the same FDA class as bexarotene or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 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 (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other retinoids
- the pharmacologic class, with prices and generics
- Bexarotene side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other