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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

Boxed warning

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 usage

TARGRETIN ® (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December 29, 1999 Targretin, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 usage

TARGRETIN ® (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.

StartedClassCompanyReason
July 29, 2019Class IIUpsher 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 namedSectionWhat the label says
Atorvastatinwarnings and precautionsAtorvastatin was used in 48% (73/152) of patients with CTCL.
Chorionic gonadotropincontraindicationsA 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.
Erythromycindrug interactionsOn the basis of the metabolism of bexarotene by cytochrome P450 3A4, concomitant ketoconazole, itraconazole, erythromycin and grapefruit juice could increase bexarotene plasma concentrations.
Gemfibrozildrug interactionsDRUG INTERACTIONS Effect of Other Drugs on TARGRETIN Gemfibrozil: Concomitant administration of TARGRETIN and gemfibrozil resulted in increases in plasma concentrations of bexarotene.
Itraconazoledrug interactionsOn the basis of the metabolism of bexarotene by cytochrome P450 3A4, concomitant ketoconazole, itraconazole, erythromycin and grapefruit juice could increase bexarotene plasma concentrations.
Ketoconazoledrug interactionsOn the basis of the metabolism of bexarotene by cytochrome P450 3A4, concomitant ketoconazole, itraconazole, erythromycin and grapefruit juice could increase bexarotene plasma concentrations.
Vitamin awarnings and precautionsBecause of the relationship of bexarotene to vitamin A, patients should be advised to limit vitamin A supplements to avoid potential additive toxic effects.

Check bexarotene against other medicines

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

  • Drug Ineffective (a use or a product term, not a reaction)111
  • Death (an outcome recorded in the report)76
  • Hypothyroidism (named in the label)75
  • Off Label Use (a use or a product term, not a reaction)74
  • Hypertriglyceridaemia (named in the label)59
  • Disease Progression (a use or a product term, not a reaction)57
  • Fatigue50
  • Pruritus (named in the label)47

Side effects: the label's list and every FAERS reaction

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.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
LenalidomideLeukemia, lymphoma and myeloma18 labelersn/aNo current entry
DasatinibLeukemia, lymphoma and myeloma14 labelers$26.46 per tablet 100 mg tabletNo current entry
PomalidomideLeukemia, lymphoma and myeloma11 labelersn/aNo current entry
ImatinibLeukemia, lymphoma and myeloma20 labelers$0.624 per tablet 100 mg tabletNo current entry
Arsenic trioxideLeukemia, lymphoma and myelomanone listedn/aA presentation being discontinued
NilotinibLeukemia, lymphoma and myeloma6 labelersn/aNo current entry
HydroxyureaLeukemia, lymphoma and myeloma10 labelers$0.184 per capsule 500 mg capsuleNo current entry
CyclophosphamideLeukemia, lymphoma and myeloma4 labelers$1.67 per capsule 50 mg capsuleNo 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