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Bexarotene

Bexarotene is a retinoid used to treat the skin manifestations of cutaneous T-cell lymphoma (a type of skin cancer) in patients who have not responded to other treatments.

Brand names Targretin CapsulesTargretin
Drug class Retinoids
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 8 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Other forms & routes:
Topical
Bexarotene at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Bexarotene is a specialist retinoid (a vitamin A relative) that binds retinoid X receptors, gene switches that control cell growth and maturation, used for the skin signs of cutaneous T-cell lymphoma (a cancer mainly in the skin) after other treatments fall short, marketed since about 1999 and available generically. The capsules are hard going, with headache, tiredness and dry skin common, while the bigger effects, very high triglycerides (blood fats) and an underactive thyroid, often appear first on blood tests, hence blood fat, liver and thyroid checks. Its boxed warning covers birth defects, so it is never used in pregnancy and anyone who could conceive needs reliable contraception.

Clinical pearls

  • Take the capsules with a meal, and avoid extra vitamin A supplements, which raise the risk of vitamin A toxicity.
  • Gemfibrozil sharply raises bexarotene levels, so if your triglycerides need treating, your prescriber should choose a different lipid medicine.
  • Hormonal birth control may work less well with the capsules, so always add a non-hormonal method such as condoms.
  • Apply the gel only to lesions, away from normal skin, mouth and nose, and let it dry before clothing touches it.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Bexarotene can cause serious, life-threatening birth defects and must never be used during pregnancy. As a member of the retinoid drug class, it is known to cause birth defects in humans. Animal studies showed cleft palate, eye abnormalities, and other severe developmental problems. If you are pregnant or planning to become pregnant, you cannot use this medication. If pregnancy occurs while taking bexarotene, stop the drug immediately and contact your healthcare provider right away.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule, Topical cream, ointment or gel
Earliest FDA record1999
Companies listing it with the FDA8
FDA label last updatedApr 30, 2020
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Bexarotene, written from its FDA label.

What Bexarotene is used for

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Bexarotene is a retinoid used to treat cutaneous T-cell lymphoma (CTCL) — a cancer that primarily affects the skin. It is available in different forms for different disease stages and situations:

  • Targretin capsules and bexarotene capsules (oral) are used to treat skin manifestations of CTCL in patients who have already tried at least one other systemic therapy without adequate results.
  • Targretin gel 1% and bexarotene gel 1% (topical) are used specifically for early-stage CTCL (Stage IA and IB) skin lesions when other therapies haven't worked, haven't been tolerated, or disease has persisted.

How Bexarotene works

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Bexarotene is a retinoid — a class of compounds related to vitamin A. It works by selectively binding to and activating a group of proteins inside cells called retinoid X receptors (RXRs). These activated receptors act as gene regulators, switching on or off genes that control how cells grow and differentiate (mature into specialized cell types). By influencing these pathways, bexarotene can slow or stop the growth of abnormal cancer cells. The precise mechanism by which it fights CTCL is not yet fully understood.

Bexarotene dosage

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Bexarotene capsules are taken orally once a day with a meal. The dose is calculated by your prescriber based on your body surface area and may be adjusted depending on how well you respond and how well you tolerate the drug. The topical gel forms are applied directly to skin lesions, starting with every-other-day use and gradually increased to up to four times daily as your skin tolerates it.

  • Capsules: once daily with food — do not skip or double up on doses without guidance from your prescriber
  • Gel: apply a generous layer to lesions only; let dry before dressing; increase frequency gradually as directed
  • Both forms should be continued as long as you are benefiting, as determined by your prescriber

Dosing details from the FDA-approved label

From the Bexarotene prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Topical gel (Targretin gel / bexarotene gel, 1%) - application
    • Initially applied once every other day for the first week
    • Frequency increased at weekly intervals to once daily, then twice daily, then three times daily and finally four times daily according to individual lesion tolerance
    • Generally, patients were able to maintain a dosing frequency of two to four times per day
    • Sufficient gel applied to cover the lesion
    • Maximum: Four times daily
    • If application site toxicity occurs, frequency can be reduced; if severe irritation occurs, may temporarily discontinue for a few days. Avoid normal skin and mucosal surfaces; no occlusive dressings. Continue as long as patient derives benefit (applied up to 172 weeks in trials).
  • Oral capsules (CTCL) - initial dose
    • 300 mg/m2/day as a single oral daily dose with a meal
    • By body surface area: 0.88 to 1.12 m2 = 300 mg/day (4 x 75 mg capsules)
    • 1.13 to 1.37 = 375 mg/day (5)
    • 1.38 to 1.62 = 450 mg/day (6)
    • 1.63 to 1.87 = 525 mg/day (7)
    • 1.88 to 2.12 = 600 mg/day (8)
    • 2.13 to 2.37 = 675 mg/day (9)
    • 2.38 to 2.62 = 750 mg/day (10)
    • Taken with a meal
  • Oral capsules (CTCL) - dose modification
    • 300 mg/m2/day may be adjusted to 200 mg/m2/day then to 100 mg/m2/day, or temporarily suspended, if necessitated by toxicity
    • When toxicity is controlled, doses may be carefully readjusted upward
    • If no tumor response after 8 weeks and initial dose is well tolerated, dose may be escalated to 400 mg/m2/day with careful monitoring
    • Maximum: 400 mg/m2/day
    • Continue as long as patient is deriving benefit (up to 97 weeks in clinical trials)
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The recommended initial dose of bexarotene capsules is 300 mg/m 2 /day (see Table 1). Bexarotene capsules should be taken as a single oral daily dose with a meal. For precautions to prevent pregnancy and birth defects in women of child-bearing potential [see Use in Specific Populations (8.1) ]. Table 1: Bexarotene Capsules Initial Dose Calculation According to Body Surface Area Initial Dose Level (300 mg/m 2 /day) Body Surface Area (m 2 ) Total Daily Dose (mg/day) Number of 75 mg Bexarotene Capsules 0.88 to 1.12 300 4 1.13 to 1.37 375 5 1.38 to 1.62 450 6 1.63 to 1.87 525 7 1.88 to 2.12 600 8 2.13 to 2.37 675 9 2.38 to 2.62 750 10 Dose Modification Guidelines: The 300 mg/m 2 /day dose level of bexarotene capsules may be adjusted to 200 mg/m 2 /day then to 100 mg/m 2 /day, or temporarily suspended, if necessitated by toxicity. When toxicity is controlled, doses may be carefully readjusted upward. If there is no tumor response after eight weeks of treatment and if the initial dose of 300 mg/m 2 /day is well tolerated, the dose may be escalated to 400 mg/m 2 /day with careful monitoring. Duration of Therapy: In clinical trials in CTCL, bexarotene capsules were administered for up to 97 weeks. Bexarotene capsules should be continued as long as the patient is deriving benefit. Recommended initial dose is 300 mg/m 2 /day. ( 2 ) Take bexarotene capsules as a single oral daily dose with a meal. ( 2 ) Dose adjustment: May be adjusted to 200 mg/m 2 /day then to 100 mg/m 2 /day. ( 2 )

Read the full Dosage and Administration section on DailyMed →

Bexarotene side effects

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The most common side effects with bexarotene capsules include:

Common side effects

  • High triglycerides (fats in the blood)
  • High cholesterol
  • Hypothyroidism (underactive thyroid)
  • Headache
  • Low white blood cell count (leukopenia)
  • Rash or dry skin
  • Nausea
  • Fatigue or weakness
  • Swelling of the hands or feet (peripheral edema)

When to get medical help

  • Call your doctor right away if you develop severe stomach or back pain — this may be a sign of pancreatitis (inflamed pancreas)
  • Tell your doctor about yellowing of the skin or eyes, or dark urine — these may be signs of liver problems
  • Report signs of very low white blood cell count: frequent infections, fever, or chills
  • Tell your doctor if you feel unusually tired, cold, or gain unexplained weight — signs of hypothyroidism
  • Seek help immediately if you are pregnant or become pregnant while taking bexarotene — this drug causes serious birth defects
  • Tell your doctor about vision changes or eye discomfort — cataracts have been reported

Serious reactions including pancreatitis, liver damage, and severe decreases in blood cell counts have been reported — contact your doctor immediately if you develop severe abdominal pain, jaundice (yellowing skin or eyes), or signs of infection such as fever or chills.

Bexarotene warnings and precautions

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  • Birth defects: Bexarotene must never be used during pregnancy — it causes serious fetal harm. Reliable contraception (two methods, at least one non-hormonal) is required before, during, and for one month after treatment. Monthly pregnancy tests are mandatory.
  • High blood fats (hyperlipidemia): Most patients develop significantly elevated triglycerides and cholesterol. This can trigger pancreatitis. Blood fats must be monitored before and throughout treatment.
  • Pancreatitis: Acute, potentially fatal pancreatitis has been reported. Severe abdominal or back pain requires immediate medical attention.
  • Liver toxicity: Bexarotene can elevate liver enzymes and, rarely, cause liver failure. Liver function tests must be checked regularly.
  • Hypothyroidism: About half of patients develop low thyroid function — monitoring and thyroid hormone replacement may be needed.
  • Low white blood cell count (neutropenia/leukopenia): Increases infection risk — watch for fever, chills, or unusual infections.
  • Sun sensitivity (photosensitivity): Avoid prolonged sun exposure and tanning beds during treatment.
  • Vitamin A supplements: Avoid extra vitamin A — it can compound bexarotene's toxicity.

Bexarotene interactions

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Bexarotene capsules can interact with several medications and supplements. Key ones to know:

  • Gemfibrozil (a triglyceride-lowering drug): raises bexarotene blood levels significantly — this combination should be avoided with capsules
  • Hormonal contraceptives (pills, patches, rings): bexarotene may reduce their effectiveness by speeding up their breakdown — a non-hormonal method must be used as one of two contraceptive forms
  • Tamoxifen (breast cancer drug): bexarotene capsules may lower tamoxifen levels by roughly 35%, potentially reducing its effectiveness
  • Atorvastatin (cholesterol drug): bexarotene can cut atorvastatin blood levels by about half
  • Paclitaxel plus carboplatin (chemotherapy agents): this combination can approximately double bexarotene exposure
  • Vitamin A supplements: combining with bexarotene raises the risk of retinoid toxicity — avoid unless specifically directed

Interactions listed in the FDA-approved label

From the Bexarotene prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Gemfibrozil: Concomitant administration with bexarotene capsules resulted in increases in plasma concentrations of bexarotene. Concomitant administration is not recommended.
  • CYP3A4 substrates, including oral or other systemic hormonal contraceptives: Bexarotene may be an inducer of CYP3A4 enzymes and may reduce plasma concentrations of other substrates metabolized by CYP3A4. If treating a female with reproductive potential, it is strongly recommended that a non-hormonal contraception be considered.
  • CA125 assay (laboratory test): CA125 assay values in patients with ovarian cancer may be increased by bexarotene capsule therapy.
  • Ketoconazole: Multiple doses with bexarotene capsules did not alter bexarotene plasma concentrations, suggesting bexarotene elimination is not dependent on CYP3A4 metabolism.
  • Paclitaxel plus carboplatin: Co-administration with bexarotene capsules (400 mg/m2 orally once daily) increased exposure to bexarotene (AUC 0-24 and Cmax) by 2-fold compared to bexarotene capsules alone.
  • Atorvastatin: Bexarotene concentrations were not affected by atorvastatin, but the exposure (AUC) to atorvastatin decreased by half when co-administered with bexarotene capsules (400 mg/m2 orally once daily).
  • Tamoxifen: Concomitant administration with bexarotene capsules resulted in approximately a 35% decrease in plasma concentrations of tamoxifen, possibly through induction of CYP3A4 by bexarotene.
  • Paclitaxel: Exposure (AUC) to paclitaxel decreased by 19% when co-administered with bexarotene capsules (400 mg/m2 orally once daily).
  • Carboplatin: Co-administration of bexarotene capsules (400 mg/m2 orally once daily) had no effect on the exposure to free or total carboplatin.
Read the label’s full interactions text

7 DRUG INTERACTIONS Effect of Other Drugs on Bexarotene Capsules Gemfibrozil: Concomitant administration of bexarotene capsules and gemfibrozil resulted in increases in plasma concentrations of bexarotene. Concomitant administration of gemfibrozil with bexarotene capsules is not recommended. Effect of Bexarotene Capsules on Other Drugs Bexarotene may be an inducer for the CYP3A4 enzymes, and may reduce plasma concentrations of other substrates metabolized by CYP3A4. Drug products which may be affected include oral or other systemic hormonal contraceptives. Thus, if treatment with bexarotene capsules is intended for a female with reproductive potential, it is strongly recommended that a non-hormonal contraception be considered [ see Use in Specific Populations (8.3) , Clinical Pharmacology (12.3) ]. Laboratory Test Interference CA125 assay values in patients with ovarian cancer may be increased by bexarotene capsule therapy.

Drug Interactions Effect of Other Drugs on Bexarotene CYP3A4 Inhibitors/Inducers: In a clinical study, concomitant administration of multiple doses of ketoconazole with bexarotene capsules did not alter bexarotene plasma concentrations. This suggests that bexarotene elimination is not dependent on CYP3A4 metabolism. Paclitaxel plus Carboplatin: The co-administration of paclitaxel (200 mg/m 2 IV dose over 3 hours) plus carboplatin (at a dose expected to achieve an AUC of 6 mg●min/mL) with bexarotene capsules (400 mg/m 2 orally once daily) increased the exposure to bexarotene (AUC 0-24 and C max ) by 2-fold compared to bexarotene capsules alone. Atorvastatin: Bexarotene concentrations were not affected by concomitant atorvastatin administration. Effect of Bexarotene on Other Drugs Bexarotene did not significantly inhibit the following enzymes in human liver microsomes: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4. In vitro data suggested a potential for bexarotene to inhibit CYP2C8 and induce CYP3A4.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿139 supplements and herbs with documented Bexarotene interactions, ranked by severity Check Bexarotene against a supplement or herb →

Before taking Bexarotene

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  • Pregnancy: Bexarotene is absolutely contraindicated during pregnancy — it causes serious birth defects. Must be stopped immediately if pregnancy occurs.
  • Women of reproductive potential: Require a negative pregnancy test before starting, monthly tests during treatment, and two reliable forms of contraception (at least one non-hormonal) for one month before, throughout, and one month after treatment.
  • Male patients: Must use condoms if their partner is pregnant or could become pregnant, during and for at least one month after treatment.
  • Breastfeeding: Breastfeeding should be discontinued during bexarotene capsule treatment due to potential serious harm to a nursing infant.
  • Children: Safety and effectiveness in pediatric patients have not been established.
  • Older adults: No major overall safety differences were seen in patients 70 and older, but increased sensitivity to the drug cannot be ruled out.
  • Liver impairment: No formal studies have been done — use with caution; bexarotene may accumulate and increase toxicity risk.
  • Diabetes: Bexarotene may affect blood sugar control — tell your prescriber if you have diabetes.
  • History of pancreatitis or high triglycerides: Risk of pancreatitis is higher — discuss with your prescriber before starting.
  • Hypersensitivity: Do not use if you have a known allergy to bexarotene or any ingredient in the product.

Bexarotene overdose

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For the topical gel forms, serious systemic toxicity from accidental overuse is unlikely because very little of the drug enters the bloodstream under normal use. There is no specific antidote for bexarotene overdose. If an overdose occurs with either form, seek medical attention and treatment will focus on managing any symptoms that develop.

What Bexarotene does in the body

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Bexarotene activates retinoid X receptors (RXRs) in cells, which regulate genes involved in cell growth and differentiation. In laboratory studies, it has been shown to inhibit the growth of certain tumor cell lines and trigger tumor regression in some animal models. When taken as capsules, it commonly causes measurable changes in blood lipids (raising triglycerides and cholesterol, lowering HDL) and suppresses thyroid hormone levels — effects that require monitoring and management throughout treatment.

How your body processes Bexarotene

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When bexarotene capsules are taken by mouth, the drug is absorbed within about two hours and absorption is meaningfully higher (roughly 35–48%) when taken with a fat-containing meal rather than on an empty stomach. The drug is almost completely bound to proteins in the blood (over 99%) and has a half-life of approximately seven hours, meaning it takes about that long for blood levels to drop by half. It is broken down primarily by a liver enzyme called CYP3A4 and is cleared mainly through non-urinary pathways — very little is excreted in the urine. When bexarotene gel is applied to the skin, blood levels remain very low under typical use conditions.

How to store Bexarotene

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Store at 2° to 25°C (36° to 77°F). Protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

139

Supplements & herbs that interact with Bexarotene

139 supplements and herbal products have documented interactions with Bexarotene in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 94
  • Minor · 41
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major VITAMIN A Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate AMERICAN ELDER Moderate +131 more
Every supplement checked against Bexarotene — ranked by severity The full interaction hub: 4 major · 94 moderate · 41 minor · every one linked to its full report. Check Bexarotene against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Bexarotene: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Bexarotene — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is bexarotene used for?

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Bexarotene is used to treat cutaneous T-cell lymphoma — a type of cancer that mainly shows up in the skin. The capsule form (Targretin or generic bexarotene) is for people who've already tried at least one other treatment that didn't work well enough. The gel form is used for early-stage disease, applied right on the skin lesions when other options haven't been effective or weren't tolerated.

Why do I need so many blood tests while taking the capsules?

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Bexarotene capsules significantly raise blood fat levels — especially triglycerides — in most patients, and very high triglycerides can cause a serious condition called pancreatitis. They can also affect your liver and thyroid, and lower your white blood cell count. Your doctor needs to check these things regularly to catch problems early and adjust your dose if needed. It's not routine box-ticking — these tests are genuinely important for your safety.

I'm a woman who could get pregnant. What do I need to know?

▾
This is one of the most critical things about bexarotene — it causes serious birth defects and absolutely cannot be used during pregnancy. You'll need a negative pregnancy test before you start, and monthly pregnancy tests throughout treatment. You must use two reliable forms of contraception at the same time, and at least one of those must be non-hormonal (like a condom or copper IUD), because bexarotene can reduce the effectiveness of hormonal birth control. Contraception must be continued for at least one month after your last dose.

What side effects are most likely with the capsules, and which ones should make me call my doctor?

▾
The most common side effects are high blood fat levels, underactive thyroid, headache, fatigue, and a drop in white blood cell counts. Most people also notice some skin changes like rash or dryness. Call your doctor right away if you get severe stomach or back pain (possible pancreatitis), yellowing of your skin or eyes (possible liver problem), signs of serious infection like fever or chills, or any new vision changes. These need prompt attention — don't wait for your next scheduled appointment.

Are there any medicines I should avoid while taking bexarotene capsules?

▾
Yes — a few important ones. Gemfibrozil, a drug sometimes used for cholesterol, should not be taken alongside bexarotene capsules because it raises bexarotene levels in your blood. If you're on tamoxifen or atorvastatin, your doctor should know, because bexarotene can reduce how well those drugs work. And avoid extra vitamin A supplements — since bexarotene is related to vitamin A, combining them raises the risk of toxicity. Always give your whole medication list to your prescriber and pharmacist before starting.

How do I use the gel correctly?

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Start slowly — apply the gel every other day for the first week, then increase to once daily, twice daily, and so on as your skin tolerates it, following your doctor's guidance. Apply a generous layer only on the actual lesion, and let it dry fully before putting on clothing. Avoid getting it on normal, healthy skin nearby, and keep it away from areas like your mouth or nose. If your skin gets very irritated, you can reduce how often you apply it — and if irritation is severe, you can pause for a few days. Do not use tight, sealed dressings (called occlusive dressings) over the gel.

Is Bexarotene available over the counter?

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No. Bexarotene is a prescription medicine: every Bexarotene product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Bexarotene first available?

▾
The earliest FDA record we hold for Bexarotene is from 1999: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Bexarotene was first used.

Who makes Bexarotene?

▾
8 companies currently list Bexarotene products in the FDA's NDC Directory, including Amneal Pharmaceuticals NY LLC, Bausch Health US, LLC, ANI Pharmaceuticals, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Bexarotene on HelloPharmacist

📊Bexarotene supplement interactions139 checked — ranked by severity 🌿Drug & Supplement CheckerBexarotene vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Bexarotene NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Bexarotene Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Bexarotene forms and strengths (how it comes)

Bexarotene is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Targretin
How this form is used
What it may be used for
  • Targretin capsules are indicated to treat the skin manifestations of cutaneous T-cell lymphoma (CTCL) in patients who have not responded to at least one prior systemic therapy
  • Bexarotene capsules are indicated to treat the skin manifestations of cutaneous T-cell lymphoma (CTCL) in patients who have not responded to at least one prior systemic therapy
Important instructions
  • Targretin capsules are taken as a single oral dose once daily with a meal
  • Bexarotene capsules are taken as a single oral dose once daily with a meal
  • Dose is calculated based on body surface area and may be adjusted by your prescriber based on response or side effects
  • Do not take more than a one-month supply at a time — monthly pregnancy testing is required during treatment
Available strengths 1 strength
75 mg
21 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Targretin
How this form is used
What it may be used for
  • Targretin gel 1% is indicated for the topical treatment of CTCL skin lesions in Stage IA and IB patients whose disease has persisted or not been tolerated with other therapies
  • Bexarotene gel 1% is indicated for the topical treatment of CTCL skin lesions in Stage IA and IB patients whose disease has persisted or not been tolerated with other therapies
Important instructions
  • Targretin gel is applied starting once every other day, then increased weekly up to four times daily as tolerated
  • Bexarotene gel 1% is applied starting once every other day, then increased weekly up to four times daily as tolerated
  • Apply enough gel to cover the lesion generously; let it dry completely before covering with clothing
  • Avoid applying to unaffected surrounding skin or near mucosal surfaces (mouth, nose, etc.); do not use occlusive (airtight) dressings
Available strengths 2 strengths
10 mg/g 1 g/100 g
3 FDA-listed product records ⓘ

Bexarotene on the U.S. market: products, makers and brands

How Bexarotene appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

8 companies list 10 Bexarotene product records with the FDA, mostly as capsule, topical cream, ointment or gel; the earliest marketing or approval year on record is 1999. Brand names on the directory include Targretin Capsules, Targretin; the rest are generics.

2
Dose forms ⓘ
8
Labelers (makers, repackagers, distributors)
2
Brand names
10
FDA-listed product records ⓘ
1999
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Amneal Pharmaceuticals NY LLC20%
Bausch Health US, LLC20%
ANI Pharmaceuticals, Inc.10%
Actavis Pharma, Inc.10%
AvKARE10%
Camber Pharmaceuticals, Inc.10%
Other makers20%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Bexarotene is used (Medicaid data)

A general measure of how commonly Bexarotene is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Bexarotene is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

266
Medicaid prescriptions filled (Q1–Q4 2025)
$1.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Bexarotene prescribed? Of the 1,601 medications we measure, Bexarotene ranks #1,433 by Medicaid prescriptions — more than 10% of them.

Where Bexarotene ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,433 of 1,601
#1,428 Methamphetamine 281 Rx #1,429 Adagrasib 278 Rx #1,430 Eravacycline Injection 277 Rx #1,431 Brodalumab Injection 273 Rx #1,432 Elotuzumab Injection 269 Rx #1,433 Bexarotene 266 Rx #1,434 Dexrazoxane Injection 265 Rx #1,435 Sotorasib 265 Rx #1,436 Nitisinone 264 Rx #1,437 Caffeine 262 Rx #1,438 Dopamine 259 Rx

Utilization by Bexarotene product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.01 mg/mg topical gel is the most-dispensed Bexarotene product — about 52% of these Medicaid prescriptions.

bexarotene 0.01 MG/MG Topical Gel Most dispensed

137 Medicaid prescriptions (Q1–Q4 2025) 52% of Bexarotene prescriptions shown $695,745 gross reimbursement (before rebates) ≈ $5,078 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308724

bexarotene 75 MG Oral Capsule

129 Medicaid prescriptions (Q1–Q4 2025) 48% of Bexarotene prescriptions shown $826,763 gross reimbursement (before rebates) ≈ $6,409 per prescription (gross)

Summed across the 3 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308725

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Bexarotene, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 20 listed Bexarotene NDCs with Medicaid activity.

Compare Bexarotene products

A representative set of FDA-listed product records for Bexarotene — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
75 mg Oral Actavis Pharma, Inc. ANDA View NDC →
75 mg Oral Amneal Pharmaceuticals NY LLC ANDA View NDC →
75 mg Oral ANI Pharmaceuticals, Inc. ANDA View NDC →
75 mg Oral AvKARE ANDA View NDC →
75 mg Oral Bausch Health US, LLC NDA View NDC →
75 mg Oral Camber Pharmaceuticals, Inc. ANDA View NDC →
75 mg Oral Mylan Pharmaceuticals Inc. ANDA View NDC →
75 mg Oral Upsher-Smith Laboratories, Inc. ANDA View NDC →
💊Topical cream, ointment or gel
10 mg/g Topical Amneal Pharmaceuticals NY LLC ANDA View NDC →
1 g/100 g Topical Bausch Health US, LLC NDA View NDC →

Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Bexarotene NDCs →

Bexarotene recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Bexarotene recalls since July 2021.

✅No Bexarotene recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Bexarotene RxCUI 233272 2 dose forms · 2 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 379069 In current FDA listings
    Clinical drug / strength (SCD) 75 MG RxCUI 308725
  2. Dose form (SCDF) Topical Gel RxCUI 378079 In current FDA listings
    Clinical drug / strength (SCD) 0.01 MG/MG RxCUI 308724

Look up RxCUI 233272 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Bexarotene brand names

Bexarotene is sold under 2 brand names in the FDA directory — Targretin Capsules, Targretin. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Targretin Capsules Targretin

Who makes Bexarotene: manufacturers and labelers

8 companies list Bexarotene products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals NY LLC, Bausch Health US, LLC, ANI Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Amneal Pharmaceuticals NY LLC 2 Bausch Health US, LLC 2 ANI Pharmaceuticals, Inc. 1 Actavis Pharma, Inc. 1 AvKARE 1 Camber Pharmaceuticals, Inc. 1 Mylan Pharmaceuticals Inc. 1 Upsher-Smith Laboratories, Inc. 1

Bexarotene drug class (RxNorm)

Bexarotene belongs to the Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Retinoids for cancer treatment

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Bexarotene page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 30, 2020
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Bexarotene.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Bexarotene after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
8
Finished products in the current FDA directory
10
Companies listing them (makers, repackagers, distributors)
8
FDA labeler codes behind them ⓘ
8
Linked representative label ⓘ
Bausch Health US, LLC
Linked label effective
Apr 30, 2020
Composite sections available
22
Linked SPL Set ID
1d056725-0576-4338-8089-6336e768ccdc
Linked SPL Document ID
48a80386-cbef-4555-95fe-36bbfafcd760
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Bausch Health US, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →