Bexarotene
Bexarotene is a retinoid used to treat the skin manifestations of cutaneous T-cell lymphoma (CTCL), available as an oral capsule and a topical gel.
🧬 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Bexarotene can cause serious birth defects and must never be used during pregnancy. Like other drugs in the retinoid class, bexarotene is known to cause birth defects in humans. Animal studies showed severe developmental abnormalities and fetal death. If you are pregnant, or could become pregnant, this medication is contraindicated (not allowed). Women of childbearing age must use effective contraception before, during, and for at least one month after treatment. If pregnancy occurs during treatment, the drug must be stopped immediately.
📖 Bexarotene: Patient Information Guide
A plain-language walkthrough of Bexarotene — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Bexarotene is a retinoid approved to treat skin manifestations of cutaneous T-cell lymphoma (CTCL). The oral and topical formulations have distinct approved uses:
- Bexarotene capsules and Targretin capsules are indicated for the treatment of skin symptoms of CTCL in patients whose disease has not responded to at least one prior systemic (whole-body) therapy.
- Bexarotene gel 1% and Targretin gel 1% are indicated for the topical treatment of CTCL skin lesions specifically in early-stage disease (Stage IA and IB), in patients whose disease has persisted or returned after other therapies or who could not tolerate other therapies.
⚙️How it works▾
Bexarotene is a retinoid — a compound related to vitamin A. It works by selectively binding to and switching on a group of receptors inside cells called retinoid X receptors (RXRα, RXRβ, and RXRγ). Once activated, these receptors partner with other receptors and act as transcription factors — meaning they turn specific genes on or off. The genes they affect control how cells grow, divide, and mature. By influencing these processes, bexarotene can slow or stop the growth of certain cancer cells. The precise way this translates to benefit in CTCL is not fully known.
💊How it's taken▾
How you take bexarotene depends on which formulation you use — the capsule and the gel have very different regimens.
- Capsules (Bexarotene / Targretin): Taken once daily by mouth with a meal. Your dose is based on your body surface area (a calculation using your height and weight) — your prescriber determines the right number of capsules. The dose may be adjusted up or down depending on your response and any side effects. Treatment continues as long as you are benefiting.
- Gel 1% (Bexarotene / Targretin): Applied to the skin lesion. Started at once every other day, then increased gradually each week (to once, twice, three, and up to four times daily) based on your skin's tolerance. Treatment continues as long as you are benefiting; trials have used it for up to 172 weeks.
Always follow your prescriber's and pharmacist's specific instructions. Do not change your dose or frequency on your own.
🤒Side effects — in detail▾
Bexarotene — especially the oral capsule — causes a wide range of side effects. The most common ones include:
- High triglycerides (blood fats) and high cholesterol
- Low HDL ("good") cholesterol
- Hypothyroidism (low thyroid function)
- Headache
- Weakness or fatigue
- Low white blood cell count (leukopenia)
- Nausea, diarrhea, or stomach pain
- Rash or dry skin
- Swelling in the legs or feet (peripheral edema)
Serious reactions that require prompt medical attention include signs of pancreatitis (severe stomach pain), liver problems (yellowing of skin or eyes), severe infection (fever, chills), or signs of very low blood counts. Call your doctor right away if any of these occur.
⚠️Warnings & precautions▾
- Birth defects: Bexarotene causes serious birth defects. It must never be used during pregnancy. Women who could become pregnant must use two reliable forms of contraception (at least one non-hormonal) for one month before, throughout, and for at least one month after treatment. Pregnancy testing is required before starting and monthly during treatment.
- High blood fats (hyperlipidemia): Most patients develop significant rises in triglycerides and cholesterol. Severely high triglycerides can lead to pancreatitis. Blood lipid monitoring and often lipid-lowering medication are required throughout treatment. Gemfibrozil should be avoided due to drug interaction risk.
- Pancreatitis: Acute and sometimes fatal pancreatitis has been reported, mainly in patients with very high triglycerides. The drug must be stopped and evaluated if pancreatitis is suspected.
- Liver toxicity: Elevated liver enzymes and, rarely, liver failure have occurred. Liver function must be tested before and regularly during treatment. The drug should be paused or stopped if liver tests rise significantly.
- Hypothyroidism: About half of all patients develop low thyroid function, which may require thyroid hormone replacement therapy.
- Low white blood cell count (neutropenia/leukopenia): Can increase the risk of serious infections. Blood counts must be monitored and the dose adjusted as needed.
- Photosensitivity: Bexarotene increases sensitivity to sunlight and artificial UV light. Minimize sun exposure and avoid tanning beds during treatment.
🔀What it interacts with▾
Bexarotene can interact with several medications that may either raise bexarotene levels in your blood or have their own effectiveness reduced. Key interactions include:
- Gemfibrozil (cholesterol-lowering drug): Significantly increases bexarotene blood levels — this combination should be avoided.
- Hormonal contraceptives (birth control pills, patches, rings): Bexarotene may reduce their effectiveness by speeding up their metabolism — use a non-hormonal form of contraception as at least one of your two required methods.
- Atorvastatin: Bexarotene can reduce atorvastatin levels by about half, which may affect its cholesterol-lowering ability; monitoring is needed.
- Tamoxifen: Bexarotene can reduce tamoxifen levels by approximately 35%, potentially reducing its effectiveness.
- Paclitaxel plus carboplatin: This chemotherapy combination can increase bexarotene exposure by about 2-fold.
- Vitamin A supplements: Should be limited during bexarotene therapy due to the potential for additive retinoid toxicity.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Bexarotene is absolutely contraindicated in pregnancy — it causes serious birth defects. A negative pregnancy test is required before starting, and monthly thereafter.
- Breastfeeding: Do not breastfeed while taking bexarotene capsules — the potential risk to a nursing infant is unknown but considered serious.
- Women of childbearing potential: Must use two reliable forms of contraception (at least one non-hormonal) for one month before, during, and one month after treatment.
- Male patients: Must use condoms during sexual intercourse while taking bexarotene and for at least one month after the last dose if their partner could become pregnant.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults: No overall difference in safety was observed in patients 70 and older compared to younger patients in clinical trials, though greater sensitivity in some older individuals cannot be ruled out.
- Liver disease: No formal studies have been done; the drug may accumulate more in patients with liver impairment. Close monitoring for toxicity is required.
- Diabetes, high triglycerides, or history of pancreatitis: These conditions increase the risk of pancreatitis with bexarotene — discuss with your prescriber before starting.
- Hypersensitivity: Do not use bexarotene gel if you have a known allergy to bexarotene or any component of the product.
🚑If you take too much▾
For the topical gel, significant overdose through the skin is unlikely because blood levels from normal use are already very low. There is no specific antidote for bexarotene overdose. If an overdose occurs, treatment is supportive — meaning managing whatever symptoms appear. Contact a Poison Control Center or seek emergency medical care immediately if overdose is suspected.
📡Pharmacodynamics — effects in the body▾
When taken orally, bexarotene causes significant, measurable changes in the body. It substantially raises blood triglyceride and total cholesterol levels while lowering HDL ("good") cholesterol in the majority of patients. It also reduces levels of thyroid hormone (T4) and thyroid-stimulating hormone (TSH), resulting in hypothyroidism in roughly half of patients. These lipid and thyroid changes are generally reversible when the drug is stopped or the dose is reduced.
🔬Pharmacokinetics — how your body processes it▾
When taken by mouth, bexarotene is absorbed within about two hours, and absorption is meaningfully higher (AUC and Cmax both increase) when taken with a fat-containing meal compared to a glucose solution — which is why it should always be taken with food. The drug is more than 99% bound to proteins in the blood. It is broken down primarily by the liver enzyme CYP3A4 into several metabolites, some of which remain active. The terminal half-life (the time it takes for half the drug to leave the body) is approximately seven hours. Bexarotene and its metabolites are not excreted significantly in the urine; the kidneys play only a minor role in elimination. When applied as a gel, blood levels are generally very low, though they can increase with larger areas of skin treated or more frequent application.
📦How to store it▾
Store at 2° to 25°C (36° to 77°F). Protect from light.
📄 Written from Bexarotene’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
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.
- Major · 4
- Moderate · 94
- Minor · 41
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.
🩺 Pharmacist Counseling Corner
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 — is it a chemotherapy? ▾
Why do I need so many blood tests while I'm on this medication? ▾
I've heard this medication can cause birth defects — what do I need to do? ▾
I'm using the gel — do I still need to worry about all these side effects? ▾
Are there any medications I should avoid while taking bexarotene capsules? ▾
How long will it take before I know if it's working? ▾
Is Bexarotene available over the counter? ▾
When was Bexarotene first available? ▾
Who makes Bexarotene? ▾
💬 Answers drafted from Bexarotene’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Bexarotene 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
How this form is used
- Bexarotene capsules are used to treat the skin manifestations of cutaneous T-cell lymphoma (CTCL) in patients who have not responded to at least one prior systemic therapy
- Targretin capsules are indicated for the same CTCL indication in patients refractory to at least one prior systemic therapy
- Bexarotene capsules and Targretin capsules are each taken as a single oral dose once daily with a meal
- The dose is based on body surface area — your prescriber will calculate the right number of capsules for you; do not adjust on your own
- If side effects become a problem, your doctor may reduce the dose; if there is no response after 8 weeks and the drug is well tolerated, the dose may be increased with careful monitoring
- Treatment may continue as long as you are benefiting, and has been given in clinical trials for up to 97 weeks
Topical cream, ointment or gel
How this form is used
- Targretin gel 1% is approved for the topical treatment of CTCL skin lesions in Stage IA and IB patients whose disease has persisted or returned after other therapies, or who could not tolerate other therapies
- Bexarotene gel 1% is approved for the same Stage IA and IB CTCL indication in patients with refractory or persistent disease or intolerance to other therapies
- Targretin gel and Bexarotene gel are each started at once every other day during the first week, then increased weekly to once, twice, three times, and up to four times daily based on how your skin tolerates it
- Apply enough gel to cover the lesion with a generous coating; let it dry completely before covering with clothing
- Avoid applying the gel to unaffected (normal) skin around the lesion and keep it away from mucosal surfaces (such as lips and eyes); do not use occlusive (airtight) dressings
- If severe skin irritation occurs, the gel can be temporarily stopped for a few days until symptoms improve, then restarted
📊 Bexarotene across the U.S. market
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.
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.
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
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.
How commonly is Bexarotene prescribed? Of the 1,596 medications we measure, Bexarotene ranks #1,432 by Medicaid prescriptions — more than 10% of them.
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.
bexarotene 0.01 MG/MG Topical Gel Most dispensed
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
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. × 2 listings | ANDA | View NDC → |
| 75 mg | Oral | Amneal Pharmaceuticals NY LLC × 2 listings | ANDA | View NDC → |
| 75 mg | Oral | ANI Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 75 mg | Oral | AvKARE × 2 listings | ANDA | View NDC → |
| 75 mg | Oral | Bausch Health US, LLC × 3 listings | NDA | View NDC → |
| 75 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 75 mg | — | Catalent Pharma Solutions, LLC | EXPORT ONLY | View NDC → |
| 75 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 75 mg | Oral | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 75 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 75 mg | Oral | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | View NDC → |
| 75 mg | — | Patheon Softgels Inc. × 3 listings | DRUG FOR FURTHER PROCESSING | View NDC → |
| 75 mg | Oral | Upsher-Smith Laboratories, Inc. × 2 listings | ANDA | View NDC → |
| 💊Topical cream, ointment or gel | ||||
| 10 mg/g | Topical | Amneal Pharmaceuticals NY LLC × 2 listings | ANDA | View NDC → |
| 1 g/100 g | Topical | Bausch Health US, LLC | NDA | View NDC → |
| 1 g/100 g | Topical | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Apicore Pharmaceuticals Private limited | BULK INGREDIENT | View NDC → |
| 1 kg | — | Catalent Micron Technologies, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 kg/kg | — | Chongqing Huapont Pharmaceutical Co Limited | BULK INGREDIENT | View NDC → |
| 15 kg/15 kg | — | Emcure Pharmaceuticals Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | HAS Healthcare Advanced Synthesis SA × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hetero Labs Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
Showing 35 of 35 products — FDA National Drug Code Directory. See every product, package size and price: browse all 35 Bexarotene NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Bexarotene — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Bexarotene in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Bexarotene went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 233272 2 dose forms · 2 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 379069In current FDA listingsClinical drug / strength (SCD) 75 MGRxCUI 308725 -
Dose form (SCDF) Topical Gel RxCUI 378079In current FDA listingsClinical drug / strength (SCD) 0.01 MG/MGRxCUI 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.
📦 Supply & shortage status
Whether Bexarotene is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Bexarotene belongs to the Retinoid class.
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.
🔬 Where this comes from
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 8 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Bausch Health US, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.