Leflunomide
Leflunomide is a once-daily oral tablet used to treat adults with active rheumatoid arthritis (RA), and it carries serious warnings about pregnancy and liver injury.
🧬 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 25 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 →
Leflunomide (Arava) is a disease-modifying medicine for adults with active rheumatoid arthritis that slows the immune cells attacking the joints by blocking an enzyme they need to multiply; a familiar alternative or partner to methotrexate since the late 1990s, it is available as a generic. Most people tolerate it reasonably well, and the side effects they notice most are diarrhea, nausea and some hair thinning. Its boxed warning covers harm to an unborn baby and severe liver injury, so avoid pregnancy, keep up with the liver and blood count tests, and report yellow skin or eyes, a new cough, a blistering rash or signs of infection quickly.
Clinical pearls
- Its active form can linger up to two years, so a cholestyramine or charcoal washout comes before any planned pregnancy.
- Methotrexate and other liver-straining drugs add to the liver and blood count risk, so tell every prescriber you take leflunomide.
- If you take warfarin, expect closer INR checks, because leflunomide can lower your INR (the blood clotting test).
- Avoid live vaccines such as the nasal flu spray, MMR or yellow fever while on it; inactivated shots are generally fine.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Leflunomide must not be used during pregnancy because it can cause birth defects and loss of the pregnancy. Women who could become pregnant need a negative pregnancy test before starting and must use effective contraception during treatment and during any drug elimination procedure afterward. If pregnancy happens, stop the medicine and tell your doctor right away.
It can also cause severe liver injury, including fatal liver failure. People with existing liver disease or high liver tests should not take it. Taking other drugs that can harm the liver raises the risk. Your doctor will check liver blood tests regularly. If liver injury is suspected, treatment is stopped and an elimination procedure is started. Watch for signs such as yellow skin or eyes and report them promptly.
Patient information guide A plain-language walkthrough of Leflunomide, written from its FDA label.
What Leflunomide is used for
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Leflunomide is used for one condition across the supported products.
- Active rheumatoid arthritis (RA) in adults, for Arava tablets and for leflunomide tablets.
How Leflunomide works
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Leflunomide blocks an enzyme (dihydroorotate dehydrogenase) that cells use to make pyrimidines, which are building blocks for new cells. This slows the growth of fast-dividing immune cells. It also has an anti-inflammatory effect.
After you swallow it, your body converts leflunomide to teriflunomide, which does essentially all of the work.
Leflunomide dosage
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Leflunomide is taken by mouth as a tablet once daily. Some people start with a short 3-day loading period. Others, such as those also taking methotrexate or other immune-suppressing drugs, start without one.
- Your prescriber may lower the dose if you cannot tolerate it.
- Food did not significantly change how much active drug reaches the blood.
- Follow your prescriber's directions and your pharmacy label, and ask your pharmacist what to do about a missed dose.
Dosing details from the FDA-approved label
From the Leflunomide 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.
- Patients at low risk for leflunomide-associated hepatotoxicity and myelosuppression (loading dose)
- 100 mg once daily for 3 days, then subsequently 20 mg once daily
- Maximum: 20 mg once per day
- The loading dose provides steady-state concentrations more rapidly.
- Patients at high risk for leflunomide-associated hepatotoxicity (e.g., those taking concomitant methotrexate) or myelosuppression (e.g., patients taking concomitant immunosuppressants)
- 20 mg once daily without a loading dose
- Maximum: 20 mg once per day
- Patients not able to tolerate 20 mg daily (those who experience any adverse events listed in Table 1)
- Consider dosage reduction to 10 mg once daily
- Monitor patients carefully after dosage reduction and after stopping therapy, since teriflunomide is slowly eliminated from the plasma.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Loading dosage for patients at low risk for leflunomide tablets -associated hepatotoxicity and leflunomide tablets-associated myelosuppression: 100 mg daily for 3 days. ( 2.1 ) Maintenance dosage: 20 mg daily. ( 2.1 ) Maximum recommended daily dosage: 20 mg once daily. ( 2.1 ) If 20 mg once daily is not tolerated, may decrease dosage to 10 mg once daily. ( 2.1 ) Screen patients for active and latent tuberculosis, pregnancy test (females), blood pressure, and laboratory tests before starting leflunomide tablets. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of leflunomide tablets is 20 mg once daily. Treatment may be initiated with or without a loading dose, depending upon the patient's risk of leflunomide tablets -associated hepatotoxicity and leflunomide tablets -associated myelosuppression. The loading dose provides steady-state concentrations more rapidly. For patients who are at low risk for leflunomide tablets -associated hepatotoxicity and leflunomide tablets - associated myelosuppression, the recommended leflunomide tablets loading dose is 100 mg once daily for 3 days. Subsequently administer 20 mg once daily. For patients at high risk for leflunomide tablets - associated hepatotoxicity (e.g., those taking concomitant methotrexate) or leflunomide tablets -associated myelosuppression (e.g., patients taking concomitant immunosuppressants), the recommended leflunomide tablets dosage is 20 mg once daily without a loading dose [see Warnings and Precautions ( 5.2 , 5.4 )]. The maximum recommended daily dose is 20 mg once per day. Consider dosage reduction to 10 mg once daily for patients who are not able to tolerate 20 mg daily (i.e., for patients who experience any adverse events listed in Table 1). Monitor patients carefully after dosage reduction and after stopping therapy with leflunomide tablets, since the active metabolite of leflunomide, teriflunomide, is slowly eliminated from the plasma [ see Clinical Pharmacology ( 12.3 ) ]. After stopping leflunomide tablets treatment, an accelerated drug elimination procedure is recommended to reduce the plasma concentrations of the active metabolite, teriflunomide [see Warnings and Precautions ( 5.3 )].
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Leflunomide side effects
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The most common side effects reported were:
Common side effects
- Diarrhea
- Nausea
- Headache
- Rash
- Hair loss (alopecia)
- Abnormal liver blood tests
- Respiratory infection
- Indigestion (dyspepsia)
When to get medical help
- Call your doctor right away if you think you might be pregnant while taking leflunomide.
- Get medical help for signs of liver problems, such as yellowing of the skin or eyes (jaundice).
- Call your doctor for fever or signs of a serious infection, or for unusual bruising or bleeding.
- Seek urgent care for a severe skin reaction, such as widespread blistering or peeling skin.
- Report new or worsening cough or shortness of breath, which may signal lung disease.
- Tell your doctor about numbness, tingling or pain in the hands or feet (possible nerve damage).
- Report skin ulcers that do not heal.
- Get emergency help for signs of a severe allergic reaction, such as swelling or trouble breathing.
Leflunomide warnings and precautions
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Birth defects and liver injury are the biggest risks and are covered in the boxed warning. Pregnancy must be excluded before starting, and effective contraception is needed.
- Infections, including tuberculosis, can occur. TB screening is done before starting.
- Blood cell counts can drop, so regular blood counts are needed.
- Rare severe skin reactions, skin ulcers, nerve damage and lung disease have been reported.
- Blood pressure can rise and should be monitored.
- Live vaccines are not recommended.
- The active drug stays in the body a long time, so an elimination procedure is often recommended after stopping.
Leflunomide interactions
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Leflunomide's active form can change how other drugs behave, and some drugs change its levels.
- Teriflunomide: should not be combined, because it is the same active drug.
- Methotrexate and other liver-toxic or immune-suppressing drugs: higher risk of liver and blood problems.
- Warfarin: INR may drop, so close monitoring is needed.
- Rifampin: may raise leflunomide's active levels.
- Birth control pills: hormone levels may rise.
- Rosuvastatin and other statins: lower doses may be needed.
- Drugs such as pioglitazone, repaglinide, theophylline, duloxetine and ciprofloxacin: levels may change.
Interactions listed in the FDA-approved label
From the Leflunomide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Rifampin (potent inducer of CYP and transporters): Rifampin increased the plasma concentration of teriflunomide by 40% with leflunomide; when co-administered with teriflunomide itself, rifampin did not affect its pharmacokinetics. No dosage adjustment is recommended; use caution if patients receive both because leflunomide concentrations may continue to increase with multiple dosing.
- CYP2C8 substrates (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone): Teriflunomide is an inhibitor of CYP2C8 in vivo, so exposure of these drugs may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) as required.
- Warfarin: Teriflunomide may decrease peak INR by approximately 25%. Requires close monitoring of the international normalized ratio (INR).
- Oral contraceptives (ethinylestradiol and levonorgestrel): Teriflunomide may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with leflunomide.
- CYP1A2 substrates (e.g., alosetron, duloxetine, theophylline, tizanidine): Teriflunomide may be a weak inducer of CYP1A2 in vivo, so exposure of these drugs may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) as required.
- OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine): Teriflunomide inhibits the activity of OAT3 in vivo, so exposure of these drugs may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) as required.
- Rosuvastatin: Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo. The dose of rosuvastatin should not exceed 10 mg once daily.
- Other BCRP substrates (e.g., mitoxantrone) and OATP family drugs (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, simvastatin): Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo, which may increase exposure to these drugs. Consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposure.
Read the label’s full interactions text
7 DRUG INTERACTIONS Following oral administration, leflunomide is metabolized to an active metabolite, teriflunomide, which is responsible for essentially all of leflunomide's in vivo activity. Drug interaction studies have been conducted with both leflunomide and with its active metabolite, teriflunomide, where the metabolite was directly administered to the test subjects. Effect of Potent CYP and Transporter Inducers Leflunomide is metabolized by CYP450 metabolizing enzymes. Concomitant use of leflunomide tablets and rifampin, a potent inducer of CYP and transporters, increased the plasma concentration of teriflunomide by 40%. However, when co-administered with the metabolite, teriflunomide, rifampin did not affect its pharmacokinetics. No dosage adjustment is recommended for leflunomide tablets when coadministered with rifampin. Because of the potential for leflunomide tablets concentrations to continue to increase with multiple dosing, caution should be used if patients are to be receiving both leflunomide tablets and rifampin [see Clinical Pharmacology ( 12.3 )]. Effect on CYP2C8 Substrates Teriflunomide is an inhibitor of CYP2C8 in vivo . In patients taking leflunomide tablets, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required [see Clinical Pharmacology ( 12.3 )]. Effect on Warfarin Coadministration of leflunomide tablets with warfarin requires close monitoring of the international normalized ratio (INR) because teriflunomide, the active metabolite of leflunomide tablets, may decrease peak INR by approximately 25%. Effect on Oral Contraceptives Teriflunomide may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with leflunomide tablets [ see Clinical Pharmacology ( 12.3 )].
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.
Before taking Leflunomide
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- Do not use during pregnancy. Use effective contraception if you could become pregnant.
- Do not breastfeed while taking it.
- Not for people with severe liver impairment, pre-existing liver disease or high ALT.
- Not for people allergic to leflunomide or taking teriflunomide.
- Tell your doctor about infections, TB, weak immunity, bone marrow problems or lung disease.
- Nerve damage risk may be higher if you are over 60, have diabetes or take other nerve-toxic medicines.
Leflunomide overdose
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Overdoses have caused diarrhea, abdominal pain, low white blood cells, anemia and abnormal liver tests. For a significant overdose, an accelerated drug elimination procedure is recommended. Dialysis does not remove the active drug.
What Leflunomide does in the body
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Leflunomide inhibits an enzyme needed to make pyrimidines, which slows the growth of fast-dividing cells such as immune cells. It also shows anti-inflammatory effects in experimental models.
How your body processes Leflunomide
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Leflunomide is converted in the body to teriflunomide, which is responsible for essentially all of its activity. Peak levels occur about 6 to 12 hours after a dose. Its half-life is about 18 to 19 days, which is why a loading dose may be used and why it can take up to 2 years to clear without an elimination procedure. It leaves the body through bile and stool and through urine, and dialysis does not remove it.
How to store Leflunomide
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Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Leflunomide
59 supplements and herbal products have documented interactions with Leflunomide 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 · 46
- Minor · 9
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.
Leflunomide: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Leflunomide — the kind of thing our pharmacy team would talk through with you at the counter.
What is leflunomide used for?
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How do I take it?
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What blood tests will I need?
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Can I take it if I might get pregnant?
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What side effects are normal, and which need a call?
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Will it interact with my other medicines?
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Is Leflunomide available over the counter?
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When was Leflunomide first available?
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Who makes Leflunomide?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Leflunomide on HelloPharmacist
Leflunomide forms and strengths (how it comes)
Leflunomide is available in 1 form. 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Leflunomide inactive ingredients by manufacturer.
Tablet
How this form is used
- Arava is used to treat adults with active rheumatoid arthritis.
- Leflunomide tablets are used to treat adults with active rheumatoid arthritis.
- Arava is taken by mouth once daily, with or without a loading period depending on risk of liver and blood-cell problems.
- Leflunomide tablets are taken by mouth once daily, with or without a loading period depending on risk of liver and blood-cell problems.
- Leflunomide tablets: a high-fat meal did not significantly change levels of the active drug.
Leflunomide on the U.S. market: products, makers and brands
How Leflunomide 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.
17 companies list 40 Leflunomide product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1998. Brand names on the directory include Arava; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (7) — 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 Leflunomide is used (Medicaid data)
A general measure of how commonly Leflunomide 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 Leflunomide 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 Leflunomide prescribed? Of the 1,601 medications we measure, Leflunomide ranks #506 by Medicaid prescriptions — more than 68% of them.
Utilization by Leflunomide 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.
leflunomide 20 MG Oral Tablet Most dispensed
Summed across the 7 of 47 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 205285
leflunomide 10 MG Oral Tablet
Summed across the 6 of 37 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 205284
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 Leflunomide, 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 13 of 84 listed Leflunomide NDCs with Medicaid activity.
Compare Leflunomide products
A representative set of FDA-listed product records for Leflunomide — 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 |
|---|---|---|---|---|
| 💊Tablet | ||||
| 20 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 20 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 20 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 20 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 10 mg | Oral | AvKARE | ANDA | View NDC → |
| 20 mg | Oral | AvKARE | ANDA | View NDC → |
| 10 mg | Oral | AvPAK | ANDA | View NDC → |
| 20 mg | Oral | AvPAK | ANDA | View NDC → |
| 10 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 20 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 10 mg | Oral | Burel Pharmaceuticals, LLC | ANDA | View NDC → |
| 20 mg | Oral | Burel Pharmaceuticals, LLC | ANDA | View NDC → |
| 10 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 20 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 10 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg | Oral | KVK-Tech, Inc. | ANDA | View NDC → |
| 20 mg | Oral | KVK-Tech, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | sanofi-aventis U.S. LLC | NDA | View NDC → |
| 20 mg | Oral | sanofi-aventis U.S. LLC | NDA | View NDC → |
| 100 mg | Oral | sanofi-aventis U.S. LLC | NDA | View NDC → |
| 10 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 20 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 10 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 20 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
Showing 40 of 40 products — FDA National Drug Code Directory. See every product, package size and price: browse all 40 Leflunomide NDCs →
Leflunomide side effects reported to the 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 Leflunomide — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Leflunomide are rheumatoid arthritis, pain, arthralgia; about 82% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
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 Leflunomide 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.
Leflunomide FDA approval history
How Leflunomide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Leflunomide was first approved by the FDA in 1998 (Brand: ARAVA · Sanofi Aventis Us); the first generic version was approved in 2005. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Leflunomide 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 Leflunomide recalls since July 2021.
✅No Leflunomide recalls on record since July 2021Source: 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.
RxCUI 27169 1 dose form · 3 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 372570In current FDA listings
Look up RxCUI 27169 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.
Leflunomide supply and shortage status
Whether Leflunomide 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.
Leflunomide is not in shortage right now; the FDA has 5 past shortage records for it.
✅No current shortage of Leflunomide on recordRead the full Leflunomide shortage page — affected NDCs, other makers, and what to do →
Source: openFDA, from the FDA Drug Shortages database.
💵 What Leflunomide costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Nov 23, 2022). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 10 mg | $0.413 per tablet | NDC details & price history |
| Tablet · Oral | 20 mg | $0.549 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Leflunomide brand names
Leflunomide is sold under one brand name in the FDA directory — Arava. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Leflunomide: manufacturers and labelers
17 companies list Leflunomide products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, sanofi-aventis U.S. LLC, A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Leflunomide drug class (RxNorm)
Leflunomide belongs to the Antirheumatic Agent 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.
Sources for this Leflunomide 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.
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. sanofi-aventis U.S. 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 →