Prescription medicine
Leflunomide Brand names: Arava
Leflunomide (Arava) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.324 per leflunomide 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the leflunomide FDA label on DailyMed (effective June 4, 2025, sanofi-aventis U.S. LLC); the NDA 20905 record on Drugs@FDA; every leflunomide label on DailyMed.
Highlights of the record
FDA label of June 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
EMBRYO-FETAL.
TOXICITY and HEPATOTOXICITY WARNING: EMBRYO-FETAL TOXICITY and HEPATOTOXICITY See full prescribing information for complete boxed warning. Embryo-Fetal Toxicity Teratogenicity and embryo-lethality occurred in animals administered leflunomide. ( 5.1 , 8.1 ) Exclude pregnancy prior to initiating ARAVA therapy. ( 5.1 , 8.3 ) Advise use of effective contraception in females of reproductive potential during treatment and during a drug elimination procedure. ( 5.1 , 5.3 , 8.3 ) Stop ARAVA and use an accelerated drug elimination procedure if the patient becomes pregnant. ( 5.1 , 5.3 , 8.1 ) Hepatotoxicity Severe liver injury and fatal liver failure have been reported. ( 5.2 ) Avoid ARAVA use in patients with pre-existing liver disease, or those with serum alanine aminotransferase (ALT) >2 × ULN. ( 5.2 , 8.6 ) Use caution when ARAVA is given with other potentially hepatotoxic drugs. ( 5.2 ) Monitor ALT levels. Interrupt ARAVA treatment if ALT elevation >3-fold ULN. If likely leflunomide-induced, start accelerated drug elimination procedure and monitor liver tests weekly until normalized. ( 5.2 , 5.3 ) Embryo-Fetal Toxicity ARAVA is contraindicated for use in pregnant women because of the potential for fetal harm. Teratogenicity and embryo-lethality occurred in animals administered leflunomide at doses lower than the human exposure level. […]
Used for
From the label: indications and usageARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA).
Forms and strengths
- 10 mg
- 20 mg
- 100 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- September 10, 1998 Arava, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first September 13, 2005; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 16 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.324 per tablet Leflunomide 10 mg tablet
- Shortage (FDA)
- None current 5 past records
- Recalls by its makers (FDA)
- 2 since 2007 0 Class I among all firms' recalls; latest June 14, 2007; 1 more by firms not listed as its makers
- FAERS reports
- 104,036 through July 30, 2026
What is leflunomide used for?
From the label: indications and usageARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA). ARAVA is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis.
Conditions named in the indications of leflunomide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Antirheumatic Agent.
Source: FDA drug label (Arava), sanofi-aventis U.S. LLC, effective June 4, 2025 (SPL set 320f63f2-fac3-4aee-aff8-85724e00ef52), via openFDA; the full label on DailyMed
Is there a generic for leflunomide (Arava)?
The FDA approved the first generic leflunomide on September 13, 2005. 12 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists leflunomide from 16 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2005 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for leflunomide (Arava)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.324 per Leflunomide 10 mg tablet, down 7% from $0.349 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Leflunomide 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Leflunomide 10 mg tablet | Generic | $0.324 per tablet | $9.71 | -7% |
| Leflunomide 20 mg tablet | Generic | $0.294 per tablet | $8.83 | -10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is leflunomide in shortage?
No leflunomide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 5 records are all marked to be discontinued, the latest updated June 8, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Arava, Tablet, 10 mg (NDC 0088-2160-30) | Sanofi-Aventis U.S. LLC | To Be Discontinued | June 8, 2026 |
| Arava, Tablet, 100 mg (NDC 0088-2162-33) | Sanofi-Aventis U.S. LLC | To Be Discontinued | June 8, 2026 |
| Arava, Tablet, 20 mg (NDC 0088-2161-30) | Sanofi-Aventis U.S. LLC | To Be Discontinued | June 8, 2026 |
| Leflunomide, Tablet, 10 mg (NDC 0955-1735-30) | Sanofi-Aventis U.S. LLC | To Be Discontinued | June 8, 2026 |
| Leflunomide, Tablet, 20 mg (NDC 0955-1737-30) | Sanofi-Aventis U.S. LLC | To Be Discontinued | June 8, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has leflunomide been recalled?
The FDA's Enforcement Report lists 3 recalls naming leflunomide since 2007: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of leflunomide and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg, NDC 00143314250, Pedigree: W002645 … |
| June 14, 2007 | Class II | Apotex Corp. | Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the leflunomide label say about other medicines?
The leflunomide label names 26 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name leflunomide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alosetron | drug interactions | In patients taking ARAVA, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. |
| Atorvastatin | drug interactions | For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and … |
| Cefaclor | drug interactions | In patients taking ARAVA, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. |
| Cholestyramine | warnings and precautions | Elimination can be accelerated by the following procedures: Administer cholestyramine 8 grams orally 3 times daily for 11 days. |
| Cimetidine | drug interactions | In patients taking ARAVA, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. |
| Ciprofloxacin | drug interactions | In patients taking ARAVA, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. |
| Duloxetine | drug interactions | In patients taking ARAVA, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. |
| Furosemide | drug interactions | In patients taking ARAVA, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. |
| Ketoprofen | drug interactions | In patients taking ARAVA, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. |
| Levonorgestrel | drug interactions | Drugs metabolized by CYP2C8 and OAT3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs. ( 7 ) Teriflunomide may increase exposure of ethinylestradiol and levonorgestrel. |
| Methotrexate | drug interactions | In patients taking ARAVA, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. |
| Mitoxantrone | drug interactions | For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and … |
| Nateglinide | drug interactions | For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and … |
| Paclitaxel | drug interactions | In patients taking ARAVA, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. |
Every other medicine the leflunomide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Penicillin g | drug interactions | In patients taking ARAVA, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. |
| Pioglitazone | drug interactions | In patients taking ARAVA, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. |
| Pravastatin | drug interactions | … especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs … |
| Repaglinide | drug interactions | In patients taking ARAVA, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. |
| Rifampin | drug interactions | Concomitant use of ARAVA and rifampin, a potent inducer of CYP and transporters, increased the plasma concentration of teriflunomide by 40%. |
| Rosuvastatin | drug interactions | The dose of rosuvastatin should not exceed 10 mg once daily in patients taking ARAVA. ( 7 ) Effect of Potent CYP and Transporter Inducers Leflunomide is metabolized by CYP450 metabolizing enzymes. |
| Simvastatin | drug interactions | … inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased … |
| Teriflunomide | contraindications | Patients being treated with teriflunomide [see Drug Interactions (7) ]. |
| Theophylline | drug interactions | In patients taking ARAVA, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. |
| Tizanidine | drug interactions | In patients taking ARAVA, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. |
| Warfarin | drug interactions | Effect on Warfarin Coadministration of ARAVA with warfarin requires close monitoring of the international normalized ratio (INR) because teriflunomide, the active metabolite of ARAVA, may decrease … |
| Zidovudine | drug interactions | In patients taking ARAVA, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. |
Source: FDA drug label (Arava), sanofi-aventis U.S. LLC, effective June 4, 2025 (SPL set 320f63f2-fac3-4aee-aff8-85724e00ef52), via openFDA; the full label on DailyMed
What do FAERS reports show for leflunomide?
The FDA Adverse Event Reporting System holds 104,036 reports that list leflunomide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,331 are coded as a death and 28,778 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as leflunomide?
9 other medicines are given the same way (oral) and in the same FDA class as leflunomide or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Hydroxychloroquine | Rheumatoid arthritis | 28 labelers | $0.149 per tablet 200 mg tablet | A presentation being discontinued |
| Penicillamine | Rheumatoid arthritis | 9 labelers | n/a | No current entry |
| Indomethacin | Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Tofacitinib | Rheumatoid arthritis | 24 labelers | $0.573 per tablet 5 mg tablet | No current entry |
| Methotrexate | Rheumatoid arthritis | 25 labelers | $0.158 per tablet 2.5 mg tablet | In shortage |
| Baricitinib | Rheumatoid arthritis | none listed | $92.54 per tablet 2 mg tablet | No current entry |
| Flurbiprofen | Rheumatoid arthritis | 3 labelers | $3.17 per tablet 100 mg tablet | No current entry |
| Upadacitinib | Rheumatoid arthritis | none listed | $229.31 per tablet 15 mg tablet | No current entry |
Every medicine labeled for the same conditions as leflunomide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does leflunomide compare with medicines for the same use?
4 side-by-side pages set leflunomide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to leflunomide
- 9 medicines for the same use
- Other antirheumatic agents
- the pharmacologic class, with prices and generics
- Leflunomide side effects
- the label's list beside FAERS reports
- Leflunomide shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other