Leflunomide — Membership Pricing

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Also listed for Rheumatoid Arthritis

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• Methotrexate
• Prednisone
• Sulfasalazine

What Leflunomide is approved for (FDA label)

Leflunomide Tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. ( 1 )

Source: Read the full FDA label on DailyMed. Label effective date: May 1, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Leflunomide (FDA label)

WARNING: 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 leflunomide 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 leflunomide and use 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 leflunomide use in patients with pre-existing liver disease, or those with serum alanine aminotransferase (ALT) >2 × ULN. ( 5.2 , 8.6 ) Use caution when leflunomide is given with other potentially hepatotoxic drugs. ( 5.2 ) Monitor ALT levels. Interrupt leflunomide 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 Leflunomide 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. Exclude pregnancy before the start of treatment with leflunomide in females of reproductive potential.

Source: FDA prescribing information (DailyMed). Set ID: fc044417-cd9a-42f6-8a3d-a14e7c2f81a2. SPL document ID: 363d62c4-ffe0-40ae-8f11-4223e91e1719. Label effective date: May 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Leflunomide (FDA label)

Leflunomide Tablets, USP are available in two strengths: Tablets: 10 mg, supplied as white to off-white, round, biconvex film-coated tablets debossed with "10" on one side and "LFL" on the other side. Tablets: 20 mg, supplied as white to off-white, round, biconvex film-coated tablets debossed with "20" on one side and "LFL" on the other side. Tablets: 10 mg, 20 mg. ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: fc044417-cd9a-42f6-8a3d-a14e7c2f81a2. SPL document ID: 363d62c4-ffe0-40ae-8f11-4223e91e1719. Label effective date: May 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Leflunomide (FDA label)

The following serious adverse reactions are described elsewhere in the labeling: Hepatotoxicity [see Warnings and Precautions (5.2) ] Immunosuppression [see Warnings and Precautions (5.4) ] Bone marrow suppression [see Warnings and Precautions (5.4) ] Serious infections [see Warnings and Precautions (5.4) ] Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions with eosinophilia and systemic symptoms [see Warnings and Precautions (5.5) ] Skin ulcers [see Warnings and Precautions (5.6) ] Peripheral neuropathy [see Warnings and Precautions (5.8) ] Interstitial lung disease [see Warnings and Precautions (5.9) ] The most commonly reported adverse reactions (≥10%) regardless of relation to leflunomide treatment were diarrhea, respiratory infection, nausea, headache, rash, abnormal liver enzymes, and dyspepsia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AET Pharma US Inc, USA at 1-833-610-1604 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: fc044417-cd9a-42f6-8a3d-a14e7c2f81a2. SPL document ID: 363d62c4-ffe0-40ae-8f11-4223e91e1719. Label effective date: May 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Leflunomide (FDA label)

Leflunomide is contraindicated in: Pregnant women. Leflunomide may cause fetal harm. If a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see Warnings and Precautions (5.1 , 5.3) and Use in Specific Populations (8.1) ]. Patients with severe hepatic impairment [see Warnings and Precautions (5.2) ]. Patients with known hypersensitivity to leflunomide or any of the other components of leflunomide. Known reactions include anaphylaxis [see Adverse Reactions (6.1) ]. Patients being treated with teriflunomide [see Drug Interactions (7) ]. Pregnancy. ( 4 , 5.1 , 8.1 ) Severe hepatic impairment. ( 4 , 5.2 ) Hypersensitivity to leflunomide or any of its inactive components. ( 4 ) Current teriflunomide treatment. ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: fc044417-cd9a-42f6-8a3d-a14e7c2f81a2. SPL document ID: 363d62c4-ffe0-40ae-8f11-4223e91e1719. Label effective date: May 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Leflunomide (FDA label)

After stopping leflunomide, it is recommended that an accelerated drug elimination procedure be used to reduce the plasma concentrations of the active metabolite, teriflunomide. ( 5.3 ) Severe infections (including sepsis), pancytopenia, agranulocytosis, and thrombocytopenia: Stop leflunomide and use accelerated elimination procedure. Do not start leflunomide in patients with active infection. Monitor CBCs during treatment with leflunomide. ( 5.4 ) Stevens-Johnson syndrome and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS): Stop leflunomide and use accelerated elimination procedure. ( 5.5 ) Skin ulcers: If skin ulcer is suspected, discontinue leflunomide treatment and consider an accelerated drug elimination procedure. ( 5.6 ) Peripheral neuropathy: If patient develops symptoms consistent with peripheral neuropathy, evaluate patient and consider discontinuing leflunomide. ( 5.8 ) Interstitial lung disease: May be fatal.

Source: FDA prescribing information (DailyMed). Set ID: fc044417-cd9a-42f6-8a3d-a14e7c2f81a2. SPL document ID: 363d62c4-ffe0-40ae-8f11-4223e91e1719. Label effective date: May 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Leflunomide (FDA label)

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. 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.

Source: FDA prescribing information (DailyMed). Set ID: fc044417-cd9a-42f6-8a3d-a14e7c2f81a2. SPL document ID: 363d62c4-ffe0-40ae-8f11-4223e91e1719. Label effective date: May 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.