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Leflunomide

Leflunomide is an active ingredient of the class «immunosuppressive drug».

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Chemical compound

Informational only — not medical advice. Ask a doctor or pharmacist; never change a dose on your own.

Boxed warning (US label)

EMBRYO-FETAL TOXICITY and HEPATOTOXICITY WARNING: EMBRYO-FETAL TOXICITY and HEPATOTOXICITY Embryo-Fetal Toxicity Teratogenicity and embryo-lethality occurred in animals administered leflunomide.

What it is used for

ARAVA 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.

US label

Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis.

EMA

How it works

Class: immunosuppressive drug

Common side effects

The following serious adverse reactions are described elsewhere in the labeling: Hepatotoxicity Immunosuppression Bone marrow suppression Serious infections Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions with eosinophilia and systemic symptoms Skin ulcers Peripheral neuropathy Interstitial…

US label

Who should not take it

ARAVA is contraindicated in: Pregnant women. ARAVA may cause fetal harm. If a woman becomes pregnant while taking this drug, stop ARAVA, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure.

US label

Pregnancy and breastfeeding

Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARAVA during pregnancy.

Excerpts from the US prescribing label (public domain), copied without changes.

Interactions

Recorded interactions from open sources (Wikidata, US labels). The list is not complete — ask a pharmacist.

Brand names

United States

Arava

European Union

Arava · Leflunomide Zentiva (previously Leflunomide Winthrop)

Canada

Accel-Leflunomide · Apo-Leflunomide · Mar-Leflunomide · Odan-Leflunomide · Pro-Leflunomide · Sandoz Leflunomide · Teva-Leflunomide

Approval status

US Food and Drug Administration
prescription · since 1998
European Medicines Agency
authorised · since 1999
Health Canada
prescription · marketed
First approval anywhere
1998

Codes

ATC
L04AA13, L04AK01
RxNorm CUI
27169
ChEMBL
CHEMBL960
PubChem CID
3899
UNII
G162GK9U4W
Wikidata
Q248550

Frequently asked questions

What is Leflunomide used for?

Leflunomide is used for: Rheumatoid arthritis, Arthritis, and Psoriatic arthritis.

What kind of medicine is Leflunomide?

Leflunomide is an active ingredient of the class «immunosuppressive drug».

What are the brand names of Leflunomide?

Brand names of Leflunomide include Arava, Leflunomide Zentiva (previously Leflunomide Winthrop), Accel-Leflunomide, Apo-Leflunomide, Mar-Leflunomide, Odan-Leflunomide, Pro-Leflunomide, and Sandoz Leflunomide.

Medicines in the same class

Sources and licences

Updated November 15, 2026