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Leflunomide

Arava, Leflunomide Zentiva (previously Leflunomide Winthrop) · ATC code L04AK01

Also known as: Leflunomid, Léflunomide, Leflunomida · Brand names: Arava, Leflunomide Zentiva, Leflon, Leflunomid Stada, Aramid, As-Lunex, Bageda, Lefumix, Lypathia, Ralef, Reumil

Key facts
Active substance
Leflunomide
Drug class
Immunosuppressive drug
ATC code
L04AK01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Arava 10 mg film-coated tablets · Arava 20 mg film-coated tablets · Arava 100 mg film-coated tablets · Leflunomide Zentiva 10 mg film-coated tablets · Leflunomide Zentiva 20 mg film-coated tablets · Leflunomide Zentiva 100 mg film-coated tablets
Marketing authorisation holder
Sanofi-aventis Deutschland GmbH, Zentiva k.s.
Information as of
2026-10-27

Key facts

Leflunomide is an immunomodulating disease-modifying antirheumatic drug (DMARD). It is used in adults with active rheumatoid arthritis and active psoriatic arthritis.

What it is used for

  • Active rheumatoid arthritis in adults (as a DMARD)
  • Active psoriatic arthritis in adults

Dosing

  • Rheumatoid arthritis: usually a loading dose of 100 mg once daily for 3 days, then 10 mg to 20 mg once daily depending on disease activity; omitting the loading dose may lower the risk of adverse events
  • Psoriatic arthritis: 100 mg once daily for 3 days, then 20 mg once daily
  • Effect usually starts after 4 to 6 weeks and may improve up to 4 to 6 months
  • ALT and full blood count before starting, every two weeks for the first six months, then every 8 weeks
  • No adjustment in mild renal insufficiency or above 65 years; not recommended below 18 years

Contraindications

  • Hypersensitivity (especially previous Stevens-Johnson syndrome, TEN, erythema multiforme), including to teriflunomide
  • Impaired liver function; moderate to severe renal insufficiency
  • Severe immunodeficiency, significantly impaired bone marrow function, serious infections
  • Severe hypoproteinaemia; pregnancy

Important warnings

  • Rare severe liver injury, including fatal cases, mostly in the first 6 months; adhere strictly to monitoring
  • Active metabolite has a long half-life (usually 1 to 4 weeks); use the washout procedure (colestyramine or activated charcoal) if toxicity occurs
  • Concomitant hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) are not advisable
  • Switching to another DMARD without washout may increase the risk of serious adverse reactions

Side effects

  • Most frequent include mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness
  • Diarrhoea, nausea, vomiting, oral mucosal disorders, abdominal pain
  • Increased hair loss, eczema, rash, pruritus, dry skin
  • Elevated liver parameters (especially ALT), weight loss, asthenia

Interactions

  • Hepatotoxic or haematotoxic medicines: more side effects; monitor liver enzymes and blood counts closely after switching
  • Methotrexate: liver enzyme elevations in a small study
  • Colestyramine and activated charcoal rapidly lower levels of the active metabolite

Pregnancy and breastfeeding

  • Contraindicated in pregnancy (suspected to cause serious birth defects)
  • Effective contraception during and up to 2 years after treatment, or up to 11 days after a washout procedure

Summary of the official product information, written with AI on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Germany

  • LeflonHeumann Pharma Gmbh & Co. Generica Kg · 2 register entries
  • Leflunomid1 A Pharma Gmbh, Bluefish Pharmaceuticals Ab, Tillomed Pharma Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Aristo Pharma Gmbh (Art 57), Hexal Ag, Puren Pharma Gmbh & Co. Kg, Stadapharm Gmbh, Aliud Pharma Gmbh · 9 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Austria

  • Leflunomid StadaStada Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AramidKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 3 register entries
  • AravaSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 3 register entries
  • As-LunexAPOTEX İLAÇ SAN VE TİC. LTD. ŞTİ. · 2 register entries
  • BagedaWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • LefumixNEUTEC İLAÇ SAN. TİC. A.Ş · 3 register entries
  • LypathiaARDİ FARMA İLAÇ PAZARLAMA TİC. LTD. ŞTİ. · 2 register entries
  • RalefGENVEON İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • ReumilABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 24 more European countries
Belgium
Leflunomid Sandoz, Leflunomide Ab
Bulgaria
Багеда
Cyprus
Arotan
Czechia
Leflon, Leflugen, Leflunomid Sandoz, Leflunopharm
Denmark
Leflunomid
Estonia
Leflunomide Elvim
Finland
Leflunomide Orion, Leflunomide Stada
France
Leflunomide Arrow, Leflunomide Biogaran, Leflunomide Eg, Leflunomide Viatris
Greece
Lefid, Lefluonia
Hungary
Leflunomid Sandoz
Iceland
Arava, Leflunomide Medac, Leflunomide Ratiopharm, Leflunomide Zentiva
Ireland
Leflunomide Aspire Pharma (Malta)
Italy
Leflunomide Aurobindo, Leflunomide Mylan, Leflunomide Sandoz
Latvia
Leflunomide Elvim, Leflunomide Sandoz
Liechtenstein
Arava, Leflunomide Medac, Leflunomide Ratiopharm, Leflunomide Zentiva
Lithuania
Leflunomide Elvim, Leflunomide Sandoz
Malta
Leflunomide Normon
Netherlands
Leflunomide Aurobindo, Leflunomide Cf, Leflunomide Sandoz, Leflunomide Tillomed, Leflunomide Viatris
Norway
Arava, Leflunomide Medac, Leflunomide Ratiopharm, Leflunomide Zentiva
Poland
Leflunomid Bluefish, Leflunomid Egis, Leflunomide Aurovitas, Leflunomide Orion, Leflunomide Sandoz
Portugal
Leflunomida Farmoz, Leflunomida Generis, Leflunomida Pentafarma
Romania
Leflon, Leflunomidă Arena, Leflunomidă Sandoz
Spain
Lefluartil, Leflunomida Aurovitas, Leflunomida Cinfa, Leflunomida Normon, Leflunomida Pharmathen, Leflunomida Stada, Leflunomida Tillomed, Leflunomida Viatris
Sweden
Leflunomid Bluefish

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Arava – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/arava-epar-product-information_en.pdf
  2. European Medicines Agency. Leflunomide Zentiva (previously Leflunomide Winthrop) – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/leflunomide-zentiva-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  6. Wikidata (CC0): ATC L04AK.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.