Is Leflunomide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Leflunomide, including ARAVA 10MG FILM COATED TABLETS (10 mg, Film-coated tablet, SAR 111.40); ARAVA 20MG FILM COATED TABLETS (20 mg, Film-coated tablet, SAR 160.60); Arthfre (20 mg, Film-coated tablet, SAR 144.55); RHEUFACT 10MG FILM COATED TABLETS (10 mg, Film-coated tablet, SAR 105.85); RHEUFACT 20MG FILM COATED TABLETS (20 mg, Film-coated tablet, SAR 152.55).

Is Leflunomide approved by the US FDA?

Drugs@FDA lists 14 application product lines for Leflunomide, including ARAVA (Prescription); LEFLUNOMIDE (Prescription); LEFLUNOMIDE (Prescription); LEFLUNOMIDE (Prescription); LEFLUNOMIDE (Prescription).

Is Leflunomide authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Leflunomide: Arava, Leflunomide Zentiva (previously Leflunomide Winthrop), Leflunomide medac, Leflunomide ratiopharm.

Are there safety signals or safety updates for Leflunomide?

EMA PRAC: 10 entries; US FDA: 1 entry (latest 2025-03-13).

Active substance

Leflunomide

SFDA 5
US FDA 14
EMA 6
Health Canada 18
US price lines 2
NHS prices 3
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ARAVA 10MG FILM COATED TABLETS	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 111.40	NCE · Prescription	sanofi-aventis	Valid
ARAVA 20MG FILM COATED TABLETS	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 160.60	NCE · Prescription	sanofi-aventis	Valid
Arthfre	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 144.55	Generic · Prescription	Eva pharma for Industry	Valid
RHEUFACT 10MG FILM COATED TABLETS	10 mg	Film-coated tablet · Oral use	30 Box	SAR 105.85	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
RHEUFACT 20MG FILM COATED TABLETS	20 mg	Film-coated tablet · Oral use	30 Box	SAR 152.55	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

Indications — CHI Daman Drug Formulary

ANKYLOSING SPONDYLITIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; GRANULOMATOSIS WITH POLYANGIITIS AND MICROSCOPIC POLYANGIITIS; JUVENILE IDIOPATHIC ARTHRITIS (JIA); PSORIATIC ARTHRITIS; RHEUMATOID ARITHRITIS; SARCOIDOSIS; SJOGREN'S SYNDROME

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ARAVA	10MG; 20MG	tablet · oral	SANOFI AVENTIS US	Prescription	10 Sep 1998
LEFLUNOMIDE	10MG; 20MG	tablet · oral	HERITAGE	Prescription	13 Sep 2005
LEFLUNOMIDE	10MG; 20MG	tablet · oral	FOSUN WANBANG	Prescription	13 Sep 2005
LEFLUNOMIDE	10MG; 20MG	tablet · oral	APOTEX	Prescription	13 Sep 2005
LEFLUNOMIDE	10MG; 20MG	tablet · oral	ALEMBIC PHARMS LTD	Prescription	21 Nov 2011
LEFLUNOMIDE	10MG; 20MG	tablet · oral	ZYDUS LIFESCIENCES	Prescription	24 Apr 2019
LEFLUNOMIDE	10MG; 20MG	tablet · oral	ABHAI LLC	Prescription	3 Jun 2019
LEFLUNOMIDE	10MG; 20MG	tablet · oral	LUPIN	Prescription	4 Feb 2020
LEFLUNOMIDE	10MG; 20MG	tablet · oral	AUROBINDO PHARMA	Prescription	29 Mar 2021
LEFLUNOMIDE	10MG; 20MG	tablet · oral	AET PHARMA	Prescription	10 May 2021
ARAVA	100MG	tablet · oral	SANOFI AVENTIS US	Discontinued	10 Sep 1998
LEFLUNOMIDE	10MG; 20MG	tablet · oral	BARR	Discontinued	13 Sep 2005
LEFLUNOMIDE	10MG; 20MG	tablet · oral	TEVA PHARMS	Discontinued	13 Sep 2005
LEFLUNOMIDE	10MG; 20MG	tablet · oral	SANDOZ	Discontinued	13 Sep 2005

EMA European Union — centrally authorised medicines

Arava Sanofi-aventis Deutschland GmbH · Authorised · authorised 2 Sep 1999 · ATC L04AK01

Therapeutic indication (EMA)

Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Leflunomide Zentiva (previously Leflunomide Winthrop) Zentiva k.s. · Authorised · authorised 8 Jan 2010 · ATC L04AK01

Therapeutic indication (EMA)

Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH · Authorised · authorised 27 Jul 2010 · ATC L04AK01

Therapeutic indication (EMA)

Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD). Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Leflunomide ratiopharm Ratiopharm GmbH · Authorised · authorised 28 Nov 2010 · ATC L04AK01

Therapeutic indication (EMA)

Leflunomide Teva Teva Pharma B.V. · Lapsed · authorised 10 Mar 2011 · ATC L04AA13

Therapeutic indication (EMA)

Leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD). Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Repso Teva B.V. · Withdrawn · authorised 14 Mar 2011 · ATC L04AA13

Therapeutic indication (EMA)

Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a ‘disease-modifying antirheumatic drug’ (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACCEL-LEFLUNOMIDE	02478862	10 MG	TABLET · ORAL	ACCEL PHARMA INC
ACCEL-LEFLUNOMIDE	02478870	20 MG	TABLET · ORAL	ACCEL PHARMA INC
APO-LEFLUNOMIDE	02256495	10 MG	TABLET · ORAL	APOTEX INC
APO-LEFLUNOMIDE	02256509	20 MG	TABLET · ORAL	APOTEX INC
ARAVA	02241888	10 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC
ARAVA	02241889	20 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC
LEFLUNOMIDE	02351668	10 MG	TABLET · ORAL	SANIS HEALTH INC
LEFLUNOMIDE	02351676	20 MG	TABLET · ORAL	SANIS HEALTH INC
LEFLUNOMIDE	02543575	10 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
LEFLUNOMIDE	02543583	20 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
MAR-LEFLUNOMIDE	02551918	10 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-LEFLUNOMIDE	02551926	20 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
PRO-LEFLUNOMIDE	02415828	10 MG	TABLET · ORAL	PRO DOC LIMITEE
PRO-LEFLUNOMIDE	02415836	20 MG	TABLET · ORAL	PRO DOC LIMITEE
SANDOZ LEFLUNOMIDE	02283964	10 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ LEFLUNOMIDE	02283972	20 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TEVA-LEFLUNOMIDE	02261251	10 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-LEFLUNOMIDE	02261278	20 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	LEFLUNOMIDE 10 MG TABLET	$0.32368	per EA	23 Sep 2026
US NADAC	LEFLUNOMIDE 20 MG TABLET	$0.29435	per EA	23 Sep 2026
NHS Drug Tariff	Leflunomide 10mg tablets	£7.39	30 tablet	1 Oct 2026
NHS Drug Tariff	Leflunomide 15mg tablets	£46.00	30 tablet	1 Oct 2026
NHS Drug Tariff	Leflunomide 20mg tablets	£7.55	30 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

EMA PRAC 13 Mar 2025 PRAC signal: Pulmonary nodule
Action for MAH: update of the product information: No
US FDA 28 Jun 2024 ARAVA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 6 Apr 2017 PRAC signal: Falsely decreased ionised calcium levels
Action for MAH: update of the product information: Yes
EMA PRAC 1 Dec 2016 PRAC signal: Falsely decreased ionised calcium levels
Action for MAH: update of the product information: No
EMA PRAC 10 Sep 2015 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: Yes
EMA PRAC 7 May 2015 PRAC signal: Colitis
Action for MAH: update of the product information: Yes
EMA PRAC 10 Apr 2015 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No
EMA PRAC 9 Jan 2015 PRAC signal: Colitis
Action for MAH: update of the product information: No
EMA PRAC 7 Nov 2013 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: Yes
EMA PRAC 13 Jun 2013 PRAC signal: Myositis
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2012 PRAC signal: Myositis
Action for MAH: update of the product information: No

All safety entries for leflunomide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.