Leflunomide
Dihydroorotate Dehydrogenase (Dhodh) Inhibitors
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- Drug class
- Dihydroorotate Dehydrogenase (Dhodh) Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 61
- FDA reports (12 mo)
- 4,050
Overview
Plain-language summary, compiled from the cited regulatory records
Leflunomide is a medication classified as a dihydroorotate dehydrogenase (DHDH) inhibitor [1]. It functions as a pyrimidine synthesis inhibitor [1].
Leflunomide is approved for the treatment of active rheumatoid arthritis (RA) in adults [1]. Rheumatoid arthritis is an autoimmune condition that can cause joint pain, swelling, and stiffness.
In the past 12 months, there have been 4050 adverse event reports associated with leflunomide [2]. Some of the frequently reported adverse events include off-label use, pain, the drug being ineffective, rheumatoid arthritis, and rash [2]. Leflunomide is available under various brand names.
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 35 | May 29, 2026 |
| CA Canada | Health Canada | 20 | May 21, 2026 |
| EU European Union | EMA | 4 | May 19, 2026 |
| US United States | FDA | 2 | December 17, 2025 |
GBUnited Kingdom· MHRA
35 products
Uses
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. 4) may also increase the risk of serious adverse reactions even for a long time after the switching.
How to take
CACanada· Health Canada
20 products
Uses
TEVA-LEFLUNOMIDE (leflunomide) should be used only by physicians who have fully familiarized themselves with the efficacy and safety profile of TEVA-LEFLUNOMIDE and who are experienced in the therapy of rheumatoid diseases. TEVA-LEFLUNOMIDE is indicated in adults for the treatment of active rheumatoid arthritis.
1 Pediatrics The use in patients less than 18 years of age is contraindicated. 2 Geriatrics No dosage adjustment is needed in patients over 65 years of age. There are no overall differences in effectiveness and safety between elderly and younger patients.
How to take
EUEuropean Union· EMA
4 products
Uses
Leflunomide is indicated for the treatment of adult patients with: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD), • active psoriatic arthritis. 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.
4) may also increase the risk of serious adverse reactions even for a long time after the switching.
How to take
USUnited States· FDA
2 products
Uses
1 INDICATIONS AND USAGE Leflunomide Tablets, USP are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide tablets are a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis.
( 1 )
How to take
Drug interactions
Known interactions involving Leflunomide. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL366870305 · revised December 12, 2025
- [2]Health Canada (DPD) · 02261251 · revised November 14, 2025
- [3]European Medicines Agency · EMEA/H/C/000235 · revised May 19, 2026
- [4]FDA DailyMed · 006b5bf4-97c0-48… · revised December 17, 2025 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.