| EMA number | EMEA/H/C/001222 |
| ATC code | L04AA13 |
| Authorisation | 14 March 2011 |
| Withdrawn | 19 July 2017 |
| Revision | 11 |
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 — LUPIN, approved 2024-12-17 (ANDA211863).
239,393 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.