Leflunomide: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Leflunomide. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Respiratory infection | 32% |
| Diarrhea | 27% |
| Headache | 21% |
| Nausea | 19% |
| Abnormal liver enzymes | 17% |
| Alopecia | 17% |
| Dyspepsia | 13% |
| Rash | 12% |
| Injury accident | 11% |
| Hypertension | 10% |
| Mouth ulcer | 10% |
| Sinusitis | 10% |
| Back pain | 9% |
| Arthralgia | 9% |
| Abdominal pain | 8% |
| Gl/abdominal pain | 8% |
| Joint disorder | 8% |
| Bronchitis | 8% |
| Flu syndrome | 7% |
| Dizziness | 7% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Leflunomide tablets are indicated in adults for the treatment of active rheumatoid arthritis (RA): to reduce signs and symptoms to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing to improve physical function (see CLINICAL STUDIES ). Aspirin, nonsteroidal anti-inflammatory agents and/or low dose corticosteroids may be continued during treatment with leflunomide tablets (see PRECAUTIONS - Drug Interactions – NSAIDs ). The combined use of leflunomide tablets with antimalarials, intramuscular or oral gold, D penicillamine, azathioprine, or methotrexate has not been adequately studied. (See WARNINGS - Immunosuppression Potential/Bone Marrow Suppression ).
Medical disclaimer: Always consult a qualified healthcare professional about any medication.