Formulary
Leflunomide: Indications, Dosing, Side Effects and Interactions
Leflunomide clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Leflunomide: Indications, Dosing, Side Effects and Interactions
Leflunomide clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Moderate to severe active rheumatoid arthritis (specialist use only)**
- **Adult** (By Mouth): Initially 100 mg once daily for 3 days, then reduced to 10-20 mg once daily.
**Active psoriatic arthritis (specialist use only)**
- **Adult** (By Mouth): Initially 100 mg once daily for 3 days, then reduced to 20 mg once daily.
Cautions
Anaemia (avoid if significant and due to causes other than rheumatoid or psoriatic arthritis); history of tuberculosis; impaired bone-marrow function (avoid if significant and due to causes other than rheumatoid or psoriatic arthritis); leucopenia (avoid if significant and due to causes other than rheumatoid or psoriatic arthritis); thrombocytopenia (avoid if significant and due to causes other than rheumatoid or psoriatic arthritis)
Contraindications
Serious infection; severe hypoproteinaemia; severe immunodeficiency
Side effects
Common or very common Abdominal pain; accelerated hair loss; appetite decreased; asthenia; diarrhoea; dizziness; gastrointestinal disorders; headache; hypersensitivity; hypertension; leucopenia; nausea; oral disorder; paraesthesia; peripheral neuropathy; skin reactions; tendon disorders; vomiting; weight decreased Uncommon Anaemia; anxiety; electrolyte imbalance; hyperlipidaemia; taste altered; thrombocytopenia Rare or very rare Agranulocytosis; eosinophilia; hepatic disorders; infection; interstitial lung disease; pancreatitis; pancytopenia; sepsis; severe cutaneous adverse reactions (SCARs); vasculitis Frequency not known Cutaneous lupus erythematosus; hypouricaemia; progressive multifocal leukoencephalopathy (PML); pulmonary hypertension; renal failure; skin ulcer Side-effects, further information Discontinue treatment and institute washout procedure in case of serious side-effect (consult product literature). Hepatotoxicity Potentially life-threatening hepatotoxicity reported usually in the first 6 months. Discontinue treatment (and institute washout procedure-consult product literature) or reduce dose according to liver-function abnormality; if liver-function abnormality persists after dose reduction, discontinue treatment and institute washout procedure.
Interactions
**Severe interactions:**
- Effect of other medicinal products on leflunomide: Cholestyramine or activated charcoal It is recommended that patients receiving leflunomide are not treated with colestyramine or activated powdered...
- An in vivo interaction study with leflunomide and cimetidine (non-specific weak cytochrome P450 (CYP) inhibitor) has demonstrated a lack of a significant impact on A771726 exposure.
- Following concomitant administration of a single dose of leflunomide to subjects receiving multiple doses of rifampicin (non-specific cytochrome P450 inducer) A771726 peak levels were increased by...
**Other interactions (27):**
- Increased side effects may occur in case of recent or concomitant use of hepatotoxic or haematotoxic medicinal products or when leflunomide treatment is followed by such medicinal products without a...
- Methotrexate In a small (n=30) study with co-administration of leflunomide (10 to 20 mg per day) with methotrexate (10 to 25 mg per week) a 2- to 3-fold elevation in liver enzymes was seen on 5 of...
- All elevations resolved, 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
- All of these also resolved, 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
- In patients with rheumatoid arthritis, no pharmacokinetic interaction between the leflunomide (10 to 20 mg per day) and methotrexate (10 to 25 mg per week) was demonstrated.
- Vaccinations No clinical data are available on the efficacy and safety of vaccinations under leflunomide treatment.
Pregnancy
Avoid-active metabolite teratogenic in animal studies.
Breast feeding
Present in milk in animal studies-manufacturer advises avoid.
Hepatic impairment
Manufacturer advises avoid-active metabolite may accumulate.
Renal impairment
Manufacturer advises avoid in moderate or severe impairment-no information available.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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