Leflunomide Side Effects
Brand Names: Arava
Please note - some side effects for Leflunomide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Leflunomide - for the consumer
Leflunomide
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Leflunomide:
Seek medical attention right away if any of these SEVERE side effects occur when using Leflunomide:Back pain; bronchitis; diarrhea; dizziness; dry skin; hair loss; headache; increased cough; indigestion; joint disorder; loss of appetite; muscle aches; nausea; runny nose; sinus infection; upper respiratory tract infection; urinary tract infection; vomiting; weakness; weight loss.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering or peeling skin; blisters on the inside of eyes, nose, or mouth; chest pain; dark urine; easy bruising/bleeding; feelings of numbness or tingling; fever; infection; muscle cramps, including leg cramps; pale skin; pale stools; sore throat; stomach pain; unusual tiredness; vomiting; yellowing of the eyes or skin.
For the professional
Leflunomide
Adverse reactions associated with the use of Leflunomide in RA include diarrhea, elevated liver enzymes (ALT and AST), alopecia and rash. In the controlled studies at one year, the following adverse events were reported, regardless of causality.
| All RA Studies | Placebo-Controlled Trials | Active-Controlled Trials | |||||
|---|---|---|---|---|---|---|---|
| MN 301 and US 301 | MN 302* | ||||||
| LEF (N=1339)† |
LEF (N=315) |
PBO (N=210) |
SSZ (N=133) |
MTX (N=182) |
LEF (N=501) |
MTX (N=498) |
|
| |||||||
| BODY AS A WHOLE | |||||||
| Allergic Reaction | 2% | 5% | 2% | 0% | 6% | 1% | 2% |
| Asthenia | 3% | 6% | 4% | 5% | 6% | 3% | 3% |
| Flu Syndrome | 2% | 4% | 2% | 0% | 7% | 0% | 0% |
| Infection, upper respiratory | 4% | 0% | 0% | 0% | 0% | 0% | 0% |
| Injury Accident | 5% | 7% | 5% | 3% | 11% | 6% | 7% |
| Pain | 2% | 4% | 2% | 2% | 5% | 1% | <1% |
| Abdominal Pain | 6% | 5% | 4% | 4% | 8% | 6% | 4% |
| Back Pain | 5% | 6% | 3% | 4% | 9% | 8% | 7% |
| CARDIOVASCULAR | |||||||
| Hypertension‡ | 10% | 9% | 4% | 4% | 3% | 10% | 4% |
| - New onset of hypertension | 1% | <1% | 0% | 2% | 2% | <1% | |
| Chest Pain | 2% | 4% | 2% | 2% | 4% | 1% | 2% |
| GASTROINTESTINAL | |||||||
| Anorexia | 3% | 3% | 2% | 5% | 2% | 3% | 3% |
| Diarrhea | 17% | 27% | 12% | 10% | 20% | 22% | 10% |
| Dyspepsia | 5% | 10% | 10% | 9% | 13% | 6% | 7% |
| Gastroenteritis | 3% | 1% | 1% | 0% | 6% | 3% | 3% |
| Abnormal Liver Enzymes | 5% | 10% | 2% | 4% | 10% | 6% | 17% |
| Nausea | 9% | 13% | 11% | 19% | 18% | 13% | 18% |
| GI/Abdominal Pain | 5% | 6% | 4% | 7% | 8% | 8% | 8% |
| Mouth Ulcer | 3% | 5% | 4% | 3% | 10% | 3% | 6% |
| Vomiting | 3% | 5% | 4% | 4% | 3% | 3% | 3% |
| METABOLIC AND NUTRITIONAL | |||||||
| Hypokalemia | 1% | 3% | 1% | 1% | 1% | 1% | <1% |
| Weight Loss§ | 4% | 2% | 1% | 2% | 0% | 2% | 2% |
| MUSCULO-SKELETAL SYSTEM | |||||||
| Arthralgia | 1% | 4% | 3% | 0% | 9% | <1% | 1% |
| Leg Cramps | 1% | 4% | 2% | 2% | 6% | 0% | 0% |
| Joint Disorder | 4% | 2% | 2% | 2% | 2% | 8% | 6% |
| Synovitis | 2% | <1% | 1% | 0% | 2% | 4% | 2% |
| Tenosynovitis | 3% | 2% | 0% | 1% | 2% | 5% | 1% |
| NERVOUS SYSTEM | |||||||
| Dizziness | 4% | 5% | 3% | 6% | 5% | 7% | 6% |
| Headache | 7% | 13% | 11% | 12% | 21% | 10% | 8% |
| Paresthesia | 2% | 3% | 1% | 1% | 2% | 4% | 3% |
| RESPIRATORY SYSTEM | |||||||
| Bronchitis | 7% | 5% | 2% | 4% | 7% | 8% | 7% |
| Increased Cough | 3% | 4% | 5% | 3% | 6% | 5% | 7% |
| Respiratory Infection | 15% | 21% | 21% | 20% | 32% | 27% | 25% |
| Pharyngitis | 3% | 2% | 1% | 2% | 1% | 3% | 3% |
| Pneumonia | 2% | 3% | 0% | 0% | 1% | 2% | 2% |
| Rhinitis | 2% | 5% | 2% | 4% | 3% | 2% | 2% |
| Sinusitis | 2% | 5% | 5% | 0% | 10% | 1% | 1% |
| SKIN AND APPENDAGES | |||||||
| Alopecia | 10% | 9% | 1% | 6% | 6% | 17% | 10% |
| Eczema | 2% | 1% | 1% | 1% | 1% | 3% | 2% |
| Pruritus | 4% | 5% | 2% | 3% | 2% | 6% | 2% |
| Rash | 10% | 12% | 7% | 11% | 9% | 11% | 10% |
| Dry Skin | 2% | 3% | 2% | 2% | 0% | 3% | 1% |
| UROGENITAL SYSTEM | |||||||
| Urinary Tract Infection | 5% | 5% | 7% | 4% | 2% | 5% | 6% |
Adverse events during a second year of treatment with Leflunomide in clinical trials were consistent with those observed during the first year of treatment and occurred at a similar or lower incidence.
In addition, the following adverse events have been reported in 1% to <3% of the RA patients in the Leflunomide treatment group in controlled clinical trials.
Body as a Whole: abscess, cyst, fever, hernia, malaise, pain, neck pain, pelvic pain;
Cardiovascular: angina pectoris, migraine, palpitation, tachycardia, varicose vein, vasculitis, vasodilatation;
Gastrointestinal: cholelithiasis, colitis, constipation, esophagitis, flatulence, gastritis, gingivitis, melena, oral moniliasis, pharyngitis, salivary gland enlarged, stomatitis (or aphthous stomatitis), tooth disorder;
Endocrine: diabetes mellitus, hyperthyroidism;
Hemic and Lymphatic System: anemia (including iron deficiency anemia), ecchymosis;
Metabolic and Nutritional: creatine phosphokinase increased, hyperglycemia, hyperlipidemia, peripheral edema;
Musculo-Skeletal System: arthrosis, bone necrosis, bone pain, bursitis, muscle cramps, myalgia, tendon rupture;
Nervous System: anxiety, depression, dry mouth, insomnia, neuralgia, neuritis, sleep disorder, sweating increased, vertigo;
Respiratory System: asthma, dyspnea, epistaxis, lung disorder;
Skin and Appendages: acne, contact dermatitis, fungal dermatitis, hair discoloration, hematoma, herpes simplex, herpes zoster, maculopapular rash, nail disorder, skin discoloration, skin disorder, skin nodule, subcutaneous nodule, ulcer skin;
Special Senses: blurred vision, cataract, conjunctivitis, eye disorder, taste perversion;
Urogenital System: albuminuria, cystitis, dysuria, hematuria, menstrual disorder, prostate disorder, urinary frequency, vaginal moniliasis.
Other less common adverse events seen in clinical trials include: 1 case of anaphylactic reaction occurred in Phase 2 following rechallenge of drug after withdrawal due to rash (rare); urticaria; eosinophilia; transient thrombocytopenia (rare); and leukopenia <2000 WBC/mm3 (rare).
Adverse events during a second year of treatment with Leflunomide in clinical trials were consistent with those observed during the first year of treatment and occurred at a similar or lower incidence.
In post-marketing experience, the following have been reported rarely:
Body as a whole: opportunistic infections, severe infections including sepsis that may be fatal;
Gastrointestinal: pancreatitis;
Hematologic: agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia;
Hypersensitivity: angioedema;
Hepatic: hepatitis, jaundice/cholestasis, severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal;
Respiratory: interstitial lung disease, including interstitial pneumonitis and pulmonary fibrosis, which may be fatal;
Nervous system: peripheral neuropathy;
Skin and Appendages: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vasculitis including cutaneous necrotizing vasculitis.
Adverse Reactions (Pediatric Patients)
The safety of Leflunomide was studied in 74 patients with polyarticular course juvenile rheumatoid arthritis ranging in age from 3–17 years (47 patients from the active-controlled study and 27 from an open-label safety and pharmacokinetic study). The most common adverse events included abdominal pain, diarrhea, nausea, vomiting, oral ulcers, upper respiratory tract infections, alopecia, rash, headache, and dizziness. Less common adverse events included anemia, hypertension, and weight loss. Fourteen pediatric patients experienced ALT and/or AST elevations, nine between 1.2 and 3-fold the upper limit of normal, five between 3 and 8-fold the upper limit of normal.
TopMore resources:
Leflunomide - Includes detailed dosage instructions.
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