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Leflunomide

More information: STITCH, PubChem and possibly Wikipedia

ATC Code: L04AA13

Side effects

Options: Show MedDRA Preferred Terms,   display all 23 labels

Side effect Data for drug Placebo Labels
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Respiratory tract infection 15% - 32% 20% - 32% x x x x x x x x x x x x x x x x
Diarrhoea postmarketing — 10% - 27% 10% - 27% x x x x x x x x x x x x x x x x x x x x
Nausea postmarketing — 9% - 19% 11% - 19% x x x x x x x x x x x x x x x x x x x
Alopecia postmarketing — 1% - 17% 1% - 9% x x x x x x x x x x x x x x x x x x x
Rash postmarketing — 7% - 12% 7% - 12% x x x x x x x x x x x x x x x x x x x
Headache postmarketing — 7% - 21% 11% - 21% x x x x x x x x x x x x x x x x x x x x
Back pain 3% - 9% 3% - 9% x x x x x x x x x x x x x x x x
Bronchitis 2% - 8% 2% - 7% x x x x x x x x x x x x x x x x x x x
Dyspepsia 5% - 13% 9% - 13% x x x x x x x x x x x x x x x x
Abdominal pain postmarketing — 4% - 8% 4% - 8% x x x x x x x x x x x x x x x x x x x
Liver function test abnormal 5% - 17% 2% - 10% x x x
Hepatic enzyme abnormal 2% - 17% 2% - 10% x x x x x x x x x x x x x
Dizziness postmarketing — 3% - 7% 3% - 6% x x x x x x x x x x x x x x x x x x x x
Neuropathy peripheral very rare — common x x x x x x x x x x x x x x x x x x x
Aphthous stomatitis postmarketing, common x x x x x x x x x x x x x x x x x x x
Urinary tract infection 2% - 7% 2% - 7% x x x x x x x x x x x x x x x x
Creatine phosphokinase increased common x x x x x x x x x x x x x x x
Rash maculo-papular common x x x x x x x x x x x x x x x x x x x
Cough increased 3% - 7% 3% - 6% x x x x x x x x x x x x x x x x
Hypertension 0% - 10% 0% - 9% x x x x x x x x x x x x x x x x x
Arthropathy 2% - 8% 2% x x x x x x x x x x x x x x x x
Pruritus postmarketing — 2% - 6% 2% - 5% x x x x x x x x x x x x x x x x x x x
Anorexia postmarketing — 2% - 5% 2% - 5% x x x x x x x x x x x x x x x x x x x
Asthenia postmarketing — 3% - 6% 4% - 6% x x x x x x x x x x x x x x x x x x x x
Gastroenteritis 0% - 6% 0% - 6% x x x x x x x x x x x x x x x x
Pharyngitis 1% - 3% 1% - 2% x x x x x x x x x x x x x x x x
Vomiting postmarketing — 3% - 5% 3% - 5% x x x x x x x x x x x x x x x x x x x
Mouth ulceration postmarketing — 3% - 10% 3% - 10% x x x x x x x x x x x x x x x x x x x
Mediastinal disorder postmarketing, common x x x x x x x x
Chest pain 1% - 4% 2% - 4% x x x x x x x x x x x x x x x x
Eczema postmarketing — 1% - 3% 1% x x x x x x x x x x x x x x x x x x x
Hypersensitivity postmarketing — 0% - 6% 0% - 6% x x x x x x x x x x x x x x x x x x x x
Pain 1% - 5% 2% - 5% x x x x x x x x
Paraesthesia postmarketing — 1% - 4% 1% - 3% x x x x x x x x x x x x x x x x x x x
Pneumonia 0% - 3% 0% - 3% x x x x x x x x x x x x x x x x x x x
Rhinitis 2% - 5% 2% - 5% x x x x x x x x x x x x x x x x x x x
Synovitis 0% - 4% 0% - 2% x x x x x x x x x x x x x x x x
Tenosynovitis postmarketing — 0% - 5% 0% - 2% x x x x x x x x x x x x x x x x x
Weight decreased postmarketing — 0% - 4% 0% - 2% x x x x x x x x x x x x x x x x x x x x
Dry skin postmarketing — 0% - 3% 0% - 3% x x x x x x x x x x x x x x x x x x x
Arthralgia 0% - 9% 0% - 9% x x x x x x x x x x x x x
Hypokalaemia uncommon, 1% - 3% 1% - 3% x x x x x x x x x x x x x x x x x x x x
Cramps of lower extremities 0% - 6% 2% - 6% x x x x x x x x x x x x x x x x
Sinusitis 0% - 10% 0% - 10% x x x x x x x x x x x x x x x x
Anaemia uncommon x x x x x x x x x x x x x x x x x x x
Anxiety postmarketing, uncommon x x x x x x x x x x x x x x x x x x x
Hyperlipidaemia uncommon x x x x x x x x x x x x x x x x x x x
Nervous system disorder uncommon x x x x x
Thrombocytopenia postmarketing, uncommon x x x x x x x x x x x x x x x x x x x
Urticaria postmarketing, uncommon x x x x x x x x x x x x x x x x x x x
Hypophosphataemia postmarketing, uncommon x x x x x x x
Tendon rupture postmarketing, uncommon x x x x x x x x x x x x x x x x x x x
Cholestasis rare x x x x x x x x x x x x x x x
Eosinophilia postmarketing, rare x x x x x x x x x x x x x x x x x x x
Gastrointestinal disorder postmarketing x x x x x x
Hepatitis postmarketing, rare x x x x x x x x x x x x x x x x x x x
Jaundice postmarketing, rare x x x x x x x x x x x x x x x x x x x
Leukopenia postmarketing — 3% x x x x x x x x x x x x x x x x x x x x
Liver disorder postmarketing x x x
Opportunistic infection postmarketing, rare x x x x x x x x x x x x x x x x x x x
Pancytopenia postmarketing, rare x x x x x x x x x x x x x x x x x x
Lactic dehydrogenase activity increased rare x x x
Interstitial pneumonia postmarketing, rare x x x x x x x x x x x x x x x x x x
Interstitial lung disease postmarketing, rare x x x x x x x x x x x x x x x x x x x x
Fatal outcomes postmarketing x x x x
Hypouricaemia postmarketing x x x x
Immobile postmarketing x x x x
Hepatotoxicity postmarketing x x x
Sepsis postmarketing, rare x x x x x x x x x x x x x x x x x x x x
Blood pressure increased postmarketing — common x x x x x x x x
Sperm concentration postmarketing x x x x
Agranulocytosis very rare, postmarketing x x x x x x x x x x x x x x x x
Acute yellow liver atrophy very rare, postmarketing x x x x x x x x x x x x x x x x x x x x
Toxic epidermal necrolysis very rare, postmarketing x x x x x x x x x x x x x x x x x x x x
Erythema multiforme very rare, postmarketing x x x x x x x x x x x x x x x x x x x
Cutaneous lupus erythematosus very rare, postmarketing x x x x x x x x x
Pancreatitis very rare, postmarketing x x x x x x x x x x x x x x x x x x x x
Psoriasis very rare, postmarketing x x x x x x x x x
Stevens-Johnson syndrome very rare, postmarketing x x x x x x x x x x x x x x x x x x x x
Vasculitis very rare, postmarketing x x x x x x x x x x x x x x x x x x x
Hepatic failure very rare, postmarketing x x x x x x x x x x x x x x x x x x x
Pustular psoriasis very rare, postmarketing x x x x x x x x x
Liver injury very rare, postmarketing x x x x x x x x x x x x x x x x x x x
Unspecified disorder of skin and subcutaneous tissue very rare x x x x x x x
Anaphylactoid reaction very rare, postmarketing x x x x x x x x x x
Vasculitis necrotising very rare, postmarketing x x x x x x x x x x x x x x x x x
Congenital anomaly x
Abscess x x x x x x x x x x x x x x
Acquired immunodeficiency syndrome x
Albuminuria x x x x x x x x x x x x x x x x
Amblyopia x x x
Anaphylactic shock x x x x x x x x x x x x x x x x
Angina pectoris x x x x x x x x x x x x x x x x
Angioedema x x x x x x x x x
Arrhythmia x x x x
Arthritis x x x
Asthma x x x x x x x x x x x x x x x x
Mental disorder x x x
Breast disorder x x x x x
Bursitis x x x x x x x x x x x x x x x x
Oral candidiasis x x x x x x x x x x x x x x x x
Vaginal moniliasis x x x x x x x x x x x x x x x x
Cardiovascular disorder x x
Neck pain x x x x x x x x x x x x x x
Cholelithiasis x x x x x x x x x x x x x x x x
Colitis x x x x x x x x x x x x x x x x
Infection postmarketing — 0% - 4% 0% x x x x x x x x x x x x x x x x x x x x
Conjunctivitis x x x x x x x x x x x x x x x x
Connective tissue disorder x x x x x
Constipation x x x x x x x x x x x x x x x x
Contusion x
Cough x
Cystitis x x x x x x x x x x x x x x x x
Cyst x x x
Dermatitis contact x x x x x x x x x x x x x x x x
Fungal skin infection x x x x x x x x x x x x x x x x
Diabetes mellitus x x x x x x x x x x x x x x x x
Drug abuse x
Dysgeusia x x x x x x x x x x x x x x x x
Dyspnoea x x x x x x x x x x x x x x x x
Dysuria x x x x x x x x x x x x x x x x
Ecchymosis x x x x x x x x x x x x x x x x
Endocrine disorder x x
Epistaxis x x x x x x x x x x x x x x x x
Oesophagitis x x x x x x x x x x x x x x x x
Eye disorder x x x x x x x x x x x x x x x x
Fatigue x
Body temperature increased x x x x x x x x x x x x x x
Flatulence x x x x x x x x x x x x x x x x
Gastritis x x x x x x x x x x x x x x x x
Gingivitis x x x x x x x x x x x x x x x x
Cardiac disorder x x x
Blood disorder x x
Haematoma x x x x x x x x x x x x x x x x
Haematuria x x x x x x x x x x x x x x x x
Haemorrhage x
Hernia x x x x x x x x x x x x x x
Herpes simplex x x x x x x x x x x x x x x x x
Herpes zoster x x x x x x x x x x x x x x x x
Hyperglycaemia x x x x x x x x x x x x x x x x
Malignant hypertension x
Hypertensive crisis x
Hyperthyroidism x x x x x x x x x x x x x x x x
Salivary gland enlargement x x x x x x x x x x x x x x x x
Hypotension x
Immune system disorder x x x
Inflammation x
Influenza 0% - 7% 0% - 7% x x x x x x x x x x x x x x x x
Melaena x x x x x x x x x x x x x x x x
Menstrual disorder x x x x x x x x x x x x x x x x
Cramp muscle x x x x x x x x x x x x x x x x
Nail disorder x x x x x x x x x x x x x x x x
Neoplasm x x x
Neuralgia x x x x x x x x x x x x x x x x
Neuritis x x x x x x x x x x x x x x x x
Neutropenia x x x x x x x x x
Osteonecrosis x x x x x x x x x x x x x x x x
Pallor x
Palpitations x x x x x x x x x x x x x x x x
Pelvic pain x x x x x x x x x x x x x x
Polyp x x x
Prostatic disorder x x x x x x x x x x x x x x x x
Pulmonary fibrosis x x x x x x x x x x x
Renal failure x x x
Skin disorder x x x x x x x x x x x x x x x x x
Skin nodule x x x x x x x x x x x x x x x x
Skin ulcer x x x x x x x x x x x x x x x
Stomatitis x x x x x x x x x x x x x x x x
Tachycardia x x x x x x x x x x x x x x x x
Tooth disorder x x x x x x x x x x x x x x x x
Tuberculosis x
Ulcer x x
Upper respiratory tract infection x x x x x x x x x x x
Pollakiuria x x x x x x x x x x x x x x x x
Urinary tract disorder x x x x x
Varicose vein x x x x x x x x x x x x x x x x
Vasodilation x x x x
Vertigo x x x x x x x x x x x x x x x x
Dry mouth x x x x x x x x x x x x x x x x
Chills x
Oedema peripheral x x x x x x x x x x x x x x x x
Cataract x x x x x x x x x x x x x x x x
Migraine x x x x x x x x x x x x x x
Hair discoloration x x x x x x x x x x x x x x x x
Subcutaneous nodule x x x x x x x x x x x x x x x x
Bone pain x x x x x x x x x x x x x x x x
Skin discolouration x x x x x x x x x x x x x
Iron deficiency anaemia x x x x x x x x x x x x x x x x
Malnutrition x x x x x
Malaise x x x x x x x x x x x x x x
Myalgia x x x x x x x x x x x x x x x x
Digestion impaired x x x
Hepatic enzyme increased x x x x x x x x x x x x x
Throat sore x
Hepatobiliary disease x x x x x
Vision blurred x x x x x x x x x x x x x
Lymphadenopathy x x x x x x x
Pre-existing disease x x x x x x x x x x
Sweating increased x x x x x x x x x
Acne x
Infestation NOS x x x x x
Blood and lymphatic system disorders x x x x x
Sleep disorder x x x x x x x x x x x x x x x x
Raised liver function tests x
Insomnia x x x x x x x x x x x x x x x x
Urine phosphate increased x
Acute overdose x
Appetite absent x
Tingling sensation x
Juvenile idiopathic arthritis x x x x x x x x

Indications

Information about indications was extracted from the indications and usage sections of the labels.

LEFLUNOMIDE / SANDOZ LEFLUNOMIDE

Side effects:23
Source:Health Canada

leflunomide / leflunomide

Side effects:79
Source:EMA

leflunomide / leflunomide

Side effects:79
Source:EMA

leflunomide / leflunomide

Side effects:79
Source:EMA

leflunomide / Arava

Side effects:141
Source:FDA

LEFLUNOMIDE

Side effects:146
Source:FDA Structured Product Label

LEFLUNOMIDE

Side effects:146
Source:FDA Structured Product Label

LEFLUNOMIDE / ARAVA

Side effects:146
Source:FDA

LEFLUNOMIDE

Side effects:147
Source:FDA Structured Product Label

leflunomide

Side effects:149
Source:FDA Structured Product Label

LEFLUNOMIDE

Side effects:149
Source:FDA Structured Product Label

LEFLUNOMIDE

Side effects:149
Source:FDA Structured Product Label

LEFLUNOMIDE / ARAVA 10MG

Side effects:150
Source:Health Canada

LEFLUNOMIDE

Side effects:150
Source:FDA Structured Product Label

LEFLUNOMIDE / PHL-LEFLUNOMIDE

Side effects:151
Source:Health Canada

Leflunomide / LEFLUNOMIDE TABLETS

Side effects:151
Source:medicines.org.au

AUSTRALIAN APPROVED NAME / ARAVA

Side effects:152
Source:medicines.org.au

Arava Tablets / Arava, Film coated tablet

Side effects:152
Source:Medsafe

LEFLUNOMIDE / NOVO-LEFLUNOMIDE

Side effects:159
Source:Health Canada

Color scheme:

standardalternative

    100%
    75%
    50%
    10%
    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    postmarketing
    0%
    no frequency information
    not found on label