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Leflunomide

More information: STITCH, PubChem and possibly Wikipedia

ATC Code: L04AA13

Side effects

Options: Hide MedDRA Preferred Terms ,   display all 23 labels

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

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

LEFLUNOMIDE / NOVO-LEFLUNOMIDE

Side effects:159
Source:Health Canada

Color scheme:

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    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