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Summary

FDA Adverse Reports: 254. View All

Leflunomide FDA safety alerts: 2003

Reported deaths: 22

Reported hospitalizations: 116

Leflunomide Dosage, Warnings, Usage.

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Often additional risks of using a medication, such as Leflunomide, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Leflunomide users, Learn more about unwanted side effects & find ways to reduce them. Browse Leflunomide Adverse Reports reported to FDA and participate in Leflunomide discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Leflunomide. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Leflunomide Adverse Effect Reports (FDA)

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6609585-8 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased
on Mar 02, 2010 Male patient from JAPAN , 64 years of age, weighting 119.0 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased. Leflunomide dosage: . During the same period patient was treated with QUESTRAN (View Questran Review and Questran Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), MOBIC (View Mobic Review and Mobic Label ).

6607648-4 | Lymphadenopathy, Non-hodgkin's Lymphoma, Pyrexia
Patient was taking Leflunomide (View Usage). Patient had the following side effects: lymphadenopathy, non-hodgkin's lymphoma, pyrexia on Feb 24, 2010 from SPAIN Additional patient health information: Male patient , 62 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: .

6588376-0 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Gamma-glutamyltransferase Increased, Hepatitis, Liver Function Test Abnormal
Adverse event was reported on Feb 12, 2010 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with juvenile arthritis and. Location: BELGIUM , 43 years of age, After Leflunomide was administered, patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, hepatitis (What is hepatitis?), liver function test abnormal. During the same period patient was treated with LEDERTREXATE /NET/ (View Ledertrexate /net/ Review and Ledertrexate /net/ Label ), CELEBREX (View Celebrex Review and Celebrex Label ).

6588372-3 | Convulsion, Musculoskeletal Stiffness, Pyrexia, Vomiting
on Feb 08, 2010 Female patient from INDIA , 43 years of age, weighting 172.0 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: convulsion, musculoskeletal stiffness, pyrexia, vomiting. Leflunomide dosage: . During the same period patient was treated with HYDROXYCHLOROQUINE SULFATE (View Hydroxychloroquine Sulfate Review and Hydroxychloroquine Sulfate Label ), FOLVITE (View Folvite Review and Folvite Label ), SULFASALAZINE (View Sulfasalazine Review and Sulfasalazine Label ). Patient was hospitalized.


6582431-7 | Colitis, Diarrhoea, Hepatitis, Keratitis, Mucosal Inflammation, Pneumothorax, Respiratory Distress, Stevens-johnson Syndrome
on Feb 05, 2010 Female patient from TRINIDAD AND TOBAGO , 31 years of age, weighting 97.00 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). Patient had the following side effects: colitis, diarrhoea, hepatitis (What is hepatitis?), keratitis, mucosal inflammation, pneumothorax, respiratory distress, stevens-johnson syndrome. Leflunomide dosage: . Patient was hospitalized.

6579223-1 | Dehydration, Diarrhoea, Headache, Hyperkalaemia, Hypertensive Crisis, Nausea
Patient was taking Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: dehydration, diarrhoea, headache (What is headache?), hyperkalaemia, hypertensive crisis, nausea (What is nausea?) on Feb 03, 2010 from CANADA Additional patient health information: Female patient , 65 years of age, weighting 200.0 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: . During the same period patient was treated with CELEBREX (View Celebrex Review and Celebrex Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ), INSULIN GLARGINE (View Insulin Glargine Review and Insulin Glargine Label ), OMEPRAZOLE (In Morning) (View Omeprazole Review and Omeprazole Label ), METFORMIN (View Metformin Review and Metformin Label ). Patient was hospitalized.

6555570-4 | Abdominal Pain, Confusional State, Decreased Appetite, Hepatic Function Abnormal, Hepatomegaly, Jaundice, Liver Function Test Abnormal, Myelodysplastic Syndrome, Nausea
Adverse event was reported on Jan 20, 2010 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), supraventricular tachycardia, osteoporosis (What is osteoporosis?), abdominal pain (What is abdominal pain?) and. Location: UNITED KINGDOM , 62 years of age, weighting 102.5 lb, Patient experienced the following unwanted or unexpected effects: abdominal pain (What is abdominal pain?), confusional state, decreased appetite, hepatic function abnormal, hepatomegaly, jaundice (What is jaundice?), liver function test abnormal, myelodysplastic syndrome, nausea (What is nausea?). During the same period patient was treated with ARTHROTEC (View Arthrotec Review and Arthrotec Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), VERAPAMIL (View Verapamil Review and Verapamil Label ), ADCAL (2 Tablets Daily) (View Adcal Review and Adcal Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), MERBENTYL (View Merbentyl Review and Merbentyl Label ), SIMVASTATIN (View Simvastatin Review and Simvastatin Label ), AMITRIPTYLINE HCL (View Amitriptyline Hcl Review and Amitriptyline Hcl Label ).

6545076-0 | Gastric Cancer, Gastric Ulcer
on Jan 13, 2010 Male patient from GERMANY , weighting 222.7 lb, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Leflunomide (View Usage). Patient had the following side effects: gastric cancer, gastric ulcer. Leflunomide dosage: . During the same period patient was treated with ETANERCEPT (View Etanercept Review and Etanercept Label ), ANTIVIRALS FOR SYSTEMIC USE (View Antivirals For Systemic Use Review and Antivirals For Systemic Use Label ), METHOTREXAT (View Methotrexat Review and Methotrexat Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ), COLECALCIFEROL (View Colecalciferol Review and Colecalciferol Label ).

6534164-0 | Adenocarcinoma, Cardiomegaly, Cough, Left Atrial Dilatation, Lung Neoplasm, Pericardial Effusion
on Jan 06, 2010 Female patient from AUSTRALIA , 43 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: adenocarcinoma, cardiomegaly, cough, left atrial dilatation, lung neoplasm, pericardial effusion. Leflunomide dosage: . During the same period patient was treated with METHOTREXATE (Dose As Used: Unk) (View Methotrexate Review and Methotrexate Label ), SULFASALAZINE (Dose As Used: Unk) (View Sulfasalazine Review and Sulfasalazine Label ), PREDNISONE (Dose As Used: Unk) (View Prednisone Review and Prednisone Label ), FOLIC ACID (Dose As Used: Unk) (View Folic Acid Review and Folic Acid Label ), LOSEC /SWE/ (Dose As Used: Unk) (View Losec /swe/ Review and Losec /swe/ Label ), FISH OIL (Dose As Used: Unk) (View Fish Oil Review and Fish Oil Label ), CALTRATE (Dose As Used: Unk) (View Caltrate Review and Caltrate Label ).

6532056-4 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Liver Disorder
Patient was taking Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, liver disorder on Jan 07, 2010 from JAPAN Additional patient health information: Female patient , 41 years of age, weighting 110.2 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: . During the same period patient was treated with MEVALOTIN (View Mevalotin Review and Mevalotin Label ), MUCOSTA (View Mucosta Review and Mucosta Label ), LOXONIN (View Loxonin Review and Loxonin Label ), PARIET (View Pariet Review and Pariet Label ).

6527943-7 | Dyspnoea, Pleural Effusion
Adverse event was reported on Dec 28, 2009 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Location: SPAIN , 64 years of age, Patient had the following side effects: dyspnoea, pleural effusion. During the same period patient was treated with ADALIMUMAB (View Adalimumab Review and Adalimumab Label ). Patient was hospitalized.

6527911-5 | Oligohydramnios
on Nov 30, 2009 Female patient from COSTA RICA , 29 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: oligohydramnios. Leflunomide dosage: .

6517694-7 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Bone Marrow Failure, Hepatotoxicity, Thrombocytopenia
on Dec 21, 2009 Male patient from BELGIUM , 59 years of age, was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, bone marrow failure, hepatotoxicity, thrombocytopenia. Leflunomide dosage: . During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ). Patient was hospitalized.

6509610-9 | Amnesia, Confusional State, Headache
Patient was taking Leflunomide (View Usage). Patient had the following side effects: amnesia, confusional state, headache (What is headache?) on Dec 17, 2009 from UNITED KINGDOM Additional patient health information: Female patient , 39 years of age, . Leflunomide dosage: . During the same period patient was treated with ARCOXIA (View Arcoxia Review and Arcoxia Label ), TRAMADOL HCL (Dose As Used: Approximately 3/day) (View Tramadol Hcl Review and Tramadol Hcl Label ), AMITYIPTYLINE (Dose As Used: Unk) (View Amityiptyline Review and Amityiptyline Label ). Patient was hospitalized.

6509594-3 | Acute Pulmonary Oedema, Asthenia, Congestive Cardiomyopathy, Dyspnoea, Tachycardia
Adverse event was reported on Dec 16, 2009 by a Female patient taking Leflunomide (View Usage) (Dosage: Dose Unit: 20 Mg) was diagnosed with asthma (What is asthma?) and. Location: FRANCE , 46 years of age, After Leflunomide was administered, patient had the following side effects: acute pulmonary oedema, asthenia, congestive cardiomyopathy, dyspnoea, tachycardia. During the same period patient was treated with CORTANCYL (View Cortancyl Review and Cortancyl Label ), IXPRIM (View Ixprim Review and Ixprim Label ), SYMBICORT (View Symbicort Review and Symbicort Label ), FORADIL (View Foradil Review and Foradil Label ). Patient was hospitalized.

6502879-6 | Atelectasis, Cerebrovascular Accident, Dizziness, Loss Of Consciousness, Pneumonitis, Respiratory Depression
on Dec 15, 2009 Female patient from SOUTH AFRICA , 74 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: atelectasis, cerebrovascular accident, dizziness (What is dizziness?), loss of consciousness, pneumonitis, respiratory depression. Leflunomide dosage: 6x Weekly. During the same period patient was treated with AMOCLAV PLUS (View Amoclav Plus Review and Amoclav Plus Label ), FLUCONAZOLE (View Fluconazole Review and Fluconazole Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), MELOXICAM (View Meloxicam Review and Meloxicam Label ). Patient was hospitalized.

6497583-7 | Histiocytosis Haematophagic
on Dec 10, 2009 Female patient from JAPAN , 51 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), vitamin c deficiency, peripheral circulatory failure, hypovitaminosis and was treated with Leflunomide (View Usage). Patient had the following side effects: histiocytosis haematophagic. Leflunomide dosage: . During the same period patient was treated with PREDNISOLONE (2 Tabletsx2/day) (View Prednisolone Review and Prednisolone Label ), LOXOPROFEN SODIUM (1 Tabletx3/day) (View Loxoprofen Sodium Review and Loxoprofen Sodium Label ), HICEE (1packagex3/day) (View Hicee Review and Hicee Label ), TOCOPHERYL NICOTINATE (1capsulesx3/day) (View Tocopheryl Nicotinate Review and Tocopheryl Nicotinate Label ), NEUROVITAN (1 Tablet X3/day) (View Neurovitan Review and Neurovitan Label ).

6486788-7 | Atelectasis, Cerebrovascular Accident, Dizziness, Loss Of Consciousness, Pneumonitis, Respiratory Depression
Patient was taking Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: atelectasis, cerebrovascular accident, dizziness (What is dizziness?), loss of consciousness, pneumonitis, respiratory depression on Nov 30, 2009 from SOUTH AFRICA Additional patient health information: Female patient , 74 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: 6x Weekly. During the same period patient was treated with AMOCLAV PLUS (View Amoclav Plus Review and Amoclav Plus Label ), FLUCONAZOLE (View Fluconazole Review and Fluconazole Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), MELOXICAM (View Meloxicam Review and Meloxicam Label ). Patient was hospitalized.

6482956-9 | Cranial Nerve Paralysis, Diplopia, Extraocular Muscle Paresis, Eyelid Disorder, Idiopathic Thrombocytopenic Purpura, Myasthenia Gravis, Platelet Count Decreased, Pyrexia
Adverse event was reported on Nov 20, 2009 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Location: UNITED STATES , 57 years of age, weighting 178.0 lb, Patient experienced the following unwanted or unexpected effects: cranial nerve paralysis, diplopia, extraocular muscle paresis, eyelid disorder, idiopathic thrombocytopenic purpura, myasthenia gravis, platelet count decreased, pyrexia. During the same period patient was treated with LIPITOR (Dose As Used: 10 Mg Qod) (View Lipitor Review and Lipitor Label ), TRAMADOL HCL (50 Mg- Rare) (View Tramadol Hcl Review and Tramadol Hcl Label ), NASAL SPRAY (Dose As Used: Unk) (View Nasal Spray Review and Nasal Spray Label ), MULTI VITAMINS (1 Per Day) (View Multi-vitamins Review and Multi-vitamins Label ), CALCIUM (Dose As Used: Unk) (View Calcium Review and Calcium Label ), PARACETAMOL (Dose As Used: Unk) (View Paracetamol Review and Paracetamol Label ), SOLARAZE (Dose As Used: Unk) (View Solaraze Review and Solaraze Label ), TUMS (Dose As Used: Unk) (View Tums Review and Tums Label ).

6479943-3 | Diverticulitis
on Nov 18, 2009 Male patient from JAPAN , 32 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). Patient had the following side effects: diverticulitis. Leflunomide dosage: . Patient was hospitalized.

6479936-6 | Condition Aggravated, Malaise, Type 1 Diabetes Mellitus
on Nov 16, 2009 Male patient from UNITED KINGDOM , 70 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: condition aggravated, malaise, type 1 diabetes mellitus. Leflunomide dosage: . During the same period patient was treated with ETANERCEPT (View Etanercept Review and Etanercept Label ), ALENDRONATE SODIUM (View Alendronate Sodium Review and Alendronate Sodium Label ), HYPURIN ISOPHANE (View Hypurin Isophane Review and Hypurin Isophane Label ), INSULIN ISOPHANE BOVINE/INSULIN ISOPHANE PORCINE (View Insulin Isophane Bovine/insulin Isophane Porcine Review and Insulin Isophane Bovine/insulin Isophane Porcine Label ), IRBESARTAN (View Irbesartan Review and Irbesartan Label ), METFORMIN HCL (View Metformin Hcl Review and Metformin Hcl Label ). Patient was hospitalized.

6479929-9 | Off Label Use, Polyomavirus-associated Nephropathy, Renal Impairment, Therapeutic Response Unexpected
Patient was taking Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: off label use, polyomavirus-associated nephropathy, renal impairment, therapeutic response unexpected on Nov 12, 2009 from GERMANY Additional patient health information: Male patient , 56 years of age, was diagnosed with prophylaxis and. Leflunomide dosage: . During the same period patient was treated with MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ). Patient was hospitalized.

6479921-4 | Liver Function Test Abnormal
Adverse event was reported on Oct 11, 2009 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), urinary tract infection (What is urinary tract infection?) and. Location: UNITED KINGDOM , 63 years of age, Patient had the following side effects: liver function test abnormal. During the same period patient was treated with TRIMETHOPRIM (View Trimethoprim Review and Trimethoprim Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ), CO CODAMOL (2 Dose Forms) (View Co-codamol Review and Co-codamol Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ). Patient was hospitalized.

6479913-5 | Dizziness, Loss Of Consciousness
on Nov 09, 2009 Female patient from SOUTH AFRICA , 74 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: dizziness (What is dizziness?), loss of consciousness. Leflunomide dosage: 6x Weekly. During the same period patient was treated with AMOCLAV PLUS (View Amoclav Plus Review and Amoclav Plus Label ), FLUCONAZOLE (View Fluconazole Review and Fluconazole Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), MELOXICAM (View Meloxicam Review and Meloxicam Label ).

6479887-7 | Congestive Cardiomyopathy, Dyspnoea Exertional
on Nov 16, 2009 Female patient from FRANCE , 55 years of age, weighting 132.3 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), osteoporosis prophylaxis and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: congestive cardiomyopathy, dyspnoea exertional. Leflunomide dosage: Dose Unit: 20 Mg. During the same period patient was treated with CORTANCYL (View Cortancyl Review and Cortancyl Label ), ACTONEL (View Actonel Review and Actonel Label ), CACIT VITAMINE D3 (View Cacit Vitamine D3 Review and Cacit Vitamine D3 Label ). Patient was hospitalized.

6479881-6 | Chest Pain, Transaminases Increased
Patient was taking Leflunomide (View Usage). Patient had the following side effects: chest pain (What is chest pain?), transaminases increased on Oct 29, 2009 from FRANCE Additional patient health information: Male patient , 86 years of age, weighting 145.5 lb, was diagnosed with parkinson's disease (What is parkinson's disease?), angina pectoris, dysuria and. Leflunomide dosage: Dose Unit: 10 Mg. During the same period patient was treated with DERMOVAL (View Dermoval Review and Dermoval Label ), COMTAN (Dose Unit: 200 Mg) (View Comtan Review and Comtan Label ), IKOREL (Dose Unit: 10 Mg) (View Ikorel Review and Ikorel Label ), KARDEGIC /FRA/ (View Kardegic /fra/ Review and Kardegic /fra/ Label ), PERMIXON (View Permixon Review and Permixon Label ), CARBIDOPA LEVODOPA (View Carbidopa-levodopa Review and Carbidopa-levodopa Label ), EXELON (View Exelon Review and Exelon Label ). Patient was hospitalized.

6479877-4 | Histiocytosis Haematophagic
Adverse event was reported on Oct 29, 2009 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), vitamin c deficiency, peripheral circulatory failure and. Location: JAPAN , 51 years of age, After Leflunomide was administered, patient had the following side effects: histiocytosis haematophagic. During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), INFLIXIMAB (View Infliximab Review and Infliximab Label ), PREDNISOLONE (2 Tabletsx2/day) (View Prednisolone Review and Prednisolone Label ), LOXOPROFEN SODIUM (1 Tabletx3/day) (View Loxoprofen Sodium Review and Loxoprofen Sodium Label ), HICEE (1packagex3/day) (View Hicee Review and Hicee Label ), JUVELA N (1capsulesx3/day) (View Juvela N Review and Juvela N Label ).

6479715-X | Anaemia, Leukaemia
on Dec 03, 2009 Male patient from JAPAN , 62 years of age, weighting 145.5 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: anaemia, leukaemia. Leflunomide dosage: . During the same period patient was treated with MEDROL (View Medrol Review and Medrol Label ), MOBIC (View Mobic Review and Mobic Label ). Patient was hospitalized.

6474795-X | Osteoporosis, Rib Fracture
on Nov 19, 2009 Male patient from AUSTRALIA , 62 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). Patient had the following side effects: osteoporosis (What is osteoporosis?), rib fracture. Leflunomide dosage: . During the same period patient was treated with METHOTREXATE (Dose As Used: Unk) (View Methotrexate Review and Methotrexate Label ), FOLIC ACID (Dose As Used: Unk) (View Folic Acid Review and Folic Acid Label ), ENBREL (Dose As Used: Unk) (View Enbrel Review and Enbrel Label ), PREDNISONE (Dose As Used: Unk) (View Prednisone Review and Prednisone Label ).

6456682-6 | Acute Pulmonary Oedema, Asthenia, Congestive Cardiomyopathy, Dyspnoea, Tachycardia
Patient was taking Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: acute pulmonary oedema, asthenia, congestive cardiomyopathy, dyspnoea, tachycardia on Nov 16, 2009 from FRANCE Additional patient health information: Female patient , 46 years of age, was diagnosed with asthma (What is asthma?) and. Leflunomide dosage: Dose Unit: 20 Mg. During the same period patient was treated with CORTANCYL (View Cortancyl Review and Cortancyl Label ), IXPRIM (View Ixprim Review and Ixprim Label ), SYMBICORT (View Symbicort Review and Symbicort Label ), FORADIL (View Foradil Review and Foradil Label ). Patient was hospitalized.

6456635-8 | Oligohydramnios
Adverse event was reported on Nov 16, 2009 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Location: COSTA RICA , 29 years of age, Patient experienced the following unwanted or unexpected effects: oligohydramnios.

6450584-7 | No Adverse Event
on Nov 13, 2009 Female patient from BELGIUM , 38 years of age, weighting 165.3 lb, was diagnosed with contraception and was treated with Leflunomide (View Usage). Patient had the following side effects: no adverse event. Leflunomide dosage: Dose Unit: 20 Mg. During the same period patient was treated with ORAL CONTRACEPTIVE NOS (View Oral Contraceptive Nos Review and Oral Contraceptive Nos Label ).

6449126-1 | Cytomegalovirus Infection, Epstein-barr Virus Infection, Histiocytosis Haematophagic
on Nov 16, 2009 Male patient from ITALY , 64 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: cytomegalovirus infection (What is cytomegalovirus infection?), epstein-barr virus infection, histiocytosis haematophagic. Leflunomide dosage: . During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), MEDROL (Dose As Used: Unk) (View Medrol Review and Medrol Label ). Patient was hospitalized.

6446341-8 | Alopecia Totalis
Patient was taking Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: alopecia totalis on Oct 27, 2009 from UNITED KINGDOM Additional patient health information: Female patient , 39 years of age, weighting 154.3 lb, . Leflunomide dosage: . During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), SULFASALAZINE (View Sulfasalazine Review and Sulfasalazine Label ), DICLOFENAC (View Diclofenac Review and Diclofenac Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ).

6446326-1 | Gestational Diabetes, Prolonged Labour
Adverse event was reported on Nov 16, 2009 by a Female patient taking Leflunomide (View Usage) (Dosage: Dose As Used: Unk) was diagnosed with arthritis (What is arthritis?) and. Location: AUSTRALIA , 29 years of age, weighting 211.6 lb, Patient had the following side effects: gestational diabetes, prolonged labour.

6441811-0 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Gamma-glutamyltransferase Increased
on Nov 09, 2009 Female patient from POLAND , 48 years of age, was treated with Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased. Leflunomide dosage: .

6441793-1 | Condition Aggravated, Epistaxis, Hypertensive Crisis, Rectal Haemorrhage
on Nov 03, 2009 Female patient from ITALY , 57 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), hypertension and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: condition aggravated, epistaxis, hypertensive crisis, rectal haemorrhage. Leflunomide dosage: . During the same period patient was treated with NIMESULIDE (View Nimesulide Review and Nimesulide Label ), TAREG (View Tareg Review and Tareg Label ), ENBREL (View Enbrel Review and Enbrel Label ).

6441727-X | Abdominal Pain, Decreased Appetite, Inflammation, Pancreatic Carcinoma Resectable
Patient was taking Leflunomide (View Usage). Patient had the following side effects: abdominal pain (What is abdominal pain?), decreased appetite, inflammation, pancreatic carcinoma resectable on Nov 10, 2009 from GERMANY Additional patient health information: Male patient , 64 years of age, weighting 178.6 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), hypertension, polyarthritis and. Leflunomide dosage: Dose Unit: 10 Mg. During the same period patient was treated with CORTISON CIBA (Dose As Used: Not Reported) (View Cortison Ciba Review and Cortison Ciba Label ), KARVEZIDE (Dose As Used: 150 Mg / 125 Mg) (View Karvezide Review and Karvezide Label ), DECORTIN (Dose Unit: 5 Mg) (View Decortin Review and Decortin Label ), LEVEMIR (Dose As Used: Not Reported) (View Levemir Review and Levemir Label ), INSULIN HUMAN (Dose As Used: Not Reported) (View Insulin Human Review and Insulin Human Label ), APROVEL (View Aprovel Review and Aprovel Label ), NORVASC (View Norvasc Review and Norvasc Label ). Patient was hospitalized.

6419596-3 | Bronchiectasis, Dyspnoea, Wheezing
Adverse event was reported on Oct 22, 2009 by a Female patient taking Leflunomide (View Usage) (Dosage: Dose: Unk) . Location: , 65 years of age, weighting 150.4 lb, After Leflunomide was administered, patient had the following side effects: bronchiectasis, dyspnoea, wheezing. During the same period patient was treated with ALENDRONIC ACID (Dose: Unk) (View Alendronic Acid Review and Alendronic Acid Label ), ASPIRIN (Dose: Unk) (View Aspirin Review and Aspirin Label ), CALCIUM CARBONATE (Dose: Unk) (View Calcium Carbonate Review and Calcium Carbonate Label ), CO CODAMOL (Dose: Unk) (View Co-codamol Review and Co-codamol Label ), CODEINE PHOSPHATE (Dose: Unk) (View Codeine Phosphate Review and Codeine Phosphate Label ), COMBIVENT (Dose: Unk) (View Combivent Review and Combivent Label ), DILTIAZEM (View Diltiazem Review and Diltiazem Label ), ESOMEPRAZOLE MAGNESIUM (Dose: Unk) (View Esomeprazole Magnesium Review and Esomeprazole Magnesium Label ).

6419593-8 | Diplopia, Idiopathic Thrombocytopenic Purpura, Myasthenia Gravis, Platelet Count Decreased, Splenomegaly
on Oct 19, 2009 Female patient from UNITED STATES , weighting 178.0 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: diplopia, idiopathic thrombocytopenic purpura, myasthenia gravis, platelet count decreased, splenomegaly. Leflunomide dosage: . During the same period patient was treated with LIPITOR (Dose: 10 Mg Qod) (View Lipitor Review and Lipitor Label ), TRAMADOL HCL (View Tramadol Hcl Review and Tramadol Hcl Label ), ASTIPRO NASAL SPRAY (Dose: Unk) (View Astipro Nasal Spray Review and Astipro Nasal Spray Label ), MULTI VITAMINS (Dose: Unk) (View Multi-vitamins Review and Multi-vitamins Label ), CALCIUM (Dose: Unk) (View Calcium Review and Calcium Label ), TYLENOL (Dose: Unk) (View Tylenol Review and Tylenol Label ), SOLARAZE (Dose: Unk) (View Solaraze Review and Solaraze Label ), TUMS /00108001/ (Dose: Unk) (View Tums /00108001/ Review and Tums /00108001/ Label ).

6417396-1 | Liver Function Test Abnormal, Liver Injury
on Oct 27, 2009 Female patient from UNITED STATES , 45 years of age, weighting 105.8 lb, was diagnosed with immunosuppression and was treated with Leflunomide (View Usage). Patient had the following side effects: liver function test abnormal, liver injury. Leflunomide dosage: 20mg Qd Po. During the same period patient was treated with CALCIUM CARBONATE (View Calcium Carbonate Review and Calcium Carbonate Label ), PREMARIN (View Premarin Review and Premarin Label ), GLARGINE (View Glargine Review and Glargine Label ), MULTI VITAMIN (View Multi-vitamin Review and Multi-vitamin Label ), OXYCODONE (View Oxycodone Review and Oxycodone Label ), PANCREASE MT (View Pancrease Mt Review and Pancrease Mt Label ), PROTONIX (View Protonix Review and Protonix Label ), PREDNISONE (View Prednisone Review and Prednisone Label ).

6372011-0 | Anaemia, Asthenia, Cough, Cutaneous Vasculitis, Dyspnoea, Glomerulonephritis, Haematuria, Haemoptysis, Hypoxia
Patient was taking Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: anaemia, asthenia, cough, cutaneous vasculitis, dyspnoea, glomerulonephritis, haematuria, haemoptysis, hypoxia on Sep 07, 2009 from ITALY Additional patient health information: Male patient , 30 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: . Patient was hospitalized.

6326985-4 | Headache, Vision Blurred
Adverse event was reported on Aug 18, 2009 by a Male patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), prophylaxis and. Location: , 73 years of age, weighting 176.4 lb, Patient experienced the following unwanted or unexpected effects: headache (What is headache?), vision blurred. During the same period patient was treated with FOLIC ACID (View Folic Acid Review and Folic Acid Label ), IBUPROFEN (View Ibuprofen Review and Ibuprofen Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ).

6316449-6 | Blood Creatinine Increased, Renal Failure, Tubulointerstitial Nephritis
on Aug 13, 2009 Female patient from , 60 years of age, weighting 116.8 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). Patient had the following side effects: blood creatinine increased, renal failure, tubulointerstitial nephritis. Leflunomide dosage: . During the same period patient was treated with ALENDRONIC ACID (View Alendronic Acid Review and Alendronic Acid Label ), DICLOFENAC (View Diclofenac Review and Diclofenac Label ), ETANERCEPT (View Etanercept Review and Etanercept Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ), ATORVASTATIN (View Atorvastatin Review and Atorvastatin Label ), CALCICHEW D3 (Dose: 1 Dose) (View Calcichew D3 Review and Calcichew D3 Label ).

6289601-6 | Product Substitution Issue, Pruritus
on Jul 29, 2009 Female patient from UNITED STATES , weighting 241.0 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: product substitution issue, pruritus. Leflunomide dosage: . During the same period patient was treated with FENTANYL (View Fentanyl Review and Fentanyl Label ), SINGULAIR (View Singulair Review and Singulair Label ), FUROSEMIDE (View Furosemide Review and Furosemide Label ), THYROID TAB (View Thyroid Tab Review and Thyroid Tab Label ), POPOXYPHENE (View Popoxyphene Review and Popoxyphene Label ).

6289186-4 | Cardiac Disorder, Interstitial Lung Disease, Weight Decreased
Patient was taking Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: cardiac disorder, interstitial lung disease, weight decreased on Jul 17, 2009 from Additional patient health information: Female patient , 67 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: 20 Mg, Qd, Po. During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), NITROGLYCERIN COMP. (View Nitroglycerin Comp. Review and Nitroglycerin Comp. Label ). Patient was hospitalized.

6282533-9 | Dysphonia, Malaise, Periorbital Oedema, Rash
Adverse event was reported on Jul 20, 2009 by a Female patient taking Leflunomide (View Usage) (Dosage: Dose: Unk) . Location: , 73 years of age, weighting 105.8 lb, Patient had the following side effects: dysphonia, malaise, periorbital oedema, rash (What is rash?). During the same period patient was treated with ADALAT (View Adalat Review and Adalat Label ), ADCAL D3 (Dose: 1 Dose) (View Adcal-d3 Review and Adcal-d3 Label ), ALENDRONIC ACID (View Alendronic Acid Review and Alendronic Acid Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), BENDROFLUMETHIAZIDE (View Bendroflumethiazide Review and Bendroflumethiazide Label ), ACETAMINOPHEN W/ CODEINE (View Acetaminophen W/ Codeine Review and Acetaminophen W/ Codeine Label ), LATANOPROST (Dose: Unk) (View Latanoprost Review and Latanoprost Label ).

6279373-3 | Skin Ulcer
on Jul 16, 2009 Female patient from ITALY , 31 years of age, was treated with Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: skin ulcer. Leflunomide dosage: . During the same period patient was treated with PREDNISOLONE (Dose: Unk) (View Prednisolone Review and Prednisolone Label ). Patient was hospitalized.

6276454-5 | Rash
on Jul 17, 2009 Male patient from UNITED STATES , 82 years of age, weighting 179.0 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: rash (What is rash?). Leflunomide dosage: 20 Mg Every Day Po.

6274554-7 | Bronchitis, Hypertension, Myocardial Infarction, Oedema Peripheral, Pulmonary Oedema
Patient was taking Leflunomide (View Usage). Patient had the following side effects: bronchitis (What is bronchitis?), hypertension, myocardial infarction, oedema peripheral, pulmonary oedema on Jun 17, 2009 from Additional patient health information: Male patient , 71 years of age, . Leflunomide dosage: . During the same period patient was treated with FELODIPINE (View Felodipine Review and Felodipine Label ), BENDROFLUAZIDE (View Bendrofluazide Review and Bendrofluazide Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

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Leflunomide Questions, Answers, Feedback and Comments

Comments to date: 1. Page 1 of 1.

Evelyn Jacob   Vancouver B.C. 

10:02am on Monday, August 31st, 2009

i have a diagnosis of RA for the past 27 years. I was recently prescribed Leflunomide 10 mg. by my r... read more »

To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Leflunomide risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Leflunomide quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Leflunomide use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Leflunomide Reactions
Alanine Aminotransferase Increased
Anaemia
Aspartate Aminotransferase Increased
Asthenia
Blood Alkaline Phosphatase Increased
Blood Lactate Dehydrogenase Increased
Condition Aggravated
Cutaneous Lupus Erythematosus
Death
Diarrhoea
DizzinessWhat is Dizziness?
Dyspnoea
Fatigue
Gamma-glutamyltransferase Increased
HeadacheWhat is Headache?
Hepatic Enzyme Increased
Hepatic Function Abnormal
HepatitisWhat is Hepatitis?
Hepatotoxicity
Liver Function Test Abnormal
Lung Neoplasm
Malaise
NauseaWhat is Nausea?
Off Label Use
Pancytopenia
Pneumonitis
Pyrexia
Thrombocytopenia
Vomiting
Weight Decreased
Leflunomide Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Leflunomide adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!