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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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7020460-X | Abdominal Distension, Diarrhoea, Malaise, Rash, Shock
on Dec 14, 2009 Male patient from JAPAN , 76 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), osteoporosis (What is osteoporosis?) and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal distension, diarrhoea, malaise, rash (What is rash?), shock. Leflunomide dosage: . During the same period patient was treated with RIMATIL (View Rimatil Review and Rimatil Label ), MEDROL (View Medrol Review and Medrol Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), ALFAROL (View Alfarol Review and Alfarol Label ), OSTELUC (View Osteluc Review and Osteluc Label ). Patient was hospitalized.

7020349-6 | Hepatitis
Patient was taking Leflunomide (View Usage). Patient had the following side effects: hepatitis (What is hepatitis?) on Sep 20, 2010 from MEXICO Additional patient health information: Female patient , 59 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: . During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), CELEBREX (View Celebrex Review and Celebrex Label ).

7018329-X | Arthralgia, Insomnia, Mobility Decreased, Product Substitution Issue
Adverse event was reported on Sep 27, 2010 by a Male patient taking Leflunomide (View Usage) (Dosage: ) . Location: UNITED STATES , weighting 200.0 lb, After Leflunomide was administered, patient had the following side effects: arthralgia, insomnia, mobility decreased, product substitution issue.

6985006-0 | Aspergillosis, No Therapeutic Response, Tracheobronchitis
on Aug 28, 2010 Female patient from UNITED STATES , 72 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), chronic obstructive pulmonary disease and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: aspergillosis, no therapeutic response, tracheobronchitis. Leflunomide dosage: . During the same period patient was treated with FLUTICASONE PROPIONATE (1 Df; Bid; Inh) (View Fluticasone Propionate Review and Fluticasone Propionate Label ), PREDNISONE (Po) (View Prednisone Review and Prednisone Label ). Patient was hospitalized.


6962368-1 | Hepatitis Acute, Urticaria
on Aug 27, 2010 Female patient from ITALY , 35 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), autoimmune thyroiditis and was treated with Leflunomide (View Usage). Patient had the following side effects: hepatitis acute, urticaria. Leflunomide dosage: . During the same period patient was treated with EUTIROX (View Eutirox Review and Eutirox Label ), CORTISONE ACETATE (Dose As Used: Unk) (View Cortisone Acetate Review and Cortisone Acetate Label ). Patient was hospitalized.

6931641-5 | Hypoaesthesia, Pain In Extremity, Peroneal Nerve Palsy
Patient was taking Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: hypoaesthesia, pain in extremity, peroneal nerve palsy on Aug 12, 2010 from TURKEY Additional patient health information: Male patient , 65 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), osteoporosis prophylaxis and. Leflunomide dosage: . During the same period patient was treated with SULFASALAZINE (View Sulfasalazine Review and Sulfasalazine Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), CALCIUM/VITAMIN D (View Calcium/vitamin D Review and Calcium/vitamin D Label ). Patient was hospitalized and became disabled.

6929743-2 | Paraesthesia, Tachycardia
Adverse event was reported on Aug 05, 2010 by a Male patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with insomnia, depression (What is depression?) and. Location: SPAIN , 71 years of age, Patient experienced the following unwanted or unexpected effects: paraesthesia, tachycardia. During the same period patient was treated with METOTREXATO (View Metotrexato Review and Metotrexato Label ), ZOLPIDEM (View Zolpidem Review and Zolpidem Label ), BESITRAN (View Besitran Review and Besitran Label ).

6926411-8 | Diarrhoea
on Aug 16, 2010 Male patient from UNITED STATES , 71 years of age, weighting 176.4 lb, was diagnosed with diarrhoea and was treated with Leflunomide (View Usage). Patient had the following side effects: diarrhoea. Leflunomide dosage: 20 Mg Every Day Po. Patient was hospitalized.

6885223-4 | Hepatomegaly, Malaise
on Jul 29, 2010 Female patient from UNITED STATES , 74 years of age, weighting 150.0 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: hepatomegaly, malaise. Leflunomide dosage: One Once A Day. Patient was hospitalized.

6879752-7 | Abdominal Distension, Acute Hepatic Failure, Nausea
Patient was taking Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal distension, acute hepatic failure, nausea (What is nausea?) on Jul 16, 2010 from CHINA Additional patient health information: Male patient , 27 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: .

6879739-4 | Hepatic Function Abnormal
Adverse event was reported on Jul 19, 2010 by a Female patient taking Leflunomide (View Usage) (Dosage: ) . Location: KOREA, REPUBLIC OF , 28 years of age, Patient had the following side effects: hepatic function abnormal. During the same period patient was treated with GANCICLOVIR (View Ganciclovir Review and Ganciclovir Label ), ACYCLOVIR (View Acyclovir Review and Acyclovir Label ), SULFAMETHOXAZOLE AND TRIMETHOPRIM (320/1600 Mg/day) (View Sulfamethoxazole And Trimethoprim Review and Sulfamethoxazole And Trimethoprim Label ). Patient was hospitalized.

6860026-5 | 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). After Leflunomide was administered, patient had the following side 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 ).

6855839-X | Confusional State, Dysarthria, Headache, Hemiplegia, Ischaemic Stroke, Meningitis Tuberculous, Pyrexia, Somnolence, Vomiting
on Jul 06, 2010 Female patient from FRANCE , weighting 132.3 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: confusional state, dysarthria, headache (What is headache?), hemiplegia, ischaemic stroke, meningitis tuberculous, pyrexia, somnolence, vomiting. Leflunomide dosage: Dose Unit: 20 Mg. During the same period patient was treated with REMICADE (Dose Unit: 100 Mg) (View Remicade Review and Remicade Label ), NOVATREX ^LEDERLE^ (Dose Unit: 2.5 Mg) (View Novatrex ^lederle^ Review and Novatrex ^lederle^ Label ), ETANERCEPT (View Etanercept Review and Etanercept Label ). Patient was hospitalized.

6844008-5 | Abortion Spontaneous
Patient was taking Leflunomide (View Usage). Patient had the following side effects: abortion spontaneous on Jul 07, 2010 from GUATEMALA Additional patient health information: Female patient , 22 years of age, was diagnosed with arthritis (What is arthritis?) and. Leflunomide dosage: . During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), METICORTEN (View Meticorten Review and Meticorten Label ).

6831008-4 | Abscess, Aplastic Anaemia, Ecchymosis, Fatigue, Lung Infiltration, Purpura, Pyrexia
Adverse event was reported on Jul 05, 2010 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Location: GERMANY , 32 years of age, After Leflunomide was administered, patient had the following side effects: abscess (What is abscess?), aplastic anaemia, ecchymosis, fatigue, lung infiltration, purpura, pyrexia. Patient was hospitalized.

6822622-0 | Abortion Spontaneous
on Jun 25, 2010 Female patient from GUATEMALA , 22 years of age, was diagnosed with arthritis (What is arthritis?) and was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: abortion spontaneous. Leflunomide dosage: . During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), METICORTEN (View Meticorten Review and Meticorten Label ).

6822497-X | Haemoglobin Decreased, Vaginal Haemorrhage
on Jun 30, 2010 Female patient from BELGIUM , 47 years of age, was treated with Leflunomide (View Usage). Patient had the following side effects: haemoglobin decreased, vaginal haemorrhage. Leflunomide dosage: . Patient was hospitalized.

6767883-1 | Rhabdomyolysis
Patient was taking Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: rhabdomyolysis on Jun 03, 2010 from BELGIUM Additional patient health information: Female patient , weighting 169.8 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: . During the same period patient was treated with BISOPROLOL (View Bisoprolol Review and Bisoprolol Label ), LEVOTHYROXINE SODIUM (View Levothyroxine Sodium Review and Levothyroxine Sodium Label ).

6767878-8 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Hepatic Function Abnormal
Adverse event was reported on Jun 09, 2010 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), gastritis, hepatic steatosis and. Location: JAPAN , 54 years of age, Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic function abnormal. During the same period patient was treated with QUESTRAN (View Questran Review and Questran Label ), PREDONINE (Dose As Used: 1 Tablet) (View Predonine Review and Predonine Label ), CIMETIDINE (Dose As Used: 1 Tablet) (View Cimetidine Review and Cimetidine Label ), URSO 250 (Dose As Used: 6 Tablets) (View Urso 250 Review and Urso 250 Label ), RHEUMATREX (Dose As Used: 6 Mg/week) (View Rheumatrex Review and Rheumatrex Label ).

6761997-8 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Lactate Dehydrogenase Increased, Diarrhoea, Gamma-glutamyltransferase Increased, Nausea
on Jun 04, 2010 Female patient from JAPAN , 58 years of age, weighting 119.0 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), hypertension and was treated with Leflunomide (View Usage). Patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, diarrhoea, gamma-glutamyltransferase increased, nausea (What is nausea?). Leflunomide dosage: . During the same period patient was treated with QUESTRAN (View Questran Review and Questran Label ), INDOMETHACIN SODIUM (View Indomethacin Sodium Review and Indomethacin Sodium Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), TAKEPRON (View Takepron Review and Takepron Label ), AMLODIN (View Amlodin Review and Amlodin Label ), AZULFIDINE (View Azulfidine Review and Azulfidine Label ), BERAPROST SODIUM (View Beraprost Sodium Review and Beraprost Sodium Label ).

6753408-3 | Amnesia, Anxiety, Condition Aggravated, Confusional State, Depression, Dyskinesia, Extrapyramidal Disorder, Headache
on May 26, 2010 Female patient from UNITED KINGDOM , 72 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: amnesia, anxiety (What is anxiety?), condition aggravated, confusional state, depression (What is depression?), dyskinesia, extrapyramidal disorder, headache (What is headache?). Leflunomide dosage: . During the same period patient was treated with ABILIFY (View Abilify Review and Abilify Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), DOXAZOSIN MESYLATE (View Doxazosin Mesylate Review and Doxazosin Mesylate Label ), FELODIPINE (View Felodipine Review and Felodipine Label ), FERROUS SULFATE TAB (View Ferrous Sulfate Tab Review and Ferrous Sulfate Tab Label ), FLUOXETINE (View Fluoxetine Review and Fluoxetine Label ), INDAPAMIDE (View Indapamide Review and Indapamide Label ). Patient was hospitalized.

6746369-4 | Haemoglobin Decreased, Vaginal Haemorrhage
Patient was taking Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: haemoglobin decreased, vaginal haemorrhage on May 21, 2010 from BELGIUM Additional patient health information: Female patient , 47 years of age, . Leflunomide dosage: . Patient was hospitalized.

6746356-6 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Lactate Dehydrogenase Increased, Diarrhoea, Gamma-glutamyltransferase Increased, Nausea
Adverse event was reported on May 21, 2010 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), hypertension and. Location: JAPAN , 58 years of age, weighting 119.0 lb, Patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, diarrhoea, gamma-glutamyltransferase increased, nausea (What is nausea?). During the same period patient was treated with QUESTRAN (View Questran Review and Questran Label ), INDOMETHACIN SODIUM (View Indomethacin Sodium Review and Indomethacin Sodium Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), TAKEPRON (View Takepron Review and Takepron Label ), AMLODIN (View Amlodin Review and Amlodin Label ), AZULFIDINE (View Azulfidine Review and Azulfidine Label ), BERAPROST SODIUM (View Beraprost Sodium Review and Beraprost Sodium Label ).

6743253-7 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Gamma-glutamyltransferase Increased, Pancytopenia
on May 21, 2010 Male patient from JAPAN , 60 years of age, weighting 99.21 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), gastritis prophylaxis, muscle tightness, abdominal distension and 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, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, pancytopenia. Leflunomide dosage: . During the same period patient was treated with OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), ERISPAN (Dose As Used: 2 Tablets) (View Erispan Review and Erispan Label ), GASMOTIN (View Gasmotin Review and Gasmotin Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ).

6741432-6 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Gamma-glutamyltransferase Increased, Pancytopenia
on May 21, 2010 Male patient from JAPAN , 60 years of age, weighting 99.21 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), gastritis prophylaxis, muscle tightness, abdominal distension 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, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, pancytopenia. Leflunomide dosage: . During the same period patient was treated with OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), ERISPAN (Dose As Used: 2 Tablets) (View Erispan Review and Erispan Label ), GASMOTIN (View Gasmotin Review and Gasmotin Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ).

6741405-3 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Vomiting
Patient was taking Leflunomide (View Usage). Patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, vomiting on May 20, 2010 from JAPAN Additional patient health information: Female patient , 66 years of age, weighting 121.3 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), gastritis, osteoporosis (What is osteoporosis?) and. Leflunomide dosage: . During the same period patient was treated with PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), SELBEX (View Selbex Review and Selbex Label ), CALCIUM PHOSPHATE DIBASIC (View Calcium Phosphate Dibasic Review and Calcium Phosphate Dibasic Label ), CLINORIL (Dose As Used: 4 Tablets Dose Unit: 100 Mg) (View Clinoril Review and Clinoril Label ), GLAKAY (Dose As Used: 2 Capsules) (View Glakay Review and Glakay Label ), FERROMIA (Dose As Used: 2 Tablets) (View Ferromia Review and Ferromia Label ), ACTONEL (Dose As Used: 1 Tablet) (View Actonel Review and Actonel Label ). Patient was hospitalized.

6735482-3 | Acute Hepatic Failure
Adverse event was reported on May 14, 2010 by a Male patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Location: TAIWAN, PROVINCE OF CHINA , 53 years of age, After Leflunomide was administered, patient had the following side effects: acute hepatic failure. Patient was hospitalized.

6725634-0 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Histiocytosis Haematophagic, Platelet Count Decreased, Rash, White Blood Cell Count Decreased
on May 10, 2010 Female patient from JAPAN , 51 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), vitamin c deficiency, vitamin supplementation 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, blood lactate dehydrogenase increased, histiocytosis haematophagic, platelet count decreased, rash (What is rash?), white blood cell count decreased. Leflunomide dosage: . During the same period patient was treated with QUESTRAN (View Questran Review and Questran 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 ).

6725599-1 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Constipation, Enteritis, Gamma-glutamyltransferase Increased, Liver Disorder, Nasopharyngitis
on May 10, 2010 Female patient from JAPAN , 36 years of age, weighting 110.2 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), gastrointestinal disorder, constipation (What is constipation?) and was treated with Leflunomide (View Usage). Patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, constipation (What is constipation?), enteritis, gamma-glutamyltransferase increased, liver disorder, nasopharyngitis. Leflunomide dosage: . During the same period patient was treated with QUESTRAN (View Questran Review and Questran Label ), LOXONIN (Dose Unit: 60 Mg) (View Loxonin Review and Loxonin Label ), MUCOSTA (Dose Unit: 100 Mg) (View Mucosta Review and Mucosta Label ), BACILLUS SUBTILIS/LACTOBACILLUS ACIDOPHILUS/STREPTOCOCCUS FAECALIS (View Bacillus Subtilis/lactobacillus Acidophilus/streptococcus Faecalis Review and Bacillus Subtilis/lactobacillus Acidophilus/streptococcus Faecalis Label ).

6721450-4 | Acute Hepatic Failure
Patient was taking Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: acute hepatic failure on May 03, 2010 from TAIWAN, PROVINCE OF CHINA Additional patient health information: Male patient , 53 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: . Patient was hospitalized.

6709199-5 | Acute Myeloid Leukaemia, Diabetes Mellitus, Diarrhoea, Hepatic Function Abnormal, Mouth Ulceration, Neuropathy Peripheral, Pancytopenia
Adverse event was reported on Apr 28, 2010 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Location: NETHERLANDS , 62 years of age, Patient experienced the following unwanted or unexpected effects: acute myeloid leukaemia, diabetes mellitus, diarrhoea, hepatic function abnormal, mouth ulceration, neuropathy peripheral, pancytopenia. Patient was hospitalized.

6694000-9 | Threatened Labour
on Apr 12, 2010 Female patient from POLAND , 38 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: threatened labour. Leflunomide dosage: . Patient was hospitalized.

6691486-0 | Gastric Cancer, Gastric Ulcer
on Apr 19, 2010 Male patient from GERMANY , 47 years of age, weighting 222.7 lb, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: gastric cancer, gastric ulcer. Leflunomide dosage: . During the same period patient was treated with ETANERCEPT (Daily Dose: 50 / 7) (View Etanercept Review and Etanercept Label ), ANTIVIRALS FOR SYSTEMIC USE (Daily Dose: 0.5) (View Antivirals For Systemic Use Review and Antivirals For Systemic Use Label ), METHOTREXAT (Dayily Dose:15 / 7) (View Methotrexat Review and Methotrexat Label ), PREDNISOLON (Daily Dose: 5-20) (View Prednisolon Review and Prednisolon Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ), COLECALCIFEROL (View Colecalciferol Review and Colecalciferol Label ), ANTIINFLAMMATORY/ANTIRHEUMATIC NON STEROIDS (View Antiinflammatory/antirheumatic Non-steroids Review and Antiinflammatory/antirheumatic Non-steroids Label ). Patient was hospitalized.

6686046-1 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Constipation, Enteritis, Gamma-glutamyltransferase Increased, Liver Disorder, Nasopharyngitis
Patient was taking Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, constipation (What is constipation?), enteritis, gamma-glutamyltransferase increased, liver disorder, nasopharyngitis on Apr 15, 2010 from JAPAN Additional patient health information: Female patient , 36 years of age, weighting 110.2 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?), gastrointestinal disorder, constipation (What is constipation?) and. Leflunomide dosage: . During the same period patient was treated with QUESTRAN (View Questran Review and Questran Label ), LOXONIN (Dose Unit: 60 Mg) (View Loxonin Review and Loxonin Label ), MUCOSTA (Dose Unit: 100 Mg) (View Mucosta Review and Mucosta Label ), BACILLUS SUBTILIS/LACTOBACILLUS ACIDOPHILUS/STREPTOCOCCUS FAECALIS (View Bacillus Subtilis/lactobacillus Acidophilus/streptococcus Faecalis Review and Bacillus Subtilis/lactobacillus Acidophilus/streptococcus Faecalis Label ).

6684897-0 | Hepatic Function Abnormal
Adverse event was reported on Apr 14, 2010 by a Female patient taking Leflunomide (View Usage) (Dosage: ) . Location: KOREA, REPUBLIC OF , 28 years of age, Patient had the following side effects: hepatic function abnormal. During the same period patient was treated with GANCICLOVIR (View Ganciclovir Review and Ganciclovir Label ), ACYCLOVIR (View Acyclovir Review and Acyclovir Label ), SULFAMETHOXAZOLE AND TRIMETHOPRIM (320/1600 Mg/day) (View Sulfamethoxazole And Trimethoprim Review and Sulfamethoxazole And Trimethoprim Label ). Patient was hospitalized.

6680777-5 | Dehydration, Diarrhoea, Headache, Hyperkalaemia, Hypertensive Crisis, Nausea
on Apr 09, 2010 Female patient from CANADA , 65 years of age, weighting 200.0 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: dehydration, diarrhoea, headache (What is headache?), hyperkalaemia, hypertensive crisis, nausea (What is nausea?). 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 HCL (View Metformin Hcl Review and Metformin Hcl Label ). Patient was hospitalized.

6674140-0 | Alveolitis Allergic, Diarrhoea, Urticaria
on Mar 24, 2010 Female patient from HONG KONG , 32 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: alveolitis allergic, diarrhoea, urticaria. Leflunomide dosage: 20 Mg;qd. During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), HYDROXYCHLOROQUINE SULFATE (View Hydroxychloroquine Sulfate Review and Hydroxychloroquine Sulfate Label ), SULPASALAZINE (SULFASALAZINE) (View Sulpasalazine (sulfasalazine) Review and Sulpasalazine (sulfasalazine) Label ). Patient was hospitalized.

6668510-4 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Gamma-glutamyltransferase Increased, Hepatitis, Liver Function Test Abnormal
Patient was taking Leflunomide (View Usage). 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 on Apr 01, 2010 from BELGIUM Additional patient health information: Female patient , 43 years of age, was diagnosed with juvenile arthritis and. Leflunomide dosage: . 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 ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ).

6665292-7 | Bladder Cancer Recurrent, Pruritus, Stomatitis
Adverse event was reported on Mar 31, 2010 by a Male patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Location: JAPAN , 73 years of age, weighting 160.9 lb, After Leflunomide was administered, patient had the following side effects: bladder cancer recurrent, pruritus, stomatitis. During the same period patient was treated with MOBIC (Dose Unit: 10 Mg) (View Mobic Review and Mobic Label ), PROMAC /JPN/ (Dose Unit: 1 G) (View Promac /jpn/ Review and Promac /jpn/ Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), PREDNISOLONE (Dose As Used: 1/2 Tablets Dose Unit: 5 Mg) (View Prednisolone Review and Prednisolone Label ), HYPEN (View Hypen Review and Hypen Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), EVIPROSTAT (View Eviprostat Review and Eviprostat Label ), HARNAL (View Harnal Review and Harnal Label ).

6657368-5 | Hepatic Function Abnormal
on Mar 25, 2010 Female patient from KOREA, REPUBLIC OF , 28 years of age, was treated with Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: hepatic function abnormal. Leflunomide dosage: . During the same period patient was treated with GANCICLOVIR (View Ganciclovir Review and Ganciclovir Label ). Patient was hospitalized.

6657365-X | Diarrhoea, Fatigue, Hepatic Enzyme Increased
on Mar 23, 2010 Female patient from ROMANIA , 68 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: diarrhoea, fatigue, hepatic enzyme increased. Leflunomide dosage: .

6655256-1 | Cardiac Failure, Cytomegalovirus Gastroenteritis
Patient was taking Leflunomide (View Usage). After Leflunomide was administered, patient had the following side effects: cardiac failure, cytomegalovirus gastroenteritis on Mar 23, 2010 from JAPAN Additional patient health information: Female patient , 72 years of age, weighting 83.78 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: . During the same period patient was treated with INFLIXIMAB (200 Mg Every Two Months) (View Infliximab Review and Infliximab Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), ISCOTIN (View Iscotin Review and Iscotin Label ), PYDOXAL (View Pydoxal Review and Pydoxal Label ), GASMOTIN (Dose As Used: 5 Mg, 3 Tablets) (View Gasmotin Review and Gasmotin Label ). Patient was hospitalized.

6642394-2 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Asthenia, Bone Marrow Failure, Gingival Bleeding, Hepatotoxicity, Thrombocytopenia
Adverse event was reported on Jan 19, 2010 by a Male patient taking Leflunomide (View Usage) (Dosage: ) . Location: BELGIUM , 59 years of age, weighting 264.6 lb, Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, asthenia, bone marrow failure, gingival bleeding, hepatotoxicity, thrombocytopenia. During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ). Patient was hospitalized.

6639787-6 | Syncope
on Oct 16, 2009 Female patient from AUSTRALIA , 84 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: syncope. 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 ), TRAMAL (Dose As Used: Unk) (View Tramal Review and Tramal Label ), PARACETAMOL (Dose As Used: Unk) (View Paracetamol Review and Paracetamol Label ).

6639782-7 | Blood Creatinine Increased, Nephropathy
on Sep 29, 2009 Female patient from POLAND , 61 years of age, weighting 132.3 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: blood creatinine increased, nephropathy. Leflunomide dosage: Dose As Used: 20 Mg/10mg. During the same period patient was treated with MOVALIS (Dose As Used: 7.5 To 15 Mg) (View Movalis Review and Movalis Label ), HELICID (View Helicid Review and Helicid Label ), ZALDIAR (Dose As Used: 1-2 Tablet) (View Zaldiar Review and Zaldiar Label ). Patient was hospitalized.

6639084-9 | Atrial Fibrillation, Liver Function Test Abnormal
Patient was taking Leflunomide (View Usage). Patient experienced the following unwanted or unexpected effects: atrial fibrillation (What is atrial fibrillation?), liver function test abnormal on Sep 18, 2009 from AUSTRALIA Additional patient health information: Female patient , 72 years of age, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: . During the same period patient was treated with METHOTREXATE (Dose As Used: Unk) (View Methotrexate Review and Methotrexate Label ), PREDNISONE (Dose As Used: Unk) (View Prednisone Review and Prednisone Label ), CALCIUM (Dose As Used: Unk) (View Calcium Review and Calcium Label ), FOLIC ACID (Dose As Used: Unk) (View Folic Acid Review and Folic Acid Label ), HORMONES AND RELATED AGENTS (Dose As Used: Unk) (View Hormones And Related Agents Review and Hormones And Related Agents Label ).

6639067-9 | Hepatic Function Abnormal
Adverse event was reported on Mar 16, 2010 by a Female patient taking Leflunomide (View Usage) (Dosage: ) was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Location: JAPAN , 65 years of age, weighting 117.9 lb, Patient had the following side effects: hepatic function abnormal. During the same period patient was treated with RHEUMATREX (View Rheumatrex Review and Rheumatrex Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), LOPRESSOR (View Lopressor Review and Lopressor Label ), ALTAT (View Altat Review and Altat Label ), DORAL (View Doral Review and Doral Label ), HALCION (View Halcion Review and Halcion Label ).

6617806-0 | Bladder Cancer Recurrent, Pruritus, Stomatitis
on Mar 03, 2010 Male patient from JAPAN , 73 years of age, weighting 160.9 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: bladder cancer recurrent, pruritus, stomatitis. Leflunomide dosage: . During the same period patient was treated with MOBIC (Dose Unit: 10 Mg) (View Mobic Review and Mobic Label ), PROMAC /JPN/ (Dose Unit: 1 G) (View Promac /jpn/ Review and Promac /jpn/ Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), PREDONINE (Dose As Used: 1/2 Tablets Dose Unit: 5 Mg) (View Predonine Review and Predonine Label ), HYPEN (View Hypen Review and Hypen Label ), GASTER D (View Gaster D Review and Gaster D Label ).

6615783-X | Colitis, Diarrhoea, Hepatitis, Keratitis, Mucosal Inflammation, Pneumothorax, Respiratory Distress, Stevens-johnson Syndrome
on Feb 19, 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 experienced the following unwanted or unexpected effects: colitis, diarrhoea, hepatitis (What is hepatitis?), keratitis, mucosal inflammation, pneumothorax, respiratory distress, stevens-johnson syndrome. Leflunomide dosage: . Patient was hospitalized.

6611525-2 | Breast Cancer In Situ
Patient was taking Leflunomide (View Usage). Patient had the following side effects: breast cancer in situ on Feb 25, 2010 from UNITED KINGDOM Additional patient health information: Female patient , 60 years of age, weighting 149.9 lb, was diagnosed with rheumatoid arthritis (What is rheumatoid arthritis?) and. Leflunomide dosage: . During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), DICLOFENAC (View Diclofenac Review and Diclofenac Label ), FOLIC ACID (View Folic Acid Review and Folic Acid 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 drug discussion forum | I started treatment with this drug about a year ago in addition to salazopyrine which i had started | Sun, 16 May 2010 |

... Bortezomib (Velcade) Cisplatin & Oxaliplatin Colchicine (extended use) Dapsone Didanosine (ddI, Videx) Dichloroacetate Disulfiram (Antabuse) Gold salts Leflunomide (Arava ...

I have stoped methotrexate and folic acid and now started taking Leflunomide (Arava). ... About Arava | Risks and Benefits Leflunomide (Arava®) is another DMARD used ...

I have stoped methotrexate and folic acid and now started taking Leflunomide (Arava). ... About Arava | Risks and Benefits Leflunomide (Arava®) is another DMARD used ...

ASCITES, view Drugs and Side Effects associated with ASCITES, ,ASCITES KETEK,ASCITES GEMZAR,ASCITES GLEEVEC,ASCITES AVASTIN,ASCITES NEXAVAR,ASCITES SUTENT,ASCITES ...

During the same period patient was treated with LEFLUNOMIDE (View Leflunomide Review and Leflunomide Label ), CYTOSIDE ARABINOSIDE (View Cytoside Arabinoside Review and ...

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leflunomide Episodes: 3: Diagnosed with major depression.Side effects: cardiac failure, myocarditis More: methotrexate Episodes: 1: Diagnosed with major depression ...

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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!