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Leflunomide Side Effects summary
Total Leflunomide reports: 58.Leflunomide FDA safety alerts: 2003 .
Reported deaths: 6 Reported hospitalizations: 28.
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Leflunomide Side Effects: pyrexia, myelodysplastic syndrome, leukopenia, diarrhoea, pregnancy of partner, transaminases increased, accidental overdose, accidental exposure, dyspnoea, condition aggravated, infection,
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Leflunomide Side Effects reported to FDA
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Leflunomide Side Effects Report #5772026-7Consumer or non-health professional from UNITED STATES reported LEFLUNOMIDE problem on June 04, 2008. Female patient, 51 years of age, was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood lactate dehydrogenase increased, ecchymosis, off label use, thrombocytopenia, thrombotic microangiopathy. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with TACROLIMUS, THYMOGLOBULIN, MYCOPHENOLATE MOFETIL. Patient recovered.
Leflunomide Side Effects Report #5786907-1
LEFLUNOMIDE problem was reported by a Physician from UNITED STATES on June 23, 2008. Male patient, weighting 187.0 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: haematochezia, prothrombin time prolonged. LEFLUNOMIDE dosage: 20 MG ONE/ DAY PO. Patient recovered.
Leflunomide Side Effects Report #5792307-0
Physician from ITALY reported LEFLUNOMIDE problem on June 09, 2008. Female patient, 24 years of age, was diagnosed with ankylosing spondylitis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: cutaneous lupus erythematosus, erythema multiforme, mucosal ulceration, odynophagia, photophobia. LEFLUNOMIDE dosage: 20 MG/DAY. During the same period patient was treated with METHYLPREDNISOLONE. Patient recovered.
Leflunomide Side Effects Report #5794739-3
LEFLUNOMIDE problem was reported by a Physician from UNITED KINGDOM on June 23, 2008. Female patient, 49 years of age, was diagnosed with rheumatoid arthritis, blood pressure, prophylaxis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: beta haemolytic streptococcal infection, cardio-respiratory arrest, pneumonia, septic shock. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with ENBREL, DICLOFENAC W, BENDROFLUMETHIAZIDE, PREDNISOLONE, PREGADAY, OMEPRAZOLE, TRAMADOL, DOXAZOSIN MESYLATE. Patient was hospitalized. Patient died on 01/02/2008.

Leflunomide Side Effects Report #5794740-X
Consumer or non-health professional from UNITED STATES reported LEFLUNOMIDE problem on June 17, 2008. Female patient, 51 years of age, was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood lactate dehydrogenase increased, ecchymosis, haemolysis, off label use, overdose, thrombocytopenia, thrombotic microangiopathy. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with TACROLIMUS, THYMOGLOBULIN, MYCOPHENOLATE MOFETIL, CORTICOSTEROIDS, IVIGG, RITUXIMAB. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5733388-X
LEFLUNOMIDE problem was reported by a Consumer or non-health professional from TURKEY on May 01, 2008. Female patient, 62 years of age, was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: hepatitis c. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with METHOTREXATE, ETANERCEPT, SULFASALAZINE. Patient recovered.
Leflunomide Side Effects Report #5752116-5
Physician from AUSTRIA reported LEFLUNOMIDE problem on May 15, 2008. Female patient, 66 years of age, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood glucose increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, infection, leukopenia, mucosal inflammation, myelodysplastic syndrome, pyrexia. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with METAMIZOL, ATACAND HCT, THYREX, PANTOLOC. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5753037-4
LEFLUNOMIDE problem was reported by a Consumer or non-health professional from GERMANY on May 13, 2008. Female patient, 42 years of age, was diagnosed with arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: cutaneous lupus erythematosus, leukopenia, mucosal ulceration. LEFLUNOMIDE dosage: 100 MG/DAY; 20 MG/DAY. During the same period patient was treated with PREDNISOLONE. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5694840-9
Consumer or non-health professional from reported LEFLUNOMIDE problem on Mar 27, 2008. Female patient, 80 years of age, was diagnosed with rheumatoid arthritis, pain and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with GABAPENTIN, LANSOPRAZOLE, PREDNISOLONE, TRAMADOL. Patient died on 09/25/2007.

Leflunomide Side Effects Report #5712633-0
LEFLUNOMIDE problem was reported by a Physician from HUNGARY on Apr 14, 2008. Female patient, 34 years of age, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: rheumatoid lung. LEFLUNOMIDE dosage: unknown. Patient recovered.
Leflunomide Side Effects Report #5712636-6
Consumer or non-health professional from UNITED STATES reported LEFLUNOMIDE problem on Apr 16, 2008. Female patient, 66 years of age, weighting 153.2 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: asthenia, blood pressure increased, dizziness, dyspnoea, heart rate irregular, nausea, vision blurred, weight decreased. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with HUMIRA, PRINZIDE, ATORVASTATIN CALCIUM, IBUPROFEN. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5719096-X
LEFLUNOMIDE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Apr 10, 2008. Male patient, 69 years of age, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: alveolitis allergic, atelectasis, chest pain, decreased appetite, fatigue, fungal infection, ill-defined disorder. LEFLUNOMIDE dosage: 20 MG. During the same period patient was treated with METHOTREXATE, ETODOLAC, RANITIDINE, ACETAMINOPHEN, NIFEDIPINE. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5719635-9
Consumer or non-health professional from UNITED STATES reported LEFLUNOMIDE problem on Apr 21, 2008. Female patient, weighting 200.4 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: colitis collagenous. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with HUMIRA. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5724722-5
LEFLUNOMIDE problem was reported by a Physician from UNITED STATES on Apr 30, 2008. Male patient, weighting 160.9 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: tuberculosis, weight decreased. LEFLUNOMIDE dosage: 20MG DAILY PO. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient recovered.

Leflunomide Side Effects Report #5370254-6
Physician from UNITED STATES reported LEFLUNOMIDE problem on June 25, 2007. Female patient, weighting 154.0 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident, coagulopathy, hepatic failure, nausea, pulmonary embolism, vomiting. LEFLUNOMIDE dosage: 10MG. During the same period patient was treated with HUMIRA. Patient died on 11/25/2006.
Leflunomide Side Effects Report #5301489-6
LEFLUNOMIDE problem was reported by a Health Professional from UNITED STATES on Mar 28, 2007. Female patient, 35 years of age, weighting 242.1 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, pregnancy. LEFLUNOMIDE dosage: 20 MG, QD, ORAL. During the same period patient was treated with PRENATAL VITAMINS, PLAQUENIL, PREDNISONE, VICODIN, AMBIEN, SYTHROID, TYLENOL. Patient recovered.
Leflunomide Side Effects Report #5262507-7
Consumer or non-health professional from reported LEFLUNOMIDE problem on Feb 27, 2007. Female patient, 24 years of age, weighting 123.2 lb, was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with ACECLOFENAC, CYCLOSPORINE. Patient recovered.
Leflunomide Side Effects Report #5277207-7
LEFLUNOMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 22, 2007. Male patient, 43 years of age, weighting 200.0 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: disease recurrence, rheumatoid arthritis. LEFLUNOMIDE dosage: 20MG DAILY PO. Patient recovered.
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Leflunomide Side Effects


