Arava Safety Reports submitted to FDA

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Total Arava reports: 492.
Arava FDA safety alerts: 2003 .
Reported deaths: 61 Reported hospitalizations: 238.
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FDA Reported Arava Side Effects: alanine aminotransferase increased, aspartate aminotransferase increased, diarrhoea, blood alkaline phosphatase increased, pyrexia, gamma-glutamyltransferase increased, blood lactate dehydrogenase increased, vomiting, hepatic function abnormal, myocardial infarction, alopecia.
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Arava Side Effects Report #5371830-7
Consumer or non-health professional from AUSTRALIA reported ARAVA problem on June 21, 2007. Female patient, 54 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: lung neoplasm malignant. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, FOLIC ACID, HYDROXYCHLOROQUINE SULPHATE, PREDNISONE, MOBIC, FLUCONAZOLE. Patient was hospitalized and became disabled. Patient recovered.

Arava Side Effects Report #5374411-4
ARAVA problem was reported by a Consumer or non-health professional from TUNISIA on June 22, 2007. Female patient, 36 years of age, was diagnosed with polyarthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: computerised tomogram normal, convulsion, keratitis, multi-organ failure, neutropenia, optic atrophy, rash maculo-papular, sepsis, toxic epidermal necrolysis. ARAVA dosage: unknown. During the same period patient was treated with PREDNISONE, INDOCIN, ANALGAN, CALPEROS. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5374414-X
Physician from SPAIN reported ARAVA problem on June 21, 2007. Male patient, 30 years of age, was diagnosed with polyarthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: cardiomyopathy, dilatation ventricular, palpitations. ARAVA dosage: unknown. During the same period patient was treated with ENBREL. Patient recovered.

Arava Side Effects Report #5374417-5
ARAVA problem was reported by a Physician from UNITED STATES on June 20, 2007. Female patient, weighting 115.2 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: anaemia, anorexia, blood creatinine increased, blood urea increased, diarrhoea, dizziness postural, dyspnoea, eosinophilia, gamma-glutamyltransferase. ARAVA dosage: unknown. During the same period patient was treated with CYTOXAN, PREDNISONE, METFORMIN, SIMVASTATIN, NIFEDIPINE, DIOVAN HCT, FOSAMAX, VIT D. Patient recovered.

Arava Side Effects Report #5374418-7
Consumer or non-health professional from AUSTRALIA reported ARAVA problem on June 25, 2007. Male patient, 75 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, FOLIC ACID, PREDNISOLONE, BISPROLOL, COVERSYL, LIPITOR, ASTRIX, PLAVIX. Patient recovered.

Arava Side Effects Report #5042729-0
ARAVA problem was reported by a Physician from UNITED KINGDOM on June 05, 2006. Female patient was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: hypocalcaemia. ARAVA dosage: unknown. Patient recovered.

Arava Side Effects Report #5042730-7
Physician from FRANCE reported ARAVA problem on Jan 05, 2006. Female patient, 64 years of age, weighting 110.2 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: constipation, creatinine renal clearance decreased, haemorrhoids, renal failure. ARAVA dosage: unknown. During the same period patient was treated with QUESTRAN, NSAID. Patient recovered.

Arava Side Effects Report #5044071-0
ARAVA problem was reported by a Physician from JAPAN on Aug 09, 2005. Female patient, 74 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic function abnormal, rash. ARAVA dosage: unknown. During the same period patient was treated with LOXONIN, CYTOTEC, LENDORMIN, DEPAS, BONALON, FERROMIA, BENET, AMLODIN. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5044073-4
Physician from JAPAN reported ARAVA problem on Mar 05, 2004. Male patient, 70 years of age, weighting 144.4 lb, was diagnosed with rheumatoid arthritis, prophylaxis against gastrointestinal ulcer, gastritis, neuralgia, hyperlipidaemia, osteoporosis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood albumin decreased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, interstitial lung disease, liver disorder. ARAVA dosage: unknown. During the same period patient was treated with INFREE, PREDONINE, CYTOTEC, ANTACID, CYANOCOBALAMIN, LIPITOR. Patient was hospitalized. Patient died on 04/30/2004.

Arava Side Effects Report #5044074-6
ARAVA problem was reported by a Physician from AUSTRALIA on June 13, 2006. Female patient, 70 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: gastric haemorrhage. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, KETOPROFEN. Patient recovered.

Arava Side Effects Report #5044262-9
Health Professional from JAPAN reported ARAVA problem on June 12, 2006. Female patient, 23 years of age, weighting 103.6 lb, was diagnosed with rheumatoid arthritis, gastritis, prophylaxis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, diarrhoea, enterocolitis haemorrhagic, platelet count increased, pyrexia. ARAVA dosage: unknown. During the same period patient was treated with PREDONINE, LOXONIN, MUCOSTA. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5044901-2
ARAVA problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 29, 2006. Female patient, 56 years of age, was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: cellulitis, neutropenia, sjogren's syndrome, skin ulcer. ARAVA dosage: unknown. Patient recovered.

Arava Side Effects Report #5045963-9
Consumer or non-health professional from reported ARAVA problem on July 04, 2006. Female patient, 46 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: colitis, diarrhoea, melanosis. ARAVA dosage: unknown. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5047805-4
ARAVA problem was reported by a Pharmacist from UNITED STATES on July 10, 2006. Male patient, 55 years of age, weighting 246.0 lb, was diagnosed with psoriatic arthropathy and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, decreased appetite, faeces discoloured, haemodialysis, hepatotoxicity, hypoxia, jaundice, leukopenia. ARAVA dosage: 20 MG EVERY OTHER DAY PO. During the same period patient was treated with METHOTREXATE. Patient died on 06/03/2006.

Arava Side Effects Report #5048731-7
Physician from POLAND reported ARAVA problem on June 12, 2006. Female patient, 70 years of age, weighting 138.9 lb, was diagnosed with rheumatoid arthritis, hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, transaminases increased, urinary tract infection. ARAVA dosage: unknown. During the same period patient was treated with PRESTARIUM, BETALOC ZOK, ACARD. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5051276-1
ARAVA problem was reported by a Consumer or non-health professional from UNITED STATES on July 10, 2006. Female patient was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: hepatic cirrhosis, hepatocellular damage. ARAVA dosage: unknown. Patient died on 06/07/2004.

Arava Side Effects Report #5051277-3
Consumer or non-health professional from AUSTRALIA reported ARAVA problem on July 07, 2006. Female patient, 53 years of age, weighting 264.6 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: hypertension, myocardial infarction. ARAVA dosage: unknown. During the same period patient was treated with KARVEZIDE, ENDONE, VALIUM, AVAPRO, HUMIRA. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5051279-7
ARAVA problem was reported by a Physician from UNITED STATES on July 06, 2006. Female patient was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alpha 1 foetoprotein increased, laboratory test abnormal, neural tube defect, oestriol abnormal. ARAVA dosage: unknown. Patient recovered.

Arava Side Effects Report #5051281-5
Physician from AUSTRALIA reported ARAVA problem on May 22, 2006. Female patient, 41 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, gamma-glutamyltransferase increased, hepatic enzyme increased. ARAVA dosage: unknown. During the same period patient was treated with FOLIC ACID, METHOTREXATE, OROXINE. Patient recovered.

Arava Side Effects Report #5051283-9
ARAVA problem was reported by a Physician from BRAZIL on Dec 12, 2005. Female patient, 57 years of age, was diagnosed with rheumatoid arthritis, hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: pleural effusion, pneumonia bacterial, rheumatoid nodule, treatment noncompliance, tuberculosis. ARAVA dosage: unknown. During the same period patient was treated with MELOXICAM, AMITRIPTYLINE, FOLIC ACID, COMBINATIONS OF ANTIHYPERTENSIVES IN ATC. Patient recovered.

Arava Side Effects Report #5051284-0
Physician from FRANCE reported ARAVA problem on Nov 23, 2005. Male patient, 60 years of age, weighting 143.3 lb, was diagnosed with rheumatoid arthritis, prophylaxis, arthralgia, blood calcium decreased and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aldolase increased, anaemia, aspartate aminotransferase increased, autoimmune disorder, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, dry skin, electromyogram abnormal. ARAVA dosage: unknown. During the same period patient was treated with SOLUPRED, MOPRAL, DAFALGAN, OROCAL VITAMINE D3. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5052504-9
ARAVA problem was reported by a Physician from JAPAN on June 29, 2006. Female patient, 56 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: purpura, ulcer, vasculitis necrotising. ARAVA dosage: unknown. During the same period patient was treated with RHEUMATREX, FOLIAMIN, PREDNISOLONE, SALIGREN, TAKEPRON, SELBEX. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5053581-1
Consumer or non-health professional from FRANCE reported ARAVA problem on July 10, 2006. Female patient, 60 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: mucosal erosion, photosensitivity reaction, rhabdomyolysis. ARAVA dosage: unknown. During the same period patient was treated with METHYLPREDNISONE. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5053585-9
ARAVA problem was reported by a Physician from UNITED KINGDOM on June 29, 2006. Female patient, 56 years of age, was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: cellulitis, neutropenia, sjogren's syndrome, skin ulcer. ARAVA dosage: unknown. Patient recovered.

Arava Side Effects Report #5053588-4
Consumer or non-health professional from UNITED STATES reported ARAVA problem on May 17, 2006. Female patient, weighting 176.3 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: dysfunctional uterine bleeding, non-hodgkin's lymphoma, uterine cancer. ARAVA dosage: unknown. During the same period patient was treated with METHATREXATE, PLAQUENIL, NSAID, FOLIC ACID, RELAFEN. Patient recovered.

Arava Side Effects Report #5054760-X
ARAVA problem was reported by a Consumer or non-health professional from CANADA on July 10, 2006. Female patient, 64 years of age, was diagnosed with rheumatoid arthritis, pain and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: blister, erythema, food aversion, gangrene, insomnia, paraesthesia, plantar fasciitis, refusal of treatment by patient, renal disorder. ARAVA dosage: unknown. During the same period patient was treated with OMEGA, VITAMIN D, ACETAMINOPHEN. Patient was hospitalized and became disabled. Patient recovered.

Arava Side Effects Report #5054762-3
Consumer or non-health professional from reported ARAVA problem on July 10, 2006. Female patient, 51 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: sarcoidosis. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, ENBREL. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5054767-2
ARAVA problem was reported by a Health Professional from JAPAN on Feb 24, 2004. Female patient, 62 years of age, weighting 99.21 lb, was diagnosed with rheumatoid arthritis, hyperuricaemia and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, arrhythmia, dehydration, diarrhoea, pancytopenia, renal impairment, stomatitis. ARAVA dosage: unknown. During the same period patient was treated with ALLOPURINOL, RHEUMATREX, ALLOZYM. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5057018-8
Physician from JAPAN reported ARAVA problem on Dec 07, 2005. Male patient, 50 years of age, was diagnosed with rheumatoid arthritis, thrombosis prophylaxis, disseminated tuberculosis, hypertension, prophylaxis against gastrointestinal ulcer, osteoporosis, constipation and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, gastric ulcer, iron deficiency anaemia. ARAVA dosage: unknown. During the same period patient was treated with ASPIRIN, ISCOTIN, ACECOL, SELECTOL, PROMAC, ACINON, BONALON, PURSENNID. Patient recovered.

Arava Side Effects Report #5057020-6
ARAVA problem was reported by a Physician from JAPAN on Nov 25, 2004. Female patient, 28 years of age, weighting 165.3 lb, was diagnosed with rheumatoid arthritis, prophylaxis, asthma and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, liver disorder, purpura, rash. ARAVA dosage: unknown. During the same period patient was treated with CELESTONE, METALCAPTASE, PYDOXAL. Patient recovered.

Arava Side Effects Report #5059450-5
Physician from POLAND reported ARAVA problem on June 12, 2006. Female patient, 70 years of age, weighting 138.9 lb, was diagnosed with rheumatoid arthritis, hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, transaminases increased. ARAVA dosage: unknown. During the same period patient was treated with PRESTARIUM, BETALOC ZOK, ACARD. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5059452-9
ARAVA problem was reported by a Physician from ITALY on July 17, 2006. Female patient was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, neuropathy peripheral, paraparesis. ARAVA dosage: unknown. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5060761-8
Physician from BRAZIL reported ARAVA problem on July 18, 2006. Female patient, 65 years of age, weighting 152.1 lb, was diagnosed with rheumatoid arthritis, pain, inflammation and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, choluria, hepatitis, icterus index increased, pyrexia, vomiting. ARAVA dosage: unknown. During the same period patient was treated with METICORTEN, FLOTAC. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5060763-1
ARAVA problem was reported by a Physician from JAPAN on July 19, 2006. Female patient, 37 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, hepatic function abnormal, nausea, pollakiuria, radiculitis brachial. ARAVA dosage: unknown. During the same period patient was treated with RHEUMATREX, PREDNISOLONE, LOXONIN, MUCOSTA, TAGAMET. Patient recovered.

Arava Side Effects Report #5060764-3
Physician from JAPAN reported ARAVA problem on July 20, 2006. Female patient, 40 years of age, was diagnosed with rheumatoid arthritis, hyperlipidaemia and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal. ARAVA dosage: unknown. During the same period patient was treated with ANTILIPEMIC. Patient recovered.

Arava Side Effects Report #5062004-8
ARAVA problem was reported by a Physician from FRANCE on Jan 31, 2002. Female patient, 61 years of age, weighting 180.8 lb, was diagnosed with rheumatoid arthritis, hypertension, hypercholesterolaemia and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: asthenia, cardiac murmur, cyanosis, diabetes mellitus insulin-dependent, dysaesthesia, erythema, hypercholesterolaemia, hypertriglyceridaemia. ARAVA dosage: unknown. During the same period patient was treated with CORTANCYL, SPIRONOLACTONE, FUROSEMIDE, MOXONIDINE, ATORVASTATIN CALCIUM. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5062005-X
Physician from JAPAN reported ARAVA problem on Mar 13, 2006. Female patient, 47 years of age, weighting 103.6 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, hepatic function abnormal. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, PREDNISOLONE, GASTER, RIMATIL, BENET, NEORAL, IMURAN. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5065397-0
ARAVA problem was reported by a Physician from GERMANY on July 24, 2006. Female patient, 36 years of age, was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: systemic lupus erythematosus. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient recovered.

Arava Side Effects Report #5065398-2
Physician from JAPAN reported ARAVA problem on July 24, 2006. Male patient, 77 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: pancreatic carcinoma. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAC, GASTER, PROMAC, PREDNISOLONE, HERBAL PREPARATION. Patient was hospitalized. Patient died.

Arava Side Effects Report #5065399-4
ARAVA problem was reported by a Physician from JAPAN on July 24, 2006. Female patient, 55 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: ovarian cancer. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAC, MUCOSTA, VOLTAREN, RHEUMATREX, RIMATIL. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5065400-8
Physician from JAPAN reported ARAVA problem on July 24, 2006. Female patient, 59 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: uterine cancer. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAC, VOLTAREN. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5065401-X
ARAVA problem was reported by a Physician from JAPAN on July 24, 2006. Female patient, 74 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: gastric cancer recurrent. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAC, FERROMIA, GEFANIL, TAKEPRON, PREDNISOLONE, AZULFIDINE. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5065409-4
Physician from JAPAN reported ARAVA problem on Mar 30, 2005. Female patient, 55 years of age, weighting 101.4 lb, was diagnosed with rheumatoid arthritis, prophylaxis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, hepatic function abnormal, pyrexia, rash. ARAVA dosage: unknown. During the same period patient was treated with GASTER, FOSAMAC, RHEUMATREX, MOVER, CYTOTEC, SELBEX. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5065410-0
ARAVA problem was reported by a Physician from JAPAN on June 29, 2006. Female patient, 56 years of age, weighting 101.4 lb, was diagnosed with rheumatoid arthritis, prophylaxis, sjogren's syndrome, prophylaxis against gastrointestinal ulcer and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: purpura, ulcer, vasculitis necrotising. ARAVA dosage: unknown. During the same period patient was treated with RHEUMATREX, FOLIAMIN, PREDNISOLONE, SALIGREN, TAKEPRON, SELBEX. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5065411-2
Physician from JAPAN reported ARAVA problem on Feb 14, 2006. Female patient, 75 years of age, weighting 121.3 lb, was diagnosed with rheumatoid arthritis, prophylaxis against gastrointestinal ulcer, osteoporosis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic function abnormal. ARAVA dosage: unknown. During the same period patient was treated with ZANTAC, PREDNISOLONE, AZULFIDINE, BENET, VOLTAREN. Patient recovered.

Arava Side Effects Report #5066386-2
ARAVA problem was reported by a Consumer or non-health professional from on July 26, 2006. Female patient, 46 years of age, was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, pneumonia. ARAVA dosage: unknown. Patient died on 05/29/2006.

Arava Side Effects Report #5066388-6
Consumer or non-health professional from reported ARAVA problem on July 26, 2006. Female patient, 66 years of age, was diagnosed with rheumatoid arthritis, crohn's disease and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: constipation, electrolyte imbalance, metabolic acidosis, nausea, pneumonia, sepsis, urinary tract infection, vomiting. ARAVA dosage: unknown. During the same period patient was treated with ATENOLOL, LANSOPRAZOLE, SALAZOPYRIN, KALCIPOS, GABAPENTIN, NORFLOXACIN, PREDNISOLONE. Patient recovered.

Arava Side Effects Report #5066390-4
ARAVA problem was reported by a Pharmacist from IRELAND on Mar 21, 2006. Male patient, 79 years of age, was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: cardiac failure, pneumonia. ARAVA dosage: unknown. During the same period patient was treated with PREDNISOLONE, ENBREL, WARFARIN, ACETYLSALICYLIC ACID SRT, DILTIAZEM, FOSAMAX, CALCICHEW, NEXIUM. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5067685-0
Health Professional from JAPAN reported ARAVA problem on Dec 16, 2003. Female patient, 73 years of age, weighting 112.4 lb, was diagnosed with rheumatoid arthritis, thrombosis prophylaxis, pain, arrhythmia, hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: gastroduodenal ulcer, melaena. ARAVA dosage: unknown. During the same period patient was treated with WARFARIN, VOLTAREN, SUNRYTHM, ALDACTONE, NORVASC. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5067688-6
ARAVA problem was reported by a Physician from UNITED STATES on Feb 09, 2006. Male patient, weighting 183.0 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: asthenia, blood creatinine increased, blood urea increased, chronic obstructive pulmonary disease, confusional state, cryptococcosis, diverticulum intestinal, dysphagia, lung infiltration. ARAVA dosage: unknown. During the same period patient was treated with REMICADE, METHOTREXATE, PREDNISONE, GLYBURIDE. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5067689-8
Physician from JAPAN reported ARAVA problem on Feb 16, 2004. Female patient, 21 years of age, weighting 94.80 lb, was diagnosed with rheumatoid arthritis, gastritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, alanine aminotransferase increased, anaemia, anaphylactoid shock, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, diarrhoea. ARAVA dosage: unknown. During the same period patient was treated with PREDNISOLONE, MARZULENE S, RHEUMATREX, FOLIAMIN, VOLTAREN. Patient was hospitalized. Patient died on 03/05/2004.

Arava Side Effects Report #5069379-4
ARAVA problem was reported by a Consumer or non-health professional from on Apr 10, 2006. Female patient, 55 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: hypoaesthesia, paraesthesia. ARAVA dosage: unknown. During the same period patient was treated with REMICADE. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5069741-X
Physician from JAPAN reported ARAVA problem on July 27, 2006. Female patient, 57 years of age, was diagnosed with rheumatoid arthritis, osteoporosis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: uterine cancer. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAX, VOLTAREN. Patient recovered.

Arava Side Effects Report #5070956-5
ARAVA problem was reported by a Physician from UNITED KINGDOM on Nov 28, 2005. Male patient, 77 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, circulatory collapse, dehydration, diarrhoea, eating disorder, muscle strain. ARAVA dosage: unknown. During the same period patient was treated with DISOPYRAMIDE, NEORAL, FOSAMAX, LANSOPRAZOLE, MELOXICAM. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5071276-5
Physician from UNITED STATES reported ARAVA problem on Aug 03, 2006. Female patient, 58 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: abdominal distension, alanine aminotransferase increased, antinuclear antibody positive, aspartate aminotransferase increased, autoimmune hepatitis, blood bilirubin increased, chromaturia, hepatic trauma, hepatomegaly. ARAVA dosage: 20 MG QD PO. During the same period patient was treated with LOVASTATIN, LISINOPRIL, LOPRESSOR, PROTONIX, TRAMADOLOL, ZHIBAI, ISOCORT, FLAX SEED OIL. Patient recovered.

Arava Side Effects Report #5072225-6
ARAVA problem was reported by a Consumer or non-health professional from on July 04, 2006. Female patient, 46 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: colitis, crohn's disease, diarrhoea, ileitis, melanosis. ARAVA dosage: unknown. During the same period patient was treated with PENTASA, VOLTAREN, EUPHYTOSE, DIDRONEL, FIXICAL, CORTANCYL, BREXIN, NEXIUM. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5072226-8
Physician from JAPAN reported ARAVA problem on July 20, 2006. Female patient, 40 years of age, was diagnosed with rheumatoid arthritis, hyperlipidaemia and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, hepatic function abnormal. ARAVA dosage: unknown. During the same period patient was treated with SERUMLIPIDREDUCING AGENTS. Patient recovered.

Arava Side Effects Report #5075600-9
ARAVA problem was reported by a Physician from JAPAN on July 24, 2006. Female patient, 55 years of age, weighting 143.3 lb, was diagnosed with rheumatoid arthritis, osteoporosis, gastritis, prophylaxis, pain and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, blood lactate dehydrogenase increased, malignant ascites, neutrophil percentage increased, ovarian cancer, platelet count increased, white blood cell count increased. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAC, MUCOSTA, VOLTAREN. Patient recovered.

Arava Side Effects Report #5075601-0
Physician from JAPAN reported ARAVA problem on July 24, 2006. Female patient, 59 years of age, weighting 147.7 lb, was diagnosed with rheumatoid arthritis, osteoporosis prophylaxis, analgesic effect and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: laboratory test abnormal, uterine cancer. ARAVA dosage: unknown. During the same period patient was treated with BENET, FOSAMAC, VOLTAREN. Patient recovered.

Arava Side Effects Report #5075602-2
ARAVA problem was reported by a Physician from JAPAN on July 24, 2006. Female patient, 74 years of age, weighting 94.80 lb, was diagnosed with rheumatoid arthritis, osteoporosis, iron deficiency anaemia, prophylaxis against gastrointestinal ulcer and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: abdominal distension, anorexia, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gastric cancer recurrent, gastroenteritis, rash, spinal compression fracture. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAC, FERROMIA, GEFANIL, TAKEPRON, PREDNISOLONE. Patient recovered.

Arava Side Effects Report #5076657-1
Physician from JAPAN reported ARAVA problem on July 24, 2006. Male patient, 76 years of age, weighting 110.2 lb, was diagnosed with rheumatoid arthritis, osteoporosis, gastritis, prophylaxis, inflammation and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: aspiration, back pain, bladder cancer, dehydration, nasopharyngitis, obstructive airways disorder, pancreatic carcinoma, productive cough. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAC, GASTER, PROMAC, PREDONINE. Patient died on 10/27/2005.

Arava Side Effects Report #5076663-7
ARAVA problem was reported by a Physician from UNITED STATES on July 28, 2006. Female patient was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: colitis collagenous, diarrhoea. ARAVA dosage: unknown. Patient recovered.

Arava Side Effects Report #5078097-8
Physician from JAPAN reported ARAVA problem on July 24, 2006. Female patient, 66 years of age, weighting 110.2 lb, was diagnosed with rheumatoid arthritis, osteoporosis prophylaxis, inflammation, prophylaxis against gastrointestinal ulcer, iron deficiency anaemia and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: bladder cancer, blood lactate dehydrogenase increased, malaise, transitional cell cancer of the renal pelvis and ureter, ureteral disorder. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAC, PREDNISOLONE, GEFANIL, FERROMIA, TAKEPRON. Patient recovered.

Arava Side Effects Report #5079195-5
ARAVA problem was reported by a Consumer or non-health professional from AUSTRALIA on Aug 08, 2006. Female patient, 63 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: pleurisy, rash. ARAVA dosage: unknown. During the same period patient was treated with HYDROXYCHLOROQUIN, METHOTREXATE, PREDNISONE, FOLIC ACID, DYMADON, VENTOLIN. Patient recovered.

Arava Side Effects Report #5079196-7
Physician from NEW ZEALAND reported ARAVA problem on July 26, 2006. Female patient, 48 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alopecia, pleurisy, pneumonitis. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, HYDROXYCHLOROQUINE SULPHATE. Patient recovered.

Arava Side Effects Report #5079245-6
ARAVA problem was reported by a Physician from JAPAN on July 27, 2006. Female patient, 59 years of age, weighting 147.7 lb, was diagnosed with rheumatoid arthritis, osteoporosis prophylaxis, inflammation and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: uterine cancer. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAX, VOLTAREN, RISEDRONATE, ONEALFA. Patient recovered.

Arava Side Effects Report #5080164-X
Physician from FRANCE reported ARAVA problem on Sept 01, 2005. Female patient, 65 years of age, weighting 110.2 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alopecia, scleritis. ARAVA dosage: unknown. During the same period patient was treated with ENBREL, ACTONEL, SULFASALAZINE, OMEPRAZOLE, IDEOS. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5080165-1
ARAVA problem was reported by a Physician from CZECH REPUBLIC on Aug 03, 2006. Female patient, 59 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: rheumatoid nodule. ARAVA dosage: unknown. Patient recovered.

Arava Side Effects Report #5083338-7
Physician from FRANCE reported ARAVA problem on Aug 08, 2006. Male patient, 51 years of age, was diagnosed with rheumatoid arthritis, neuralgia and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, cervical root pain, cholestasis, gamma-glutamyltransferase increased, lung adenocarcinoma, metastases to bone. ARAVA dosage: unknown. During the same period patient was treated with BIPROFENID, CORTANCYL. Patient recovered.

Arava Side Effects Report #5083341-7
ARAVA problem was reported by a Physician from FRANCE on Aug 11, 2006. Female patient, 70 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: breast cancer, breast cancer female, breast cancer recurrent, neutropenia. ARAVA dosage: unknown. Patient recovered.

Arava Side Effects Report #5084479-0
Consumer or non-health professional from UNITED STATES reported ARAVA problem on Aug 10, 2006. Female patient, 26 years of age, weighting 220.5 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, pregnancy induced hypertension, twin pregnancy. ARAVA dosage: unknown. During the same period patient was treated with PRENATAL VITAMINS, ACETAMINOPHEN, PARAMETHASONE ACETATE. Patient recovered.

Arava Side Effects Report #5086296-4
ARAVA problem was reported by a Physician from UNITED KINGDOM on July 17, 2006. Male patient, 41 years of age, was diagnosed with rheumatoid arthritis, dyspepsia and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, myositis, pain in extremity, rash. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, DICLOFENAC, RANITIDINE, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5087363-1
Consumer or non-health professional from CANADA reported ARAVA problem on July 10, 2006. Female patient, 64 years of age, was diagnosed with rheumatoid arthritis, pain and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: blister, erythema, gangrene, paraesthesia, plantar fasciitis, refusal of treatment by patient, renal disorder, tooth fracture, tooth loss. ARAVA dosage: unknown. During the same period patient was treated with OMEGA, VITAMIN D, TYLENOL. Patient was hospitalized and became disabled. Patient recovered.

Arava Side Effects Report #5087838-5
ARAVA problem was reported by a Consumer or non-health professional from on May 02, 2006. Female patient, 72 years of age, was diagnosed with psoriatic arthropathy, diabetes mellitus and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, diabetic microangiopathy, haemoglobin decreased, microalbuminuria, skin necrosis, skin ulcer, toe amputation. ARAVA dosage: unknown. During the same period patient was treated with LANTUS, FONZYLANE, STILNOX, OSTRAM, OMEPRAZOLE, LIPANTHYL, FLECAINIDE ACETATE. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5088704-1
Physician from UNITED STATES reported ARAVA problem on May 12, 2005. Male patient, 70 years of age, was diagnosed with transplant, prophylaxis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: lung infiltration, pulmonary haemorrhage. ARAVA dosage: unknown. During the same period patient was treated with PROGRAF, PREDNISONE, NORVASC, PROTONIX, METOPROLOL TARTRATE. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5091279-4
ARAVA problem was reported by a Consumer or non-health professional from on Aug 24, 2006. Male patient, 67 years of age, weighting 94.80 lb, was diagnosed with polyarthritis, lower respiratory tract infection fungal and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, bronchitis, cytolytic hepatitis, escherichia infection, lower respiratory tract infection fungal, malnutrition, streptococcal infection. ARAVA dosage: unknown. During the same period patient was treated with TRIFLUCAN. Patient died on 08/09/2006.

Arava Side Effects Report #5091285-X
Physician from FRANCE reported ARAVA problem on July 07, 2006. Male patient, 83 years of age, weighting 180.8 lb, was diagnosed with rheumatoid arthritis, hypertension, back pain and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: back pain. ARAVA dosage: unknown. During the same period patient was treated with CORTANCYL, ALLOPURINOL, HERBAL PREPARATION, ATACAND, CALCIUM WITH VITAMIN D. Patient recovered.

Arava Side Effects Report #5091288-5
ARAVA problem was reported by a Consumer or non-health professional from on Aug 03, 2006. Female patient, 60 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: ear pain, neuralgia, pyrexia. ARAVA dosage: unknown. During the same period patient was treated with CORTANCYL, ANAFRANIL, ENBREL, NEXIUM, HUMIRA. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5092570-8
Consumer or non-health professional from reported ARAVA problem on Aug 21, 2006. Male patient, 51 years of age, was diagnosed with psoriatic arthropathy and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: food aversion, neuropathy, paraesthesia, weight decreased. ARAVA dosage: unknown. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5092572-1
ARAVA problem was reported by a Consumer or non-health professional from CANADA on July 10, 2006. Female patient, 64 years of age, was diagnosed with rheumatoid arthritis, pain and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: arthralgia, blister, erythema, gangrene, glomerulonephritis proliferative, insomnia, leukocytoclastic vasculitis, necrotising fasciitis. ARAVA dosage: unknown. During the same period patient was treated with OMEGA, VITAMIN D, TYLENOL, PREDNISONE, DIDROCAL. Patient was hospitalized and became disabled. Patient recovered.

Arava Side Effects Report #5093747-8
Consumer or non-health professional from UNITED STATES reported ARAVA problem on Aug 23, 2006. Male patient was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: amnesia, anaemia, anxiety, cataract, cerebrovascular accident, chest pain, coronary arterial stent insertion, coronary artery bypass, depression. ARAVA dosage: unknown. During the same period patient was treated with MOTRIN. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5095002-9
ARAVA problem was reported by a Physician from CZECH REPUBLIC on Aug 03, 2006. Female patient, 59 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: lung neoplasm, pleural effusion, rheumatoid nodule. ARAVA dosage: unknown. Patient recovered.

Arava Side Effects Report #5095003-0
Consumer or non-health professional from AUSTRALIA reported ARAVA problem on July 07, 2006. Female patient, 53 years of age, weighting 264.6 lb, was diagnosed with rheumatoid arthritis, hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: hypertension, myocardial infarction. ARAVA dosage: unknown. During the same period patient was treated with KARVEZIDE, ENDONE, VALIUM, AVAPRO, HUMIRA, ACETAMINOPHEN W, PREDNISOLONE, METHOTREXATE. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5095610-5
ARAVA problem was reported by a Physician from JAPAN on July 27, 2006. Female patient, 59 years of age, weighting 147.7 lb, was diagnosed with rheumatoid arthritis, osteoporosis prophylaxis, inflammation and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: uterine cancer. ARAVA dosage: unknown. During the same period patient was treated with FOSAMAX, VOLTAREN, BENET, ONEALFA. Patient recovered.

Arava Side Effects Report #5096318-2
Physician from FINLAND reported ARAVA problem on Aug 23, 2006. Female patient, 52 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: malignant melanoma. ARAVA dosage: unknown. During the same period patient was treated with ENBREL, REMICADE. Patient recovered.

Arava Side Effects Report #5096321-2
ARAVA problem was reported by a Health Professional from CANADA on Aug 25, 2006. Female patient, 65 years of age, weighting 170.4 lb, was diagnosed with rheumatoid arthritis, thyroid disorder and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: asthenia, cerebrovascular accident, fall, haemoglobin decreased, impaired self-care, neutropenia, pulmonary oedema, thyroid disorder. ARAVA dosage: unknown. During the same period patient was treated with SYNTHROID, FOLIC ACID, VITAMINS, PANTOPRAZOLE, METHOTREXATE, AGGRENOX, DIOVAN, FERROUS GLUCONATE. Patient died on 08/13/2006.

Arava Side Effects Report #5098235-0
Physician from FRANCE reported ARAVA problem on Aug 29, 2006. Female patient, 54 years of age, was diagnosed with rheumatoid arthritis, essential hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, headache, hypertension, renal failure, retinopathy hypertensive. ARAVA dosage: unknown. During the same period patient was treated with CORTANCYL, ZANIDIP. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5098888-7
ARAVA problem was reported by a Physician from NEW ZEALAND on July 26, 2006. Female patient, 48 years of age, was diagnosed with rheumatoid arthritis, depression and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alopecia, pleurisy, pneumonitis. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, HYDROXYCHLOROQUINE SULPHATE, SALAZOPYRIN, FLUOXETINE, ARCOXIA. Patient recovered.

Arava Side Effects Report #5099651-3
Consumer or non-health professional from FRANCE reported ARAVA problem on Aug 26, 2004. Male patient, 69 years of age, weighting 152.1 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: antinuclear antibody positive, neutrophil count increased, non-hodgkin's lymphoma. ARAVA dosage: unknown. During the same period patient was treated with ENBREL, VASTAREL, OGAST. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5101262-8
ARAVA problem was reported by a Consumer or non-health professional from INDIA on Aug 29, 2006. Female patient, 21 years of age, was diagnosed with rheumatoid arthritis, arthralgia and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: hepatomegaly, jaundice, pleural effusion, pyrexia, rash pruritic, toxic epidermal necrolysis, white blood cell count increased. ARAVA dosage: unknown. During the same period patient was treated with ROFECOXIB. Patient died.

Arava Side Effects Report #5101263-X
Consumer or non-health professional from INDIA reported ARAVA problem on Aug 29, 2006. Male patient, 24 years of age, was diagnosed with arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: anorexia, asthenia, eosinophilia, lymphadenopathy, ocular hyperaemia, oedema peripheral, pyrexia, rash. ARAVA dosage: unknown. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5101271-9
ARAVA problem was reported by a Physician from TUNISIA on Jan 13, 2006. Female patient, 36 years of age, was diagnosed with polyarthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: computerised tomogram normal, convulsion, corneal abscess, keratitis, multi-organ failure, neutropenia, optic atrophy, rash maculo-papular, sepsis. ARAVA dosage: unknown. During the same period patient was treated with PREDNISONE, INDOCIN, ANALGAN, CALPEROS D. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5101272-0
Consumer or non-health professional from INDIA reported ARAVA problem on Aug 29, 2006. Female patient, 50 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, bilirubin conjugated increased, blood bilirubin unconjugated increased, dermatitis, dermatitis exfoliative, diarrhoea. ARAVA dosage: unknown. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5102535-5
ARAVA problem was reported by a Consumer or non-health professional from INDIA on Aug 29, 2006. Male patient, 52 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, conjunctival hyperaemia, dermatitis, dermatitis exfoliative, diarrhoea, lymphadenopathy, monocyte percentage decreased, mucous membrane disorder. ARAVA dosage: unknown. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5102536-7
Consumer or non-health professional from INDIA reported ARAVA problem on Aug 29, 2006. Female patient, 47 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: blood bilirubin increased, dermatitis, hepatic enzyme increased, platelet count decreased, rash papular, vomiting. ARAVA dosage: unknown. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5102537-9
ARAVA problem was reported by a Consumer or non-health professional from on Sept 04, 2006. Female patient was treated with ARAVA. ARAVA dosage: unknown. Patient died.

Arava Side Effects Report #5103534-X
Physician from POLAND reported ARAVA problem on Sept 05, 2006. Female patient, 41 years of age, weighting 275.6 lb, was diagnosed with rheumatoid arthritis, hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: ovarian cancer. ARAVA dosage: unknown. During the same period patient was treated with DICLAC, TIALORID. Patient recovered.

Arava Side Effects Report #5103539-9
ARAVA problem was reported by a Physician from NEW ZEALAND on July 26, 2006. Female patient, 48 years of age, was diagnosed with rheumatoid arthritis, depression and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alopecia, pleurisy, pneumonitis. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, HYDROXYCHLOROQUINE SULPHATE, SALAZOPYRIN, FLUOXETINE, ARCOXIA. Patient recovered.

Arava Side Effects Report #5104468-7
Health Professional from UNITED STATES reported ARAVA problem on Sept 07, 2006. Female patient was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, cholecystitis, cholelithiasis, dysgeusia, hepatic enzyme increased. ARAVA dosage: unknown. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5104469-9
ARAVA problem was reported by a Physician from JAPAN on Sept 08, 2006. Male patient, 54 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: electrocardiogram st segment elevation, pulmonary oedema. ARAVA dosage: unknown. Patient was hospitalized. Patient recovered.

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Drug Information: Leflunomide

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a600032.html

(le floo' na mide)

IMPORTANT WARNING:

Pregnant women and women of childbearing age who are not using a reliable method of birth control should not take leflunomide. Pregnancy must be avoided during treatment and for 2 years after treatment with leflunomide. If your period is late or you miss a period during treatment with leflunomide, call your doctor immediately. Talk to your doctor if you plan to become pregnant after stopping treatment with leflunomide. Your doctor can prescribe a treatment that will decrease the risk of harm to the fetus.

Why is this medication prescribed?

Leflunomide is used to treat rheumatoid arthritis. Leflunomide decreases the symptoms of rheumatoid arthritis and slows damage to joints caused by the disease.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Leflunomide comes as a tablet to take by mouth. It is usually taken once a day. You will need to take a larger dose for the first 3 days of treatment. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take leflunomide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

What special precautions should I follow?

Before taking leflunomide,

tell your doctor and pharmacist if you are allergic to leflunomide or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially cholestyramine (Cholybar, Questran), colestipol (Colestid), felbamate (Felbatol), mercaptopurine (Purinethol), rifampin (Rifadin, Rimactane, Rifater), methotrexate (Rheumatrex), tolbutamide (Orinase), troglitazone (Rezulin), and vitamins.
tell your doctor if you have or have ever had liver or kidney disease, hepatitis, severe infections, or conditions affecting the bone marrow or the immune system (including human immunodeficiency virus [HIV] and acquired immunodeficiency syndrome [AIDS]).
tell your doctor if you are breast-feeding.
if you are planning to father a child, you should talk to your doctor about stopping leflunomide prior to conception.
you should not receive any vaccinations while taking leflunomide unless you have talked with your doctor.
you should know that there is a special treatment for removing leflunomide from your body once you stop taking it. Ask your doctor or pharmacist for more information about this treatment.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Leflunomide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

diarrhea
hair loss
headache
dizziness
upset stomach
vomiting
stomach pain
loss of appetite
weight loss
mouth sores
runny nose
back pain
dry or itchy skin
muscle pain or weakness
flu-like symptoms
urinary tract infection

If you experience any of the following symptoms, call your doctor immediately:

rash
difficulty breathing
chest pain
increased heart rate

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor. Your doctor will order certain laboratory tests to monitor your response to leflunomide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

Arava®

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