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Arava Side Effects summary
Total Arava reports: 597.Arava FDA safety alerts: 2003 .
Reported deaths: 91 Reported hospitalizations: 269.
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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 reported to FDA
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Arava Side Effects Report #5517385-5Consumer or non-health professional from AUSTRALIA reported ARAVA problem on Nov 07, 2007. Female patient, 83 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: dyspnoea, fatigue, musculoskeletal pain, myocardial infarction. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, MEGAFOL, PREDNISOLONE, NATRILIX. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5517387-9
ARAVA problem was reported by a Consumer or non-health professional from on Nov 08, 2007. Female patient, 54 years of age, was diagnosed with rheumatoid arthritis, pharyngotonsillitis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, liver function test abnormal. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, DOXYCYCLINE, TYLENOL, MAGNESIUM OXIDE, MAGNESIUM OXIDE, STILLEN CAP, STILLEN CAP, ALMAGEL. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5517388-0
Physician from UNITED KINGDOM reported ARAVA problem on Nov 08, 2007. Female patient, 62 years of age, weighting 136.5 lb, was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal. ARAVA dosage: unknown. During the same period patient was treated with PREDNISOLONE, HYDROXYCHLOROQUINE SULPHATE, LEVOTHYROXINE, ALENDRONATE. Patient recovered.
Arava Side Effects Report #5518311-5
ARAVA problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 07, 2007. Female patient, 86 years of age, was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: asthenia, dysphagia, dyspnoea, fall, hypersensitivity, lip swelling, oedema mouth, pain, pharyngeal oedema. ARAVA dosage: unknown. Patient recovered.

Arava Side Effects Report #5519265-8
Consumer or non-health professional from reported ARAVA problem on Nov 06, 2007. Female patient, 32 years of age, weighting 176.4 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: chest pain, erythema nodosum, mouth ulceration, tachycardia, uveitis. ARAVA dosage: unknown. During the same period patient was treated with CORTANCYL, ENBREL, APRANAX, EUPANTOL, DAFALGAN, LOPERAMIDE. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5519266-X
ARAVA problem was reported by a Physician from FRANCE on Nov 06, 2007. Female patient, 47 years of age, was diagnosed with rheumatoid arthritis, cystitis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hepatocellular damage, hypercholesterolaemia, hypertriglyceridaemia. ARAVA dosage: unknown. During the same period patient was treated with DAFALGAN, MEDROL, MONOFLOCET. Patient recovered.
Arava Side Effects Report #5519268-3
Consumer or non-health professional from AUSTRALIA reported ARAVA problem on Nov 09, 2007. Male patient, 69 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: osteitis deformans. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, FOLIC ACID, PREDNISOLONE, LIPITOR, ZOTON, PROGOUT. Patient recovered.
Arava Side Effects Report #5519270-1
ARAVA problem was reported by a Physician from AUSTRALIA on Nov 12, 2007. 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: lung neoplasm, pneumonia. ARAVA dosage: unknown. During the same period patient was treated with DICLOFENAC, TRAMADOL, PANADEINE. Patient recovered.
Arava Side Effects Report #5519271-3
Physician from AUSTRALIA reported ARAVA problem on Nov 12, 2007. Female patient, 68 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, pain. ARAVA dosage: unknown. Patient recovered.

Arava Side Effects Report #5519272-5
ARAVA problem was reported by a Physician from MALAYSIA on Nov 12, 2007. Female patient, 31 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, alopecia, dyspnoea, excoriation, grand mal convulsion, hepatic steatosis, leukopenia, pneumonitis, pruritus. ARAVA dosage: unknown. During the same period patient was treated with PREDNISOLONE, ARCOXIA. Patient was hospitalized. Patient died on 11/05/2007.
Arava Side Effects Report #5520640-6
Physician from GERMANY reported ARAVA problem on Nov 14, 2007. Male patient, 69 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: hepatic failure, liver disorder, pancytopenia. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient was hospitalized. Patient died on 10/13/2007.
Arava Side Effects Report #5520641-8
ARAVA problem was reported by a Pharmacist from UNITED STATES on Nov 13, 2007. Female patient, weighting 173.1 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: anorexia, asthenia, blood creatinine increased, dyspnoea exertional, excessive granulation tissue, hypotension, pancytopenia, petechiae. ARAVA dosage: unknown. During the same period patient was treated with HYDROXYCHLOROQUINE SULPHATE. Patient recovered.
Arava Side Effects Report #5521777-8
Physician from JAPAN reported ARAVA problem on Nov 15, 2007. Female patient, 65 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: liver disorder. ARAVA dosage: unknown. During the same period patient was treated with ISCOTIN. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5521781-X
ARAVA problem was reported by a Physician from CZECH REPUBLIC on Nov 13, 2007. Male patient, 73 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: asthenia, fatigue, myelodysplastic syndrome, pallor. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, FOSAMAX, FOLIC ACID, CALCICHEW D. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5523211-0
Consumer or non-health professional from UNITED STATES reported ARAVA problem on Nov 16, 2007. Female patient, 50 years of age, weighting 130.0 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: neuropathy peripheral. ARAVA dosage: 20MG EVERY OTHER DAY. Patient recovered.
Arava Side Effects Report #5523290-0
ARAVA problem was reported by a Consumer or non-health professional from on Nov 14, 2007. Female patient, 86 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: pancytopenia. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, ACTONEL, DACORTIN, LEDERFOLIN, OMEPRAZOLE. Patient died on 06/24/2007.
Arava Side Effects Report #5523291-2
Consumer or non-health professional from AUSTRALIA reported ARAVA problem on Nov 15, 2007. Female patient, 66 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: retinal detachment. ARAVA dosage: unknown. Patient recovered.
Arava Side Effects Report #5525860-2
ARAVA problem was reported by a Physician from FRANCE on Nov 16, 2007. Female patient, 71 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: bronchitis, bronchospasm, cough, dyspnoea, pyrexia. ARAVA dosage: unknown. During the same period patient was treated with PREDNISONE, IRBESARTAN. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5525867-5
Physician from ARGENTINA reported ARAVA problem on Oct 25, 2007. Female patient was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: jaundice neonatal. ARAVA dosage: unknown. During the same period patient was treated with FOLIC ACID. Patient recovered.

Arava Side Effects Report #5525868-7
ARAVA problem was reported by a Physician from UNITED KINGDOM on Oct 29, 2007. Female patient, 32 years of age, was diagnosed with psoriatic arthropathy and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: abortion induced. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, FOLIC ACID, DICLOFENAC, OMEPRAZOLE. Patient recovered.
Arava Side Effects Report #5526562-9
Consumer or non-health professional from UNITED STATES reported ARAVA problem on Nov 21, 2007. Male patient, 64 years of age, weighting 165.0 lb, was diagnosed with connective tissue disorder and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: coma, influenza, organ failure. ARAVA dosage: unknown. Patient died on 03/21/2007.
Arava Side Effects Report #5526567-8
ARAVA problem was reported by a Pharmacist from UNITED STATES on Nov 21, 2007. Female patient, weighting 176.2 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: accelerated hypertension, no therapeutic response. ARAVA dosage: 20 MG DAILY ORAL. During the same period patient was treated with DETROL LA, LISINOPRIL AND HYDROCHLOROTHIAZIDE, ATENOLOL, DAYPRO, PREMARIN, FOLIC ACID. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5527356-0
Consumer or non-health professional from FRANCE reported ARAVA problem on Nov 15, 2007. Female patient, 64 years of age, weighting 125.7 lb, was diagnosed with bk virus infection and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: anaemia, cytomegalovirus infection, gamma-glutamyltransferase increased, hypertension, pyelonephritis acute, renal failure, thrombocytopenia, ureteric stenosis. ARAVA dosage: unknown. During the same period patient was treated with DIANTALVIC. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5527357-2
ARAVA problem was reported by a Physician from MALAYSIA on Nov 19, 2007. Female patient, 31 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, alopecia, dyspnoea, excoriation, grand mal convulsion, hepatic steatosis, leukopenia, pneumonitis, pruritus. ARAVA dosage: unknown. During the same period patient was treated with PREDNISOLONE, ARCOXIA. Patient was hospitalized. Patient died on 11/05/2007.
Arava Side Effects Report #5528356-7
Physician from GREECE reported ARAVA problem on Nov 21, 2007. Female patient, 41 years of age, was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: hepatitis cholestatic, pruritus. ARAVA dosage: unknown. During the same period patient was treated with LEVOTHYROXINE, SERTRALINE. Patient recovered.
Arava Side Effects Report #5528359-2
ARAVA problem was reported by a Consumer or non-health professional from FRANCE on Nov 20, 2007. Female patient, 65 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, dyspnoea, faecaloma, hypertension, hypotension, hypoxia, interstitial lung disease, pneumomediastinum, pneumothorax. ARAVA dosage: unknown. During the same period patient was treated with SALAZOPYRINE, CORTICOSTEROIDS. Patient was hospitalized. Patient died on 07/31/2006.
Arava Side Effects Report #5528904-7
Physician from FRANCE reported ARAVA problem on Nov 21, 2007. 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: breast cancer, breast cancer female. ARAVA dosage: unknown. During the same period patient was treated with CORTICOSTEROIDS. Patient recovered.
Arava Side Effects Report #5528905-9
ARAVA problem was reported by a Pharmacist from UNITED KINGDOM on Nov 21, 2007. Male patient, 68 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: dyspnoea, respiratory failure. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, PREDNISOLONE, ANALGESICS, ANTIHYPERTENSIVES. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5528909-6
Health Professional from POLAND reported ARAVA problem on Nov 23, 2007. Female patient, 46 years of age, weighting 132.3 lb, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: liver injury. ARAVA dosage: unknown. During the same period patient was treated with ENCORTON, MAJAMIL. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5528910-2
ARAVA problem was reported by a Consumer or non-health professional from FRANCE on Nov 15, 2007. Male patient, 58 years of age, was diagnosed with bk virus infection and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: anaemia, asthenia, blood creatinine increased, renal failure, thrombocytopenia. ARAVA dosage: unknown. During the same period patient was treated with LASIX, NEORAL. Patient recovered.
Arava Side Effects Report #5530519-1
Physician from VENEZUELA reported ARAVA problem on Nov 21, 2007. Female patient, 29 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: arteritis, feeling of body temperature change, pain, thrombosis. ARAVA dosage: unknown. During the same period patient was treated with RITUXIMAB. Patient recovered.
Arava Side Effects Report #5530524-5
ARAVA problem was reported by a Physician from SPAIN on Nov 20, 2007. Female patient, 72 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: angioedema, encephalopathy, hepatocellular damage, multi-organ failure, pyrexia, shock, stevens-johnson syndrome, transaminases increased. ARAVA dosage: unknown. During the same period patient was treated with CAPTOPRIL, ORFIDAL, OMEPRAZOLE, NAPROXEN, EQUISETUM ARVENSE, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient died.
Arava Side Effects Report #5530526-9
Physician from NORWAY reported ARAVA problem on Nov 23, 2007. 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: anorexia, dysgeusia, periorbital oedema, photosensitivity reaction, rash erythematous, swelling, weight decreased. ARAVA dosage: unknown. During the same period patient was treated with VENTOLIN, CLARITIN, IBUMETIN, KLACID, SALAZOPYRIN, AERIUS, PREDNISOLONE. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5472755-9
ARAVA problem was reported by a Consumer or non-health professional from AUSTRALIA on Sept 24, 2007. 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: blood glucose increased, dry eye, fatigue, mucosal dryness, sjogren's syndrome. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, CELECOXIB, DIAMICRON, DIAFORMIN, EFEXOR, LIPITOR. Patient recovered.
Arava Side Effects Report #5474391-7
Physician from TURKEY reported ARAVA problem on Sept 21, 2007. Female patient, 75 years of age, weighting 165.3 lb, was diagnosed with hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: off label use, pruritus, wound. ARAVA dosage: unknown. During the same period patient was treated with CALCIUM WITH VITAMIN D, FOSAMAX, DELTACORTRIL, TENSINOR, COZAAR, DIAMICRON, PROSEK, HYZAAR. Patient recovered.
Arava Side Effects Report #5475646-2
ARAVA problem was reported by a Physician from NORWAY on Sept 24, 2007. 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: anorexia, dysgeusia, periorbital oedema, photosensitivity reaction, rash erythematous, swelling, weight decreased. ARAVA dosage: unknown. During the same period patient was treated with VENTOLINE, CLARITIN, IBUMETIN, KLACID, SALAZOPYRIN, AERIUS, PREDNISOLONE. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5475647-4
Physician from AUSTRALIA reported ARAVA problem on Sept 27, 2007. Female patient, 59 years of age, was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: poor peripheral circulation, skin discolouration. ARAVA dosage: unknown. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5475651-6
ARAVA problem was reported by a Physician from AUSTRALIA on Sept 27, 2007. Female patient, 68 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: arrhythmia, hypertension, palpitations. ARAVA dosage: unknown. During the same period patient was treated with NOTEN, NORVASC, MICARDIS, NOVOMIX, PREDNISOLONE, SALAZOPYRIN, PANTOPRAZOLE, ASPIRIN. Patient was hospitalized. Patient recovered.
Arava Side Effects Report #5478209-8
Consumer or non-health professional from AUSTRALIA reported ARAVA problem on Sept 28, 2007. Female patient, 72 years of age, was diagnosed with rheumatoid arthritis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal. ARAVA dosage: unknown. Patient recovered.
Arava Side Effects Report #5478213-X
ARAVA problem was reported by a Health Professional from JAPAN on Sept 26, 2007. Female patient, 38 years of age, weighting 106.9 lb, was diagnosed with rheumatoid arthritis, musculoskeletal pain and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, bronchitis, hepatic function abnormal, upper respiratory tract infection. ARAVA dosage: unknown. During the same period patient was treated with METHOTREXATE, PREDNISOLONE. Patient recovered.
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Arava Side Effects


