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Azasan Safety Reports submitted to FDA

Total Azasan reports: 4.
Azasan FDA safety alerts: 2008 .
   Reported hospitalizations: 4.
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Reported Azasan Side Effects: pancreatitis, renal tubular necrosis, renal failure acute, pyrexia, dehydration, gastrointestinal disorder, extranodal marginal zone b-cell lymphoma (malt type), thrombocythaemia, hepatic neoplasm malignant, anaemia, lipase increased.
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Azasan Side Effects Report #5123780-9
Physician from UNITED STATES reported AZASAN problem on Sept 27, 2005. Female patient, 35 years of age, weighting 137.0 lb, was diagnosed with crohn's disease, colitis ulcerative and was treated with AZASAN. After drug was administered, patient experienced the following problems/side effects: blood amylase increased, lipase increased, pancreatitis. AZASAN dosage: 75 MG QDAY PO. During the same period patient was treated with COLAZAL, PENTASA, REMICADE. Patient was hospitalized. Patient recovered.

Azasan Side Effects Report #5132247-3
AZASAN problem was reported by a Physician from UNITED STATES on Sept 29, 2006. Female patient, 28 years of age, was diagnosed with crohn's disease and was treated with AZASAN. After drug was administered, patient experienced the following problems/side effects: anaemia, hepatic neoplasm malignant, thrombocythaemia. AZASAN dosage: 150 MG; DAILY. During the same period patient was treated with INFLIXIMAB. Patient was hospitalized. Patient recovered.

Azasan Side Effects Report #5193658-3
Physician from UNITED STATES reported AZASAN problem on Nov 30, 2006. Female patient, 46 years of age, weighting 131.2 lb, was diagnosed with systemic lupus erythematosus and was treated with AZASAN. After drug was administered, patient experienced the following problems/side effects: extranodal marginal zone b-cell lymphoma (malt type), gastrointestinal disorder, pancreatitis. AZASAN dosage: 100 MG; DAILY. Patient was hospitalized. Patient recovered.

Azasan Side Effects Report #5405712-9
AZASAN problem was reported by a Consumer or non-health professional from UNITED STATES on July 23, 2007. Male patient, 33 years of age, was diagnosed with colitis ulcerative and was treated with AZASAN. After drug was administered, patient experienced the following problems/side effects: dehydration, pyrexia, renal failure acute, renal tubular necrosis. AZASAN dosage: unknown. During the same period patient was treated with COLAZAL. Patient was hospitalized. Patient recovered.


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blood amylase increased, lipase increased, pancreatitis anaemia, hepatic neoplasm malignant, thrombocythaemia, was diagnosed with crohn's disease, colitis ulcerative and was diagnosed with crohn's disease and was diagnosed with systemic lupus erythematosus and