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Review Imuran Safety Reports submitted to FDA

Total Imuran reports: 18.
Imuran FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 13.
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FDA Reported Imuran Side Effects: pancreatitis, pyrexia, asthenia, sepsis, multiple sclerosis, condition aggravated, non-hodgkin's lymphoma stage ii, mediastinal mass, pancreatic pseudocyst, therapeutic product contamination, laboratory test abnormal.
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Imuran Side Effects Report #5656641-7
Pharmacist from UNITED STATES reported IMURAN problem on Mar 07, 2008. Female patient, 81 years of age, was diagnosed with crohn's disease and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal. IMURAN dosage: 50 MG DAILY PO. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5672955-9
IMURAN problem was reported by a Physician from JAPAN on Mar 13, 2008. Female patient, 24 years of age, was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, convulsion, cyst, cytomegalovirus viraemia, hyperglycaemia, lymphoma, pleural effusion, pneumonia staphylococcal, pneumothorax. IMURAN dosage: 100MG PER DAY. During the same period patient was treated with PROGRAF, FENTANEST, FUNGIZONE, DIPRIVAN, ROPIVACAINE, VANCOMYCIN, MYSLEE. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5681019-X
Physician from UNITED STATES reported IMURAN problem on Aug 17, 2006. Female patient, 51 years of age, was diagnosed with crohn's disease, graft versus host disease and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, aspergillosis, bone marrow transplant, graft versus host disease, hemiparesis, leukopenia, transplant failure. IMURAN dosage: unknown. During the same period patient was treated with REMICADE, SULFSALAZINE. Patient was hospitalized. Patient died on 07/31/2006.

Imuran Side Effects Report #5683515-8
IMURAN problem was reported by a Health Professional from UNITED STATES on Sept 11, 2006. Female patient, 19 years of age, weighting 124.0 lb, was diagnosed with crohn's disease and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: body temperature increased, duodenal ulcer, duodenitis, gastritis, gastroenteritis viral, haematemesis, nausea, treatment noncompliance, urinary tract infection. IMURAN dosage: 2.5 MG/KG; QD; PO. During the same period patient was treated with YASMIN, LEXAPRO, ENTOCORT EC, PROPACET, CLARITIN, BENTYL. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5683516-X
Physician from UNITED STATES reported IMURAN problem on Oct 26, 2007. Male patient, 43 years of age, was diagnosed with multiple sclerosis and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: chest pain, chills, dyspnoea, pulmonary embolism, pyrexia. IMURAN dosage: unknown. During the same period patient was treated with COPAXONE. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5683517-1
IMURAN problem was reported by a Health Professional from UNITED STATES on Oct 13, 2006. Female patient, child 10 years of age, weighting 68.34 lb, was diagnosed with colitis ulcerative and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, anaemia, anorexia, atelectasis, blood albumin decreased, blood alkaline phosphatase increased, chest pain, dehydration, dyspnoea. IMURAN dosage: 59 MG; 25 MG; QD. During the same period patient was treated with REMICADE, ASACOL, CALCIUM WITH VITAMIN D AND IRON, PREDNISONE, FLAGYL. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5689757-X
Health Professional from UNITED STATES reported IMURAN problem on Jan 26, 2007. Male patient, 64 years of age, was diagnosed with multiple sclerosis and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: malaise. IMURAN dosage: unknown. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5631591-0
IMURAN problem was reported by a Physician from UNITED STATES on Feb 01, 2008. Female patient, 18 years of age, was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: abscess bacterial, biliary anastomosis complication, hepatic artery stenosis, liver abscess. IMURAN dosage: unknown. During the same period patient was treated with METHYLPREDNISOLONE, TACROLIMUS. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5647978-6
Physician from UNITED STATES reported IMURAN problem on Feb 13, 2008. Male patient, 65 years of age, was diagnosed with immunosuppression and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, b-cell lymphoma, blood amylase increased, catheter related complication, fatigue, hyperkalaemia, lethargy, lipase increased. IMURAN dosage: 200 MG; QD; PO. During the same period patient was treated with TACROLIMUS, PREDNISONE. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5598205-X
IMURAN problem was reported by a Health Professional from UNITED STATES on Jan 17, 2008. Male patient, weighting 263.0 lb, was diagnosed with crohn's disease and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: squamous cell carcinoma. IMURAN dosage: 150MG QD PO. During the same period patient was treated with REMICADE, LISINOPRIL, IBUPROFEN, ASPIRIN, FLOMAX. Patient recovered.

Imuran Side Effects Report #5563615-3
Consumer or non-health professional from UNITED STATES reported IMURAN problem on Dec 14, 2007. Female patient, 38 years of age, was diagnosed with systemic lupus erythematosus and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: diarrhoea, pain, pancreatic enlargement, vomiting. IMURAN dosage: unknown. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5568533-2
IMURAN problem was reported by a Physician from UNITED STATES on Nov 27, 2007. Male patient, 65 years of age, was diagnosed with autoimmune hepatitis and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: leg amputation, metastases to lymph nodes, neuroendocrine carcinoma of the skin. IMURAN dosage: unknown. During the same period patient was treated with PREDNISONE. Patient recovered.

Imuran Side Effects Report #5574384-5
Health Professional from UNITED STATES reported IMURAN problem on Dec 11, 2007. Male patient, child 11 years of age, weighting 75.00 lb, was diagnosed with immunosuppression, growth hormone deficiency and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: graft versus host disease, squamous cell carcinoma. IMURAN dosage: 50 MG;QOD;PO. During the same period patient was treated with PROGRAF, SAIZEN, VFEND, ACYCLOVIR, CORTEF, LEVAQUIN, PREDNISONE. Patient recovered.

Imuran Side Effects Report #5441435-8
IMURAN problem was reported by a Pharmacist from UNITED STATES on Aug 28, 2007. Female patient, 40 years of age, was diagnosed with multiple sclerosis and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: asthenia, condition aggravated, multiple sclerosis, pyrexia. IMURAN dosage: 50MG TID PO 3 WKS PTA. During the same period patient was treated with PREVACID, BACLOFEN, ACTONEL, KLONOPIN, COPAXONE. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5396872-7
Physician from UNITED STATES reported IMURAN problem on July 06, 2007. Male patient, 38 years of age, was diagnosed with crohn's disease and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: mediastinal mass, non-hodgkin's lymphoma stage ii. IMURAN dosage: 150 MG;QD;PO. During the same period patient was treated with ACETAMINOPHEN, CYANOCOBALAMIN, BUDESONIDE, ACETAMINOPHEN W. Patient recovered.

Imuran Side Effects Report #5421159-3
IMURAN problem was reported by a Physician from UNITED STATES on Aug 07, 2006. Male patient, 62 years of age, was diagnosed with colitis and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: pancreatitis. IMURAN dosage: unknown. During the same period patient was treated with URSODIOL, RABEPRAZOLE, CLOPIDOGREL, ASPIRIN, EZETIMIBE, MESALAMINE. Patient was hospitalized. Patient recovered.

Imuran Side Effects Report #5396872-7
Physician from UNITED STATES reported IMURAN problem on July 06, 2007. Male patient, 38 years of age, was diagnosed with crohn's disease and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: mediastinal mass, non-hodgkin's lymphoma stage ii. IMURAN dosage: 150 MG;QD;PO. During the same period patient was treated with ACETAMINOPHEN, CYANOCOBALAMIN, BUDESONIDE, ACETAMINOPHEN W. Patient recovered.

Imuran Side Effects Report #5421159-3
IMURAN problem was reported by a Physician from UNITED STATES on Aug 07, 2006. Male patient, 62 years of age, was diagnosed with colitis and was treated with IMURAN. After drug was administered, patient experienced the following problems/side effects: pancreatitis. IMURAN dosage: unknown. During the same period patient was treated with URSODIOL, RABEPRAZOLE, CLOPIDOGREL, ASPIRIN, EZETIMIBE, MESALAMINE. Patient was hospitalized. Patient recovered.


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liver function test abnormal, altered state of consciousness, convulsion, cyst, cytomegalovirus viraemia, hyperglycaemia, lymphoma, pleural effusion, pneumonia staphylococcal, pneumothorax, , was diagnosed with crohn's disease and was diagnosed with crohn's disease, graft versus host disease and