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Review Mesalamine Safety Reports submitted to FDA

Total Mesalamine reports: 15.
Mesalamine FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 9.
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FDA Reported Mesalamine Side Effects: pleural effusion, allergic granulomatous angiitis, pancreatitis acute, diarrhoea haemorrhagic, condition aggravated, colitis, nephritis interstitial, nausea, iron deficiency anaemia, focal glomerulosclerosis, fatigue.
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Mesalamine Side Effects Report #5664309-6
Physician from MEXICO reported MESALAMINE problem on Mar 07, 2008. Female patient, 32 years of age, weighting 121.3 lb, was diagnosed with cervix carcinoma and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased, platelet count decreased, rectal haemorrhage. MESALAMINE dosage: unknown. During the same period patient was treated with STEROIDS NOS, GLEEVEC. Patient was hospitalized. Patient died on 05/27/2006.

Mesalamine Side Effects Report #5688221-1
MESALAMINE problem was reported by a Consumer or non-health professional from CANADA on Mar 17, 2008. Female patient was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, pregnancy. MESALAMINE dosage: unknown. Patient recovered.

Mesalamine Side Effects Report #5625443-X
Physician from UNITED STATES reported MESALAMINE problem on Jan 25, 2008. Female patient, 31 years of age, was diagnosed with crohn's disease and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, anaemia, atelectasis, constipation, diarrhoea, diarrhoea haemorrhagic, headache, ileitis, lung infiltration. MESALAMINE dosage: unknown. Patient was hospitalized. Patient recovered.

Mesalamine Side Effects Report #5635730-7
MESALAMINE problem was reported by a Health Professional from ITALY on Feb 05, 2008. Male patient, child 7 years of age, was diagnosed with colitis ulcerative and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune, gastrointestinal haemorrhage, hyperbilirubinaemia. MESALAMINE dosage: unknown. During the same period patient was treated with AZATHIOPRINE. Patient was hospitalized. Patient recovered.

Mesalamine Side Effects Report #5605706-4
Consumer or non-health professional from UNITED STATES reported MESALAMINE problem on Jan 23, 2008. Male patient, 43 years of age, weighting 207.0 lb, was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: headache. MESALAMINE dosage: unknown. Patient recovered.

Mesalamine Side Effects Report #5576047-9
MESALAMINE problem was reported by a Physician from GREECE on Dec 06, 2007. Male patient, 18 years of age, was diagnosed with colitis ulcerative and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, eosinophilic pneumonia, fatigue, hepatitis toxic, thrombocythaemia. MESALAMINE dosage: unknown. During the same period patient was treated with AZATHIOPRINE. Patient was hospitalized. Patient recovered.

Mesalamine Side Effects Report #5513684-1
Physician from TURKEY reported MESALAMINE problem on Oct 24, 2007. Female patient, 15 years of age, was diagnosed with colitis ulcerative and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: acidosis, anorexia, antineutrophil cytoplasmic antibody positive, beta 2 microglobulin increased, blood glucose increased, blood potassium decreased, blood sodium decreased, blood uric acid decreased, dehydration. MESALAMINE dosage: (500 MG TID ORAL). During the same period patient was treated with PREDNISOLONE. Patient was hospitalized. Patient recovered.

Mesalamine Side Effects Report #5517842-1
MESALAMINE problem was reported by a Physician from UNITED STATES on Oct 31, 2007. Female patient, 52 years of age, was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: aplastic anaemia, bone marrow failure, petechiae, rectal haemorrhage. MESALAMINE dosage: 1000MG, QD,. Patient was hospitalized. Patient recovered.

Mesalamine Side Effects Report #5528399-3
Physician from UNITED KINGDOM reported MESALAMINE problem on Nov 07, 2007. Female patient, 13 years of age, was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: crohn's disease, dehydration, haemodialysis, haemoglobin decreased, nephritis interstitial, renal cortical necrosis, renal failure acute, renal infarct, renal tubular necrosis. MESALAMINE dosage: unknown. During the same period patient was treated with DICLOFENAC, CEFOTAXIME, HYDROCORTISONE, METRONIDAZOLE. Patient was hospitalized. Patient recovered.

Mesalamine Side Effects Report #5465437-0
MESALAMINE problem was reported by a Pharmacist from UNITED STATES on Sept 20, 2007. Male patient, 70 years of age, was diagnosed with crohn's disease and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: urinary retention. MESALAMINE dosage: unknown. Patient recovered.

Mesalamine Side Effects Report #5465708-8
Consumer or non-health professional from UNITED STATES reported MESALAMINE problem on Sept 19, 2007. Male patient, weighting 175.0 lb, was diagnosed with colitis ulcerative and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: colitis. MESALAMINE dosage: 4G/60ML NIGHTLY RECTAL. Patient recovered.

Mesalamine Side Effects Report #5317850-X
MESALAMINE problem was reported by a Health Professional from ITALY on Apr 13, 2007. Male patient, 39 years of age, was diagnosed with crohn's disease and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: allergic granulomatous angiitis. MESALAMINE dosage: unknown. During the same period patient was treated with URSODIOL, SALBUTAMOL. Patient recovered.

Mesalamine Side Effects Report #5386358-8
Consumer or non-health professional from UNITED STATES reported MESALAMINE problem on June 27, 2007. Male patient, 32 years of age, was diagnosed with colitis ulcerative and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: cardiac tamponade, cardiomegaly, diarrhoea, jugular vein distension, pericardial effusion, pericarditis, pleural effusion, tachycardia, tachypnoea. MESALAMINE dosage: unknown. During the same period patient was treated with INDOMETHACIN. Patient was hospitalized. Patient recovered.

Mesalamine Side Effects Report #5317850-X
MESALAMINE problem was reported by a Health Professional from ITALY on Apr 13, 2007. Male patient, 39 years of age, was diagnosed with crohn's disease and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: allergic granulomatous angiitis. MESALAMINE dosage: unknown. During the same period patient was treated with URSODIOL, SALBUTAMOL. Patient recovered.

Mesalamine Side Effects Report #5386358-8
Consumer or non-health professional from UNITED STATES reported MESALAMINE problem on June 27, 2007. Male patient, 32 years of age, was diagnosed with colitis ulcerative and was treated with MESALAMINE. After drug was administered, patient experienced the following problems/side effects: cardiac tamponade, cardiomegaly, diarrhoea, jugular vein distension, pericardial effusion, pericarditis, pleural effusion, tachycardia, tachypnoea. MESALAMINE dosage: unknown. During the same period patient was treated with INDOMETHACIN. Patient was hospitalized. Patient recovered.


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haemoglobin decreased, platelet count decreased, rectal haemorrhage, abortion spontaneous, pregnancy, , was diagnosed with cervix carcinoma and was diagnosed with crohn's disease and was diagnosed with colitis ulcerative and