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Pentasa Safety Reports reported to FDA

Total Pentasa reports: 235.
Pentasa FDA safety alerts: No.
Reported deaths: 6    Reported hospitalizations: 150.
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Reported Pentasa Side Effects: pyrexia, pancreatitis acute, diarrhoea, pancreatitis necrotising, pericarditis, nephritis interstitial, eosinophilic pneumonia, colitis ulcerative, headache, arthralgia, alanine aminotransferase increased.
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Pentasa Side Effects Report #5378556-4
Consumer or non-health professional from UNITED KINGDOM reported PENTASA problem on June 18, 2007. Male patient, 38 years of age, was diagnosed with crohn's disease, anaemia, abdominal discomfort and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: neutropenia. PENTASA dosage: unknown. During the same period patient was treated with FERROUS SULPHATE, OMEPRAZOLE, PREDNISOLONE. Patient was hospitalized and became disabled. Patient recovered.

Pentasa Side Effects Report #5380905-8
PENTASA problem was reported by a Consumer or non-health professional from DENMARK on July 31, 2006. Male patient, 14 years of age, was diagnosed with gastroenteritis and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: myocarditis. PENTASA dosage: unknown. During the same period patient was treated with CALCIUM CARBONATE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380906-X
Physician from JAPAN reported PENTASA problem on Aug 02, 2006. Female patient, 18 years of age, was diagnosed with behcet's syndrome and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: aplastic anaemia. PENTASA dosage: unknown. During the same period patient was treated with ALFACALCIDOL, TEPRENONE, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380907-1
PENTASA problem was reported by a Physician from JAPAN on Aug 18, 2006. Male patient, 25 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: liver disorder. PENTASA dosage: 750 MG 3XS DAILY, ORAL. During the same period patient was treated with LOPERMIDE, ACETAMINOPHEN, PREDNISOLONE, FOSFOMYCIN. Patient recovered.

Pentasa Side Effects Report #5380908-3
Health Professional from JAPAN reported PENTASA problem on Aug 23, 2006. Female patient, 30 years of age, was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: melaena. PENTASA dosage: 1000 MG DAILY, RECTAL. Patient recovered.

Pentasa Side Effects Report #5380909-5
PENTASA problem was reported by a Health Professional from JAPAN on Aug 29, 2006. Male patient, 56 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: liver disorder. PENTASA dosage: 2250 MG DAILY, ORAL. During the same period patient was treated with CEFMETAZOLE, RILMAZAFONE HYDROCHLORIDE. Patient recovered.

Pentasa Side Effects Report #5380911-3
Physician from JAPAN reported PENTASA problem on Sept 05, 2006. Male patient, 20 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: nephritis interstitial. PENTASA dosage: unknown. During the same period patient was treated with PREDNISOLONE, TIQUIZIUM BROMIDE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380912-5
PENTASA problem was reported by a Health Professional from FRANCE on Sept 08, 2006. Male patient, 48 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: agranulocytosis. PENTASA dosage: unknown. During the same period patient was treated with NEXIUM, PREDNISOLONE SULFOBENZOATE, POTASSIUM CHLORIDE, VITAMIN D, HYDROCORTISONE ACETATE. Patient recovered.

Pentasa Side Effects Report #5380927-7
Health Professional from FRANCE reported PENTASA problem on Sept 18, 2006. Male patient, 35 years of age, was diagnosed with crohn's disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, pyrexia. PENTASA dosage: unknown. During the same period patient was treated with PREDNISOLONE SULFOBENZOATE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380928-9
PENTASA problem was reported by a Health Professional from JAPAN on Sept 08, 2006. Male patient, 18 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: melaena. PENTASA dosage: unknown. During the same period patient was treated with CEFPIROME SULPHATE. Patient recovered.

Pentasa Side Effects Report #5380935-6
Physician from FRANCE reported PENTASA problem on Oct 16, 2006. Male patient, 43 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pericarditis. PENTASA dosage: unknown. Patient recovered.

Pentasa Side Effects Report #5380940-X
PENTASA problem was reported by a Pharmacist from FRANCE on May 29, 2006. Female patient, child 8 years of age, was diagnosed with crohn's disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pancreatitis. PENTASA dosage: unknown. During the same period patient was treated with ENTOCROT. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380941-1
Physician from GERMANY reported PENTASA problem on Mar 13, 2007. Female patient, 81 years of age, was diagnosed with colitis and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: colitis ulcerative. PENTASA dosage: unknown. During the same period patient was treated with FENTOTEROL HYDROBROMIDE, FUROSEMIDE, LISINOPRIL, NEBIVOLOL HYDROCHLORIDE, NEXIUM, SYMBICORT. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380947-2
PENTASA problem was reported by a Physician from JAPAN on June 22, 2006. Male patient, 47 years of age, was diagnosed with colitis ulcerative, peptic ulcer, peritonitis, pancreatitis and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, white blood cell count decreased. PENTASA dosage: 1500 MG DAILY, ORAL. During the same period patient was treated with LANSOPRAZOLE, ZANTAC, ROCEPHIN, FUTHAN, PREDISOLONE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380950-2
Health Professional from UNITED KINGDOM reported PENTASA problem on July 03, 2006. Female patient, 44 years of age, was diagnosed with colitis and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea. PENTASA dosage: unknown. Patient recovered.

Pentasa Side Effects Report #5380951-4
PENTASA problem was reported by a Pharmacist from FRANCE on July 11, 2006. Male patient, 14 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pancreatitis acute. PENTASA dosage: 1500 MG DAILY, ORAL, 1 G DAILY, RECTAL, 3 G DAILY. During the same period patient was treated with FLAGYL. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380952-6
Health Professional from FRANCE reported PENTASA problem on Oct 16, 2006. Male patient, 33 years of age, was diagnosed with crohn's disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: myocarditis. PENTASA dosage: unknown. During the same period patient was treated with PAROXETINE HYROCHLORIDE. Patient recovered.

Pentasa Side Effects Report #5380963-0
PENTASA problem was reported by a Health Professional from FRANCE on July 31, 2006. Male patient, 68 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: neutropenia, thrombocytopenia. PENTASA dosage: unknown. During the same period patient was treated with PRAZEPAM, NORSET. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380964-2
Health Professional from FRANCE reported PENTASA problem on Sept 08, 2006. Male patient, 44 years of age, was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: thrombocytopenia. PENTASA dosage: unknown. During the same period patient was treated with REBETOL, VIRAFERONPEG, FOSAMPRENAVIR, RITONAVIR, EMTRICITABINE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380965-4
PENTASA problem was reported by a Physician from JAPAN on July 27, 2006. Female patient, 28 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: nephritis interstitial. PENTASA dosage: 1500MG DAILY, ORAL, 750MG, 3XDAY:TID. During the same period patient was treated with FERROUS CITRATE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380972-1
Physician from JAPAN reported PENTASA problem on July 27, 2006. Male patient, 61 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: nausea, vomiting. PENTASA dosage: 750 MG, 3XDAY:TID, ORAL, 750 MG, 3XDAY:TID. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380976-9
PENTASA problem was reported by a Consumer or non-health professional from DENMARK on Nov 29, 2006. Female patient was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea, rectal haemorrhage. PENTASA dosage: 2-250MG TABLETS, 3X/DAY, ORAL. During the same period patient was treated with VITAMIN, HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380978-2
Consumer or non-health professional from DENMARK reported PENTASA problem on Nov 02, 2006. Female patient, 20 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pyrexia. PENTASA dosage: 1000 MG, DAILY, RECTAL. During the same period patient was treated with BETAMETHASONE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380982-4
PENTASA problem was reported by a Consumer or non-health professional from DENMARK on Nov 16, 2006. Female patient, 29 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pyrexia. PENTASA dosage: 750 MG 3X DAILY, ORAL. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380986-1
Consumer or non-health professional from DENMARK reported PENTASA problem on Nov 23, 2006. Male patient, 49 years of age, was diagnosed with inflammatory bowel disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pancreatitis. PENTASA dosage: unknown. During the same period patient was treated with CORTICOSTEROIDS. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380987-3
PENTASA problem was reported by a Consumer or non-health professional from DENMARK on Dec 01, 2006. Male patient, 16 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: thrombocytopenia. PENTASA dosage: unknown. During the same period patient was treated with PREDNISONE, FERROUS SULPHATE, FOLIC AICD, OROCAL VITAMIN D. Patient recovered.

Pentasa Side Effects Report #5380988-5
Consumer or non-health professional from DENMARK reported PENTASA problem on Dec 20, 2006. Female patient, 79 years of age, was diagnosed with crohn's disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pancreatitis acute. PENTASA dosage: 1000 MG 3XS DAILY, ORAL; 1000 MG 3XS DAILY, ORAL. During the same period patient was treated with AZATHIOPRINE, TRIMEBUTINE MALAEAT, BENIDIPINE HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380989-7
PENTASA problem was reported by a Consumer or non-health professional from DENMARK on Jan 18, 2007. Female patient, 24 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pancreatitis acute. PENTASA dosage: 750 MG 3XS DAILY, ORAL; 1250 MG DAILY; 750 MG 3XS DAILY, ORAL. During the same period patient was treated with FERROUS CITRATE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380990-3
Physician from DENMARK reported PENTASA problem on Mar 23, 2007. Male patient, 49 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pyrexia. PENTASA dosage: 1250 MG 3XS DAILY, ORAL. During the same period patient was treated with AZATHIOPRINE, CARBOCISTEIN, MEQUITAZINE, SUPLATAST TOSILATE, LANSOPRAZOLE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380991-5
PENTASA problem was reported by a Physician from DENMARK on Feb 27, 2007. Male patient, 29 years of age, was diagnosed with pancreatitis acute and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pancreatitis acute. PENTASA dosage: 2000 MG DAILY, ORAL. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5380992-7
Consumer or non-health professional from DENMARK reported PENTASA problem on Jan 19, 2007. Female patient, 32 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pancreatitis acute. PENTASA dosage: unknown. Patient recovered.

Pentasa Side Effects Report #5381266-0
PENTASA problem was reported by a Physician from DENMARK on Apr 13, 2007. Female patient, 34 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: aplastic anaemia, hepatic function abnormal, urticaria. PENTASA dosage: 750 MG 3X'S DAILY, ORAL. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381267-2
Physician from DENMARK reported PENTASA problem on Apr 27, 2007. Male patient, 29 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pyrexia, rash. PENTASA dosage: 250 MG 3X'S DAILY, ORAL. During the same period patient was treated with SALAZOPYRIN. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381268-4
PENTASA problem was reported by a Health Professional from DENMARK on Apr 26, 2007. Female patient, 62 years of age, was diagnosed with colitis ulcerative, cholangitis and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: hypoplastic anaemia. PENTASA dosage: unknown. During the same period patient was treated with IMUREL, DELURSAN, FOSAMAX, INEXIUM, XYZALL. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381269-6
Physician from JAPAN reported PENTASA problem on May 24, 2007. Female patient, 20 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pyrexia. PENTASA dosage: 750 MG, 3X/DAY;TID, ORAL ; 2000 MG, ORAL. During the same period patient was treated with LORATADINE, MAGNESIUM OXIDE, HYOSCINE HYDROBROMIDE, GLYCERIN, LOPERAMIDE HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381270-2
PENTASA problem was reported by a Consumer or non-health professional from DENMARK on Aug 23, 2006. Female patient, 56 years of age, was diagnosed with crohn's disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: arthralgia, myalgia, pyrexia. PENTASA dosage: unknown. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381271-4
Consumer or non-health professional from DENMARK reported PENTASA problem on July 11, 2006. Male patient, 21 years of age, was diagnosed with crohn's disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pericarditis. PENTASA dosage: unknown. Patient recovered.

Pentasa Side Effects Report #5381272-6
PENTASA problem was reported by a Consumer or non-health professional from DENMARK on July 28, 2006. Male patient, 15 years of age, was diagnosed with inflammatory bowel disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pericarditis. PENTASA dosage: unknown. During the same period patient was treated with AZATHIOPRINE, INFLIXIMAB. Patient recovered.

Pentasa Side Effects Report #5381273-8
Consumer or non-health professional from DENMARK reported PENTASA problem on May 29, 2006. Male patient, 20 years of age, was diagnosed with crohn's disease, gastritis and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: granulocytopenia. PENTASA dosage: unknown. During the same period patient was treated with GASTER. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381274-X
PENTASA problem was reported by a Consumer or non-health professional from DENMARK on Sept 18, 2006. Male patient, 46 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pancreatitis acute. PENTASA dosage: unknown. During the same period patient was treated with IMUREL, SOLUPRED, AMINOSALICYLATE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381275-1
Consumer or non-health professional from JAPAN reported PENTASA problem on May 12, 2006. Female patient, 64 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pyrexia. PENTASA dosage: 750 MG, 3X/DAY;TID, ORAL. During the same period patient was treated with FUTHAN. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381276-3
PENTASA problem was reported by a Physician from JAPAN on Mar 26, 2007. Male patient, 39 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: liver disorder. PENTASA dosage: ORAL; 500 MG 3X'S DAILY; 250 3X'S DAILY; 250 M X2.500MG X1; 1250 MG DAILY; 1500 MG DAILY; 2000 MG DA. During the same period patient was treated with PREDNISOLONE. Patient recovered.

Pentasa Side Effects Report #5381277-5
Health Professional from FRANCE reported PENTASA problem on Feb 14, 2007. Male patient, 15 years of age, was diagnosed with crohn's disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: pericarditis. PENTASA dosage: unknown. During the same period patient was treated with METRONIDAZOLE, FOLIC ACID, CIPROFLOXACIN, CACIT D, ACETAMINOPHEN, PREDNISOLONE SULFOBENZOATE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381278-7
PENTASA problem was reported by a Physician from JAPAN on Mar 16, 2007. Female patient, 21 years of age, was diagnosed with crohn's disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: aplasia pure red cell. PENTASA dosage: 750 MG 3X'S DAILY, ORAL. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381279-9
Health Professional from FRANCE reported PENTASA problem on Mar 28, 2007. Male patient, 55 years of age, was diagnosed with crohn's disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: lipase increased, neutrophil count decreased, pancreatitis. PENTASA dosage: unknown. During the same period patient was treated with OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381280-5
PENTASA problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 30, 2007. Female patient, 40 years of age, weighting 192.0 lb, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: anaemia, blood creatinine increased, blood pressure increased, nephritis interstitial. PENTASA dosage: 500 MG 3XS DAILY, ORAL. During the same period patient was treated with ASACOL, VITAMIN. Patient recovered.

Pentasa Side Effects Report #5381281-7
Physician from JAPAN reported PENTASA problem on Apr 09, 2007. Male patient, 13 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: colitis ulcerative. PENTASA dosage: 1500 MG DAILY, ORAL; 2250 MG DAILY. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381282-9
PENTASA problem was reported by a Health Professional from FRANCE on Mar 21, 2007. Male patient, 13 years of age, was diagnosed with acute leukaemia and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: blood amylase increased, pancreatitis. PENTASA dosage: 1500 MG DAILY, ORAL. During the same period patient was treated with FOSCAVIR, GLEEVEC, MOPRAL, ALIZAPRIDE HYDROCHLORIDE, ITRACONAZOLE, IMMUNE GLOBULIN INTRAVENOUS, NALBUPHINE. Patient was hospitalized. Patient recovered.

Pentasa Side Effects Report #5381283-0
Physician from JAPAN reported PENTASA problem on Apr 20, 2007. Female patient, child 12 years of age, was diagnosed with colitis ulcerative and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: nephritis interstitial, pericarditis. PENTASA dosage: 500 MG 3X'S DAILY, ORAL. During the same period patient was treated with CEFMETAZOLE, GENTAMICIN SULPHATE, FAMOTIDINE, MINOCYCLINE HYDROCHLORIDE, PREDNISOLONE, PREDNISOLONE SUCCINATE, PENTAZOCINE LACTATE, TEPRENONE. Patient recovered.

Pentasa Side Effects Report #5381284-2
PENTASA problem was reported by a Physician from UNITED STATES on May 10, 2007. Male patient, 48 years of age, was diagnosed with crohn's disease and was treated with PENTASA. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased, white blood cell count decreased. PENTASA dosage: 1000 MG 3X'S DAILY, ORAL. During the same period patient was treated with MERCAPTOPURINE, QUESTRAN. Patient recovered.

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