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Review Irbesartan Safety Reports submitted to FDA

Total Irbesartan reports: 76.
Irbesartan FDA safety alerts: No.
Reported deaths: 9    Reported hospitalizations: 53.
Take Irbesartan Side Effects Survey, Discuss Irbesartan with others
FDA Reported Irbesartan Side Effects: renal failure, renal failure acute, renal impairment, international normalised ratio increased, pneumonia, cardiac failure, therapeutic agent toxicity, shock haemorrhagic, pyrexia, gastroduodenal ulcer, cardiac failure congestive.
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Irbesartan Side Effects Report #5668896-3
Consumer or non-health professional from UNITED KINGDOM reported IRBESARTAN problem on Mar 10, 2008. Male patient was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anorexia, pollakiuria, thirst, vision blurred, weight decreased. IRBESARTAN dosage: INITIATED AS 150MG. Patient recovered.

Irbesartan Side Effects Report #5669206-8
IRBESARTAN problem was reported by a Health Professional from AUSTRALIA on Mar 13, 2008. Female patient, 87 years of age, was diagnosed with arthritis, coagulopathy and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaemia, gastric ulcer, hyperkalaemia. IRBESARTAN dosage: unknown. During the same period patient was treated with MELOXICAM, ASPIRIN, ATORVASTATIN CALCIUM, AMITRIPTYLINE, ALBUTEROL, TIOTROPIUM BROMIDE, ISOSORBIDE DINITRATE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5670636-9
Pharmacist from UNITED STATES reported IRBESARTAN problem on Mar 14, 2008. Female patient, 85 years of age, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: leukocytoclastic vasculitis. IRBESARTAN dosage: 75 MG DAILY PO. During the same period patient was treated with VITAMIN D SUPPLEMENT. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5674913-7
IRBESARTAN problem was reported by a Health Professional from FRANCE on Jan 31, 2008. Female patient, 87 years of age, weighting 110.2 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaemia, diarrhoea, thrombocytopenia, urinary tract infection. IRBESARTAN dosage: unknown. During the same period patient was treated with ASPIRIN, OFLOCET, LASILIX, CARDENSIEL, OMEPRAZOLE, NITRODERM. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5624411-1
Consumer or non-health professional from GERMANY reported IRBESARTAN problem on Feb 08, 2008. Female patient, 55 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: poisoning, suicide attempt. IRBESARTAN dosage: unknown. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5632052-5
IRBESARTAN problem was reported by a Health Professional from FRANCE on Feb 19, 2008. Female patient, 81 years of age, was diagnosed with hypertension, dizziness, gout and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: asthenia, bone marrow failure, dizziness, pancytopenia, temperature intolerance. IRBESARTAN dosage: unknown. During the same period patient was treated with TANAKAN, LECTIL, ALLOPURINOL. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5634415-0
Consumer or non-health professional from GERMANY reported IRBESARTAN problem on Feb 18, 2008. Female patient, 55 years of age, was diagnosed with coronary artery bypass and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: dizziness, hypotension, poisoning, suicide attempt. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5636330-5
IRBESARTAN problem was reported by a Health Professional from FRANCE on Feb 20, 2008. Male patient, 78 years of age, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: rash vesicular, skin reaction. IRBESARTAN dosage: unknown. During the same period patient was treated with TAREG, FUROSEMIDE, CARDENSIEL, FENOFIBRATE, DIFFU, PREVISCAN, TRIMEBUTINE, DEXTROPROPOXYPHENE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5636349-4
Health Professional from UNITED KINGDOM reported IRBESARTAN problem on Feb 22, 2008. Male patient, 48 years of age, weighting 154.3 lb, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: alopecia, ascites, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hepatitis acute, rash. IRBESARTAN dosage: unknown. During the same period patient was treated with BENDROFLUMETHIAZIDE, LANSOPRAZOLE, NIFEDIPINE. Patient recovered.

Irbesartan Side Effects Report #5642818-3
IRBESARTAN problem was reported by a Consumer or non-health professional from FRANCE on Feb 26, 2008. Male patient, 61 years of age, weighting 242.5 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, liver function test abnormal. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, PANTOPRAZOLE, HYDROMORPHONE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5580208-2
Health Professional from AUSTRALIA reported IRBESARTAN problem on Jan 02, 2008. Male patient, 75 years of age, weighting 165.3 lb, was diagnosed with essential hypertension, depression and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: balance disorder, hyponatraemia, inappropriate antidiuretic hormone secretion, renal impairment. IRBESARTAN dosage: unknown. During the same period patient was treated with MIRTAZAPINE, BRICANYL, ASPIRIN, NEXIUM, VOLTAREN, SPIRIVA. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5582700-3
IRBESARTAN problem was reported by a Physician from SPAIN on Jan 03, 2008. Male patient, 65 years of age, was diagnosed with hypertension, diabetes mellitus, ischaemic cardiomyopathy, hyperlipidaemia and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cardiogenic shock, hyperkalaemia, renal failure acute, sinus bradycardia. IRBESARTAN dosage: unknown. During the same period patient was treated with METFORMIN, CAPOTEN, ASPIRIN, CARVEDILOL, FLUVASTATIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5582713-1
Health Professional from UNITED KINGDOM reported IRBESARTAN problem on Jan 04, 2008. Male patient, 54 years of age, weighting 136.7 lb, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. IRBESARTAN dosage: unknown. During the same period patient was treated with BENDROFLUMETHIAZIDE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5593403-3
IRBESARTAN problem was reported by a Consumer or non-health professional from FRANCE on Jan 10, 2008. Female patient, 63 years of age, weighting 238.1 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: asthma. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, METOPROLOL, HYDROCORTISONE, NOVALGIN, BERODUAL. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5603107-6
Physician from UNITED KINGDOM reported IRBESARTAN problem on Jan 23, 2008. Male patient, 78 years of age, was diagnosed with prostate cancer and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: systemic lupus erythematosus, vasculitis. IRBESARTAN dosage: unknown. During the same period patient was treated with ASPIRIN, AMLODIPINE, CASODEX. Patient recovered.

Irbesartan Side Effects Report #5532750-8
IRBESARTAN problem was reported by a Physician from BELGIUM on Nov 23, 2007. Female patient, 54 years of age, was diagnosed with psoriasis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, dyspepsia, muscle spasms. IRBESARTAN dosage: unknown. During the same period patient was treated with DAFLON, BIOFENAC, ALDACTAZIDE, ASAFLOW, EMCONCOR, CYCLOSPORINE. Patient recovered.

Irbesartan Side Effects Report #5532833-2
Health Professional from AUSTRALIA reported IRBESARTAN problem on Dec 03, 2007. Male patient, 75 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cough, dehydration, hypotension. IRBESARTAN dosage: unknown. During the same period patient was treated with FUROSEMIDE, METOPROLOL TARTRATE, CLOPIDOGREL BISULPHATE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5541720-5
IRBESARTAN problem was reported by a Consumer or non-health professional from FRANCE on Dec 05, 2007. Male patient, 81 years of age, weighting 147.7 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: colonic polyp, diverticulum intestinal, haemorrhage. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5545569-9
Health Professional from FRANCE reported IRBESARTAN problem on Dec 06, 2007. Female patient, 67 years of age, weighting 119.0 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaemia, haemorrhage urinary tract, renal failure. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, TIAZAC. Patient was hospitalized and became disabled. Patient recovered.

Irbesartan Side Effects Report #5549885-6
IRBESARTAN problem was reported by a Health Professional from FRANCE on Dec 10, 2007. Female patient, 49 years of age, was diagnosed with pain and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cardiac failure, hyperkalaemia, hypoxia, renal failure, respiratory acidosis. IRBESARTAN dosage: unknown. During the same period patient was treated with ASPEGIC, ANTADYS, LASILIX RETARD, TENORMIN, FENOFIBRATE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5557293-7
Consumer or non-health professional from AUSTRALIA reported IRBESARTAN problem on Dec 12, 2007. Male patient, 61 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: chest pain, hemiplegia, loss of consciousness, road traffic accident, type 2 diabetes mellitus. IRBESARTAN dosage: unknown. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5503782-0
IRBESARTAN problem was reported by a Health Professional from AUSTRALIA on Oct 30, 2007. Female patient, 83 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: dehydration, diarrhoea, renal impairment. IRBESARTAN dosage: unknown. During the same period patient was treated with MELOXICAM, FRUSEMIDE, CALTRATE, MADOPAR, CLOPIDOGREL BISULPHATE, VERAPAMIL. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5504047-3
Health Professional from AUSTRALIA reported IRBESARTAN problem on Oct 31, 2007. Male patient, 79 years of age, weighting 121.3 lb, was diagnosed with essential hypertension, metabolic disorder and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: alveolitis allergic, dyspnoea. IRBESARTAN dosage: unknown. During the same period patient was treated with SIMVASTATIN, ASPIRIN, FOLIC ACID. Patient recovered.

Irbesartan Side Effects Report #5508164-3
IRBESARTAN problem was reported by a Physician from LEBANON on Oct 25, 2007. Male patient, 65 years of age, weighting 231.5 lb, was diagnosed with acute coronary syndrome and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: dyspnoea, pulmonary embolism. IRBESARTAN dosage: unknown. During the same period patient was treated with TRITACE, CORVASAL, STAVINE, PLAVIX, ASPIRIN. Patient died on 07/01/2007.

Irbesartan Side Effects Report #5510399-0
Consumer or non-health professional from FRANCE reported IRBESARTAN problem on Nov 05, 2007. Female patient, 78 years of age, was diagnosed with hypertension, laxative supportive care, hypothyroidism, cerebrovascular accident, oedema and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: acrodermatitis enteropathica, lip oedema, zinc deficiency. IRBESARTAN dosage: unknown. During the same period patient was treated with LEVOTHYROXINE, ASPIRIN, PLAVIX, TORSEMIDE, METOPROLOL TARTRATE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5518050-0
IRBESARTAN problem was reported by a Health Professional from FRANCE on Nov 12, 2007. Female patient, 59 years of age, weighting 209.4 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: renal failure. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, LASIX, CIPROFLOXACIN, AMLODIPINE, LISINOPRIL, METFORMIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5519068-4
Health Professional from UNITED KINGDOM reported IRBESARTAN problem on Nov 14, 2007. Male patient, 56 years of age, weighting 154.3 lb, was diagnosed with dressler's syndrome, pain and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. IRBESARTAN dosage: unknown. During the same period patient was treated with ASPIRIN, ATORVASTATIN CALCIUM, CLOPIDOGREL BISULPHATE, IBUPROFEN, RAMIPRIL. Patient recovered.

Irbesartan Side Effects Report #5520308-6
IRBESARTAN problem was reported by a Health Professional from UNITED KINGDOM on Nov 14, 2007. Female patient, 60 years of age, weighting 220.5 lb, was diagnosed with hypertension, hiv infection, hypercholesterolaemia and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: renal impairment. IRBESARTAN dosage: unknown. During the same period patient was treated with TENOFOVIR DISOPROXIL FUMARATE, ASPIRIN, ATAZANAVIR SULPHATE, ATORVASTATIN CALCIUM, EMTRIVA, EZETIMIBE. Patient recovered.

Irbesartan Side Effects Report #5521937-6
Consumer or non-health professional from UNITED STATES reported IRBESARTAN problem on May 09, 2007. Female patient, 58 years of age, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: dysgeusia. IRBESARTAN dosage: unknown. Patient recovered.

Irbesartan Side Effects Report #5523402-9
IRBESARTAN problem was reported by a Health Professional from FRANCE on Oct 31, 2007. Male patient, 80 years of age, weighting 176.4 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: bradyarrhythmia. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5525151-X
Health Professional from FRANCE reported IRBESARTAN problem on Nov 16, 2007. Male patient, 76 years of age, weighting 176.4 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: hepatocellular damage. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, CALCIUM DOBESILATE, LACIDIPINE, PRESTARIUM, SOTALOL HYDROCHLORIDE, RANITIDINE. Patient was hospitalized and became disabled. Patient recovered.

Irbesartan Side Effects Report #5526620-9
IRBESARTAN problem was reported by a Health Professional from AUSTRALIA on Nov 26, 2007. Female patient, 79 years of age, was diagnosed with essential hypertension, arrhythmia and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: dyspnoea, liver function test abnormal, renal failure acute. IRBESARTAN dosage: unknown. During the same period patient was treated with AMIODARONE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5527501-7
Health Professional from FRANCE reported IRBESARTAN problem on Nov 26, 2007. Female patient, 83 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: aplasia, pancytopenia, renal failure. IRBESARTAN dosage: unknown. During the same period patient was treated with PROTELOS, DICYNONE, NOCTRAN, BROMAZEPAM, STRUCTUM, SEGLOR, TANAKAN, METEOXANE. Patient was hospitalized. Patient died on 07/08/2007.

Irbesartan Side Effects Report #5527572-8
IRBESARTAN problem was reported by a Health Professional from FRANCE on Nov 26, 2007. Female patient, 67 years of age, weighting 119.0 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaemia, blood pressure systolic increased, gastric polyps, haemorrhage urinary tract, refusal of treatment by patient. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, TIAZAC. Patient was hospitalized and became disabled. Patient recovered.

Irbesartan Side Effects Report #5475894-1
Health Professional from UNITED KINGDOM reported IRBESARTAN problem on Sept 28, 2007. Male patient, 77 years of age, weighting 202.8 lb, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: onychomadesis, paraesthesia. IRBESARTAN dosage: unknown. During the same period patient was treated with ASPIRIN, BENDROFLUMETHIAZIDE, BISOPROLOL FUMARATE, METFORMIN. Patient recovered.

Irbesartan Side Effects Report #5478046-4
IRBESARTAN problem was reported by a Consumer or non-health professional from COLOMBIA on Aug 31, 2006. Female patient, 55 years of age, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: headache, hypertension. IRBESARTAN dosage: unknown. Patient recovered.

Irbesartan Side Effects Report #5486935-X
Health Professional from FRANCE reported IRBESARTAN problem on Oct 11, 2007. Male patient, 73 years of age, weighting 187.4 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: duodenal ulcer, gastrointestinal haemorrhage. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, DICLOFENAC, TRANEXAMIC ACID, AMOXICILLIN, ENSURE, VOLTAREN, LANSOPRAZOLE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5489955-4
IRBESARTAN problem was reported by a Physician from LEBANON on Oct 10, 2007. Male patient, 65 years of age, weighting 231.5 lb, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: dyspnoea, post procedural complication, pulmonary embolism. IRBESARTAN dosage: unknown. During the same period patient was treated with TRITACE, CORVASAL, ASPIRIN, PLAVIX, STAVINE. Patient died on 09/01/2007.

Irbesartan Side Effects Report #5496189-6
Consumer or non-health professional from ARGENTINA reported IRBESARTAN problem on Oct 23, 2007. Male patient, 65 years of age, was diagnosed with cardiac failure and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: syncope. IRBESARTAN dosage: 02DEC04-15DEC04 75 MG, 16DEC04-29DEC04 150 MG, 30DEC04-CONT 300 MG.. During the same period patient was treated with CARVEDILOL, AMLODIPINE, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5441541-8
IRBESARTAN problem was reported by a Consumer or non-health professional from NORWAY on Aug 30, 2007. Female patient, 75 years of age, was diagnosed with cardiac failure and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cardiac failure, renal failure. IRBESARTAN dosage: unknown. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5442971-0
Health Professional from FRANCE reported IRBESARTAN problem on Aug 31, 2007. Female patient, 59 years of age, weighting 209.4 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: renal failure. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, LASIX, CIPROFLOXACIN, AMLODIPINE, LISINOPRIL, METFORMIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5447317-X
IRBESARTAN problem was reported by a Consumer or non-health professional from NORWAY on Sept 07, 2007. Female patient, 87 years of age, was diagnosed with cardiac failure and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: dehydration, renal failure. IRBESARTAN dosage: unknown. During the same period patient was treated with MAREVAN, CENTYL, ISOPTIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5447319-3
Consumer or non-health professional from NORWAY reported IRBESARTAN problem on Sept 07, 2007. Female patient, 75 years of age, was diagnosed with cardiac failure and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cardiac failure, renal failure. IRBESARTAN dosage: unknown. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5455351-9
IRBESARTAN problem was reported by a Health Professional from UNITED KINGDOM on Sept 17, 2007. Female patient, 35 years of age, weighting 224.9 lb, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: menorrhagia. IRBESARTAN dosage: unknown. During the same period patient was treated with PARACETAMOL. Patient recovered.

Irbesartan Side Effects Report #5458621-3
Health Professional from UNITED STATES reported IRBESARTAN problem on Sept 17, 2007. Male patient, 82 years of age, was diagnosed with convulsion and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: akinesia, dementia, hypertonia, muscle rigidity, tremor. IRBESARTAN dosage: unknown. During the same period patient was treated with FUROSEMIDE, MEMANTINE, VALPROIC ACID. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5406852-0
IRBESARTAN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 31, 2007. Male patient, 59 years of age, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cold agglutinins positive. IRBESARTAN dosage: unknown. During the same period patient was treated with IOPIDINE. Patient recovered.

Irbesartan Side Effects Report #5407036-2
Health Professional from AUSTRALIA reported IRBESARTAN problem on Aug 02, 2007. Male patient, 75 years of age, weighting 165.3 lb, was diagnosed with essential hypertension, depression and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: balance disorder, hyponatraemia, inappropriate antidiuretic hormone secretion, renal impairment. IRBESARTAN dosage: unknown. During the same period patient was treated with MIRTAZAPINE, BRICANYL, ASPIRIN, NEXIUM, VOLTAREN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5409408-9
IRBESARTAN problem was reported by a Health Professional from on Aug 07, 2007. Female patient, 24 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: congenital central nervous system anomaly, pregnancy, renal aplasia. IRBESARTAN dosage: unknown. During the same period patient was treated with HYDROCHLOROTHIAZIDE, CALCIUM SUPPLEMENT, IRON SUPPLEMENT, EPOGEN, LEVOTHYROXINE, INSULIN. Patient recovered.

Irbesartan Side Effects Report #5410007-3
Health Professional from FRANCE reported IRBESARTAN problem on Aug 07, 2007. Female patient, 81 years of age, weighting 165.3 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: brain neoplasm malignant, haemorrhagic stroke. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, CORTICOSTEROID. Patient was hospitalized and became disabled. Patient recovered.

Irbesartan Side Effects Report #5411009-3
IRBESARTAN problem was reported by a Health Professional from SPAIN on Aug 07, 2007. Female patient, 24 years of age, weighting 134.5 lb, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: abortion induced, congenital central nervous system anomaly, pregnancy, renal aplasia. IRBESARTAN dosage: unknown. During the same period patient was treated with INSULIN GLARGINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE. Patient recovered.

Irbesartan Side Effects Report #5411433-9
Consumer or non-health professional from FRANCE reported IRBESARTAN problem on Aug 01, 2007. Male patient, 80 years of age, weighting 116.8 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: renal failure acute, sepsis. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, DIGOXIN. Patient was hospitalized and became disabled. Patient died on 07/24/2007.

Irbesartan Side Effects Report #5418117-1
IRBESARTAN problem was reported by a Health Professional from AUSTRALIA on Aug 16, 2007. Male patient, 75 years of age, weighting 165.3 lb, was diagnosed with essential hypertension, depression and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: balance disorder, hyponatraemia, inappropriate antidiuretic hormone secretion, renal impairment. IRBESARTAN dosage: unknown. During the same period patient was treated with MIRTAZAPINE, BRICANYL, ASPIRIN, NEXIUM, VOLTAREN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5419325-6
Consumer or non-health professional from FRANCE reported IRBESARTAN problem on Aug 15, 2007. Male patient, 81 years of age, weighting 147.7 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: colonic polyp. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5419888-0
IRBESARTAN problem was reported by a Consumer or non-health professional from FRANCE on Aug 09, 2007. Male patient, 80 years of age, weighting 116.8 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: renal failure acute, sepsis. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, DIGOXIN. Patient was hospitalized and became disabled. Patient died on 07/24/2007.

Irbesartan Side Effects Report #5420667-9
Health Professional from SWITZERLAND reported IRBESARTAN problem on Aug 20, 2007. Female patient, 77 years of age, weighting 132.3 lb, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: mixed hepatocellular-cholestatic injury. IRBESARTAN dosage: unknown. During the same period patient was treated with LASIX, MARCUMAR, CONCOR, CALCIMAGON, CHONDROSULF. Patient recovered.

Irbesartan Side Effects Report #5422177-1
IRBESARTAN problem was reported by a Health Professional from FRANCE on Aug 21, 2007. Male patient, 74 years of age, weighting 377.0 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaemia, gastroduodenal ulcer, international normalised ratio increased, pneumonia, pyrexia, shock haemorrhagic, upper gastrointestinal haemorrhage. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, COUMADIN, INDOCIN, TOPROL, LISINOPRIL. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5423834-3
Health Professional from FRANCE reported IRBESARTAN problem on Aug 22, 2007. Male patient, 81 years of age, was diagnosed with cardiac failure and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: renal failure. IRBESARTAN dosage: unknown. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5424819-3
IRBESARTAN problem was reported by a Health Professional from FRANCE on Aug 23, 2007. Male patient, 74 years of age, weighting 377.0 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaemia, gastroduodenal ulcer, international normalised ratio increased, pneumonia, pyrexia, shock haemorrhagic. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, COUMADIN, INDOCIN, TOPROL, LISINOPRIL. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5429100-4
Health Professional from FRANCE reported IRBESARTAN problem on Aug 27, 2007. Male patient, 74 years of age, weighting 377.0 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaemia, gastroduodenal ulcer, international normalised ratio increased, pneumonia, pyrexia, shock haemorrhagic, upper gastrointestinal haemorrhage. IRBESARTAN dosage: unknown. During the same period patient was treated with COUMADIN, CLOPIDOGREL BISULPHATE, ASPIRIN, INDOCIN, TOPROL, LISINOPRIL, LASIX. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5433846-1
IRBESARTAN problem was reported by a Health Professional from FRANCE on Aug 29, 2007. Male patient, 74 years of age, weighting 377.0 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaemia, gastroduodenal ulcer, gouty arthritis, international normalised ratio increased, pneumonia, pyrexia, shock haemorrhagic, upper gastrointestinal haemorrhage. IRBESARTAN dosage: unknown. During the same period patient was treated with COUMADIN, CLOPIDOGREL BISULPHATE, ASPIRIN, INDOCIN, TOPROL, LISINOPRIL, LASIX. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5382634-3
Health Professional from FRANCE reported IRBESARTAN problem on July 03, 2007. Male patient, 80 years of age, weighting 187.4 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: arteriovenous fistula operation, inguinal hernia repair, renal failure, sepsis. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, ASPIRIN, DIGOXIN, DOBUTREX, NEXIUM, PERINDOPRIL ERBUMINE, LANOXIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5383848-9
IRBESARTAN problem was reported by a Health Professional from FRANCE on July 09, 2007. Male patient, 67 years of age, weighting 293.2 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: post procedural haematoma, pyelonephritis. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, PLAVIX, ENOXAPARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5383908-2
Physician from KOREA, REPUBLIC OF reported IRBESARTAN problem on July 06, 2007. Male patient, 62 years of age, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cardioplegia. IRBESARTAN dosage: unknown. During the same period patient was treated with PLAVIX, INDOBUFEN, AMLODIPINE, CARVEDILOL. Patient died on 10/02/2006.

Irbesartan Side Effects Report #5383973-2
IRBESARTAN problem was reported by a Health Professional from FRANCE on June 29, 2007. Female patient, 76 years of age, weighting 213.8 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: intestinal obstruction. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, ENALAPRIL, HYDROCHLOROTHIAZIDE, CARVEDILOL, RANITIDINE, LACTULONA. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5385639-1
Health Professional from SWITZERLAND reported IRBESARTAN problem on July 09, 2007. Male patient, child 12 years of age, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaemia. IRBESARTAN dosage: unknown. During the same period patient was treated with AMLODIPINE, METOPROLOL SUCCINATE. Patient recovered.

Irbesartan Side Effects Report #5387497-8
IRBESARTAN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 12, 2007. Male patient, 59 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cold agglutinins positive. IRBESARTAN dosage: unknown. During the same period patient was treated with IOPIDINE. Patient recovered.

Irbesartan Side Effects Report #5391385-0
Physician from AUSTRALIA reported IRBESARTAN problem on July 17, 2007. Female patient, 55 years of age, weighting 169.8 lb, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: arthritis, diarrhoea, dry mouth, dysphagia, dyspnoea, fatigue, fluid retention, hot flush, pain in extremity. IRBESARTAN dosage: unknown. During the same period patient was treated with TELFAST. Patient recovered.

Irbesartan Side Effects Report #5401673-7
IRBESARTAN problem was reported by a Health Professional from FRANCE on July 27, 2007. Female patient, 59 years of age, weighting 209.4 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: renal failure. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, LASIX, CIPROFLOXACIN, AMLODIPINE, LISINOPRIL, METFORMIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5382634-3
Health Professional from FRANCE reported IRBESARTAN problem on July 03, 2007. Male patient, 80 years of age, weighting 187.4 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: arteriovenous fistula operation, inguinal hernia repair, renal failure, sepsis. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, ASPIRIN, DIGOXIN, DOBUTREX, NEXIUM, PERINDOPRIL ERBUMINE, LANOXIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5383848-9
IRBESARTAN problem was reported by a Health Professional from FRANCE on July 09, 2007. Male patient, 67 years of age, weighting 293.2 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: post procedural haematoma, pyelonephritis. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, PLAVIX, ENOXAPARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5383908-2
Physician from KOREA, REPUBLIC OF reported IRBESARTAN problem on July 06, 2007. Male patient, 62 years of age, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cardioplegia. IRBESARTAN dosage: unknown. During the same period patient was treated with PLAVIX, INDOBUFEN, AMLODIPINE, CARVEDILOL. Patient died on 10/02/2006.

Irbesartan Side Effects Report #5383973-2
IRBESARTAN problem was reported by a Health Professional from FRANCE on June 29, 2007. Female patient, 76 years of age, weighting 213.8 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: intestinal obstruction. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, ENALAPRIL, HYDROCHLOROTHIAZIDE, CARVEDILOL, RANITIDINE, LACTULONA. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5385639-1
Health Professional from SWITZERLAND reported IRBESARTAN problem on July 09, 2007. Male patient, child 12 years of age, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anaemia. IRBESARTAN dosage: unknown. During the same period patient was treated with AMLODIPINE, METOPROLOL SUCCINATE. Patient recovered.

Irbesartan Side Effects Report #5387497-8
IRBESARTAN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 12, 2007. Male patient, 59 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cold agglutinins positive. IRBESARTAN dosage: unknown. During the same period patient was treated with IOPIDINE. Patient recovered.

Irbesartan Side Effects Report #5391385-0
Physician from AUSTRALIA reported IRBESARTAN problem on July 17, 2007. Female patient, 55 years of age, weighting 169.8 lb, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: arthritis, diarrhoea, dry mouth, dysphagia, dyspnoea, fatigue, fluid retention, hot flush, pain in extremity. IRBESARTAN dosage: unknown. During the same period patient was treated with TELFAST. Patient recovered.

Irbesartan Side Effects Report #5401673-7
IRBESARTAN problem was reported by a Health Professional from FRANCE on July 27, 2007. Female patient, 59 years of age, weighting 209.4 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: renal failure. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN, LASIX, CIPROFLOXACIN, AMLODIPINE, LISINOPRIL, METFORMIN. Patient was hospitalized. Patient recovered.


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