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Review Irbesartan Safety Reports submitted to FDA

Total Irbesartan reports: 137.
Irbesartan FDA safety alerts: No.
Reported deaths: 18    Reported hospitalizations: 98.
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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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Showing 1-100 of 137 Next >

Irbesartan Side Effects Report #5353586-7
Health Professional from FRANCE reported IRBESARTAN problem on June 08, 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 #5353814-8
IRBESARTAN problem was reported by a Health Professional from FRANCE on June 08, 2007. Male patient, 76 years of age, weighting 185.2 lb, was diagnosed with hypertension, prophylaxis, cardiac failure, atrial fibrillation and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: therapeutic agent toxicity. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, DIGOXIN, SPIRONOLACTONE, RAMIPRIL, FURIX. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5356966-9
Consumer or non-health professional from FRANCE reported IRBESARTAN problem on June 11, 2007. Female patient, 64 years of age, weighting 152.1 lb, was diagnosed with hypertension, blood cholesterol increased, coronary artery bypass, diabetes mellitus and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: atrioventricular block second degree, syncope. IRBESARTAN dosage: unknown. During the same period patient was treated with VERAPAMIL, ATORVASTATIN CALCIUM, ASPIRIN, INSULINE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5363392-5
IRBESARTAN problem was reported by a Health Professional from FRANCE on June 18, 2007. Male patient, 73 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 #5367516-5
Health Professional from CANADA reported IRBESARTAN problem on June 18, 2007. Female patient, 35 years of age, weighting 132.3 lb, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: abortion missed, pregnancy, turner's syndrome. IRBESARTAN dosage: unknown. During the same period patient was treated with ATORVASTATIN, SIBUTRAMINE, BROMPHENIRAMINE, IBUPROFEN, ALCOHOL. Patient recovered.

Irbesartan Side Effects Report #5374562-4
IRBESARTAN problem was reported by a Health Professional from on June 22, 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 #5316743-1
Health Professional from UNITED KINGDOM reported IRBESARTAN problem on May 02, 2007. Male patient, 68 years of age, weighting 187.4 lb, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: dizziness, hypotension. IRBESARTAN dosage: unknown. During the same period patient was treated with YENTREVE, ASPIRIN, ISOSORBIDE MONONITRATE, NICORANDIL, PANTOPRAZOLE, RAMIPRIL. Patient recovered.

Irbesartan Side Effects Report #5319430-9
IRBESARTAN problem was reported by a Physician from UNITED KINGDOM on Apr 26, 2007. Male patient, 68 years of age, weighting 187.4 lb, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: dizziness, hypotension. IRBESARTAN dosage: 300 MG, UNK. During the same period patient was treated with ASPIRIN, ISOSORBIDE MONONITRATE, NICORANDIL, PANTOPRAZOLE, RAMIPRIL, YENTREVE. Patient recovered.

Irbesartan Side Effects Report #5321108-2
Health Professional from FRANCE reported IRBESARTAN problem on May 08, 2007. Female patient, 73 years of age, weighting 178.6 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: epistaxis. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, AMIODARONE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5322098-9
IRBESARTAN problem was reported by a Health Professional from FRANCE on May 09, 2007. Male patient, 89 years of age, weighting 183.0 lb, was diagnosed with hypertension, prophylaxis, cardiac disorder, prostatic disorder and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: gastroenteritis, renal failure, retroperitoneal haematoma, therapeutic agent toxicity. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, DIGOXIN, WARFARIN, CARVEDILOL, FINASTERIDE, FOLIC ACID. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5323723-9
Health Professional from BRAZIL reported IRBESARTAN problem on May 10, 2007. Female patient, 69 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 impairment. IRBESARTAN dosage: PT TOOK 300 MG 18-APR-2005 THROUGH 19-FEB-2007. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5324985-4
IRBESARTAN problem was reported by a Consumer or non-health professional from GERMANY on May 04, 2007. Female patient, 60 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: anorexia, hyperkalaemia, malaise, renal failure acute, retching, vomiting. IRBESARTAN dosage: unknown. During the same period patient was treated with METFORMIN, GEMFIBROZIL, RAMIPRIL, GLICLAZIDE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ASPIRIN, AMLODIPINE, CALTRATE. Patient recovered.

Irbesartan Side Effects Report #5328541-3
Physician from GREECE reported IRBESARTAN problem on May 15, 2007. Male patient, 58 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: vitamin b12 decreased. IRBESARTAN dosage: unknown. Patient recovered.

Irbesartan Side Effects Report #5329822-X
IRBESARTAN problem was reported by a Health Professional from SPAIN on May 16, 2007. Female patient, 65 years of age, was diagnosed with hypertension, atrial fibrillation and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, coronary artery stenosis. IRBESARTAN dosage: unknown. During the same period patient was treated with THIAZIDE, ATENOLOL, ACETYLSALICYLIC ACID SRT, FLECAINIDE ACETATE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5331153-9
Consumer or non-health professional from SPAIN reported IRBESARTAN problem on Jan 31, 2007. Female patient, 60 years of age, was diagnosed with hypertension and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: amaurosis fugax, cerebrovascular accident, chest pain, headache, palpitations. IRBESARTAN dosage: unknown. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5282988-2
IRBESARTAN problem was reported by a Consumer or non-health professional from FRANCE on Mar 28, 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 #5286121-2
Consumer or non-health professional from FRANCE reported IRBESARTAN problem on Mar 30, 2007. Female patient, 76 years of age, weighting 154.3 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: haematoma, pneumonia, sepsis. IRBESARTAN dosage: unknown. During the same period patient was treated with PHENPROCOUMON. Patient was hospitalized. Patient died on 02/06/2005.

Irbesartan Side Effects Report #5289371-4
IRBESARTAN problem was reported by a Consumer or non-health professional from FRANCE on Apr 03, 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 #5290404-X
Health Professional from FRANCE reported IRBESARTAN problem on Jan 15, 2007. Female patient, 72 years of age, was diagnosed with essential hypertension, atrial fibrillation and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: bradycardia. IRBESARTAN dosage: unknown. During the same period patient was treated with CORDARONE, ALMARYTM, TENORETIC. Patient recovered.

Irbesartan Side Effects Report #5290445-2
IRBESARTAN problem was reported by a Health Professional from FRANCE on Apr 05, 2007. Female patient, 69 years of age, weighting 185.2 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, peptic ulcer. IRBESARTAN dosage: unknown. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5291709-9
Health Professional from FRANCE reported IRBESARTAN problem on Apr 05, 2007. Male patient, 73 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, 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 #5296381-X
IRBESARTAN problem was reported by a Health Professional from FRANCE on Apr 02, 2007. Female patient, 83 years of age, was diagnosed with cardiac failure and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: brain neoplasm, glioblastoma multiforme. IRBESARTAN dosage: unknown. Patient recovered.

Irbesartan Side Effects Report #5297389-0
Health Professional from FRANCE reported IRBESARTAN problem on Apr 13, 2007. Female patient, 72 years of age, was diagnosed with essential hypertension, atrial fibrillation and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: bradycardia. IRBESARTAN dosage: unknown. During the same period patient was treated with CORDARONE, ALMARYTM, TENORETIC. Patient recovered.

Irbesartan Side Effects Report #5299421-7
IRBESARTAN problem was reported by a Consumer or non-health professional from FRANCE on Apr 16, 2007. Male patient, 89 years of age, weighting 141.1 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, CILAZAPRIL. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5299493-X
Health Professional from GERMANY reported IRBESARTAN problem on Apr 13, 2007. Female patient, weighting 143.3 lb, was diagnosed with atrial fibrillation and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: gastric perforation. IRBESARTAN dosage: 150 MG/DAY FOR 2 WEEKS FOLLOWING BY 300 MG/DAY. During the same period patient was treated with CLOPIDOGREL, ASPIRIN, ARAVA, METHOTREXATE, PREDNISOLONE. Patient was hospitalized. Patient died.

Irbesartan Side Effects Report #5303070-1
IRBESARTAN problem was reported by a Health Professional from BRAZIL on Apr 16, 2007. Female patient, 69 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 impairment. IRBESARTAN dosage: PT TOOK 300 MG 18-APR-2005 THROUGH 19-FEB-2007. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5306174-2
Health Professional from GERMANY reported IRBESARTAN problem on Apr 13, 2007. Female patient, weighting 143.3 lb, was diagnosed with atrial fibrillation and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: gastric perforation. IRBESARTAN dosage: 150 MG/DAY FOR 2 WEEKS FOLLOWING BY 300 MG/DAY. During the same period patient was treated with CLOPIDOGREL, ASPIRIN, ARAVA, METHOTREXATE, PREDNISOLONE. Patient was hospitalized. Patient died on 08/19/2005.

Irbesartan Side Effects Report #5306193-6
IRBESARTAN problem was reported by a Consumer or non-health professional from FRANCE on Apr 20, 2007. Male patient, 89 years of age, weighting 141.1 lb, was diagnosed with hypertension, prophylaxis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: convulsion. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, CLOPIDOGREL BISULPHATE. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5309611-2
Health Professional from BRAZIL reported IRBESARTAN problem on Apr 23, 2007. Female patient, 69 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, cardiogenic shock, condition aggravated, hypotension, renal failure, renal impairment, respiratory distress. IRBESARTAN dosage: PT TOOK 300 MG 18-APR-2005 THROUGH 19-FEB-2007. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5310125-4
IRBESARTAN problem was reported by a Health Professional from FRANCE on Apr 16, 2007. Female patient, 83 years of age, was diagnosed with cardiac failure and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: brain neoplasm. IRBESARTAN dosage: unknown. Patient recovered.

Irbesartan Side Effects Report #5310292-2
Health Professional from GERMANY reported IRBESARTAN problem on Apr 13, 2007. Female patient, weighting 143.3 lb, was diagnosed with atrial fibrillation and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: gastric perforation. IRBESARTAN dosage: 150 MG/DAY FOR 2 WEEKS FOLLOWING BY 300 MG/DAY. During the same period patient was treated with CLOPIDOGREL, ASPIRIN, ARAVA, METHOTREXATE, PREDNISOLONE. Patient was hospitalized. Patient died on 08/19/2005.

Irbesartan Side Effects Report #5311077-3
IRBESARTAN problem was reported by a Health Professional from BRAZIL on Apr 25, 2007. Female patient, 69 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, cardiogenic shock, hypotension, renal impairment, respiratory distress. IRBESARTAN dosage: PT TOOK 300 MG 18-APR-2005 THROUGH 19-FEB-2007. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5312480-8
Health Professional from FRANCE reported IRBESARTAN problem on Apr 26, 2007. Male patient, 89 years of age, weighting 183.0 lb, was diagnosed with hypertension, prophylaxis, cardiac disorder, prostatic disorder and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: gastroenteritis, renal failure, retroperitoneal haematoma, therapeutic agent toxicity. IRBESARTAN dosage: unknown. During the same period patient was treated with CLOPIDOGREL BISULPHATE, ASPIRIN, DIGOXIN, WARFARIN, CARVEDILOL, FINASTERIDE, FOLIC ACID. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5252281-2
IRBESARTAN problem was reported by a Health Professional from UNITED KINGDOM on Feb 26, 2007. Male patient, 44 years of age, weighting 176.4 lb, was diagnosed with hypertension, troponin t increased, diabetes mellitus insulin-dependent, hypercholesterolaemia and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis, hyperkalaemia, renal impairment. IRBESARTAN dosage: unknown. During the same period patient was treated with ASPIRIN, DILTIAZEM, NOVOMIX, SIMVASTATIN. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5254534-0
Health Professional from AUSTRALIA reported IRBESARTAN problem on Mar 01, 2007. Female patient, 81 years of age, was diagnosed with gastritis, duodenitis and was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: nephritis interstitial, renal failure. IRBESARTAN dosage: unknown. During the same period patient was treated with HYDRENE, LASIX, PARIET, ALDOMET. Patient recovered.

Irbesartan Side Effects Report #5262566-1
IRBESARTAN problem was reported by a Health Professional from FRANCE on Mar 08, 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, DIURETIC, BETA BLOCKER, NEXIUM. Patient was hospitalized. Patient recovered.

Irbesartan Side Effects Report #5276648-1
Health Professional from FRANCE reported IRBESARTAN problem on Mar 22, 2007. Male patient, 63 years of age, was treated with IRBESARTAN. After drug was administered, patient experienced the following problems/side effects: loss of consciousness, malaise, myoclonus. IRBESARTAN dosage: unknown. During the same period patient was treated with XATRAL LP, ATHYMIL. Patient was hospitalized. Patient recovered.

Showing 1-100 of 137 Next >


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post procedural haematoma, pyelonephritis, therapeutic agent toxicity, atrioventricular block second degree, syncope, , was diagnosed with hypertension, prophylaxis and was diagnosed with hypertension, prophylaxis, cardiac failure, atrial fibrillation and