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Review Cardensiel Safety Reports submitted to FDA

Total Cardensiel reports: 9.
Cardensiel FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 9.
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FDA Reported Cardensiel Side Effects: renal failure acute, dehydration, fall, atrial fibrillation, hepatitis cholestatic, bradycardia, aortic aneurysm, international normalised ratio increased, cytolytic hepatitis, hypotension, anaemia.
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Cardensiel Side Effects Report #5501514-3
Consumer or non-health professional from FRANCE reported CARDENSIEL problem on Oct 22, 2007. Female patient, 76 years of age, was treated with CARDENSIEL. After drug was administered, patient experienced the following problems/side effects: fall, haematemesis, international normalised ratio increased, overdose, ulcer. CARDENSIEL dosage: unknown. During the same period patient was treated with COUMADIN, LIPANTHYL, ZOLPIDEM, COLCHICINE, TRAMADOL. Patient was hospitalized. Patient died.

Cardensiel Side Effects Report #5458132-5
CARDENSIEL problem was reported by a Consumer or non-health professional from FRANCE on Aug 28, 2007. Male patient, 77 years of age, was treated with CARDENSIEL. After drug was administered, patient experienced the following problems/side effects: bradycardia, fall. CARDENSIEL dosage: 3,7500 MG (1,25 MG,3 IN 1 D), ORAL. During the same period patient was treated with ARICEPT, KARDEGIC, RAMIPRIL, PRAVASTATIN, NEXIUM, EUROBIOL, PROBIOLOG, NASONEX. Patient was hospitalized. Patient recovered.

Cardensiel Side Effects Report #5412764-9
Consumer or non-health professional from FRANCE reported CARDENSIEL problem on July 19, 2007. Male patient, 84 years of age, was treated with CARDENSIEL. After drug was administered, patient experienced the following problems/side effects: cytolytic hepatitis, hepatitis cholestatic. CARDENSIEL dosage: 2,5 MG (2,5 MG, 1 D) ORAL. During the same period patient was treated with ANDROCUR, FUROSEMIDE, SINTROM, CORDARONE, COVERSYL. Patient was hospitalized. Patient recovered.

Cardensiel Side Effects Report #5416749-8
CARDENSIEL problem was reported by a Health Professional from FRANCE on Aug 08, 2007. Female patient, 79 years of age, was diagnosed with hypertension, atrial fibrillation, cardiac failure and was treated with CARDENSIEL. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, bradycardia, dehydration, diarrhoea, renal failure. CARDENSIEL dosage: 1,0714 MG (7, 5 MG, 1 IN 1 WK) ORAL. During the same period patient was treated with DIGOXIN, COZAAR, LASIX, ALDACTONE, COUMADIN, CALCIDOSE, RALOXIFENE. Patient was hospitalized. Patient recovered.

Cardensiel Side Effects Report #5429158-2
Consumer or non-health professional from FRANCE reported CARDENSIEL problem on Aug 20, 2007. Female patient, 69 years of age, was diagnosed with hypertension and was treated with CARDENSIEL. After drug was administered, patient experienced the following problems/side effects: haemolytic anaemia. CARDENSIEL dosage: 5 MG (5 MG, 1 IN 1 D) ORAL. During the same period patient was treated with KENZEN. Patient was hospitalized. Patient recovered.

Cardensiel Side Effects Report #5390698-6
CARDENSIEL problem was reported by a Consumer or non-health professional from FRANCE on July 09, 2007. Male patient, 84 years of age, was treated with CARDENSIEL. After drug was administered, patient experienced the following problems/side effects: aortic aneurysm, hepatitis cholestatic. CARDENSIEL dosage: 2.5 MG (2.5 MG, 1 D), ORAL. During the same period patient was treated with ANDROCUR, FUROSEMIDE, SINTROM, CORDARONE, COVERSYL. Patient was hospitalized. Patient died.

Cardensiel Side Effects Report #5401927-4
Consumer or non-health professional from FRANCE reported CARDENSIEL problem on July 19, 2007. Male patient, 84 years of age, was treated with CARDENSIEL. After drug was administered, patient experienced the following problems/side effects: aortic aneurysm, hepatitis cholestatic. CARDENSIEL dosage: 2,5 MG (2,5 MG, 1 D). During the same period patient was treated with ANDROCUR, LASIX, SINTROM, CORDARONE, COVERSYL. Patient was hospitalized. Patient recovered.

Cardensiel Side Effects Report #5390698-6
CARDENSIEL problem was reported by a Consumer or non-health professional from FRANCE on July 09, 2007. Male patient, 84 years of age, was treated with CARDENSIEL. After drug was administered, patient experienced the following problems/side effects: aortic aneurysm, hepatitis cholestatic. CARDENSIEL dosage: 2.5 MG (2.5 MG, 1 D), ORAL. During the same period patient was treated with ANDROCUR, FUROSEMIDE, SINTROM, CORDARONE, COVERSYL. Patient was hospitalized. Patient died.

Cardensiel Side Effects Report #5401927-4
Consumer or non-health professional from FRANCE reported CARDENSIEL problem on July 19, 2007. Male patient, 84 years of age, was treated with CARDENSIEL. After drug was administered, patient experienced the following problems/side effects: aortic aneurysm, hepatitis cholestatic. CARDENSIEL dosage: 2,5 MG (2,5 MG, 1 D). During the same period patient was treated with ANDROCUR, LASIX, SINTROM, CORDARONE, COVERSYL. Patient was hospitalized. Patient recovered.


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fall, haematemesis, international normalised ratio increased, overdose, ulcer, bradycardia, fall, , was diagnosed with hypertension, atrial fibrillation, cardiac failure and was diagnosed with hypertension and