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Review Ranexa Safety Reports submitted to FDA

Total Ranexa reports: 235.
Ranexa FDA safety alerts: 2007 .
Reported deaths: 15    Reported hospitalizations: 66.
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FDA Reported Ranexa Side Effects: dizziness, nausea, hypotension, cardiac failure congestive, oedema peripheral, chest pain, confusional state, fatigue, constipation, rash, fall.
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Ranexa Side Effects Report #5280636-9
Physician from UNITED STATES reported RANEXA problem on Aug 15, 2006. Male patient was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: chest discomfort, fatigue. RANEXA dosage: 500 MG, BID, ORAL. Patient recovered.

Ranexa Side Effects Report #5280637-0
RANEXA problem was reported by a Health Professional from UNITED STATES on Aug 15, 2006. Male patient, 79 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: fatigue. RANEXA dosage: 500MG,BID,ORAL. During the same period patient was treated with FELODIPINE, ATENOLOL, DIGOXIN, DIXAZOSIN, SIMVASTATIN. Patient recovered.

Ranexa Side Effects Report #5280639-4
Physician from UNITED STATES reported RANEXA problem on Oct 07, 2006. Female patient, 80 years of age, was diagnosed with ventricular tachycardia and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: cardiac failure, therapeutic response unexpected. RANEXA dosage: 600MG, BID, ORAL. Patient died on 01/01/2006.

Ranexa Side Effects Report #5280641-2
RANEXA problem was reported by a Physician from UNITED STATES on Oct 03, 2006. Male patient, 79 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, post procedural haematoma. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with TOPROL, IMUDR, VICODIN, INSULIN, PROTONIX, LASIX, LEXAPRO, NORVASC. Patient was hospitalized. Patient died on 09/20/2006.


Ranexa Side Effects Report #5280647-3
Physician from UNITED STATES reported RANEXA problem on Sept 19, 2006. Male patient, 72 years of age, was diagnosed with angina pectoris and was treated with RANEXA. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with ATENOLOL, ASPIRIN, PRAVACHOL, ZETIA, PROSCAR, FOLIC ACID, ASCORBIC ACID. Patient died on 09/10/2006.

Ranexa Side Effects Report #5280649-7
RANEXA problem was reported by a Physician from UNITED STATES on Oct 11, 2006. Female patient, 76 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: ventricular fibrillation. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with NITROGLYCERIN, METOPROLOL, ASPIRIN, FISH OIL, LEVOTHYROXINE, PRAVACHOL, RENAGEL, VITAMINS. Patient died on 09/09/2006.

Ranexa Side Effects Report #5280659-X
Physician from UNITED STATES reported RANEXA problem on Oct 11, 2006. Female patient, 78 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: balance disorder, muscular weakness, oedema peripheral, paraesthesia, tremor. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with LIPITOR, LYRICA, CORTICOSTEROID NOS. Patient was hospitalized. Patient recovered.

Ranexa Side Effects Report #5280672-2
RANEXA problem was reported by a Pharmacist from UNITED STATES on Aug 17, 2006. Female patient, 78 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: bradycardia, electrocardiogram qt prolonged, hypotension. RANEXA dosage: 500 MG, BID ^FOR 2 MONTHS^, ORAL. During the same period patient was treated with PROZAC, AMARYL, PLAVIX, NITROBID, PROTONIX, ASPIRIN, INSULIN, DIGOXIN. Patient was hospitalized. Patient recovered.

Ranexa Side Effects Report #5280674-6
Physician from UNITED STATES reported RANEXA problem on Aug 16, 2006. Male patient, 80 years of age, was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: cardiac failure, pleural effusion. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with HYDROCHLOROTHIAZIDE, LOVENOX, INSULIN, PROCANBID, ROCEPHIN, XOPENEX, ZOCOR. Patient was hospitalized. Patient recovered.


Ranexa Side Effects Report #5280681-3
RANEXA problem was reported by a Physician from UNITED STATES on Aug 21, 2006. Female patient, 69 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: asthenia, dizziness, fatigue, malaise, nausea. RANEXA dosage: 500 MG, QD, ORAL. During the same period patient was treated with ALTACE, COREG, PLAVIX, CHOLESTEROL. Patient recovered.

Ranexa Side Effects Report #5280683-7
Physician from UNITED STATES reported RANEXA problem on Aug 31, 2006. Male patient, 66 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: restless legs syndrome. RANEXA dosage: 500 MG, BID, ORAL. Patient recovered.

Ranexa Side Effects Report #5280685-0
RANEXA problem was reported by a Pharmacist from UNITED STATES on Sept 01, 2006. Male patient, 45 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: joint swelling, osteoarthritis. RANEXA dosage: unknown. Patient recovered.

Ranexa Side Effects Report #5280687-4
Physician from UNITED STATES reported RANEXA problem on Aug 31, 2006. Female patient was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: electrocardiogram t wave inversion. RANEXA dosage: unknown. Patient recovered.

Ranexa Side Effects Report #5280688-6
RANEXA problem was reported by a Physician from UNITED STATES on Sept 08, 2006. Male patient, 69 years of age, weighting 198.9 lb, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: rash. RANEXA dosage: 500 MG, ORAL. Patient recovered.


Ranexa Side Effects Report #5280697-7
Physician from UNITED STATES reported RANEXA problem on Sept 11, 2006. Male patient, 89 years of age, weighting 145.1 lb, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: angina pectoris, constipation. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with ZETIA, FELODIPINE, PLAVIX, ISOSORBIDE, LESCOL, MAXZIDE, TOPROL, FOSAMAX. Patient recovered.

Ranexa Side Effects Report #5280699-0
RANEXA problem was reported by a Physician from UNITED STATES on Sept 25, 2006. Female patient, 58 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus non-insulin-dependent, increased insulin requirement. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with LOTREL, AVAPRO, ISOSORBIDE, TOPROL, BUMEX, DOXAZOSIN, LIPITOR, TRICOR. Patient recovered.

Ranexa Side Effects Report #5280700-4
Physician from UNITED STATES reported RANEXA problem on Sept 27, 2006. Male patient, 79 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: bursitis. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with ASPIRIN, ATENOLOL, COREG, COUMADIN, DIGOXIN, IMDUR, LASIX, NITROSTAT. Patient recovered.

Ranexa Side Effects Report #5280707-7
RANEXA problem was reported by a Physician from UNITED STATES on Oct 05, 2006. Female patient, 62 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: fall, loss of consciousness. RANEXA dosage: 500 MG, BID, ORAL. Patient recovered.

Ranexa Side Effects Report #5280709-0
Physician from UNITED STATES reported RANEXA problem on Oct 06, 2006. Female patient, 74 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: dyspepsia, flatulence. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with IMDUR, LIPITOR, ASPIRIN, ACEON, TOPROL. Patient recovered.


Ranexa Side Effects Report #5280711-9
RANEXA problem was reported by a Physician from UNITED STATES on Oct 09, 2006. Male patient, 74 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: constipation, fatigue, hypoaesthesia, paraesthesia. RANEXA dosage: 500 MG, BID, ORAL. Patient recovered.

Ranexa Side Effects Report #5280716-8
Physician from UNITED STATES reported RANEXA problem on Oct 09, 2006. Male patient, 83 years of age, weighting 209.9 lb, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: dizziness, fatigue. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with METOPROLOL TARTRATE, DIOVAN, LESCOL, ISOSORBIDE MONONITRATE, PLAVIX, ASPIRIN. Patient recovered.

Ranexa Side Effects Report #5280724-7
RANEXA problem was reported by a Physician from UNITED STATES on Oct 11, 2006. Male patient, 74 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: prostatic specific antigen increased. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with LANTUS, LIPITOR, AVAPRO, PLAVIX, LASIX, NORVASC, NITROLINGUAL, NITROGLYCERIN LA. Patient recovered.

Ranexa Side Effects Report #5280727-2
Physician from UNITED STATES reported RANEXA problem on Oct 11, 2006. Male patient, 65 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: fall, tremor. RANEXA dosage: unknown. Patient recovered.

Ranexa Side Effects Report #5280728-4
RANEXA problem was reported by a Physician from UNITED STATES on Oct 13, 2006. Female patient, 88 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: chills, peripheral coldness. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with PREVACID, SYNTHROID, METOPROLOL TARTRATE, DEMADEX, SPIRONOLACTONE, LOVENOX, COUMADIN, INSULIN. Patient recovered.

Ranexa Side Effects Report #5280735-1
Physician from UNITED STATES reported RANEXA problem on Oct 23, 2006. Male patient was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: atrial flutter. RANEXA dosage: unknown. Patient recovered.

Ranexa Side Effects Report #5280737-5
RANEXA problem was reported by a Physician from UNITED STATES on Oct 26, 2006. Male patient was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: diplopia. RANEXA dosage: unknown. Patient recovered.

Ranexa Side Effects Report #5284240-8
Physician from UNITED STATES reported RANEXA problem on Mar 12, 2007. Male patient, 77 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: confusional state, disorientation, hypotension, meningitis viral, mental status changes. RANEXA dosage: unknown. During the same period patient was treated with LABETALOL, VYTORIN, ASPIRIN, TERAZOSIN, NITROL, HYDROCHOROTHIAZIDE, BUDESONIDE. Patient was hospitalized. Patient recovered.

Ranexa Side Effects Report #5285986-8
RANEXA problem was reported by a Physician from UNITED STATES on Mar 14, 2007. Male patient was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: abasia, asthenia, chest pain, dialysis, fluid retention, international normalised ratio increased, renal failure, vision blurred. RANEXA dosage: unknown. During the same period patient was treated with TOPROL, NORVASC, HYZAAR, COUMADIN, COREG. Patient was hospitalized. Patient recovered.

Ranexa Side Effects Report #5335787-7
Physician from UNITED STATES reported RANEXA problem on Jan 04, 2007. Female patient, 60 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. RANEXA dosage: unknown. During the same period patient was treated with COREG, SYNTHROID, LIPITOR, ASPIRIN, HUMULIN REGULAR. Patient died on 12/26/2006.

Ranexa Side Effects Report #5335788-9
RANEXA problem was reported by a Health Professional from UNITED STATES on Dec 28, 2006. Male patient, 77 years of age, weighting 177.9 lb, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, coronary bypass thrombosis. RANEXA dosage: unknown. During the same period patient was treated with IMDUR, NITROGLYCERIN, COUMADIN, RELAFEN, PRILOSEC, LISINOPRIL, LASIX. Patient was hospitalized. Patient recovered.

Ranexa Side Effects Report #5335789-0
Physician from UNITED STATES reported RANEXA problem on Jan 02, 2007. Male patient, 84 years of age, weighting 157.0 lb, was diagnosed with angina pectoris and was treated with RANEXA. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with NITROGLYCERIN, ASPIRIN, LOPRESSOR, ISOSORBIDE DINITRATE, DIGOXIN, ALDACTONE, CRESTOR. Patient died on 11/08/2006.

Ranexa Side Effects Report #5335790-7
RANEXA problem was reported by a Physician from UNITED STATES on Nov 29, 2006. Female patient was diagnosed with angina pectoris and was treated with RANEXA. RANEXA dosage: unknown. Patient died on 01/01/2006.

Ranexa Side Effects Report #5335792-0
Physician from UNITED STATES reported RANEXA problem on Nov 20, 2006. Female patient was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. RANEXA dosage: unknown. Patient died.

Ranexa Side Effects Report #5335793-2
RANEXA problem was reported by a Physician from UNITED STATES on Nov 10, 2006. Female patient, 78 years of age, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: nausea. RANEXA dosage: 500 MG, BID, ORAL. Patient died on 01/01/2006.

Ranexa Side Effects Report #5335794-4
Physician from UNITED STATES reported RANEXA problem on Nov 01, 2006. Male patient, 88 years of age, weighting 162.0 lb, was diagnosed with angina pectoris and was treated with RANEXA. After drug was administered, patient experienced the following problems/side effects: cardiac failure, dyspnoea, electrocardiogram qt corrected interval prolonged. RANEXA dosage: 500 MG, BID, ORAL. During the same period patient was treated with IMDUR, LISINOPRIL, COUMADIN, TOPROL, SIMVASTATIN, PROZAC, VITAMIN B, FOLIC ACID. Patient was hospitalized. Patient recovered.

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