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Review Nitroglycerin Safety Reports submitted to FDA

Total Nitroglycerin reports: 20.
Nitroglycerin FDA safety alerts: 2004 2005 2006 2007 2008 .
Reported deaths: 3    Reported hospitalizations: 5.
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FDA Reported Nitroglycerin Side Effects: hypotension, chest pain, headache, condition aggravated, dizziness, blood pressure decreased, accidental overdose, dyspnoea, heart rate irregular, heart rate abnormal, coronary arterial stent insertion.
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Nitroglycerin Side Effects Report #5689337-6
Consumer or non-health professional from SPAIN reported NITROGLYCERIN problem on Mar 19, 2008. Male patient, 68 years of age, was diagnosed with diabetes mellitus and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: metabolic acidosis, renal failure. NITROGLYCERIN dosage: unknown. During the same period patient was treated with DILTIAZEM, METFORMIN, ACETYLSALICYLATE LYSINE, GLYBURIDE, RAMIPRIL, CLOPIDOGREL, TORSEMIDE, TRIMETAZIDINE. Patient died.

Nitroglycerin Side Effects Report #5618671-0
NITROGLYCERIN problem was reported by a Pharmacist from UNITED STATES on Feb 05, 2008. Female patient was diagnosed with chest pain, myocardial ischaemia and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: no therapeutic response. NITROGLYCERIN dosage: 0.4MG EVERY 5 MINUTES SL -2 DOSES-. Patient recovered.

Nitroglycerin Side Effects Report #5623550-9
Consumer or non-health professional from SPAIN reported NITROGLYCERIN problem on Jan 29, 2008. Male patient, 68 years of age, was diagnosed with diabetes mellitus and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: metabolic acidosis. NITROGLYCERIN dosage: unknown. During the same period patient was treated with DILTIAZEM, METFORMIN, GLIBENCLAMIDE, ASPIRIN, RAMIPRIL, CLOPIDOGREL, TORSEMIDE, TRIMETAZIDINE. Patient died.

Nitroglycerin Side Effects Report #5648024-0
NITROGLYCERIN problem was reported by a Pharmacist from UNITED STATES on Feb 29, 2008. Male patient, 62 years of age, was diagnosed with chest pain and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, shock. NITROGLYCERIN dosage: 0.4MG ONCE SUBLINGUAL. Patient was hospitalized. Patient recovered.

Nitroglycerin Side Effects Report #5592991-0
Health Professional from UNITED STATES reported NITROGLYCERIN problem on Jan 14, 2008. Female patient, 66 years of age, weighting 117.0 lb, was diagnosed with chest pain and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: chest pain. NITROGLYCERIN dosage: unknown. Patient recovered.

Nitroglycerin Side Effects Report #5605936-1
NITROGLYCERIN problem was reported by a Consumer or non-health professional from JAPAN on Jan 07, 2008. Female patient, 40 years of age, was diagnosed with arteriospasm coronary and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: angina pectoris, coronary artery occlusion, coronary artery stenosis, electrocardiogram st segment elevation, loss of consciousness, ventricular tachycardia. NITROGLYCERIN dosage: .5 MG, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with ISOSORBIDE DINITRATE, NICORANDIL, DILTIAZEM, NIFEDIPINE, MIDAZOLAM, DOPAMINE. Patient recovered.

Nitroglycerin Side Effects Report #5611762-X
Consumer or non-health professional from GERMANY reported NITROGLYCERIN problem on Jan 14, 2008. Male patient, 45 years of age, was diagnosed with pulmonary oedema and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: accidental overdose, cerebral infarction, hypotension. NITROGLYCERIN dosage: 50 MG. Patient died.

Nitroglycerin Side Effects Report #5546218-6
NITROGLYCERIN problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 06, 2007. Female patient was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, chest pain. NITROGLYCERIN dosage: unknown. Patient recovered.

Nitroglycerin Side Effects Report #5578734-5
Health Professional from JAPAN reported NITROGLYCERIN problem on Dec 10, 2007. Male patient, 72 years of age, was diagnosed with prinzmetal angina and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: no therapeutic response, skin reaction. NITROGLYCERIN dosage: unknown. During the same period patient was treated with NIFEDIPINE, DILTIAZEM, NICORANDIL, DOXAZOSIN. Patient was hospitalized. Patient recovered.

Nitroglycerin Side Effects Report #5509637-X
NITROGLYCERIN problem was reported by a Health Professional from UNITED STATES on Nov 07, 2007. Female patient, 66 years of age, weighting 117.0 lb, was diagnosed with chest pain and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: chest pain. NITROGLYCERIN dosage: unknown. Patient recovered.

Nitroglycerin Side Effects Report #5518913-6
Pharmacist from UNITED STATES reported NITROGLYCERIN problem on Oct 26, 2007. Male patient, 67 years of age, was diagnosed with angina pectoris and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: coronary artery thrombosis, myocardial infarction. NITROGLYCERIN dosage: 0.4MG PRN SUBLINGUAL. During the same period patient was treated with PLAVIX, LISINOPRIL, ZOCOR, COREG. Patient was hospitalized. Patient recovered.

Nitroglycerin Side Effects Report #5526575-7
NITROGLYCERIN problem was reported by a Health Professional from UNITED STATES on Nov 21, 2007. Female patient, 66 years of age, weighting 117.0 lb, was diagnosed with chest pain and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: chest pain. NITROGLYCERIN dosage: unknown. Patient recovered.

Nitroglycerin Side Effects Report #5503121-5
Pharmacist from UNITED STATES reported NITROGLYCERIN problem on Oct 29, 2007. Male patient, 26 years of age, was diagnosed with chest pain and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: headache, respiratory arrest, syncope. NITROGLYCERIN dosage: .4MG OTHER SUBLINGUAL. Patient recovered.

Nitroglycerin Side Effects Report #5503525-0
NITROGLYCERIN problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 11, 2007. Male patient, 34 years of age, was diagnosed with peripheral vascular disorder, pain in extremity and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: cyanosis, finger amputation, gangrene, no therapeutic response, peripheral arterial occlusive disease, peripheral ischaemia, peripheral vascular disorder. NITROGLYCERIN dosage: unknown. During the same period patient was treated with NIFEDIPINE, HYDROXYUREA, ASPIRIN. Patient was hospitalized and became disabled. Patient recovered.

Nitroglycerin Side Effects Report #5447358-2
Pharmacist from UNITED STATES reported NITROGLYCERIN problem on Sept 05, 2007. Female patient was diagnosed with chest pain and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, bradycardia, chest pain, disease recurrence, dizziness, hyperhidrosis, hypotension. NITROGLYCERIN dosage: 0.4 MG SL. Patient was hospitalized. Patient recovered.

Nitroglycerin Side Effects Report #5463354-3
NITROGLYCERIN problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 17, 2007. Female patient was diagnosed with myocardial infarction and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: accidental overdose, blood pressure decreased, device malfunction, vomiting. NITROGLYCERIN dosage: unknown. Patient recovered.

Nitroglycerin Side Effects Report #5465431-X
Pharmacist from UNITED STATES reported NITROGLYCERIN problem on Sept 20, 2007. Male patient, 70 years of age, was diagnosed with cardiac failure congestive and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: headache. NITROGLYCERIN dosage: 0.2MG OTHER OTHER. Patient recovered.

Nitroglycerin Side Effects Report #5470604-6
NITROGLYCERIN problem was reported by a Health Professional from UNITED STATES on Sept 27, 2007. Male patient, 70 years of age, weighting 135.0 lb, was diagnosed with acute myocardial infarction and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: device malfunction, incorrect dose administered. NITROGLYCERIN dosage: 12 ML/HOUR. Patient recovered.

Nitroglycerin Side Effects Report #5403593-0
Consumer or non-health professional from UNITED STATES reported NITROGLYCERIN problem on July 26, 2007. Female patient, 50 years of age, was diagnosed with heart rate abnormal and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: coronary arterial stent insertion, heart rate abnormal, heart rate irregular. NITROGLYCERIN dosage: unknown. During the same period patient was treated with TOPROL, ZANAFLEX, NEURONTIN, LYRICA, DARVOCET, MEPERIDINE W, ALBUTEROL SULATE, LIPITOR. Patient recovered.

Nitroglycerin Side Effects Report #5420640-0
NITROGLYCERIN problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 15, 2007. Male patient, 67 years of age, weighting 158.7 lb, was diagnosed with arteriospasm coronary, percutaneous coronary intervention and was treated with NITROGLYCERIN. After drug was administered, patient experienced the following problems/side effects: dyspnoea, headache, hypotension, vomiting. NITROGLYCERIN dosage: unknown. During the same period patient was treated with CLOPIDOGREL, HEPARIN. Patient recovered.


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