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Control Lisinopril Lisinopril GTN + GTN alone
Event n = 4729 n = 4713 n = 4722 n = 4731
%%%% Persistent hypotension 3.6 8.8 9.3 3.9
Shock 2.5 2.8 2.2 1.9
Renal dysfunction 1.1 2.4 2.4 1.1
Stroke 0.6 0.6 0.9 0.8
Re-infarction 2.2 2.2 2.2 1.9
Hemorrhagic events 1.2 1.3 1.1 0.9
Post-infarction angina 13.2 13.9 12.3 11.8
Ventricular fibrillation 3.1 2.5 2.4 2.2
Sustained ventricular tachycardia 2.5 2.1 1.8 2.3
Atrial flutter or fibrillation 6.4 6.3 5.3 5.7
Complete atrioventricular block 2.4 2.9 2.5 2.1
Asystole 1.2 1.2 1.3 1.2
Intraventricular septal rupture 0.3 0.4 0.2 0.2
Papillary muscle rupture 0.3 0.4 0.5 0.4
Late CHF (> 4 days) 4.5 4.5 4.2 4.2 Other Events in Controlled Clinical Trials or Post-Marketing Experience
Additional adverse reactions which were reported rarely, either during controlled clinical trials or after the drug was marketed, include: Text Continues Below
Cardiovascular ° Myocardial infarction or cerebrovascular accident possibly secondary to excessive hypotension in high risk patients (see WARNINGS, Hypotension) ° Tachycardia Dermatologic ° Alopecia
° Diaphoresis
° Pruritis
° Urticaria Severe Skin Disorders such as ° Erythema multiforme
° Pemphigus
° Stevens-Johnson syndrome
° Toxic epidermal necrolysis Gastrointestinal ° Abdominal pain and indigestion
° Dry mouth
° Pancreatitis
° Vomiting Hematologic ° Hemolytic anemia Hepatic ° Hepatitis
° Jaundice (hepatocellular and/ or cholestatic)
° Liver function abnormalities Nervous System ° Mental confusion
° Mood alterations
° Paresthesia
° Vertigo Respiratory
° Bronchospasm
° Rhinitis
° Sinusitus Special Senses ° Taste disorders Urogenital ° Acute renal failure
° Impotence
° Oliguria/ anuria
° Renal dysfunction
° Uremia A symptom complex has been reported which may include fever, vasculitis, myalgia, arthralgia/ arthritis, a positive ANA, elevated ESR, eosinophilia, and leukocytosis. Rash, photosensitivity, or other dermatologic manifestations may also occur. Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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