Drug Information for Enalapril Maleate Tablets, USP (Sandoz Inc.): Heart failure

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  • Adverse experiences occurring in greater than one percent of patients with heart failure treated with enalapril are shown below. The incidences represent the experiences from both controlled and uncontrolled clinical trials (maximum duration of therapy was approximately one year). In the placebo treated patients, the incidences reported are from the controlled trials (maximum duration of therapy is 12 weeks). The percentage of patients with severe heart failure (NYHA Class IV) was 29% and 43% for patients treated with enalapril and placebo, respectively.

    Enalapril

    Maleate

    (n = 673)

    Incidence

    (discontinuation)

    Placebo

    (n = 339)

    Incidence
    Body as a whole
    Orthostatic Effects 2.2 (0.1)0.3
    Syncope 2.2 (0.1)0.9
    Chest Pain 2.1 (0.0)2.1
    Fatigue 1.8 (0.0)1.8
    Abdominal Pain1.6 (0.4)2.1
    Asthenia 1.6 (0.1)0.3
    Cardiovascular
    Hypotension 6.7 (1.9) 0.6
    Orthostatic Hypotension 1.6 (0.1) 0.3
    Angina Pectoris1.5 (0.1)1.8
    Myocardial Infarction1.2 (0.3)1.8
    Digestive
    Diarrhea 2.1 (0.1)1.2
    Nausea 1.3 (0.1)0.6
    Vomiting 1.3 (0.0) 0.9
    Nervous/Psychiatric
    Dizziness 7.9 (0.6) 0.6
    Headache 1.8 (0.1)0.9
    Vertigo 1.6 (0.1)1.2
    Respiratory
    Cough 2.2 (0.0)0.6
    Bronchitis 1.3 (0.0)0.9
    Dyspnea 1.3 (0.1)0.4
    Pneumonia 1.0 (0.0)2.4
    Skin
    Rash1.3 (0.0)2.4
    Urogenital
    Urinary Tract Infection 1.3 (0.0)2.4
  • Drug Information Provided by National Library of Medicine (NLM).
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