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

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  • Adverse experiences occurring in greater than one percent of patients with

    hypertension treated with enalapril in controlled clinical trials are shown below. In

    patients treated with enalapril, the maximum duration of therapy was three years;

    in placebo treated patients the maximum duration of therapy was 12 weeks.

    Enalapril

    Maleate

    (n = 2314)

    Incidence

    (discontinuation)

    Placebo

    (n = 230)

    Incidence
    Body as a whole
    Fatigue3.0 (<0.1)2.6
    Orthostatic Effects 1.2 (<0.1)0.0
    Asthenia 1.1 (0.1)0.9
    Digestive
    Diarrhea 1.4 (<0.1) 1.7
    Nausea 1.4 (0.2)1.7
    Nervous/Psychiatric
    Headache5.2 (0.3)9.1
    Dizziness 4.3 (0.4)4.3
    Respiratory
    Cough 1.3 (0.1)0.9
    Skin
    Rash 1.4 (0.4)0.4
  • Drug Information Provided by National Library of Medicine (NLM).
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