Quinapril has been evaluated for safety in 4960 subjects and patients and was well tolerated. Of these, 3203 patients including 655 elderly patients participated in controlled clinical trials. Quinapril has been evaluated for long-term safety in over 1400 patients treated for 1 year or more.
Adverse experiences were usually mild and transient in nature. The most frequent clinical adverse reactions in controlled trials were headache (7.2%), dizziness (5.5%), cough (3.9%), fatigue (3.5%), rhinitis (3.2%), nausea and/or vomiting (2.8%), and myalgia (2.2%). It should be noted that, characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy.
Discontinuation of therapy because of adverse events was required in 5.3% of the patients treated with quinapril in controlled clinical trials.
Adverse experiences occurring in 1% or more of the 3203 patients in controlled clinical trials who were treated with quinapril with or without a concomitant diuretic are shown as follows. Incidence of adverse experiences in the subset of 655 patients aged 65 years and older is given for comparison. A subset of the 2005 patients in controlled clinical trials who were treated with quinapril monotherapy for hypertension is also presented. (See Table 2.)
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Clinical adverse experiences probably, possibly, or definitely related, or of uncertain relationship to therapy occurring in 0.5% to <1.0% (except as noted) of the patients treated with quinapril (with or without concomitant diuretic) in controlled or uncontrolled trials and less frequent events seen in clinical trials or post-marketing experience (indicated by *) included: Blood and Lymphatic System Disorders: Hemolytic anemia*, thrombocytopenia*.
Immune System Disorders: Anaphylactoid reaction*.
Psychiatric Disorders: Depression, nervousness.
Nervous System Disorders: Somnolence, vertigo.
Eye Disorders: Ambylopia.
Cardiac Disorders: Angina pectoris, palpitations, tachycardia.
Vascular Disorders: Postural hypotension*, syncope*, vasodilatation.
Gastrointestinal Disorders: Dry mouth or throat, flatulence, pancreatitis*.
Skin and Subcutaneous Tissue Disorders: Alopecia*, exfoliative dermatitis*, increased perspiration, pemphigus*, photosensitivity reaction*, pruritus, rash.
Musculoskeletal and Connective Tissue Disorders: Arthralgia.
Renal and Urinary Disorders: Urinary tract infection (see Precautions).
Reproductive System and Breast Disorders: Impotence.
Congenital, Familial, and Genetic Disorders: see Contraindications and Use in Pregnancy & Lactation.
General Disorders and Administration Site Conditions: Edema (peripheral and generalized).
Rare Events: Angioedema* (0.1%) was reported in patients receiving quinapril (see Contraindications and Precautions). While rarely seen with quinapril, eosinophilic pneumonitis*, hepatitis have been reported with other ACE inhibitors.
Clinical Laboratory Test Findings: Agranulocytosis and neutropenia have been reported rarely (see Precautions).
Hyperkalemia: See Contraindications and Precautions.
Creatinine and Blood Urea Nitrogen: Increases (>1.25 times the upper limit of normal) in serum creatinine and blood urea nitrogen were observed in 2% and 2%, respectively, of the patients treated with quinapril alone. These increases often reversed on continued therapy (see Precautions).