ADVERSE REACTIONS
Hypertension
Quinapril has been evaluated for safety in 4960 subjects and patients. 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 placebo-controlled trials, discontinuation of therapy because of adverse events was required in 4.7% of patients with hypertension.
Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 1563 patients in placebo-controlled hypertension trials who were treated with quinapril are shown below.
| Adverse Events in Placebo-Controlled Trials |
| Quinapril
(N=1563)
Incidence
(Discontinuance) | Placebo
(N=579)
Incidence
(Discontinuance) |
| Headache | 5.6 (0.7) | 10.9 (0.7) |
| Dizziness | 3.9 (0.8) | 2.6 (0.2) |
| Fatigue | 2.6 (0.3) | 1.0 |
| Coughing | 2.0 (0.5) | 0.0 |
| Nausea and/or Vomiting | 1.4 (0.3) | 1.9 (0.2) |
| Abdominal Pain | 1.0 (0.2) | 0.7 |
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 (N=4847) and less frequent, clinically significant events seen in clinical trials or post-marketing experience (the rarer events are in italics) include (listed by body system):
General: anaphylactoid reaction, back pain, dyspepsia, malaise, viral infections
Cardiovascular: palpitation, vasodilation, tachycardia, heart failure, hyperkalemia, myocardial infarction, cerebrovascular accident, hypertensive crisis, angina pectoris, orthostatic hypotension, cardiac rhythm disturbances, cardiogenic shock
Hematology: hemolytic anemia
Gastrointestinal: anaphylactoid reaction, dyspepsia, flatulence, dry mouth or throat, constipation, gastrointestinal hemorrhage, pancreatitis, abnormal liver function tests
Nervous/Psychiatric: somnolence, vertigo, syncope, nervousness, depression, insomnia, paresthesia
Integumentary: alopecia, increased sweating, pemphigus, pruritus, exfoliative dermatitis, photosensitivity reaction, dermatopolymyositis
Urogenital: urinary tract infection, impotence, acute renal failure, worsening renal failure
Respiratory: eosinophilic pneumonitis
Other: amblyopia, edema, arthralgia, pharyngitis, agranulocytosis, hepatitis, thrombocytopenia
Fetal/Neonatal Morbidity and Mortality
See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
Angioedema
Angioedema has been reported in patients receiving quinapril (0.1%). Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis, and/or larynx occurs, treatment with quinapril should be discontinued and appropriate therapy instituted immediately. (See WARNINGS.)
Clinical Laboratory Test Findings
Hematology
(See WARNINGS)
Hyperkalemia
(See 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 all patients treated with quinapril alone. Increases are more likely to occur in patients receiving concomitant diuretic therapy than in those on quinapril alone. These increases often remit on continued therapy.
|
