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 hydrochloride are shown below.
Adverse Events in Placebo-Controlled Trials
|
|
Quinapril Hydrochloride
(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
|
Hypertension
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 with hypertension treated with quinapril hydrochloride (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
Back pain, malaise, viral infections,
anaphylactoid reaction
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
Flatulence, dry mouth or throat, constipation,
gastrointestinal hemorrhage, pancreatitis, abnormal liver function tests, dyspepsia
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
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.
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REPORTS OF SUSPECTED QUINAPRIL SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Quinapril. The information is not vetted and should not be considered as verified clinical evidence.
Possible Quinapril side effects / adverse reactions in 48 year old female
Reported by a consumer/non-health professional from United States on 2011-10-19
Patient: 48 year old female weighing 106.6 kg (234.5 pounds)
Reactions: Angioedema
Adverse event resulted in: hospitalization
Suspect drug(s):
Quinapril
Possible Quinapril side effects / adverse reactions in 67 year old female
Reported by a consumer/non-health professional from Greece on 2011-10-28
Patient: 67 year old female
Reactions: Convulsion
Suspect drug(s):
Quinapril
Possible Quinapril side effects / adverse reactions in 64 year old male
Reported by a consumer/non-health professional from United States on 2011-11-02
Patient: 64 year old male weighing 74.8 kg (164.7 pounds)
Reactions: White Blood Cell Count Decreased, Dyspnoea, RED Blood Cell Count Decreased, Diabetes Mellitus, Chills, Feeling Abnormal, Hyperhidrosis
Suspect drug(s):
Quinapril
Other drugs received by patient: Hydrochlorothiazide
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