Quinapril Side Effects

Brand Names: Accupril

Please note - some side effects for Quinapril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Quinapril - for the consumer

Quinapril/Hydrochlorothiazide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Quinapril/Hydrochlorothiazide:

Diarrhea; difficulty breathing, dizziness, or lightheadedness when sitting up or standing; fatigue; headache; loss of appetite; nausea; persistent dry cough; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; darkening of urine; decrease in the amount of urine; drowsiness; dry mouth; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; prolonged nausea, vomiting, or diarrhea; restlessness; severe dizziness or lightheadedness; unusual joint pain; unusual muscle pain, cramps, or weakness; unusual or severe stomach pain; unusual thirst; unusual tiredness or weakness; unusual weight gain; yellowing of the skin or eyes.

Quinapril

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Quinapril:

Chest pain; coughing; diarrhea; difficulty breathing; dizziness; headache; lightheadedness; nausea; persistent, dry cough; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty swallowing or breathing; fainting; hoarseness; infection (sore throat, fever); irregular or slow heartbeat; shortness of breath; unusual stomach pain; yellowing of the skin or eyes.

For the professional

Quinapril

Hypertension

Quinapril hydrochloride has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Quinapril hydrochloride 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.

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.

Fetal/Neonatal Morbidity and Mortality

See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

Angioedema

Angioedema has been reported in patients receiving Quinapril hydrochloride (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 hydrochloride should be discontinued and appropriate therapy instituted immediately.

Clinical Laboratory Test Findings

Hematology:

Hyperkalemia:

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 hydrochloride alone. Increases are more likely to occur in patients receiving concomitant diuretic therapy than in those on Quinapril hydrochloride alone. These increases often remit on continued therapy.

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