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ACCUPRIL (QUINAPRIL HYDROCHLORIDE): ADVERSE REACTIONS / SIDE EFFECTS

Hypertension

Accupril (Quinapril HCl) tablets has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Accupril (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 Accupril (Quinapril Hydrochloride) tablets are shown below.

Adverse Events in Placebo-Controlled Trials: dizziness, headache, fatigue, nausea, vomiting, coughing, abdominal pain, heart failure

This drug has been evaluated for safety in 1222 Quinapril (Accupril) treated patients. Of these, 632 patients participated in controlled clinical trials. In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 6.8% of patients with congestive heart failure.

Adverse experiences probably or possibly related or of unknown relationship to therapy occurring in 1% or more of the 585 patients in placebo-controlled congestive heart failure trials who were treated with Quinapril (Accupril) tablets: coughing, dizziness, nausea, vomiting, fatigue, chest pain, dyspnea, hypotension, diarrhea, myalgia, headache, rash, back pain.

Hypertension and/or Heart Failure

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 CHF or hypertension treated with Accupril (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: malaise, back pain, viral infections, anaphylactoid reaction

Cardiovascular: vasodilation, palpitation, tachycardia, hyperkalemia, heart failure, myocardial infarction, hypertensive crisis, cerebrovascular accident, angina pectoris, cardiac rhythm disturbances, orthostatic hypotension, cardiogenic shock

Hematology: hemolytic anemia

Gastrointestinal: dry mouth or throat, flatulence, constipation, pancreatitis, gastrointestinal hemorrhage, abnormal liver function tests, dyspepsia

Nervous / Psychiatric: vertigo, somnolence, syncope, depression, nervousness, insomnia, paresthesia

Integumentary: increased sweating, alopecia, pemphigus, exfoliative dermatitis, pruritus, photosensitivity reaction, dermatopolymyositis

Urogenital: urinary tract infection, acute renal failure, impotence, worsening renal failure

Respiratory: eosinophilic pneumonitis

Other: edema, amblyopia, arthralgia, agranulocytosis, pharyngitis, hepatitis, thrombocytopenia

Fetal / Neonatal Morbidity and Mortality

Angioedema

Angioedema has been reported in patients receiving Quinapril HCl (Accupril) 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 HCl (Accupril) tablets should be discontinued and appropriate therapy instituted immediately.

Clinical Laboratory Test Findings

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 (Accupril) alone. Increases are more likely to occur in patients receiving concomitant diuretic therapy than in those on Quinapril Hydrochloride (Accupril) tablets alone. These increases often remit on continued therapy. In controlled studies of heart failure, increases in blood urea nitrogen and serum creatinine were observed in 11% and 8%, respectively, of patients treated with Accupril; most often these patients were receiving diuretics with or without digitalis.

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