Accupril Side Effects

Generic Name: quinapril

Please note - some side effects for Accupril 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 Accupril - for the Consumer

Accupril

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 Accupril:

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.

Accupril Side Effects - for the Professional

Accupril

Hypertension

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

Heart Failure

Accupril has been evaluated for safety in 1222 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 Accupril are shown below.

See PRECAUTIONS, Cough.

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: 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 has been reported in patients receiving 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 Accupril should be discontinued and appropriate therapy instituted immediately.

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 Accupril alone. Increases are more likely to occur in patients receiving concomitant diuretic therapy than in those on Accupril 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.

Side Effects by Body System

General

Quinapril is generally well-tolerated. Overall, 12% to 37% of patients experience an adverse drug event associated with quinapril, but less than 6% of patients discontinue therapy due to an adverse drug event. Side effects are not more common in the elderly.

Nervous system

Nervous system side effects are the most common. Dizziness, headache, and fatigue occur in 2% to 7% of patients. Somnolence, paresthesias, or asthenia are reported in less than 1% of patients.

Cardiovascular

Cardiovascular side effects include orthostatic hypotension in 6% of patients and angioedema in 0.1% of patients. First-dose orthostatic hypotension is less common than with other ACE inhibitors, occurring in only 0.4% to 2.5% of patients. Less than 1% of patients report chest pain during quinapril therapy.

Exacerbation of congestive heart failure (CHF) and of angina pectoris are each reported in one patient with preexisting NYHA class II to III CHF.

Gastrointestinal

Gastrointestinal side effects are uncommon, and limited mainly to general abdominal pain in up to 6% of patients. Dysgeusia, nausea, vomiting, dyspepsia, or diarrhea is reported in 0.5% to 2.0% of patients. Several reports of pancreatitis have been associated with ACE inhibitor therapy.

An 83-year-old female developed signs of pancreatitis after eleven days of quinapril therapy. Upon admission to the hospital, the patient complained of epigastric and left upper-quadrant abdominal tenderness. Laboratory values revealed elevated serum amylase, serum lipase, and white blood cell count. Quinapril was discontinued on admission in the view of possible ACE inhibitor-associated pancreatitis. Three days after discontinuation of quinapril, the patient's abdominal pain resolved and laboratory values were normal.

Respiratory

Respiratory system complaints are limited to an idiosyncratic cough in 1% to 8% of patients. Bronchitis or rhinitis occurs in approximately 2% of patients.

A retrospective study has revealed a significantly higher incidence of discontinuation of angiotensin converting enzyme inhibitor therapy due to cough among black patients compared with non-black patients (9.6% vs. 2.4%).

Several agents have been studied for treating cough with ACE inhibitors. No long term trials exist to allow a definitive treatment option. Cromolyn has the most data showing some benefit. Other agents studied include baclofen, theophylline, sulindac, and benzonatate.

Hematologic

Hematologic side effects are extremely uncommon. No cases of agranulocytosis have been reported. Decreased white blood cell counts in 0.4% and reductions in neutrophil counts in 2.0% of patients are reported.

Musculoskeletal

Musculoskeletal pain is reported in 2% to 5% of patients.

Renal

Renal insufficiency is rare. Data from a study of 37 patients with renal insufficiency reveal no significant adverse effect of quinapril on renal function. Elevated serum creatinine and BUN is reported in 1.0% and 0.1% of patients, respectively.

Genitourinary

Genitourinary problems are limited to complaints of impotence in less than 0.5% of men.

Hypersensitivity

Hypersensitivity reactions to angiotensin converting enzyme (ACE) inhibitors may be life threatening. Angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. In addition, intestinal angioedema has been reported in patients treated with ACE inhibitors. It is recommended that any patient with dyspnea, dysphagia, or significant facial angioedema stop therapy immediately and avoid ACE inhibitor therapy in general.

Rash and photosensitivity are each reported in small studies of patients with NYHA class II to III congestive heart failure and in approximately 0.2% of 1417 patients in a large study. Anaphylactoid reaction has also been reported.

Patients with intestinal angioedema generally present with abdominal pain (with or without nausea or vomiting) and in some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. These symptoms resolve after stopping the ACE inhibitor.

Psychiatric

Psychiatric side effects including symptoms of major depression have been associated with quinapril therapy in at least one documented case report.

A 90-year-old white male developed symptoms of depression including lessened appetite, insomnia, anhedonia, lessened energy and suicidal ideation soon after initiating quinapril therapy. The patient had no prior psychiatric history or history of drug abuse. The decision was made to discontinue quinapril therapy and the patient was subsequently given diltiazem treatment. The patient reported improvement in mood within the first 48 hours of discontinuing quinapril.

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