Benazepril Side Effects

Brand Names: Lotensin

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

Benazepril

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 Benazepril:

Cough; dizziness, especially upon standing; headache; nausea; sleepiness; tiredness.

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Benazepril/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 Benazepril/Hydrochlorothiazide:

Coughing; diarrhea; dizziness; headache; lightheadedness; nausea; persistent nonproductive cough; tiredness; vomiting.

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

Benazepril Side Effects - for the Professional

Benazepril

Benazepril hydrochloride has been evaluated for safety in over 6000 patients with hypertension; over 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was comparable in Benazepril hydrochloride and placebo patients.

The reported side effects were generally mild and transient, and there was no relation between side effects and age, duration of therapy, or total dosage within the range of 2 to 80 mg. Discontinuation of therapy because of a side effect was required in approximately 5% of U.S. patients treated with Benazepril hydrochloride and in 3% of patients treated with placebo.

The most common reasons for discontinuation were headache (0.6%) and cough (0.5%).

The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with Benazepril hydrochloride are shown below.

Other adverse experiences reported in controlled clinical trials (in less than 1% of Benazepril patients), and rarer events seen in postmarketing experience, include the following (in some, a causal relationship to drug use is uncertain):

Cardiovascular

Symptomatic hypotension was seen in 0.3% of patients, postural hypotension in 0.4%, and syncope in 0.1%; these reactions led to discontinuation of therapy in 4 patients who had received Benazepril monotherapy and in 9 patients who had received Benazepril with hydrochlorothiazide. Other reports included angina pectoris, palpitations, and peripheral edema.

Renal

Of hypertensive patients with no apparent preexisting renal disease, about 2% have sustained increases in serum creatinine to at least 150% of their baseline values while receiving Benazepril hydrochloride, but most of these increases have disappeared despite continuing treatment. A much smaller fraction of these patients (less than 0.1%) developed simultaneous (usually transient) increases in blood urea nitrogen and serum creatinine.

Fetal/Neonatal Morbidity and Mortality

See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

Angioedema

Angioedema has been reported in patients receiving ACE inhibitors. During clinical trials in hypertensive patients with Benazepril, 0.5% of patients experienced edema of the lips or face without other manifestations of angioedema. Angioedema associated with laryngeal edema and/or shock may be fatal. If angioedema of the face, extremities, lips, tongue, or glottis and/or larynx occurs, treatment with Benazepril hydrochloride should be discontinued and appropriate therapy instituted immediately.

Dermatologic

Stevens-Johnson syndrome, pemphigus, apparent hypersensitivity reactions (manifested by dermatitis, pruritus, or rash), photosensitivity, and flushing.

Gastrointestinal

Pancreatitis, constipation, gastritis, vomiting, and melena.

Hematologic

Thrombocytopenia and hemolytic anemia.

Neurologic and Psychiatric

Anxiety, decreased libido, hypertonia, insomnia, nervousness, and paresthesia.

Other

Asthma, bronchitis, dyspnea, sinusitis, urinary tract infection, frequent urination, infection, arthritis, impotence, alopecia, arthralgia, myalgia, asthenia, and sweating.

Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.

The following adverse events of unknown frequency have been reported during postmarketing use of Benazepril: small bowel angioedema, anaphylactoid reactions, hyperkalemia, agranulocytosis, and neutropenia.

Pediatric Patients

The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients. Infants below the age of 1 year should not be given ACE inhibitors due to concerns over possible effects on kidney development.

The long-term effects of Benazepril on growth and development have not been studied.

Clinical Laboratory Test Findings

Of hypertensive patients with no apparent preexisting renal disease, about 2% have sustained increases in serum creatinine to at least 150% of their baseline values while receiving Benazepril hydrochloride, but most of these increases have disappeared despite continuing treatment. A much smaller fraction of these patients (less than 0.1%) developed simultaneous (usually transient) increases in blood urea nitrogen and serum creatinine. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis.

Since Benazepril decreases aldosterone secretion, elevation of serum potassium can occur. Potassium supplements and potassium-sparing diuretics should be given with caution, and the patient’s serum potassium should be monitored frequently.

Decreases in hemoglobin (a low value and a decrease of 5 g/dL) were rare, occurring in only 1 of 2014 patients receiving Benazepril hydrochloride alone and in 1 of 1357 patients receiving Benazepril hydrochloride plus a diuretic. No U.S. patients discontinued treatment because of decreases in hemoglobin.

Clinically important changes in standard laboratory tests were rarely associated with Benazepril hydrochloride administration. Elevations of uric acid, blood glucose, serum bilirubin, and liver enzymes have been reported, as have scattered incidents of hyponatremia, electrocardiographic changes, leukopenia, eosinophilia, and proteinuria. In U.S. trials, less than 0.5% of patients discontinued treatment because of laboratory abnormalities.

Side Effects by Body System

General

Benazepril has generally been well-tolerated. In large analyses, 20% to 52% of patients experienced an adverse drug event associated with benazepril, but most were mild to moderate and did not require cessation of therapy.

Nervous system

Nervous system side effects have included headache (5% to 13%), fatigue (5%), and dizziness (5%). Somnolence or vertigo has been reported in 1% of patients.

Respiratory

Respiratory side effects have been unusually reported. An increase in cough or rhinitis has been reported in 2% to 3% of patients. Up to 7% of patients experienced an upper respiratory tract infection during benazepril therapy.

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 been shown with the most data showing some benefit. Other agents studied have included baclofen, theophylline, sulindac, and benzonatate.

Gastrointestinal

Gastrointestinal side effects have been rarely reported. General abdominal pain or diarrhea has been reported in 2% of patients. Rare cases of pancreatitis associated with benazepril have been reported.

A 70 year old man with non-insulin dependent diabetes developed epigastric pain with cramping 30 minutes after taking a single dose of 5 mg benazepril. The same response occurred the following day after the next dose. After the third dose, the man presented to the emergency room with severe epigastric pain, nausea, and vomiting. Serum amylase was 234 units/L and serum lipase was 755 units/L. The signs and symptoms of pancreatitis resolved over the next several days once the drug was discontinued.

Cardiovascular

Cardiovascular effects have included postural hypotension or dizziness in 1% of patients. Angioneurotic edema has been reported rarely.

Angiotensin converting enzyme (ACE) inhibitors, in general, have been more likely to cause hypotension in sodium depleted or dehydrated patients.

Postural hypotension or dizziness has been more likely to occur with concomitant diuretic therapy.

Renal

Renal side effects have included renal insufficiency (increase in serum creatinine by 150% above pretreatment value) in 2% of patients.

Metabolic

Hyperkalemia is due to inhibition of aldosterone by benazepril.

Metabolic side effects including hyperkalemia have been reported.

Hypersensitivity

Hypersensitivity side effects including angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. Intestinal angioedema, including small bowel angioedema, has been reported in patients treated with ACE inhibitors, including benazepril. Dermatitis, rash, flushing, and pruritus have been reported. Anaphylactoid reactions have been reported during postmarketing experience.

Patients with intestinal angioedema generally presented 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 resolved after stopping the ACE inhibitor.

Hypersensitivity reactions to ACE inhibitors have been life threatening.

Hematologic

Hematologic side effects have been rarely reported and have included thrombocytopenia and hemolytic anemia. Agranulocytosis and neutropenia have been reported during postmarketing experience.

In two studies, 1 of 2,014 and 1 of 1,357 patients developed decreased hemoglobin during benazepril therapy. Neither patient required stopping the drug.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.