Benazepril Side Effects

Some side effects of benazepril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to benazepril: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking benazepril: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

You may be more likely to have an allergic reaction to benazepril if you are African-American.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• little or no urinating;

• swelling or rapid weight gain;

• fever, chills, body aches, flu symptoms;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• jaundice (yellowing of the skin or eyes);

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• cough;

• headache;

• dizziness, drowsiness, tired feeling;

• anxiety, sleep problems (insomnia);

• flushing (warmth, redness, or tingly feeling);

• nausea, vomiting, constipation; or

• mild skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to benazepril: oral tablet

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 included eosinophilic pneumonitis which has been reported with other ACE inhibitors.

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 nonblack 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.

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.

Gastrointestinal

Gastrointestinal side effects have included nausea, pancreatitis, constipation, gastritis, vomiting, and melena.

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 insufficiency has been more likely to occur in patients with renal artery stenosis, hypovolemia, and sodium depletion.

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

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.

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.

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.

Genitourinary

Genitourinary side effects including frequent urination have been reported during postmarketing experience.

Dermatologic

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

Psychiatric

Psychiatric side effects have included anxiety, decreased libido, hypertonia, insomnia, nervousness, and paresthesia.

Other

Other side effects have included fatigue, asthma, bronchitis, dyspnea, sinusitis, urinary tract infection, frequent urination, infection, arthritis, impotence, alopecia, arthralgia, myalgia, asthenia, and sweating.

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