Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
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 similar 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%).
Adverse reactions seen in at least 1% greater frequency in patients treated with benazepril hydrochloride than placebo were headache (6% vs.
4%), dizziness (4% vs.
5 WARNINGS AND PRECAUTIONS • Angioedema: Discontinue benazepril hydrochloride and treat appropriately.
( 5.2 ) • Monitor renal function periodically.
( 5.3 ) • Monitor blood pressure after initiation.
( 5.4 ) • Hyperkalemia: Monitor serum potassium periodically.
( 5.5 ) • Hepatic toxicity: Monitor for jaundice or signs of liver failure.
Like all medications, Benazepril Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: