Benazepril

Mechanism-of-action classes: Angiotensin-converting Enzyme Inhibitors; Neprilysin Inhibitors.

• Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.ICD-10: I10

• Benazepril hydrochloride tablets are contraindicated in patients: • who are hypersensitive to benazepril or to any other ACE inhibitor • with a history of angioedema with or without previous ACE inhibitor treatment Benazepril hydrochloride tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril hydrochloride tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.2)].contraindicated

• Adult Patients: Initiate with 10 mg once daily (or 5 mg if patient is on diuretic). Titrate to 40 mg daily based on blood pressure response. ( 2.1 ) • Pediatric patients age 6 years and above with glomerular filtration rate (GFR) >30 mL/min/1.73 m 2 : Initiate with 0.2 mg/kg once daily. Maximum dose is 0.6 mg/kg once daily. • Renal Impairment: Initiate with 5 mg once daily in patients with GFR <30 mL/min/1.73 m 2 (serum creatinine >3 mg/dL) ( 2 .2) 2.1 Recommended Dosage ADULTS The recommended initial dose for patients not receiving a diuretic is 10 mg once a day. The usual maintenance dosage range is 20 to 40 mg per day administered as a single dose or in two equally divided doses. A dose of 80 mg gives an increased response, but experience with this dose is limited. The divided regimen was more effective in controlling trough (pre-dosing) blood pressure than the same dose given as a once-daily regimen. Use with diuretics in adults The recommended starting dose of benazepril hydrochloride tablets in a patient on a diuretic is 5 mg once daily. If blood pressure is not controlled with benazepril hydrochloride alone, a low dose of diuretic may be added. PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER The recommended starting dose for pediatric patients is 0.2 mg/kg once per day. Titrate as needed to 0.6 mg/kg once per day. Doses above 0.6 mg/kg (or in excess of 40 mg daily) have not been studied in pediatric patients.

• 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. ( 5.6 ) 5.1 Fetal Toxicity PREGNANCY CATEGORY D Benazepril hydrochloride tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible [see Use in Specific Populations ( 8.1 )] . 5.2 Angioedema and Anaphylactoid Reactions Angioedema Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis, and/or larynx including some fatal reactions, have occured in patients treated with benazepril hydrochloride. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. Benazepril hydrochloride should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms of angioedema has occurred.

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. 2%), somnolence (2% vs. 0%) and postural dizziness (2% vs. 0%).

• Pediatrics: Safety and effectiveness have not been established in patients < 6 years of age or with GFR < 30 mL/min/1.73 m2 ( Error! Hyperlink reference not valid. ) • Race: Less antihypertensive effect in Blacks as monotherapy ( 8.5 ) 8.1 Pregnancy Risk Summary Benazepril hydrochloride can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue benazepril hydrochloride as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Single oral doses of 3 g/kg benazepril were associated with significant lethality in mice. Rats, however, tolerated single oral doses of up to 6 g/kg. Reduced activity was seen at 1 g/kg in mice and at 5 g/kg in rats. Human overdoses of benazepril have not been reported, but the most common manifestation of human benazepril overdosage is likely to be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Hypotension can be associated with electrolyte disturbances and renal failure. Benazepril is only slightly dialyzable, but consider dialysis to support patients with severely impaired renal function [see Warnings and Precautions ( 5.3 )]. If ingestion is recent, consider activated charcoal. Consider gastric decontamination (e.g., vomiting, gastric lavage) in the early period after ingestion. Monitor for blood pressure and clinical symptoms. Supportive management should be employed to ensure adequate hydration and to maintain systemic blood pressure. In the case of marked hypotension, infuse physiological saline solution; as needed, consider vasopressors (e.g., catecholamines i.v.).

• Jun 25, 1991NDANDA019851Validus Pharms
• May 19, 1992NDANDA020033Validus Pharms
• Mar 3, 1995NDANDA020364Sandoz
• Feb 11, 2004ANDAANDA076267Heritage Pharma
• Feb 11, 2004ANDAANDA076118Prinston Inc
• Feb 11, 2004ANDAANDA076342Ani Pharms
• Feb 11, 2004ANDAANDA076631Sandoz
• Feb 3, 2006ANDAANDA076820Amneal Pharms

1. 1Nausea1,0696.4%
2. 2Fatigue9495.7%
3. 3Drug Ineffective9335.6%
4. 4Dizziness8825.3%
5. 5Diarrhoea8325.0%
6. 6Dyspnoea8054.9%
7. 7Headache7734.7%
8. 8Pain7594.6%
9. 9Asthenia6654.0%
10. 10Myocardial Infarction6614.0%
11. 11Hypertension6193.7%
12. 12Vomiting5753.5%
13. 13Cerebrovascular Accident5513.3%
14. 14Renal Failure5483.3%
15. 15Anxiety5413.3%

The 10 most recently updated of 57 ClinicalTrials.gov registrations naming Benazepril as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
  Not yet recruiting · Phase 4 · Interventional · 64 enrolled · Baylor Research Institute
  NCT07547878updated 2026-05-08
• Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets
  Not yet recruiting · Phase 1 · Interventional · 60 enrolled · Shenzhen Salubris Pharmaceuticals Co., Ltd.
  NCT07486453updated 2026-03-20
• Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)
  Completed · Phase 2 · Interventional · 50 enrolled · Shanghai Children's Hospital
  NCT04937907updated 2026-03-02
• Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
  Not yet recruiting · Observational · 13,656 enrolled · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  NCT07262710updated 2025-12-04
• Centrally Acting ACE Inhibition in SLE
  Active not recruiting · Phase 2 · Interventional · 36 enrolled · Northwell Health
  NCT04486118updated 2025-09-19
• Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
  Recruiting · Observational · 180 enrolled · Beijing Friendship Hospital
  NCT05498675updated 2025-02-13
• Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions
  Completed · Phase 1 · Interventional · 48 enrolled · Teva Pharmaceuticals USA
  NCT00834977updated 2024-09-19
• Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions
  Completed · Phase 1 · Interventional · 68 enrolled · Teva Pharmaceuticals USA
  NCT00835367updated 2024-08-21
• Benazepril HCl 40 mg Tablets, Fasting
  Completed · Phase 1 · Interventional · 40 enrolled · Teva Pharmaceuticals USA
  NCT00836576updated 2024-08-19
• Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
  Completed · Phase 1 · Interventional · 64 enrolled · Mylan Pharmaceuticals Inc
  NCT00649402updated 2024-04-24

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

• EnalaprilAngiotensin Converting Enzyme Inhibitor77%
• QuinaprilAngiotensin Converting Enzyme Inhibitor76%

Frequently asked questions

How does Benazepril work?

Mechanism-of-action classes: Angiotensin-converting Enzyme Inhibitors; Neprilysin Inhibitors.

What is Benazepril used for?

According to FDA labeling, Benazepril carries indications including: Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Benazepril?

Benazepril is classified as ACE inhibitors, plain, Angiotensin Converting Enzyme Inhibitor, Angiotensin-converting Enzyme Inhibitors, Neprilysin Inhibitors, Decreased Blood Pressure, Decreased Bradykinin Degradation, Decreased Intravascular Volume, Decreased Mineralocorticoid Secretion, Decreased Renal K+ Excretion, Increased Renal Na+ Excretion, Renal Arterial Vasodilation.

What are the brand names for Benazepril?

Benazepril is marketed under brand names including Cardalis, Lotensin, Lotensin HCT, Lotrel.

What are the contraindications for Benazepril?

Benazepril labeling lists contraindications including: Benazepril hydrochloride tablets are contraindicated in patients: • who are hypersensitive to benazepril or to any other ACE inhibitor • with a history of angioedema with or without previous ACE inhibitor treatment Benazepril hydrochloride tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril hydrochloride tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.2)].. Always consult the full prescribing information and a clinician.