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Benazepril

Cibacen · ATC code C09AA07

Key facts
Active substance
Benazepril
Drug class
ACE inhibitor
ATC code
C09AA07
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

When pregnancy is detected, discontinue benazepril hydrochloride as soon as possible.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)].

Key facts

Benazepril is an ACE inhibitor. Per the US prescribing information, it is used to treat hypertension in adults and in children aged 6 years and older.

What it is used for

  • Hypertension, to lower blood pressure and thereby reduce the risk of cardiovascular events, primarily strokes and myocardial infarctions; alone or with other antihypertensives

Dosing

  • Adults not on a diuretic: initially 10 mg once a day; usual maintenance 20 mg to 40 mg per day as a single dose or in two equally divided doses; experience with 80 mg is limited
  • Adults on a diuretic: starting dose 5 mg once daily
  • Children 6 years and older: 0.2 mg/kg once per day, titrated as needed to 0.6 mg/kg once per day; not recommended under 6 years or with GFR less than 30 mL/min/1.73 m²
  • Adults with GFR < 30 mL/min/1.73 m²: initially 5 mg once daily, up to a maximum of 40 mg per day
  • An oral suspension can be prepared from the tablets – see the full text

Contraindications

  • Hypersensitivity to benazepril or any other ACE inhibitor
  • History of angioedema, with or without previous ACE inhibitor treatment
  • Combination with a neprilysin inhibitor (e.g. sacubitril); not within 36 hours of switching to or from sacubitril/valsartan
  • Co-administration with aliskiren in patients with diabetes

Important warnings

  • Boxed warning – fetal toxicity: drugs acting on the renin-angiotensin system can injure and kill the developing fetus; discontinue as soon as pregnancy is detected
  • Angioedema of the face, lips, tongue, glottis and/or larynx, including fatal cases; stop promptly and treat
  • Hypotension, especially in patients on diuretics
  • Worsening of renal function
  • Hyperkalemia

Side effects

  • More frequent than with placebo: headache (6% versus 4%), dizziness (4% versus 2%), somnolence and postural dizziness
  • Cough was a common reason for discontinuation
  • Serious: angioedema, hypotension, renal impairment

Interactions

  • Diuretics: excessive drop in blood pressure at the start of treatment
  • Potassium-sparing diuretics (spironolactone, amiloride, triamterene) and potassium supplements: risk of hyperkalemia; monitor serum potassium
  • Aliskiren, ARBs or other ACE inhibitors (dual RAS blockade); neprilysin inhibitors
  • Antidiabetics: see the full text

Pregnancy and breastfeeding

  • Can cause fetal harm, particularly in the second and third trimesters; discontinue as soon as pregnancy is detected

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Germany

  • Benazepril1 A Pharma Gmbh, Aliud Pharma Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • CibacenVİATRİS İLAÇLARI LİMİTED ŞİRKETİ · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • LotensinValidus Pharmaceuticals LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 4 more European countries
France
Benazepril Arrow, Benazepril Eg
Greece
Cibacen
Italy
Benazepril Eg, Benazepril Sandoz, Zinadril
Netherlands
Cibacen

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Benazepril Hydrochloride (Amneal Pharmaceuticals of New York LLC) – Prescribing Information, 2026-08-03. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  5. Wikidata (CC0): ATC C09AA.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.