🇺🇸 Amlodipine Besylate / Benazepril Hydrochloride in United States

417 US adverse-event reports

Marketing authorisation

FDA

  • Application: ANDA078652
  • Marketing authorisation holder: ZYDUS PHARMS USA INC
  • Local brand name: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Fatigue — 62 reports (14.87%)
  2. Drug Ineffective — 53 reports (12.71%)
  3. Nausea — 46 reports (11.03%)
  4. Diarrhoea — 40 reports (9.59%)
  5. Off Label Use — 40 reports (9.59%)
  6. Pain — 40 reports (9.59%)
  7. Dizziness — 37 reports (8.87%)
  8. Product Dose Omission Issue — 36 reports (8.63%)
  9. Pruritus — 32 reports (7.67%)
  10. Dyspnoea — 31 reports (7.43%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is Amlodipine Besylate / Benazepril Hydrochloride approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Amlodipine Besylate / Benazepril Hydrochloride in United States?

ZYDUS PHARMS USA INC holds the US marketing authorisation.