🇺🇸 cardiac output changes with "ephedrine" in United States

FDA authorised cardiac output changes with "ephedrine" on 3 October 2020 · 1,533 US adverse-event reports

Marketing authorisations

FDA — authorised 3 October 2020

  • Application: ANDA212649
  • Marketing authorisation holder: DR REDDYS
  • Status: approved

FDA — authorised 14 June 2021

  • Application: ANDA214579
  • Marketing authorisation holder: EUGIA PHARMA
  • Status: supplemented

FDA — authorised 16 May 2023

  • Application: ANDA217276
  • Marketing authorisation holder: ZYDUS PHARMS
  • Status: approved

FDA — authorised 11 October 2024

  • Application: ANDA217721
  • Marketing authorisation holder: HIKMA
  • Status: approved

FDA — authorised 19 March 2026

  • Application: ANDA219991
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Status: approved

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. Hypotension — 323 reports (21.07%)
  2. Toxicity To Various Agents — 183 reports (11.94%)
  3. Drug Ineffective — 162 reports (10.57%)
  4. Bradycardia — 139 reports (9.07%)
  5. Pain — 127 reports (8.28%)
  6. Dyspnoea — 126 reports (8.22%)
  7. Tachycardia — 124 reports (8.09%)
  8. Cardiac Arrest — 118 reports (7.7%)
  9. Nausea — 116 reports (7.57%)
  10. Anaphylactic Shock — 115 reports (7.5%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is cardiac output changes with "ephedrine" approved in United States?

Yes. FDA authorised it on 3 October 2020; FDA authorised it on 14 June 2021; FDA authorised it on 16 May 2023.

Who is the marketing authorisation holder for cardiac output changes with "ephedrine" in United States?

DR REDDYS holds the US marketing authorisation.