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

FDA authorised cardiac output changes with "ondansetron" on 31 January 1995 · 125,338 US adverse-event reports

Marketing authorisations

FDA — authorised 31 January 1995

  • Application: NDA020403
  • Marketing authorisation holder: GLAXOSMITHKLINE
  • Status: supplemented

FDA — authorised 24 January 1997

  • Application: NDA020605
  • Marketing authorisation holder: SANDOZ
  • Status: supplemented

FDA — authorised 25 June 2007

  • Application: ANDA077517
  • Marketing authorisation holder: CHARTWELL RX
  • Status: supplemented

FDA — authorised 15 June 2012

  • Application: ANDA090648
  • Marketing authorisation holder: GLAND PHARMA LTD
  • Status: supplemented

FDA — authorised 31 July 2017

  • Application: ANDA204906
  • Marketing authorisation holder: RISING
  • Status: supplemented

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. Nausea — 23,771 reports (18.97%)
  2. Fatigue — 16,545 reports (13.2%)
  3. Diarrhoea — 15,097 reports (12.05%)
  4. Vomiting — 14,110 reports (11.26%)
  5. Off Label Use — 11,242 reports (8.97%)
  6. Death — 9,606 reports (7.66%)
  7. Dyspnoea — 9,022 reports (7.2%)
  8. Headache — 9,005 reports (7.18%)
  9. Pain — 8,742 reports (6.97%)
  10. Pyrexia — 8,198 reports (6.54%)

Source database →

Frequently asked questions

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

Yes. FDA authorised it on 31 January 1995; FDA authorised it on 24 January 1997; FDA authorised it on 25 June 2007.

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

GLAXOSMITHKLINE holds the US marketing authorisation.