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

FDA authorised cardiac output changes with "phenylephrine" on 21 January 1952 · 182,457 US adverse-event reports

Marketing authorisations

FDA — authorised 21 January 1952

  • Application: NDA008306
  • Marketing authorisation holder: ANI PHARMS
  • Status: supplemented

FDA — authorised 12 September 1975

  • Application: ANDA084300
  • Marketing authorisation holder: ALCON LABS INC
  • Status: supplemented

FDA — authorised 1 July 2019

  • Application: ANDA210183
  • Marketing authorisation holder: LUPIN LTD
  • Status: approved

FDA — authorised 5 June 2020

  • Application: ANDA211920
  • Marketing authorisation holder: GLAND
  • Status: approved

FDA — authorised 18 December 2024

  • Application: ANDA218129
  • Marketing authorisation holder: GLAND
  • 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. Drug Ineffective — 27,119 reports (14.86%)
  2. Fatigue — 22,932 reports (12.57%)
  3. Headache — 19,478 reports (10.68%)
  4. Pain — 19,376 reports (10.62%)
  5. Nausea — 19,340 reports (10.6%)
  6. Off Label Use — 17,786 reports (9.75%)
  7. Diarrhoea — 15,629 reports (8.57%)
  8. Dyspnoea — 15,475 reports (8.48%)
  9. Arthralgia — 13,557 reports (7.43%)
  10. Dizziness — 11,765 reports (6.45%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

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

Yes. FDA authorised it on 21 January 1952; FDA authorised it on 12 September 1975; FDA authorised it on 1 July 2019.

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

ANI PHARMS holds the US marketing authorisation.