🇺🇸 PROPOFOL in United States

FDA authorised PROPOFOL on 19 April 2005 · 17,243 US adverse-event reports

Marketing authorisations

FDA — authorised 19 April 2005

  • Application: ANDA074848
  • Marketing authorisation holder: HIKMA
  • Status: approved

FDA — authorised 17 March 2006

  • Application: ANDA077908
  • Marketing authorisation holder: HOSPIRA
  • Status: approved

FDA — authorised 15 November 2018

  • Application: ANDA205067
  • Marketing authorisation holder: DR REDDYS
  • Status: supplemented

FDA — authorised 16 September 2020

  • Application: ANDA205576
  • Marketing authorisation holder: INNOPHARMA
  • Status: approved

FDA — authorised 12 October 2021

  • Application: ANDA206408
  • Marketing authorisation holder: AVET LIFESCIENCES
  • Status: supplemented

FDA

  • 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 — 2,754 reports (15.97%)
  2. Drug Ineffective — 2,572 reports (14.92%)
  3. Anaphylactic Shock — 2,031 reports (11.78%)
  4. Anaphylactic Reaction — 1,801 reports (10.44%)
  5. Cardiac Arrest — 1,736 reports (10.07%)
  6. Off Label Use — 1,592 reports (9.23%)
  7. Drug Interaction — 1,539 reports (8.93%)
  8. Bradycardia — 1,125 reports (6.52%)
  9. Tachycardia — 1,121 reports (6.5%)
  10. Pyrexia — 972 reports (5.64%)

Source database →

PROPOFOL in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is PROPOFOL approved in United States?

Yes. FDA authorised it on 19 April 2005; FDA authorised it on 17 March 2006; FDA authorised it on 15 November 2018.

Who is the marketing authorisation holder for PROPOFOL in United States?

HIKMA holds the US marketing authorisation.