🇺🇸 Intralipid in United States

FDA authorised Intralipid on 7 October 1975 · 546 US adverse-event reports

Marketing authorisations

FDA — authorised 7 October 1975

  • Application: NDA017643
  • Marketing authorisation holder: FRESENIUS
  • Status: supplemented

FDA — authorised 23 January 1981

  • Application: NDA018449
  • Marketing authorisation holder: FRESENIUS
  • Status: supplemented

FDA — authorised 30 December 1993

  • Application: NDA019942
  • Marketing authorisation holder: FRESENIUS
  • Status: supplemented

FDA — authorised 7 August 1996

  • Application: NDA020248
  • Marketing authorisation holder: FRESENIUS
  • 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. Chills — 80 reports (14.65%)
  2. Pyrexia — 74 reports (13.55%)
  3. Nausea — 64 reports (11.72%)
  4. Dyspnoea — 58 reports (10.62%)
  5. Vomiting — 57 reports (10.44%)
  6. Parenteral Nutrition Associated Liver Disease — 56 reports (10.26%)
  7. Diarrhoea — 44 reports (8.06%)
  8. Chest Discomfort — 43 reports (7.88%)
  9. Off Label Use — 36 reports (6.59%)
  10. Drug Ineffective — 34 reports (6.23%)

Source database →

Intralipid in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Intralipid approved in United States?

Yes. FDA authorised it on 7 October 1975; FDA authorised it on 23 January 1981; FDA authorised it on 30 December 1993.

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

FRESENIUS holds the US marketing authorisation.