🇺🇸 OLIVE OIL in United States

FDA authorised OLIVE OIL on 3 October 2013 · 393 US adverse-event reports

Marketing authorisation

FDA — authorised 3 October 2013

  • Application: NDA204508
  • Marketing authorisation holder: BAXTER HLTHCARE CORP
  • Local brand name: CLINOLIPID 20%
  • Indication: EMULSION — INTRAVENOUS
  • Status: approved

Read official source →

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. Fatigue — 57 reports (14.5%)
  2. Nausea — 56 reports (14.25%)
  3. Vomiting — 54 reports (13.74%)
  4. Back Pain — 34 reports (8.65%)
  5. Pleural Effusion — 33 reports (8.4%)
  6. Sepsis — 33 reports (8.4%)
  7. C-Reactive Protein Increased — 32 reports (8.14%)
  8. Diarrhoea — 32 reports (8.14%)
  9. Brain Oedema — 31 reports (7.89%)
  10. Vascular Device Infection — 31 reports (7.89%)

Source database →

OLIVE OIL 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 OLIVE OIL approved in United States?

Yes. FDA authorised it on 3 October 2013.

Who is the marketing authorisation holder for OLIVE OIL in United States?

BAXTER HLTHCARE CORP holds the US marketing authorisation.