🇺🇸 SMOFlipid in United States

402 US adverse-event reports

Marketing authorisation

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. Pyrexia — 55 reports (13.68%)
  2. Off Label Use — 51 reports (12.69%)
  3. Vomiting — 46 reports (11.44%)
  4. Nausea — 45 reports (11.19%)
  5. Malaise — 38 reports (9.45%)
  6. Death — 36 reports (8.96%)
  7. Dyspnoea — 36 reports (8.96%)
  8. Intentional Product Use Issue — 34 reports (8.46%)
  9. Hypertriglyceridaemia — 31 reports (7.71%)
  10. Chills — 30 reports (7.46%)

Source database →

SMOFlipid 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 SMOFlipid approved in United States?

Yes. FDA has authorised it.

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

Baylor College of Medicine is the originator. The local marketing authorisation holder may differ — check the official source linked above.