🇺🇸 ETHIODIZED OIL in United States

FDA authorised ETHIODIZED OIL on 10 June 2020 · 284 US adverse-event reports

Marketing authorisation

FDA — authorised 10 June 2020

  • Application: NDA009190
  • Marketing authorisation holder: GUERBET
  • Indication: Labeling
  • 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. Off Label Use — 136 reports (47.89%)
  2. Pancytopenia — 25 reports (8.8%)
  3. Liver Abscess — 24 reports (8.45%)
  4. Disease Progression — 21 reports (7.39%)
  5. Drug Ineffective — 15 reports (5.28%)
  6. Metastases To Central Nervous System — 14 reports (4.93%)
  7. Metastases To Liver — 13 reports (4.58%)
  8. Skin Injury — 13 reports (4.58%)
  9. Pancreatic Carcinoma Metastatic — 12 reports (4.23%)
  10. Cholecystitis Acute — 11 reports (3.87%)

Source database →

ETHIODIZED 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 ETHIODIZED OIL approved in United States?

Yes. FDA authorised it on 10 June 2020.

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

GUERBET holds the US marketing authorisation.