🇺🇸 Ethyol in United States

FDA authorised Ethyol on 8 December 1995 · 804 US adverse-event reports

Marketing authorisations

FDA — authorised 8 December 1995

  • Application: NDA020221
  • Marketing authorisation holder: COSETTE
  • 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. Pyrexia — 144 reports (17.91%)
  2. Nausea — 117 reports (14.55%)
  3. Hypotension — 99 reports (12.31%)
  4. Vomiting — 95 reports (11.82%)
  5. Chills — 68 reports (8.46%)
  6. Dehydration — 66 reports (8.21%)
  7. Mucosal Inflammation — 62 reports (7.71%)
  8. Rash — 58 reports (7.21%)
  9. Rash Generalised — 49 reports (6.09%)
  10. Pruritus — 46 reports (5.72%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Ethyol approved in United States?

Yes. FDA authorised it on 8 December 1995; FDA has authorised it.

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

COSETTE holds the US marketing authorisation.