🇺🇸 Extraneal in United States

FDA authorised Extraneal on 20 December 2002 · 16,698 US adverse-event reports

Marketing authorisations

FDA — authorised 20 December 2002

  • Application: NDA021321
  • Marketing authorisation holder: VANTIVE US HLTHCARE
  • 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. Death — 6,318 reports (37.84%)
  2. Peritonitis — 1,896 reports (11.35%)
  3. Peritonitis Bacterial — 1,489 reports (8.92%)
  4. Peritoneal Dialysis Complication — 1,478 reports (8.85%)
  5. Hypotension — 1,178 reports (7.05%)
  6. Pneumonia — 1,008 reports (6.04%)
  7. Myocardial Infarction — 993 reports (5.95%)
  8. Infection — 810 reports (4.85%)
  9. Sepsis — 791 reports (4.74%)
  10. Fluid Overload — 737 reports (4.41%)

Source database →

Extraneal in other countries

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

Other Other approved in United States

Frequently asked questions

Is Extraneal approved in United States?

Yes. FDA authorised it on 20 December 2002; FDA has authorised it.

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

VANTIVE US HLTHCARE holds the US marketing authorisation.