🇺🇸 AmBisome in United States

FDA authorised AmBisome on 11 August 1997 · 3,742 US adverse-event reports

Marketing authorisations

FDA — authorised 11 August 1997

  • Application: NDA050740
  • Marketing authorisation holder: ASTELLAS
  • 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. Drug Ineffective — 1,101 reports (29.42%)
  2. Off Label Use — 689 reports (18.41%)
  3. Pyrexia — 309 reports (8.26%)
  4. Hypokalaemia — 292 reports (7.8%)
  5. Febrile Neutropenia — 245 reports (6.55%)
  6. Renal Impairment — 243 reports (6.49%)
  7. Acute Kidney Injury — 236 reports (6.31%)
  8. Death — 218 reports (5.83%)
  9. Pneumonia — 215 reports (5.75%)
  10. Sepsis — 194 reports (5.18%)

Source database →

AmBisome 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 AmBisome approved in United States?

Yes. FDA authorised it on 11 August 1997; FDA has authorised it.

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

ASTELLAS holds the US marketing authorisation.