🇺🇸 PERFLUTREN in United States

FDA authorised PERFLUTREN on 31 December 1997 · 126 US adverse-event reports

Marketing authorisations

FDA — authorised 31 December 1997

  • Application: NDA020899
  • Marketing authorisation holder: GE HEALTHCARE
  • 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. Back Pain — 36 reports (28.57%)
  2. Dyspnoea — 14 reports (11.11%)
  3. Anaphylactic Reaction — 12 reports (9.52%)
  4. Cardio-Respiratory Arrest — 11 reports (8.73%)
  5. Contrast Media Reaction — 11 reports (8.73%)
  6. Hypotension — 11 reports (8.73%)
  7. Chest Pain — 9 reports (7.14%)
  8. Headache — 8 reports (6.35%)
  9. Acute Kidney Injury — 7 reports (5.56%)
  10. Pain In Extremity — 7 reports (5.56%)

Source database →

PERFLUTREN 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 PERFLUTREN approved in United States?

Yes. FDA authorised it on 31 December 1997; FDA has authorised it.

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

GE HEALTHCARE holds the US marketing authorisation.