🇺🇸 Plasma in United States

FDA authorised Plasma on 2 February 1979 · 5,012 US adverse-event reports

Marketing authorisations

FDA — authorised 2 February 1979

  • Application: NDA017378
  • Marketing authorisation holder: BAXTER 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. Renal Failure — 606 reports (12.09%)
  2. Pain — 600 reports (11.97%)
  3. Off Label Use — 591 reports (11.79%)
  4. Injury — 543 reports (10.83%)
  5. Unevaluable Event — 530 reports (10.57%)
  6. Anxiety — 501 reports (10%)
  7. Fear — 454 reports (9.06%)
  8. Death — 406 reports (8.1%)
  9. Renal Impairment — 395 reports (7.88%)
  10. Renal Injury — 386 reports (7.7%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Plasma approved in United States?

Yes. FDA authorised it on 2 February 1979; FDA has authorised it.

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

BAXTER HLTHCARE holds the US marketing authorisation.