🇺🇸 Plasma-Lyte A in United States

FDA authorised Plasma-Lyte A on 2 February 1979 · 60 US adverse-event reports

Marketing authorisation

FDA — authorised 2 February 1979

  • Application: NDA017378
  • Marketing authorisation holder: BAXTER HLTHCARE
  • Status: supplemented

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. Acute Kidney Injury — 9 reports (15%)
  2. Drug Ineffective — 6 reports (10%)
  3. Emotional Distress — 6 reports (10%)
  4. Pain — 6 reports (10%)
  5. Pyrexia — 6 reports (10%)
  6. Renal Failure — 6 reports (10%)
  7. Respiratory Failure — 6 reports (10%)
  8. Anxiety — 5 reports (8.33%)
  9. Arrhythmia — 5 reports (8.33%)
  10. Injury — 5 reports (8.33%)

Source database →

Other Critical Care / Fluid Management approved in United States

Frequently asked questions

Is Plasma-Lyte A approved in United States?

Yes. FDA authorised it on 2 February 1979.

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

BAXTER HLTHCARE holds the US marketing authorisation.