FDA
- Status: approved
🇺🇸 Plasmalyte in United States
480 US adverse-event reports
Marketing authorisation
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.
- Window: 28 March 2025 – 28 March 2026
- Total reports: 480
Most-reported reactions
- Pain — 61 reports (12.71%)
- Renal Failure — 59 reports (12.29%)
- Anxiety — 57 reports (11.88%)
- Fear — 49 reports (10.21%)
- Injury — 49 reports (10.21%)
- Unevaluable Event — 48 reports (10%)
- Emotional Distress — 41 reports (8.54%)
- Renal Injury — 41 reports (8.54%)
- Anhedonia — 39 reports (8.12%)
- Renal Impairment — 36 reports (7.5%)
Other Other approved in United States
Frequently asked questions
Is Plasmalyte approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Plasmalyte in United States?
Post Graduate Institute of Medical Education and Research, Chandigarh is the originator. The local marketing authorisation holder may differ — check the official source linked above.