🇺🇸 Volulyte in United States

11 US adverse-event reports

Marketing authorisation

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.

• Window: 28 March 2025 – 28 March 2026
• Total reports: 11

Most-reported reactions

1. Diarrhoea — 2 reports (18.18%)
2. Abdominal Pain Upper — 1 report (9.09%)
3. Acute Myocardial Infarction — 1 report (9.09%)
4. Anal Haemorrhage — 1 report (9.09%)
5. Cerebrospinal Fluid Leakage — 1 report (9.09%)
6. Clostridium Difficile Infection — 1 report (9.09%)
7. Compression Fracture — 1 report (9.09%)
8. Decreased Appetite — 1 report (9.09%)
9. Diabetes Mellitus — 1 report (9.09%)
10. Fall — 1 report (9.09%)

Source database →

Frequently asked questions

Is Volulyte approved in United States?

Yes. FDA has authorised it.

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

Brugmann University Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.