🇺🇸 Sedation in United States

25 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: 27 March 2025 – 27 March 2026
• Total reports: 25

Most-reported reactions

1. Vomiting — 5 reports (20%)
2. International Normalised Ratio Increased — 3 reports (12%)
3. Respiratory Failure — 3 reports (12%)
4. Blood Bilirubin Increased — 2 reports (8%)
5. Brain Oedema — 2 reports (8%)
6. Coagulopathy — 2 reports (8%)
7. Deep Vein Thrombosis — 2 reports (8%)
8. Diarrhoea — 2 reports (8%)
9. Disorientation — 2 reports (8%)
10. Drug Ineffective For Unapproved Indication — 2 reports (8%)

Source database →

Frequently asked questions

Is Sedation approved in United States?

Yes. FDA has authorised it.

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

Van Training and Research Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.