🇺🇸 Mouthrinse in United States

40 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: 40

Most-reported reactions

1. Fatigue — 6 reports (15%)
2. Death — 5 reports (12.5%)
3. Nausea — 5 reports (12.5%)
4. Headache — 4 reports (10%)
5. Pain — 4 reports (10%)
6. Peripheral Swelling — 4 reports (10%)
7. Chest Pain — 3 reports (7.5%)
8. Dizziness — 3 reports (7.5%)
9. Dyspnoea — 3 reports (7.5%)
10. Off Label Use — 3 reports (7.5%)

Source database →

Frequently asked questions

Is Mouthrinse approved in United States?

Yes. FDA has authorised it.

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

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