🇺🇸 Homotaurine in United States

9 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: 9

Most-reported reactions

1. Gingival Disorder — 3 reports (33.33%)
2. Tooth Loss — 3 reports (33.33%)
3. Mental Impairment — 1 report (11.11%)
4. Off Label Use — 1 report (11.11%)
5. Product Use In Unapproved Indication — 1 report (11.11%)

Source database →

Frequently asked questions

Is Homotaurine approved in United States?

Yes. FDA has authorised it.

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

Aristotle University Of Thessaloniki is the originator. The local marketing authorisation holder may differ — check the official source linked above.