🇺🇸 Safinamide Mesilate 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.

Most-reported reactions

  1. Agitation — 3 reports (33.33%)
  2. Confusional State — 3 reports (33.33%)
  3. Labelled Drug-Drug Interaction Medication Error — 2 reports (22.22%)
  4. Drug Interaction — 1 report (11.11%)

Source database →

Safinamide Mesilate in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Safinamide Mesilate approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Safinamide Mesilate in United States?

Eisai Korea Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.