🇺🇸 Circadin in United States

426 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. Fall — 49 reports (11.5%)
  2. Agitation — 47 reports (11.03%)
  3. Fatigue — 46 reports (10.8%)
  4. Intentional Overdose — 46 reports (10.8%)
  5. Dizziness — 44 reports (10.33%)
  6. Somnolence — 43 reports (10.09%)
  7. Anxiety — 41 reports (9.62%)
  8. Drug Ineffective — 38 reports (8.92%)
  9. Nausea — 37 reports (8.69%)
  10. Intentional Self-Injury — 35 reports (8.22%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Circadin approved in United States?

Yes. FDA has authorised it.

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

Neurim Pharmaceuticals Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.