🇺🇸 antipsychotics in United States

322 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. Completed Suicide — 38 reports (11.8%)
  2. Overdose — 38 reports (11.8%)
  3. Somnolence — 38 reports (11.8%)
  4. Agitation — 36 reports (11.18%)
  5. Coma — 31 reports (9.63%)
  6. Multiple Drug Overdose — 31 reports (9.63%)
  7. Psychotic Disorder — 29 reports (9.01%)
  8. Confusional State — 27 reports (8.39%)
  9. Suicide Attempt — 27 reports (8.39%)
  10. Tachycardia — 27 reports (8.39%)

Source database →

Other Neuroscience approved in United States

Frequently asked questions

Is antipsychotics approved in United States?

Yes. FDA has authorised it.

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

Janssen-Cilag, S.A. is the originator. The local marketing authorisation holder may differ — check the official source linked above.