🇺🇸 Fazaclo in United States

384 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. Death — 119 reports (30.99%)
  2. Agranulocytosis — 47 reports (12.24%)
  3. Pneumonia — 45 reports (11.72%)
  4. Hospitalisation — 37 reports (9.64%)
  5. Cardiac Arrest — 29 reports (7.55%)
  6. Myocardial Infarction — 29 reports (7.55%)
  7. Chronic Obstructive Pulmonary Disease — 20 reports (5.21%)
  8. Neutropenia — 20 reports (5.21%)
  9. Completed Suicide — 19 reports (4.95%)
  10. Convulsion — 19 reports (4.95%)

Source database →

Other Neuroscience approved in United States

Frequently asked questions

Is Fazaclo approved in United States?

Yes. FDA has authorised it.

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

Manhattan Psychiatric Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.