🇺🇸 SSRIs in United States

12 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. Cardiac Arrest — 2 reports (16.67%)
  2. Tremor — 2 reports (16.67%)
  3. Activation Syndrome — 1 report (8.33%)
  4. Anger — 1 report (8.33%)
  5. Aortic Thrombosis — 1 report (8.33%)
  6. Apathy — 1 report (8.33%)
  7. Aphasia — 1 report (8.33%)
  8. Asthenia — 1 report (8.33%)
  9. Autoimmune Haemolytic Anaemia — 1 report (8.33%)
  10. Blood Pressure Increased — 1 report (8.33%)

Source database →

SSRIs 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 SSRIs approved in United States?

Yes. FDA has authorised it.

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

The Third Affiliated hospital of Zhejiang Chinese Medical University is the originator. The local marketing authorisation holder may differ — check the official source linked above.