🇺🇸 Antidepressant in United States

713 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 — 133 reports (18.65%)
  2. Depression — 103 reports (14.45%)
  3. Drug Ineffective — 85 reports (11.92%)
  4. Toxicity To Various Agents — 66 reports (9.26%)
  5. Fatigue — 65 reports (9.12%)
  6. Nausea — 56 reports (7.85%)
  7. Insomnia — 55 reports (7.71%)
  8. Somnolence — 53 reports (7.43%)
  9. Headache — 51 reports (7.15%)
  10. Anxiety — 46 reports (6.45%)

Source database →

Antidepressant in other countries

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

Other Neuroscience approved in United States

Frequently asked questions

Is Antidepressant approved in United States?

Yes. FDA has authorised it.

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

Janssen Research & Development, LLC is the originator. The local marketing authorisation holder may differ — check the official source linked above.