🇺🇸 Paroxetine in United States

26,638 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. Drug Ineffective — 3,338 reports (12.53%)
  2. Nausea — 3,087 reports (11.59%)
  3. Fatigue — 2,991 reports (11.23%)
  4. Anxiety — 2,798 reports (10.5%)
  5. Drug Interaction — 2,665 reports (10%)
  6. Dizziness — 2,516 reports (9.45%)
  7. Headache — 2,507 reports (9.41%)
  8. Diarrhoea — 2,384 reports (8.95%)
  9. Depression — 2,246 reports (8.43%)
  10. Confusional State — 2,106 reports (7.91%)

Source database →

Paroxetine 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 Paroxetine approved in United States?

Yes. FDA has authorised it.

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

Pfizer Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.