🇺🇸 PAROXETINE in United States

FDA authorised PAROXETINE on 31 October 2014 · 26,638 US adverse-event reports

Marketing authorisations

FDA — authorised 31 October 2014

  • Application: ANDA203854
  • Marketing authorisation holder: PRINSTON INC
  • Local brand name: PAROXETINE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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.

Frequently asked questions

Is PAROXETINE approved in United States?

Yes. FDA authorised it on 31 October 2014; FDA has authorised it.

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

PRINSTON INC holds the US marketing authorisation.