🇺🇸 Paxil-CR in United States

FDA authorised Paxil-CR on 16 February 1999 · 4,697 US adverse-event reports

Marketing authorisation

FDA — authorised 16 February 1999

  • Application: NDA020936
  • Marketing authorisation holder: APOTEX
  • Status: supplemented

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 — 782 reports (16.65%)
  2. Dizziness — 588 reports (12.52%)
  3. Nausea — 507 reports (10.79%)
  4. Drug Withdrawal Syndrome — 496 reports (10.56%)
  5. Anxiety — 493 reports (10.5%)
  6. Drug Exposure During Pregnancy — 436 reports (9.28%)
  7. Headache — 393 reports (8.37%)
  8. Insomnia — 362 reports (7.71%)
  9. Depression — 330 reports (7.03%)
  10. Weight Increased — 310 reports (6.6%)

Source database →

Other Psychiatry / Neurology approved in United States

Frequently asked questions

Is Paxil-CR approved in United States?

Yes. FDA authorised it on 16 February 1999.

Who is the marketing authorisation holder for Paxil-CR in United States?

APOTEX holds the US marketing authorisation.