🇺🇸 Seroquel in United States

FDA authorised Seroquel on 26 September 1997 · 49,147 US adverse-event reports

Marketing authorisations

FDA — authorised 26 September 1997

  • Application: NDA020639
  • Marketing authorisation holder: CHEPLAPHARM
  • Status: supplemented

FDA — authorised 17 May 2007

  • Application: NDA022047
  • Marketing authorisation holder: CHEPLAPHARM
  • Status: approved

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. Diabetes Mellitus — 7,799 reports (15.87%)
  2. Insomnia — 6,235 reports (12.69%)
  3. Drug Dose Omission — 5,871 reports (11.95%)
  4. Off Label Use — 4,688 reports (9.54%)
  5. Weight Increased — 4,490 reports (9.14%)
  6. Drug Ineffective — 4,326 reports (8.8%)
  7. Depression — 4,030 reports (8.2%)
  8. Type 2 Diabetes Mellitus — 3,998 reports (8.13%)
  9. Anxiety — 3,994 reports (8.13%)
  10. Somnolence — 3,716 reports (7.56%)

Source database →

Other Neuroscience approved in United States

Frequently asked questions

Is Seroquel approved in United States?

Yes. FDA authorised it on 26 September 1997; FDA authorised it on 17 May 2007; FDA has authorised it.

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

CHEPLAPHARM holds the US marketing authorisation.