🇺🇸 Xcopri in United States

FDA authorised Xcopri on 21 November 2019 · 6,394 US adverse-event reports

Marketing authorisations

FDA — authorised 21 November 2019

  • Application: NDA212839
  • Marketing authorisation holder: SK LIFE
  • Local brand name: XCOPRI
  • 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. Seizure — 1,705 reports (26.67%)
  2. Product Dose Omission Issue — 1,260 reports (19.71%)
  3. Fatigue — 621 reports (9.71%)
  4. Somnolence — 601 reports (9.4%)
  5. Dizziness — 496 reports (7.76%)
  6. Off Label Use — 407 reports (6.37%)
  7. Product Use Issue — 381 reports (5.96%)
  8. Fall — 345 reports (5.4%)
  9. Headache — 307 reports (4.8%)
  10. Wrong Technique In Product Usage Process — 271 reports (4.24%)

Source database →

Xcopri 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 Xcopri approved in United States?

Yes. FDA authorised it on 21 November 2019; FDA has authorised it.

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

SK LIFE holds the US marketing authorisation.