🇺🇸 Qudexy XR in United States

FDA authorised Qudexy XR on 11 March 2014 · 190 US adverse-event reports

Marketing authorisation

FDA — authorised 11 March 2014

  • Application: NDA205122
  • Marketing authorisation holder: UPSHER SMITH LABS
  • Local brand name: QUDEXY XR
  • Indication: CAPSULE, EXTENDED RELEASE — ORAL
  • Status: approved

Read official source →

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. Dizziness — 24 reports (12.63%)
  2. Drug Ineffective — 22 reports (11.58%)
  3. Nausea — 22 reports (11.58%)
  4. Feeling Abnormal — 21 reports (11.05%)
  5. Seizure — 19 reports (10%)
  6. Headache — 18 reports (9.47%)
  7. Fatigue — 17 reports (8.95%)
  8. Somnolence — 17 reports (8.95%)
  9. Paraesthesia — 16 reports (8.42%)
  10. Memory Impairment — 14 reports (7.37%)

Source database →

Other Neurology approved in United States

Frequently asked questions

Is Qudexy XR approved in United States?

Yes. FDA authorised it on 11 March 2014.

Who is the marketing authorisation holder for Qudexy XR in United States?

UPSHER SMITH LABS holds the US marketing authorisation.