🇺🇸 Quillivant XR in United States

FDA authorised Quillivant XR on 27 September 2012 · 1,533 US adverse-event reports

Marketing authorisation

FDA — authorised 27 September 2012

  • Application: NDA202100
  • Marketing authorisation holder: NEXTWAVE
  • Local brand name: QUILLIVANT XR
  • Indication: FOR SUSPENSION, 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. Drug Ineffective — 503 reports (32.81%)
  2. Abnormal Behaviour — 165 reports (10.76%)
  3. Off Label Use — 163 reports (10.63%)
  4. Decreased Appetite — 148 reports (9.65%)
  5. Drug Effect Incomplete — 118 reports (7.7%)
  6. Aggression — 102 reports (6.65%)
  7. Product Use Issue — 93 reports (6.07%)
  8. Feeling Abnormal — 83 reports (5.41%)
  9. Disturbance In Attention — 80 reports (5.22%)
  10. Psychomotor Hyperactivity — 78 reports (5.09%)

Source database →

Other Psychiatry / Neurology approved in United States

Frequently asked questions

Is Quillivant XR approved in United States?

Yes. FDA authorised it on 27 September 2012.

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

NEXTWAVE holds the US marketing authorisation.