🇺🇸 Adhansia XR in United States

FDA authorised Adhansia XR on 27 February 2019 · 51 US adverse-event reports

Marketing authorisation

FDA — authorised 27 February 2019

  • Application: NDA212038
  • Marketing authorisation holder: PURDUE PHARMA LP
  • Local brand name: ADHANSIA 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. Drug Ineffective — 14 reports (27.45%)
  2. Anger — 6 reports (11.76%)
  3. Headache — 6 reports (11.76%)
  4. Insomnia — 6 reports (11.76%)
  5. Unevaluable Event — 5 reports (9.8%)
  6. Abdominal Pain Upper — 3 reports (5.88%)
  7. Aggression — 3 reports (5.88%)
  8. Feeling Abnormal — 3 reports (5.88%)
  9. Off Label Use — 3 reports (5.88%)
  10. Agitation — 2 reports (3.92%)

Source database →

Other Neurology / Psychiatry approved in United States

Frequently asked questions

Is Adhansia XR approved in United States?

Yes. FDA authorised it on 27 February 2019.

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

PURDUE PHARMA LP holds the US marketing authorisation.