🇺🇸 Abilify Maintena in United States

FDA authorised Abilify Maintena on 28 February 2013 · 6,078 US adverse-event reports

Marketing authorisation

FDA — authorised 28 February 2013

  • Application: NDA202971
  • Marketing authorisation holder: OTSUKA PHARM CO LTD
  • Status: supplemented

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. Product Use In Unapproved Indication — 966 reports (15.89%)
  2. Off Label Use — 853 reports (14.03%)
  3. Drug Ineffective — 834 reports (13.72%)
  4. Weight Increased — 633 reports (10.41%)
  5. No Adverse Event — 532 reports (8.75%)
  6. Psychotic Disorder — 488 reports (8.03%)
  7. Anxiety — 484 reports (7.96%)
  8. Schizophrenia — 475 reports (7.82%)
  9. Treatment Noncompliance — 416 reports (6.84%)
  10. Underdose — 397 reports (6.53%)

Source database →

Other Psychiatry approved in United States

Frequently asked questions

Is Abilify Maintena approved in United States?

Yes. FDA authorised it on 28 February 2013.

Who is the marketing authorisation holder for Abilify Maintena in United States?

OTSUKA PHARM CO LTD holds the US marketing authorisation.