🇺🇸 Rexulti in United States

FDA authorised Rexulti on 10 July 2015 · 7,776 US adverse-event reports

Marketing authorisations

FDA — authorised 10 July 2015

  • Application: NDA205422
  • Marketing authorisation holder: OTSUKA
  • Status: approved

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. Weight Increased — 1,599 reports (20.56%)
  2. Product Use In Unapproved Indication — 1,123 reports (14.44%)
  3. Off Label Use — 967 reports (12.44%)
  4. Akathisia — 788 reports (10.13%)
  5. Drug Ineffective — 701 reports (9.01%)
  6. Tremor — 593 reports (7.63%)
  7. Tardive Dyskinesia — 549 reports (7.06%)
  8. Anxiety — 523 reports (6.73%)
  9. Depression — 473 reports (6.08%)
  10. Product Use Issue — 460 reports (5.92%)

Source database →

Rexulti 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 Rexulti approved in United States?

Yes. FDA authorised it on 10 July 2015; FDA has authorised it.

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

OTSUKA holds the US marketing authorisation.