🇺🇸 Risperdal Consta in United States

FDA authorised Risperdal Consta on 29 October 2003 · 8,677 US adverse-event reports

Marketing authorisation

FDA — authorised 29 October 2003

  • Application: NDA021346
  • Marketing authorisation holder: JANSSEN PHARMS
  • 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. Drug Dose Omission — 1,622 reports (18.69%)
  2. Gynaecomastia — 1,420 reports (16.37%)
  3. Device Leakage — 904 reports (10.42%)
  4. Device Malfunction — 878 reports (10.12%)
  5. Drug Ineffective — 697 reports (8.03%)
  6. Off Label Use — 663 reports (7.64%)
  7. Weight Increased — 657 reports (7.57%)
  8. Accidental Exposure To Product — 644 reports (7.42%)
  9. Hospitalisation — 605 reports (6.97%)
  10. Product Dose Omission Issue — 587 reports (6.77%)

Source database →

Other Psychiatry approved in United States

Frequently asked questions

Is Risperdal Consta approved in United States?

Yes. FDA authorised it on 29 October 2003.

Who is the marketing authorisation holder for Risperdal Consta in United States?

JANSSEN PHARMS holds the US marketing authorisation.