🇺🇸 Risperidone microspheres in United States

FDA authorised Risperidone microspheres on 29 October 2003 · 11 US adverse-event reports

Marketing authorisations

FDA — authorised 29 October 2003

  • Application: NDA021346
  • Marketing authorisation holder: JANSSEN PHARMS
  • Local brand name: RISPERDAL CONSTA
  • Indication: POWDER — INTRAMUSCULAR
  • Status: approved

Read official source →

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. Dizziness — 2 reports (18.18%)
  2. Chest Pain — 1 report (9.09%)
  3. Conjunctival Haemorrhage — 1 report (9.09%)
  4. Convulsion — 1 report (9.09%)
  5. Drooling — 1 report (9.09%)
  6. Dysphagia — 1 report (9.09%)
  7. Eczema — 1 report (9.09%)
  8. Epistaxis — 1 report (9.09%)
  9. Eyelid Oedema — 1 report (9.09%)
  10. Face Oedema — 1 report (9.09%)

Source database →

Risperidone microspheres in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Risperidone microspheres approved in United States?

Yes. FDA authorised it on 29 October 2003; FDA has authorised it.

Who is the marketing authorisation holder for Risperidone microspheres in United States?

JANSSEN PHARMS holds the US marketing authorisation.