🇺🇸 Intrathecal morphine in United States

FDA authorised Intrathecal morphine on 3 July 1996 · 16 US adverse-event reports

Marketing authorisations

FDA — authorised 3 July 1996

  • Application: NDA020616
  • Marketing authorisation holder: ALLERGAN
  • Local brand name: KADIAN
  • Indication: CAPSULE, EXTENDED RELEASE — ORAL
  • 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. Death — 3 reports (18.75%)
  2. Pain — 3 reports (18.75%)
  3. Cough — 2 reports (12.5%)
  4. Pneumonia — 2 reports (12.5%)
  5. Cold Sweat — 1 report (6.25%)
  6. Confusional State — 1 report (6.25%)
  7. Device Breakage — 1 report (6.25%)
  8. Device Leakage — 1 report (6.25%)
  9. Diarrhoea — 1 report (6.25%)
  10. Discomfort — 1 report (6.25%)

Source database →

Intrathecal morphine 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 Intrathecal morphine approved in United States?

Yes. FDA authorised it on 3 July 1996; FDA has authorised it.

Who is the marketing authorisation holder for Intrathecal morphine in United States?

ALLERGAN holds the US marketing authorisation.