🇺🇸 Oxycodone-Naloxone in United States

103 US adverse-event reports

Marketing authorisation

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. Nausea — 14 reports (13.59%)
  2. Neutropenia — 13 reports (12.62%)
  3. Off Label Use — 13 reports (12.62%)
  4. Pain — 11 reports (10.68%)
  5. Drug Interaction — 10 reports (9.71%)
  6. Somnolence — 10 reports (9.71%)
  7. Vomiting — 10 reports (9.71%)
  8. Anaemia — 8 reports (7.77%)
  9. Asthenia — 7 reports (6.8%)
  10. Constipation — 7 reports (6.8%)

Source database →

Oxycodone-Naloxone 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 Oxycodone-Naloxone approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Oxycodone-Naloxone in United States?

Mario Negri Institute for Pharmacological Research is the originator. The local marketing authorisation holder may differ — check the official source linked above.