🇺🇸 Naltrexon in United States

113 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. Beta Haemolytic Streptococcal Infection — 17 reports (15.04%)
  2. Loss Of Consciousness — 17 reports (15.04%)
  3. Necrosis Ischaemic — 17 reports (15.04%)
  4. Pneumonia Streptococcal — 17 reports (15.04%)
  5. Septic Shock — 17 reports (15.04%)
  6. Drug Interaction — 9 reports (7.96%)
  7. Constipation — 5 reports (4.42%)
  8. Fatigue — 5 reports (4.42%)
  9. Suicide Attempt — 5 reports (4.42%)
  10. Depressed Mood — 4 reports (3.54%)

Source database →

Naltrexon in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Naltrexon approved in United States?

Yes. FDA has authorised it.

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

Institute of Liver and Biliary Sciences, India is the originator. The local marketing authorisation holder may differ — check the official source linked above.