🇺🇸 Marinol in United States

FDA authorised Marinol on 31 May 1985 · 2,991 US adverse-event reports

Marketing authorisations

FDA — authorised 31 May 1985

  • Application: NDA018651
  • Marketing authorisation holder: ALKEM LABS LTD
  • Status: supplemented

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 — 515 reports (17.22%)
  2. Fatigue — 372 reports (12.44%)
  3. Vomiting — 364 reports (12.17%)
  4. Diarrhoea — 297 reports (9.93%)
  5. Death — 289 reports (9.66%)
  6. Decreased Appetite — 249 reports (8.32%)
  7. Weight Decreased — 244 reports (8.16%)
  8. Asthenia — 232 reports (7.76%)
  9. Pain — 231 reports (7.72%)
  10. Dyspnoea — 198 reports (6.62%)

Source database →

Marinol 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 Marinol approved in United States?

Yes. FDA authorised it on 31 May 1985; FDA has authorised it.

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

ALKEM LABS LTD holds the US marketing authorisation.