🇺🇸 Revlimid in United States

FDA authorised Revlimid on 27 December 2005 · 163,730 US adverse-event reports

Marketing authorisations

FDA — authorised 27 December 2005

  • Application: NDA021880
  • Marketing authorisation holder: BRISTOL MYERS SQUIBB
  • 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. Diarrhoea — 27,458 reports (16.77%)
  2. Fatigue — 23,671 reports (14.46%)
  3. Death — 23,484 reports (14.34%)
  4. Pneumonia — 15,984 reports (9.76%)
  5. Rash — 15,935 reports (9.73%)
  6. Plasma Cell Myeloma — 13,896 reports (8.49%)
  7. Off Label Use — 12,381 reports (7.56%)
  8. White Blood Cell Count Decreased — 10,751 reports (6.57%)
  9. Neuropathy Peripheral — 10,418 reports (6.36%)
  10. Constipation — 9,752 reports (5.96%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Revlimid approved in United States?

Yes. FDA authorised it on 27 December 2005; FDA has authorised it.

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

BRISTOL MYERS SQUIBB holds the US marketing authorisation.