🇺🇸 Nulojix in United States

FDA authorised Nulojix on 15 June 2011 · 854 US adverse-event reports

Marketing authorisations

FDA — authorised 15 June 2011

  • Application: BLA125288
  • Marketing authorisation holder: BRISTOL MYERS SQUIBB
  • Status: approved

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. Product Storage Error — 164 reports (19.2%)
  2. Hospitalisation — 119 reports (13.93%)
  3. Death — 112 reports (13.11%)
  4. Off Label Use — 101 reports (11.83%)
  5. Product Preparation Error — 81 reports (9.48%)
  6. Kidney Transplant Rejection — 70 reports (8.2%)
  7. Transplant Rejection — 56 reports (6.56%)
  8. Product Preparation Issue — 55 reports (6.44%)
  9. Adverse Event — 51 reports (5.97%)
  10. Intentional Product Use Issue — 45 reports (5.27%)

Source database →

Other Nephrology approved in United States

Frequently asked questions

Is Nulojix approved in United States?

Yes. FDA authorised it on 15 June 2011; FDA has authorised it.

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

BRISTOL MYERS SQUIBB holds the US marketing authorisation.