🇺🇸 Orencia in United States

FDA authorised Orencia on 23 December 2005 · 178,423 US adverse-event reports

Marketing authorisations

FDA — authorised 23 December 2005

  • Application: BLA125118
  • 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. Drug Ineffective — 36,532 reports (20.47%)
  2. Rheumatoid Arthritis — 22,245 reports (12.47%)
  3. Pain — 19,689 reports (11.04%)
  4. Joint Swelling — 19,022 reports (10.66%)
  5. Arthralgia — 18,518 reports (10.38%)
  6. Contraindicated Product Administered — 13,384 reports (7.5%)
  7. Fatigue — 13,154 reports (7.37%)
  8. Drug Intolerance — 12,696 reports (7.12%)
  9. Rash — 12,368 reports (6.93%)
  10. Off Label Use — 10,815 reports (6.06%)

Source database →

Orencia in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Orencia approved in United States?

Yes. FDA authorised it on 23 December 2005; FDA has authorised it.

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

BRISTOL MYERS SQUIBB holds the US marketing authorisation.