🇺🇸 Remicade in United States

FDA authorised Remicade on 24 August 1998 · 157,225 US adverse-event reports

Marketing authorisations

FDA — authorised 24 August 1998

  • Application: BLA103772
  • Marketing authorisation holder: CENTOCOR INC
  • 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 — 30,603 reports (19.46%)
  2. Off Label Use — 22,525 reports (14.33%)
  3. Infusion Related Reaction — 16,732 reports (10.64%)
  4. Rheumatoid Arthritis — 16,152 reports (10.27%)
  5. Pain — 14,913 reports (9.49%)
  6. Fatigue — 12,530 reports (7.97%)
  7. Arthralgia — 12,026 reports (7.65%)
  8. Rash — 10,756 reports (6.84%)
  9. Product Use Issue — 10,672 reports (6.79%)
  10. Alopecia — 10,316 reports (6.56%)

Source database →

Remicade in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Remicade approved in United States?

Yes. FDA authorised it on 24 August 1998; FDA has authorised it.

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

CENTOCOR INC holds the US marketing authorisation.