🇺🇸 Humira in United States

FDA authorised Humira on 31 December 2002 · 406,363 US adverse-event reports

Marketing authorisations

FDA — authorised 31 December 2002

  • Application: BLA125057
  • Marketing authorisation holder: ABBVIE 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 — 86,103 reports (21.19%)
  2. Injection Site Pain — 50,410 reports (12.41%)
  3. Pain — 48,047 reports (11.82%)
  4. Arthralgia — 47,030 reports (11.57%)
  5. Fatigue — 38,038 reports (9.36%)
  6. Rheumatoid Arthritis — 33,886 reports (8.34%)
  7. Headache — 27,732 reports (6.82%)
  8. Nausea — 26,307 reports (6.47%)
  9. Psoriasis — 24,475 reports (6.02%)
  10. Rash — 24,335 reports (5.99%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Humira approved in United States?

Yes. FDA authorised it on 31 December 2002; FDA has authorised it.

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

ABBVIE INC holds the US marketing authorisation.