🇺🇸 Cimzia in United States

FDA authorised Cimzia on 22 April 2008 · 123,245 US adverse-event reports

Marketing authorisations

FDA — authorised 22 April 2008

• Application: BLA125160
• Marketing authorisation holder: UCB INC
• 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.

• Window: 27 March 2025 – 27 March 2026
• Total reports: 123,245

Most-reported reactions

1. Drug Ineffective — 23,768 reports (19.29%)
2. Rheumatoid Arthritis — 16,485 reports (13.38%)
3. Pain — 14,180 reports (11.51%)
4. Fatigue — 11,905 reports (9.66%)
5. Rash — 10,133 reports (8.22%)
6. Alopecia — 9,591 reports (7.78%)
7. Arthralgia — 9,455 reports (7.67%)
8. Off Label Use — 9,448 reports (7.67%)
9. Joint Swelling — 9,205 reports (7.47%)
10. Abdominal Discomfort — 9,075 reports (7.36%)

Source database →

Frequently asked questions

Is Cimzia approved in United States?

Yes. FDA authorised it on 22 April 2008; FDA has authorised it.

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

UCB INC holds the US marketing authorisation.