Safety assessment of ustekinumab in inflammatory bowel disease: a real-world analysis based on the FDA adverse event reporting system (FAERS)
Likang Xu, Zhenkai Huang, Gong Chen, Chao Sun, Yang Yu, Sujun Gao · 2025
Read Safety assessment of ustekinumab in inflammatory bowel disease: a real-world analysis based on the FDA adverse event reporting system (FAERS) by Likang Xu, Zhenkai Huang, Gong Chen, Chao Sun, Yang Yu, Sujun Gao (2025) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-12817861.txt.
Description
Xu and co-authors mine a national side-effect database to check the safety of ustekinumab, a drug used for bowel disease. The drug blocks parts of two immune signals and has spread widely in practice. The team pulled 22,687 reports naming it as the prime suspect, filed between 2009 and 2024, and tested which harms appear more often than chance.
Known harms showed up as expected, led by injuries, gut complaints, and infections. New possible signals also surfaced: urinary infections, seizures, raised liver enzymes, fatty liver, gallstones, strokes, and brief stroke-like attacks. Reports clustered early in treatment and faded over time. The authors urge steady watchfulness and care matched to each patient.
Catalog record
| CREATOR | Likang Xu, Zhenkai Huang, Gong Chen, Chao Sun, Yang Yu, Sujun Gao |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 36 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |