Comprehensive post-marketing safety analysis of tildrakizumab: insights from the FDA adverse event reporting system
This study confirmed some known AEs and identified several unexpected AEs, highlighting the importance of early-stage monitoring. These findings may provide preliminary insights into the safe use of tildrakizumab. However, the FAERS database has limitations, including reporting bias, incomplete clinical information, and the inability to establish causality. These findings warrant further validation through prospective studies.
Authors
- Shengxiang Xiao (ORCID: https://orcid.org/0000-0002-3863-1065)
- Yang Zhao (ORCID: https://orcid.org/0000-0002-6011-5948)
- Chingkuang Tu
- Kaidi Zhao (ORCID: https://orcid.org/0000-0001-6716-3179)
Institutions
- Second Affiliated Hospital of Xi'an Jiaotong University (CN)
- Xi'an Jiaotong University (CN)
Publication Details
- Journal
- Expert Opinion on Drug Safety
- Published
- 2025-06-13
- DOI
- https://doi.org/10.1080/14740338.2025.2520422
- Citations
- 5
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 6.54
Funders
- National Natural Science Foundation of China
- Natural Science Foundation of Shaanxi Province