Comprehensive safety assessment of donepezil: pharmacovigilance analysis based on the FDA adverse event reporting system
Shuo Li, Wenlong Qian, Zhuo Zhang, Yonghua Chen, Xiaoxiao Hou, Bingjie Min, Hui Zhou, Xinyu Zhu, Jia Ling, Wenming Yang, Shijian Cao · 2025
Read Comprehensive safety assessment of donepezil: pharmacovigilance analysis based on the FDA adverse event reporting system by Shuo Li, Wenlong Qian, Zhuo Zhang, Yonghua Chen, Xiaoxiao Hou, Bingjie Min, Hui Zhou, Xinyu Zhu, Jia Ling, Wenming Yang, Shijian Cao (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-12728744.txt.
Description
Li and co-authors report a 2025 safety study of donepezil, a common drug for Alzheimer's disease. Reports of side effects went into a US federal database over two decades. The team pulled every report naming the drug as the first suspect, from 2004 through 2024. They then used several signal methods to spot effects reported more often than expected.
The pull yielded 26,120 reports in total. Nausea, vomiting, fainting, and dizziness topped the list, matching the drug's label and trial data. Falls, low blood pressure, tremor, and mania also stood out as major signals. One rare posture disorder gave the strongest signal of all. The authors map the full risk picture for prescribers.
Catalog record
| CREATOR | Shuo Li, Wenlong Qian, Zhuo Zhang, Yonghua Chen, Xiaoxiao Hou, Bingjie Min, Hui Zhou, Xinyu Zhu, Jia Ling, Wenming Yang, Shijian Cao |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 41 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |