Analysis signals of disproportionate reporting associated with donanemab: A retrospective pharmacovigilance study using the FAERS database

Objective This study aims to identify signals of disproportionate reporting (SDR) associated with donanemab by analyzing data from the Food and Drug Administration’s Adverse Event Reporting System (FAERS) database. Methods A retrospective analysis was conducted on reports related to donanemab in the FAERS database from the third quarter of 2024 to the second quarter of 2025. Four signal detection methods were employed: reporting odds ratio (ROR), proportional reporting ratio (PRR), Multi-item gamma poisson shrinkage (MGPS), and Bayesian confidence propagation neural network (BCPNN). Additionally, descriptive analysis was performed on the time to onset of reports associated with donanemab. Results A total of 646 reports identified donanemab as the primary suspect drug. We identified common SDRs listed on the drug label, including amyloid related imaging abnormality-oedema/effusion, amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits, headache, and infusion-related reactions. In addition, some SDRs not previously listed on the drug label, such as back pain, feeling hot, and influenza like illness, were also detected. The median time to onset for donanemab-related adverse events was 31.5 days (interquartile range: 25–58 days). Conclusion This study provides a comprehensive analysis of SDRs associated with donanemab. These results are merely statistical indicators and require further validation through clinical trials.