Abstract: Objective To investigate romosozumab-related adverse drug events (ADE) in the real world based on the FDA Adverse Event Reporting System (FAERS) in order to contribute to management of safety of clinical drugs. Methods The FAERS database was searched for romosozumab-related articles that were published between April 1, 2019 and January 31, 2024. Romosozumab-related ADE were identified and evaluated using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Results A total of 8 432 351 reports of ADE were retrieved, 7 477 of which identified romosozumab as the “primary suspect”. Romosozumab was associated with 195 ADE across 16 system organ classes (SOCs), involving injuries and poisoning, general disorders, musculoskeletal and connective tissue disorders, and cardiac disorders. Common ADE included fractures, abnormal bone density, injection site reactions, arthralgia, limb pain and cardiac events. Additionally, some ADE that were not mentioned in the instruction manual, such as vertebral compression fractures, radial fractures, elevated parathyroid hormone and renal dysfunction, showed significant signals. Serious events associated with Romosozumab included hospitalization and death. Conclusion This study has confirmed common ADE associated with romosozumab and identified potential safety risks in actual clinical practices. Physicians and pharmacists should be alert to ADE signals not mentioned in the instructions, such as new fractures or bone density abnormalities, and take precautions.

Key words: Romosozumab, FAERS, Adverse Drug Events, Signal Detection, Pharmacovigilance, Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, Multi-Item Gamma Poisson Shrinker