Adverse drug events of denosumab: Data-mining based on the United States Food and Drug Administration Adverse Event Reporting System database

: Objective: This study seeks to analyze data from the United States (U.S.) Food and Drug Administration Adverse Event Reporting System (FAERS) to identify potential adverse drug event (ADE) signals associated with denosumab and provide valuable insights into the clinical safety of denosumab usage. Methods: Data on denosumabrelated ADEs reported from the FAERS between the second quarter of 2010 to the first quarter of 2022 were extracted using OpenVigil 2.1. The Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) were calculated as measures to detect potential ADE signals. Results: The analysis of FAERS data uncovers potential ADE signals associated with the use of denosumab. These signals encompass a spectrum of adverse effects, including well- established risks such as musculoskeletal pain, hypocalcemia, and osteonecrosis of the jaw. Moreover, novel potential adverse events emerge, including oral diseases, fractures occurring in various locations, and signals indicating tumors beyond the drug's approved indications. Conclusions: This study highlights the significance of closely monitoring patients for potential adverse events during denosumab treatment. Healthcare professionals should exercise heightened vigilance for the development of oral diseases, fractures, and tumors in individuals receiving denosumab therapy. The identification of these additional ADE signals should inform clinical decision-making, patient risk assessments, and ongoing efforts in pharmacovigilance, thereby ensuring the safe and effective utilization of denosumab.