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

Year 2024, Volume: 28 Issue: 4, 1220 - 1230, 28.06.2025

Shaohua Liu Wangyan Jiang Jieru Guo Xinrong Zhou Zhelong Liu

Abstract

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 denosumab- related 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.

Keywords

Denosumab adverse drug events FAERS drug safety signal detection

References

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There are 31 citations in total.

Details

Primary Language English
Subjects Clinical Pharmacology and Therapeutics
Journal Section Articles
Authors

Shaohua Liu 0000-0003-1448-3827

Wangyan Jiang 0000-0001-8445-5632

Jieru Guo 0000-0001-8275-2828

Xinrong Zhou 0009-0001-1427-6249

Zhelong Liu 0000-0003-2567-2287

Publication Date June 28, 2025
Published in Issue Year 2024 Volume: 28 Issue: 4

Cite

APA Liu, S., Jiang, W., Guo, J., Zhou, X., et al. (2025). Adverse drug events of denosumab: Data-mining based on the United States Food and Drug Administration Adverse Event Reporting System database. Journal of Research in Pharmacy, 28(4), 1220-1230.
AMA Liu S, Jiang W, Guo J, Zhou X, Liu Z. Adverse drug events of denosumab: Data-mining based on the United States Food and Drug Administration Adverse Event Reporting System database. J. Res. Pharm. July 2025;28(4):1220-1230.
Chicago Liu, Shaohua, Wangyan Jiang, Jieru Guo, Xinrong Zhou, and Zhelong Liu. “Adverse Drug Events of Denosumab: Data-Mining Based on the United States Food and Drug Administration Adverse Event Reporting System Database”. Journal of Research in Pharmacy 28, no. 4 (July 2025): 1220-30.
EndNote Liu S, Jiang W, Guo J, Zhou X, Liu Z (July 1, 2025) Adverse drug events of denosumab: Data-mining based on the United States Food and Drug Administration Adverse Event Reporting System database. Journal of Research in Pharmacy 28 4 1220–1230.
IEEE S. Liu, W. Jiang, J. Guo, X. Zhou, and Z. Liu, “Adverse drug events of denosumab: Data-mining based on the United States Food and Drug Administration Adverse Event Reporting System database”, J. Res. Pharm., vol. 28, no. 4, pp. 1220–1230, 2025.
ISNAD Liu, Shaohua et al. “Adverse Drug Events of Denosumab: Data-Mining Based on the United States Food and Drug Administration Adverse Event Reporting System Database”. Journal of Research in Pharmacy 28/4 (July 2025), 1220-1230.
JAMA Liu S, Jiang W, Guo J, Zhou X, Liu Z. Adverse drug events of denosumab: Data-mining based on the United States Food and Drug Administration Adverse Event Reporting System database. J. Res. Pharm. 2025;28:1220–1230.
MLA Liu, Shaohua et al. “Adverse Drug Events of Denosumab: Data-Mining Based on the United States Food and Drug Administration Adverse Event Reporting System Database”. Journal of Research in Pharmacy, vol. 28, no. 4, 2025, pp. 1220-3.
Vancouver Liu S, Jiang W, Guo J, Zhou X, Liu Z. Adverse drug events of denosumab: Data-mining based on the United States Food and Drug Administration Adverse Event Reporting System database. J. Res. Pharm. 2025;28(4):1220-3.