Abstract: Objective To describe the characteristics of zoledronic acid related osteonecrosis of the jaw (ONJ) in China, explore the risk factors, and to give tips about risk control. Methods Zoledronic acid related ONJ reports received by the National Adverse Drug Reaction Monitoring System between January 1, 2004 and June 30, 2021 were analyzed to identify the characteristics of ONJ reports. Results A total of 73 zoledronic acid related ONJ reports were retrieved, 90.41% of which were serious reports. The information about 2 cases was missing. Among the 71 cases reported, 94.37% (67/71) were related to anti-tumor drugs and 5.63% (4/71) anti-osteoporosis drugs. Cancer-related reports mainly involved middle-aged and elderly women. 44.78% of primary tumors were breast cancer, 59.70% of the patients had received concomitant therapies, 41.79% had undergone dental surgery, and 52.24% had fully recovered or were recovering. The four reports about osteoporosis patients were all elderly women with a dental surgery history. Conclusion Zoledronic acid related ONJ is rarely reported in China, most of the reports involve serious cases. There have been more reports from patients with cancer than from patients with osteoporosis. A dental surgery history is an important risk factor for ONJ, and the concomitant therapy might have some effect on the onset of ONJ. The risk of ONJ induced by zoledronic acid deserves more attention and effective measures should be taken to ensure drug safety.

Key words: zoledronic acid, osteonecrosis of the jaw, adverse drug reaction