Abstract: Objective To summarize and analyze the regularity and characteristics of adverse drug reactions (ADR) in clinical use of zoledronic acid injection, so as to provide reference for clinical safe medication. Methods Cases of ADR induced by the use of zoledronic acid injection and reported to the national adverse drug reaction monitoring center from October 2012 to November 2018 were included. At the same time articles in the CNKI database, Wanfang database and VIP Chinese full-text database were searched, and the patients in the references which met the inclusion criteria were extracted. Then the ADR information of the patients both from the hospital and the literatures were analyzed together. Results The age of patients in both clinical cases and literature cases was mainly over 40 years old, accounting for 91.14% and 96.30% of all patients with medication respectively. All the patients suffered from malignant tumor with bone related diseases, and the primary tumor lesions were mainly lung cancer and breast cancer. In clinical cases, systemic response was the most involved organ/system of ADR(78.57%), while musculoskeletal system was the most reported (51.85%) in literature. A total of 28 severe cases were collected, except one from clinical cases, and the remaining 27 cases were all from literature. Among them, there were 13 severe cases of jaw necrosis and 1 death. Conclusion Most of ADR in the acute phase of this drug have achieved good results, and we should be alert to the possible delayed severe adverse reactions, especially the rare osteonecrosis of the jaw. It is suggested that ADR monitoring should be strengthened during the period of medication to promote the safety of clinical drug use.

Key words: zoledronic acid injection, malignant tumor, osteonecrosis of the jaws, adverse drug reactions