Table4_Indications and adverse events of teriparatide: based on FDA adverse event reporting system (FAERS).DOCX

BackgroundTeriparatide is approved for osteoporosis. Post-marketing surveillance is critical given its widespread use.
ObjectiveTo investigate adverse events (AEs) associated with teriparatide using the FAERS database, compare association strengths for key AEs, and explore potential applications to provide clinical reference.
MethodsFAERS data from 2004 to 2023 were analyzed. Reports where teriparatide was the primary suspect drug were included. Adverse events were mapped to System Organ Classes and Preferred Terms. Disproportionality analysis using ROR, PRR, BCPNN and EBGM algorithms was conducted to detect safety signals.
ResultsOut of 107,123 reports with teriparatide as the primary suspect, key AEs identified included pain in extremity (PRR: 4.54), muscle spasms (PRR: 5.11), fractures (PRR range: 17.67–552.95), and increased calcium levels (PRR: 50.73). Teriparatide exhibited a stronger association with increased calcium levels (PRR: 50.73) compared to fractures (PRR range: 17.67–552.95). Notably, only 10.86% of AE reports were submitted by physicians and another 10% by other health professionals. Subset analyses showed a higher consistency of reported AEs from health professionals compared to the general dataset. Off-label uses were noted in conditions such as arthritis (0.57%) and cancer (0.12%). For osteoporosis, main AEs were pain (18.2%), fractures (12.4%), muscle spasms (7.7%), and nausea (6.5%), while glucocorticoid-induced osteoporosis AEs included fractures (24.1%), pain (13.2%), decreased bone density (9.8%), and nausea (5.1%).
ConclusionOur findings provide real-world safety data on teriparatide, revealing key AEs and their association strengths. The low proportion of reports by healthcare professionals suggests the need for cautious interpretation. Continuous vigilance and further research are imperative to guide teriparatide’s clinical use.

背景
特立帕肽（Teriparatide）获批用于骨质疏松症的治疗。鉴于其临床应用广泛，上市后监测至关重要。

目的
利用FAERS数据库分析特立帕肽相关不良事件（Adverse Events, AEs），比较关键不良事件的关联强度，并探索其潜在应用价值以提供临床参考。

方法
分析2004年至2023年的FAERS数据库数据，纳入以特立帕肽为首要怀疑药物的不良事件报告。将不良事件映射至系统器官分类（System Organ Classes, SOC）与首选术语（Preferred Terms, PT），采用ROR、PRR、BCPNN及EBGM算法进行比例失衡分析以检测安全信号。

结果
在107,123份以特立帕肽为首要怀疑药物的报告中，识别出的关键不良事件包括肢体疼痛（PRR：4.54）、肌肉痉挛（PRR：5.11）、骨折（PRR范围：17.67~552.95）及血钙水平升高（PRR：50.73）。相较于骨折（PRR范围：17.67~552.95），特立帕肽与血钙水平升高的关联强度更强（PRR：50.73）。值得注意的是，仅10.86%的不良事件报告由医师提交，另有10%由其他卫生专业人员提交。亚组分析显示，相较于整体数据集，卫生专业人员报告的不良事件一致性更高。研究还观察到超适应症用药情况，涉及关节炎（0.57%）与癌症（0.12%）相关适应症。针对骨质疏松症，主要不良事件为疼痛（18.2%）、骨折（12.4%）、肌肉痉挛（7.7%）及恶心（6.5%）；而糖皮质激素诱导性骨质疏松症的不良事件则包括骨折（24.1%）、疼痛（13.2%）、骨密度降低（9.8%）及恶心（5.1%）。

结论
本研究结果提供了特立帕肽的真实世界安全性数据，明确了其关键不良事件及关联强度。卫生专业人员提交的报告占比偏低，提示解读研究结果时需谨慎。持续监测与进一步研究对于指导特立帕肽的临床应用至关重要。