目的：基于食品和药物管理局（FDA）不良事件报告系统（FAERS）数据库，挖掘乌帕达欣尼布的不良药物事件（ADE）信号，为该药物的安全临床使用提供参考。方法：检索FAERS数据库中2004年第一季度至2023年第一季度的乌帕达欣尼布ADE数据，并使用报告比和比例报告比进行数据挖掘。结果：共获得乌帕达欣尼布原始疑似药物的21,213份ADE报告，涉及444种ADE。年龄≥60岁（21.48%）和女性（70.11%）患者患乌帕达欣尼布ADE的风险较高。数据清理后，得到了19个系统器官类（SOCs）的182个ADE信号。其中，发生频率较高且未在药物标签中提及的SOCs包括肾脏和尿路系统（1.09%）、生殖和乳腺疾病（1.14%）、耳和前庭疾患（0.57%）、精神疾病（0.57%）、血液和淋巴系统疾病（0.57%）和内分泌疾患（0.57%）。乌帕达欣尼布报告频率最高的十个ADE信号主要与感染和寄生虫感染（7）、检查（2）和皮肤和皮下组织疾患（1）相关。信号强度排名前十的ADE有唇肿瘤、输尿管肿瘤、疱疹性湿疹、外阴变性、纵隔肿瘤、嗜酸细胞减少症、带状疱疹全身播散、眼溃疡、囊肿性痤疮和摩殴菌感染。导致严重不良事件发生的十个高频事件包括尿路感染（2.74%）、带状疱疹（1.63%）、结肠憩室炎（1.19%）、支气管炎（0.68%）、鼻咽炎（0.68%）、局部感染（0.66%）、肾结石（0.66%）、肺血栓（0.66%）、血胆固醇增高（0.55%）和肺孢子虫肺炎（0.53%）。结论：临床医生应对药物标签中未涉及的系统中乌帕达欣尼布引起的事件和新的高信号ADE保持警惕，以确保乌帕达欣尼布的安全有效使用。版权所有©2023年吴维和张。

Objective: To mine the adverse drug event (ADE) signals of upadacitinib based on the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to provide a reference for the safe clinical use of the drug. Methods: The ADE data for upadacitinib from Q1 2004 to Q1 2023 in the FAERS database were retrieved, and data mining was performed using the reporting odds ratio and proportional reporting ratio. Results: A total of 21,213 ADE reports for the primary suspect drug upadacitinib were obtained, involving 444 ADEs. Patients aged ≥60 years (21.48%) and female (70.11%) patients were at a higher risk of ADEs with upadacitinib. After data cleaning, 182 ADE signals from 19 system organ classes (SOCs) were obtained. Six of these SOCs that occurred more frequently and were not mentioned in the drug labeling information included renal and urinary system (1.09%), reproductive and breast diseases (1.14%), ear and labyrinth disorders (0.57%), psychiatric disease (0.57%), blood and lymphatic system disorders (0.57%), and endocrine disorders (0.57%). The top ten most frequent ADE signals reported for upadacitinib were mainly related to: infections and infestations (7), investigations (2), and skin and subcutaneous tissue disorders (1). The top 10 ADEs in signal intensity ranking were lip neoplasm, ureteral neoplasm, eczema herpeticum, vulvar dysplasia, mediastinum neoplasm, eosinopenia, herpes zoster cutaneous disseminated, eye ulcer, acne cystic, and Moraxella infection. The top 10 high-frequency events leading to serious adverse events were urinary tract infection (2.74%), herpes zoster (1.63%), diverticulitis (1.19%), bronchitis (0.68%), nasopharyngitis (0.68%), localised infection (0.66%), nephrolithiasis (0.66%), pulmonary thrombosis (0.66%), blood cholesterol increased (0.55%), and Pneumocystis jirovecii pneumonia (0.53%). Conclusion: Clinicians should be vigilant to upadacitinib-induced events in systems not covered in the drug labeling information and to new and highly signaled ADEs to ensure the safe and effective use of upadacitinib.Copyright © 2023 Wu, Wei and Zhang.