目的 基于FAERS数据库对原发性免疫球蛋白A（IgA）肾病新型药物布地奈德肠溶胶囊不良事件信号进行挖掘与分析。方法 检索并提取FAERS数据库2021年第4季度—2025年第1季度收录以目标药物通用名“budesonide”及商品名“Tarpeyo^®、Kinpeygo^®、Nefecon^®”为首要怀疑对象的不良事件报告，利用ROR法和BCPNN法对布地奈德肠溶胶囊的相关报告进行数据挖掘和分析，并利用MedDRA医学用语词典进行汉化及系统归类。结果 纳入分析15 969 959份不良事件报告中，以布地奈德肠溶胶囊相关名称为首要怀疑药物的不良事件报告3 581份。发现该药不良反应信号涉及多个系统，具有临床参考意义的高风险信号包括高血压亚急症、类库欣综合征、体质量增加等等；另检测出高风险且说明书中未提及的安全警戒信号如牙齿感觉敏感和尿异常。结论 布地奈德肠溶胶囊长期使用需关注如高血压、类库欣综合征、体质量高增加等不良安全信号。此外用药期间还需注意口腔健康，必要时应及时就医。

Objective To mine and analyze adverse events related to the Budesonide Enteric Capsules for treating IgA nephropathy based on the FAERS database. Methods The FAERS database was searched and extraced the adverse event reports with the target drug generic name “budesonide” and brand names “Tarpeyo^®, Kinpeygo^®, Nefecon^®” as the primary suspects from Q4 of 2021 to Q1 of 2025. The ROR method and BCPNN method were employed for data mining and analysis of Budesonide Enteric Capsules-related reports. The MedDRA medical terminology was used for localization and systematic classification. Results Among the 15 969 959 adverse event reports included in the analysis, 3 581 adverse event reports were related to the name of Budesonide Enteric Capsules as the primary suspected drug. It was found that the adverse reaction signals of this drug involve multiple systems. High-risk signals with clinical reference significance include subacute hypertension, Cushing’s syndrome, weight gain, etc. In addition, high-risk safety warning signals not mentioned in the instruction manual were detected, such as tooth sensitivity and abnormal urine. Conclusion Long-term use of Budesonide Enteric Capsules requires attention to adverse safety signals such as hypertension, Cushing’s syndrome, and increased body weight. In addition, during the medication period, oral health should be paid attention to. If necessary, medical attention should be sought in a timely manner.

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