Xiong Chun-Yan, Yang Yong-Min, Zhou Ying, He Tian-Shu, Luo Xing-Wei, Wang Jiang, Mao Chen-Xue
the First People's Hospital of Zhaotong, Zhaotong, Yunnan province, China.
Kunming Kingmed Institute for Clinical Laboratory Co. Ltd, Kunming, Yunnan province, China.
Expert Opin Drug Saf. 2025 Aug;24(8):949-957. doi: 10.1080/14740338.2024.2392865. Epub 2024 Aug 19.
Tetracyclines are a class of antibacterial drugs commonly used in clinical practice, but there is no systematic analysis of the adverse effects (AEs) of these drugs. We performed such pharmacovigilance analyses using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database to explore tetracycline-related AEs.
We used the pharmacovigilance analysis tool Open Vigil 2.1 to access FAERS data and obtained AE reports from January 2004 to June 2023, including doxycycline, minocycline, tigecycline, omadacycline, sarecycline, and eravacycline as the top suspect drugs. The signal value of the AE of the analyzed drug was calculated by the reporting odds ratio (ROR).
A total of 15,020 cases were identified by analyzing drugs. In terms of adverse signals, doxycycline caused gastrointestinal mucosal necrosis (ROR = 1699.652); minocycline was reported to cause bone hyperpigmentation (ROR = 30976.223); tigecycline is responsible for blood fibrinogen decreased (ROR = 1714.078).
AE reports of tetracycline drugs varied significantly. We found some AEs not mentioned in the instruction, such as the ototoxicity of tetracyclines. Doxycycline was associated with psychiatric side effects; minocycline presented in thyroid and skin tissue-associated tumors; abnormal signals were detected with eravacycline in the blood system.
四环素类是临床实践中常用的一类抗菌药物，但目前尚无对这些药物不良反应的系统分析。我们使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库进行了此类药物警戒分析，以探究四环素相关的不良反应。
我们使用药物警戒分析工具Open Vigil 2.1访问FAERS数据，并获取了2004年1月至2023年6月的不良反应报告，其中多西环素、米诺环素、替加环素、奥马环素、沙瑞环素和依拉环素为主要可疑药物。通过报告比值比（ROR）计算分析药物不良反应的信号值。
通过分析药物共识别出15020例病例。在不良信号方面，多西环素导致胃肠道黏膜坏死（ROR = 1699.652）；米诺环素被报告可导致骨色素沉着（ROR = 30976.223）；替加环素导致血纤维蛋白原降低（ROR = 1714.078）。
四环素类药物的不良反应报告差异显著。我们发现了一些说明书中未提及的不良反应，如四环素类的耳毒性。多西环素与精神方面的副作用有关；米诺环素与甲状腺和皮肤组织相关肿瘤有关；依拉环素在血液系统中检测到异常信号。
