Article(id=1309634615497814171, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634614356968036, articleNumber=null, orderNo=null, doi=10.12048/j.issn.1674-229X.2026.03.008, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1751558400000, receivedDateStr=2025-07-04, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1790170824169, onlineDateStr=2026-09-23, pubDate=1774368000000, pubDateStr=2026-03-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1790170824169, onlineIssueDateStr=2026-09-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1790170824169, creator=13701087609, updateTime=1790170824169, updator=13701087609, issue=Issue{id=1309634614356968036, tenantId=1146029695717560320, journalId=1227999776411738115, year='2026', volume='36', issue='3', pageStart='161', pageEnd='240', issueExtLink='null', onlineDate='null', pubDate='1774368000000', pubDateStr='2026-03-25', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1790170823897, creator='13701087609', updateTime=1790219059643, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1309836929789682362, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634614356968036, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1309836929789682363, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634614356968036, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=206, endPage=212, ext={EN=ArticleExt(id=1309634615833358492, articleId=1309634615497814171, tenantId=1146029695717560320, journalId=1227999776411738115, language=EN, title=Safety Signal Mining Study of Tazemetostat Based on the FAERS Database, columnId=null, journalTitle=Pharmacy Today, columnName=null, runingTitle=null, highlight=null, articleAbstract=
OBJECTIVE To first systematically mine and characterize the real-world drug safety signals of the EZH2 inhibitor tazemetostat using the FDA Adverse Event Reporting System (FAERS) database, to provide evidence-based support for clinical risk management.
METHODS A dual-algorithm validation framework (Reporting Odds Ratio, ROR + Proportional Reporting Ratio, PRR) was applied to analyze 1 225 reports listing tazemetostat as the primary suspected drug submitted between Q1 2020 and Q1 2025. False positives were controlled using χ2 > 4. After excluding Preferred Terms (PTs) related to the drug's indication and non‐drug-related System Organ Classes (SOCs), 94 valid signals (involving 1 690 reports) were ultimately identified.
RESULTS (1) Twenty- four signals (25.5% of total signals) not listed in the current drug package insert were detected. Strong signals included dysgeusia (ROR = 17.39, 95%CI = 13.00-23.27), parosmia (ROR = 10.91, 95%CI = 4.53-26.25), and decreased red blood cell count (ROR=6.94, 95%CI = 4.11-11.73). (2) The most frequently reported signals were fatigue (12.8%), nausea (9.3%), and diarrhea (7.6%). (3) Multisystem toxicity was observed, primarily involving the gastrointestinal system (33.08%), general reactions (25.21%), and nervous system (9.23%).
CONCLUSION This is the first comprehensive pharmacovigilance study of tazemetostat reveals its potential to induce multisystem toxicity, mediated through neurosensory pathways and bone marrow hematopoietic homeostasis. The identification of unlisted signals challenges the traditional view that EZH2 inhibitor toxicity is confined to proliferative tissues. These findings provide crucial real-world evidence supporting the theory of systemic toxicity for epigenetic drugs and hold significant value for optimizing clinical drug monitoring strategies during tazemetostat therapy.
, authors=Xiuzhong CAI
1, Qianhua LUO
2, Xiaoshan CHEN
3, Wenfeng LIAO
1, Caifu FANG
1, *, authorsList=Xiuzhong CAI, Qianhua LUO, Xiaoshan CHEN, Wenfeng LIAO, Caifu FANG, authorCompany=null, correspAuthors=Caifu FANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1309634616353452189, articleId=1309634615497814171, tenantId=1146029695717560320, journalId=1227999776411738115, language=CN, title=基于FAERS数据库的他泽司他安全信号挖掘研究, columnId=1228268589086606089, journalTitle=今日药学, columnName=论著, runingTitle=null, highlight=null, articleAbstract=
目的 基于FDA不良事件报告系统（FAERS）数据库，首次系统挖掘EZH2抑制剂他泽司他（tazemetostat）在真实世界中的药物安全性信号，为临床风险管理提供循证依据。
方法 采用双算法验证框架（报告比值比ROR+比例报告比值PRR），分析2020Q1~2025Q1期间以他泽司他为首要怀疑药物的报告1225例。通过χ2>4控制假阳性，排除适应证相关PT及非药物相关SOC后，最终识别有效信号94个（涉及1690份报告）。
结果 ①检出24个药品说明书未收录信号（占总信号25.5%），其中高强度信号包括味觉障碍（ROR=17.39，95%CI=13.00~23.27）、嗅觉异常（ROR=10.91，95%CI=4.53~26.25）及红细胞计数下降（ROR=6.94，95%CI=4.11~11.73）；②高频信号为疲劳（12.8%）、恶心（9.3%）和腹泻（7.6%）；③多系统毒性累及胃肠系统（33.08%）、全身性反应（25.21%）及神经系统（9.23%）。
结论 本研究首次揭示他泽司他可通过神经感觉通路与骨髓造血稳态介导多系统毒性，其未收录信号挑战了“EZH2抑制剂毒性限于增殖组织”的传统认知，为表观遗传药物的全身毒性理论提供了关键真实世界证据，对优化临床用药监测策略具有重要价值。
, authors=蔡秀忠
1, 罗茜华
2, 陈肖珊
3, 廖文锋
1, 房财富
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