Full
Outline
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.
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.
(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%).
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.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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