基于美国食品药品监督管理局不良事件报告系统(FAERS)数据，挖掘来特莫韦相关不良事件(ADE)信号并评估发生特征，为临床安全用药提供参考。

检索2017年第4季度至2025年第2季度FAERS数据，采用报告比值比、比例报告比值和贝叶斯置信传播神经网络进行不成比例分析。计算时间到事件(TTO)，结合威布尔拟合和经验累积分布函数分析ADE发生时间模式，并按指定医疗事件(DME)分层。

共检出来特莫韦相关报告1 007份，获得65个阳性首选术语信号，涉及15个系统器官分类。纳入有效TTO记录778例，总体中位TTO为43(8，124)d，威布尔拟合形状参数β＝0.58(<1)，≤30 d和≤90 d累积发生率分别为44.1%和66.8%。关键DME中，肝衰竭中位TTO为5(5，5)d(β＝0.88)，表现为早期集中发生(≤30 d占96.4%)；粒细胞缺乏症[中位TTO为74(40，95)d，β＝1.44]与急性肾损伤[中位TTO为88(14，579)d，β＝0.68]均呈现明显延迟发生与拖尾现象。

来特莫韦相关ADE整体呈早发倾向，但不同器官时间异质性显著。肝衰竭多见于用药初期，而粒细胞缺乏症与急性肾损伤可延迟发生。临床在用药1~2个月内应加强肝功能与血液学监测，并适当延长肾功能随访周期。

To detect safety signals and characterize the time-to-onset (TTO) profile of letermovir-associated adverse events (ADE) based on the U. S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.

FAERS data from Q4 2017 to Q2 2025 were retrieved. Disproportionality analyses were performed using reporting odds ratio, proportional reporting ratio, and Bayesian confidence propagation neural network. TTO was calculated and fitted using the Weibull distribution, with stratification by designated medical events (DME).

A total of 1 007 letermovir-related reports were identified, yielding 65 positive signals across 15 system organ classes. Among 778 cases with valid TTO, the overall median TTO was 43 (8, 124) days with a Weibull shape parameter β=0.58, indicating an early-onset pattern (cumulative proportion ≤30 days: 44.1%; ≤90 days: 66.8%). For key DMEs, liver failure exhibited typical early onset [median 5 (5, 5) days, β=0.88], whereas agranulocytosis [median 74 (40, 95) days, β=1.44] and acute kidney injury [median 88 (14, 579) days, β=0.68] demonstrated delayed and prolonged risk profiles.

Letermovir-associated ADE predominantly occurs early, but onset patterns vary across organ toxicities. Hepatic monitoring should be prioritized during early therapy, while hematologic and renal surveillance should be extended over a longer window.