A curated and standardized adverse drug event resource to accelerate drug safety research

Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results. We provide a curated and standardized version of FAERS removing duplicate case records, applying standardized vocabularies with drug names mapped to RxNorm concepts and outcomes mapped to SNOMED-CT concepts, and pre-computed summary statistics about drug-outcome relationships for general consumption. This publicly available resource, along with the source code, will accelerate drug saf...药物上市后阶段的药品不良反应（Adverse Drug Reactions, ADRs）识别，是药物安全监测的核心目标之一。自发报告系统（Spontaneous Reporting Systems, SRS）数据作为传统药物安全监测的主流支撑手段，常被用于假设生成与新型监测方法的验证。公开可获取的美国食品药品监督管理局（Food and Drug Administration, FDA）不良事件报告系统（Adverse Event Reporting System, FAERS）数据，在合理应用前需开展大量精细化整理工作；不同的数据清洗与标准化策略，会对分析结果产生显著影响。本研究提供经过整理与标准化的FAERS数据版本：剔除了重复病例记录，采用标准化词汇体系将药品名称映射至RxNorm概念、将不良结局映射至SNOMED-CT概念，并预先计算了药品-结局关联的汇总统计量，以供通用场景使用。该公开可用的数据集及其配套源代码，将加速药物安全...