FDA AEMS Adverse Events Dataset

Name: FDA AEMS Adverse Events Dataset
Creator: Dataplex Consulting & Data Products
Published: 2026-06-01 22:38:26
License: 暂无描述

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# Overview The **FDA AEMS Adverse Events Dataset** unifies **23M+ U.S. FDA adverse event reports** for both drugs and medical devices into a single, analysis-ready schema — with **built-in pharmacovigilance signal detection** so safety teams move straight from raw reports to actionable signals. Sourced from the FDA's openFDA FAERS (drug) and MAUDE (device) systems and normalized into one consistent set of tables, it removes the work of parsing openFDA JSON and stitching two separate reporting systems together. **Dataset Size:** **23M+ reports** (8.8M+ drug · 14.4M+ device) | **17 analysis-ready tables** | **Coverage 2020–present** | **Updated daily** # What's Included - **23M+ adverse event reports** - Drug and device events unified in one consistent schema - **Built-in signal detection** - Precomputed Proportional Reporting Ratio (PRR), 95% confidence intervals (Evans 2001), and an IS_SIGNAL flag (PRR≥2, N≥3) - **MedDRA-coded reactions** - 25.8M+ drug-reaction rows mapped to standardized medical terms - **openFDA drug enrichment** - NDC, RxNorm RxCUI, UNII, pharmacologic class, brand & generic names - **32M+ device narratives** - Full-text MDR event descriptions for free-text mining and NLP - **Manufacturer rollups & dashboards** - Pre-built event aggregations and device surveillance summaries - **Full lineage** - Every event traces back to its source report **[View the complete table list in documentation](https://docs.dataplex-consulting.com/data-catalog/fda-aems-dataset)** ## Drug Side (FAERS source) - Reports, MedDRA-coded reactions, and openFDA-enriched substances (NDC, RxNorm, UNII, pharmacologic class, brand & generic) - Reporter / sender / receiver provenance, duplicate-chain tracking, and an NDC reference directory - Analytics: PRR reaction-associations (signal detection), safety trends, and manufacturer rollups ## Device Side (MAUDE source) - Reports, device details, full-text MDR narratives, patient outcomes, and coded product problems - FDA device-classification reference for risk stratification - Analytics: manufacturer rollups and an executive post-market surveillance dashboard # Use Cases ## Drug Safety & Pharmacovigilance - Disproportionality analysis - Surface drug-reaction signals with precomputed PRR and confidence intervals - Signal triage - Filter to high-priority pairs with the IS_SIGNAL flag (PRR≥2, N≥3) - Reaction profiling - Analyze MedDRA-coded reactions by substance and pharmacologic class - Seriousness analysis - Quantify death, hospitalization, and serious-event rates ## Medical Device Post-Market Surveillance - Event trending - Track malfunction, injury, and death events over time by device class - Product-problem analysis - Break events down by coded problem and product code - Manufacturer benchmarking - Compare event volumes and rates across manufacturers - Narrative mining - Run NLP across 32M+ full-text MDR descriptions ## Regulatory Affairs - Safety submission support - Build evidence from drug and device reports in one place - Label-change evidence - Support labeling updates with disproportionality metrics - Benefit-risk monitoring - Track a product's evolving safety profile over time ## Life Sciences & Competitive Intelligence - Competitor safety profiling - Compare adverse event profiles across rival products - Therapeutic-area landscape - Map reaction trends by pharmacologic class - Manufacturer landscape - Benchmark event volumes across the market ## Research, Payers & HEOR - Pharmacoepidemiology at scale - Study adverse event patterns across 23M+ reports and both FDA systems - ML feature engineering - Train models on MedDRA-coded reactions and signal-flagged data - Formulary & value inputs - Factor real-world safety signals into coverage and HEOR models ## Data Quality & Updates Drug and device adverse events are normalized to one consistent schema and refreshed daily as the FDA publishes new reports, with every row traceable to its source. ## Attribute - Source - FDA openFDA: FAERS (drug adverse events) and MAUDE (device adverse events) - History - Coverage from 2020 to present - Updates - Daily automated processing as the FDA publishes new reports - Schema - Drug and device events normalized to one consistent set of 17 tables - Signal-ready - PRR, 95% confidence intervals, and signal flags precomputed - Lineage - Every event traces back to its source report ## Getting Started **Marketplace access includes:** - Complete access to all 17 analysis-ready tables - All 23M+ drug and device adverse event reports - Precomputed PRR signal detection with confidence intervals and IS_SIGNAL flags - MedDRA-coded reactions and 32M+ full-text device narratives - openFDA enrichment (NDC, RxNorm, UNII, pharmacologic class) on drug events - Daily updates as the FDA publishes new data **Example Analyses** - Detect emerging drug safety signals - Rank drug-reaction pairs by PRR and confidence interval - Profile a drug's reaction landscape - Break down MedDRA reactions by active substance - Mine device failure narratives - Extract failure modes from 32M+ MDR narrative rows - Benchmark manufacturer safety - Compare event volumes across drug and device makers - Monitor post-market trends - Track adverse event volumes over time by product **Documentation & Support** - Full Documentation - [docs.dataplex-consulting.com/data-catalog/fda-aems-dataset](https://docs.dataplex-consulting.com/data-catalog/fda-aems-dataset) - Support - support@dataplex-consulting.com *Data provided by Dataplex Consulting | [dataplex-consulting.com](https://dataplex-consulting.com)*

提供机构：

Dataplex Consulting & Data Products

创建时间：

2026-05-22

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