FDA FAERS Dataset

## Overview

Unlock pharmacovigilance intelligence from **18M+ adverse event reports** spanning two decades of FDA safety data. The FDA Adverse Event Reporting System (FAERS) captures every reported drug safety signal in the United States, providing the foundation for drug safety surveillance and competitive intelligence.

**Dataset Size:** 70+ GB | **191M+ records** | **Updated quarterly with daily corrections**

> **[Start Free Trial](https://trial.dataplex-consulting.com)** | **[Purchase Full Access](https://checkout.dataplex-consulting.com/b/eVqaEQcXFdGoeUocKgbQY03)**

### What's Included

- **drug__events** - Core adverse event reports with demographics and outcomes (18M+ reports)
- **drug__events_drugs** - Drug details per event: suspect, concomitant, interacting (70M+ records)
- **drug__events_reactions** - MedDRA-coded reactions per event (55M+ reactions)
- **drug__events_patients** - Anonymized patient demographics: age, sex, weight (18M+ patients)
- **drug__agg_safety_trends** - Pre-aggregated monthly/quarterly safety trends (27M+ rows)
- **drug__agg_drug_reaction_associations** - Drug-reaction pair statistics with PRR metrics (130K+ associations)

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## Use Cases

### Pharmaceutical & Biotech
- **Post-market surveillance**: Monitor safety signals across your drug portfolio
- **Competitive intelligence**: Benchmark adverse event rates against competitors
- **Regulatory submissions**: Support safety sections with real-world evidence
- **Label updates**: Identify emerging safety concerns before they escalate

### Healthcare & Research
- **Safety signal detection**: Identify unusual adverse event patterns early
- **Demographic risk stratification**: Analyze safety profiles by age, sex, and weight
- **Drug interaction analysis**: Examine concomitant medication patterns
- **Outcome severity analysis**: Track death, hospitalization, and disability rates

### Consulting & Analytics
- **Market intelligence**: Size the safety burden for any therapeutic area
- **Due diligence**: Assess drug safety profiles for M&A and investment decisions
- **Trend analysis**: Track reporting patterns over time with pre-built aggregates

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## Data Quality & Updates

- **Source**: FDA Adverse Event Reporting System (FAERS) public data
- **History**: Complete data back to 2004
- **Updates**: Quarterly bulk releases + daily corrections and amendments
- **Coding**: MedDRA standardized reaction terms
- **Normalization**: Drug names normalized, duplicates flagged

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## Getting Started

### Start a Free Trial

Get 14 days of access to explore the FDA FAERS dataset:

**[Start Free Trial](https://trial.dataplex-consulting.com)**

Trial includes:
- Full schema access with sample data
- Pre-built analytics tables
- Databricks notebook with example queries

### Get Full Access

Ready for production use? Get unlimited access to all 18M+ adverse event reports:

**[Purchase Full Access](https://checkout.dataplex-consulting.com/b/eVqaEQcXFdGoeUocKgbQY03)**

Full access includes:
- Complete historical data (2004-present)
- All 191M+ records across all tables
- Pre-aggregated analytics tables
- Quarterly updates within days of FDA release
- Daily corrections and amendments

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## Documentation & Support

- **Full Documentation**: [docs.dataplex-consulting.com/fda-faers-dataset](https://docs.dataplex-consulting.com/healthcare-data-catalog/fda-faers-dataset)
- **Data Dictionary**: Comprehensive field-level documentation
- **Sample Notebooks**: Ready-to-run Databricks notebooks
- **Support**: [e-mail]

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## Related Products

- **FDA MAUDE** - 14M+ medical device adverse events
- **CMS Medicare/Medicaid** - 73B+ claims and provider records
- **NPI Registry** - 8M+ healthcare provider directory
- **CDC Public Health** - 1.7B+ population health records

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*Data provided by Dataplex Consulting | [dataplex-consulting.com](https://dataplex-consulting.com)*

搜集汇总

背景与挑战

背景概述

FDA FAERS数据集源自美国FDA不良事件报告系统，涵盖2004年以来的超过1800万份不良事件报告，数据量超过70GB，包含191M+条记录，每季度更新并支持每日修正。该数据集提供药物安全监测和竞争情报的基础，包括事件报告、药物详情、反应编码和患者人口统计等多个核心表，适用于制药、医疗和研究领域的药物安全分析和趋势追踪。