faers

is a Data Source.

The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports, and product quality complaints resulting in adverse events submitted to the FDA. FAERS supports the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. The database adheres to ICH E2B international safety reporting guidance, and adverse events are coded using MedDRA (Medical Dictionary for Regulatory Activities) terminology. FAERS provides quarterly data files in ASCII and XML formats dating back to 2012, with archives available for earlier data.

Domains

pharmacology, drug discovery, clinical, public health

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Homepage

faers

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Infores ID

infores:faers

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Product Summary

Products

From this Resource
ID Name URL Category Format Description
faers.public_dashboard FAERS Public Dashboard analysis GraphicalInterface http Interactive dashboard for exploring F...
faers.quarterly_data_ascii FAERS Quarterly Data Files (ASCII) FPD-QDE-FAERS.html Product txt Quarterly data extracts in ASCII form...
faers.quarterly_data_xml FAERS Quarterly Data Files (XML) FPD-QDE-FAERS.html Product xml Quarterly data extracts in XML format...
faers.faq FAERS FAQ FPD-FAQ.html DocumentationProduct http Frequently asked questions about FAER...
faers.electronic_submissions FAERS Electronic Submissions Portal fda-adverse-event-reporting-system-faers-electronic-submissions GraphicalInterface http Portal for submitting adverse event r...
From other Resources
ID Name URL Category Format Description
aeolus.standardized_data AEOLUS Standardized FAERS Data dryad.8q0s4 Product ❔ Standardized and deduplicated version...

Details

FDA Adverse Event Reporting System

Overview

The FDA Adverse Event Reporting System (FAERS) is a comprehensive database maintained by the FDA Center for Drug Evaluation and Research (CDER) that collects and analyzes adverse event reports, medication error reports, and product quality complaints for drug and therapeutic biologic products. The system is a critical component of the FDA’s post-marketing safety surveillance program, enabling ongoing monitoring of drug safety after products reach the market.

Data Content

FAERS contains reports from multiple sources:

  • Healthcare professionals (physicians, pharmacists, nurses)
  • Consumers
  • Pharmaceutical manufacturers (mandatory reporting)
  • Legal representatives

Data Structure

The FAERS database follows the ICH E2B international safety reporting standard and includes:

  • Demographic and administrative information: Patient age, sex, weight, report dates
  • Drug information: Name, dose, route, indication, therapy dates
  • Adverse event information: MedDRA-coded reactions, outcomes, seriousness
  • Reporter information: Source type, qualifications
  • Narrative descriptions: Event details and outcomes

All adverse events are coded using MedDRA (Medical Dictionary for Regulatory Activities) terminology, enabling standardized analysis and international data exchange.

Data Products

Quarterly Data Files

FAERS provides complete data extracts on a quarterly basis:

  • Available from: 2012-present (with archives for earlier data)
  • Formats: ASCII and XML (SGML for older files)
  • Update frequency: Quarterly (posted ~30-60 days after quarter end)
  • Most recent: Q3 2025 (July-September 2025, posted October 30, 2025)

Public Dashboard

Interactive web-based dashboard providing:

  • Searchable database of adverse event reports
  • Visualization tools for trend analysis
  • Summary statistics and aggregated data views
  • Export capabilities for further analysis

Use Cases

  1. Pharmacovigilance: Post-marketing surveillance and signal detection
  2. Drug Safety Research: Studying patterns of adverse events
  3. Regulatory Science: Supporting FDA safety assessments and label updates
  4. Comparative Effectiveness Research: Analyzing real-world drug outcomes
  5. Clinical Decision Support: Informing prescribing decisions
  6. Public Health Monitoring: Tracking medication error trends
  • AEOLUS: A cleaned and standardized version of FAERS with duplicate removal, RxNorm drug mapping, and SNOMED-CT outcome mapping
  • nSIDES: Machine learning-based adverse drug event databases including OnSIDES, OffSIDES, and TwoSIDES
  • AERO: Adverse Event Reporting Ontology for standardizing adverse event data entry

Information Resource ID

This resource has the Information Resource identifier: infores:faers

Important Notes

  • FAERS data cannot prove that a drug caused an adverse event; reports reflect suspicions of healthcare providers and consumers
  • Reporting biases exist: serious events, new drugs, and heavily marketed drugs may be over-represented
  • Duplicate reports may exist despite FDA efforts to remove them
  • Individual case reports are available through FOIA requests
  • The database does not include denominators (total number of people taking drugs), limiting causal inference

Is this information incorrect or incomplete? Request an update.

Created: November 04, 2025 | Last modified: November 04, 2025