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  1. FDA Adverse Event Monitoring System (AEMS)

FDA Adverse Event Monitoring System (AEMS) Latest Quarterly Data Files

[Formerly FDA Adverse Event Reporting System (FAERS)]

FDA Adverse Event Monitoring System (AEMS)

FDA is implementing the Adverse Event Monitoring System (AEMS) to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines. 

This unified platform is designed to enhance data quality and consistency through standardized reporting protocols, streamline reporting processes to reduce administrative burden on both internal FDA staff and external stakeholders, and strengthen safety surveillance capabilities through advanced case processing workflows, AI-based redaction and digitization tools, enhanced analytics, and comprehensive cross-product surveillance. 

Beyond adverse event reporting, AEMS will serve as a centralized platform for managing consumer complaints, regulatory misconduct reports, and whistleblower submissions across all FDA centers. This comprehensive approach will enable more effective safety monitoring, facilitate trend identification across diverse product categories, and support timely regulatory decision-making to protect public health through improved data integration and analysis capabilities.

 

The FAERS Quarterly Data files listed on this page contain raw data extracted from the AERS database for the indicated time ranges and are not cumulative.

Users of these files need to be familiar with creation of relational databases using applications such as ORACLE®, Microsoft Office Access, MySQL® and IBM DB2 or the use of ASCII files with SAS® analytic tools.

A simple search of FAERS data cannot be performed with these files by persons who are not familiar with creation of relational databases. However, you can get a summary FAERS report for a product by sending a Freedom of Information Act (FOIA) request to FDA. You can also request individual case reports by submitting a FOIA request listing case report numbers. 

The quarterly data files, which are available in ASCII or SGML formats, include: 

  • demographic and administrative information and the initial report image ID number (if available);
  • drug information from the case reports;
  • reaction information from the reports;
  • patient outcome information from the reports;
  • information on the source of the reports;
  • a "README" file containing a description of the files.
FDA Adverse Event Reporting System (FAERS) Quarterly Data Extract Files
How to Make a Freedom of Information Act (FOIA) Request

You can get a summary FAERS report for a product by submitting a Freedom of Information Act (FOIA) request. You can also request individual case reports by submitting a FOIA request. Your request must include the FAERS case numbers.

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