Archived Quarterly Reports | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
[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 following reports list new safety information or potential signals of serious risks that were identified using the FAERS database during the indicated quarter. Data from AERS was moved to FAERS for the launch of FAERS on September 10, 2012. Data from FAERS was moved to AEMS for the launch of AEMS on March 11, 2026.
After FDA determines that no regulatory action is necessary or takes a regulatory action for each potential signal on a quarterly report, no further updates will be communicated and the quarterly report is added to the list of archived reports on this webpage.
Archived Quarterly Reports
FDA is no longer updating these reports.