FDA Launches New Adverse Event Monitoring System to Replace Legacy Systems

The Food and Drug Administration (FDA) has launched a new unified platform for analyzing adverse event (AE) reports: the FDA Adverse Event Monitoring System (AEMS). The new system replaces older, fragmented systems that were difficult to search and had limited postmarket surveillance capabilities, according to a statement from the Agency.

By the end of May 2026, AEMS will provide real-time AE reports for all FDA-regulated products, including drugs, biologics, vaccines, medical devices, cosmetics, human foods and dietary supplements, and animal drugs and food, in a single streamlined dashboard. The FDA also plans to migrate historical AE reports to AEMS and roll out enhanced application program interfaces (APIs) and data analytics tools for the new system over the coming months.

In its press release, the FDA emphasized that the real-time AE reports from patients, clinicians, consumers, and manufacturers provided by the new system will be an important part of postmarket surveillance. Although these reports have limitations, they can reveal AE patterns or clusters that point to previously unrecognized risks.

The FDA previously processed approximately 6 million adverse event reports annually across multiple databases, which were associated with substantial operational costs and limited usability. The Agency expects the new system to improve access to safety data and reduce inefficiencies in reporting and analysis, according to their published statement.

Legacy systems replaced by AEMS include:

• FAERS (FDA Adverse Event Reporting System): Reports for drugs, biologics, cosmetic products, and color additives. 
• VAERS (Vaccine Adverse Event Reporting System): Reports for vaccines.
• AERS (Adverse Event Reporting System): Reports for animal drugs and animal foods. 
• MAUDE (Manufacturer and User Facility Device Experience): Reports for medical devices (to be migrated to AEMS in May 2026).
• HFCS (Human Foods Complaint System): Reports for human foods and dietary supplements (to be migrated to AEMS in May 2026).
• CTPAE (Center for Tobacco Products Adverse Event Reporting System): Reports for Electronic Nicotine Delivery Systems (ENDS) and other tobacco products (to be migrated to AEMS in May 2026).

The new AEMS platform can be accessed at https://www.fda.gov/safety/fda-adverse-event-monitoring-system-aems.

Source: US Food and Drug Administration. FDA launches new adverse event look-up tool. Press release. Published March 11, 2026. Accessed March 24, 2026. https://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool