FDA's New Adverse Event Look-Up Tool

The U.S. Food and Drug Administration (FDA) has launched a new unified platform for analyzing adverse event reports. The AEMS platform represents a major achievement in the agency's mission to modernize and provide transparency into the safety of regulated products. 

FDA's Adverse Event Monitoring System (AEMS)

Adverse event reports (AERs) can be submitted by patients, consumers, clinicians and manufacturers. Although these reports have limitations, they can help identify potential safety signals, such as patterns or clusters of adverse events that might indicate previously unknown risks. With the new system, AERs submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food can be displayed in a single streamlined dashboard. The agency will also migrate historical adverse event data to AEMS, decommission certain legacy systems, and roll out enhanced application program interfaces (APIs) and data analytics tools. By the end of May 2026, AEMS will contain real-time adverse event reports for all FDA-regulated products, consistent with meeting FDA's obligations not to release individually identifiable patient or consumer information.

The AEMS now includes:

• FAERS (FDA Adverse Event Reporting System) - containing reports for drugs, biologics, cosmetic products, and color additives.
• VAERS (Vaccine Adverse Event Reporting System) - containing reports for vaccines. 
• AERS (Adverse Event Reporting System) - two databases containing reports for animal drugs and animal foods.

Systems to be replaced by AEMS in May include:

• MAUDE (Manufacturer and User Facility Device Experience) - containing reports for medical devices.
• HFCS (Human Foods Complaint System) - containing reports for human foods and dietary supplements.
• CTPAE (Center for Tobacco Products Adverse Event Reporting System) - containing reports for Electronic Nicotine Delivery Systems (ENDS) and other tobacco products.

For more information please see FDA's Adverse Event Monitoring System (AEMS).