The U.S. Food and Drug Administration (FDA) has unveiled a new Adverse Event Monitoring System (AEMS) that streamlines adverse event complaints for all FDA-regulated products into a single platform. AEMS will publish reports in real time, rather than quarterly.

The AEMS Public Dashboard is now available.

Animal foods and color additive complaints have already been integrated into the new system. Human foods complaints will be added in May 2026, along with adverse event reports for all remaining FDA-regulated products.

FDA also intends to migrate historical adverse event data to AEMS and roll out enhanced application program interfaces (APIs) and data analytics tools.

Human Foods Complaints Coming to AEMS in May

At the time of the March 11 launch, legacy adverse event reporting systems that have been replaced by AEMS include:

• The FDA Adverse Event Reporting System (FAERS): Drugs, biologics, cosmetic products, and color additives
• The Vaccine Adverse Event Reporting System (VAERS): Vaccines
• The Adverse Event Reporting System (AERS): Animal drugs and animal foods.

In May, the remaining FDA adverse event and complaint reporting systems will be replaced by AEMS, including:

• The Human Foods Complaint System (HFCS): Human foods and dietary supplements
• The Manufacturer and User Facility Device Experience (MAUDE): Medical devices
• The Center for Tobacco Products Adverse Event Reporting System (CTPAE): Tobacco products and electronic nicotine delivery systems.

All legacy systems will eventually be decommissioned.

FDA Expects to Save Millions

In the past, the agency processed approximately 6 million adverse event reports per year across a patchwork of seven databases, which were expensive to maintain and cumbersome to navigate. These platforms cost FDA approximately $37 million per year to operate.

Given the efficiencies of AEMS, the agency expects to save approximately $120 million over the next five years.

FDA also expects AEMS to significantly reduce agency Freedom of Information Act (FOIA) requests for unreleased adverse event reports, given that the system will be updated in real time.

Improving Surveillance Capabilities

According to FDA, transparency around adverse event reports submitted by patients, consumers, clinicians, and manufacturers is a critical component of the agency's postmarket surveillance capability. 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. However, the utility of these reports has often been undermined by inefficient infrastructure—a pain point which AEMS is designed to address.