U.S. FDA Launches Unified Adverse Event Monitoring System (AEMS)

The FDA’s new AEMS centralizes adverse event reporting for all regulated products—including cosmetics—providing real-time, publicly accessible data to streamline reporting and reduce administrative burdens.

On March 11, 2026, the U.S. Food and Drug Administration (FDA) announced the launch of the FDA Adverse Event Monitoring System (AEMS), a new unified platform and interactive public dashboard for analyzing adverse event reports. According to the agency, the system will be fully operational by the end of May 2026 to provide real-time adverse event reports for all FDA-regulated product categories, including medical products, vaccines, medical devices, tobacco products, food, cosmetics, and veterinary medicines.

The newly introduced AEMS is designed to replace several previously separate and outdated reporting systems used across different FDA centers. These include the FDA Adverse Event Reporting System (FAERS), which collects reports related to drugs, biologics, cosmetic products, and color additives; the Vaccine Adverse Event Reporting System (VAERS) for vaccine-related events; and the Adverse Event Reporting System (AERS) used for animal drugs and animal foods. By integrating these systems into a single platform, the FDA aims to streamline adverse event reporting and improve regulatory oversight across product sectors.

Beyond adverse event reports, AEMS will also function as a centralized hub for managing consumer complaints, regulatory misconduct reports, and whistleblower submissions submitted to different FDA centers. The agency expects that consolidating these functions and retiring legacy systems will generate approximately $120 million in cost savings over the next five years. Additionally, by publishing data in near real time rather than quarterly through the public dashboard, the FDA anticipates a significant reduction in requests submitted under the Freedom of Information Act (FOIA).

Through the FDA AEMS Public Dashboard, the general public, healthcare providers, and industry stakeholders can easily search for information related to adverse events. However, the agency emphasizes several limitations regarding the data: the existence of a report does not establish that a product caused the event, the submitted information is not independently verified, duplicate or incomplete reports may be present, and the data cannot be used to establish exact rates of occurrence.

U.S. FDA Launches Unified Adverse Event Monitoring System (AEMS)

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