FDA Launches Unified Adverse Event Monitoring System to Replace Seven Legacy Databases

The US Food and Drug Administration launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency's mission to modernize and provide radical transparency into the safety of regulated products. The new system went live on Wednesday, housing four legacy systems, with three more to move under the AEMS umbrella by the end of May.

With the new system, adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food can be displayed in a single streamlined dashboard. By the end of May 2026, AEMS will contain real-time adverse event reports for all FDA-regulated products, consistent with meeting agency obligations not to release individually identifiable patient or consumer information.

In the past, the agency processed approximately 6 million adverse event reports per year across a patchwork of seven databases, which were expensive and had a poor user interface, making searches difficult. These platforms collectively cost the agency 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. The agency also expects the new searchable system to significantly reduce agency FOIA requests for unreleased adverse event reports, given that AEMS will publish reports in real time, rather than quarterly.

Legacy systems to be replaced by AEMS now include FAERS (FDA Adverse Event Reporting System) — containing reports for drugs, biologics, cosmetic products, and colour additives; VAERS (Vaccine Adverse Event Reporting System) — containing reports for vaccines, which is co-managed by the FDA and Centers for Disease Control and Prevention; and AERS (Adverse Event Reporting System) — two databases containing reports for animal drugs and animal foods.

Legacy 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; and CTPAE (Center for Tobacco Products Adverse Event Reporting System) — containing reports for Electronic Nicotine Delivery Systems (ENDS) and other tobacco products.

The FDA had already been tweaking the reporting of adverse events. Last August, the agency announced that FAERS would be updated daily rather than quarterly. In the months ahead, all remaining product centres will begin processing adverse event reports in AEMS. 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.

AEMS does not overcome all limitations of the old systems. Adverse events posted to the legacy databases were unverified, and events listed in AEMS will also be unverified. As with the legacy systems, a listing in AEMS does not mean a particular product caused a particular event. The FDA also said the new system may include duplicate or incomplete reports and the rates of occurrence of an event cannot be established by these reports. However, the FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public.

Transparency around adverse event reports submitted by patients, consumers, clinicians and manufacturers is a critical component of the FDA'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.