FDA Announcement: FDA Launches AEMS: Making Adverse Event Reports Easier to Access and Understand
Have you ever wondered how the Food and Drug Administration (FDA) keeps track of reported problems and side effects related to drugs, biologics, vaccines, cosmetics, and animal food? For years, the FDA’s reporting systems were not particularly user friendly, complicated, and tough to navigate. Important safety information often got buried, costing millions of tax dollars, and made it hard for the public and FDA’s scientists to find the information they needed. On 03/11/2026, the FDA announced they would launch a new platform for analyzing adverse event reports. This platform unveiled by the FDA is the Adverse Event Monitoring System (AEMS) which represents an achievement in the agency’s mission to modernize and provide radical transparency into how adverse event reports are collected, analyzed, and addressed for the safety of regulated products [1] .
With AEMS, reports about side effects or problems with drugs, biologics, vaccines, cosmetics, and animal food are all available in one place. No more jumping between different websites or waiting months for the latest data. In the coming months, the FDA will move its product safety reports (new and legacy) into this single dashboard. Proposed by the end of May 2026, AEMS will give real-time updates for every product the FDA oversees, while still protecting people’s private information.
Before AEMS, the FDA juggled about 6 million reports every year using multiple separate systems. These were not just hard to use; they cost millions to run! The switch to AEMS is expected to save taxpayers $120 million over the next five (5) years. Also, because reports will be available instantly (instead of every few months), there should be far fewer public information requests. People will be able to look up safety issues themselves.
Why does this matter? When doctors, patients, or manufacturers notice something unusual or notice safety issue concerns, they can file a repot with the FDA. These reports help spot trends that the FDA might not have seen otherwise. But when these reports are stuck in clunky and slow systems, it’s harder to spot problems quickly. AEMS changes all of this making important safety information is easier to find and act on.
Legacy systems to be replaced by AEMS include:
FAERS (FDA Adverse Event Reporting System) – Contains reports for drugs, biologics, cosmetic products, and color additives.
VAERS (Vaccine Adverse Event Reporting System) – Contains reports for vaccines. NOTE: The FDA will display VAERS data in AEMS. VAERS is co-managed by the FDA and Centers for Disease Control and Prevention.
AERS (Adverse Event Reporting System) – Two (2) 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) – Contains reports for medical devices.
HFCS (Human Foods Complaint System) – Contains reports for human foods and dietary supplements.
CTPAE (Center for Tobacco Products Adverse Event Reporting System) – Contains reports for Electronic Nicotine Delivery Systems (ENDS) and other tobacco products.
Using the FDA AEMS Public Dashboard[2]
The FDA AEMS Public Dashboard is an interactive web-based tool that allows users to query AEMS data.
AEMS Data Limitations[2]
While the FDA AEMS Public Dashboard offers users more ways of searching for and organizing data reported to the FDA, there are still some limitations to the data. For example, while AEMS contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the AEMS data by itself is not an indicator of the safety profile of a product. Some additional limitations to note include:
There are instances of duplicate and incomplete reports in the system.
For any given report, there is no certainty that a suspected product caused the event. While consumers and healthcare professionals are encouraged to report adverse events, the event may have been related to the underlying disease being treated or caused by some other drug being taken concurrently, or occurred for other reasons. The information in these reports reflects only the reporter’s observations and opinions.
Submission of a report does not mean that the information included in it has been confirmed nor it is an admission from the reporter that the product caused or contributed to the event.
Rates of occurrence cannot be established with reports. The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Patients should talk to their doctor before stopping or changing how they take their medications.
Improving data access and transparency are core concepts that drove the development of the FDA AEMS Public Dashboard. 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. Complete and detailed reports are immensely helpful to the agency when monitoring the benefit-risk profile of regulated products throughout their entire lifecycle.
In short, the FDA’s new AEMS system makes it easier for everyone to keep track of product safety. It’s a leap forward for transparency, public health, and your right to know.
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References
[2] https://www.fda.gov/safety/fda-adverse-event-monitoring-system-aems