FDA Adverse Event Monitoring System (AEMS) Public Dashboard

FDA Adverse Event Monitoring System (AEMS)

FDA is implementing the Adverse Event Monitoring System (AEMS) to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines. This unified platform is designed to enhance data quality and consistency through standardized reporting protocols, streamline reporting processes to reduce administrative burden on both internal FDA staff and external stakeholders, and strengthen safety surveillance capabilities through advanced case processing workflows, AI-based redaction and digitization tools, enhanced analytics, and comprehensive cross-product surveillance. Beyond adverse event reporting, AEMS will serve as a centralized platform for managing consumer complaints, regulatory misconduct reports, and whistleblower submissions across all FDA centers. This comprehensive approach will enable more effective safety monitoring, facilitate trend identification across diverse product categories, and support timely regulatory decision-making to protect public health through improved data integration and analysis capabilities.

The FDA AEMS Public Dashboard is a highly interactive web-based tool that will allow for the querying of AEMS data in a user friendly fashion. The intention of this tool is to expand access of AEMS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers.

Launch the FDA Adverse Event Monitoring System (AEMS) Public Dashboard

 AEMS Public Dashboard

While the FDA AEMS Public Dashboard offers stakeholders many more ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products, there remain 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 themselves are not an indicator of the safety profile of the drug or biologic. Some additional limitations to note include:

1. Duplicate and incomplete reports are in the system: There are many instances of duplicative reports and some reports do not contain all the necessary information.
2. Existence of a report does not establish causation: For any given report, there is no certainty that a suspected drug 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.
3. Information in reports has not been verified: Submission of a report does not mean that the information included in it has been medically confirmed nor it is an admission from the reporter that the drug caused or contributed the event.
4. 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.
5. 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 this 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.