FDA Adverse Event Monitoring System (AEMS): Unified Safety Reporting Platform

The FDA Adverse Event Monitoring System (AEMS) is a centralized platform designed to streamline adverse event reporting across all FDA-regulated products. It improves safety monitoring, data quality, and regulatory transparency.

AEMS uses standardized reporting and advanced analytics, including AI-driven tools, to strengthen safety surveillance and enable cross-product risk analysis. It also reduces administrative burden for both FDA staff and industry stakeholders.

The system supports reporting of adverse events, consumer complaints, regulatory misconduct, and whistleblower inputs. The AEMS Public Dashboard allows users to explore and analyze safety data through an interactive interface.

However, AEMS data may include duplicates or unverified reports and does not establish causation. Users are advised to consult healthcare professionals before making any medical decisions based on reported data.

Region: United States
Source: https://www.fda.gov/safety/fda-adverse-event-monitoring-system-aems