FDA Begins Daily Publication of Drug Adverse Event Data

On August 22, 2025, the FDA began publishing adverse event data from the FDA Adverse Event Reporting System (FAERS) on a daily basis, transitioning from quarterly updates1 5.

FAERS is the FDA’s primary database for collecting and analyzing adverse event reports, serious medication errors, and product quality complaints involving prescription drugs and biological products, with reports submitted by healthcare professionals, consumers, and manufacturers2 5.

FDA Commissioner Marty Makary emphasized the agency’s commitment to making adverse event reporting fast, seamless, and transparent, eliminating the previous months-long wait for public data access1 2 3 4 5.

This initiative is part of a broader FDA data modernization strategy aimed at streamlining all adverse event reporting systems, increasing reporting frequency, and improving identification of safety signals for better patient protection1 2 3 5.

Daily publication will allow healthcare professionals and patients timely access to safety signals and adverse events, potentially enabling quicker clinical decision-making and improved public health oversight3 5.

The daily reports are available to the public via the FAERS Public Dashboard, and healthcare professionals and consumers are encouraged to continue reporting adverse events to the FDA’s MedWatch site2 3 5.