FDA Begins Real-Time Reporting of Adverse Event Data

August 25, 2025—The FDA announced it has commenced daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS).

As noted in the press release, FAERS is the FDA’s primary database for collecting and analyzing adverse event reports, serious medication errors, and product quality complaints for prescription drugs and therapeutic biologics. It contains reports submitted by health care professionals, consumers, and manufacturers.

According to FDA, this step is intended to modernize the agency’s safety monitoring infrastructure and demonstrate its commitment to transparency and real-time protection of public health.

The agency further stated that the shift is part of its broader data modernization strategy to streamline all of its adverse event reporting systems and increase reporting frequency across all systems to identify safety signals faster.

“Adverse event reporting should be fast, seamless, and transparent,” commented FDA Commissioner Marty Makary, MD, in the press release. “People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public. We’re closing that waiting period and will continue to streamline the process from start to finish.”

The public can view the latest adverse event data on the FAERS Public Dashboard. Health care professionals and consumers are encouraged to report adverse events to the FDA’s MedWatch site, advised the agency.