United States' FDA begins real-time publication of adverse event data

The United States Food and Drug Administration (FDA) has begun daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS). The agency says that the move represents a significant step in the modernisation of its safety monitoring infrastructure and has demonstrated its commitment to greater transparency and real-time protection of public health.

“Adverse event reporting should be fast, seamless and transparent,” said FDA Commissioner Marty Makary, M.D., M.P.H., who was formally sworn in as the 27th FDA Commissioner on 1 April 2025, following his proposal to the appointment by President Donald J. Trump at the start of his second administration.

“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,” Makary said.

FAERS is the FDA’s primary database to collect and analyse reports of adverse events, serious medication errors and product quality complaints relating to prescription medicines and therapeutic biologics. Reports are submitted by healthcare professionals, consumers and manufacturers.

The shift has formed part of the FDA’s wider data modernisation strategy to streamline adverse event reporting and to increase reporting frequency across all systems in order to identify safety signals more quickly.

The public can now view the latest data through the FAERS Public Dashboard. Healthcare professionals and consumers are encouraged to submit adverse event reports through the FDA’s MedWatch website.

The FDA is an agency within the US Department of Health and Human Services, regulates the safety, effectiveness and security of medicines, vaccines and other biological products for human use, as well as medical devices. It also carries responsibility for the safety of the food supply, cosmetics, dietary supplements and radiation-emitting electronic products, and for the regulation of tobacco products.