FDA Launches Real-Time Reporting of Adverse Event Data

by Emmitt Barry, with reporting from Washington D.C. Bureau Staff

(Worthy News) – The U.S. Food and Drug Administration (FDA) announced Friday that it has begun publishing daily reports of adverse event data, a move officials call a major leap toward “radical transparency” in public health oversight.

The change marks the first time the FDA’s Adverse Event Reporting System (FAERS) will provide real-time updates, rather than requiring the public to wait months for new information. FAERS is the agency’s primary database for collecting and analyzing reports of medication side effects, serious drug errors, and product quality complaints from healthcare professionals, consumers, and manufacturers.

“Adverse event reporting should be fast, seamless and transparent,” said FDA Commissioner Marty Makary, M.D., M.P.H., in a statement. “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 also posted on his X account that the move reflects the agency’s commitment to “radical transparency” and modernizing its safety infrastructure. The shift is part of a broader FDA data modernization strategy designed to boost reporting frequency and allow safety signals to be identified more quickly.

The Department of Health and Human Services, under Secretary Robert F. Kennedy, Jr., has backed the move as part of an effort to modernize medical oversight systems. The FDA defines an adverse event as “any undesirable experience associated with the use of a medical product in a patient.”

The latest daily data can be accessed on the FAERS Public Dashboard, and both healthcare providers and consumers are encouraged to continue submitting reports through the FDA’s MedWatch portal.

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