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FDA to Begin Publishing Adverse Event Data Daily

08/25/2025

With the goal of modernizing safety oversight, the FDA said it will begin publishing adverse event data from the FDA Adverse Event Reporting System (FAERS) on a daily basis.

“Adverse event reporting should be fast, seamless and transparent,” said FDA Commissioner Marty Makary, MD, MPH. “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.”

FAERS serves as the FDA’s primary database for tracking adverse event reports, serious medication errors, and product quality complaints. The reports come from healthcare professionals, consumers, and manufacturers. \

For eye care professionals, this shift offers immediate access to signals about ophthalmic drugs, biologics, and systemic therapies with ocular side effects. Conditions such as ocular inflammation, retinal toxicity, corneal damage, or drug-induced visual disturbances—often reported late in the current system—can now be monitored in near real-time, helping practitioners make faster, evidence-based clinical decisions.

The daily release of FAERS data is one component of the FDA’s broader effort to overhaul its safety monitoring infrastructure. The initiative aims to: streamline adverse event reporting systems across the agency, increase reporting frequency across all therapeutic categories, and identify safety signals faster to improve patient protection.

The latest adverse event data can be accessed on the FAERS Public Dashboard.

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