FDA Updates Adverse Drug Events Reporting Schedule

The Food and Drug Administration (FDA) announced that adverse event information from the FDA Adverse Event Reporting System (FAERS) will now be published daily, replacing the previous quarterly reporting schedule. This change is intended to improve transparency and accelerate the identification of potential drug safety issues, according to a statement issued by the Agency.

FAERS collects reports on adverse events, serious medication errors, and product quality concerns related to prescription drugs and biologics from healthcare professionals, patients, and manufacturers. The public can access this information through the FAERS Public Dashboard.

According to the FDA, the FAERS system processes more than 2 million reports annually. Moving to daily publication is part of the agency’s broader data modernization strategy, which aims to streamline adverse event reporting across platforms and enhance public health protections. Clinicians are encouraged to continue submitting suspected adverse drug events through the FDA’s MedWatch program, which remains a critical pathway for identifying new safety signals in real time: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm

Source: HealthDay News. FDA now providing daily updates on adverse events. NeurologyAdvisor.com. Published 3 September, 2025. Accessed 9 September, 2025. https://www.neurologyadvisor.com/news/fda-now-providing-daily-updates-on-adverse-events

US Food & Drug Administration. FDA begins real-time reporting of adverse event data. FDA.gov. Published 22 August, 2025. Accessed 9 September, 2025. https://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data#xd_co_f=NzhmMWMyZGYtNDk0OC00MDg2LTliYTMtZjJlZjNkY2YxNzMw~