FAERS

The FDA Adverse Event Reporting System (FAERS) is a database maintained by the U.S. Food and Drug Administration for postmarketing safety surveillance of approved drugs and therapeutic biologics. It collects reports of adverse events and medication errors to monitor drug safety and inform regulatory actions.

Reports to FAERS originate from healthcare professionals, consumers, manufacturers, importers, and other entities. Submissions can be voluntary or mandatory depending on regulatory requirements. FAERS uses standardized terminology from MedDRA and records information such as patient demographics, suspected drugs and concomitant medications, adverse event descriptions, seriousness, outcome, reporter type, and report date. The data are analyzed to identify safety signals and trends.

FAERS supports regulatory activities including signal detection, risk assessment, labeling changes, safety communications, and other actions aimed at protecting public health. Data limitations reflect those of spontaneous reporting systems: under-reporting, reporting biases, incomplete information, potential duplicates, and the inability to establish causality from individual reports. Causal relationships are usually evaluated through broader risk-benefit analyses and follow-up studies.

Access to FAERS information is provided to the public through the FDA’s FAERS Public Dashboard and quarterly data extracts, enabling researchers and clinicians to explore safety data while applying appropriate methodological controls. For vaccines, separate reporting occurs through the Vaccine Adverse Event Reporting System (VAERS), which is distinct from FAERS. Overall, FAERS serves as a key component of the FDA’s pharmacovigilance infrastructure for monitoring the safety of marketed drugs and biologics.