FAERS

Also known as: FDA Adverse Event Reporting System

The FDA database of post-marketing adverse event and medication error reports.

Definition

The FDA Adverse Event Reporting System (FAERS) is a public database of adverse event and medication error reports submitted to the FDA after a drug is marketed. Reporting is mandatory for sponsors and voluntary for healthcare professionals and patients. FAERS is the primary source for post-marketing safety signal detection.

See also

• Adverse event — Any untoward medical occurrence in a patient receiving a drug, regardless of causality.
• PV — The science of detecting and managing adverse drug effects after marketing.

Other safety terms

• Drug interaction
• Adverse event
• Boxed warning
• REMS
• PV