FDA Adverse Event Reporting System

GPTKB entity

Statements (25)
Predicate Object
gptkbp:instanceOf pharmacovigilance database
gptkbp:abbreviation FAERS
gptkbp:access publicly available
gptkbp:country gptkb:United_States
gptkbp:dataSource manufacturers
consumers
healthcare professionals
gptkbp:established 1998
gptkbp:frequency quarterly
https://www.w3.org/2000/01/rdf-schema#label FDA Adverse Event Reporting System
gptkbp:language English
gptkbp:operatedBy gptkb:U.S._Food_and_Drug_Administration
gptkbp:predecessor FDA Spontaneous Reporting System
gptkbp:provides adverse drug reactions
medication errors
gptkbp:purpose monitoring adverse drug events
postmarketing drug safety surveillance
gptkbp:type mandatory reports
spontaneous reports
voluntary reports
gptkbp:usedFor signal detection
regulatory decision making
gptkbp:website https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers
gptkbp:bfsParent gptkb:US_Food_and_Drug_Administration
gptkbp:bfsLayer 6