FDA Adverse Event Reporting System (FAERS)

GPTKB entity

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:format	XML ASCII
gptkbp:frequency	quarterly
https://www.w3.org/2000/01/rdf-schema#label	FDA Adverse Event Reporting System (FAERS)
gptkbp:includes	drug information patient demographics adverse event details outcome information reporter information
gptkbp:language	English
gptkbp:limitation	underreporting incomplete information duplicate reports no proof of causality
gptkbp:maintainedBy	gptkb:U.S._Food_and_Drug_Administration
gptkbp:predecessor	FDA Spontaneous Reporting System (SRS)
gptkbp:provides	biologics drugs therapeutic biologic products
gptkbp:purpose	monitoring adverse events and medication error reports
gptkbp:relatedTo	gptkb:Vaccine_Adverse_Event_Reporting_System_(VAERS) EudraVigilance WHO VigiBase
gptkbp:reportingIs	mandatory for manufacturers voluntary for consumers and healthcare professionals
gptkbp:type	adverse event reports medication error reports
gptkbp:usedFor	research regulatory review signal detection public health monitoring regulatory decision making drug safety analysis postmarketing surveillance signal detection and evaluation
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:U.S._Food_and_Drug_Administration_(FDA)
gptkbp:bfsLayer	7