FDA Adverse Event Reporting System (FAERS)
GPTKB entity
Statements (46)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb: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
|
| 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 |
gptkb:research
gptkb: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
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Adverse Event Reporting System (FAERS)
|