title: A curated and standardized adverse drug event resource to accelerate drug safety research.
abstract: Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results. We provide a curated and standardized version of FAERS removing duplicate case records, applying standardized vocabularies with drug names mapped to RxNorm concepts and outcomes mapped to SNOMED-CT concepts, and pre-computed summary statistics about drug-outcome relationships for general consumption. This publicly available resource, along with the source code, will accelerate drug safety research by reducing the amount of time spent performing data management on the source FAERS reports, improving the quality of the underlying data, and enabling standardized analyses using common vocabularies.
authors.affiliation: Center for Biomedical Informatics Research, Stanford University, Stanford, California 94305, USA.
authors.forename: Juan M
authors.identifier: 0000-0001-8499-824X
authors.initials: JM
authors.lastname: Banda
authors.affiliation: LTS Computing LLC, West Chester, Pennsylvania 19380, USA.
authors.forename: Lee
authors.initials: L
authors.lastname: Evans
authors.affiliation: Department of Biomedical Informatics, Columbia University, New York, New York 10032, USA.
authors.forename: Rami S
authors.initials: RS
authors.lastname: Vanguri
authors.affiliation: Department of Biomedical Informatics, Columbia University, New York, New York 10032, USA.
authors.forename: Nicholas P
authors.initials: NP
authors.lastname: Tatonetti
authors.affiliation: Janssen Research &Development, LLC, Titusville, New Jersey 08869, USA.
authors.forename: Patrick B
authors.initials: PB
authors.lastname: Ryan
authors.affiliation: Center for Biomedical Informatics Research, Stanford University, Stanford, California 94305, USA.
authors.forename: Nigam H
authors.initials: NH
authors.lastname: Shah
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration