FDA Adverse Events Reporting System Drug Reaction 2017

$395 / year

FAERS (FDA Adverse Events Reporting System) database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The “Drug Reaction” file contains all “Medical Dictionary for Regulatory Activities” (MedDRA) terms coded for the adverse event (1 or more).

Complexity

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA (U.S. Food and Drug Administration). The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

FAERS is used for the spontaneous reporting of adverse events and medication errors involving human drugs and therapeutic biological products. FAERS began on September 10, 2012, and replaced the Adverse Event Reporting System (also known as Legacy AERS), which was decommissioned on August 27, 2012.

FAERS is a useful tool for FDA for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer’s compliance to reporting regulations and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor the safety of products after they are approved by FDA. If a potential safety concern is identified in FAERS, further evaluation is performed. Further evaluation might include conducting studies using other large databases, such as those available in the Sentinel System. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.

Reporting of adverse events and medication errors by healthcare professionals and consumers is voluntary in the United States. FDA receives some adverse event and medication error reports directly from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report adverse events and/or medication errors to the products’ manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations. The reports received directly and the reports from manufacturers are entered into FAERS.

Date Created

2017-01-01

Last Modified

2017-12-02

Version

2017-12-02

Update Frequency

Quarterly

Temporal Coverage

2017-01-01 to 2017-09-30

Spatial Coverage

United States

Source

John Snow Labs => U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Adverse Drug Reactions, US Demographics, Drug Reaction Data by FDA, AERS database, FAERS Database, FDA Adverse Events

Other Titles

FDA Adverse Events Reporting System Quarterly Report 2017, FAERS Drug Reaction Report 2017

NameDescriptionTypeConstraints
YearThe year in which the data was submitteddaterequired : 1
QuarterThe quarter of the year in which the data was submittedstringrequired : 1
Primary_IdNumber for identifying a FAERS report. This is the primary link field (primary key) between data files. This is a concatenated key of Case_Id and Case_Version_Number. It is the Identifier for the case sequence (version) number as reported by the manufacturerintegerrequired : 1 level : Nominal
Case_IdCase number for identifying a FAERS case.integerrequired : 1 level : Nominal
Preferred_Term_For_Event"Preferred Term"-level medical terminology describing the event, using the Medical Dictionary for Regulatory Activities (MedDRA). The order of the terms for a given event does not imply priority. In other words, the first term listed is not necessarily considered more significant than the last one listed.string-
Drug_Recur_ActionDrug Recur Action data - populated with reaction/event information (Preferred_Term_For_Event) if/when the event reappears upon readministration of the drug.string-
YearQuarterPrimary_IdCase_IdPreferred_Term_For_EventDrug_Recur_Action
2017Q2935884129358841Tic
2017Q1404264734042647Fall
2017Q1410294934102949Rash
2017Q1609196256091962Coma
2017Q1624412526244125Pain
2017Q1698051956980519Pain
2017Q1706343947063439Fall
2017Q1738230057382300Fear
2017Q1747622627476226Acne
2017Q1749026667490266Rash