FDA Adverse Events Reporting System Drug Indication 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 Indication file contains all “Medical Dictionary for Regulatory Activities” (MedDRA) terms coded for the indications for use (diagnoses) for the reported drugs (0 or more per drug per event).

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

FAERS, FDA Adverse Events, FDA AERS, FDA Indications For Use, MedDRA, Adverse Event Reports

Other Titles

FDA Adverse Events Reporting System Indications For Use 2017, MedDRA FDA Adverse Events Reporting System Indications 2017, FDA Event Reports Indication For Use 2017

Name Description Type Constraints
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 caseintegerrequired : 1 level : Nominal
Drug_Sequence_NumberDrug sequence number for identifying a drug for a Case. To link to the “Drug” data file, both the Primary_Id (primary key) and the Drug_Sequence_Number (secondary key) are neededintegerrequired : 1 level : Ordinal
Preferred_Term_Indication_For_Use"Preferred Term"-level medical terminology describing the indication for use, using the Medical Dictionary for Regulatory Activities (MedDRA)stringrequired : 1
YearQuarterPrimary_IdCase_IdDrug_Sequence_NumberPreferred_Term_Indication_For_Use
2017Q16140575261405757Pain
2017Q16140575261405758Pain
2017Q16140575261405759Pain
2017Q16141903461419031Pain
2017Q16141903461419032Pain
2017Q16141903461419033Pain
2017Q16276032962760321Pain
2017Q16276032962760322Pain
2017Q16276032962760323Pain
2017Q16276032962760324Pain