FDA Adverse Events Reporting System Drug Indication 2019

$179 / year

The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to the FDA (U.S. Food and Drug Administration) in 2019. The Indication dataset 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

FAERS (FDA Adverse Event Reporting System) is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. It is a useful tool for FDA (U.S. Food and Drug Administration) 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.

The reports in FAERS are submitted to FDA by 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 to the products’ manufacturers who then send these reports to the FDA.

Date Created

2019-04-26

Last Modified

2019-04-26

Version

2019-04-26

Update Frequency

Quarterly

Temporal Coverage

2019-01-01 to 2019-03-01

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

Source License Requirements

N/A

Source Citation

N/A

Keywords

Adverse Events of Medication, Adverse Event Reporting Form, Geographical Indication, Medwatch, Event Reports, FDA Adverse Events Reporting, FAERS System Indications, FAERS Percentage Average, US Drug Indications

Other Titles

FDA Adverse Events Reporting System Indications For Use 2019, MedDRA FDA Adverse Events Reporting System Indications 2019, FDA Event Reports Indication For Use 2019

NameDescriptionTypeConstraints
YearThe year in which the data was submitteddaterequired : 1
QuarterThe quarter of the year in which the data was submittedstringrequired : 1 enum : Array
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
2019Q11000808590100080851Neuroendocrine tumour
2019Q11000808590100080852Metastases to liver
2019Q11000808590100080858Neuroendocrine tumour
2019Q11000808590100080859Metastases to liver
2019Q110008085901000808510Product used for unknown indication
2019Q110008085901000808513Product used for unknown indication
2019Q110008085901000808514Arrhythmia
2019Q110008085901000808515Atrial fibrillation
2019Q110008085901000808516Product used for unknown indication
2019Q110008085901000808518Product used for unknown indication