FDA Adverse Events Reporting System Drug Reaction 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 FDA (U.S. Food and Drug Administration) in 2019. The drug reaction dataset contains all “Medical Dictionary for Regulatory Activities” (MedDRA) terms coded for the adverse event (1 or more).

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 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

FAERS Database, Adverse Reaction, Adverse Events of Medication, Adverse Event Reporting Form, Serious Adverse Event, Adverse Events Reporting System, FDA Adverse Events Reporting, FAERS System Reactions, FAERS Percentage Average, States Population

Other Titles

FDA Adverse Events Reporting System Quarterly Report 2019, FAERS Drug Reaction Report 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 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 re-administration of the drug.string-
YearQuarterPrimary IdCase IdPreferred Term For EventDrug Recur Action
2019Q1100066181210006618Drug hypersensitivity
2019Q1100066181210006618Muscular weakness
2019Q1100066181210006618Rash
2019Q1100066181210006618Urticaria
2019Q1100080859010008085Abdominal adhesions
2019Q1100080859010008085Anaemia
2019Q1100080859010008085Arrhythmia
2019Q1100080859010008085Arthralgia
2019Q1100080859010008085Atrial fibrillation
2019Q1100080859010008085Back pain