FDA Adverse Events Reporting System Drug 2018

$716 / 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 2018. The Drug dataset contains drug/biologic information for as many medications as were reported for the event (1 or more 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 FDA.

Date Created

2018-05-12

Last Modified

2019-02-07

Version

2019-02-07

Update Frequency

Quarterly

Temporal Coverage

2018-01-01 to 2018-12-31

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, FAERS, Serious Adverse Event, Adverse Events Reporting System

Other Titles

FDA Adverse Events Reporting System Drugs Quarterly Report 2018, FDA Adverse Events Reporting System US Drugs 2018, FAERS Drugs Report 2018

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
Drug_Sequence_NumberSequence number for identifying a drug for a Case. To link to the "Drug Therapy Dates" file, both the Primary_Id (primary key) and the Drug_Sequence_Number (secondary key) are needed.integerrequired : 1 level : Ordinal
Role_of_Drug_in_EventCode for drug's reported role in event.string-
Drug_NameName of medicinal product. If a "Valid Trade Name" is populated for this ISR (Individual Safety Report), then Drug_Name = Valid Trade Name; if not, then Drug_Name = "Verbatim" name, exactly as entered on the report. For the great majority of reports, there is a "Valid Trade Name."string-
Product_Active_IngredientActive Ingredient of the product, when availablestring-
Source_of_Drug_NameCode for source of Drug_Name, either validated trade name or verbatim name.string-
Route_of_AdministrationThe route of drug administrationstring-
Dose_Verbatim_TextVerbatim text for dose, frequency, and route, exactly as entered on report.string-
Cumulative_Dose_to_First_ReactionCumulative dose to first reaction of the drugnumberlevel : Ratio
Unit_of_Cumulative_Dose_to_First_ReactionCumulative dose to first reaction unitstring-
Dechallenge_CodeDechallenge code, indicating if reaction abated when drug therapy was stoppedstring-
Rechallenge_CodeRechallenge code, indicating if reaction recurred when drug therapy was restartedstring-
Drug_Lot_NumberLot number of the drugstring-
Drug_Expiration_DateExpiration date of the drug. If a complete date is not available, a partial date is provideddate-
NDA_NumberNDA (New Drug Application) number of the drugstring-
Dose_AmountAmount of drug dose reportednumberlevel : Ratio
Dose_Unitstring-
Drug_Dosage_FormForm of drug dosage reportedstring-
Dose_FrequencyFrequency of dose reportedstring-
YearQuarterPrimary IdCase IdDrug Sequence NumberRole of Drug in EventDrug NameProduct Active IngredientSource of Drug NameRoute of AdministrationDose Verbatim TextCumulative Dose to First ReactionUnit of Cumulative Dose to First ReactionDechallenge CodeRechallenge CodeDrug Lot NumberDrug Expiration DateNDA NumberDose AmountDose UnitDrug Dosage FormDose Frequency
2018Q1145280162145280167ConcomitantLYRICAPREGABALINValidated trade name usedUnknown
2018Q1145280162145280168ConcomitantMantidanAMANTADINE HYDROCHLORIDEValidated trade name usedUnknown
2018Q1145280181145280181Primary Suspect DrugHUMIRAADALIMUMABValidated trade name usedSubcutaneousPositive dechallengeNegative rechallenge UNKNOWN,UNKNOWN125057.040.0Milligram(s)SOLUTION FOR INJECTION IN PRE-FILLED PENQOW
2018Q1145280181145280182Secondary Suspect DrugHUMIRAADALIMUMABValidated trade name usedSubcutaneousPositive dechallengeNegative rechallenge UNKNOWN,UNKNOWN125057.040.0Milligram(s)SOLUTION FOR INJECTION IN PRE-FILLED PENQOW
2018Q1145280181145280183ConcomitantGLIPIZIDE.GLIPIZIDEValidated trade name used
2018Q1145280181145280184ConcomitantMETFORMINMETFORMIN HYDROCHLORIDEValidated trade name used
2018Q1145280181145280185ConcomitantINDOMETHACIN.INDOMETHACINValidated trade name used
2018Q1145280181145280186ConcomitantENALAPRILENALAPRILValidated trade name used
2018Q1145280191145280191Primary Suspect DrugPROLIADENOSUMABValidated trade name usedUnknown60 MG/ML, UNKUnknown125320.0SOLUTION FOR INJECTION
2018Q1145280201145280201Primary Suspect DrugPROLIADENOSUMABValidated trade name usedUnknownUNKUnknown125320.0SOLUTION FOR INJECTION