FDA Adverse Events Reporting System Drug 2016

$716 / year

FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.
The Drug file contains drug/biologic information for as many medications as were reported for the event (1 or more 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. 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

2012-09-10

Last Modified

2017-02-25

Version

2017-02-25

Update Frequency

Quarterly

Temporal Coverage

2016-01-01 to 2016-12-31

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

Medwatch, FDA Maude, CDC Vaccines, CDC immunization

Other Titles

Medwatch FDA Adverse Events Reporting System Drug Therapy Dates 2016, FDA Maude FDA Adverse Events Reporting System Drug Therapy Dates 2016, CDC Vaccines FDA Adverse Events Reporting System Drug Therapy Dates 2016, CDC immunization FDA Adverse Events Reporting System Drug Therapy Dates 2016

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
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
2016Q1100036613100036611Primary Suspect DrugAMPYRADALFAMPRIDINE1Unknown10 MG, BIDHZTG22250.010.0MGTABLETBID
2016Q1100043112100043111Primary Suspect DrugPRADAXADABIGATRAN ETEXILATE MESYLATE1Oral220 MG22512.0110.0MGTABLETQ12H
2016Q1100043112100043112Secondary Suspect DrugPRADAXADABIGATRAN ETEXILATE MESYLATE122512.0
2016Q1100045852100045851Primary Suspect DrugXALATANLATANOPROST1OphthalmicUNK20597.0EYE DROPS, SOLUTION
2016Q1100045852100045852ConcominantGLAUCOTENSIL2
2016Q1100049985100049981Primary Suspect DrugAFINITOREVEROLIMUS1Oral2.5 MG, 3 TIMES PER WEEK22334.02.5MG
2016Q1100049985100049982Secondary Suspect DrugAFINITOREVEROLIMUS1Oral2.5 MG, QD (DAILY)22334.02.5MGQD
2016Q1100049985100049983ConcominantKEPPRALEVETIRACETAM1Unknown
2016Q1100049985100049984ConcominantSABRILVIGABATRIN1Unknown
2016Q1100049985100049985ConcominantFELBAMATE.FELBAMATE1Unknown