FDA Adverse Events Reporting System Drug 2014

$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).


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


Last Modified




Update Frequency


Temporal Coverage

2014-01-01 to 2014-12-31

Spatial Coverage

United States


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


Source Citation



FDA Adverse Events Reporting, FAERS System Drugs Data, FAERS Percentage Average, US Drugs, States Population, FAERS Database

Other Titles

Medwatch FDA Adverse Events Reporting System Drug Therapy Dates 2014, FDA Maude FDA Adverse Events Reporting System Drug Therapy Dates 2014, CDC Vaccines FDA Adverse Events Reporting System Drug Therapy Dates 2014, CDC immunization FDA Adverse Events Reporting System Drug Therapy Dates 2014

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 manufacturerintegerlevel : Nominal required : 1
Case_IdCase number for identifying a FAERS case.integerlevel : Nominal required : 1
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.integerlevel : Ordinal required : 1
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 provided.date-
NDA_NumberNDA (New Drug Application) number of the drugstring-
Dose_AmountAmount of drug dose reportednumberlevel : Ratio
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
2014Q11007835811007835821ConcomitantSENNAPUR (SENNOSIDE A+B CALCIUM)22014-12-31
2014Q19960758199607581Primary Suspect DrugACTIVASE1UNKNOWNDD2014-12-31103172.0
2014Q1103777231103777231Primary Suspect DrugREVLIMID (LENALIDOMIDE) (10 MILLIGRAM, CAPSULES)1ORALYA0206A2014-12-3121880.010.0MGQD
2014Q1100783431100783431Primary Suspect DrugAUBAGIO1ORAL2CK3DSA2014-12-3114.0MGQD
2014Q1100783461100783461Primary Suspect DrugINFUMORPH1YD2014-12-3118565.00.5MGQD
2014Q18761681387616811Primary Suspect DrugMATULANE1ORALB1102532014-12-3116785.0100.0MG/M**2CAPSULE
2014Q18761860287618601Primary Suspect DrugMATULANE CAPSULES1ORALB1102532014-12-3116785.0100.0MG
2014Q18789413387894131Primary Suspect DrugMATULANE CAPSULES1ORALDDB1102532014-12-3116785.0100.0MG
2014Q18789718287897181Primary Suspect DrugMATULANE CAPSULES1ORALB1102532014-12-3116785.0100.0MG
2014Q18984675389846751Primary Suspect DrugMATULANE CAPSULES1ORAL2012 FOR 10 DAYSB1102532014-12-3116785.0100.0MG