FDA Adverse Events Reporting System Drug 2015

$395 / 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

2016-03-15

Version

2016-03-15

Update Frequency

Quarterly

Temporal Coverage

2015-01-01 to 2015-12-31

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

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

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

Other Titles

Medwatch FDA Adverse Events Reporting System Drug Therapy Dates 2015, FDA Maude FDA Adverse Events Reporting System Drug Therapy Dates 2015, CDC Vaccines FDA Adverse Events Reporting System Drug Therapy Dates 2015, CDC immunization FDA Adverse Events Reporting System Drug Therapy Dates 2015

Name Description Type Constraints
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 manufacturer.integerrequired : 1 level : Nominal
Case_idNumber for identifying a FAERS case.integerrequired : 1 level : Nominal
Sequence_Number_for_Drug_IdentificationNumber for identifying a drug for an ISR. To link to the “Drug Therapy Dates” data file, both the ISR number (primary key) and the Drug Sequence number (secondary key) are needed.integerrequired : 1 level : Nominal
Role_of_Drug_in_EventCode for drug's reported role in event. Abbreviations: PS means Primary Suspect Drug, SS means Secondary Suspect Drug, C means Concomitant, I means Interactingstring-
Drug_NameName of medicinal product. If a "Valid Trade Name" is populated for this ISR, 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-
Drug_Name_Source_CodeCode for source of DRUGNAME. Abbreviations: 1 means Validated trade name used, 2 means Verbatim name usedintegerrequired : 1 level : Nominal
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 drugstring-
Unit_of_Cumulative_Dose_to_First_ReactionCumulative dose to first reaction unitstring-
Dechallenge_CodeDechallenge code, indicating if reaction abated when drug therapy was stopped. Abbreviations: Y means Positive dechallenge, N means Negative dechallenge, U means Unknown, D means Does not applystring-
Rechallenge_CodeRechallenge code, indicating if reaction recurred when drug therapy was restarted. Abbreviations: Y means Positive rechallenge, N means Negative rechallenge, U means Unknown, D means Does not applystring-
Drug_Lot_NumberLot number of the drug.string-
Drug_Expiration_DateExpiration date of the drug. (YYYYMMDD format) - If a complete date is not available, a partial date is providedstring-
New_Drug_Application_NumberNDA number (numeric only)string-
Reported_Dose_AmountAmount of drug dose reportedstring-
Dose_Unitstring-
Reported_Drug_Dosage_FormForm of dose reportedstring-
Reported_Dose_FrequencyCode for Dose Frequency. NOTE: The list below provides frequency codes which are commonly reported; however, dose frequency codes are not limited to this list and other code values may be present.string-
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