FDA Adverse Events Reporting System Drug Indication 2015

$395 / year

FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.
The Indication file contains all “Medical Dictionary for Regulatory Activities” (MedDRA) terms coded for the indications for use (diagnoses) for the reported drugs (0 or more per drug 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 Indications, FAERS Percentage Average, US Drug Indications, States Population, FAERS Database

Other Titles

Geographical Indication FDA Adverse Events Reporting System Indication 2015, Medwatch FDA Adverse Events Reporting System Indication 2015, Event Reports FDA Adverse Events Reporting System Indication 2015

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 manufacturer.integerrequired : 1 level : Nominal
Case_idNumber for identifying a FAERS case.integerrequired : 1 level : Nominal
Sequence_Number_for_Drug_IdentificationDrug sequence number for identifying a drug for a Case. To link to the “Drug” data file, both the Case number (primary key) and the drug sequence number (secondary key) are needed.integerrequired : 1 level : Ordinal
Indication_for_Use"Preferred Term"-level medical terminology describing the Indication for use, using the Medical Dictionary for Regulatory Activities (MedDRA).stringrequired : 1
YearQuarterPrimary_idCase_idSequence_Number_for_Drug_IdentificationIndication_for_Use
2015Q19835781298357812Tic
2015Q15752492757524921Acne
2015Q15978143759781431Acne
2015Q17105460371054604Gout
2015Q17163911671639115Pain
2015Q17163911671639116Pain
2015Q17163911671639117Pain
2015Q17163911671639118Pain
2015Q17228735972287356Pain
2015Q17293069572930697Pain