Others titles
- FDA Adverse Events Reporting System Drugs Quarterly Report 2017
- FDA Adverse Events Reporting System US Drugs 2017
- FAERS Drugs Report 2017
Keywords
- Percentage Average
- US Demographics
- States Population
- AERS database
- FAERS Database
- FDA Adverse Events
FDA Adverse Events Reporting System Drug 2017
FAERS (FDA Adverse Events Reporting System) 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).
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Description
The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA (U.S. Food and Drug Administration). 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.
About this Dataset
Data Info
Date Created | 2017-01-01 |
---|---|
Last Modified | 2017-12-02 |
Version | 2017-12-02 |
Update Frequency |
Quarterly |
Temporal Coverage |
2017-01-01 to 2017-09-30 |
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 | Percentage Average, US Demographics, States Population, AERS database, FAERS Database, FDA Adverse Events |
Other Titles | FDA Adverse Events Reporting System Drugs Quarterly Report 2017, FDA Adverse Events Reporting System US Drugs 2017, FAERS Drugs Report 2017 |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Year | The year in which the data was submitted | date | required : 1 |
Quarter | The quarter of the year in which the data was submitted | string | required : 1 |
Primary_Id | Number 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 | integer | level : Nominalrequired : 1 |
Case_Id | Case number for identifying a FAERS case. | integer | level : Nominalrequired : 1 |
Drug_Sequence_Number | Sequence 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. | integer | level : Ordinalrequired : 1 |
Role_of_Drug_in_Event | Code for drug's reported role in event. | string | - |
Drug_Name | Name 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_Ingredient | Active Ingredient of the product, when available | string | - |
Source_of_Drug_Name | Code for source of Drug_Name, either validated trade name or verbatim name. | string | - |
Route_of_Administration | The route of drug administration | string | - |
Dose_Verbatim_Text | Verbatim text for dose, frequency, and route, exactly as entered on report. | string | - |
Cumulative_Dose_to_First_Reaction | Cumulative dose to first reaction of the drug | number | level : Ratio |
Unit_of_Cumulative_Dose_to_First_Reaction | Cumulative dose to first reaction unit | string | - |
Dechallenge_Code | Dechallenge code, indicating if reaction abated when drug therapy was stopped | string | - |
Rechallenge_Code | Rechallenge code, indicating if reaction recurred when drug therapy was restarted | string | - |
Drug_Lot_Number | Lot number of the drug | string | - |
Drug_Expiration_Date | Expiration date of the drug. If a complete date is not available, a partial date is provided | date | - |
NDA_Number | NDA (New Drug Application) number of the drug | string | - |
Dose_Amount | Amount of drug dose reported | number | level : Ratio |
Dose_Unit | string | - | |
Drug_Dosage_Form | Form of drug dosage reported | string | - |
Dose_Frequency | Frequency of dose reported | string | - |
Data Preview
Year | Quarter | Primary Id | Case Id | Drug Sequence Number | Role of Drug in Event | Drug Name | Product Active Ingredient | Source of Drug Name | Route of Administration | Dose Verbatim Text | Cumulative Dose to First Reaction | Unit of Cumulative Dose to First Reaction | Dechallenge Code | Rechallenge Code | Drug Lot Number | Drug Expiration Date | NDA Number | Dose Amount | Dose Unit | Drug Dosage Form | Dose Frequency |
2017 | Q1 | 100039237 | 10003923 | 1 | Primary Suspect Drug | JAKAFI | RUXOLITINIB | Validated trade name used | Oral | 20 MG, BID | Unknown | Unknown | A81294Q | 202192.0 | 20.0 | MG | TABLET | Twice a day | |||
2017 | Q1 | 100039237 | 10003923 | 2 | Secondary Suspect Drug | JAKAFI | RUXOLITINIB | Validated trade name used | Oral | 7.5 MG, BID | Unknown | Unknown | A79945S | 202192.0 | 7.5 | MG | TABLET | Twice a day | |||
2017 | Q1 | 100039237 | 10003923 | 3 | Secondary Suspect Drug | JAKAFI | RUXOLITINIB | Validated trade name used | Oral | 15 MG | Unknown | Unknown | 202192.0 | TABLET | |||||||
2017 | Q1 | 100039237 | 10003923 | 4 | Concomitant | ASPIRIN. | ASPIRIN | Validated trade name used | |||||||||||||
2017 | Q1 | 100039237 | 10003923 | 5 | Concomitant | PLAVIX | CLOPIDOGREL BISULFATE | Validated trade name used | TABLET | ||||||||||||
2017 | Q1 | 100039237 | 10003923 | 6 | Concomitant | ALLOPURINOL. | ALLOPURINOL | Validated trade name used | TABLET | ||||||||||||
2017 | Q1 | 100039237 | 10003923 | 7 | Concomitant | LEVOTHYROXINE. | LEVOTHYROXINE | Validated trade name used | TABLET | ||||||||||||
2017 | Q1 | 100039237 | 10003923 | 8 | Concomitant | CIMETIDINE | CIMETIDINE | Validated trade name used | TABLET | ||||||||||||
2017 | Q1 | 100039237 | 10003923 | 9 | Concomitant | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | Validated trade name used | TABLET | ||||||||||||
2017 | Q1 | 100039237 | 10003923 | 10 | Concomitant | SIMVASTATIN. | SIMVASTATIN | Validated trade name used |