Others titles
- FDA Adverse Events Reporting System Quarterly Report 2023
- FAERS Drug Reaction Report 2023
Keywords
- FAERS Database
- Adverse Reaction
- Adverse Events of Medication
- Adverse Event Reporting Form
- Serious Adverse Event
- Adverse Events Reporting System
- FDA Adverse Events Reporting
- FAERS System Reactions
- FAERS Percentage Average
- States Population
FDA Adverse Events Reporting System Drug Reaction 2023
The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to FDA (U.S. Food and Drug Administration) in 2023. The drug reaction dataset contains all “Medical Dictionary for Regulatory Activities” (MedDRA) terms coded for the adverse event (1 or more).
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Description
FAERS (FDA Adverse Event Reporting System) is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. It is a useful tool for FDA (U.S. Food and Drug Administration) 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.
The reports in FAERS are submitted to FDA by 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 to the products’ manufacturers who then send these reports to FDA.
About this Dataset
Data Info
Date Created | 2023-04-27 |
---|---|
Last Modified | 2023-04-25 |
Version | 2023-04-25 |
Update Frequency |
Quarterly |
Temporal Coverage |
2023-01 to 2023-03 |
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 | FAERS Database, Adverse Reaction, Adverse Events of Medication, Adverse Event Reporting Form, Serious Adverse Event, Adverse Events Reporting System, FDA Adverse Events Reporting, FAERS System Reactions, FAERS Percentage Average, States Population |
Other Titles | FDA Adverse Events Reporting System Quarterly Report 2023, FAERS Drug Reaction Report 2023 |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Year | The year in which the data was submitted | date | - |
Quarter | The quarter of the year in which the data was submitted | string | enum : Array ( [0] => Q1 [1] => Q2 [2] => Q3 [3] => Q4 ) |
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 : Nominal |
Case_Id | Case number for identifying a FAERS case. | integer | level : Nominal |
Preferred_Term_For_Event | "Preferred Term"-level medical terminology describing the event, using the Medical Dictionary for Regulatory Activities (MedDRA). The order of the terms for a given event does not imply priority. In other words, the first term listed is not necessarily considered more significant than the last one listed. | string | - |
Drug_Recur_Action | Drug Recur Action data - populated with reaction/event information (Preferred_Term_For_Event) if/when the event reappears upon re-administration of the drug. | string | - |
Data Preview
Year | Quarter | Primary Id | Case Id | Preferred Term For Event | Drug Recur Action |
2023 | Q1 | 1001678118 | 10016781 | Injection site mass | |
2023 | Q1 | 1001678118 | 10016781 | Blood creatine increased | |
2023 | Q1 | 1001678118 | 10016781 | Mobility decreased | |
2023 | Q1 | 1001678118 | 10016781 | Oedema peripheral | |
2023 | Q1 | 1001678118 | 10016781 | Disturbance in attention | |
2023 | Q1 | 1001678118 | 10016781 | Bronchitis | |
2023 | Q1 | 1001678118 | 10016781 | Erythema | |
2023 | Q1 | 1001678118 | 10016781 | Nasopharyngitis | |
2023 | Q1 | 1001678118 | 10016781 | Urinary tract infection | |
2023 | Q1 | 1001678118 | 10016781 | Acne |