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Others titles
- FDA Adverse Events Reporting System Indications For Use 2023
- MedDRA FDA Adverse Events Reporting System Indications 2023
- FDA Event Reports Indication For Use 2023
Keywords
- Adverse Events of Medication
- Adverse Event Reporting Form
- Geographical Indication
- Medwatch
- Event Reports
- FDA Adverse Events Reporting
- FAERS System Indications
- FAERS Percentage Average
- US Drug Indications
FDA Adverse Events Reporting System Drug Indication 2023
The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to the FDA (U.S. Food and Drug Administration) in 2023. The Indication dataset 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).
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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 the FDA.
About this Dataset
Data Info
| Date Created | 2023-04-27 |
|---|---|
| Last Modified | 2024-01-31 |
| Version | 2024-01-31 |
| Update Frequency |
Quarterly |
| Temporal Coverage |
2023-01 to 2023-12 |
| 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 | Adverse Events of Medication, Adverse Event Reporting Form, Geographical Indication, Medwatch, Event Reports, FDA Adverse Events Reporting, FAERS System Indications, FAERS Percentage Average, US Drug Indications |
| Other Titles | FDA Adverse Events Reporting System Indications For Use 2023, MedDRA FDA Adverse Events Reporting System Indications 2023, FDA Event Reports Indication For Use 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 |
| Drug_Sequence_Number | Drug sequence number for identifying a drug for a Case. To link to the “Drug” data file, both the Primary_Id (primary key) and the Drug_Sequence_Number (secondary key) are needed | integer | level : Ordinal |
| Preferred_Term_Indication_For_Use | "Preferred Term"-level medical terminology describing the indication for use, using the Medical Dictionary for Regulatory Activities (MedDRA) | string | required : 1 |
Data Preview
| Year | Quarter | Primary Id | Case Id | Drug Sequence Number | Preferred Term Indication For Use |
| 2023 | Q1 | 1001678118 | 10016781 | 1 | Neuroendocrine tumour |
| 2023 | Q1 | 1001678118 | 10016781 | 4 | Neuroendocrine tumour |
| 2023 | Q1 | 1001678118 | 10016781 | 10 | Neuroendocrine tumour |
| 2023 | Q1 | 1001678118 | 10016781 | 11 | Product used for unknown indication |
| 2023 | Q1 | 1001678118 | 10016781 | 12 | Product used for unknown indication |
| 2023 | Q1 | 1001678118 | 10016781 | 13 | Product used for unknown indication |
| 2023 | Q1 | 1001678118 | 10016781 | 14 | Product used for unknown indication |
| 2023 | Q1 | 1001678118 | 10016781 | 15 | Product used for unknown indication |
| 2023 | Q1 | 1001678118 | 10016781 | 16 | Product used for unknown indication |
| 2023 | Q1 | 1001678118 | 10016781 | 17 | Product used for unknown indication |
