Others titles
- FDA Adverse Events Reporting System Drugs Quarterly Report 2022
- FDA Adverse Events Reporting System US Drugs 2022
- FAERS Drugs Report 2022
Keywords
- FAERS Database
- Adverse Reaction
- Adverse Events of Medication
- Adverse Event Reporting Form
- FAERS
- Serious Adverse Event
- Adverse Events Reporting System
FDA Adverse Events Reporting System Drug 2022
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 2022. The Drug dataset contains drug/biologic information for as many medications as were reported for the event (1 or more 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 FDA.
About this Dataset
Data Info
Date Created | 2020-04-29 |
---|---|
Last Modified | 2023-01-30 |
Version | 2023-01-30 |
Update Frequency |
Quarterly |
Temporal Coverage |
2022-01 to 2023-01 |
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, FAERS, Serious Adverse Event, Adverse Events Reporting System |
Other Titles | FDA Adverse Events Reporting System Drugs Quarterly Report 2022, FDA Adverse Events Reporting System US Drugs 2022, FAERS Drugs Report 2022 |
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 : 1enum : 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 : 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 |
2022 | Q1 | 1000597210 | 1 | PS | NILOTINIB | NILOTINIB | 1 | Oral | 300 mg, BID | 22068.0 | 300.0 | MG | Capsule | BID | |||||||
2022 | Q1 | 1000597210 | 2 | C | HYDROCHLOROTHIAZIDE\IRBESARTAN | HYDROCHLOROTHIAZIDE\IRBESARTAN | 1 | Unknown | 300 mg, UNK | 300.0 | MG | ||||||||||
2022 | Q1 | 1000597210 | 3 | C | LEVOTHYROXINE SODIUM\POTASSIUM IODIDE | LEVOTHYROXINE SODIUM\POTASSIUM IODIDE | 1 | Unknown | 75 mg, UNK | 75.0 | MG | ||||||||||
2022 | Q1 | 1000597210 | 4 | C | TORSEMIDE | TORSEMIDE | 1 | Unknown | 5 mg, UNK | 5.0 | MG | ||||||||||
2022 | Q1 | 1000597210 | 5 | C | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | 1 | Unknown | 2000 mg, UNK | 2000.0 | MG | ||||||||||
2022 | Q1 | 1000597210 | 6 | C | MOLSIDOMINE | MOLSIDOMINE | 1 | Unknown | 8 mg, UNK | 8.0 | MG | ||||||||||
2022 | Q1 | 1000597210 | 7 | C | INSULIN NOS | INSULIN NOS | 1 | Unknown | Scheduled | ||||||||||||
2022 | Q1 | 1001443244 | 1 | PS | MOMETASONE FUROATE | MOMETASONE FUROATE | 1 | Unknown | UNK | U | 19543.0 | Ointment | |||||||||
2022 | Q1 | 1001443244 | 2 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Unknown | UNK | U | Tablet | ||||||||||
2022 | Q1 | 1001443244 | 3 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | UNK | U | Tablet |