FDA Drug Adverse Events (FAERS) Dataset
About the Dataset
The FDA Drug Adverse Events (FAERS) Dataset is a comprehensive collection of data related to adverse events reported for FDA-approved drugs since 2004. This dataset is crucial for monitoring drug safety and understanding the effects of medications on patients. It contains over 18 million entries, providing extensive coverage of adverse drug events.
Dataset Features
Extensive Coverage: Includes adverse drug events dating back to 2004.
Detailed Information: Provides patient demographics, drug-related information, and adverse reaction details.
Regular Updates: Reflects the latest FDA reports and findings with daily updates.
Streamlined Access: Offers easy access to comprehensive drug safety data.
Single Table Structure: Organized for seamless integration with existing systems.
Data Quality and Maintenance
Data Source: Directly sourced from FDA reports.
Update Frequency: Daily updates to ensure the most current information.
Quality Assurance: Rigorous data cleaning and standardization processes.
Version Control: Maintains the most recent version of each report.
Business Applications
Pharmacovigilance and drug safety monitoring
Clinical research and drug development
Healthcare policy and regulation
Patient safety initiatives
Pharmaceutical market analysis
Example Use Cases
Trend Analysis: Identify patterns in adverse events for specific drugs over time.
Safety Profile Assessment: Evaluate the safety profile of newly approved drugs.
Comparative Studies: Compare adverse event profiles across different drugs in the same therapeutic class.
Demographic Analysis: Investigate adverse event patterns across different patient demographics.
Signal Detection: Early detection of potential safety issues for prompt intervention.
Data Structure
The dataset is organized into a single table named DRUG__EVENTS with the following key fields:
ID
VARCHAR(PK)
Unique identifier for the row.
FEED_ID
VARCHAR(FK)
ID associated with the data and data_sub_type in the FEEDS table.
FILE_FEED_ID
VARCHAR(FK)
ID associated with the specific file the record was sourced from in the FEEDS_FILES table.
COMPANY_NUMB
VARCHAR
Identifier for the company providing the report. This is self-assigned.
SENDER_ORGANIZATION_NAME
VARCHAR
The name of the organization sending the report, extracted from the second part of the companynumb field.
DUPLICATE
BOOLEAN
True if earlier versions of this report were submitted to FDA, otherwise False. openFDA only shows the most recent version.
FULFILL_EXPEDITE_CRITERIA
NUMBER
Identifies expedited reports (those that were processed within 15 days).
OCCUR_COUNTRY
VARCHAR
The name of the country where the event occurred.
PATIENT_DRUG
ARRAY
Array containing information about the drugs involved in the event.
PATIENT_AGE_GROUP
VARCHAR
Populated with Patient Age Group code.
PATIENT_ONSET_AGE
NUMBER
Age of the patient when the event first occurred.
PATIENT_ONSET_AGE_UNIT
VARCHAR
The unit for the interval in the field patient_onset_age
.
PATIENT_SEX
VARCHAR
The sex of the patient (M/F).
PATIENT_WEIGHT
NUMBER
The patient weight, in kg (kilograms).
PATIENT_REACTION
ARRAY
Array containing information about the patient's reaction to the drug.
PATIENT_SUMMARY_NARRATIVE_INCLUDE_CLINICAL
VARCHAR
Summary of the event, including clinical information.
PRIMARY_SOURCE_QUALIFICATION
NUMBER
Category of individual who submitted the report.
PRIMARY_SOURCE_REPORTER_COUNTRY
VARCHAR
Country from which the report was submitted.
PRIMARY_SOURCE_COUNTRY
VARCHAR
Country of the reporter of the event.
RECEIPT_DATE
DATE
Date that the most recent information in the report was received by FDA.
RECEIVE_DATE
DATE
Date that the report was first received by FDA. If this report has multiple versions, this will be the date the first version was received by FDA.
RECEIVER_ORGANIZATION
VARCHAR
Name of the organization receiving the report. Because FDA received the report, the value is always FDA
.
RECEIVER_TYPE
NUMBER
The type of organization receiving the report. The value, 6
, is only specified if it is other
, otherwise it is left blank.
REPORT_DUPLICATE_NUMBER
VARCHAR
The case identifier for the duplicate.
REPORT_DUPLICATE_SOURCE
VARCHAR
The name of the organization providing the duplicate.
REPORT_TYPE
NUMBER
Code indicating the circumstances under which the report was generated.
SAFETY_REPORT_ID
VARCHAR
The 8-digit Safety Report ID number, also known as the case report number or case ID.
SAFETY_REPORT_VERSION
NUMBER
The version number of the safety_report_id
. Multiple versions of the same report may exist.
SENDER_ORGANIZATION
VARCHAR
Name of the organization sending the report. Because FDA is providing these reports to you, the value is always FDA-Public Use.
SENDER_TYPE
VARCHAR
The type of organization sending the report. Because FDA is providing these reports to you, the value is always 2
.
SERIOUS
BOOLEAN
Seriousness of the adverse event.
SERIOUSNESS_CONGENITAL_ANOMALI
BOOLEAN
True if the adverse event resulted in a congenital anomaly, and False otherwise.
SERIOUSNESS_DEATH
BOOLEAN
True if the adverse event resulted in death, and False otherwise.
SERIOUSNESS_DISABLING
BOOLEAN
True if the adverse event resulted in disability, and False otherwise.
SERIOUSNESS_HOSPITALIZATION
BOOLEAN
True if the adverse event resulted in a hospitalization, and False otherwise.
SERIOUSNESS_LIFETHREATENING
BOOLEAN
True if the adverse event resulted in a life-threatening condition, and False otherwise.
SERIOUSNESS_OTHER
BOOLEAN
True if the adverse event resulted in some other serious condition, and False otherwise.
TRANSMISSION_DATE
DATE
Date that the record was created. This may be earlier than the date the record was received by the FDA.
CREATED_AT
TIMESTAMP
Timestamp the record was created.
UPDATED_AT
TIMESTAMP
Timestamp the record was updated.
Sample Queries
Count of adverse events by drug name:
Serious adverse events by patient age group:
Top 5 reported reactions:
Support and Contact
For any questions or support regarding the FDA Drug Adverse Events Dataset, please contact our team at support@dataplex-consulting.com. We're here to help you make the most of your data insights!
About Dataplex
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