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

1. Trend Analysis: Identify patterns in adverse events for specific drugs over time.

2. Safety Profile Assessment: Evaluate the safety profile of newly approved drugs.

3. Comparative Studies: Compare adverse event profiles across different drugs in the same therapeutic class.

4. Demographic Analysis: Investigate adverse event patterns across different patient demographics.

5. 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:

Field Name	Data Type	Comments
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

1. Count of adverse events by drug name:

SELECT 
  d.value:drugcharacterization::string as drug_name,
  COUNT(*) as event_count
FROM 
  DRUG__EVENTS,
  TABLE(FLATTEN(PATIENT_DRUG)) d
GROUP BY 
  drug_name
ORDER BY 
  event_count DESC
LIMIT 10;

1. Serious adverse events by patient age group:

SELECT 
  PATIENT_AGE_GROUP,
  COUNT(*) as serious_event_count
FROM 
  DRUG__EVENTS
WHERE 
  SERIOUS = TRUE
GROUP BY 
  PATIENT_AGE_GROUP
ORDER BY 
  serious_event_count DESC;

1. Top 5 reported reactions:

SELECT 
  r.value:reactionmeddrapt::string as reaction,
  COUNT(*) as reaction_count
FROM 
  DRUG__EVENTS,
  TABLE(FLATTEN(PATIENT_REACTION)) r
GROUP BY 
  reaction
ORDER BY 
  reaction_count DESC
LIMIT 5;

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