How to download FAERS data on drug safety surveillance

The FDA Adverse Event Reporting System (FAERS) is a database maintained by the U.S. Food and Drug Administration (FDA) to track adverse event reports, medication errors, and product quality complaints related to drugs and biologics. These reports are submitted by healthcare professionals, consumers, and manufacturers. FAERS serves as a key tool for post-market surveillance, allowing the FDA to monitor the safety of medications once they are on the market.

For more details, visit FDA’s FAERS Q&A page.

To learn how to access and download FAERS data, keep reading.

Accessing FAERS Data

FAERS data can be accessed through various channels, including quarterly data files and APIs.

1. FDA Quarterly Data Files

FDA releases FAERS data quarterly, which can be accessed through the following portal:

• FDA FAERS Quarterly Data Files

The data files are downloadable in multiple formats (e.g., XML, ASCII) and contain information on adverse events, including patient demographic details, drug names, and outcomes.

2. FAERS API

The FDA also provides access to FAERS data via an open API, allowing developers and researchers to programmatically query adverse event data.

• FAERS API

This API provides detailed reports about drug events, including patient outcomes, drug indications, and reported reactions. Using the API enables real-time access to data, which can be filtered by specific criteria such as drug names, reactions, or report dates.

Quarterly data files are also available in JSON format, which can be accessed via the following portal:

• FDA FAERS Quarterly Data Files in JSON

Additionally, you can explore the data with an interactive chart builder.

Understanding FAERS Data Relationships from ASCII Files

Download the ASCII files from the FDA website.

FAERS data is organized into multiple tables that are related by key identifiers like caseid (identifying individual reports) and drug_seq (identifying the sequence of drugs within a case). Below are the key tables in the FAERS dataset:

• DEMO: Contains patient demographic and administrative information, including age, sex, and report source.
• DRUG: Lists the drugs involved in the report, including drug names, role (primary suspect, secondary suspect, etc.), and administration details.
• REAC: Contains information on the adverse reactions reported in a case, including reaction terms and outcomes.
• OUTC: Lists the patient outcomes associated with the report, such as recovery or fatality.

Each report may include multiple drugs and reactions, allowing for complex relationships within a single report. Understanding these relationships is key for effective analysis of FAERS data.

Conclusion

By accessing and analyzing FAERS data, researchers and healthcare professionals can identify trends, spot potential drug safety issues, and ultimately improve patient outcomes. The combination of quarterly data files and open APIs makes FAERS a valuable resource for post-market drug surveillance.