FDA Adverse Event Reports for Marketed Drugs and Biologics

The Adverse Event Reporting System (AERS) database supports FDA post-marketing safety surveillance for all approved drug and therapeutic biologic products. It contains voluntary reports of adverse events and medication errors submitted by healthcare professionals, consumers, and manufacturers. The raw data files are not cumulative and require relational database expertise for analysis.

Use Cases

• Analyze temporal patterns in adverse event reports for specific drug products to identify potential safety signals.
• Investigate correlations between reported medication errors and product types using voluntary submission data.
• Monitor post-marketing safety profiles by aggregating reports from healthcare professionals and consumers.

Strengths

• Data originates from the U.S. Food and Drug Administration, a primary regulatory authority.
• Covers all approved drug and therapeutic biologic products in the U.S. market.
• Includes reports from multiple sources: healthcare professionals, consumers, and mandated manufacturer submissions.

Limitations

• Reporting is voluntary, leading to potential under-reporting and non-representative data.
• Data files are raw extracts requiring significant technical skill in relational database creation for use.
• Files are provided for specific time ranges and are not cumulative, complicating longitudinal analysis.

Provenance

Source

U.S. Department of Health & Human Services

Collection Method

Voluntary and mandatory reports from healthcare professionals, consumers, and product manufacturers.

Time Range

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Freshness

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Geography

United States