Adverse Event Reporting System (AERS): FDA Post-Marketing Drug Safety Reports

The Adverse Event Reporting System (AERS) is a computerized information database supporting the FDA's post-marketing safety surveillance for approved drug and therapeutic biologic products. It contains raw data extracted from the AERS database for specific, non-cumulative time ranges. Reporting of adverse events from the point of care is voluntary in the United States, with reports submitted by healthcare professionals, consumers, and mandated from manufacturers.

Use Cases

• Signal detection for new adverse drug reactions based on voluntary reports from healthcare professionals and consumers.
• Monitoring medication error trends based on reports submitted to the FDA.
• Analyzing post-marketing safety profiles of therapeutic biologic products based on mandated manufacturer reports.

Strengths

• Supports the FDA's official post-marketing safety surveillance program.
• Contains reports from multiple sources, including healthcare professionals, consumers, and manufacturers.

Limitations

• Row count, column definitions, and file size are unknown.
• Data is provided in non-cumulative time ranges, requiring assembly for longitudinal analysis.
• Description metadata is limited; actual data quality requires manual inspection after download.

Provenance

Source

U.S. Food and Drug Administration (FDA)

Collection Method

Voluntary and mandated reporting of adverse events and medication errors.

Geography

United States