Post-Marketing Safety Signals for Ramucirumab from FAERS Database

7,901 adverse event reports for the drug ramucirumab were analyzed from the FDA Adverse Event Reporting System (FAERS) database. The study, authored by Hong Zhou and updated in April 2026, identified 233 risk signals across 19 system organ classes. It highlights both known and newly detected potential adverse events, including a detailed subgroup analysis of 490 hemorrhage cases.

Use Cases

• Identify unexpected adverse drug reaction signals based on disproportionality analysis methods (ROR, PRR, BCPNN).
• Analyze temporal patterns of adverse event onset based on the reported median onset time of 27 days.
• Investigate hemorrhage safety profiles across different system organ classes based on the subgroup of 490 cases.
• Validate known drug safety information against spontaneous report data based on mentions of package insert consistency.

Strengths

• Analysis is based on 7,901 adverse event reports from the authoritative FAERS database.
• Identified 233 risk signals and performed a detailed subgroup analysis of 490 hemorrhage cases.
• Uses multiple statistical methods (ROR, PRR, BCPNN) for signal detection.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count for the underlying dataset is unknown, which may limit suitability assessment.
• Data may reflect reporting bias inherent to spontaneous adverse event reporting systems.

Provenance

Source

Food and Drug Administration Adverse Event Reporting System (FAERS)

Collection Method

Retrospective disproportionality analysis of spontaneous reports.

Time Range

Time range of the FAERS data analyzed is not specified.

Freshness

Last updated 2026-04-20 05:22:54; freshness should be verified.

Geography

Geographic coverage is not specified, but FAERS is a U.S. system.