Mosunetuzumab Adverse Event Reports from FDA FAERS, 2004-2025

Jiahui Liu published a pharmacovigilance study analyzing 1,154 adverse event reports for the lymphoma drug mosunetuzumab from the FDA FAERS database. The analysis spans reports from Q1 2004 to Q4 2025 and uses disproportionality analysis to identify safety signals. The dataset was last updated on 2026-05-26.

Use Cases

• Identify disproportionate adverse event signals for mosunetuzumab based on disproportionality analysis results.
• Analyze the time to onset of adverse reactions based on the reported median and interquartile range.
• Compare safety profiles across different System Organ Classes and Preferred Terms mentioned in the results.
• Investigate long-term adverse events occurring at or beyond 180 days post-treatment initiation.

Strengths

• Analysis includes 1,154 adverse event reports specifically for mosunetuzumab.
• Data covers a long time range from the first quarter of 2004 to the fourth quarter of 2025.
• Study employs four established disproportionality analysis algorithms (ROR, PRR, BCPNN, MGPS).

Limitations

• The dataset is very small at 13.1 KB, suggesting limited scope or summary-level data.
• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment.

Provenance

Source

Food and Drug Administration Adverse Event Reporting System (FAERS)

Collection Method

Disproportionality analysis of pharmacovigilance reports.

Time Range

Q1 2004 to Q4 2025

Freshness

Last updated 2026-05-26 04:38:55; freshness should be verified.