Enfortumab Vedotin Cutaneous Adverse Reactions from FAERS, 2020-2025

1,389 adverse event reports for cutaneous reactions associated with enfortumab vedotin were analyzed from the FDA Adverse Event Reporting System (FAERS) database between 2020 and 2025. The dataset, authored by Pan Ding and released in April 2026, includes descriptive characterization, disproportionality analyses, and time-to-onset evaluation. It identifies 44 positive safety signals, including 10 not previously described in the drug label.

Use Cases

• Signal detection for drug safety based on disproportionality analysis results
• Risk stratification for adverse events based on reported clinical factors like concomitant medications
• Evaluating time-to-onset patterns for cutaneous reactions after treatment initiation
• Identifying previously unlabeled adverse events based on the 10 new safety signals

Strengths

• Contains 1,389 specific adverse event cases
• Analyzes data from a 5-year period (2020-2025)
• Identifies 44 positive safety signals and 10 new, unlabeled events

Limitations

• Row count for the underlying data is unknown
• Column-level documentation is absent; field semantics must be inferred after download
• Data may reflect reporting bias inherent to spontaneous reporting systems like FAERS

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Pharmacovigilance study using spontaneous reports

Time Range

2020-2025

Freshness

Last updated 2026-04-09 04:06:55

Geography

United States