Vortioxetine Adverse Events and Suicide Risk Signals from FDA FAERS, 2013-2025

13,698 adverse event reports for the antidepressant vortioxetine were extracted from the US FDA FAERS database from Q4 2013 to Q2 2025. The data was analyzed using disproportionality methods to identify safety signals, particularly for suicide-related events. The study was authored by Guanguan Qiu and published under a CC-BY-4.0 license.

Use Cases

• Analyzing disproportionality signals for suicide-related adverse events based on reported odds ratios (ROR).
• Investigating demographic associations with adverse event reporting based on sex and age subgroup analysis.
• Comparing adverse event profiles across system organ classes (SOCs) and preferred terms (PTs).
• Validating regulatory black box warnings for antidepressants using real-world evidence.

Strengths

• Data sourced from the authoritative FDA FAERS database.
• Analysis covers a 12-year time range from 2013 to 2025.
• Reports were analyzed using four established signal detection methods (ROR, PRR, BCPNN, MGPS).
• Specific risk signals quantified, e.g., ROR=19.87 for suicidal ideation.

Limitations

• Row count and column-level documentation are unknown, limiting suitability assessment.
• Data reflects inherent limitations of spontaneous reporting systems, as noted in the study conclusion.
• Description metadata is limited; actual data structure requires manual inspection after download.

Provenance

Source

US FDA Adverse Event Reporting System (FAERS) database.

Collection Method

Disproportionality analysis of spontaneous adverse event reports.

Time Range

Fourth quarter (Q4) of 2013 to the second quarter (Q2) of 2025.

Freshness

Last updated 2026-04-15 05:43:54.

Geography

Primarily United States (inferred from FDA source).