Table 3_Serotonin syndrome risk with concomitant opioid and serotonergic antidepressant us

A multinational pharmacovigilance study using data from the US FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER) from Q1 2004 to Q2 2025. The dataset, created by Junge Zhang and last updated in March 2026, quantifies signals for serotonin syndrome and other adverse events associated with concomitant opioid and serotonergic antidepressant use.

Use Cases

• Quantify disproportionate reporting signals for serotonin syndrome based on Reporting Odds Ratio (ROR) metrics.
• Analyze distinct adverse event profiles (e.g., cardiac disorders, withdrawal syndrome) linked to specific drug combinations.
• Conduct gender-stratified analyses of adverse event reporting proportions.
• Perform time-to-onset analyses for adverse events occurring long after therapy initiation.

Strengths

• Multinational data from two major pharmacovigilance systems (US FAERS and Japanese JADER).
• Specific, strong statistical signals reported (e.g., SSRI-opioid ROR 95.94).
• Includes gender-stratified and time-to-onset analyses, with up to 30% of events occurring after 300 days.
• Clear temporal coverage from Q1 2004 to Q2 2025.

Limitations

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

Provenance

Source

US FDA Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report database (JADER).

Collection Method

Disproportionality analyses, including Reporting Odds Ratio (ROR) with a multi-algorithm framework.

Time Range

Q1 2004 to Q2 2025

Freshness

Last updated 2026-03-18 08:44:20; freshness should be verified.

Geography

United States and Japan