Serotonin Syndrome Risk from Opioid-Antidepressant Use: Pharmacovigilance Study 2004-2025

A pharmacovigilance study analyzes adverse event reports 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 research, authored by Junge Zhang and published on figshare, quantifies the risk of serotonin syndrome and other adverse events from concomitant opioid and serotonergic antidepressant use. It employs disproportionality analyses, including Reporting Odds Ratio (ROR), and includes gender-stratified and time-to-onset analyses.

Use Cases

• Quantifying serotonin syndrome risk signals based on Reporting Odds Ratio (ROR) calculations for drug combinations.
• Analyzing gender-stratified reporting proportions for adverse events based on the study's stratified analysis.
• Investigating time-to-onset patterns for adverse events based on the finding that up to 30% occurred after 300 days.
• Comparing adverse event profiles (e.g., cardiac disorders vs. withdrawal syndrome) between SSRI-opioid and SNRI-opioid combinations.

Strengths

• Multinational data source combining US FAERS and Japanese JADER databases.
• Specific risk metrics provided, such as an SSRI-opioid ROR of 95.94 (95% CI 88.9–103.53).
• Includes temporal analysis covering Q1 2004 to Q2 2025.
• Conducts stratified analyses by gender and time-to-onset.

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 geographic and reporting bias inherent to pharmacovigilance databases.

Provenance

Source

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

Collection Method

Disproportionality analyses (Reporting Odds Ratio) on adverse event reports.

Time Range

Q1 2004 to Q2 2025.

Freshness

Last updated 2026-03-18 08:44:21; freshness should be verified.

Geography

Multinational (United States and Japan).