Serotonin Syndrome Risk from Opioid-Antidepressant Use, 2004-2025

623.8 KB of pharmacovigilance data from a multinational study analyzing adverse event reports from 2004 to 2025. The dataset, authored by Junge Zhang and last updated in March 2026, provides evidence on the risk of serotonin syndrome from concomitant opioid and serotonergic antidepressant use. It includes disproportionality analysis results, gender-stratified findings, and time-to-onset data.

Use Cases

• Quantifying serotonin syndrome risk signals based on reported disproportionality analysis metrics like Reporting Odds Ratios (ROR).
• Analyzing gender-stratified reporting patterns for adverse events based on the gender-stratified analysis mentioned.
• Investigating time-to-onset profiles for adverse events based on the finding that up to 30% occurred after 300 days.
• Comparing adverse event profiles between SSRI-opioid and SNRI-opioid combinations based on the distinct cardiac and withdrawal syndrome associations described.

Strengths

• Data spans over two decades, from Q1 2004 to Q2 2025, providing long-term temporal coverage.
• Multinational scope, incorporating reports from the US FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER).
• Specific statistical results are provided, such as an SSRI-opioid ROR of 95.94 for serotonin syndrome.

Limitations

• Row count is unknown, which may limit suitability assessment.
• Column-level documentation is absent; field semantics must be inferred after download.

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 08:44:19; freshness should be verified.

Geography

Multinational (United States and Japan).