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

A pharmacovigilance dataset from a multinational study analyzing adverse event reports from the US FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER) between Q1 2004 and Q2 2025. The data quantifies the risk of serotonin syndrome and other adverse events associated with the concurrent use of serotonergic antidepressants and opioid analgesics. The dataset was authored by Junge Zhang and published on figshare in March 2026.

Use Cases

• Identify disproportionate reporting signals for serotonin syndrome based on Reporting Odds Ratio (ROR) metrics.
• Analyze gender-stratified risk profiles for adverse events associated with SSRI-opioid combinations.
• Examine time-to-onset patterns for adverse events, including those occurring more than 300 days after therapy initiation.
• Compare adverse event profiles between SSRI-opioid and SNRI-opioid combinations, such as links to cardiac disorders or withdrawal syndrome.

Strengths

• Multinational data coverage from two major pharmacovigilance databases (FAERS and JADER).
• Specific risk metrics are provided, such as an SSRI-opioid ROR of 95.94 for serotonin syndrome.
• Includes time-to-onset analysis, noting up to 30% of adverse events occurred 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 analysis (Reporting Odds Ratio) of spontaneous adverse event reports.

Time Range

Q1 2004 to Q2 2025

Freshness

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

Geography

United States and Japan