Table 6_Serotonin syndrome risk with concomitant opioid and serotonergic antidepressant us

Table 6 from a multinational pharmacovigilance study by Junge Zhang, last updated March 2026. The dataset contains results from disproportionality analyses of adverse event reports from the US FDA FAERS and Japanese JADER databases between Q1 2004 and Q2 2025. It quantifies the association between concomitant opioid and serotonergic antidepressant use and the risk of serotonin syndrome and other adverse events.

Use Cases

• Quantify serotonin syndrome risk signals based on Reporting Odds Ratio (ROR) metrics for specific drug combinations.
• Analyze gender-stratified reporting patterns for adverse events based on the study's stratified analysis.
• Investigate time-to-onset profiles for adverse events based on the reported occurrence of events more than 300 days after therapy initiation.
• Compare adverse event profiles between SSRI-opioid and SNRI-opioid combinations based on the distinct associated disorders mentioned.
• Validate pharmacovigilance signals using a multi-algorithm disproportionality analysis framework described in the methods.

Strengths

• Provides multinational evidence from two major pharmacovigilance databases (US FAERS and Japanese JADER).
• Covers a long time range from Q1 2004 to Q2 2025.
• Reports specific, strong statistical signals (e.g., SSRI-opioid ROR 95.94) for serotonin syndrome.
• Includes stratified analyses by gender and time-to-onset, with up to 30% of events occurring after 300 days.

Limitations

• Row count and column-level documentation are absent; field semantics must be inferred after download.
• Data may reflect reporting bias inherent to spontaneous adverse event reporting systems.
• The dataset is small (28.8 KB), indicating limited scope, likely containing summary results rather than raw case reports.

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, applied to pharmacovigilance reports.

Time Range

Q1 2004 to Q2 2025

Freshness

Last updated 2026-03-18 08:44:19

Geography

Multinational (United States and Japan)