Table 5_Serotonin syndrome risk with concomitant opioid and serotonergic antidepressant us

A pharmacovigilance dataset from a 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 research by Junge Zhang, published on figshare in March 2026, quantifies the risk of serotonin syndrome and other adverse events associated with concomitant opioid and serotonergic antidepressant use using disproportionality analyses.

Use Cases

• Analyzing disproportionality signals for serotonin syndrome based on reported adverse events.
• Investigating gender-stratified reporting proportions for adverse drug reactions.
• Examining time-to-onset patterns for adverse events following therapy initiation.
• Comparing adverse event profiles between SSRI-opioid and SNRI-opioid combinations.

Strengths

• Multinational data from two major pharmacovigilance databases (FAERS and JADER).
• Specific statistical results are provided, such as an SSRI-opioid ROR of 95.94 for serotonin syndrome.
• Time range covers over two decades, from Q1 2004 to Q2 2025.
• Includes gender-stratified and time-to-onset analyses.

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 (Reporting Odds Ratio) on adverse event reports.

Time Range

Q1 2004 to Q2 2025

Freshness

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

Geography

Multinational (United States and Japan)