Suzetrigine Adverse Event Signals from FAERS Database Disproportionality Analysis

Four potential adverse event signals for the new analgesic suzetrigine were identified using disproportionality analysis of the FDA Adverse Event Reporting System (FAERS). The signals include paresthesia, burning sensations, swollen tongue, and abnormal dreams, with specific statistical indices like Reporting Odds Ratio (ROR) and Information Component (IC) provided. This dataset, authored by Slobodan M. Janković and shared under a CC-BY-4.0 license, analyzes spontaneous reports to characterize the drug's safety profile after its first year of widespread use.

Use Cases

• Signal detection for novel analgesics based on disproportionality analysis metrics
• Comparative safety profiling of non-opioid pain relievers based on adverse event reports
• Validating clinical trial safety findings with real-world evidence from the FAERS database
• Training machine learning models for pharmacovigilance using calculated indices like ROR and IC

Strengths

• Includes four specific disproportionality indices (ROR, PRR, IC, Yule's Q) for each adverse event signal
• Focuses on a newly approved analgesic with a distinct safety profile from opioids
• Results are derived from the FDA's authoritative FAERS database

Limitations

• Dataset size is only 106.1 KB, indicating very limited scope and likely summary-level data
• Column-level documentation is absent; field semantics must be inferred after download
• Data reflects potential reporting biases inherent to spontaneous reporting systems like FAERS

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Disproportionality analysis of spontaneous adverse event reports

Time Range

Covers the first year of suzetrigine's widespread use

Freshness

Last updated 2026-05-18 06:45:16