Soroush Farsi
Background
Effective postoperative pain control remains a critical component of surgical care, with increasing emphasis on identifying analgesic options that provide adequate pain relief while minimizing adverse effects. Suzetrigine (Journavx), a novel selective sodium channel (NaV1.8) inhibitor, has emerged as a promising non-opioid alternative. We aimed to evaluate early post-marketing safety signals associated with suzetrigine to assess its potential as a well-tolerated postoperative analgesic.
Methods
Adverse event reports listing suzetrigine as the primary suspect drug were extracted from the Food and Drug Administration (FDA) post-marketing surveillance datasets (FAERS/AEMS). Demographics, temporal trends, and adverse events were analyzed, and event frequencies were summarized descriptively.
Results
A total of 875 reports were identified, reflecting early adoption in clinical practice. Reporting peaked in 2025 (n=633, 72.3%) with continued reporting in 2026 (n=242, 27.7%). The most frequently reported adverse events were pruritus (11.2%), rash (7.7%), paraesthesia (7.3%), nausea (6.9%), dizziness (6.4%), and muscle spasms (5.3%). Adverse events were predominantly dermatologic and neurologic in nature. Reports of drug ineffectiveness (4.0%) and off-label use (19.1%) were also observed, reflecting evolving real-world utilization patterns. Importantly, no strong signal for major cardiovascular events was identified.
Conclusion
Suzetrigine demonstrates a favorable early safety profile with predominantly mild adverse events and no significant cardiovascular signal, supporting its role as a well-tolerated postoperative analgesic. Continued surveillance is warranted as clinical use expands.
Authors
Hadi Rezaei, Moe Abou Chaar, Shahd Mansour, Soroush Farsi, Bradley Peters, Veljko Strajina, Daniel Stephens
Mayo Clinic, Rochester, USA