Most Common Adverse Events with Suzetrigine
The most frequently observed adverse events with suzetrigine are mild to moderate in severity and include nausea, headache, and constipation, with most adverse events being transient and well-tolerated across clinical trials. 1, 2
Evidence from Phase 3 Clinical Trials
Acute Pain Studies (Abdominoplasty and Bunionectomy)
In the two largest randomized, controlled phase 3 trials evaluating suzetrigine for moderate-to-severe acute pain following abdominoplasty (n=1,118) and bunionectomy (n=1,073), adverse events were similar to those typically seen in postsurgical settings and were predominantly mild to moderate in severity. 1
Single-Arm Safety Study
The phase 3 single-arm study (N=256) evaluating suzetrigine across various surgical and non-surgical acute pain conditions provided the most detailed adverse event severity data:
- 71 participants (27.7%) experienced adverse events of mild severity 2
- 21 participants (8.2%) experienced adverse events of moderate severity 2
- The drug was generally safe and well-tolerated across diverse pain conditions 2
Specific Adverse Events Reported
Based on clinical trial data and systematic reviews, the most common adverse events include:
- Nausea - reported as one of the most frequent adverse events 3
- Headache - commonly observed across trials 3
- Constipation - noted as mild and infrequent 3
These adverse events were consistently described as mild and infrequent in occurrence. 3
Safety Profile Characteristics
Absence of CNS and Addictive Effects
Suzetrigine demonstrates a favorable safety profile due to its selective mechanism of action:
- No CNS side effects due to high selectivity for NaV1.8 channels, which are not expressed in the central nervous system 2, 4
- No addictive potential - comprehensive nonclinical and clinical assessments show no evidence of dependence or behavioral effects associated with addiction 4
- No adverse cardiovascular effects documented in safety assessments 4
Comparison to Opioid Side Effects
Unlike opioids, suzetrigine does not carry the typical opioid-related adverse events such as respiratory depression, sedation, or risk of addiction. 2, 4
Special Populations and Neurological Considerations
Important caveat: While the expanded question asks specifically about patients with neurological disorders or epilepsy, the available clinical trial evidence does not provide specific adverse event data for these subpopulations. The FDA label 5 does not list seizure disorders or neurological conditions as contraindications or special warnings, which differs markedly from many other analgesics. However, the absence of specific data in these populations means clinicians should monitor carefully when initiating treatment in patients with significant neurological comorbidities.
Clinical Implications
The adverse event profile of suzetrigine represents a significant advantage over traditional opioid analgesics, with most events being transient, mild to moderate in severity, and not requiring treatment discontinuation in the majority of cases. 1, 2 The peripheral mechanism of action (selective NaV1.8 inhibition in peripheral pain-sensing neurons) explains the absence of CNS-related adverse events that commonly limit other analgesic options. 4