Side Effects of Suzetrigine (JOURNAVX)
Suzetrigine is generally well-tolerated with predominantly mild to moderate side effects, most commonly headache and constipation, and notably lacks the central nervous system effects, addiction potential, and respiratory depression associated with opioids. 1, 2, 3
Most Common Side Effects
The adverse event profile from clinical trials demonstrates favorable tolerability:
- Headache and constipation are the most frequently reported side effects in clinical trials 3, 4
- Most adverse events are mild (27.7% of participants) or moderate (8.2% of participants) in severity 3
- Drowsiness may occur if more than the directed dose is taken 1
Emerging Side Effects from Post-Marketing Experience
- Paresthesia (abnormal sensations) has been reported following commercial availability, though this was not prominent in clinical trials 4
- This represents a newly identified side effect as the drug enters broader clinical use outside controlled trial settings 4
Absent Side Effects (Key Safety Advantages)
Suzetrigine's peripheral-only mechanism provides critical safety advantages:
- No central nervous system side effects including no sedation, dependence, addiction, or respiratory depression 2, 5
- No addictive potential or evidence of dependence in nonclinical and clinical safety studies 5
- No adverse cardiovascular effects demonstrated in comprehensive safety assessments 5
- No behavioral effects observed in safety evaluations 5
This favorable profile results from suzetrigine's selective action on NaV1.8 channels in peripheral pain-sensing neurons without crossing the blood-brain barrier 2, 5
Contraindications and Precautions
Do not use suzetrigine if: 1
- History of allergic reaction to suzetrigine or its ingredients 1
- Currently taking or within 2 weeks of stopping a monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, emotional conditions, or Parkinson's disease 1
Consult a physician before use if you have: 1
- Heart disease 1
- Thyroid disease 1
- High blood pressure 1
- Diabetes 1
- Urinary retention due to enlarged prostate 1
- Liver or kidney disease (dose adjustment may be required) 1
When to Stop and Seek Medical Attention
Discontinue suzetrigine immediately and seek medical help if: 1
- Allergic reaction occurs 1
- Symptoms do not improve within 7 days or are accompanied by fever 1
- Nervousness, dizziness, or sleeplessness develops 1
Special Populations
- Pregnancy and breastfeeding: Consult a healthcare professional before use 1
- Pediatric use: Keep out of reach of children; contact Poison Control (1-800-222-1222) immediately in case of overdose 1
Clinical Context
In the largest phase 3 trials involving 2,447 participants, suzetrigine demonstrated statistically significant pain reduction with 83.2% of participants rating its effectiveness as good, very good, or excellent 3. The safety profile remained consistent across both surgical and non-surgical acute pain conditions 3.