What the label lists and what reports show
Suzetrigine side effects
Suzetrigine's FDA label: “The most common adverse reactions (greater incidence in JOURNAVX-treated patients compared to placebo-treated patients) were pruritus, muscle spasms, increased creatine phosphokinase, and rash.” FAERS holds 1,274 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pruritus (142 reports).
- No generic listed
Check it at the source: the suzetrigine FDA label on DailyMed (effective April 13, 2026, Vertex Pharmaceuticals Incorporated); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of JOURNAVX?The most common side effects of JOURNAVX include: itching muscle spasms increased blood level of creatine phosphokinase rash JOURNAVX may temporarily reduce the chance of females becoming pregnant while on treatment. Talk to your healthcare provider if you have concerns about becoming pregnant. If you are using contraceptives, you should continue to use contraceptives during treatment with JOURNAVX. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of JOURNAVX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Vertex Pharmaceuticals Incorporated, effective April 13, 2026 (SPL set f0976da4-1d20-4517-945c-b60ed2f41c12), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (greater incidence in JOURNAVX-treated patients compared to placebo-treated patients) were pruritus, muscle spasms, increased creatine phosphokinase, and rash.
Table 2: Adverse Reactions Reported in ≥1% of JOURNAVX-Treated Patients and Greater than Rate of Placebo in Two 48-hour Trials in Moderate to Severe Acute Pain (Trials 1 and 2, Pooled)
| Adverse Reactions (Preferred Term) | Placebo (N = 438) n (%) | JOURNAVX (N = 874) n (%) | HB/APAP Patients received 5 mg/325 mg of oral hydrocodone bitartrate/acetaminophen… |
|---|---|---|---|
| Pruritus | 7 (1.6) | 18 (2.1) | 30 (3.4) |
| Muscle spasms | 2 (0.5) | 11 (1.3) | 6 (0.7) |
| Increased blood creatine phosphokinase | 2 (0.5) | 10 (1.1) | 7 (0.8) |
| Rash | 2 (0.5) | 10 (1.1) | 6 (0.7) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions (greater incidence in JOURNAVX-treated patients compared to placebo-treated patients) were pruritus, muscle spasms, increased creatine phosphokinase, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vertex Pharmaceuticals Incorporated at 1-877-634-8789 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety profile of JOURNAVX is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 adult patients with moderate to severe acute pain following full abdominoplasty (Trial 1) and bunionectomy (Trial 2) [see Clinical Studies (14) ], with supportive safety data from one single arm trial in 256 adult patients with moderate to severe acute pain in a broad range of acute pain conditions (Trial 3). In Trials 1 and 2, 874 patients received at least one dose of JOURNAVX.
Source: FDA drug label, Vertex Pharmaceuticals Incorporated, effective April 13, 2026 (SPL set f0976da4-1d20-4517-945c-b60ed2f41c12), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,274 reports list suzetrigine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 67 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Suzetrigine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions