What the label lists and what reports show
Deucravacitinib side effects
Deucravacitinib's FDA label: “Most common adverse reactions (≥ 1%) are: upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne.” FAERS holds 2,800 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 acne (243 reports).
- No generic listed
Check it at the source: the deucravacitinib FDA label on DailyMed (effective June 30, 2026, E.R. Squibb & Sons, L.L.C.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SOTYKTU?SOTYKTU may cause serious side effects, including: • See “ What is the most important information I should know about SOTYKTU? ” • Changes in certain laboratory test results. Changes in laboratory tests have happened in some people taking SOTYKTU. Your healthcare provider may do blood tests before you start taking SOTYKTU and during treatment with SOTYKTU to check for the following: o Increased triglycerides. Triglycerides are a type of fat found in your blood. Too much fat in your blood can cause problems with your heart. o Increased liver enzymes. Liver enzymes are found in your blood and help to tell if your liver is functioning normally. If your liver enzymes increase too much, your healthcare provider may need to do additional tests on your liver and may tell you to stop taking SOTYKTU if they think that SOTYKTU is harming your liver. […]
Source: FDA drug label, NDA214958 (Bristol), as published by E.R. Squibb & Sons, L.L.C., effective June 30, 2026 (SPL set ff4d7258-5068-4cdf-9692-8cae04c3198e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 1%) are: upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne.
Table 1: Adverse Reactions that Occurred in ≥ 1% of Subjects with Plaque Psoriasis in the SOTYKTU Group and More Frequently than in the Placebo Group in Trials PSO-1 and PSO-2 through Week 16
| Adverse Reaction | SOTYKTU 6 mg once daily N=840 n (%) | Placebo N=419 n (%) |
|---|---|---|
| Upper respiratory infections a | 161 (19.2) | 62 (14.8) |
| Blood creatine phosphokinase increased | 23 (2.7) | 5 (1.2) |
| Herpes simplex b | 17 (2) | 1 (0.2) |
| Mouth ulcers c | 16 (1.9) | 0 (0.0) |
| Folliculitis | 14 (1.7) | 0 (0.0) |
| Acne d | 12 (1.4) | 1 (0.2) |
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 following adverse reactions are discussed in greater detail in other sections of labeling: • Infections [see Warnings and Precautions (5.2) ] • Malignancy including Lymphomas [see Warnings and Precautions (5.4) ] • Elevated CPK [see Warnings and Precautions (5.5) ] • Laboratory Abnormalities [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥ 1%) are: upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 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. Plaque Psoriasis Clinical Trials The safety of SOTYKTU was evaluated in two placebo- and active-controlled trials (Trial PSO-1 and Trial PSO-2) and an open-label extension trial in which subjects who completed Trial PSO-1 or Trial PSO-2 could enroll [see Clinical Studies (14.1) ]. …
Source: FDA drug label, NDA214958 (Bristol), as published by E.R. Squibb & Sons, L.L.C., effective June 30, 2026 (SPL set ff4d7258-5068-4cdf-9692-8cae04c3198e), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,800 reports list deucravacitinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 43 are coded as a death and 153 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. Reports rose sharply in 2023 (1,052, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 8 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?
- Deucravacitinib: 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