Deucravacitinib side effects: what 2,778 FDA adverse event reports show
Drug class
Tyrosine Kinase 2 Inhibitor
Brand names
Sotyktu
Who reports
2,778 reports · 21% serious · 43 with death outcome · 63% female
Used for
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for: • the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other potent immunosuppressants. • the treatment of active psoriatic arthritis in adults.
What it is
Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor and is described chemically as: 6-(cyclopropanecarbonylamido)-4-[2-methoxy-3-(1-methyl-1,2,4-triazol-3-yl)anilino]-N-(trideuteriomethyl)pyridazine-3-carboxamide.
Boxed warning
None in the current label
Causality screen of the 24 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 19 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Folliculitis | 66 | 48.1 37.9–61.2ROR 49.3 · χ² 2,982 / p <1e-300 | 47.2 EB05 38.4 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.2 | no trial data cached |
| Mouth ulceration | 74 | 26.4 21.1–33.1ROR 27.1 · χ² 1,781 / p <1e-300 | 26.2 EB05 21.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Acne | 243 | 24.0 21.2–27.0ROR 26.1 · χ² 5,326 / p <1e-300 | 23.8 EB05 21.4 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.4 | no trial data cached |
| Oral herpes | 34 | 13.1 9.4–18.3ROR 13.3 · χ² 368 / p 2e-82 | 12.7 EB05 9.3 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.3 | no trial data cached |
| Oral pain | 33 | 11.0 7.8–15.5ROR 11.1 · χ² 290 / p 2e-65 | 10.5 EB05 7.6 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Psoriasis | 174 | 10.0 8.6–11.5ROR 10.6 · χ² 1,404 / p <1e-300 | 9.9 EB05 8.7 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.6 | no trial data cached |
| Skin burning sensation | 78 | 8.2 6.6–10.2ROR 8.4 · χ² 489 / p 1e-108 | 7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 95% clinician | no trial data cached |
| Blood triglycerides increased | 18 | 7.6 4.8–12.1ROR 7.7 · χ² 97 / p 4e-23 | 6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Adverse event | 81 | 6.6 5.3–8.2ROR 6.8 · χ² 380 / p 7e-85 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Skin disorder | 29 | 6.5 4.5–9.4ROR 6.6 · χ² 130 / p 2e-30 | 6.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Erythema (skin redness) | 153 | 5.6 4.8–6.5ROR 5.9 · χ² 577 / p 1e-127 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Psoriatic arthropathy | 28 | 5.2 3.6–7.5ROR 5.3 · χ² 91 / p 6e-22 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 17.8 | no trial data cached |
| Insurance issue | 10 | 5.0 2.7–9.4ROR 5.1 · χ² 29 / p 5e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Pruritus (itching) | 226 | 4.5 4.0–5.1ROR 4.8 · χ² 618 / p 9e-137 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.4 | no trial data cached |
| Therapy interrupted | 39 | 4.2 3.1–5.8ROR 4.3 · χ² 93 / p 2e-22 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Burning sensation | 37 | 4.0 2.9–5.4ROR 4.0 · χ² 79 / p 3e-19 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 1.3 · 95% clinician | no trial data cached |
| Stomatitis (mouth sores) | 32 | 4.0 2.8–5.6ROR 4.0 · χ² 68 / p 9e-17 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Herpes zoster (shingles) | 26 | 3.4 2.3–5.0ROR 3.4 · χ² 41 / p 6e-11 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Rash | 195 | 3.4 2.9–3.9ROR 3.5 · χ² 329 / p 7e-74 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Product dose omission in error | 12 | 3.3 1.9–5.9ROR 3.4 · χ² 17 / p 1e-5 | 3.0 EB05 1.9 · IC025 +0.6 | Reporting / coding artifact | – | no trial data cached |
| Blood creatine phosphokinase increased | 13 | 3.3 1.9–5.7ROR 3.3 · χ² 19 / p 7e-6 | 3.0 EB05 1.9 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Chromaturia | 10 | 3.3 1.8–6.2ROR 3.3 · χ² 14 / p 9e-5 | 3.0 EB05 1.8 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Swelling face | 27 | 3.1 2.1–4.5ROR 3.1 · χ² 37 / p 7e-10 | 3.0 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Lip swelling | 11 | 2.5 1.4–4.5ROR 2.5 · χ² 8 / p 0.002 | 2.3 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Acne | 243 | 24.0 21.2–27.0ROR 26.1 · χ² 5,326 / p <1e-300 | 23.8 EB05 21.4 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.4 | no trial data cached |
| Pruritus (itching) | 226 | 4.5 4.0–5.1ROR 4.8 · χ² 618 / p 9e-137 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.4 | no trial data cached |
| Rash | 195 | 3.4 2.9–3.9ROR 3.5 · χ² 329 / p 7e-74 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Psoriasis | 174 | 10.0 8.6–11.5ROR 10.6 · χ² 1,404 / p <1e-300 | 9.9 EB05 8.7 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.6 | no trial data cached |
| Erythema (skin redness) | 153 | 5.6 4.8–6.5ROR 5.9 · χ² 577 / p 1e-127 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Adverse event | 81 | 6.6 5.3–8.2ROR 6.8 · χ² 380 / p 7e-85 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Skin burning sensation | 78 | 8.2 6.6–10.2ROR 8.4 · χ² 489 / p 1e-108 | 7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 95% clinician | no trial data cached |
| Mouth ulceration | 74 | 26.4 21.1–33.1ROR 27.1 · χ² 1,781 / p <1e-300 | 26.2 EB05 21.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Folliculitis | 66 | 48.1 37.9–61.2ROR 49.3 · χ² 2,982 / p <1e-300 | 47.2 EB05 38.4 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.2 | no trial data cached |
| Therapy interrupted | 39 | 4.2 3.1–5.8ROR 4.3 · χ² 93 / p 2e-22 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Burning sensation | 37 | 4.0 2.9–5.4ROR 4.0 · χ² 79 / p 3e-19 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 1.3 · 95% clinician | no trial data cached |
| Oral herpes | 34 | 13.1 9.4–18.3ROR 13.3 · χ² 368 / p 2e-82 | 12.7 EB05 9.3 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.3 | no trial data cached |
| Oral pain | 33 | 11.0 7.8–15.5ROR 11.1 · χ² 290 / p 2e-65 | 10.5 EB05 7.6 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Stomatitis (mouth sores) | 32 | 4.0 2.8–5.6ROR 4.0 · χ² 68 / p 9e-17 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Skin disorder | 29 | 6.5 4.5–9.4ROR 6.6 · χ² 130 / p 2e-30 | 6.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Skin burning sensation — n=78, PRR 8.2
- Erythema — n=153, PRR 5.6
- Burning sensation — n=37, PRR 4.0
- Rash — n=195, PRR 3.4
- Swelling face — n=27, PRR 3.1
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Deucravacitinib?
In FDA FAERS, the most frequently co-reported reaction terms for Deucravacitinib are acne, pruritus, rash, psoriasis, erythema, skin burning sensation. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Deucravacitinib have an FDA boxed warning?
No. The FDA label retrieved for Deucravacitinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Deucravacitinib causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID ff4d7258-5068-4cdf-9692-8cae04c3198e, effective 20260630; matched on
openfda.generic_name.exact:"DEUCRAVACITINIB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 43 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.