Ustekinumab-Stba side effects: what 265 FDA adverse event reports show

Ustekinumab-Stba · Steqeyma · 8 reaction terms · 157 drug–reaction co-reports · data 2026-09-14

Drug class

Interleukin-12 Antagonist, Interleukin-23 Antagonist

FDA label (Established Pharmacologic Class)

Brand names

Steqeyma

openFDA label

Who reports

265 reports · 81% serious · 18 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

1. INDICATIONS AND USAGE STEQEYMA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) moderately to severely active Crohn's disease (CD) . ( 1.3 ) moderately to severely active ulcerative colitis.

FDA label, Indications and Usage

What it is

11. DESCRIPTION Ustekinumab-stba, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-stba is produced in a Chinese Hamster Ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 7 strongest signals

Reporting / coding artifact 5Not in label — unassessed 2

What the badges mean

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. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Exposure via skin contact	17	59.5 37.6–94.3ROR 63.5 · χ² 921 / p 1e-202	56.0 EB05 37.0 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Intentional dose omission	20	57.9 38.0–88.3ROR 62.6 · χ² 1,063 / p 2e-233	55.0 EB05 37.6 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 80.2	no trial data cached
Intentional product use issue	52	46.8 36.7–59.7ROR 58.0 · χ² 2,294 / p <1e-300	46.0 EB05 36.5 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 37.6	no trial data cached
Needle issue	14	38.7 23.3–64.5ROR 40.9 · χ² 478 / p 3e-106	37.0 EB05 23.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Drug dose omission by device	22	22.7 15.2–33.9ROR 24.7 · χ² 437 / p 2e-97	22.3 EB05 15.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=1 · 91% consumer	no trial data cached
Accidental exposure to product	17	13.5 8.5–21.3ROR 14.3 · χ² 185 / p 2e-42	12.6 EB05 7.7 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 12.7	no trial data cached
Device malfunction	11	13.0 7.3–23.1ROR 13.5 · χ² 110 / p 5e-26	11.2 EB05 5.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Intentional product use issue	52	46.8 36.7–59.7ROR 58.0 · χ² 2,294 / p <1e-300	46.0 EB05 36.5 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 37.6	no trial data cached
Drug dose omission by device	22	22.7 15.2–33.9ROR 24.7 · χ² 437 / p 2e-97	22.3 EB05 15.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=1 · 91% consumer	no trial data cached
Intentional dose omission	20	57.9 38.0–88.3ROR 62.6 · χ² 1,063 / p 2e-233	55.0 EB05 37.6 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 80.2	no trial data cached
Accidental exposure to product	17	13.5 8.5–21.3ROR 14.3 · χ² 185 / p 2e-42	12.6 EB05 7.7 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 12.7	no trial data cached
Exposure via skin contact	17	59.5 37.6–94.3ROR 63.5 · χ² 921 / p 1e-202	56.0 EB05 37.0 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Needle issue	14	38.7 23.3–64.5ROR 40.9 · χ² 478 / p 3e-106	37.0 EB05 23.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Device malfunction	11	13.0 7.3–23.1ROR 13.5 · χ² 110 / p 5e-26	11.2 EB05 5.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device leakage	4	7.5 2.8–19.8ROR 7.6 · χ² 16 / p 2e-5	4.5 EB05 1.9 · IC025 +0.4	Reporting / coding artifact	serious n=1	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.

Drug dose omission by device — n=22, PRR 22.7

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 Ustekinumab-Stba?

In FDA FAERS, the most frequently co-reported reaction terms for Ustekinumab-Stba are drug dose omission by device, needle issue. 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 Ustekinumab-Stba have an FDA boxed warning?

No. The FDA label retrieved for Ustekinumab-Stba has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Ustekinumab-Stba 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 66085e17-e3f2-4196-8c81-87448e804b0c, effective 20260407; matched on openfda.generic_name.exact:"USTEKINUMAB-STBA")
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, field patient.drug.openfda.generic_name.exact, 8 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.