Delgocitinib side effects: what 233 FDA adverse event reports show

Delgocitinib · Anzupgo · 5 reaction terms · 67 drug–reaction co-reports · data 2026-09-14

Drug class

Janus Kinase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Anzupgo

openFDA label

Who reports

233 reports · 33% serious · 2 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.

FDA label, Indications and Usage

What it is

ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5.

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 4 strongest signals

Not in label — unassessed 4

What the badges mean

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
Dermatitis	20	86.9 57.2–132.2ROR 95.0 · χ² 1,614 / p <1e-300	80.4 EB05 55.0 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	90% clinician	no trial data cached
Erythema multiforme	8	77.3 39.1–152.7ROR 80.0 · χ² 528 / p 3e-117	65.7 EB05 35.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 68.5	no trial data cached
Dermatitis atopic	25	45.1 31.1–65.3ROR 50.4 · χ² 1,035 / p 2e-227	43.6 EB05 31.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Skin burning sensation	10	12.7 6.9–23.2ROR 13.2 · χ² 96 / p 5e-23	10.7 EB05 5.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	–	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
Dermatitis atopic	25	45.1 31.1–65.3ROR 50.4 · χ² 1,035 / p 2e-227	43.6 EB05 31.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Dermatitis	20	86.9 57.2–132.2ROR 95.0 · χ² 1,614 / p <1e-300	80.4 EB05 55.0 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	90% clinician	no trial data cached
Skin burning sensation	10	12.7 6.9–23.2ROR 13.2 · χ² 96 / p 5e-23	10.7 EB05 5.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Erythema multiforme	8	77.3 39.1–152.7ROR 80.0 · χ² 528 / p 3e-117	65.7 EB05 35.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 68.5	no trial data cached
Product administered at inappropriate site	4	19.8 7.5–52.4ROR 20.2 · χ² 54 / p 1e-13	13.8 EB05 3.8 · IC025 +0.9 3/3 methods agree	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.

Dermatitis — n=20, PRR 86.9
Dermatitis atopic — n=25, PRR 45.1

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 Delgocitinib?

In FDA FAERS, the most frequently co-reported reaction terms for Delgocitinib are dermatitis atopic, dermatitis, skin burning sensation, erythema multiforme. 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 Delgocitinib have an FDA boxed warning?

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

Do FAERS signals prove that Delgocitinib 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 a59bf36e-6f04-4b47-b385-8040c95f040c, effective 20260710; matched on openfda.generic_name.exact:"DELGOCITINIB")
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, 5 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.