Mogamulizumab-Kpkc side effects: what 2 FDA adverse event reports show

Mogamulizumab-Kpkc · 23 reaction terms · 664 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

2 reports · 50% serious · 1 with death outcome · 0% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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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 19 strongest signals

Reporting / coding artifact 3No label text to screen 16

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 4 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
Drug eruption	77	69.9 56.3–86.9ROR 74.2 · χ² 5,143 / p <1e-300	68.5 EB05 56.6 · IC025 +5.2 3/3 methods agree	No label text to screen	–	no trial data cached
Lymphopenia	26	29.5 20.2–43.2ROR 30.1 · χ² 687 / p 1e-151	28.9 EB05 20.7 · IC025 +3.6 3/3 methods agree	No label text to screen	–	no trial data cached
Myocarditis	16	22.5 13.8–36.7ROR 22.8 · χ² 308 / p 3e-69	21.9 EB05 14.2 · IC025 +2.9 3/3 methods agree	No label text to screen	–	no trial data cached
Therapy partial responder	16	16.9 10.4–27.6ROR 17.1 · χ² 224 / p 5e-51	16.3 EB05 10.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	16	16.9 10.4–27.5ROR 17.1 · χ² 224 / p 6e-51	16.3 EB05 10.1 · IC025 +2.7 3/3 methods agree	No label text to screen	–	no trial data cached
Disease progression	119	16.1 13.6–19.1ROR 17.6 · χ² 1,677 / p <1e-300	16.0 EB05 13.7 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Hepatic cytolysis	11	14.4 8.0–25.9ROR 14.5 · χ² 124 / p 5e-29	12.8 EB05 6.6 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Infusion related reaction (reaction during infusion)	57	13.8 10.7–17.7ROR 14.3 · χ² 663 / p 1e-146	13.6 EB05 10.8 · IC025 +3.2 3/3 methods agree	No label text to screen	–	no trial data cached
Skin disorder	27	12.9 8.9–18.8ROR 13.2 · χ² 286 / p 2e-64	12.4 EB05 8.6 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Skin lesion	20	11.7 7.6–18.1ROR 11.9 · χ² 185 / p 2e-42	10.8 EB05 7.0 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Toxic skin eruption	7	11.0 5.3–23.1ROR 11.1 · χ² 54 / p 9e-14	8.1 EB05 3.7 · IC025 +1.4 3/3 methods agree	No label text to screen	–	no trial data cached
Hypercalcaemia	7	9.0 4.3–18.9ROR 9.1 · χ² 42 / p 4e-11	6.4 EB05 3.2 · IC025 +1.3 3/3 methods agree	No label text to screen	–	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	12	8.6 4.9–15.1ROR 8.7 · χ² 73 / p 6e-18	7.0 EB05 4.1 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
Adverse reaction	7	8.4 4.0–17.6ROR 8.4 · χ² 39 / p 3e-10	6.0 EB05 3.0 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Neoplasm	6	8.3 3.7–18.4ROR 8.3 · χ² 32 / p 1e-8	5.6 EB05 2.7 · IC025 +1.0 3/3 methods agree	No label text to screen	–	no trial data cached
Rash	188	6.9 6.1–7.9ROR 7.9 · χ² 964 / p 6e-212	6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Cholestasis (bile flow blockage)	8	6.7 3.3–13.3ROR 6.7 · χ² 33 / p 4e-9	5.0 EB05 2.7 · IC025 +1.1 3/3 methods agree	No label text to screen	–	no trial data cached
Cytomegalovirus infection	6	5.7 2.6–12.8ROR 5.8 · χ² 19 / p 6e-6	4.2 EB05 2.1 · IC025 +0.7 3/3 methods agree	No label text to screen	–	no trial data cached
Skin exfoliation	24	4.6 3.1–6.8ROR 4.7 · χ² 64 / p 5e-16	4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree	No label text to screen	–	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
Rash	188	6.9 6.1–7.9ROR 7.9 · χ² 964 / p 6e-212	6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Disease progression	119	16.1 13.6–19.1ROR 17.6 · χ² 1,677 / p <1e-300	16.0 EB05 13.7 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug eruption	77	69.9 56.3–86.9ROR 74.2 · χ² 5,143 / p <1e-300	68.5 EB05 56.6 · IC025 +5.2 3/3 methods agree	No label text to screen	–	no trial data cached
Infusion related reaction (reaction during infusion)	57	13.8 10.7–17.7ROR 14.3 · χ² 663 / p 1e-146	13.6 EB05 10.8 · IC025 +3.2 3/3 methods agree	No label text to screen	–	no trial data cached
Skin disorder	27	12.9 8.9–18.8ROR 13.2 · χ² 286 / p 2e-64	12.4 EB05 8.6 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Lymphopenia	26	29.5 20.2–43.2ROR 30.1 · χ² 687 / p 1e-151	28.9 EB05 20.7 · IC025 +3.6 3/3 methods agree	No label text to screen	–	no trial data cached
Skin exfoliation	24	4.6 3.1–6.8ROR 4.7 · χ² 64 / p 5e-16	4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree	No label text to screen	–	no trial data cached
Skin lesion	20	11.7 7.6–18.1ROR 11.9 · χ² 185 / p 2e-42	10.8 EB05 7.0 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	16	16.9 10.4–27.5ROR 17.1 · χ² 224 / p 6e-51	16.3 EB05 10.1 · IC025 +2.7 3/3 methods agree	No label text to screen	–	no trial data cached
Therapy partial responder	16	16.9 10.4–27.6ROR 17.1 · χ² 224 / p 5e-51	16.3 EB05 10.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Myocarditis	16	22.5 13.8–36.7ROR 22.8 · χ² 308 / p 3e-69	21.9 EB05 14.2 · IC025 +2.9 3/3 methods agree	No label text to screen	–	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	12	8.6 4.9–15.1ROR 8.7 · χ² 73 / p 6e-18	7.0 EB05 4.1 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
Hepatic cytolysis	11	14.4 8.0–25.9ROR 14.5 · χ² 124 / p 5e-29	12.8 EB05 6.6 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Cholestasis (bile flow blockage)	8	6.7 3.3–13.3ROR 6.7 · χ² 33 / p 4e-9	5.0 EB05 2.7 · IC025 +1.1 3/3 methods agree	No label text to screen	–	no trial data cached
Adverse reaction	7	8.4 4.0–17.6ROR 8.4 · χ² 39 / p 3e-10	6.0 EB05 3.0 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Mogamulizumab-Kpkc?

In FDA FAERS, the most frequently co-reported reaction terms for Mogamulizumab-Kpkc are rash, drug eruption, infusion related reaction, skin disorder, lymphopenia, skin exfoliation. 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 Mogamulizumab-Kpkc have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Mogamulizumab-Kpkc 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 23 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.