Abrocitinib side effects: what 3,839 FDA adverse event reports show

Abrocitinib · Cibinqo · 83 reaction terms · 2,956 drug–reaction co-reports · data 2026-09-14

Drug class

Janus Kinase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Cibinqo

openFDA label

Who reports

3,839 reports · 34% serious · 65 with death outcome · 55% female

openFDA FAERS counts, all years, deduplication not applied

Used for

CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

FDA label, Indications and Usage

What it is

CIBINQO (abrocitinib) tablets contain the free base of abrocitinib, a Janus kinase (JAK) inhibitor, for oral administration. Abrocitinib is a white to pale colored powder with the following ch.

FDA label, Description section

Boxed warning

SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning.

FDA 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 40 strongest signals

Labeled — boxed warning 3Labeled adverse reaction 2Labeled (related wording) 5Likely indication confounding 2Reporting / coding artifact 11Lab value / disease marker 1Not in label — unassessed 16

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 43 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 atopic	171	18.8 16.2–21.7ROR 19.6 · χ² 2,853 / p <1e-300	18.7 EB05 16.4 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=33	no trial data cached
Therapeutic product effect incomplete	207	16.0 14.0–18.3ROR 16.9 · χ² 2,903 / p <1e-300	16.0 EB05 14.2 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 6.3	no trial data cached
Eczema	91	9.9 8.1–12.1ROR 10.1 · χ² 719 / p 1e-158	9.7 EB05 8.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Oral herpes	32	9.0 6.4–12.7ROR 9.1 · χ² 219 / p 6e-50	8.3 EB05 6.1 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.3	no trial data cached
Folliculitis	15	7.9 4.8–13.2ROR 8.0 · χ² 84 / p 2e-20	6.7 EB05 4.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Sleep disorder due to a general medical condition	22	7.4 4.9–11.3ROR 7.5 · χ² 116 / p 2e-27	6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Skin fissures	25	7.2 4.9–10.7ROR 7.3 · χ² 128 / p 5e-30	6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Tuberculosis	17	7.2 4.5–11.6ROR 7.3 · χ² 85 / p 1e-20	6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 12.3	no trial data cached
Drug effect less than expected	18	7.0 4.4–11.1ROR 7.0 · χ² 86 / p 8e-21	6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Therapeutic response unexpected	56	6.8 5.2–8.8ROR 6.9 · χ² 271 / p 3e-61	6.5 EB05 5.2 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 5.6	no trial data cached
Condition aggravated	363	6.6 6.0–7.2ROR 7.2 · χ² 1,732 / p <1e-300	6.5 EB05 6.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 4.0	no trial data cached
Conjunctivitis	22	6.5 4.3–9.9ROR 6.6 · χ² 98 / p 2e-23	5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Blood triglycerides increased	21	6.5 4.2–9.9ROR 6.5 · χ² 92 / p 5e-22	5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.3	no trial data cached
Product prescribing error	28	6.5 4.5–9.4ROR 6.5 · χ² 124 / p 4e-29	5.9 EB05 4.3 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.5	no trial data cached
Acne	88	6.3 5.1–7.8ROR 6.4 · χ² 389 / p 6e-87	6.1 EB05 5.1 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.2	no trial data cached
Skin haemorrhage	16	6.1 3.7–9.9ROR 6.1 · χ² 63 / p 1e-15	5.2 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Skin infection	12	5.9 3.3–10.3ROR 5.9 · χ² 44 / p 2e-11	4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.9	no trial data cached
Skin disorder	35	5.7 4.1–8.0ROR 5.8 · χ² 133 / p 5e-31	5.4 EB05 4.0 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.7 · 71% consumer	no trial data cached
Blood cholesterol increased	47	5.5 4.1–7.3ROR 5.6 · χ² 169 / p 6e-39	5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.2	no trial data cached
Liver function test increased	21	5.4 3.5–8.2ROR 5.4 · χ² 71 / p 2e-17	4.8 EB05 3.3 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 1.3	no trial data cached
Blood creatine phosphokinase increased	28	5.2 3.6–7.6ROR 5.3 · χ² 92 / p 5e-22	4.8 EB05 3.5 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious PRR 7.0 · ♀ 9% (drug 55%) · 93% clinician	no trial data cached
Drug effective for unapproved indication	27	5.0 3.5–7.4ROR 5.1 · χ² 84 / p 3e-20	4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Herpes zoster (shingles)	53	5.0 3.9–6.6ROR 5.1 · χ² 168 / p 1e-38	4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 9.1	no trial data cached
Product dose omission in error	24	4.9 3.3–7.3ROR 4.9 · χ² 70 / p 3e-17	4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.4	no trial data cached
Dermatitis	17	4.5 2.8–7.2ROR 4.5 · χ² 43 / p 3e-11	4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 5.4	no trial data cached
Sleep disorder	55	4.3 3.3–5.6ROR 4.3 · χ² 136 / p 1e-31	4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 1.3 · 91% clinician	no trial data cached
Lymphoma	12	4.2 2.4–7.4ROR 4.2 · χ² 26 / p 1e-7	3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 7.2	no trial data cached
Blood test abnormal	10	3.9 2.1–7.2ROR 3.9 · χ² 19 / p 8e-6	3.4 EB05 2.0 · IC025 +0.7	Reporting / coding artifact	serious PRR 2.0	no trial data cached
Skin exfoliation	59	3.9 3.0–5.0ROR 3.9 · χ² 124 / p 5e-29	3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Skin lesion	19	3.8 2.4–6.0ROR 3.8 · χ² 37 / p 7e-10	3.5 EB05 2.4 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.8	no trial data cached
Drug ineffective for unapproved indication	38	3.7 2.7–5.1ROR 3.8 · χ² 73 / p 6e-18	3.6 EB05 2.7 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Rash erythematous	31	3.6 2.5–5.1ROR 3.6 · χ² 56 / p 3e-14	3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 2.4	no trial data cached
Pruritus (itching)	238	3.4 3.0–3.9ROR 3.6 · χ² 417 / p 6e-93	3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Therapeutic product effect decreased	27	3.3 2.3–4.8ROR 3.3 · χ² 42 / p 6e-11	3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Illness	56	3.0 2.3–3.9ROR 3.1 · χ² 75 / p 2e-18	3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Eye disorder	18	3.0 1.9–4.8ROR 3.0 · χ² 22 / p 1e-6	2.8 EB05 1.9 · IC025 +0.7	Not in label — unassessed	serious PRR 3.3	no trial data cached
Intentional product misuse	43	2.7 2.0–3.6ROR 2.7 · χ² 45 / p 1e-11	2.6 EB05 2.1 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.1	no trial data cached
Dry skin	59	2.4 1.9–3.2ROR 2.5 · χ² 49 / p 1e-12	2.4 EB05 1.9 · IC025 +0.8	Labeled (related wording) related wording	serious PRR 5.1	no trial data cached
Hypoacusis	19	2.4 1.5–3.8ROR 2.4 · χ² 14 / p 7e-5	2.3 EB05 1.6 · IC025 +0.5	Not in label — unassessed	serious PRR 3.0	no trial data cached
Eye swelling	16	2.4 1.4–3.9ROR 2.4 · χ² 11 / p 4e-4	2.3 EB05 1.5 · IC025 +0.3	Not in label — unassessed	serious PRR 4.7	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
Drug ineffective (drug did not work)	529	2.2 2.0–2.4ROR 2.4 · χ² 366 / p 9e-82	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.3	no trial data cached
Condition aggravated	363	6.6 6.0–7.2ROR 7.2 · χ² 1,732 / p <1e-300	6.5 EB05 6.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 4.0	no trial data cached
Pruritus (itching)	238	3.4 3.0–3.9ROR 3.6 · χ² 417 / p 6e-93	3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Therapeutic product effect incomplete	207	16.0 14.0–18.3ROR 16.9 · χ² 2,903 / p <1e-300	16.0 EB05 14.2 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 6.3	no trial data cached
Dermatitis atopic	171	18.8 16.2–21.7ROR 19.6 · χ² 2,853 / p <1e-300	18.7 EB05 16.4 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=33	no trial data cached
Eczema	91	9.9 8.1–12.1ROR 10.1 · χ² 719 / p 1e-158	9.7 EB05 8.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Acne	88	6.3 5.1–7.8ROR 6.4 · χ² 389 / p 6e-87	6.1 EB05 5.1 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.2	no trial data cached
Dry skin	59	2.4 1.9–3.2ROR 2.5 · χ² 49 / p 1e-12	2.4 EB05 1.9 · IC025 +0.8	Labeled (related wording) related wording	serious PRR 5.1	no trial data cached
Skin exfoliation	59	3.9 3.0–5.0ROR 3.9 · χ² 124 / p 5e-29	3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Illness	56	3.0 2.3–3.9ROR 3.1 · χ² 75 / p 2e-18	3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Therapeutic response unexpected	56	6.8 5.2–8.8ROR 6.9 · χ² 271 / p 3e-61	6.5 EB05 5.2 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 5.6	no trial data cached
Sleep disorder	55	4.3 3.3–5.6ROR 4.3 · χ² 136 / p 1e-31	4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 1.3 · 91% clinician	no trial data cached
Herpes zoster (shingles)	53	5.0 3.9–6.6ROR 5.1 · χ² 168 / p 1e-38	4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 9.1	no trial data cached
Blood cholesterol increased	47	5.5 4.1–7.3ROR 5.6 · χ² 169 / p 6e-39	5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.2	no trial data cached
Intentional product misuse	43	2.7 2.0–3.6ROR 2.7 · χ² 45 / p 1e-11	2.6 EB05 2.1 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.1	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.

Eczema — n=91, PRR 9.9
Sleep disorder due to a general medical condition — n=22, PRR 7.4
Skin fissures — n=25, PRR 7.2
Conjunctivitis — n=22, PRR 6.5
Liver function test increased — n=21, PRR 5.4
Drug effective for unapproved indication — n=27, PRR 5.0
Sleep disorder — n=55, PRR 4.3
Skin exfoliation — n=59, PRR 3.9
Rash erythematous — n=31, PRR 3.6
Pruritus — n=238, PRR 3.4

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 Abrocitinib?

In FDA FAERS, the most frequently co-reported reaction terms for Abrocitinib are pruritus, dermatitis atopic, eczema, acne, dry skin, 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 Abrocitinib have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning.

Do FAERS signals prove that Abrocitinib 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 3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed258, effective 20260909; matched on openfda.generic_name.exact:"ABROCITINIB")
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, 83 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.