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Drug · FAERS side-effect profile with label screen

Dupilumab side effects: what 478,943 FDA adverse event reports show

Dupilumab · Dupixent · 1,268 reaction terms · 1,231,391 drug–reaction co-reports · data 2026-09-14

Drug class

Interleukin-4 Receptor alpha Antagonist

FDA label (Established Pharmacologic Class)

Brand names

Dupixent

openFDA label

Who reports

478,943 reports · 11% serious · 2,193 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

DUPIXENT is an interleukin-4 receptor alpha antagonist indicated: Atopic Dermatitis for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

FDA label, Indications and Usage

What it is

Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa.

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 40 strongest signals

Labeled adverse reaction 3Labeled (related wording) 5Likely indication confounding 6Reporting / coding artifact 3Not in label — unassessed 23

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,228 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
Rebound atopic dermatitis	2,005	12,087.9 5,755.2–25,388.6ROR 12,138.7 · calibrated p 5e-26 ✓	43.0 EB05 41.5 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=86 · 90% clinician	not reported in cached trials
Rebound eczema	2,010	2,925.0 2,027.4–4,220.2ROR 2,937.4 · calibrated p 5e-22 ✓	42.6 EB05 41.0 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=97	not reported in cached trials
Dermatitis atopic	45,026	444.6 430.9–458.7ROR 490.6 · calibrated p 7e-14 ✓	39.5 EB05 39.2 · IC025 +5.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 377.5 · serious n=1,831	NCT01949311: 6/2,677 (0.2%) on Dupilumab (serious AE)
Eosinophilic oesophagitis	1,830	106.7 97.9–116.3ROR 107.1 · calibrated p 7e-8 ✓	30.9 EB05 29.8 · IC025 +4.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=220	not reported in cached trials
Neurodermatitis	2,356	91.8 85.4–98.7ROR 92.3 · calibrated p 2e-7 ✓	29.6 EB05 28.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=188	not reported in cached trials
Eczema infantile	58	84.4 54.0–131.8ROR 84.4 · calibrated p 1e-6 ✓	28.6 EB05 22.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	♀ 0% (drug 61%)	not reported in cached trials
Periorbital irritation	201	73.8 58.7–92.8ROR 73.8 · calibrated p 1e-6 ✓	27.4 EB05 24.4 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Exposure via skin contact	13,934	70.1 68.3–72.1ROR 72.2 · calibrated p 1e-6 ✓	27.0 EB05 26.6 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 69.8 · serious n=486	not reported in cached trials
Skin weeping	1,946	61.4 57.3–65.9ROR 61.7 · calibrated p 4e-6 ✓	25.6 EB05 24.7 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=166	not reported in cached trials
Eczema eyelids	297	54.7 46.1–65.0ROR 54.8 · calibrated p 9e-6 ✓	24.4 EB05 22.1 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Eyelid skin dryness	643	53.1 47.3–59.6ROR 53.2 · calibrated p 1e-5 ✓	24.1 EB05 22.5 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=27	not reported in cached trials
Eczema	26,626	48.8 48.0–49.7ROR 51.6 · calibrated p 1e-5 ✓	23.2 EB05 22.9 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 45.3 · serious PRR 21.4	NCT01949311: 2/2,677 (0.1%) on Dupilumab (serious AE)
Nasal polypectomy	75	41.6 30.3–57.3ROR 41.7 · calibrated p 6e-5 ✓	21.4 EB05 17.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	♀ 0% (drug 61%)	not reported in cached trials
Periorbital inflammation	107	38.3 29.5–49.7ROR 38.3 · calibrated p 9e-5 ✓	20.5 EB05 17.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Chronic rhinosinusitis with nasal polyps	65	37.1 26.6–51.7ROR 37.1 · calibrated p 1e-4 ✓	20.1 EB05 16.3 · IC025 +3.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	–	not reported in cached trials
Injection site dryness	389	33.9 29.7–38.8ROR 33.9 · calibrated p 1e-4 ✓	19.2 EB05 17.7 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious n=25 · ♀ 86% (drug 61%)	not reported in cached trials
Injection site eczema	82	33.6 25.1–44.9ROR 33.6 · calibrated p 2e-4 ✓	19.1 EB05 15.8 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	♀ 100% (drug 61%)	NCT01949311: 2/2,677 (0.1%) on Dupilumab (serious AE)
Nasal polyps	2,083	32.8 31.0–34.7ROR 33.0 · calibrated p 2e-4 ✓	18.9 EB05 18.2 · IC025 +4.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=185	not reported in cached trials
Sleep disorder due to a general medical condition	6,838	31.6 30.7–32.6ROR 32.1 · calibrated p 2e-4 ✓	18.5 EB05 18.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 37.0 · serious PRR 16.4	not reported in cached trials
Unintentional use for unapproved indication	247	30.6 26.0–36.0ROR 30.6 · calibrated p 3e-4 ✓	18.1 EB05 16.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=41	not reported in cached trials
Mood disorder due to a general medical condition	90	29.9 22.8–39.2ROR 29.9 · calibrated p 3e-4 ✓	17.9 EB05 15.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Injection site exfoliation	261	28.1 24.0–32.9ROR 28.1 · calibrated p 4e-4 ✓	17.2 EB05 15.6 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	♀ 89% (drug 61%)	not reported in cached trials
Eyelid rash	366	27.3 24.0–31.2ROR 27.4 · calibrated p 4e-4 ✓	17.0 EB05 15.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=21	not reported in cached trials
Skin fissures	7,194	26.5 25.8–27.3ROR 26.9 · calibrated p 5e-4 ✓	16.7 EB05 16.4 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 24.5 · serious n=412	not reported in cached trials
Hand dermatitis	251	26.5 22.6–31.0ROR 26.5 · calibrated p 5e-4 ✓	16.6 EB05 15.0 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	–	not reported in cached trials
Product dose omission in error	9,767	24.6 24.0–25.2ROR 25.1 · calibrated p 7e-4 ✓	15.9 EB05 15.7 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 27.7 · serious PRR 23.2	not reported in cached trials
Ocular surface disease	96	24.6 19.1–31.6ROR 24.6 · calibrated p 9e-4 ✓	15.8 EB05 13.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=95 · ♀ 0% (drug 61%) · 100% clinician	not reported in cached trials
Lack of injection site rotation	624	24.5 22.2–27.0ROR 24.5 · calibrated p 8e-4 ✓	15.8 EB05 14.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=31	not reported in cached trials
Oesophageal food impaction	183	22.8 19.1–27.4ROR 22.9 · calibrated p 0.001 ✓	15.1 EB05 13.4 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=183	NCT02134028: 1/517 (0.2%) control (serious AE)
Conjunctivitis	5,872	20.2 19.6–20.8ROR 20.4 · calibrated p 0.002 ✓	14.0 EB05 13.7 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 13.7 · serious PRR 15.1	NCT01949311: 1/2,677 (0.0%) on Dupilumab (serious AE)
Perioral dermatitis	194	20.0 16.8–23.7ROR 20.0 · calibrated p 0.002 ✓	13.8 EB05 12.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Eyelid margin crusting	884	19.7 18.1–21.3ROR 19.7 · calibrated p 0.002 ✓	13.7 EB05 13.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=87	not reported in cached trials
Eyelids pruritus	939	19.0 17.6–20.5ROR 19.1 · calibrated p 0.002 ✓	13.4 EB05 12.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=66	not reported in cached trials
Idiopathic urticaria	299	18.7 16.4–21.5ROR 18.8 · calibrated p 0.003 ✓	13.3 EB05 12.0 · IC025 +3.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	not reported in cached trials
Eye pruritus	9,986	18.7 18.3–19.1ROR 19.1 · calibrated p 0.002 ✓	13.3 EB05 13.0 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 21.3 · serious PRR 18.4	NCT01949311: 1/2,677 (0.0%) on Dupilumab (serious AE)
Skin swelling	2,554	18.4 17.6–19.3ROR 18.5 · calibrated p 0.003 ✓	13.1 EB05 12.7 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=184	not reported in cached trials
Skin haemorrhage	4,214	17.7 17.1–18.4ROR 17.9 · calibrated p 0.003 ✓	12.8 EB05 12.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	age-adj. PRR 18.0 · serious n=330	not reported in cached trials
Therapeutic response shortened	9,229	17.6 17.1–18.0ROR 17.9 · calibrated p 0.003 ✓	12.7 EB05 12.5 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 23.9 · serious PRR 10.4	not reported in cached trials
Dyshidrotic eczema	199	17.4 14.8–20.6ROR 17.4 · calibrated p 0.004 ✓	12.6 EB05 11.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	–	NCT02134028: 1/1,013 (0.1%) on Dupilumab; 1/19 (5.3%) control
Eyelid exfoliation	223	17.0 14.6–19.9ROR 17.0 · calibrated p 0.004 ✓	12.4 EB05 11.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Opportunistic infection	2,230	0.70.7–0.7	lower than other drugs
Serious infection	9,619	0.50.5–0.6	lower than other drugs
Tendon disorder	346	0.40.4–0.4	lower than other drugs
Anaphylaxis / angioedema	1,014	0.30.3–0.4	lower than other drugs
Fall / fracture	2,971	0.30.3–0.3	lower than other drugs
Depression	2,179	0.30.3–0.3	lower than other drugs
Stroke	1,145	0.20.2–0.2	lower than other drugs
Malignancy	1,705	0.20.2–0.2	lower than other drugs
Venous thromboembolism	817	0.20.2–0.2	lower than other drugs
Arrhythmia / qt	705	0.20.1–0.2	lower than other drugs
Pancreatitis	288	0.20.1–0.2	lower than other drugs
Myocardial infarction	693	0.10.1–0.2	lower than other drugs
Heart failure	581	0.10.1–0.2	lower than other drugs
Hyperglycaemia / diabetes	1,060	0.10.1–0.1	lower than other drugs
Seizure	558	0.10.1–0.1	lower than other drugs
Interstitial lung disease	264	0.10.1–0.1	lower than other drugs

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Dupilumab as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (7 of 40 signal terms matched).

NCT01949311 — Open-label Study of Dupilumab in Patients With Atopic Dermatitis (N=2733, PHASE3; 251 AE terms posted; arms: Dupilumab)
NCT02134028 — Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE) (N=2282, PHASE3; 294 AE terms posted; arms: Participants From DRI12544 Study Placebo; Participants From DRI12544 Study Dupilum; Participants From EFC13579 Study Placebo; Participants From EFC13579 Study Dupilum)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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
Pruritus (itching)	58,692	7.9 7.8–7.9ROR 8.8 · calibrated p 0.048 ✓	6.8 EB05 6.8 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 8.2 · serious PRR 5.6	NCT01949311: 1/2,677 (0.0%) on Dupilumab (serious AE)
Dermatitis atopic	45,026	444.6 430.9–458.7ROR 490.6 · calibrated p 7e-14 ✓	39.5 EB05 39.2 · IC025 +5.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 377.5 · serious n=1,831	NCT01949311: 6/2,677 (0.2%) on Dupilumab (serious AE)
Product use in unapproved indication	41,225	8.7 8.6–8.8ROR 9.4 · calibrated p 0.039 ✓	7.4 EB05 7.3 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 9.0 · serious PRR 9.2	not reported in cached trials
Rash	38,629	4.2 4.1–4.2ROR 4.5 · calibrated p 0.301	3.9 EB05 3.9 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.9 · serious PRR 3.2	NCT02134028: 1/517 (0.2%) control (serious AE)
Injection site pain (pain where injected)	36,707	5.9 5.8–6.0ROR 6.3 · calibrated p 0.132	5.3 EB05 5.2 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 5.6 · serious PRR 10.1	NCT01949311: 2/2,677 (0.1%) on Dupilumab (serious AE)
Drug ineffective (drug did not work)	30,015	1.0 1.0–1.0ROR 1.0 · calibrated p 0.305	1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 1.1 · serious PRR 1.1	not reported in cached trials
Eczema	26,626	48.8 48.0–49.7ROR 51.6 · calibrated p 1e-5 ✓	23.2 EB05 22.9 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 45.3 · serious PRR 21.4	NCT01949311: 2/2,677 (0.1%) on Dupilumab (serious AE)
Dry skin	25,981	10.6 10.4–10.7ROR 11.1 · calibrated p 0.022 ✓	8.6 EB05 8.6 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 9.2 · serious PRR 9.7	NCT01949311: 8/2,677 (0.3%) on Dupilumab (serious AE)
Product dose omission issue	25,295	4.2 4.1–4.2ROR 4.4 · calibrated p 0.318	3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 4.3 · serious PRR 5.0	not reported in cached trials
Condition aggravated	20,686	3.1 3.1–3.2ROR 3.2 · calibrated p 0.552	3.0 EB05 3.0 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.9 · serious PRR 2.9	not reported in cached trials
Arthralgia (joint pain)	19,297	2.1 2.1–2.1ROR 2.1 · calibrated p 0.984	2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 2.4	NCT01949311: 1/2,677 (0.0%) on Dupilumab (serious AE)
Inappropriate schedule of product administration	18,597	5.0 5.0–5.1ROR 5.2 · calibrated p 0.214	4.6 EB05 4.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 5.2 · serious PRR 5.0	not reported in cached trials
Asthma	16,153	7.2 7.1–7.3ROR 7.4 · calibrated p 0.083	6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 7.7 · serious PRR 10.0	NCT01949311: 3/2,677 (0.1%) on Dupilumab (serious AE)
Accidental exposure to product	15,818	8.1 7.9–8.2ROR 8.3 · calibrated p 0.059	6.9 EB05 6.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 8.4 · serious PRR 13.7	not reported in cached trials
Skin exfoliation	14,757	9.3 9.1–9.4ROR 9.5 · calibrated p 0.038 ✓	7.8 EB05 7.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	age-adj. PRR 7.8 · serious PRR 8.8	not reported in cached trials

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.

Rebound atopic dermatitis — n=2,005, PRR 12,087.9
Rebound eczema — n=2,010, PRR 2,925.0
Neurodermatitis — n=2,356, PRR 91.8
Eczema infantile — n=58, PRR 84.4
Periorbital irritation — n=201, PRR 73.8
Skin weeping — n=1,946, PRR 61.4
Eczema eyelids — n=297, PRR 54.7
Eyelid skin dryness — n=643, PRR 53.1
Nasal polypectomy — n=75, PRR 41.6
Periorbital inflammation — n=107, PRR 38.3

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 Dupilumab?

In FDA FAERS, the most frequently co-reported reaction terms for Dupilumab are pruritus, dermatitis atopic, rash, injection site pain, eczema, dry skin. 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 Dupilumab have an FDA boxed warning?

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

Do FAERS signals prove that Dupilumab 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 595f437d-2729-40bb-9c62-c8ece1f82780, effective 20260422; matched on openfda.generic_name.exact:"DUPILUMAB" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
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, 1,268 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
ClinicalTrials.gov API v2 (query DUPILUMAB, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.