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dupilumab

Sold as Dupixent. Class: Agents for dermatitis, excluding corticosteroids. First FDA approval 03/28/2017: 9 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

C

Score breakdown (72/100)

Safety ×35%
B
Evidence ×25%
C
Regulatory ×15%
A
Money & lawsuits ×15%
F
Options ×10%
C

Safety: 85

Evidence: 73

Regulatory history: 95

Money & lawsuits: 15

Options: 70

What the FDA label says

Approved uses

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. ( 1.1 ) Asthma as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. ( 1.2 ) Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. ( 1.2 ) Chronic Rhinosinusitis with Nasal Polyps as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.3 ) Eosinophilic Esophagitis for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). ( 1.4 ) Prurigo Nodularis for the treatment of adult patients with prurigo nodularis (PN). ( 1.5 ) Chronic Obstructive Pulmonary Diseas...

Contraindications

is contraindicated in patients who have known hypersensitivity to dupilumab or any excipients of DUPIXENT [see Warnings and Precautions (5.1) ] . Known hypersensitivity to dupilumab or any excipients in DUPIXENT. ( 4 )

Warnings and precautions

Hypersensitivity: Hypersensitivity reactions including anaphylaxis, acute generalized exanthematous pustulosis (AGEP), serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme have occurred. Discontinue DUPIXENT in the event of a hypersensitivity reaction. ( 5.1 ) Conjunctivitis, Keratitis, and Blepharitis: Advise patients to promptly report new onset or worsening eye symptoms to their healthcare provider. If symptoms persist or worsen, consider discontinuation of DUPIXENT. Consider ophthalmological examination, as appropriate. ( 5.2 ) Eosinophilic Conditions: Be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, kidney injury and/or neuropathy, especially upon reduction of oral corticosteroids. ( 5.3 ) Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Decrease steroids gradually, if appropriate. ( 5.5 ) Psoriasis: Advise patients to report new-onset psoriasis symptoms to their healthcare provider. If symptoms persist or worsen, consider dermatologic evaluation and/or discontinuation of DUPIXENT. ( 5.7 ) Arthralgia and Psoriatic Arthriti...

Adverse reactions (label)

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Conjunctivitis and Keratitis [see Warnings and Precautions (5.2) ] Psoriasis [see Warnings and Precautions (5.7) ] Arthralgia and Psoriatic Arthritis [see Warnings and Precautions (5.8) ] Parasitic (Helminth) Infections [see Warnings and Precautions (5.9) ] Most common adverse reactions are: Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. ( 6.1 ) Asthma (incidence ≥1%): injection site reactions, oropharyngeal pain, and eosinophilia. ( 6.1 ) Chronic Rhinosinusitis with Nasal Polyps (incidence ≥1%): injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis. ( 6.1 ) Eosinophilic Esophagitis (incidence ≥2%): injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. ( 6.1 ) Prurigo Nodularis (incidence ≥2%): nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea. ( 6.1 ) Chronic ...

Recent major label changes

Indications and Usage, Chronic Spontaneous Urticaria ( 1.7 ) 04/2026 Indications and Usage, Bullous Pemphigoid ( 1.8 ) 06/2025 Indications and Usage, Allergic Fungal Rhinosinusitis ( 1.9 ) 02/2026 Dosage and Administration, Chronic Spontaneous Urticaria ( 2.9 ) 04/2026 Dosage and Administration, Bullous Pemphigoid ( 2.10 ) 06/2025 Dosage and Administration, Allergic Fungal Rhinosinusitis ( 2.11 ) 02/2026 Dosage and Administration, Missed Doses ( 2.12 ) 06/2025 Warnings and Precautions, Hypersensitivity ( 5.1 ) 06/2025 Warnings and Precautions, Conjunctivitis, Keratitis, and Blepharitis ( 5.2 ) 04/2026

Source: FDA SPL label for Dupixent (Sanofi-Aventis U.S. LLC), effective 20260422. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

479,026reports that mention this drug
478,974of those blame this drug, not another one the person was taking
11%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
0.5%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Pruritus · 58,695Dermatitis Atopic · 45,026Product Use In Unapproved Indication · 41,226Rash · 38,630Injection Site Pain · 36,707Drug Ineffective · 30,014Eczema · 26,628Dry Skin · 25,981Product Dose Omission Issue · 25,295Condition Aggravated · 20,687Arthralgia · 19,297Inappropriate Schedule Of Product Administration · 18,597Asthma · 16,153Accidental Exposure To Product · 15,818Skin Exfoliation · 14,758

Reports per year

20192020202120222023202420252026
14,91220,26540,31058,51066,76988,403114,88066,184

433,600 reports blaming this drug for every million Medicare prescriptions filled, which is 156.6× the typical drug on this site. (269,437 reports in 2024–2026, against 621,396 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

0recall actions on file
0 / 0brand / generic applications
0label changes since 2021
NoREMS program

Evidence base

165randomized trials (PubMed)
100systematic reviews
308registered trials
60%of completed trials posted results
7%terminated or withdrawn
68%industry-funded

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $38,721,105 in payments to US physicians and hospitals tied to this drug across 283,304 transactions (Dupixent $38,721,105).

Pending federal multidistrict litigation

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

88,374Medicare Part D patients (2024)
621,396prescriptions filled
$4,010average cost per fill
$2,492Mtotal Medicare spend
ProductFills$/fill
Dupixent Pen450,526$4,006
Dupixent Syringe170,870$4,021

Same-class alternatives

2 drugs in the same class grade a letter or more higher than dupilumab on this site. Worth asking whether one of them would do the same job for you.

alitretinoincrisaborolecromolyndelgocitinibnemolizumabpimecrolimusruxolitinib

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. The most-reported problems in FDA's adverse event data are pruritus, dermatitis atopic, product use in unapproved indication, rash. How would we recognize and handle those?
  2. Why this one over abrocitinib, alitretinoin, crisaborole? What would make you pick one of those instead?
  3. There is no generic. Is there an older generic in the same class that works as well for my situation?
  4. The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
  5. This drug is in active federal litigation. What is the claim, and does it affect my risk?
  6. What result are we expecting, by when, and what is the plan if it does not happen?
  7. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)