The Dupixent Label: 2017 to Today, and the Warning That Is Not There

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The Dupixent label never warned about lymphoma

Nine years of label history, no malignancy warning. That gap is the heart of these lawsuits.

ACTIVE LITIGATION — NO SETTLEMENT. MDL 3180 underway · filing deadlines vary by state.

Were you — or someone you love — diagnosed with CTCL or another T-cell lymphoma after taking Dupixent?

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Claims are brought against Sanofi and Regeneron, the makers of Dupixent — not against your doctor. Conversations are confidential. Some matters may be referred to other lawyers. No settlement has been reached, and most cases are in their earliest stages; every case must be proven on its own facts. Attorney Advertising.

Lawsuits consolidated in MDL 3180 (D.N.J.) allege that Dupixent (dupilumab) is associated with an increased risk of cutaneous T-cell lymphoma (CTCL) and that the manufacturers failed to warn about it. No court has ruled on these allegations, no settlement exists, and the litigation is in its earliest stages. Published studies report a statistical association — which the study authors themselves note does not establish causation — and the FDA has identified a potential safety signal it is still evaluating; Dupixent’s FDA label does not currently warn about lymphoma. Whether any individual has a claim depends on their medical records and the law of their state.

When was Dupixent approved, and how did its uses expand?

The original approval came on March 28, 2017, for moderate-to-severe atopic dermatitis in adults; the label confirms an initial U.S. approval year of 2017. From there the drug expanded, roughly annually, into new diseases and younger age groups:

• October 2018 — asthma, 12 and up; March 2019 — atopic dermatitis, 12 to 17
• June 2019 — chronic rhinosinusitis with nasal polyposis; May 2020 — atopic dermatitis, 6 to 11
• October 2021 — asthma, 6 to 11; May 2022 — eosinophilic esophagitis, 12 and up
• June 2022 — atopic dermatitis, 6 months to 5 years; September 2022 — prurigo nodularis
• January 2024 — eosinophilic esophagitis extended to ages 1 and up
• September 2024 — nasal polyposis extended to adolescents; COPD with an eosinophilic phenotype
• April 2025 — chronic spontaneous urticaria; June 2025 — bullous pemphigoid
• February 2026 — allergic fungal rhinosinusitis; April 2026 — urticaria in young children

The original March 28, 2017 approval is confirmed by the FDA-approved label itself; expansion dates are drawn from the manufacturers’ FDA-approval announcements (prurigo nodularis: approved September 28, 2022, per the companies’ joint release).

The expansion matters as arithmetic of exposure: each new indication put the drug in front of a broader patient population, and the volume of FDA adverse event reports rose with it.

What nine indications does the current label carry?

Per the label as published with data last updated August 14, 2026: atopic dermatitis (6 months+), asthma (6+), chronic rhinosinusitis with nasal polyposis (12+), eosinophilic esophagitis (1+), prurigo nodularis (adults), COPD with an eosinophilic phenotype (adults), chronic spontaneous urticaria (2+), bullous pemphigoid (adults), and allergic fungal rhinosinusitis (6+).

Does the Dupixent label say anything about lymphoma?

No. This finding matters most here, and it was checked twice, independently, against the current label text: the words “lymphoma,” “cutaneous T-cell,” “CTCL,” “mycosis fungoides,” “malignancy,” “neoplasm,” and “cancer” appear nowhere in the label — not in Warnings and Precautions, not in Adverse Reactions, not in postmarketing experience.

What the Warnings and Precautions section does cover is a defined list: hypersensitivity; conjunctivitis, keratitis, and blepharitis; eosinophilic conditions; acute symptoms of asthma or COPD; abrupt reduction of corticosteroid dosage; co-morbid asthma; psoriasis; arthralgia and psoriatic arthritis; parasitic helminth infections; and vaccinations. It is a substantial safety section. Lymphoma is simply not in it — the accurate statement is that the label is silent on malignancy while the FDA evaluates a potential CTCL signal.

What does the label’s postmarketing section actually say?

Section 6.2, Postmarketing Experience, quoted in full from the current label:

“The following adverse reactions have been identified during post-approval use of DUPIXENT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune system disorders: angioedema Musculoskeletal system disorders: psoriatic arthritis Skin and subcutaneous tissue disorders: Facial skin reactions, including erythema, rash, scaling, edema, papules, pruritus, burning, and pain; new-onset psoriasis, vasculitis Ocular disorders: Ectropion, cicatricial disease/cicatricial ectropion, punctal stenosis/canalicular obstruction, symblepharon, and temporary or ongoing vision loss, including visual impairment and blindness associated with conjunctivitis, keratitis, or blepharitis.”

That is the complete postmarketing list — where a newly recognized safety observation would ordinarily first appear in a label. No lymphoma or malignancy entry has been added to it.

Why does a missing warning matter to a failure-to-warn claim?

Because that is the claim. A failure-to-warn case does not ask a jury whether a drug is good or bad; it asks what the manufacturer knew or should have known about a risk, when, and whether the approved labeling told physicians and patients what they needed to weigh it. The label is the document through which that duty is performed.

Plaintiffs in the Dupixent lawsuit allege that the manufacturers failed to warn about an association between Dupixent and cutaneous T-cell lymphoma, pointing to the accumulation of published studies and adverse event reports as the notice they say triggered a duty to act. The manufacturers dispute this. No court has ruled, and the causation science is contested by the researchers themselves.

Has the FDA required any lymphoma-related change to the label?

Not as of August 19, 2026. In its quarterly table of potential signals for October–December 2024, the agency listed “Dupixent (dupilumab) injection” with the potential signal “Cutaneous T-cell lymphoma” and the stated action “FDA is evaluating the need for regulatory action.” No label change and no safety communication has followed; an evaluation is not a conclusion in either direction. Label status is tracked as the MDL 3180 proceeding develops.

What does the label question mean for you personally?

If you used Dupixent and were later diagnosed with CTCL or a related T-cell lymphoma, the label matters as evidence, not as a decision you have to make. Your claim would be evaluated on your records: proof of use, the pathology report, and the timeline. There is no minimum length of use, and where the patient has died a claim may be brought through the estate. No attorney-client relationship is created until a written engagement agreement is signed.

This page is about a lawsuit — it is not medical advice, and filing a claim does not require you to stop taking Dupixent. Decisions about your medication belong with you and your doctor.

What else do people ask about the Dupixent label?