Can Dupixent Cause Cancer?

A question that wasn’t on the table five years ago is now sitting in the middle of every dermatology waiting room: can the eczema shot you trusted to fix your skin be causing cancer?

Patients are asking it. Doctors are asking it. The FDA is officially asking it.

Dupixent (dupilumab) was approved in 2017 as a breakthrough biologic for moderate-to-severe eczema, and it’s since become a $13-billion-a-year blockbuster used for asthma, COPD, chronic sinus disease, and more. But a stack of peer-reviewed studies — and more than 300 adverse event reports filed with the FDA — now suggests the drug may be tied to a rare, aggressive blood cancer called cutaneous T-cell lymphoma (CTCL).

Here’s what the evidence actually shows, what regulators are doing about it, and what your legal options look like if you or a family member was diagnosed with CTCL after taking Dupixent.

Research Has Linked Dupixent to a Rare Skin Cancer

Multiple peer-reviewed studies have found that Dupixent users develop cutaneous T-cell lymphoma at significantly higher rates than non-users.

A 2024 study in Dermatologic Therapy analyzed nearly 20,000 atopic dermatitis patients and found that those treated with Dupixent were roughly 4.6 times more likely to be diagnosed with CTCL than patients who didn’t use the drug. A 2025 analysis published in the Journal of Allergy and Clinical Immunology reviewed FDA safety data and found that Dupixent users reported CTCL at rates roughly 30 times higher than users of other medications. A separate 2025 European Respiratory Journal study reported that asthma patients on Dupixent had a 79% higher risk of lymphoma overall.

That’s not a single fluky paper. That’s a pattern.

But the most important word in this entire conversation is association — not proof of causation. Researchers and regulators are still working to determine whether Dupixent is causing CTCL, unmasking a CTCL that was already there, or accelerating a cancer that the drug’s anti-inflammatory effect was hiding from view.

Why the Eczema-Lymphoma Confusion Matters So Much

Early-stage CTCL — particularly its most common form, mycosis fungoides — looks almost identical to eczema. Red patches. Scaling. Itching. Plaques that come and go.

A dermatologist seeing a patient with itchy, inflamed skin will reasonably reach for the eczema diagnosis first, because eczema is overwhelmingly more common. CTCL affects roughly 1 in a million Americans per year. Eczema affects more than 30 million.

The clinical danger is this: if Dupixent suppresses the inflammation of what was actually early-stage CTCL, the cancer can keep progressing silently underneath. By the time the rash returns or worsens despite treatment, the disease may have advanced from a localized patch to a more aggressive stage involving lymph nodes or blood — including the more dangerous variant, Sézary syndrome.

That’s the heart of the lawsuits now being filed. Plaintiffs argue Sanofi and Regeneron knew — or should have known — that Dupixent could mask or accelerate CTCL, and that doctors and patients were never given the chance to weigh that risk.

What the FDA Has Actually Done

In March 2025, the FDA added Dupixent to its quarterly FAERS Potential Signals of Serious Risk list, citing CTCL and confirming the agency is “evaluating the need for regulatory action.” That’s a significant step. The list is how the FDA publicly flags drugs whose adverse event data has crossed a concerning threshold.

Despite that signal:

• As of 2026, no cancer warning appears on the U.S. Dupixent label.
• The agency has not ordered a recall.
• The FDA’s review is still ongoing.

That gap — a publicly identified safety signal with no corresponding warning to prescribers — is exactly what product liability law was built to address. When a manufacturer learns of a serious risk and fails to update warnings, patients and their physicians can’t make informed decisions.

You can verify the current FDA label and adverse event data through the FDA’s drug safety reporting portal and the agency’s Adverse Event Reporting System.

Warning Signs to Watch For if You’re on Dupixent

Talk to your dermatologist if any of the following develop during treatment:

• A rash that initially improved on Dupixent but returns, spreads, or changes in appearance (raised plaques, thicker skin, or tumor-like growths)
• New patches of skin that don’t fit your prior eczema pattern, especially on the trunk, buttocks, or other sun-protected areas
• Swollen lymph nodes in the neck, armpits, or groin
• Unexplained weight loss, night sweats, or persistent fevers
• A widespread red, scaly rash with intense itching (“erythroderma”) — a possible sign of Sézary syndrome
• Skin that becomes thick or hardened on the palms or soles

These symptoms don’t automatically mean cancer. But they’re worth a biopsy and a conversation with a dermatologist who can rule out CTCL — and you should not wait.

Who’s Most at Risk?

Based on what’s been published so far:

• Adult-onset eczema patients — particularly those who developed atopic dermatitis later in life — appear overrepresented in CTCL diagnoses. Adult-onset itchy skin is a known red flag for early CTCL even outside the Dupixent context.
• Patients diagnosed within the first year of starting Dupixent. The majority of CTCL diagnoses in the medical literature occurred in the first 12 months of treatment.
• Patients who don’t fully respond to Dupixent or whose skin worsens despite the drug.
• Older adults (CTCL incidence rises with age), though the Dupixent literature includes younger patients than the cancer normally affects.

What the Lawsuits Allege

The lawsuits filed against Sanofi and Regeneron in federal courts across the country share a common core:

1. Failure to warn. Plaintiffs allege that mounting case reports, observational studies, and adverse event data gave the manufacturers fair notice of a potential CTCL link long before the FDA flagged it publicly in 2025.
2. Defective design or marketing. Plaintiffs argue Dupixent was promoted as a safe, well-tolerated long-term treatment for chronic skin conditions when the manufacturers knew or should have known the risk profile was incomplete.
3. Damages. Cases involve patients diagnosed with CTCL, mycosis fungoides, or Sézary syndrome after using Dupixent — including, as of late 2025, the first wrongful death claims.

In February 2026, plaintiffs filed a motion to consolidate Dupixent cases into a federal multidistrict litigation (MDL), which would centralize pretrial proceedings and likely accelerate the litigation. No verdicts or settlements have been reached yet.

Tennessee Law and Defective Drug Claims

If you live in Tennessee and were injured by a prescription drug, your case is governed by the Tennessee Products Liability Act (TPLA) and the state’s general personal injury rules.

A few things to know:

• Statute of limitations. Tennessee gives you generally one year from the date of injury to file a personal injury lawsuit under Tenn. Code § 28-3-104. For drug injury cases, the clock can sometimes be tolled until the injury is — or reasonably should have been — discovered, but this is fact-specific and you should not assume you have time.
• Comparative fault. Tennessee follows a modified comparative fault system established in McIntyre v. Balentine, 833 S.W.2d 52 (Tenn. 1992). You can recover compensation as long as your share of fault is less than 50%.
• Damages. You can pursue economic damages (medical bills, lost wages, future care) and non-economic damages (pain, suffering, loss of enjoyment), as outlined in our overview of types of damages in a Tennessee personal injury claim.

In October 2025, a Tennessee family filed one of the first Dupixent wrongful death lawsuits in the country, after their mother died of T-cell lymphoma months after starting the drug. That case underscores how quickly this litigation is moving.

What to Do If You Suspect Dupixent Caused Your Cancer

1. Get a confirmed diagnosis. A dermatologist or oncologist should perform a biopsy and, if needed, blood work and imaging to stage the disease.
2. Preserve your records. Save prescription receipts, pharmacy histories, dermatology notes, biopsy reports, and any communication with your doctors about your symptoms.
3. Don’t stop Dupixent without your doctor’s input. Stopping a biologic abruptly can have its own consequences. Coordinate any change with your prescribing physician.
4. Talk to a lawyer who handles defective drug cases. Document review and case evaluation are free, and the deadline to file in Tennessee is shorter than most people realize.

Our team is actively reviewing Dupixent CTCL cases. You can read more about the ongoing investigation on our Dupixent lawsuit page or our overview of Dupixent side effects your doctor may not have warned you about.

You Don’t Pay Unless We Win

If you or a loved one used Dupixent and were later diagnosed with cutaneous T-cell lymphoma, mycosis fungoides, Sézary syndrome, or another T-cell lymphoma, contact The Higgins Firm for a free, confidential case review. Our attorneys are licensed in Tennessee, Kentucky, Georgia, and Texas, and we work on a contingency fee — you owe nothing unless we recover compensation for you.

Time matters in these cases. The sooner we can review your medical records and prescription history, the more options you’ll have.