Dupixentdupilumab
According to the FDA label: 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.
438,499 adverse event reports submitted to the FDA (2013–2026)
Top Reported Adverse Events
The most frequently reported events in association with Dupixent in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Pruritus 52,379 reports
- Dermatitis Atopic 41,045 reports
Product Use in Unapproved Indication 38,078 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Rash 35,570 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Injection Site Pain 32,857 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Drug Ineffective 27,750 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →- Eczema 24,172 reports
Product Dose Omission Issue 23,332 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Dry Skin 23,316 reports
Skin that lacks moisture, which can feel rough, tight, or flaky.
Full definition in the glossary → See all drugs reporting this event →Condition Aggravated 19,621 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Arthralgia 17,651 reports
Inappropriate Schedule of Product Administration 17,346 reports
A report that the medication was taken on the wrong schedule, such as too often, not often enough, or at the wrong time. This is a usage category, not a sign of a problem with the drug.
Full definition in the glossary →Asthma 14,715 reports
A condition where the airways narrow and swell, causing wheezing and difficulty breathing.
Full definition in the glossary →Accidental Exposure to Product 13,305 reports
A report that someone was unintentionally exposed to a medication, for example a child or another person who was not the patient. This is a safety-tracking category.
Full definition in the glossary →Skin Exfoliation 13,299 reports
Peeling or shedding of the outer layer of skin.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 252,872 |
| Male | 161,818 |
| Unknown | 46 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 48,729 |
| 18-34 | 56,058 |
| 35-49 | 53,724 |
| 50-64 | 79,019 |
| 65-74 | 39,047 |
| 75+ | 25,983 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Dupixent. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 389,891 |
| Other Serious | 36,212 |
| Hospitalization | 20,609 |
| Death | 1,972 |
| Disability | 1,541 |
| Life-Threatening | 561 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Dupixent. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2013 | 2 |
| 2016 | 7 |
| 2017 | 1,107 |
| 2018 | 7,626 |
| 2019 | 14,912 |
| 2020 | 20,259 |
| 2021 | 40,306 |
| 2022 | 58,513 |
| 2023 | 66,771 |
| 2024 | 88,405 |
| 2025 | 114,829 |
| 2026 (partial) | 25,762 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Dupixent
In FDA adverse event reports that mention Dupixent, these medications appeared most often in the same report.
- Albuterol (15,162 reports)
- Montelukast (8,964 reports)
- Prednisone (8,875 reports)
- Ergocalciferol (8,291 reports)
- Cetirizine (8,013 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026