Drugs › Interleukin-4 receptor alpha antagonist
Generic name
Dupilumab: adverse event reports filed with FDA
12,726 reports list it as a suspect or interacting product, 2016–2026. Class: Interleukin-4 receptor alpha antagonist.
- 12,726
- reports as suspect product
- 0.1% of all reports · about 1,223 a year
- 1,844
- reports, 12 months to June 2026
- 1,699 in the 12 months before
- 44.4%
- marked serious by the reporter
- 10.7% across the class
- 2.5%
- record death among outcomes, as reported
- 313 reports · not verified by FDA
12,726 adverse event reports received by FDA list dupilumab, a generic name as a suspect or interacting product, from February 2016 to June 2026. A further 698 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 1,844 reports listed it, close to the 1,699 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 1,223 reports a year and 0.1% of the 20,646,523 reports in the database, and 2.7% of the reports for the interleukin-4 receptor alpha antagonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are pruritus (11.7%), rash (9.5%) and injection site pain (9.1%). A report can list several reactions, so shares add to more than 100%; 1,309 different terms appear across these reports. Pruritus is recorded in 11.7% of these reports, about the same share as in the median interleukin-4 receptor alpha antagonist drug (12%).
44.4% of the reports are marked serious by the reporter (10.7% across the class); 2.5% record death among the outcomes and 17.8% record hospitalisation, as reported. 44% of the reports came from consumers, and the largest patient age group is 45 to 64 (25.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Dupilumab reports recording the termmedian drug in interleukin-4 receptor alpha antagonist
- Pruritusitching11.7%1,490
- Rashskin rash9.5%1,207
- Injection site painpain where the injection was given9.1%1,159
- Off label useused for a purpose or in a way not on the label7.6%969
- Drug ineffectivethe medicine did not work as expected7.1%908
- Dermatitis atopic6.9%879
- Condition aggravatedthe condition being treated got worse5.7%724
- Dyspnoeashortness of breath5.4%689
- Product use in unapproved indicationused for a purpose not on the label5.4%682
- Arthralgiajoint pain5.2%664
- Product use issuea problem in how the product was used5.1%651
- Eczemaeczema4.8%617
- Erythemaskin redness4.5%568
- Coughcough4.4%562
- Product dose omission issuea dose was missed4.3%552
- Dry skindry skin3.9%497
- Inappropriate schedule of product administrationthe product was taken at the wrong times3.9%493
- Asthmaasthma3.7%469
- Eye pruritus3.4%429
- Skin exfoliationpeeling skin3.3%416
- Fatiguetiredness3.2%413
- Painpain, site not specified3.2%410
- Pneumonialung infection3.2%404
- Headachehead pain3.1%394
- Dry eyedry eye3.1%390
- Incorrect dose administeredthe wrong dose was given3%381
- Injection site swellingswelling where the injection was given3%381
- Injection site erythemaredness where the injection was given3%380
- Ocular hyperaemiaa red eye3%378
Top 30 of 1,309 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the interleukin-4 receptor alpha antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 474,914 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 77.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Dermatitis atopic | 5,637 | 44.3% |
| Asthma | 2,056 | 16.2% |
| Eczema | 699 | 5.5% |
| Nasal polyps | 568 | 4.5% |
| Neurodermatitis | 283 | 2.2% |
| Eosinophilic oesophagitis | 276 | 2.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 12,726 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Dupilumab reports |
|---|---|---|
| Prednisone | 606 | 4.8% |
| Albuterol sulfate | 349 | 2.7% |
| Montelukast | 249 | 2% |
| Methotrexate | 244 | 1.9% |
| Dupixent | 233 | 1.8% |
| Symbicort | 227 | 1.8% |
| Gabapentin | 207 | 1.6% |
| Ergocalciferol | 204 | 1.6% |
| Cyclosporine | 199 | 1.6% |
| Tacrolimus | 187 | 1.5% |
Other products listed in reports where Dupilumab is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Dupilumab | Interleukin-4 receptor alpha antagonist | All reports |
|---|---|---|---|
| Reports as suspect product | 12,726 | 474,914 | 20,646,523 |
| Share of that pool | — | 2.7% | 0.1% |
| Reports, latest 12 months | 1,844 | — | 1,332,454 |
| Marked serious | 44.4% | 10.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 25 | 4 | 91 |
| Hospitalisation recorded, per 1,000 reports | 178 | 46 | 213 |
| Consumer-filed share | 44% | 31.5% | 45.8% |
| Top term, share of reports | Pruritus 11.7% | median 12% | 1.8% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the interleukin-4 receptor alpha antagonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Dupixent | brand | 462,188 | 122,091 | 9.8% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Dupilumab reports
How many adverse event reports has FDA received for Dupilumab?
12,726 reports list Dupilumab as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,844 of them arrived in the latest 12 months. Another 698 list it only as a concomitant medication.
What reactions are recorded in Dupilumab reports?
pruritus (11.7%), rash (9.5%), injection site pain (9.1%), off label use (7.6%) and drug ineffective (7.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Dupilumab was responsible.
How serious are the reports?
44.4% are marked serious by the reporter. Among the outcomes recorded, 2.5% of reports include death and 17.8% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (44%), physician (38.8%) and other health professional (15.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Dupilumab rising?
1,844 reports in the 12 months to June 2026, close to the 1,699 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Dupilumab was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Dupilumab?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Dupilumab as a suspect or interacting product; reports listing it only as a concomitant medication (698) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.