Dupixent: adverse event reports filed with FDA

462,188

reports as suspect product

2.2% of all reports · about 50,437 a year

122,091

reports, 12 months to June 2026

102,531 in the 12 months before

9.8%

marked serious by the reporter

10.7% across the class

0.4%

record death among outcomes, as reported

1,804 reports · not verified by FDA

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 Dupixent reports recording the termmedian drug in interleukin-4 receptor alpha antagonist

1. Pruritusitching12.3%57,011
2. Dermatitis atopic9.5%44,092
3. Product use in unapproved indicationused for a purpose not on the label8.8%40,458
4. Rashskin rash8.1%37,279
5. Injection site painpain where the injection was given7.7%35,533
6. Drug ineffectivethe medicine did not work as expected6.2%28,677
7. Eczemaeczema5.6%25,900
8. Dry skindry skin5.5%25,447
9. Product dose omission issuea dose was missed5.3%24,549
10. Condition aggravatedthe condition being treated got worse4.3%19,824
11. Arthralgiajoint pain4%18,474
12. Inappropriate schedule of product administrationthe product was taken at the wrong times3.9%18,033
13. Asthmaasthma3.3%15,469
14. Accidental exposure to product3.3%15,376
15. Skin exfoliationpeeling skin3.1%14,311
16. Exposure via skin contact2.9%13,585
17. Dyspnoeashortness of breath2.9%13,579
18. Dry eyedry eye2.8%13,006
19. Erythemaskin redness2.8%12,969
20. Off label useused for a purpose or in a way not on the label2.7%12,493
21. Incorrect dose administeredthe wrong dose was given2.6%12,173
22. Injection site swellingswelling where the injection was given2.5%11,517
23. Coughcough2.3%10,568
24. Injection site erythemaredness where the injection was given2.3%10,540
25. Product use issuea problem in how the product was used2.2%9,993
26. Product dose omission in error2.1%9,643
27. Eye pruritus2.1%9,549
28. Therapeutic response shortened2%9,068
29. Therapeutic response decreasedthe medicine worked less well1.9%8,968
30. Painpain, site not specified1.9%8,915

Top 30 of 3,618 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 98.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 462,188 reports.

Drugs most often listed in the same reports

Other products listed in reports where Dupixent 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

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

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.

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 Dupixent as a suspect or interacting product; reports listing it only as a concomitant medication (3,621) 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.