Pharmacologic class (EPC) · 2 drug pages

Interleukin-4 receptor alpha antagonist: adverse event reports filed with FDA

474,914 reports list a drug in this class as a suspect or interacting product, 2016–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

474,914
reports across the class: 2.3% of all reports; 123,935
reports, 12 months to June 2026: 104,230 in the 12 months before; 10.7%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Interleukin-4 receptor alpha antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 474,914 adverse event reports received by FDA, 2.3% of the database, from February 2016 to June 2026.

123,935 reports arrived in the 12 months to June 2026, up 19% from 104,230 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 10.7% of the class's reports are marked serious, 0.4% record death among the outcomes and 4.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are pruritus (12.3%), dermatitis atopic (9.5%) and product use in unapproved indication (8.7%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
DupixentDupilumab	brand	462,188	122,091	9.8%	Pruritus
Dupilumab	generic	12,726	1,844	44.4%	Pruritus

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Pruritusitching12.3%58,501
Dermatitis atopic9.5%44,971
Product use in unapproved indicationused for a purpose not on the label8.7%41,140
Rashskin rash8.1%38,486
Injection site painpain where the injection was given7.7%36,692
Drug ineffectivethe medicine did not work as expected6.2%29,585
Eczemaeczema5.6%26,517
Dry skindry skin5.5%25,944
Product dose omission issuea dose was missed5.3%25,101
Condition aggravatedthe condition being treated got worse4.3%20,548
Arthralgiajoint pain4%19,138
Inappropriate schedule of product administrationthe product was taken at the wrong times3.9%18,526
Asthmaasthma3.4%15,938
Accidental exposure to product3.3%15,813
Skin exfoliationpeeling skin3.1%14,727
Dyspnoeashortness of breath3%14,268
Exposure via skin contact2.9%13,937
Erythemaskin redness2.9%13,537
Off label useused for a purpose or in a way not on the label2.8%13,462
Dry eyedry eye2.8%13,396
Incorrect dose administeredthe wrong dose was given2.6%12,554
Injection site swellingswelling where the injection was given2.5%11,898
Coughcough2.3%11,130
Injection site erythemaredness where the injection was given2.3%10,920
Product use issuea problem in how the product was used2.2%10,644

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death0.4%2,117

Life-threatening0.1%559

Hospitalisation (initial or prolonged)4.6%21,745

Disability0.3%1,544

Congenital anomaly0%79

Other serious8%37,858

Not serious89.3%424,082

Patient age

Under 20.5%2,523

2 to 115.8%27,387

12 to 174.9%23,383

18 to 4420.5%97,508

45 to 6422.2%105,646

65 to 749.1%43,417

75 and over6.2%29,679

Age not given30.6%145,371

Who reported

Physician44.1%209,536

Pharmacist1.3%5,993

Other health professional23%109,334

Lawyer0%32

Consumer or non-health professional31.5%149,690

Not given0.1%329

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Interleukin-4 receptor alpha antagonist reports

Which drugs are in the Interleukin-4 receptor alpha antagonist class on this site?

Dupixent and Dupilumab. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

474,914 reports through June 2026, 123,935 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

pruritus (12.3%), dermatitis atopic (9.5%), product use in unapproved indication (8.7%), rash (8.1%) and injection site pain (7.7%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.