What the label lists and what reports show
Dupilumab side effects
Dupilumab's FDA label: “Most common adverse reactions are: Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.” FAERS holds 478,975 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pruritus (58,692 reports).
- No generic listed
Check it at the source: the dupilumab FDA label on DailyMed (effective April 22, 2026, Sanofi-Aventis U.S. LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of DUPIXENT?DUPIXENT can cause serious side effects, including: Allergic reactions. DUPIXENT can cause allergic reactions, including skin reactions, that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing fast pulse fever general ill feeling swollen lymph nodes joint pain swelling of the face, lips, mouth, tongue, or throat hives itching nausea or vomiting cramps in your stomach-area fainting, dizziness, feeling lightheaded skin rash, including rash that looks like a bullseye, painful red or blue bumps under the skin, or red pus-filled spots on the skin Eye problems. Tell your healthcare provider right away if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. […]
Source: FDA drug label, BLA761055 (Regeneron Pharmaceuticals), as published by Sanofi-Aventis U.S. LLC, effective April 22, 2026 (SPL set 595f437d-2729-40bb-9c62-c8ece1f82780), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are: Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.
Table 14: Adverse Reactions That Occurred in ≥2% of Adult Subjects with COPD Treated with DUPIXENT in BOREAS and NOTUS Trials (Pooled Safety Population) and Greater than Placebo
| Reaction | Adverse Reaction DUPIXENT 300 mg Q2W N=938 n (%) | BOREAS and NOTUS Placebo N=934 n (%) |
|---|---|---|
| Viral Infection Consists of multiple similar terms. | 133 (14.2) | 115 (12.3) |
| Headache | 73 (7.8) | 62 (6.6) |
| Nasopharyngitis | 73 (7.8) | 69 (7.4) |
| Back Pain | 42 (4.5) | 29 (3.1) |
| Diarrhea | 35 (3.7) | 30 (3.2) |
| Arthralgia | 29 (3.1) | 25 (2.7) |
| Urinary Tract Infection | 28 (3.0) | 18 (1.9) |
| Local Administration Reaction | 26 (2.8) | 6 (0.6) |
| Injection Site Reaction | 11 (1.2) | 2 (0.2) |
| Rhinitis | 24 (2.6) | 17 (1.8) |
| Eosinophilia Eosinophilia was defined as blood eosinophils ≥3,000 cells/mcL or deemed by… | 22 (2.3) | 7 (0.7) |
| Toothache | 20 (2.1) | 11 (1.2) |
| Gastritis | 19 (2) | 7 (0.7) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Conjunctivitis and Keratitis [see Warnings and Precautions (5.2) ] Psoriasis [see Warnings and Precautions (5.7) ] Arthralgia and Psoriatic Arthritis [see Warnings and Precautions (5.8) ] Parasitic (Helminth) Infections [see Warnings and Precautions (5.9) ] Most common adverse reactions are: Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. ( 6.1 ) Asthma (incidence ≥1%): injection site reactions, oropharyngeal pain, and eosinophilia. ( 6.1 ) Chronic Rhinosinusitis with Nasal Polyps (incidence ≥1%): injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis. ( 6.1 ) Eosinophilic Esophagitis (incidence ≥2%): injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. ( 6.1 ) Prurigo Nodularis (incidence ≥2%): nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea. …
Source: FDA drug label, BLA761055 (Regeneron Pharmaceuticals), as published by Sanofi-Aventis U.S. LLC, effective April 22, 2026 (SPL set 595f437d-2729-40bb-9c62-c8ece1f82780), via openFDA; the full label on DailyMed
What do FAERS reports show?
478,975 reports list dupilumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,193 are coded as a death and 22,558 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (114,880, against a median of 20,259 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 16 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dupilumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions