What are the side effects of Dupixent for babies?

October 13, 2025 •

2 min read

Clinical studies of Dupixent in infants and young children aged 6 months to 5 years have shown its safety profile to be generally consistent with that observed in older patients. Understanding what are the side effects of Dupixent for babies is important for caregivers.

Quick Summary

An overview of Dupixent side effects in infants and young children, based on clinical trial data, highlighting common injection site reactions, eye problems, and less frequent, more serious concerns.

Key Points

Common Side Effects: Include injection site reactions, pink eye (conjunctivitis), cold sores (oral herpes), upper respiratory infections, and elevated eosinophil counts.
Infant-Specific Findings: Clinical trials also reported hand-foot-and-mouth disease and skin papilloma (warts) in infants and preschoolers.
Serious Allergic Reactions: Watch for signs like breathing problems or facial swelling; seek immediate medical help if observed.
Eye Concerns: Eye-related issues like conjunctivitis, dry eyes, and keratitis are known side effects; severe symptoms may need ophthalmologist care.
Joint and Psoriasis Risk: New or worsening joint aches and new-onset psoriasis have been reported; notify a healthcare provider of new skin or joint symptoms.
Safe Long-Term Use: Long-term safety studies have reinforced the acceptable safety profile of Dupixent over time in young children.
Vaccination Warning: Avoid live vaccines during Dupixent treatment and discuss all vaccinations with a doctor.

Common Side Effects of Dupixent in Infants and Young Children

Clinical trial data for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis indicate that the safety profile of Dupixent is generally similar to that seen in older patients. Most side effects are typically mild to moderate. Common reactions include:

General and Skin-Related Reactions

Injection Site Reactions: Pain, redness, swelling, burning, or itching where the injection is given.
Skin Papilloma (Warts): Observed in some young children.
Hand-Foot-and-Mouth Disease: Reported in clinical trials.
Oral Herpes: Outbreaks around the mouth.

Eye-Related Complications

Conjunctivitis: Inflammation, redness, and itching of the eyes and eyelids.
Eyelid Inflammation (Blepharitis).
Keratitis: Inflammation of the cornea.
Dry Eye and Eye Itching.

Other Common Side Effects

Upper Respiratory Tract Infections.
Eosinophilia: An increase in certain white blood cells.
Diarrhea.
Headache.

Serious and Less Common Side Effects

Less common but serious side effects require immediate medical attention. These include:

Severe Allergic Reactions

Hypersensitivity reactions, including anaphylaxis, characterized by breathing problems, facial swelling, rapid heartbeat, or hives.

New or Worsening Psoriasis

Some children may develop new or worsening psoriasis; any new skin symptoms should be reported.

Joint Pain

New or worsening joint pain, which has been severe in rare cases. Report any new joint symptoms.

Side Effect Comparison: Common vs. Serious


Feature	Common Side Effects	Serious Side Effects
Frequency	More frequently observed	Less common, require immediate attention
Symptom Type	Localized skin reactions, viral infections, eye irritation, upper respiratory issues	Severe allergic reactions (anaphylaxis), worsening joint pain, new-onset psoriasis, keratitis, significant eosinophilia
Severity	Typically mild to moderate	Potentially severe and life-threatening
Management	Often managed by monitoring or simple treatments	May require discontinuation, emergency medical care, or specialist evaluation
Caregiver Action	Report to healthcare provider	Seek immediate medical help or contact provider right away

Managing Side Effects and Important Safety Information

Healthcare providers offer guidance on managing side effects. Eye issues may need standard treatments or ophthalmologist evaluation. Do not stop Dupixent or change other medications without consulting the doctor. Live vaccines should not be given during treatment; discuss vaccinations with your child's provider. More detailed information can be found on the {Link: Dupixent website https://www.dupixent.com/atopicdermatitis/dupixent-results/infants}.

Conclusion

Dupixent is a treatment option for moderate-to-severe atopic dermatitis in infants and young children 6 months and older. Its safety profile in this age group generally aligns with older patients. Common side effects include injection site reactions and eye issues, while rare, serious side effects like severe allergic reactions or unusual joint pain need immediate medical attention. Caregivers should discuss side effects with healthcare providers.

Frequently Asked Questions

The most common side effects of Dupixent in babies and young children are injection site reactions, such as pain, redness, swelling, or itching at the injection site.

Yes, Dupixent can cause eye problems in babies, including conjunctivitis (pink eye), eyelid inflammation (blepharitis), dry eye, and eye itching. Caregivers should report new or worsening eye symptoms to a healthcare provider.

Clinical trials in infants and preschoolers have reported cases of viral infections, including hand-foot-and-mouth disease, skin papilloma (warts), and oral herpes.

If your baby shows signs of a severe allergic reaction, such as swelling of the face, tongue, or throat, or has breathing problems, stop using Dupixent immediately and seek emergency medical help.

Long-term safety data from extension studies in young children (6 months to 5 years) have shown the safety profile to be acceptable and consistent with that seen in adults.

Although less common, some patients, including children, have reported new or worsening joint pain or aches. In rare instances, this has caused trouble with walking and required hospitalization.

It is important to complete all age-appropriate vaccinations as recommended by guidelines before starting Dupixent. The use of live vaccines should be avoided during treatment. Always consult your child's doctor regarding vaccinations.

Yes, Dupixent can sometimes cause elevated eosinophil counts (eosinophilia), a type of white blood cell. Your doctor will monitor these levels, as large increases can be serious.

The only FDA-labeled contraindication for Dupixent is a known hypersensitivity to the active substance dupilumab or any of its excipients. A history of hypersensitivity reactions, like anaphylaxis, requires careful consideration.