Dupilumab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 18, 2025.

Applies to dupilumab: subcutaneous solution.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, generalized urticaria, angioedema, or serum sickness, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a feeling of discomfort, fever, pain or swelling of the joints, hives, itching, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, lightheadedness, dizziness, fainting, muscle aches, rash, swollen lymph glands, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Check with your doctor right away if you have redness, irritation, or itching the of eye, eyelid, or inner lining of the eyelid. These could be symptoms of eye problems, including conjunctivitis or keratitis.

A rare but serious condition called eosinophilia (increased white blood cells in the body) may occur while you are using this medicine. Pneumonia or a condition called vasculitis (inflammation of the blood vessels) may also be present. Eosinophilia can be serious and requires immediate medical attention. Tell your doctor right away if you or your child have worsening lung symptoms, rash or bruising of the skin, fever, chest pain, or burning, tingling, or numbness in the hands and feet after using this medicine.

If you are using a steroid medicine for your asthma, do not suddenly stop taking it without first checking with your doctor. You may need to slowly decrease your dose before stopping it completely.

Check with your doctor right away if you have difficulty in moving, joint pain, or muscle pain or stiffness.

Do not have any live vaccines (immunizations) while you are being treated with dupilumab. Check with your doctor before having any vaccines.

Serious side effects of dupilumab

Along with its needed effects, dupilumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dupilumab:

Other side effects of dupilumab

Some side effects of dupilumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to dupilumab: subcutaneous solution.

General adverse events

The most common adverse reactions were injection site reactions (which included erythema, edema, pruritus, pain, and swelling), conjunctivitis, allergic conjunctivitis, arthralgia, oral herpes, and eosinophilia.

The most common adverse reactions reported in patients with atopic dermatitis included injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.

The most common adverse reactions reported in patients with asthma included injection site reactions, oropharyngeal pain, and eosinophilia.

The most common adverse reactions reported in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) included injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

The most common adverse reactions reported in patients with eosinophilic esophagitis included injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.

The most common adverse reactions reported in patients with prurigo nodularis included nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Cardiovascular thromboembolic events (cardiovascular deaths, nonfatal myocardial infarctions, nonfatal strokes)
• Frequency not reported: Vasculitis

Vasculitis consistent with eosinophilic granulomatosis with polyangiitis was reported in adult patients in the asthma development program and adult patients with comorbid asthma in the CRSwNP development program.

Dermatologic

• Frequency not reported: Skin papilloma
• Postmarketing reports: Angioedema, facial skin reactions

Facial skin reactions (including erythema, rash, scaling, edema, papules, pruritus, burning, and pain) have been reported during postmarketing experience.

Gastrointestinal

• Common (1% to 10%): Oral herpes, gastritis, toothache, diarrhea

Hematologic

• Common (1% to 10%): Eosinophilia

Hypersensitivity

• Rare (0.01% to 0.1%): Anaphylactic reaction, serum sickness reaction, serum sickness-like reaction
• Frequency not reported: Hypersensitivity reactions

Hypersensitivity reactions (including anaphylaxis, serum sickness/serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme) have been reported.

Immunologic

• Common (1% to 10%): Antidrug antibodies (ADA), persistent ADA responses, neutralizing antibodies
• Frequency not reported: Eosinophilic granulomatosis with polyangiitis

Local

• Very common (10% or more): Injection site reaction (up to 38%), injection site erythema (up to 14.6%)
• Common (1% to 10%): Injection site edema, injection site pruritus
• Frequency not reported: Injection site bruising

Injection site reaction included injection site reaction, injection site erythema, injection site edema, injection site pruritus, injection site pain, injection site inflammation, injection site bruising, and injection site swelling.

Musculoskeletal

• Common (1% to 10%): Arthralgia, myalgia

Myalgia included musculoskeletal pain and musculoskeletal chest pain.

Nervous system

• Common (1% to 10%): Dizziness

Dizziness included postural dizziness, vertigo, and positional vertigo.

Ocular

• Very common (10% or more): Conjunctivitis (up to 21%)
• Common (1% to 10%): Blepharitis, keratitis, eye pruritus, dry eye, allergic conjunctivitis, bacterial conjunctivitis
• Frequency not reported: Ophthalmic herpes zoster
• Postmarketing reports: Ulcerative keratitis

Conjunctivitis included conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.

Keratitis included keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.

Other

• Very common (10% or more): Infections (up to 32%)
• Common (1% to 10%): Other herpes simplex virus infection, herpes infection, serious infections
• Frequency not reported: Hand-foot-and-mouth disease, helminth infections, eczema herpeticum, herpes zoster

Other herpes simplex virus infection included herpes simplex, genital herpes, herpes simplex otitis externa, and herpes virus infection, and excluded eczema herpeticum.

Herpes infection included herpes viral infections, oral herpes, herpes simplex, genital herpes simplex, herpes zoster, and ophthalmic herpes zoster.

Helminth infections (including enterobiasis and ascariasis) have been reported.

Psychiatric

• Common (1% to 10%): Insomnia

Respiratory

• Very common (10% or more): Upper respiratory tract infections (up to 18%)
• Common (1% to 10%): Oropharyngeal pain, nasopharyngitis
• Frequency not reported: Eosinophilic pneumonia

Upper respiratory tract infections included COVID-19, sinusitis, and upper respiratory tract infection.

Nasopharyngitis included pharyngitis.

Eosinophilic pneumonia was reported in adult patients in the asthma development program.

See also:

Frequently asked questions

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Further information

Dupilumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer