Dupilumab Side Effects

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

Applies to dupilumab: subcutaneous solution.

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:

More common side effects

• blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
• body aches or pain
• burning or dry eyes
• chills
• cough
• difficulty in breathing
• ear congestion
• excessive tearing
• fever
• headache
• loss of voice
• muscle aches
• numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
• pain, redness, irritation, itching, or swelling of the eye, eyelid, or inner lining of the eyelid
• sneezing
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Less common side effects

• black, tarry stools
• blistering, crusting, or reddening of the skin
• bone, joint, or muscle pain
• burning, tingling, or numbness in the hands and feet
• burning or stinging of the skin
• chest pain
• difficulty in moving
• lump or growth on the skin
• muscle cramps or stiffness
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• painful or difficult urination
• scaly patches on the skin
• skin rash
• sores or white patches on the lips, mouth, or throat
• swollen glands
• swollen joints
• unusual bleeding or bruising

Rare side effects

• feeling of discomfort
• hives, itching
• lightheadedness, dizziness, fainting
• pain in the groin or legs, especially the calves
• pain or swelling in the joints
• severe, sudden headache
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• swelling of the hands, face, or mouth
• trouble breathing
• trouble swallowing
• vision changes

Incidence not known

• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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:

More common side effects

• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Less common side effects

• burning feeling in the chest or stomach
• diarrhea
• indigestion
• mouth or throat pain
• stomach upset
• tenderness in the stomach area
• toothache
• trouble sleeping

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.

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