Dupilumab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 28, 2023.

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

• 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

• 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

• 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

• 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

• 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

The most common adverse reactions were injection site reactions (includes 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 (including erythema, rash, scaling, edema, papules, pruritus, burning, pain)

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 (including anaphylaxis, serum sickness/serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, erythema multiforme)

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 (includes injection site reaction, injection site erythema, injection site edema, injection site pruritus, injection site pain, injection site inflammation, injection site bruising, injection site swelling; up to 38%), injection site erythema (up to 14.6%)

Common (1% to 10%): Injection site edema, injection site pruritus

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia (includes musculoskeletal pain, musculoskeletal chest pain)

Nervous system

Common (1% to 10%): Dizziness (includes postural dizziness, vertigo, positional vertigo)

Ocular

Very common (10% or more): Conjunctivitis (includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, eye inflammation; up to 20%)

Common (1% to 10%): Blepharitis, keratitis (includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, ophthalmic herpes simplex), eye pruritus, dry eye, allergic conjunctivitis, bacterial conjunctivitis

Frequency not reported: Ophthalmic herpes zoster

Postmarketing reports: Ulcerative keratitis

Other

Common (1% to 10%): Other herpes simplex virus infection (includes herpes simplex, genital herpes, herpes simplex otitis externa, herpes virus infection; excludes eczema herpeticum), herpes infection (includes herpes viral infections, oral herpes, herpes simplex, genital herpes simplex, herpes zoster, ophthalmic herpes zoster), serious infections

Frequency not reported: Hand-foot-and-mouth disease, helminth infections (including enterobiasis, ascariasis), eczema herpeticum, herpes zoster

Psychiatric

Common (1% to 10%): Insomnia

Respiratory

Very common (10% or more): Upper respiratory tract infections (includes coronavirus disease 2019 [COVID-19], sinusitis, upper respiratory tract infection; up to 18%)

Common (1% to 10%): Oropharyngeal pain, nasopharyngitis (includes pharyngitis)

Frequency not reported: Eosinophilic pneumonia

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

Frequently asked questions

• What are the most common skin conditions? (with photos)
• How fast does Dupixent work?
• How do you inject Dupixent?
• What is Dupixent used for and how does it work?
• How do you use Dupixent?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer