Dupilumab Side Effects
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:
- Blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
- body aches or pain
- burning or dry eyes
- difficulty in breathing
- ear congestion
- excessive tearing
- 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
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- 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
- 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:
- 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
- Burning feeling in the chest or stomach
- mouth or throat pain
- stomach upset
- tenderness in the stomach area
- trouble sleeping
For Healthcare Professionals
Applies to dupilumab: subcutaneous solution.
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]
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.
Frequency not reported: Skin papilloma
Postmarketing reports: Angioedema, facial skin reactions (including erythema, rash, scaling, edema, papules, pruritus, burning, pain)
Common (1% to 10%): Oral herpes, gastritis, toothache, diarrhea
Common (1% to 10%): Eosinophilia
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)
Common (1% to 10%): Antidrug antibodies (ADA), persistent ADA responses, neutralizing antibodies
Frequency not reported: Eosinophilic granulomatosis with polyangiitis
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
Common (1% to 10%): Arthralgia, myalgia (includes musculoskeletal pain, musculoskeletal chest pain)
Common (1% to 10%): Dizziness (includes postural dizziness, vertigo, positional vertigo)
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
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
Common (1% to 10%): Insomnia
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?
More about dupilumab
- Check interactions
- Compare alternatives
- Reviews (418)
- Dosage information
- During pregnancy
- Drug class: interleukin inhibitors
- En español
Related treatment guides
1. Product Information. Dupixent Pre-filled Syringe (dupilumab). sanofi-aventis. 2022.
2. Product Information. Dupixent (dupilumab). Sanofi-Aventis Australia Pty Ltd. 2022.
3. Product Information. Dupixent (dupilumab). Sanofi Genzyme. 2023.
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.