Dupilumab Side Effects
Commonly reported side effects of dupilumab include: allergic conjunctivitis, conjunctivitis, injection site reaction, ophthalmic inflammation, and eye irritation. Other side effects include: oral herpes simplex infection. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to dupilumab: subcutaneous solution
Side effects requiring immediate medical attention
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
- 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
- stuffy or runny nose
- unusual tiredness or weakness
- Black, tarry stools
- blistering, crusting, or reddening of the skin
- burning, tingling, or numbness in the hands and feet
- burning or stinging of the skin
- chest pain
- lump or growth on the skin
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- painful or difficult urination
- scaly patches on the skin
- skin rash
- sore throat
- swollen glands
- unusual bleeding or bruising
- Feeling of discomfort
- hives, itching
- lightheadedness, dizziness, fainting
- muscle aches
- 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
- Difficulty in moving
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle pain or stiffness
Side effects not requiring immediate medical attention
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
Some of the more commonly reported adverse reactions have included injection site reactions, conjunctivitis, eye pruritus, oral herpes, other herpes simplex virus infections, oropharyngeal pain, and eosinophilia.
Uncommon (0.1% to 1%): Cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes)
In a placebo-controlled trial in adult and adolescent subjects with asthma, cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) were reported in 1 (0.2%) patient receiving this drug at 200 mg every 2 week, 4 (0.6%) patients receiving 300 mg every 2 weeks, and 2 (0.3%) patients in the placebo group.
Very common (10% or more): Injection site reactions (10%)[Ref]
Very common (10% or more): Conjunctivitis (cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation) (10%)
Common (1% to 10%): Herpes simplex viral infections (e.g., herpes simplex, genital herpes, herpes simplex otitis externa, herpes virus infection), immunogenicity
Very rare (less than 0.01%): Serum sickness/serum sickness-like reactions[Ref]
Uncommon (0.1% to 1%): Hypersensitivity[Ref]
Cases of vasculitis consistent with eosinophilic granulomatosis with polyangiitis have been reported in adult patients who participated in the
asthma and asthma plus chronic rhinosinusitis with nasal polyposis clinical trials.
Common (1% to 10%): Eosinophilia
Frequency not reported: Eosinophilic granulomatosis with polyangiitis
Common (1% to 10%): Headache[Ref]
Common (1% to 10%): Insomnia
Common (1% to 10%): Arthralgia
Frequency not reported: Eosinophilic pneumonia
Cases of eosinophilic pneumonia were reported in adult patients who participated in the asthma trials.
Frequently asked questions
- 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
- Drug interactions
- Dosage information
- During pregnancy or Breastfeeding
- Reviews (345)
- En español
- Drug class: interleukin inhibitors
Related treatment guides
1. "Product Information. Dupixent (dupilumab)." sanofi-aventis (2017):
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.