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Dupixent Side Effects

Generic name: dupilumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 21, 2022.

Note: This document contains side effect information about dupilumab. Some of the dosage forms listed on this page may not apply to the brand name Dupixent.

In Summary

Common side effects of Dupixent 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 (the active ingredient contained in Dupixent) 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

  • Burning or dry eyes
  • excessive tearing
  • pain, redness, irritation, itching, or swelling of the eye, eyelid, or inner lining of the eyelid

Less common

  • Black, tarry stools
  • blistering, crusting, or reddening of the skin
  • burning, tingling, or numbness in the hands and feet
  • chest pain
  • chills
  • cough
  • fever
  • 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
  • unusual tiredness or weakness

Rare

  • 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:

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

Managing side effects (general information)

For Healthcare Professionals

Applies to dupilumab: subcutaneous solution

General

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.

Cardiovascular

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.

Local

Very common (10% or more): Injection site reactions (10%)[Ref]

Ocular

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%): Blepharitis, eye pruritus, keratitis (e.g., keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, ophthalmic herpes simplex), dry eye[Ref]

Immunologic

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]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity[Ref]

Gastrointestinal

Common (1% to 10%): Oral herpes, oropharyngeal pain, toothache, gastritis[Ref]

Hematologic

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

Nervous system

Common (1% to 10%): Headache[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Musculoskeletal

Common (1% to 10%): Arthralgia

Respiratory

Frequency not reported: Eosinophilic pneumonia

Cases of eosinophilic pneumonia were reported in adult patients who participated in the asthma trials.

Frequently asked questions

References

1. "Product Information. Dupixent (dupilumab)." sanofi-aventis (2017):

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.

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