Note: This document contains side effect information about dupilumab. Some dosage forms listed on this page may not apply to the brand name Dupixent.
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. Continue reading for a comprehensive list of adverse effects.
Applies to dupilumab: parenteral pre-filled syringes and injection pens.
Side effects include:
Adverse effects (≥1%) with dupilumab (the active ingredient contained in Dupixent) in clinical studies for atopic dermatitis: injection site reactions, ocular effects (conjunctivitis, blepharitis, keratitis, pruritus, dry eye), eosinophilia, herpes simplex virus infection.
Adverse effects (≥1%) with dupilumab in clinical studies for asthma: injection site reactions, oropharyngeal pain, eosinophilia.
Adverse effects (≥1%) with dupilumab in clinical studies for CRSwNP: injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, conjunctivitis.
Adverse effects (≥2%) with dupilumab in clinical studies for eosinophilic esophagitis: injection site reactions, upper respiratory tract infections, arthralgia, herpes viral infections.
Adverse effects (≥2%) with dupilumab in clinical studies for prurigo nodularis: nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, diarrhea.
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.
