Summary

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. 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 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.