FDA label
What is Xolair used for?
Xolair contains omalizumab. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Xolair lists 4 uses: Asthma; Chronic Rhinosinusitis with Nasal Polyps; IgE-Mediated Food Allergy; Chronic Spontaneous Urticaria.
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Xolair, injection, solution
Indications and Usage, quoted from the label by Genentech, Inc. (BLA103976). Cross-references to other label sections are left out.
Asthma
XOLAIR is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
Limitations of Use:
XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus.
Chronic Rhinosinusitis with Nasal Polyps
XOLAIR is indicated for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.
IgE-Mediated Food Allergy
XOLAIR is indicated for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.
XOLAIR is to be used in conjunction with food allergen avoidance.
Limitations of Use:
XOLAIR is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
Chronic Spontaneous Urticaria
XOLAIR is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.
Limitations of Use:
XOLAIR is not indicated for treatment of other forms of urticaria.
Source: DailyMed label, set id 7f6a2191-adfb-48b9-9bfa-0d9920479f0d, version 32, effective August 13, 2026. NDC 50242-040, one of 2 listings for this product.
Questions
What is Xolair used for?
The FDA label for Xolair lists 4 uses: Asthma; Chronic Rhinosinusitis with Nasal Polyps; IgE-Mediated Food Allergy; Chronic Spontaneous Urticaria.
What drug class is Xolair?
FDA lists omalizumab in the Anti-IgE established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.