Prescription medicine
Omalizumab Brand names: Xolair, Omlyclo
Omalizumab (Xolair) is a prescription medicine with an FDA approval on record since 2003. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the omalizumab FDA label on DailyMed (effective August 13, 2026, Genentech, Inc.); the BLA 103976 record on Drugs@FDA; every omalizumab label on DailyMed.
Highlights of the record
FDA label of August 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis [see Dosage and Administration (2.6), Warnings and Precautions (5.1) and Adverse Reactions (6.1 , 6.2) ]. WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred after the first dose of XOLAIR but also has occurred beyond 1 year after beginning treatment. […]
Used for
From the label: indications and usageXOLAIR is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response
Forms and strengths
- 75 mg/.5ml
- 150 mg/ml
- 150 mg/1.2ml
- 300 mg/2ml
Injection (solution); injection.
On the market
- Earliest approval on file
- June 20, 2003 Xolair, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2021 0 Class I among all firms' recalls; latest July 30, 2025
- FAERS reports
- 84,758 through July 30, 2026
What is omalizumab used for?
From the label: indications and usageXOLAIR is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment ( 1.2 ) IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. […]
Conditions named in the indications of omalizumab's FDA labels, with every medicine labeled for each:
From other omalizumab labelsAllergies: 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.
FDA pharmacologic class: Anti-IgE.
Source: FDA drug label (XOLAIR), Genentech, Inc., effective August 13, 2026 (SPL set 7f6a2191-adfb-48b9-9bfa-0d9920479f0d), via openFDA; the full label on DailyMed
What does the patient leaflet for omalizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about XOLAIR?XOLAIR may cause serious side effects, including: Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: wheezing, shortness of breath, cough, chest tightness, or trouble breathing low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom" flushing, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.
From the patient leaflet: How should I store XOLAIR?Store XOLAIR in the refrigerator between 36°F to 46°F (2°C to 8°C). Keep your unused XOLAIR prefilled syringes or autoinjectors in the original carton until use to protect them from light. XOLAIR prefilled syringe or autoinjector can be removed from and placed back in the refrigerator if needed. The total combined time out of refrigerator may not be more than 2 days. Do not use if XOLAIR prefilled syringe or autoinjector is left at temperatures above 77°F (25°C) and discard in a sharps disposal container. Do not freeze. Do not use if XOLAIR prefilled syringes or autoinjectors have been frozen. Keep XOLAIR out of direct sunlight. Do not use XOLAIR past the expiration date. Keep the XOLAIR prefilled syringe or autoinjector, sharps disposal container and all medicines out of the reach of children.
Source: FDA drug label (XOLAIR), Genentech, Inc., effective August 13, 2026 (SPL set 7f6a2191-adfb-48b9-9bfa-0d9920479f0d), via openFDA; the full label on DailyMed
Is there a generic for omalizumab (Xolair)?
No generic omalizumab is approved (Drugs@FDA, October 8, 2026).
- 2003 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has omalizumab been recalled?
The FDA's Enforcement Report lists 3 recalls naming omalizumab since 2021: 0 Class I (the most serious), 3 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 30, 2025 | Class II | Cardinal Health Inc. | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. |
| June 9, 2021 | Class II | Genentech Inc | Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for omalizumab?
The FDA Adverse Event Reporting System holds 84,758 reports that list omalizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,453 are coded as a death and 15,677 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Omalizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other