Omalizumab: uses, dosing, side effects & brands
Omalizumab is an anti-ige sold in the U.S. under one brand, for asthma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Anti-Ige
- Treats
- Asthma
- Available as
- Injectable
- Sold as
- Xolair
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How omalizumab is dosed
From the FDA label for Xolair (application BLA103976). Other omalizumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For subcutaneous (SC) administration only. ( 2.2 , 2.3 , 2.4 , 2.5 ) See full prescribing information for administration instructions ( 2.6 , 2.7 , 2.8 ). Asthma : XOLAIR 75 to 375 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts. ( 2.2 ) Chronic Rhinosinusitis with Nasal Polyps : XOLAIR 75 to 600 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts. ( 2.3 ) IgE-Mediated Food Allergy : XOLAIR 75 mg to 600 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination chart. ( 2.4 ) Chronic Spontaneous Urticaria : XOLAIR 150 or 300 mg SC every 4 weeks. Dosing in CSU is not dependent on serum IgE level or body weight. ( 2.5 ) 2.1 Overview of Dosage Determination Asthma, and Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Determine dosage of XOLAIR by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg). For patients with asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food…
Omalizumab side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis [see Boxed Warning and Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Asthma : The most common adverse reactions (≥ 1% of patients) in clinical studies with adult and adolescent patients ≥12 years of age were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 years of age, the most common adverse reactions (≥3% of patients) were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. ( 6.1 ) Chronic Rhinosinusitis with Nasal Polyps : The most common adverse reactions (≥ 3% of patients) in clinical studies with adult patients included the following: headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness. ( 6.1 ) IgE-Mediated Food Allergy : The most common adverse reactions (≥3% of patients) were injection site reactions and pyrexia. ( 6.1 ) Chronic Spontaneous Urticaria : The most common adverse reactions (≥2% of patients) included the following: nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough. ( 6.1 ) To…
Who shouldn’t take omalizumab
XOLAIR is contraindicated in patients with severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR [see Warnings and Precautions (5.1) ] . Severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR ( 4 , 5.1 )
Omalizumab drug interactions
No formal drug interaction studies have been performed with XOLAIR. In patients with asthma, CRSwNP, and IgE-mediated food allergy the concomitant use of XOLAIR and allergen immunotherapy has not been evaluated . In patients with CSU, the use of XOLAIR in combination with immunosuppressive therapies has not been studied. No formal drug interaction studies have been performed. ( 7 )
Every omalizumab product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Xolair.
Omalizumab recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Cardinal Health Inc. · Jul 30, 2025
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Cardinal Health Inc. · Jul 30, 2025
Omalizumab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for omalizumab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadPreliminary evidence indicates that the amount of omalizumab in milk is very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Many infants have been breastfed during maternal omalizumab therapy, with no increase in infectious complications. Omalizumab is considered acceptable to use during breastfeeding. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
National Institute of Child Health and Human Development, record revised February 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about omalizumab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 11,311 reports naming omalizumab, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- asthma4,314 reports
- dyspnoea3,917 reports
- cough2,934 reports
- wheezing2,613 reports
- urticaria2,595 reports
- pneumonia2,437 reports
- malaise1,939 reports
- drug hypersensitivity1,792 reports
Read these as a signal, not a rate. A report does not mean omalizumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
What is omalizumab?
Xolair (Omalizumab) is an anti-ige used to treat Asthma.
What kind of drug is omalizumab?
The FDA classifies omalizumab as an anti-ige. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take omalizumab with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run omalizumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does omalizumab come in?
Across the brands we track, omalizumab is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic omalizumab?
We do not currently list a generic-labelled omalizumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has omalizumab been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions omalizumab. The most recent: Xolair (omalizumab injection) (Jul 30, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Omalizumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/omalizumab
- MLA
- “Omalizumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/omalizumab.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for omalizumab on DailyMed (NIH) ↗ — including its boxed warning in full.