Xolairomalizumab
According to the FDA label: XOLAIR 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…
78,329 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Xolair in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Asthma 11,709 reports
A condition where the airways narrow and swell, causing wheezing and difficulty breathing.
Full definition in the glossary →Urticaria 10,167 reports
The medical term for hives, which are raised, itchy welts on the skin.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 10,031 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →No Adverse Event 9,466 reports
A report that was filed but did not actually describe any adverse event. This is a record-keeping category.
Full definition in the glossary →Off Label Use 9,218 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Drug Ineffective 7,707 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Cough 6,901 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Pruritus 5,937 reports
Fatigue 5,881 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Malaise 5,548 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Wheezing 5,394 reports
A whistling sound when breathing, usually a sign the airways are narrowed.
Full definition in the glossary →Headache 5,261 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 5,102 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Pain 4,201 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Anaphylactic Reaction 3,915 reports
A severe, rapid allergic reaction that can be life-threatening and needs emergency care.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 51,376 |
| Male | 18,588 |
| Unknown | 179 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 3,127 |
| 18-34 | 6,088 |
| 35-49 | 9,733 |
| 50-64 | 11,879 |
| 65-74 | 6,519 |
| 75+ | 2,964 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Xolair. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 35,176 |
| Other Serious | 31,214 |
| Hospitalization | 15,171 |
| Death | 2,373 |
| Life-Threatening | 2,002 |
| Disability | 848 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Xolair. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 506 |
| 2005 | 528 |
| 2006 | 455 |
| 2007 | 705 |
| 2008 | 564 |
| 2009 | 864 |
| 2010 | 992 |
| 2011 | 1,196 |
| 2012 | 1,937 |
| 2013 | 1,613 |
| 2014 | 1,912 |
| 2015 | 2,180 |
| 2016 | 3,762 |
| 2017 | 7,651 |
| 2018 | 4,876 |
| 2019 | 5,459 |
| 2020 | 5,470 |
| 2021 | 5,290 |
| 2022 | 5,304 |
| 2023 | 5,705 |
| 2024 | 11,945 |
| 2025 | 7,616 |
| 2026 (partial) | 1,799 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Xolair
In FDA adverse event reports that mention Xolair, these medications appeared most often in the same report.
- Montelukast (11,506 reports)
- Albuterol (10,278 reports)
- Prednisone (10,062 reports)
- Budesonide And Formoterol (5,243 reports)
- Cetirizine (5,169 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026