Xolair (omalizumab) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Xolair
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Omalizumab
Class: Anti-IgE

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 65,192 adverse event reports that name Xolair. In these reports the drug is a suspect or interacting product.

In the same period, 4,667 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 5,067 reports in the 12 months to June 2026 and 8,519 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Xolair is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 1,178 reports that name Xolair.
In January to March 2026, FDA received 1,277.
In April to June 2025, FDA received 1,007.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 1,755 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 65,192 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 1,755 terms.

Reaction terms in the reports that name Xolair, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 65,192 reports
No adverse eventno adverse event was reported	9,572	14.7%
Off label useused for a purpose or in a way not on the label	8,389	12.9%
Urticariahives	7,857	12.1%
Asthma	7,561	11.6%
Dyspnoeashortness of breath	6,292	9.7%
Drug ineffectivethe medicine did not work as expected	5,411	8.3%
Pruritusitching	4,272	6.6%
Fatiguetiredness	4,162	6.4%
Cough	4,148	6.4%
Headachehead pain	3,758	5.8%
Malaisegeneral feeling of being unwell	3,723	5.7%
Anaphylactic reactiona severe, sudden allergic reaction	3,391	5.2%
Wheezing	3,014	4.6%
Pneumonialung infection	2,823	4.3%
Arthralgiajoint pain	2,786	4.3%
Painpain, site not specified	2,748	4.2%
Nasopharyngitisa cold	2,546	3.9%
Hypersensitivityan allergic-type reaction	2,502	3.8%
Dizzinesslight-headedness or unsteadiness	2,443	3.7%
Rashskin rash	2,424	3.7%
Weight decreasedweight loss	2,215	3.4%
Pyrexiafever	2,111	3.2%
Nauseafeeling sick	2,066	3.2%
Blood pressure increaseda raised blood pressure reading	2,002	3.1%
Product dose omission issuea dose was missed	1,910	2.9%
Chest discomfort	1,866	2.9%
Influenzaflu	1,825	2.8%
Weight increasedweight gain	1,823	2.8%
Pain in extremitypain in an arm or leg	1,623	2.5%
Productive cougha cough with phlegm	1,535	2.4%
Erythemaskin redness	1,495	2.3%
Heart rate increaseda fast heart rate reading	1,469	2.3%
Vomitingbeing sick	1,457	2.2%
Sinusitissinus infection	1,353	2.1%
Bronchitischest infection	1,342	2.1%
Astheniaweakness or lack of energy	1,339	2.1%
Angioedemadeep swelling of skin or mucous membranes	1,329	2%
Chest pain	1,325	2%
Deaththe patient died; cause not stated by this term	1,300	2%
Insomniadifficulty sleeping	1,296	2%
Anxiety	1,291	2%
Oropharyngeal painsore throat	1,281	2%
Nasal congestiona blocked nose	1,271	1.9%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	1,264	1.9%
Alopeciahair loss	1,252	1.9%
Myalgiamuscle pain	1,214	1.9%
Diarrhoealoose or frequent stools	1,183	1.8%
Injection site painpain where the injection was given	1,140	1.7%
Feeling abnormalfeeling odd or not right	1,125	1.7%
Swelling	1,096	1.7%

Download all 1,755 terms of Xolair (CSV)

The counts add to more than 65,192 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Omalizumab with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Omalizumab	Generic name	10,440
Xolair (this page)	Brand name	65,192
Xolair PFS	Brand name	4,380

Sum of the separately reported names: 80,012. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Xolair, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	616	124	4	15	47	7	0	59	492
2005	416	156	7	20	58	14	0	81	260
2006	455	248	12	15	70	9	0	167	207
2007	686	670	36	36	196	19	2	473	16
2008	525	517	24	38	146	11	0	360	8
2009	805	795	58	57	223	16	2	548	10
2010	822	809	58	42	273	18	0	522	13
2011	876	853	53	55	304	31	2	536	23
2012	914	897	89	38	295	26	2	624	17
2013	1,051	1,028	83	51	391	29	0	697	23
2014	1,347	1,313	105	66	478	32	18	844	34
2015	1,787	1,715	214	110	527	44	2	1,111	72
2016	3,092	1,908	139	102	646	35	8	1,333	1,184
2017	7,199	2,322	162	104	783	58	5	1,608	4,877
2018	3,911	2,230	144	92	807	44	1	1,582	1,681
2019	4,184	2,675	158	89	930	41	4	1,998	1,509
2020	4,292	2,434	175	94	817	46	2	1,760	1,858
2021	4,269	2,057	153	79	726	33	2	1,474	2,212
2022	4,253	2,068	138	80	724	30	6	1,473	2,185
2023	4,693	1,832	100	72	713	29	8	1,275	2,861
2024	10,857	2,203	74	88	751	22	9	1,702	8,654
2025	5,267	1,841	57	86	597	42	16	1,397	3,426
2026	2,875	1,109	40	50	271	29	14	903	1,766

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Xolair, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Xolair, by the year in which FDA received them
Year	Reports
2004	498
2005	521
2006	437
2007	659
2008	489
2009	758
2010	872
2011	1,012
2012	1,425
2013	1,397
2014	1,728
2015	1,925
2016	3,394
2017	7,327
2018	4,438
2019	4,305
2020	4,231
2021	4,000
2022	3,911
2023	4,386
2024	10,256
2025	4,768
2026	2,455

Reports that name Xolair, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Xolair
Age	Reports	Share
Under 2	69	0.1%
2 to 11	956	1.5%
12 to 17	1,658	2.5%
18 to 44	9,752	15%
45 to 64	11,767	18%
65 to 74	4,471	6.9%
75 and over	2,159	3.3%
Age not given	34,360	52.7%

Sex of the patient in the reports that name Xolair
Sex	Reports	Share
Female	42,967	65.9%
Male	15,581	23.9%
Unknown or not given	6,644	10.2%

Type of reporter in the reports that name Xolair
Reporter	Reports	Share
Physician	20,561	31.5%
Pharmacist	1,822	2.8%
Other health professional	10,285	15.8%
Lawyer	9	under 0.1%
Consumer or non-health professional	32,138	49.3%
Not given	377	0.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 69.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Xolair record
Indication as recorded (MedDRA)	Reports	Share
Asthma	23,145	35.5%
Idiopathic urticaria	7,332	11.2%
Chronic spontaneous urticaria	6,146	9.4%
Urticaria	4,686	7.2%
Urticaria chronic	843	1.3%
Food allergy	634	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 65,192 reports.

Drugs in the same reports

Other drugs that the reports of Xolair name, in any role, in order of name
Drug	Reports that name the two
Advair Hfa	2,698
Albuterol	2,533
Albuterol sulfate	4,330
Benadryl	1,545
Montelukast	2,927
Prednisone	5,925
Singulair	6,551
Symbicort	4,011
Tiotropium bromide	3,143
Zyrtec	1,916

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Omalizumab same ingredient
Xolair PFS same ingredient
Xofluza next in the A to Z list
Xofigo next in the A to Z list
Xopenex next in the A to Z list
Xl184 next in the A to Z list
Xopenex Hfa next in the A to Z list
Xipamide next in the A to Z list
Xospata next in the A to Z list
Xiidra next in the A to Z list
Xphozah next in the A to Z list
Xigris next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for XolairThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Xolair: adverse event reports that FDA received. https://reportedreactions.com/drug/xolair/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Xolair as a suspect or interacting product. The 4,667 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Xolair was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Xolair?

No. It is a count of what people reported to FDA: 65,192 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (49.3%), physician (31.5%) and other health professional (15.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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