Brand name · Omalizumab
Xolair PFS: adverse event reports filed with FDA
4,380 reports list it as a suspect or interacting product, 2020–2026. Class: Anti-IgE.
- 4,380
- reports as suspect product
- 0% of all reports · about 683 a year
- 2,144
- reports, 12 months to June 2026
- 2,154 in the 12 months before
- 20.3%
- marked serious by the reporter
- 53.5% across the class
- 1.3%
- record death among outcomes, as reported
- 56 reports · not verified by FDA
4,380 adverse event reports received by FDA list the brand name Xolair PFS (omalizumab) as a suspect or interacting product, from February 2020 to June 2026. A further 19 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 2,144 reports listed it, close to the 2,154 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 683 reports a year and 0% of the 20,646,523 reports in the database, and 5.5% of the reports for the anti-IgE class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are off label use (27.2%), no adverse event (26.9%) and urticaria (17.7%). A report can list several reactions, so shares add to more than 100%; 369 different terms appear across these reports. Off label use is recorded in 27.2% of these reports, a larger share than in the median anti-IgE drug (12.9%).
20.3% of the reports are marked serious by the reporter (53.5% across the class); 1.3% record death among the outcomes and 5.7% record hospitalisation, as reported. 82.7% of the reports came from consumers, and the largest patient age group is 18 to 44 (14.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Xolair PFS reports recording the termmedian drug in anti-ige
- Off label useused for a purpose or in a way not on the label27.2%1,193
- No adverse eventno adverse event was reported26.9%1,179
- Urticariahives17.7%775
- Drug ineffectivethe medicine did not work as expected8%352
- Anaphylactic reactiona severe, sudden allergic reaction7.1%310
- Idiopathic urticaria5.6%247
- Product dose omission issuea dose was missed5.1%223
- Asthmaasthma5%221
- Pruritusitching5%217
- Device defective2.6%112
- Device issuea problem with the device2.3%102
- Rashskin rash2.3%99
- Fatiguetiredness2.2%95
- Painpain, site not specified2.1%92
- Dyspnoeashortness of breath2.1%90
- Arthralgiajoint pain1.9%84
- Headachehead pain1.8%77
- Hypersensitivityan allergic-type reaction1.6%70
- Nauseafeeling sick1.4%60
- Underdoseless than the intended dose1.3%59
- Product complaint1.3%58
- Erythemaskin redness1.3%56
- Wrong technique in product usage processthe product was used in the wrong way1.3%56
- Deaththe patient died; cause not stated by this term1.3%55
- Dizzinesslight-headedness or unsteadiness1.3%55
- Illness1.3%55
- Swellingswelling1.3%55
- Stressstress1.2%54
- Pneumonialung infection1.2%53
Top 30 of 369 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the anti-ige class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 80,012 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 100% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Idiopathic urticaria | 1,704 | 38.9% |
| Asthma | 869 | 19.8% |
| Urticaria | 841 | 19.2% |
| Food allergy | 204 | 4.7% |
| Chronic spontaneous urticaria | 138 | 3.2% |
| Dermatitis atopic | 50 | 1.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 4,380 reports.
In context
| Measure | Xolair PFS | Anti-IgE | All reports |
|---|---|---|---|
| Reports as suspect product | 4,380 | 80,012 | 20,646,523 |
| Share of that pool | — | 5.5% | 0% |
| Reports, latest 12 months | 2,144 | — | 1,332,454 |
| Marked serious | 20.3% | 53.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 13 | 30 | 91 |
| Hospitalisation recorded, per 1,000 reports | 57 | 184 | 213 |
| Consumer-filed share | 82.7% | 49% | 45.8% |
| Top term, share of reports | Off label use 27.2% | median 12.9% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the anti-ige class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Xolair | brand | 65,192 | 5,067 | 48.8% |
| Omalizumab | generic | 10,440 | 1,801 | 97.1% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Xolair PFS reports
How many adverse event reports has FDA received for Xolair PFS?
4,380 reports list Xolair PFS as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 2,144 of them arrived in the latest 12 months. Another 19 list it only as a concomitant medication.
What reactions are recorded in Xolair PFS reports?
off label use (27.2%), no adverse event (26.9%), urticaria (17.7%), drug ineffective (8%) and anaphylactic reaction (7.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Xolair PFS was responsible.
How serious are the reports?
20.3% are marked serious by the reporter. Among the outcomes recorded, 1.3% of reports include death and 5.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (82.7%), other health professional (10%) and physician (5.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Xolair PFS rising?
2,144 reports in the 12 months to June 2026, close to the 2,154 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Xolair PFS was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Xolair PFS?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Xolair PFS as a suspect or interacting product; reports listing it only as a concomitant medication (19) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.