Pharmacologic class (EPC) · 3 drug pages

Anti-IgE: adverse event reports filed with FDA

80,012 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

80,012
reports across the class: 0.4% of all reports; 9,012
reports, 12 months to June 2026: 12,414 in the 12 months before; 53.5%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Anti-IgE is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 80,012 adverse event reports received by FDA, 0.4% of the database, from January 2004 to June 2026.

9,012 reports arrived in the 12 months to June 2026, down 27% from 12,414 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 53.5% of the class's reports are marked serious, 3% record death among the outcomes and 18.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are asthma (15%), urticaria (14%) and no adverse event (13.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
XolairOmalizumab	brand	65,192	5,067	48.8%	No adverse event
Omalizumab	generic	10,440	1,801	97.1%	Asthma
Xolair PFSOmalizumab	brand	4,380	2,144	20.3%	Off label use

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Asthmaasthma15%11,969
Urticariahives14%11,183
No adverse eventno adverse event was reported13.5%10,827
Off label useused for a purpose or in a way not on the label13%10,429
Dyspnoeashortness of breath12.8%10,207
Drug ineffectivethe medicine did not work as expected9.9%7,927
Coughcough8.8%7,079
Pruritusitching7.8%6,228
Fatiguetiredness7.4%5,944
Malaisegeneral feeling of being unwell7.1%5,680
Wheezingwheezing7%5,602
Headachehead pain6.6%5,286
Pneumonialung infection6.6%5,272
Painpain, site not specified5.5%4,366
Anaphylactic reactiona severe, sudden allergic reaction5.3%4,250
Nasopharyngitisa cold5%3,967
Arthralgiajoint pain4.6%3,652
Weight decreasedweight loss4.4%3,491
Hypersensitivityan allergic-type reaction4.3%3,433
Dizzinesslight-headedness or unsteadiness4.2%3,354
Pyrexiafever4.1%3,273
Rashskin rash4.1%3,251
Drug hypersensitivityan allergic-type reaction to a medicine3.8%3,066
Blood pressure increaseda raised blood pressure reading3.8%3,065
Nauseafeeling sick3.7%2,927

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death3%2,364

Life-threatening2.5%1,984

Hospitalisation (initial or prolonged)18.4%14,756

Disability1%803

Congenital anomaly0.3%247

Other serious39.2%31,328

Not serious46.5%37,180

Patient age

Under 20.2%130

2 to 111.4%1,140

12 to 172.4%1,923

18 to 4415.7%12,588

45 to 6419%15,184

65 to 748.2%6,599

75 and over3.8%3,072

Age not given49.2%39,376

Who reported

Physician28.7%22,934

Pharmacist2.4%1,938

Other health professional19.3%15,415

Lawyer0%9

Consumer or non-health professional49%39,191

Not given0.7%525

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Anti-IgE reports

Which drugs are in the Anti-IgE class on this site?

Xolair, Omalizumab and Xolair PFS. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

80,012 reports through June 2026, 9,012 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

asthma (15%), urticaria (14%), no adverse event (13.5%), off label use (13%) and dyspnoea (12.8%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.