65/100 · Elevated
Manufactured by Genentech, Inc.
Moderate Safety Concerns with Omalizumab: Asthma and Urticaria Predominant
248,573 FDA adverse event reports analyzed
Last updated: 2026-05-12
OMALIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. Based on analysis of 248,573 FDA adverse event reports, OMALIZUMAB has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for OMALIZUMAB include ASTHMA, URTICARIA, NO ADVERSE EVENT, OFF LABEL USE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OMALIZUMAB.
Omalizumab has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 248,573 adverse event reports for this medication, which is primarily manufactured by Genentech, Inc..
The most commonly reported adverse events include Asthma, Urticaria, No Adverse Event. Of classified reports, 53.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Asthma and Urticaria are the most common adverse events reported.
Serious adverse events account for 53.7% of total reports. The majority of reports are from adults aged 50-65.
Patients taking Omalizumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Omalizumab may interact with other drugs, and warnings include anaphylactic reactions and respiratory issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Omalizumab received a safety concern score of 65/100 (elevated concern). This is based on a 53.7% serious event ratio across 79,450 classified reports. The score accounts for 248,573 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 52,704, Male: 18,978, Unknown: 179. The most frequently reported age groups are age 65 (1,485 reports), age 60 (1,016 reports), age 53 (888 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 79,450 classified reports for OMALIZUMAB:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Omalizumab may interact with other drugs, and warnings include anaphylactic reactions and respiratory issues.
If you are taking Omalizumab, here are important things to know. The most commonly reported side effects include asthma, urticaria, no adverse event, off label use, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of asthma exacerbation and urticaria, especially during the first 24 hours after administration. Inform patients about the risk of serious adverse events and the importance of following prescribed dosing instructions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with no major changes to the drug's approval status.
The FDA has received approximately 248,573 adverse event reports associated with Omalizumab. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Omalizumab include Asthma, Urticaria, No Adverse Event, Off Label Use, Dyspnoea. By volume, the top reported reactions are: Asthma (11,600 reports), Urticaria (10,326 reports), No Adverse Event (10,204 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Omalizumab.
Out of 79,450 classified reports, 42,639 (53.7%) were classified as serious and 36,811 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Omalizumab break down by patient sex as follows: Female: 52,704, Male: 18,978, Unknown: 179. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Omalizumab adverse events are: age 65: 1,485 reports, age 60: 1,016 reports, age 53: 888 reports, age 57: 842 reports, age 59: 840 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Omalizumab adverse event reports is Genentech, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Omalizumab include: Drug Ineffective, Cough, Pruritus, Fatigue, Malaise. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Omalizumab to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Omalizumab has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Asthma and Urticaria are the most common adverse events reported.
Key safety signals identified in Omalizumab's adverse event data include: Asthma and Urticaria are key safety signals, with high report volumes.. Serious adverse events are a significant concern, with a high percentage of reports being serious.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Omalizumab may interact with other drugs, and warnings include anaphylactic reactions and respiratory issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Omalizumab.
Monitor patients for signs of asthma exacerbation and urticaria, especially during the first 24 hours after administration. Inform patients about the risk of serious adverse events and the importance of following prescribed dosing instructions.
Omalizumab has 248,573 adverse event reports on file with the FDA. Serious adverse events account for 53.7% of total reports. The volume of reports for Omalizumab reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with no major changes to the drug's approval status. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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