65/100 · Elevated
Manufactured by Novartis Pharmaceuticals Corporation
Moderate Safety Concerns with Ofatumumab: Fatigue, Infections, and Neurological Symptoms
82,579 FDA adverse event reports analyzed
Last updated: 2026-05-12
OFATUMUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. Based on analysis of 82,579 FDA adverse event reports, OFATUMUMAB 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 OFATUMUMAB include FATIGUE, HEADACHE, PYREXIA, PAIN, CHILLS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OFATUMUMAB.
Ofatumumab 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 82,579 adverse event reports for this medication, which is primarily manufactured by Novartis Pharmaceuticals Corporation.
The most commonly reported adverse events include Fatigue, Headache, Pyrexia. Of classified reports, 43.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and headache are the most common adverse events reported.
Infections, particularly respiratory tract infections, are a significant concern. Neurological symptoms such as dizziness and gait disturbance are also frequently reported.
Patients taking Ofatumumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ofatumumab can cause falls and balance disorders, and patients should be monitored for these symptoms, especially during the initial dosing period. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ofatumumab received a safety concern score of 65/100 (elevated concern). This is based on a 43.6% serious event ratio across 32,552 classified reports. The score accounts for 82,579 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: 21,508, Male: 7,731, Unknown: 68. The most frequently reported age groups are age 41 (414 reports), age 40 (378 reports), age 53 (374 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 32,552 classified reports for OFATUMUMAB:
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.
Ofatumumab can cause falls and balance disorders, and patients should be monitored for these symptoms, especially during the initial dosing period.
If you are taking Ofatumumab, here are important things to know. The most commonly reported side effects include fatigue, headache, pyrexia, pain, chills. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider promptly. Follow all dosing instructions carefully to minimize the risk of adverse events. 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 authorities are closely monitoring the safety profile of Ofatumumab, particularly for serious infections and neurological adverse events.
The FDA has received approximately 82,579 adverse event reports associated with Ofatumumab. 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 Ofatumumab include Fatigue, Headache, Pyrexia, Pain, Chills. By volume, the top reported reactions are: Fatigue (5,388 reports), Headache (4,533 reports), Pyrexia (3,524 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ofatumumab.
Out of 32,552 classified reports, 14,182 (43.6%) were classified as serious and 18,370 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 Ofatumumab break down by patient sex as follows: Female: 21,508, Male: 7,731, Unknown: 68. 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 Ofatumumab adverse events are: age 41: 414 reports, age 40: 378 reports, age 53: 374 reports, age 39: 372 reports, age 42: 368 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 Ofatumumab adverse event reports is Novartis Pharmaceuticals Corporation. 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 Ofatumumab include: Influenza Like Illness, Nausea, Multiple Sclerosis Relapse, Covid-19, Asthenia. 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 Ofatumumab 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.
Ofatumumab 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. Fatigue and headache are the most common adverse events reported.
Key safety signals identified in Ofatumumab's adverse event data include: High incidence of fatigue and headache.. Significant number of serious adverse events, including infections and neurological symptoms.. Multiple reports of falls and balance disorders.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ofatumumab can cause falls and balance disorders, and patients should be monitored for these symptoms, especially during the initial dosing period. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ofatumumab.
Patients should report any new or worsening symptoms to their healthcare provider promptly. Follow all dosing instructions carefully to minimize the risk of adverse events.
Ofatumumab has 82,579 adverse event reports on file with the FDA. Infections, particularly respiratory tract infections, are a significant concern. The volume of reports for Ofatumumab reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory authorities are closely monitoring the safety profile of Ofatumumab, particularly for serious infections and neurological adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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