72/100 · Elevated
Manufactured by Genentech, Inc.
Ocrelizumab Adverse Events: High Incidence of Infections and Fatigue
123,105 FDA adverse event reports analyzed
Last updated: 2026-05-12
OCRELIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. Based on analysis of 123,105 FDA adverse event reports, OCRELIZUMAB has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for OCRELIZUMAB include COVID-19, FATIGUE, URINARY TRACT INFECTION, HEADACHE, MULTIPLE SCLEROSIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OCRELIZUMAB.
Ocrelizumab has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 123,105 adverse event reports for this medication, which is primarily manufactured by Genentech, Inc..
The most commonly reported adverse events include Covid-19, Fatigue, Urinary Tract Infection. Of classified reports, 49.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ocrelizumab reports show a high incidence of infections, particularly urinary tract and pneumonia.
Fatigue and asthenia are common, indicating potential impact on patient quality of life. The drug is frequently reported to be ineffective, suggesting variability in treatment outcomes.
Patients taking Ocrelizumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ocrelizumab may interact with other immunosuppressants, and patients should be monitored for signs of infection and other adverse reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ocrelizumab received a safety concern score of 72/100 (elevated concern). This is based on a 49.7% serious event ratio across 59,589 classified reports. The score accounts for 123,105 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: 37,864, Male: 14,199, Unknown: 363. The most frequently reported age groups are age 51 (901 reports), age 50 (888 reports), age 52 (879 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 59,589 classified reports for OCRELIZUMAB:
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.
Ocrelizumab may interact with other immunosuppressants, and patients should be monitored for signs of infection and other adverse reactions.
If you are taking Ocrelizumab, here are important things to know. The most commonly reported side effects include covid-19, fatigue, urinary tract infection, headache, multiple sclerosis. 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 signs of infection or unusual fatigue to their healthcare provider promptly. Follow-up with healthcare providers is recommended to assess treatment efficacy and manage side effects. 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 includes monitoring for serious infections and ensuring patients are aware of potential side effects.
The FDA has received approximately 123,105 adverse event reports associated with Ocrelizumab. 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 Ocrelizumab include Covid-19, Fatigue, Urinary Tract Infection, Headache, Multiple Sclerosis. By volume, the top reported reactions are: Covid-19 (11,529 reports), Fatigue (6,059 reports), Urinary Tract Infection (3,721 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ocrelizumab.
Out of 59,589 classified reports, 29,623 (49.7%) were classified as serious and 29,966 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 Ocrelizumab break down by patient sex as follows: Female: 37,864, Male: 14,199, Unknown: 363. 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 Ocrelizumab adverse events are: age 51: 901 reports, age 50: 888 reports, age 52: 879 reports, age 53: 869 reports, age 49: 849 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 Ocrelizumab 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 Ocrelizumab include: Asthenia, Gait Disturbance, Multiple Sclerosis Relapse, Nasopharyngitis, Pain. 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 Ocrelizumab 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.
Ocrelizumab has a safety concern score of 72 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. Ocrelizumab reports show a high incidence of infections, particularly urinary tract and pneumonia.
Key safety signals identified in Ocrelizumab's adverse event data include: High rate of serious adverse events (49.7%). Multiple infections reported, including pneumonia and urinary tract infections. Frequent reports of fatigue and asthenia. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ocrelizumab may interact with other immunosuppressants, and patients should be monitored for signs of infection and other adverse reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ocrelizumab.
Patients should report any signs of infection or unusual fatigue to their healthcare provider promptly. Follow-up with healthcare providers is recommended to assess treatment efficacy and manage side effects.
Ocrelizumab has 123,105 adverse event reports on file with the FDA. Fatigue and asthenia are common, indicating potential impact on patient quality of life. The volume of reports for Ocrelizumab reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight includes monitoring for serious infections and ensuring patients are aware of potential side effects. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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