82/100 · Critical
Manufactured by Genentech, Inc.
High Seriousness and Diverse Reactions for Tocilizumab
689,384 FDA adverse event reports analyzed
Last updated: 2026-05-12
TOCILIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. Based on analysis of 689,384 FDA adverse event reports, TOCILIZUMAB has a safety score of 82 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 TOCILIZUMAB include DRUG INEFFECTIVE, RHEUMATOID ARTHRITIS, PAIN, OFF LABEL USE, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TOCILIZUMAB.
Tocilizumab has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 689,384 adverse event reports for this medication, which is primarily manufactured by Genentech, Inc..
The most commonly reported adverse events include Drug Ineffective, Rheumatoid Arthritis, Pain. Of classified reports, 76.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Tocilizumab reports show a high percentage of serious adverse events, particularly infections and infusions-related reactions.
The drug is associated with a wide range of reactions, including musculoskeletal and gastrointestinal issues. Fatigue and pain are among the most frequently reported symptoms, indicating a common but not necessarily severe issue.
Patients taking Tocilizumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Tocilizumab can cause serious infections and infusion-related reactions, and caution is advised when used in patients with a history of these conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tocilizumab received a safety concern score of 82/100 (high concern). This is based on a 76.7% serious event ratio across 110,076 classified reports. The score accounts for 689,384 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 75,483, Male: 20,969, Unknown: 127. The most frequently reported age groups are age 44 (2,644 reports), age 43 (2,582 reports), age 59 (1,854 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 110,076 classified reports for TOCILIZUMAB:
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.
Tocilizumab can cause serious infections and infusion-related reactions, and caution is advised when used in patients with a history of these conditions.
If you are taking Tocilizumab, here are important things to know. The most commonly reported side effects include drug ineffective, rheumatoid arthritis, pain, off label use, arthralgia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of infection, especially in patients with pre-existing conditions. Be aware of potential musculoskeletal and gastrointestinal side effects, and report any unusual symptoms to your healthcare provider. 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.
The FDA continues to monitor the safety of Tocilizumab, and updates will be provided based on ongoing studies and reports.
The FDA has received approximately 689,384 adverse event reports associated with Tocilizumab. 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 Tocilizumab include Drug Ineffective, Rheumatoid Arthritis, Pain, Off Label Use, Arthralgia. By volume, the top reported reactions are: Drug Ineffective (34,933 reports), Rheumatoid Arthritis (22,237 reports), Pain (19,781 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tocilizumab.
Out of 110,076 classified reports, 84,465 (76.7%) were classified as serious and 25,611 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 Tocilizumab break down by patient sex as follows: Female: 75,483, Male: 20,969, Unknown: 127. 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 Tocilizumab adverse events are: age 44: 2,644 reports, age 43: 2,582 reports, age 59: 1,854 reports, age 60: 1,659 reports, age 58: 1,640 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 Tocilizumab 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 Tocilizumab include: Joint Swelling, Fatigue, Rash, Drug Intolerance, Contraindicated Product Administered. 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 Tocilizumab 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.
Tocilizumab has a safety concern score of 82 out of 100 (high 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. Tocilizumab reports show a high percentage of serious adverse events, particularly infections and infusions-related reactions.
Key safety signals identified in Tocilizumab's adverse event data include: High percentage of serious adverse events (76.7%). Frequent reports of infections and infusion-related reactions. Diverse reactions including musculoskeletal and gastrointestinal issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Tocilizumab can cause serious infections and infusion-related reactions, and caution is advised when used in patients with a history of these conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tocilizumab.
Monitor for signs of infection, especially in patients with pre-existing conditions. Be aware of potential musculoskeletal and gastrointestinal side effects, and report any unusual symptoms to your healthcare provider.
Tocilizumab has 689,384 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including musculoskeletal and gastrointestinal issues. The volume of reports for Tocilizumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Tocilizumab, and updates will be provided based on ongoing studies and reports. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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