82/100 · Critical
Manufactured by Janssen Biotech, Inc.
Golimumab Adverse Events: High Serious Reaction Rate
511,555 FDA adverse event reports analyzed
Last updated: 2026-05-12
GOLIMUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Biotech, Inc.. Based on analysis of 511,555 FDA adverse event reports, GOLIMUMAB 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 GOLIMUMAB include DRUG INEFFECTIVE, RHEUMATOID ARTHRITIS, PAIN, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GOLIMUMAB.
Golimumab 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 511,555 adverse event reports for this medication, which is primarily manufactured by Janssen Biotech, Inc..
The most commonly reported adverse events include Drug Ineffective, Rheumatoid Arthritis, Pain. Of classified reports, 75.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (75.2%) indicates significant safety concerns.
A wide range of reactions, including infections and musculoskeletal issues, are reported. Report volume is substantial, with over 511,000 total reports.
Patients taking Golimumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Golimumab is contraindicated in patients with active infections and should be used with caution in patients with a history of serious infections. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Golimumab received a safety concern score of 82/100 (high concern). This is based on a 75.2% serious event ratio across 82,467 classified reports. The score accounts for 511,555 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: 55,571, Male: 16,936, Unknown: 114. The most frequently reported age groups are age 44 (2,651 reports), age 43 (2,499 reports), age 59 (1,641 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 82,467 classified reports for GOLIMUMAB:
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.
Golimumab is contraindicated in patients with active infections and should be used with caution in patients with a history of serious infections.
If you are taking Golimumab, here are important things to know. The most commonly reported side effects include drug ineffective, rheumatoid arthritis, pain, fatigue, off label use. 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 immediately. Follow prescribed dosing instructions and inform healthcare providers of any other medications being taken. 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 Golimumab for safety, and updates will be provided based on ongoing studies and reports.
The FDA has received approximately 511,555 adverse event reports associated with Golimumab. 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 Golimumab include Drug Ineffective, Rheumatoid Arthritis, Pain, Fatigue, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (21,070 reports), Rheumatoid Arthritis (14,100 reports), Pain (13,403 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Golimumab.
Out of 82,467 classified reports, 62,053 (75.2%) were classified as serious and 20,414 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 Golimumab break down by patient sex as follows: Female: 55,571, Male: 16,936, Unknown: 114. 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 Golimumab adverse events are: age 44: 2,651 reports, age 43: 2,499 reports, age 59: 1,641 reports, age 40: 1,520 reports, age 60: 1,388 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 Golimumab adverse event reports is Janssen Biotech, 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 Golimumab include: Joint Swelling, Arthralgia, Rash, Alopecia, Drug Intolerance. 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 Golimumab 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.
Golimumab 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. High percentage of serious adverse events (75.2%) indicates significant safety concerns.
Key safety signals identified in Golimumab's adverse event data include: High number of serious reactions, particularly infections and infusions-related events.. Multiple musculoskeletal issues reported, including joint swelling and arthralgia.. Significant number of reports related to drug intolerance and ineffective treatment.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Golimumab is contraindicated in patients with active infections and should be used with caution in patients with a history of serious infections. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Golimumab.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions and inform healthcare providers of any other medications being taken.
Golimumab has 511,555 adverse event reports on file with the FDA. A wide range of reactions, including infections and musculoskeletal issues, are reported. The volume of reports for Golimumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Golimumab for safety, 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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