65/100 · Elevated
Manufactured by Janssen Biotech, Inc.
Ustekinumab Adverse Events: Moderate Safety Concerns
346,490 FDA adverse event reports analyzed
Last updated: 2026-05-12
USTEKINUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Biotech, Inc.. Based on analysis of 346,490 FDA adverse event reports, USTEKINUMAB 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 USTEKINUMAB include DRUG INEFFECTIVE, OFF LABEL USE, PRODUCT DOSE OMISSION ISSUE, FATIGUE, PSORIASIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for USTEKINUMAB.
Ustekinumab 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 346,490 adverse event reports for this medication, which is primarily manufactured by Janssen Biotech, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Product Dose Omission Issue. Of classified reports, 58.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and rash are among the most common adverse events reported.
Serious adverse events, such as pneumonia and infection, are concerning. Drug intolerance and product use issues are frequent, indicating potential misuse.
Patients taking Ustekinumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ustekinumab may interact with other immunosuppressants, and patients should avoid self-administration to prevent misuse. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ustekinumab received a safety concern score of 65/100 (elevated concern). This is based on a 58.9% serious event ratio across 98,770 classified reports. The score accounts for 346,490 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: 51,238, Male: 34,660, Unknown: 192. The most frequently reported age groups are age 43 (2,196 reports), age 44 (2,137 reports), age 40 (1,555 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 98,770 classified reports for USTEKINUMAB:
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.
Ustekinumab may interact with other immunosuppressants, and patients should avoid self-administration to prevent misuse.
If you are taking Ustekinumab, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, product dose omission issue, fatigue, psoriasis. 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 respiratory issues immediately. Follow prescribed dosing instructions strictly to avoid adverse reactions. 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 Ustekinumab for safety, particularly for serious infections and respiratory issues.
The FDA has received approximately 346,490 adverse event reports associated with Ustekinumab. 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 Ustekinumab include Drug Ineffective, Off Label Use, Product Dose Omission Issue, Fatigue, Psoriasis. By volume, the top reported reactions are: Drug Ineffective (14,435 reports), Off Label Use (12,254 reports), Product Dose Omission Issue (9,763 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ustekinumab.
Out of 98,770 classified reports, 58,173 (58.9%) were classified as serious and 40,597 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 Ustekinumab break down by patient sex as follows: Female: 51,238, Male: 34,660, Unknown: 192. 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 Ustekinumab adverse events are: age 43: 2,196 reports, age 44: 2,137 reports, age 40: 1,555 reports, age 59: 1,346 reports, age 54: 1,181 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 Ustekinumab 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 Ustekinumab include: Pain, Arthralgia, Crohn^S Disease, Rash, Product Use Issue. 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 Ustekinumab 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.
Ustekinumab 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 rash are among the most common adverse events reported.
Key safety signals identified in Ustekinumab's adverse event data include: Pneumonia and other respiratory infections are reported as serious adverse events.. Infections and infusions related reactions are key safety signals.. Drug intolerance and product dose omission issues are significant.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ustekinumab may interact with other immunosuppressants, and patients should avoid self-administration to prevent misuse. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ustekinumab.
Patients should report any signs of infection or respiratory issues immediately. Follow prescribed dosing instructions strictly to avoid adverse reactions.
Ustekinumab has 346,490 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and infection, are concerning. The volume of reports for Ustekinumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Ustekinumab for safety, particularly for serious infections and respiratory issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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