65/100 · Elevated
Manufactured by Janssen Biotech, Inc.
Guselkumab Adverse Events: Dose Issues and Device Malfunctions Predominate
50,420 FDA adverse event reports analyzed
Last updated: 2026-05-12
GUSELKUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Biotech, Inc.. Based on analysis of 50,420 FDA adverse event reports, GUSELKUMAB 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 GUSELKUMAB include PRODUCT DOSE OMISSION ISSUE, ACCIDENTAL EXPOSURE TO PRODUCT, DRUG INEFFECTIVE, PSORIASIS, NEEDLE ISSUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GUSELKUMAB.
Guselkumab 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 50,420 adverse event reports for this medication, which is primarily manufactured by Janssen Biotech, Inc..
The most commonly reported adverse events include Product Dose Omission Issue, Accidental Exposure To Product, Drug Ineffective. Of classified reports, 26.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Dose issues and device malfunctions are the most common adverse events, with over 10,000 reports each.
Serious adverse events account for 26% of all reports, with pneumonia and respiratory tract infections being notable. The majority of reports (70%) are non-serious, but the serious event rate is concerning. Device issues, including malfunctions and defects, are frequently reported, indicating potential product quality concerns.
Patients taking Guselkumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Guselkumab reports include issues with dose administration and device malfunctions, which may require careful handling and monitoring. Patients should be informed about the importance of correct device use and storage. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Guselkumab received a safety concern score of 65/100 (elevated concern). This is based on a 26.0% serious event ratio across 30,744 classified reports. The score accounts for 50,420 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: 14,702, Male: 10,393, Unknown: 3. The most frequently reported age groups are age 60 (436 reports), age 62 (431 reports), age 61 (430 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,744 classified reports for GUSELKUMAB:
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.
Guselkumab reports include issues with dose administration and device malfunctions, which may require careful handling and monitoring. Patients should be informed about the importance of correct device use and storage.
If you are taking Guselkumab, here are important things to know. The most commonly reported side effects include product dose omission issue, accidental exposure to product, drug ineffective, psoriasis, needle issue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Ensure proper storage and handling of the medication to prevent product quality issues. Follow the prescribed dosing schedule and use the device as directed to avoid dose omissions and malfunctions. 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 Guselkumab for safety concerns, particularly regarding serious respiratory events and device issues. Healthcare providers should report any adverse events to the FDA.
The FDA has received approximately 50,420 adverse event reports associated with Guselkumab. 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 Guselkumab include Product Dose Omission Issue, Accidental Exposure To Product, Drug Ineffective, Psoriasis, Needle Issue. By volume, the top reported reactions are: Product Dose Omission Issue (10,011 reports), Accidental Exposure To Product (3,138 reports), Drug Ineffective (2,239 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Guselkumab.
Out of 30,744 classified reports, 7,997 (26.0%) were classified as serious and 22,747 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 Guselkumab break down by patient sex as follows: Female: 14,702, Male: 10,393, Unknown: 3. 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 Guselkumab adverse events are: age 60: 436 reports, age 62: 431 reports, age 61: 430 reports, age 56: 423 reports, age 58: 421 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 Guselkumab 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 Guselkumab include: Device Issue, Device Malfunction, Off Label Use, Product Storage Error, Device Deployment 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 Guselkumab 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.
Guselkumab 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. Dose issues and device malfunctions are the most common adverse events, with over 10,000 reports each.
Key safety signals identified in Guselkumab's adverse event data include: High frequency of dose omission and device malfunction reports. Significant number of serious events, including pneumonia and respiratory tract infections. Common device issues such as leakage and defective devices. A high number of reports related to incorrect administration and storage errors. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Guselkumab reports include issues with dose administration and device malfunctions, which may require careful handling and monitoring. Patients should be informed about the importance of correct device use and storage. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Guselkumab.
Ensure proper storage and handling of the medication to prevent product quality issues. Follow the prescribed dosing schedule and use the device as directed to avoid dose omissions and malfunctions.
Guselkumab has 50,420 adverse event reports on file with the FDA. Serious adverse events account for 26% of all reports, with pneumonia and respiratory tract infections being notable. The volume of reports for Guselkumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Guselkumab for safety concerns, particularly regarding serious respiratory events and device issues. Healthcare providers should report any adverse events to the FDA. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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