65/100 · Elevated
Manufactured by GlaxoSmithKline LLC
Belimumab Adverse Events: Moderate Safety Concerns
60,128 FDA adverse event reports analyzed
Last updated: 2026-05-12
BELIMUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. Based on analysis of 60,128 FDA adverse event reports, BELIMUMAB 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 BELIMUMAB include PRODUCT DOSE OMISSION ISSUE, SYSTEMIC LUPUS ERYTHEMATOSUS, FATIGUE, DRUG INEFFECTIVE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BELIMUMAB.
Belimumab 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 60,128 adverse event reports for this medication, which is primarily manufactured by Glaxosmithkline Llc.
The most commonly reported adverse events include Product Dose Omission Issue, Systemic Lupus Erythematosus, Fatigue. Of classified reports, 42.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and pain are the most common reported side effects, with over 1,700 reports each.
Serious adverse events account for 42.3% of all reports, indicating significant risk. The majority of reports are from female patients, with a ratio of 14:1 compared to males.
Patients taking Belimumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Belimumab should be used with caution in patients with a history of serious infections, and drug interactions with immunosuppressants should be monitored. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Belimumab received a safety concern score of 65/100 (elevated concern). This is based on a 42.3% serious event ratio across 30,234 classified reports. The score accounts for 60,128 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: 23,236, Male: 1,716, Unknown: 60. The most frequently reported age groups are age 54 (340 reports), age 52 (333 reports), age 48 (324 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,234 classified reports for BELIMUMAB:
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.
Belimumab should be used with caution in patients with a history of serious infections, and drug interactions with immunosuppressants should be monitored.
If you are taking Belimumab, here are important things to know. The most commonly reported side effects include product dose omission issue, systemic lupus erythematosus, fatigue, drug ineffective, pain. 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 carefully to avoid dose-related issues. 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 regular safety updates and monitoring for serious adverse events, particularly infections and SLE exacerbation.
The FDA has received approximately 60,128 adverse event reports associated with Belimumab. 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 Belimumab include Product Dose Omission Issue, Systemic Lupus Erythematosus, Fatigue, Drug Ineffective, Pain. By volume, the top reported reactions are: Product Dose Omission Issue (4,840 reports), Systemic Lupus Erythematosus (3,749 reports), Fatigue (2,005 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Belimumab.
Out of 30,234 classified reports, 12,796 (42.3%) were classified as serious and 17,438 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 Belimumab break down by patient sex as follows: Female: 23,236, Male: 1,716, Unknown: 60. 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 Belimumab adverse events are: age 54: 340 reports, age 52: 333 reports, age 48: 324 reports, age 44: 318 reports, age 49: 318 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 Belimumab adverse event reports is Glaxosmithkline Llc. 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 Belimumab include: Headache, Nausea, Wrong Technique In Device Usage Process, Malaise, Arthralgia. 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 Belimumab 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.
Belimumab 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 pain are the most common reported side effects, with over 1,700 reports each.
Key safety signals identified in Belimumab's adverse event data include: Systemic lupus erythematosus (SLE) is the primary condition treated, but reports of SLE exacerbation are common.. Injection site reactions, including pain and erythema, are frequent.. There are reports of serious infections, including pneumonia and sepsis, which are concerning.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Belimumab should be used with caution in patients with a history of serious infections, and drug interactions with immunosuppressants should be monitored. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Belimumab.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid dose-related issues.
Belimumab has 60,128 adverse event reports on file with the FDA. Serious adverse events account for 42.3% of all reports, indicating significant risk. The volume of reports for Belimumab reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight includes regular safety updates and monitoring for serious adverse events, particularly infections and SLE exacerbation. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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