78/100 · Elevated
Manufactured by GlaxoSmithKline LLC
Mepolizumab Adverse Events Show High Serious Reaction Rate
173,706 FDA adverse event reports analyzed
Last updated: 2026-05-12
MEPOLIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. Based on analysis of 173,706 FDA adverse event reports, MEPOLIZUMAB has a safety score of 78 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 MEPOLIZUMAB include ASTHMA, DYSPNOEA, WHEEZING, PRODUCT DOSE OMISSION ISSUE, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MEPOLIZUMAB.
Mepolizumab has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 173,706 adverse event reports for this medication, which is primarily manufactured by Glaxosmithkline Llc.
The most commonly reported adverse events include Asthma, Dyspnoea, Wheezing. Of classified reports, 63.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High rate of serious adverse events (63.2%) including pneumonia and hospitalization.
Common reactions include respiratory issues like asthma, wheezing, and dyspnea. Significant number of reports related to product misuse and dosing issues.
Patients taking Mepolizumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions and warnings include potential for respiratory issues and product misuse; patients should strictly follow dosing instructions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Mepolizumab received a safety concern score of 78/100 (high concern). This is based on a 63.2% serious event ratio across 47,097 classified reports. The score accounts for 173,706 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: 23,211, Male: 11,025, Unknown: 1. The most frequently reported age groups are age 40 (856 reports), age 43 (677 reports), age 60 (675 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 47,097 classified reports for MEPOLIZUMAB:
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.
Interactions and warnings include potential for respiratory issues and product misuse; patients should strictly follow dosing instructions.
If you are taking Mepolizumab, here are important things to know. The most commonly reported side effects include asthma, dyspnoea, wheezing, product dose omission issue, cough. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosing instructions strictly to avoid potential adverse reactions. Report any unusual symptoms or side effects to healthcare providers promptly. 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 is ongoing, with multiple safety signals identified; patients should report any adverse events immediately.
The FDA has received approximately 173,706 adverse event reports associated with Mepolizumab. 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 Mepolizumab include Asthma, Dyspnoea, Wheezing, Product Dose Omission Issue, Cough. By volume, the top reported reactions are: Asthma (12,416 reports), Dyspnoea (10,201 reports), Wheezing (6,904 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Mepolizumab.
Out of 47,097 classified reports, 29,784 (63.2%) were classified as serious and 17,313 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 Mepolizumab break down by patient sex as follows: Female: 23,211, Male: 11,025, Unknown: 1. 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 Mepolizumab adverse events are: age 40: 856 reports, age 43: 677 reports, age 60: 675 reports, age 65: 660 reports, age 62: 628 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 Mepolizumab 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 Mepolizumab include: Therapeutic Product Effect Incomplete, Pneumonia, Drug Ineffective, Loss Of Personal Independence In Daily Activities, Sleep Disorder Due To A General Medical Condition. 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 Mepolizumab 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.
Mepolizumab has a safety concern score of 78 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 rate of serious adverse events (63.2%) including pneumonia and hospitalization.
Key safety signals identified in Mepolizumab's adverse event data include: High frequency of serious respiratory events (pneumonia, asthma, wheezing).. Multiple reports of product misuse and dosing errors.. Significant number of hospitalizations and deaths reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions and warnings include potential for respiratory issues and product misuse; patients should strictly follow dosing instructions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Mepolizumab.
Follow prescribed dosing instructions strictly to avoid potential adverse reactions. Report any unusual symptoms or side effects to healthcare providers promptly.
Mepolizumab has 173,706 adverse event reports on file with the FDA. Common reactions include respiratory issues like asthma, wheezing, and dyspnea. The volume of reports for Mepolizumab reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with multiple safety signals identified; patients should report any adverse events immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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