65/100 · Elevated
Manufactured by Astellas Pharma US, Inc.
Mirabegron Adverse Events: Moderate Safety Concerns
99,871 FDA adverse event reports analyzed
Last updated: 2026-05-12
MIRABEGRON is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Astellas Pharma US, Inc.. Based on analysis of 99,871 FDA adverse event reports, MIRABEGRON 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 MIRABEGRON include DRUG INEFFECTIVE, OFF LABEL USE, FATIGUE, HEADACHE, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MIRABEGRON.
Mirabegron 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 99,871 adverse event reports for this medication, which is primarily manufactured by Astellas Pharma Us, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Fatigue. Of classified reports, 47.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, dizziness, and falls are common side effects, indicating potential risks for elderly patients.
Serious adverse events, including death and respiratory issues, account for nearly half of non-serious reports. Drug ineffectiveness and off-label use are frequently reported, suggesting potential misuse or inefficacy. A wide range of reactions, including neurological and gastrointestinal issues, are observed.
Patients taking Mirabegron should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Mirabegron is associated with falls and dizziness, which can be particularly dangerous for elderly patients. Warnings should be issued to patients and healthcare providers. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Mirabegron received a safety concern score of 65/100 (elevated concern). This is based on a 47.5% serious event ratio across 36,922 classified reports. The score accounts for 99,871 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: 23,006, Male: 11,471, Unknown: 213. The most frequently reported age groups are age 80 (774 reports), age 40 (729 reports), age 75 (674 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 36,922 classified reports for MIRABEGRON:
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.
Mirabegron is associated with falls and dizziness, which can be particularly dangerous for elderly patients. Warnings should be issued to patients and healthcare providers.
If you are taking Mirabegron, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, fatigue, headache, dizziness. 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 unusual symptoms to their healthcare provider immediately. Elderly patients should be closely monitored for signs of dizziness and falls. 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 should continue to monitor the safety profile of Mirabegron, especially for elderly patients, and consider additional warnings or restrictions based on the observed adverse events.
The FDA has received approximately 99,871 adverse event reports associated with Mirabegron. 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 Mirabegron include Drug Ineffective, Off Label Use, Fatigue, Headache, Dizziness. By volume, the top reported reactions are: Drug Ineffective (5,738 reports), Off Label Use (2,683 reports), Fatigue (2,215 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Mirabegron.
Out of 36,922 classified reports, 17,528 (47.5%) were classified as serious and 19,394 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 Mirabegron break down by patient sex as follows: Female: 23,006, Male: 11,471, Unknown: 213. 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 Mirabegron adverse events are: age 80: 774 reports, age 40: 729 reports, age 75: 674 reports, age 76: 674 reports, age 77: 663 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 Mirabegron adverse event reports is Astellas Pharma Us, 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 Mirabegron include: Fall, Diarrhoea, Pain, Nausea, Intentional Product Misuse. 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 Mirabegron 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.
Mirabegron 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, dizziness, and falls are common side effects, indicating potential risks for elderly patients.
Key safety signals identified in Mirabegron's adverse event data include: Falls and dizziness are significant safety signals, especially in elderly patients.. Serious adverse events like pneumonia and respiratory issues are notable.. Drug ineffectiveness and off-label use indicate potential misuse or inefficacy.. A high number of reports on falls and dizziness suggest these may be common and need monitoring.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Mirabegron is associated with falls and dizziness, which can be particularly dangerous for elderly patients. Warnings should be issued to patients and healthcare providers. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Mirabegron.
Patients should report any unusual symptoms to their healthcare provider immediately. Elderly patients should be closely monitored for signs of dizziness and falls.
Mirabegron has 99,871 adverse event reports on file with the FDA. Serious adverse events, including death and respiratory issues, account for nearly half of non-serious reports. The volume of reports for Mirabegron reflects both the drug's usage level and the vigilance of the reporting community.
The FDA should continue to monitor the safety profile of Mirabegron, especially for elderly patients, and consider additional warnings or restrictions based on the observed adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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