65/100 · Elevated
Manufactured by Allergan, Inc.
Oxybutynin Adverse Events: Moderate Safety Concerns
51,990 FDA adverse event reports analyzed
Last updated: 2026-05-12
OXYBUTYNIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 51,990 FDA adverse event reports, OXYBUTYNIN 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 OXYBUTYNIN include DRUG INEFFECTIVE, FATIGUE, FALL, OFF LABEL USE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXYBUTYNIN.
Oxybutynin 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 51,990 adverse event reports for this medication, which is primarily manufactured by Allergan, Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Fall. Of classified reports, 47.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Falls and dizziness are common, indicating a risk of falls and accidents.
Serious adverse events, such as pneumonia and renal failure, are reported but less frequent. Drug ineffectiveness and off-label use are significant, suggesting potential misuse. Multiple skin-related reactions, including erythema and pruritus, are commonly reported. Drug interactions and dose omissions are noted, highlighting the need for careful monitoring.
Patients taking Oxybutynin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Oxybutynin can cause dizziness and falls, which may increase the risk of accidents. Patients should be advised to use caution when engaging in activities that require alertness. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Oxybutynin received a safety concern score of 65/100 (elevated concern). This is based on a 47.3% serious event ratio across 28,425 classified reports. The score accounts for 51,990 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: 20,925, Male: 5,942, Unknown: 155. The most frequently reported age groups are age 65 (467 reports), age 72 (459 reports), age 75 (455 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,425 classified reports for OXYBUTYNIN:
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.
Oxybutynin can cause dizziness and falls, which may increase the risk of accidents. Patients should be advised to use caution when engaging in activities that require alertness.
If you are taking Oxybutynin, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, fall, off label use, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Be cautious when engaging in activities that require alertness due to the risk of dizziness and falls. Follow prescribed dosing instructions carefully to avoid drug ineffectiveness and interactions. 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 oxybutynin for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 51,990 adverse event reports associated with Oxybutynin. 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 Oxybutynin include Drug Ineffective, Fatigue, Fall, Off Label Use, Nausea. By volume, the top reported reactions are: Drug Ineffective (3,925 reports), Fatigue (1,539 reports), Fall (1,466 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Oxybutynin.
Out of 28,425 classified reports, 13,454 (47.3%) were classified as serious and 14,971 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 Oxybutynin break down by patient sex as follows: Female: 20,925, Male: 5,942, Unknown: 155. 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 Oxybutynin adverse events are: age 65: 467 reports, age 72: 459 reports, age 75: 455 reports, age 70: 448 reports, age 74: 444 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 Oxybutynin adverse event reports is Allergan, 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 Oxybutynin include: Dizziness, Diarrhoea, Pain, Urinary Tract Infection, Headache. 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 Oxybutynin 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.
Oxybutynin 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. Falls and dizziness are common, indicating a risk of falls and accidents.
Key safety signals identified in Oxybutynin's adverse event data include: Falls and dizziness are frequent, indicating a risk of accidents.. Serious events like pneumonia and renal failure are reported but less common.. Drug ineffectiveness and off-label use are significant.. Multiple skin reactions are common, including erythema and pruritus.. Drug interactions and dose omissions are noted.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Oxybutynin can cause dizziness and falls, which may increase the risk of accidents. Patients should be advised to use caution when engaging in activities that require alertness. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Oxybutynin.
Be cautious when engaging in activities that require alertness due to the risk of dizziness and falls. Follow prescribed dosing instructions carefully to avoid drug ineffectiveness and interactions.
Oxybutynin has 51,990 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and renal failure, are reported but less frequent. The volume of reports for Oxybutynin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor oxybutynin for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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