65/100 · Elevated
Manufactured by Lannett Company, Inc.
Moderate Safety Concerns with Oxybutynin Chloride
19,830 FDA adverse event reports analyzed
Last updated: 2026-05-12
OXYBUTYNIN CHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Lannett Company, Inc.. Based on analysis of 19,830 FDA adverse event reports, OXYBUTYNIN CHLORIDE 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 CHLORIDE include FATIGUE, DRUG INEFFECTIVE, NAUSEA, FALL, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXYBUTYNIN CHLORIDE.
Oxybutynin Chloride 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 19,830 adverse event reports for this medication, which is primarily manufactured by Lannett Company, Inc..
The most commonly reported adverse events include Fatigue, Drug Ineffective, Nausea. Of classified reports, 56.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and dizziness are common, indicating potential cognitive and physical impacts.
Gastrointestinal issues like nausea, diarrhea, and constipation are frequent. Serious adverse events, including falls and pneumonia, are reported but less frequent. Drug interactions and dose omissions are noted, suggesting potential misuse or interaction risks.
Patients taking Oxybutynin Chloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Oxybutynin Chloride can cause dizziness and fatigue, which may increase the risk of falls and accidents. Patients should avoid driving or operating heavy machinery until they know how the drug affects them. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Oxybutynin Chloride received a safety concern score of 65/100 (elevated concern). This is based on a 56.5% serious event ratio across 8,392 classified reports. The score accounts for 19,830 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: 5,585, Male: 2,293, Unknown: 14. The most frequently reported age groups are age 71 (178 reports), age 65 (161 reports), age 62 (149 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 8,392 classified reports for OXYBUTYNIN CHLORIDE:
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 Chloride can cause dizziness and fatigue, which may increase the risk of falls and accidents. Patients should avoid driving or operating heavy machinery until they know how the drug affects them.
If you are taking Oxybutynin Chloride, here are important things to know. The most commonly reported side effects include fatigue, drug ineffective, nausea, fall, headache. 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. Avoid driving or operating heavy machinery if you experience dizziness or fatigue. 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 Chloride for safety. Healthcare providers should be aware of the potential for serious adverse events and monitor patients closely.
The FDA has received approximately 19,830 adverse event reports associated with Oxybutynin Chloride. 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 Chloride include Fatigue, Drug Ineffective, Nausea, Fall, Headache. By volume, the top reported reactions are: Fatigue (690 reports), Drug Ineffective (674 reports), Nausea (571 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 Chloride.
Out of 8,392 classified reports, 4,742 (56.5%) were classified as serious and 3,650 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 Chloride break down by patient sex as follows: Female: 5,585, Male: 2,293, Unknown: 14. 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 Chloride adverse events are: age 71: 178 reports, age 65: 161 reports, age 62: 149 reports, age 69: 129 reports, age 66: 127 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 Chloride adverse event reports is Lannett Company, 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 Chloride include: Diarrhoea, Pain, Urinary Tract Infection, Dizziness, Constipation. 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 Chloride 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 Chloride 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 dizziness are common, indicating potential cognitive and physical impacts.
Key safety signals identified in Oxybutynin Chloride's adverse event data include: Frequent reports of falls and dizziness suggest a risk of falls and accidents.. Gastrointestinal issues are common, which could impact quality of life.. Serious adverse events like pneumonia and death are reported but less frequent.. Drug interactions and dose omissions are noted, indicating potential misuse or interaction risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Oxybutynin Chloride can cause dizziness and fatigue, which may increase the risk of falls and accidents. Patients should avoid driving or operating heavy machinery until they know how the drug affects them. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Oxybutynin Chloride.
Patients should report any unusual symptoms to their healthcare provider immediately. Avoid driving or operating heavy machinery if you experience dizziness or fatigue.
Oxybutynin Chloride has 19,830 adverse event reports on file with the FDA. Gastrointestinal issues like nausea, diarrhea, and constipation are frequent. The volume of reports for Oxybutynin Chloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Oxybutynin Chloride for safety. Healthcare providers should be aware of the potential for serious adverse events and monitor patients closely. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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