85/100 · Critical
Manufactured by Allergan, Inc.
Ursodiol Adverse Events Show High Seriousness and Diverse Reactions
36,281 FDA adverse event reports analyzed
Last updated: 2026-05-12
URSODIOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 36,281 FDA adverse event reports, URSODIOL has a safety score of 85 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 URSODIOL include OFF LABEL USE, PRURITUS, DIARRHOEA, FATIGUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for URSODIOL.
Ursodiol has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 36,281 adverse event reports for this medication, which is primarily manufactured by Allergan, Inc..
The most commonly reported adverse events include Off Label Use, Pruritus, Diarrhoea. Of classified reports, 80.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (80.6%) indicates significant safety concerns.
A wide range of reactions reported, including liver and kidney issues, infections, and hematological abnormalities. Reports of fatalities and severe conditions like hepatic failure and sepsis are notable.
Patients taking Ursodiol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ursodiol can cause drug interactions, particularly with other hepatotoxic or nephrotoxic drugs. Warnings are issued for patients with pre-existing liver or kidney conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ursodiol received a safety concern score of 85/100 (high concern). This is based on a 80.6% serious event ratio across 20,386 classified reports. The score accounts for 36,281 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: 10,164, Male: 7,932, Unknown: 7. The most frequently reported age groups are age 60 (339 reports), age 68 (328 reports), age 64 (307 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 20,386 classified reports for URSODIOL:
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.
Ursodiol can cause drug interactions, particularly with other hepatotoxic or nephrotoxic drugs. Warnings are issued for patients with pre-existing liver or kidney conditions.
If you are taking Ursodiol, here are important things to know. The most commonly reported side effects include off label use, pruritus, diarrhoea, fatigue, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of liver or kidney dysfunction, such as jaundice, dark urine, or swelling in the legs. Report any unusual symptoms 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 bodies closely monitor Ursodiol for safety, especially in elderly and patients with pre-existing liver or kidney conditions. Regular liver and kidney function tests are recommended.
The FDA has received approximately 36,281 adverse event reports associated with Ursodiol. 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 Ursodiol include Off Label Use, Pruritus, Diarrhoea, Fatigue, Nausea. By volume, the top reported reactions are: Off Label Use (1,622 reports), Pruritus (1,240 reports), Diarrhoea (1,145 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ursodiol.
Out of 20,386 classified reports, 16,436 (80.6%) were classified as serious and 3,950 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 Ursodiol break down by patient sex as follows: Female: 10,164, Male: 7,932, Unknown: 7. 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 Ursodiol adverse events are: age 60: 339 reports, age 68: 328 reports, age 64: 307 reports, age 62: 303 reports, age 67: 300 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 Ursodiol 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 Ursodiol include: Pyrexia, Drug Ineffective, Pneumonia, Death, Vomiting. 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 Ursodiol 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.
Ursodiol has a safety concern score of 85 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 percentage of serious adverse events (80.6%) indicates significant safety concerns.
Key safety signals identified in Ursodiol's adverse event data include: Liver and kidney function abnormalities are frequently reported, with increased liver enzymes and bilirubin.. Significant number of serious infections and sepsis cases.. Multiple organ dysfunction syndrome and respiratory failure are also reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ursodiol can cause drug interactions, particularly with other hepatotoxic or nephrotoxic drugs. Warnings are issued for patients with pre-existing liver or kidney conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ursodiol.
Monitor for signs of liver or kidney dysfunction, such as jaundice, dark urine, or swelling in the legs. Report any unusual symptoms to healthcare providers promptly.
Ursodiol has 36,281 adverse event reports on file with the FDA. A wide range of reactions reported, including liver and kidney issues, infections, and hematological abnormalities. The volume of reports for Ursodiol reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory bodies closely monitor Ursodiol for safety, especially in elderly and patients with pre-existing liver or kidney conditions. Regular liver and kidney function tests are recommended. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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