82/100 · Critical
Manufactured by KVK-Tech, Inc.
Ursosiol Adverse Events Show High Seriousness and Diverse Reactions
32,378 FDA adverse event reports analyzed
Last updated: 2026-05-12
URSOSIOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by KVK-Tech, Inc.. Based on analysis of 32,378 FDA adverse event reports, URSOSIOL has a safety score of 82 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 URSOSIOL include OFF LABEL USE, PRURITUS, FATIGUE, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for URSOSIOL.
Ursosiol has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 32,378 adverse event reports for this medication, which is primarily manufactured by Kvk-Tech, Inc..
The most commonly reported adverse events include Off Label Use, Pruritus, Fatigue. Of classified reports, 78.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ursosiol reports show a high percentage of serious adverse events (78.9%).
The most common reactions include pruritus, fatigue, and diarrhea, indicating a broad range of potential side effects. A significant number of reports involve liver-related issues, including hepatic failure and cholestasis.
Patients taking Ursosiol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ursosiol has multiple drug interactions and warnings, including potential liver toxicity and drug-induced liver injury. Patients should avoid certain medications that may interact with Ursosiol. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ursosiol received a safety concern score of 82/100 (high concern). This is based on a 78.9% serious event ratio across 18,066 classified reports. The score accounts for 32,378 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: 9,149, Male: 6,693, Unknown: 7. The most frequently reported age groups are age 68 (291 reports), age 60 (285 reports), age 62 (271 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 18,066 classified reports for URSOSIOL:
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.
Ursosiol has multiple drug interactions and warnings, including potential liver toxicity and drug-induced liver injury. Patients should avoid certain medications that may interact with Ursosiol.
If you are taking Ursosiol, here are important things to know. The most commonly reported side effects include off label use, pruritus, fatigue, diarrhoea, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should inform their healthcare provider of any pre-existing liver conditions before using Ursosiol. Monitor for signs of liver dysfunction, such as jaundice, dark urine, or abdominal pain, and seek medical attention if symptoms occur. 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 Ursosiol for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 32,378 adverse event reports associated with Ursosiol. 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 Ursosiol include Off Label Use, Pruritus, Fatigue, Diarrhoea, Nausea. By volume, the top reported reactions are: Off Label Use (1,607 reports), Pruritus (1,198 reports), Fatigue (995 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ursosiol.
Out of 18,066 classified reports, 14,259 (78.9%) were classified as serious and 3,807 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 Ursosiol break down by patient sex as follows: Female: 9,149, Male: 6,693, 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 Ursosiol adverse events are: age 68: 291 reports, age 60: 285 reports, age 62: 271 reports, age 64: 268 reports, age 58: 264 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 Ursosiol adverse event reports is Kvk-Tech, 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 Ursosiol include: Drug Ineffective, Pyrexia, Death, Pneumonia, 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 Ursosiol 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.
Ursosiol has a safety concern score of 82 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. Ursosiol reports show a high percentage of serious adverse events (78.9%).
Key safety signals identified in Ursosiol's adverse event data include: High percentage of serious adverse events (14,259 out of 18,066, or 78.9%).. Liver-related issues are frequent, with reports of hepatic failure, cholestasis, and hepatic enzyme increases.. A wide variety of reactions, including gastrointestinal, respiratory, and neurological symptoms, are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ursosiol has multiple drug interactions and warnings, including potential liver toxicity and drug-induced liver injury. Patients should avoid certain medications that may interact with Ursosiol. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ursosiol.
Patients should inform their healthcare provider of any pre-existing liver conditions before using Ursosiol. Monitor for signs of liver dysfunction, such as jaundice, dark urine, or abdominal pain, and seek medical attention if symptoms occur.
Ursosiol has 32,378 adverse event reports on file with the FDA. The most common reactions include pruritus, fatigue, and diarrhea, indicating a broad range of potential side effects. The volume of reports for Ursosiol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Ursosiol 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.
The following drugs share commonly reported adverse reactions with URSOSIOL:
Drugs related to URSOSIOL based on therapeutic use, drug class, or shared indications: