Poor
Not Aligned
Patient Risk:
High
Summary
Most statements are not supported by the provided FDA label excerpts (notably indications beyond gallstones, missed-dose/doubling guidance, and clinician-contact instructions). Only limited portions are supported (gallstone dissolution indication; diarrhea/abdominal pain adverse events; key drug interaction with bile acid sequestering agents; partial support for estrogens/OC/clofibrate).
Category Scores
Accurate Statements
Ursodiol is commonly prescribed for gallstone-related conditions.
INDICATIONS AND USAGE: indicated for radiolucent, noncalcified gallbladder stones < 20 mm.
Common side effects of ursodiol include gastrointestinal effects such as diarrhea or abdominal discomfort.
ADVERSE REACTIONS table includes Diarrhea and Abdominal Pain (≥5% incidence).
Ursodiol can interact with bile-acid binding agents.
Drug Interactions: bile acid sequestering agents (e.g., cholestyramine, colestipol) may interfere with ursodiol absorption/action.
Ursodiol can interact with some other therapies used for cholesterol, reflux, or liver conditions, depending on what else is being taken.
Drug Interactions: estrogens/oral contraceptives and clofibrate may counteract effectiveness of ursodiol.
Unsupported Statements
Ursodiol is a bile acid medication.
No provided label excerpt supports this phrasing.
Ursodiol is used to treat certain bile and liver conditions.
Provided label excerpts only include gallstone dissolution and gallstone prevention; no bile/liver condition treatment claim is supported.
Ursodiol 300 mg refers to a dose strength of 300 mg of ursodiol per tablet or capsule.
No provided label excerpt contains strength/labeling details for 300 mg.
Ursodiol is used for disorders involving bile flow or bile acids.
No provided label excerpt supports this general mechanism/indication description.
Ursodiol is used for some chronic liver/bile-duct diseases.
No provided label excerpt supports chronic liver/bile-duct disease indications.
The exact indication for ursodiol depends on the patient's diagnosis and clinician dosing instructions.
No provided label excerpt supports this statement; label excerpt presents specific indications.
Ursodiol dosing schedules depend on why the patient is taking it.
No dosage and administration content was provided in the label excerpts.
Many ursodiol regimens are split across the day to match how the drug is used clinically for bile-related conditions.
No dosing frequency/splitting schedule is supported by the provided label excerpts.
If a dose of ursodiol is missed, it should be taken when remembered unless it is close to the next dose time.
No missed-dose instructions are present in provided label excerpts.
After missing a ursodiol dose, the patient should not double up.
No missed-dose/double-up guidance is present in provided label excerpts.
Patients should call a clinician promptly if they develop severe or persistent symptoms, signs of an allergic reaction, or worsening liver-related symptoms while taking ursodiol.
No precaution/patient-instruction text about calling a clinician is included in provided label excerpts.
Ursodiol is used for disorders involving bile flow or bile acids.
Not supported by provided label excerpts.
Contradictions
Important Omissions
Contraindications for ursodiol (e.g., failure to dissolve certain stone types; candidates not appropriate for specific clinical scenarios; allergy to bile acids).
Importance:
High
FDA label indications are specific (radiolucent, noncalcified gallbladder stones <20 mm with certain surgery criteria; prevention in obese patients with rapid weight loss); response implied broader indications (bile/liver conditions, bile flow) without label support.
Importance:
High
Missed-dose and dosing/administration instructions (dose schedule, how to take, what to do when missed) from the label.
Importance:
High
Boxed warnings (if any) and other warnings/precautions sections text.
Importance:
Moderate
Use in specific populations (pregnancy/lactation, pediatric) from the label.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
High
Multiple high-safety-priority medication safety statements (missed-dose and do-not-double guidance, clinician-contact advice) are unsupported by the provided label excerpts; contraindications and specific labeled indications were not adequately addressed.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
Yes |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Key medication safety and administration guidance (missed dose/double up) and broad indications are not supported by the provided FDA label excerpts.
Suggested Improvement
Restrict claims to the provided label-supported indications (radiolucent, noncalcified gallbladder stones <20 mm under specified surgery criteria; prevention in obese patients with rapid weight loss), supported adverse reactions (diarrhea/abdominal pain), and explicitly supported interactions (bile acid sequestering agents; estrogens/oral contraceptives/clofibrate counteracting effectiveness). Omit or replace missed-dose and patient-contact instructions with label-provided text, and include contraindications from the label excerpt.