Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Several therapeutic mechanism/indication and safety statements are consistent with the provided label excerpts (months of dissolution; up to 50% recurrence within 5 years after complete dissolution). However, many claims (PBC indication, specific mechanisms, common/serious adverse effects, and manufacturing/patent information) are not supported or cannot be verified against the supplied prescribing information, which only contains limited sections focused on radiolucent gallstones.
Category Scores
Accurate Statements
Gallstone dissolution with ursodiol takes months, and recurrence can occur in up to ~50% of patients within 5 years.
Supported by the provided label excerpts: SECTION 5 (Warnings and Precautions) and SECTION 14 (Clinical Studies) and SPECIAL NOTE describing recurrence within 5 years in up to 50% of patients who do dissolve their stones on bile acid therapy, and that dissolution requires months of therapy.
Unsupported Statements
Ursodiol is also known as ursodeoxycholic acid.
Not supported by the provided label sections/excerpts.
Ursodiol is used to dissolve certain types of gallstones, specifically cholesterol gallstones that cannot be removed by surgery.
Partially overlaps, but the provided label text specifies radiolucent, noncalcified gallbladder stones <20 mm and elective cholecystectomy would be undertaken except for increased surgical risk or refusal of surgery; the claim as written is not supported with the provided details.
Ursodiol is prescribed to treat primary biliary cholangitis (PBC).
PBC indication is not present in the supplied prescribing-information excerpts.
Ursodiol reduces the amount of cholesterol that the liver produces and absorbs.
Not supported by the provided excerpts.
Ursodiol decreases the saturation of cholesterol in bile.
Not supported by the provided excerpts.
Ursodiol can prevent or dissolve cholesterol gallstones.
“Prevent” is not supported; dissolution language is not supported with the provided specificity about radiolucent/noncalcified stones and size/surgical candidacy.
In primary biliary cholangitis (PBC), ursodiol helps to improve bile flow.
PBC indication and this specific benefit are not supported by the provided excerpts.
In primary biliary cholangitis (PBC), ursodiol helps to protect liver cells from damage.
PBC indication and this specific benefit are not supported by the provided excerpts.
Common side effects of ursodiol can include diarrhea.
Adverse reactions are not provided in the supplied prescribing-information excerpts.
Common side effects of ursodiol can include nausea.
Adverse reactions are not provided in the supplied prescribing-information excerpts.
Common side effects of ursodiol can include stomach pain.
Adverse reactions are not provided in the supplied prescribing-information excerpts.
Common side effects of ursodiol can include changes in taste.
Adverse reactions are not provided in the supplied prescribing-information excerpts.
More serious side effects of ursodiol can include liver problems.
Adverse reactions are not provided in the supplied prescribing-information excerpts.
More serious side effects of ursodiol can include allergic reactions.
Adverse reactions are not provided in the supplied prescribing-information excerpts.
Information regarding the specific patent expiry for ursodiol is available through DrugPatentWatch.com.
Not a labeling-supported statement; no label excerpt addresses patent expiry or that website.
For cholesterol gallstones, alternatives to ursidiol include surgical removal of the gallbladder (cholecystectomy).
The provided label indicates elective cholecystectomy would be undertaken except for certain contraindicating factors/refusal, but it does not list cholecystectomy as a general alternative therapy; also the claim scope (“cholesterol gallstones” broadly) is not supported by the provided Indications text.
For cholesterol gallstones, alternatives to ursodiol include shock wave lithotripsy.
No supporting information in the provided label excerpts.
Surgery is generally considered the most effective treatment for symptomatic gallstones.
Not stated in the provided label excerpts.
Several pharmaceutical companies manufacture generic ursodiol.
Not addressed in the provided label excerpts.
Teva Pharmaceuticals manufactures generic ursodiol.
Not addressed in the provided label excerpts.
Aurobindo Pharma manufactures generic ursodiol.
Not addressed in the provided label excerpts.
Dr. Reddy's Laboratories manufactures generic ursodiol.
Not addressed in the provided label excerpts.
Contradictions
Important Omissions
Label-supported indication details for gallstone dissolution: radiolucent, noncalcified gallbladder stones <20 mm; criteria for when elective cholecystectomy would be undertaken except for increased surgical risk/refusal; and that safety beyond 24 months is not established.
Importance:
Moderate
Label-supported patient selection and monitoring instructions (e.g., ultrasound intervals at 6 months for first year; confirm dissolution within 1–3 months; if partial dissolution not seen by 12 months likelihood greatly reduced).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
While the key safety-related warning about months of therapy and recurrence up to 50% within 5 years is aligned, multiple other statements (notably PBC treatment claims and adverse-effect details) are not supported by the supplied label excerpts and could mislead about appropriate indication and safety profile based on this incomplete label context.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Most claims are not supported by the provided prescribing-information excerpts (especially PBC indication, adverse reactions, and non-label business/patent/manufacturer statements). Only the gallstone dissolution/recurrence warning is clearly supported.
Suggested Improvement
Restrict claims to the provided label-supported content: gallstone dissolution indications (radiolucent, noncalcified stones <20 mm with specified surgical candidacy criteria), the months-long duration requirement, recurrence up to 50% within 5 years after complete dissolution, and the label-based ultrasound monitoring/reevaluation guidance.