Ursodiolside effects
ursodiol 300 MG Oral Capsule
Adverse reactions
The nature and frequency of adverse experiences were similar across all groups. The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level: GALLSTONE DISSOLUTION Ursodiol Placebo 8 - 10 mg/kg/day (N = 155) (N = 159) N (%) N (%) Body as a Whole Allergy 8 7 Chest Pain 5 10 Fatigue 7 8 Infection Viral 30 41 Digestive System Abdominal Pain 67 70 Cholecystitis 8 7 Constipation 15 14 Diarrhea 42 34 Dyspepsia 26 18 Flatulence 12 12 Gastrointestinal Disorder 6 8 Nausea 22 27 Vomiting 15 11 Musculoskeletal System Arthralgia 12 24 Arthritis 9 4 Back Pain 11 18 Myalgia 9 9 Nervous System Headache 28 34 Insomnia 3 8 Respiratory System Bronchitis 10 6 Coughing 11 7 Pharyngitis 13 5 Rhinitis 8 11 Sinusitis 17 18 Upper Respiratory Tract Infection 24 21 Urogenital System Urinary Tract Infection 10 7 GALLSTONE PREVENTION Ursodiol Placebo 600 mg (N = 322) (N = 325) N (%) N (%) Body as a Whole Fatigue 25 33 Infection Viral 29 29 Influenza-like Symptoms 21 19 Digestive System Abdominal Pain 20 39 Constipation 85 72 Diarrhea 81 68 Flatulence 15 24 Nausea 56 43 Vomiting 44 44 Musculoskeletal System Back Pain 38 21 Musculoskeletal Pain 19 15 Nervous System Dizziness 53 42 Headache 80 78 Respiratory System Pharyngitis 10 19 Sinusitis 17 18 Upper Respiratory Tract Infection 40 35 Skin and Appendages Alopecia 17 8 Urogenital System Dysmenorrhea 18 19 To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 19, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Warnings
Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis There have been rare postmarketing reports of ursodiol-treated patients who developed enteroliths (bezoars) resulting in obstructive symptoms that required surgical intervention. These patients had medical conditions that predisposed them to intestinal stenosis or stasis (e.g., surgical enteroanastomoses, Crohn's disease). If a patient presents with obstructive gastrointestinal symptoms, hold Actigall until a clinical evaluation has been conducted.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 19, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Contraindications
Ursodiol will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for ursodiol therapy. Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for ursodiol therapy. Allergy to bile acids.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 19, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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