Urso

The active ingredient in Urso is ursodiol (ursodeoxycholic acid). The mechanism of action of Ursodiol involves altering bile composition in the liver and gallbladder. It reduces the amount of cholesterol made by the liver and helps dissolve cholesterol in bile, making it less likely for gallstones to form.

For people with primary biliary cholangitis, Urso improves bile flow, reduces the toxic effects of other bile acids, and can slow disease progression. These actions help protect liver tissue, support better liver function, and reduce itching (pruritus), which is a common symptom in cholestatic liver disease.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Urso. However, the following is a synopsis of the general guidelines for the use of Urso:

• Take Urso exactly as prescribed, with food to improve absorption and reduce stomach upset.
• Doses are usually split into two or three daily doses, depending on your medical condition and body weight (often measured as mg/kg/day).
• If you have difficulty swallowing tablets, some products may be split into half-tablets, but only if instructed by your healthcare provider.
• If Urso is used for gallstone dissolution, your doctor may prescribe it for several months before evaluating your response.
• If you miss a dose, take it as soon as you remember unless it’s almost time for your next dose. In that case, skip the missed dose; do not double up.
• Continue taking the medication even if your symptoms improve. Stopping too soon can slow progress or cause gallstones to return.
• Regular blood tests will be needed to monitor liver function during treatment.

Some mild or common side effects of Urso seen in clinical trials as compared to placebo include:

• Diarrhea.
• Constipation.
• Stomach upset or dyspepsia.
• Nausea.
• Abdominal pain.
• Headache.
• Dizziness.

Some individuals may experience serious side effects while using Urso. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of allergic reactions such as hives, swelling, or difficulty breathing.
• Worsening liver symptoms such as jaundice, dark urine, or severe abdominal pain.
• Sudden swelling in the ankles, legs, or abdomen (possible ascites or liver complications).
• Signs of biliary blockage, such as pale stools or intense itching.
• Severe or persistent stomach pain.
• New skin rashes or unexplained hair loss (alopecia).

These are not all of the possible side effects of Urso. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Urso, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Liver disease unrelated to cholestasis.
• Biliary obstruction or gallbladder blockage.
• Cirrhosis or complications of chronic liver disease.
• A history of gallstones that are calcified, pigment-based, or too large to dissolve.
• Crohn’s disease or other bowel conditions affecting bile absorption.
• A history of allergic reactions to bile acid medications.
• Swelling in the abdomen or signs of hepatic encephalopathy.

Urso should not be used in individuals who:

• Have complete biliary obstruction.
• Have acute inflammation of the gallbladder or bile ducts.
• Have gallstones unlikely to dissolve, including calcified or radiopaque stones.
• Have a known allergy to ursodiol or any ingredients in the product.
• Have advanced, decompensated liver disease unless closely monitored by a specialist.

The timeline depends on the condition being treated:

• Primary biliary cholangitis: Improvements in liver tests may take 3 to 6 months, and long-term treatment is often required.
• Gallstone dissolution: It may take several months to over a year for gallstones to dissolve. Some patients require continued therapy to prevent stone recurrence.
• Your doctor will use blood tests, imaging studies, and symptom tracking to assess how well Urso is working for you.

When Urso is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Cholestyramine or colestipol – reduces the absorption of ursodiol.
• Antacids containing aluminum may interfere with effectiveness.
• Estrogens or oral contraceptives can increase cholesterol in bile and counteract gallstone dissolution.
• Drugs affecting liver function, such as certain antibiotics or antifungals.
• Cyclosporine – blood level changes may occur.
• Certain cholesterol medications.
• Supplement products that affect bile production or absorption.
• Always separate bile acid–binding medications from Urso by at least 2 to 4 hours.

Urso is available in several dosage forms, including:

Tablets (commonly 250 mg and 500 mg, depending on brand)

Capsules (such as those in Actigall and Urso Forte)

Dosing is based on the patient’s body weight and medical condition, measured in mg/kg/day and divided into two or three doses. Your healthcare provider will determine the right dose for your needs.

Store at room temperature and keep out of reach of children.

Urso and Urso Forte are manufactured by Axcan Pharma US, Inc., while Actigall is manufactured by Pfizer Inc., depending on the specific product and region.

Yes. The generic name ursodiol is widely available in both tablet and capsule forms.

Do not stop taking Urso without consulting your healthcare provider. Stopping treatment early may cause symptoms to return or slow progress in liver disease.

Your doctor may adjust or discontinue treatment based on changes in liver function or imaging results. If you experience severe abdominal pain, allergic reactions, or signs of liver complications, seek medical attention promptly.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. Some studies suggest ursodiol may be used safely in certain pregnancy-related liver conditions, but you should only take it if your healthcare provider determines that the benefits outweigh potential risks.

Ursodiol passes into breast milk in small amounts. While the risks to infants appear low, always discuss breastfeeding plans with your healthcare provider before starting treatment. They will determine whether continuing therapy is appropriate.