Sara is a clinical pharmacist that believes everyone should understand their medications, and aims to achieve this through her writing.

Violetta Shamilova, PharmD, is a board-licensed pharmacist. She is an assistant professor at the Touro College School of Health Sciences, and has worked at CVS pharmacy for five years. She completed the certified APhA Delivering Medication Therapy Management Services course.

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Urso Forte (ursodiol) is a pill taken by mouth to treat a chronic liver condition called primary biliary cirrhosis, or primary biliary cholangitis (PBC).

PBC occurs when small tubes in the liver called bile ducts slowly become damaged and are eventually destroyed. Urso Forte is the brand name for ursodiol 500-milligram (mg) tablets, and Urso 250 is the brand name for ursodiol 250-mg tablets.

Ursodiol is a bile acid drug. It works to prevent gallstone formation and buildup of bile acid in the biliary ducts. Ursodiol is a prescription product, so you can’t purchase it over the counter (OTC). You’ll need a prescription from your healthcare provider to get the medication from your pharmacy.

The Food and Drug Administration (FDA) approved ursodiol to treat primary biliary cholangitis (PBC). This condition used to be called primary biliary cirrhosis, but since 2016 it has been formally called primary biliary cholangitis.

PBC is a chronic liver disease where the bile ducts become damaged and eventually destroyed. Bile ducts (the “biliary” in PBC) are small tubes that normally carry bile away from your liver, after using it to help digest food and absorb vitamins. When this function isn’t working correctly, bile can get backed up in your liver and cause scarring and damage.

High total cholesterol levels partially contribute to PBC. Ursodiol targets these high cholesterol levels by preventing your body from making too much cholesterol or absorbing too much from your intestine.

Ursodiol is available in 250-mg tablets (brand name Urso 250) and 500 mg tablets (brand name Urso Forte). It is usually taken between two and four times per day. Depending on your dose, you may take the 250-mg tablets or you may break the 500-mg tablets in half. In this case, use the scoring on the tablet to help you break it into even halves. Do not chew or crush these halves further, and take them with plenty of water.

If you take your dose by breaking 500-mg tablets in half, you can do this ahead of time as long as you store the segments in your original bottle at room temperature. They will stay good that way for 28 days.

Store ursodiol at room temperature (between 68 degrees and 77 degrees Fahrenheit) in the original container with the lid on, out of reach of children and pets. Avoid storing your pill bottle in an area with a lot of heat and moisture like the bathroom.

If you’re traveling by plane, it’s best to keep ursodiol in your carry-on luggage so that you aren’t separated from it in case your checked luggage happens to go missing. If you’re traveling by car, take care not to leave your pill bottle in especially hot or cold temperatures.

Healthcare providers may prescribe ursodiol for off-label uses, meaning for conditions not specifically indicated by the FDA.

In addition to treating PBC, ursodiol is used to treat other liver conditions involving cholestasis. Cholestasis means the flow of bile from the liver is disrupted or stopped.

Liver conditions that involve cholestasis include:

Urso Forte will begin to work right away, but the effects may not be obvious. Many people do not have symptoms of PBC when they get diagnosed with it. In those cases, it’s important to continue taking ursodiol even though you may not feel any different. People with PBC will likely be on ursodiol indefinitely.

If you do not have PBC but are taking ursodiol for a gallstone, you will likely need to take ursodiol long-term, up to several years.

This is not a complete list of side effects and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.

Ursodiol can cause some side effects. Be open with your healthcare provider about any side effects you experience while taking this medication.

Ursodiol is generally well-tolerated but some more common side effects include:

If you notice these side effects and think they are severe or do not go away you should notify your healthcare provider.

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

Taking ursodiol long-term is the way that most patients have to take it, either for PBC or to dissolve gallstones. No notable side effects apart from the ones listed above come with the long-term use of ursodiol.

Urso Forte may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules or tablets): 

For prevention of gallstones during rapid weight loss: 

For primary biliary cirrhosis: 

Using ursodiol during pregnancy hasn’t been well-studied. Tests in which pregnant animals were given higher doses than are recommended for humans did not appear to harm the fetus or to decrease fertility. However, because animal reproduction studies cannot always tell us accurate information about pregnant humans, this drug should be used during pregnancy only if clearly needed.

The use of ursodiol in children has not been formally studied, but ursodiol has been used to treat liver diseases in infants for many years.

If you forget to take a dose of Urso Forte, you can take it as soon as you remember. If you are closer to your next dose than the dose you missed, skip the missed dose and wait for your next scheduled one. For example, if you normally take ursodiol at 8 am at 8 pm, and you remember at 5 pm that you forgot your morning dose, just wait and take your next dose at 8 pm. Do not double up doses to make up for missed ones.

If you take ursodiol only as directed, you shouldn’t be too concerned about overdosing. If you accidentally double up doses, you may experience some diarrhea or other symptoms. If these symptoms are severe, go to the emergency room.

If you think you or someone else may have overdosed on Urso Forte, call your healthcare provider or the Poison Control Center (800-222-1222). 

If someone collapses or isn’t breathing after taking Urso Forte, call 911.

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It is important that your doctor check your progress at regular visits. Blood tests will have to be done every few months while you are taking this medicine to make sure that the gallstones are dissolving and your liver is working properly. 

Check with your doctor immediately if severe abdominal or stomach pain, especially toward the upper right side, or severe nausea and vomiting occur. These symptoms may mean that you have other medical problems or that your gallstone condition needs your doctor's attention.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Make sure your healthcare provider knows if you have any of the following, as you will most likely not be prescribed Urso Forte:

The following drugs may interfere with how well Urso Forte works.[1] Make sure your healthcare provider that prescribes your ursodiol is aware of all prescription and OTC medications you take:

Ursodiol is in a medication class called bile acid drugs. The other medicines in this class include:

Ursodiol treats a liver condition called primary biliary cholangitis (PBC). This disease happens when small tubes in the liver that normally help with digestion become damaged and eventually destroyed.

If you have PBC, you will likely be on ursodiol indefinitely, possibly for life. If you are taking it to dissolve gallstones, you will likely need to continue the medicine for a couple of years.

Ursodiol is generally a well-tolerated drug, but some side effects you may experience include diarrhea, pain in your abdomen area, heartburn, swelling around your ankles, or itching.

Avoid aluminum-based antacids while taking ursodiol. This includes formulations of aluminum hydroxide such as Mylanta or Gaviscon. Bile acid sequestrants like cholestyramine or colestipol that are used to treat high cholesterol may also interfere with the action of ursodiol.

Getting diagnosed with PBC can be frightening, especially since many people don’t show symptoms of PBC. Often, you may only get diagnosed as a result of a blood test performed for some other reason. PBC is an autoimmune disease, meaning your body may incorrectly recognize its own tissue as foreign, and attack your healthy cells as a result.

PBC is a serious disease and there is no cure, but medications like ursodiol exist to slow damage to your liver. Keeping regular checkups with your healthcare provider is important to monitor the health of your liver and to get any questions answered that you may have about PBC and its symptoms and treatment options.

You may also find it helpful to learn as much as you can about PBC by talking and interacting with others going through the same thing, such as on an online forum like this one.

Verywell Health's drug information is meant for education purposes only and not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your doctor before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

Food and Drug Administration. URSO Forte Package Insert.

National Institutes of Health. National Library of Medicine. Medlineplus.gov. Ursodiol: MedlinePlus Drug Information.

Tanaka A. Current understanding of primary biliary cholangitis. Clin Mol Hepatol. 2021;27(1):1-21.

Wah-Suarez MI, Danford CJ, Patwardhan VR, Jiang ZG, Bonder A. Hyperlipidaemia in primary biliary cholangitis: treatment, safety and efficacy. Frontline Gastroenterol. 2019;10(4):401-408.

LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases. Ursodiol (Ursodeoxycholic Acid).

Achufusi TGO, Safadi AO, Mahabadi N. Ursodeoxycholic Acid. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing.

Kriegermeier A, Green R. Pediatric cholestatic liver disease: Review of bile acid metabolism and discussion of current and emerging therapies. Front Med (Lausanne). 2020;7:149. Published 2020 May 5. doi:10.3389/fmed.2020.00149

LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases. Chenodiol (chenodeoxycholic acid).

Food and Drug Administration. Cholbam (cholic acid) label.

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