Ursodiol

Medically reviewed by Elizabeth Scheffel, PharmD on May 17, 2023
Written by Sarah Lewis, PharmD

Specifically, the Food and Drug Administration (FDA) has approved ursodiol to:

• treat gallstones in people who can’t have or don’t want surgery
• help prevent gallstones in people with obesity who are losing weight very quickly
• treat primary biliary cholangitis (a disease of the liver), also known as primary biliary cirrhosis

These approved uses differ based on the form of ursodiol your doctor prescribes.

This article describes ursodiol’s uses, side effects, and more. Below you’ll also find some coupon options to help save on the cost of ursodiol.

Below you’ll find answers to a few commonly asked questions about ursodiol.

Can ursodiol be used for dogs?

Yes, veterinarians can use ursodiol for dogs and other animals. To learn more about using ursodiol in animals, talk with your pet’s veterinarian.

To be safe, do not give medications to a pet without checking first with a veterinarian. Some medications could be dangerous for or cause harm to pets.

How does ursodiol work? And how long does it take to start working?

Ursodiol works for gallstones by dissolving them. It works for primary biliary cholangitis by reducing levels of other bile acids that build up and become harmful. (Ursodiol is itself a bile acid.)

Ursodiol will start working right away. But it can take some time before you feel your symptoms easing. For gallstones, it can take 6–12 months to find out whether the drug is dissolving them.

Talk with your doctor to find out more about how ursodiol works.

Will I experience any side effects when stopping ursodiol?

No, there aren’t any expected side effects from stopping ursodiol treatment. But stopping treatment could cause your symptoms to return and your condition to worsen. If you’re taking ursodiol for gallstones, they’ll likely return when you stop taking the drug.

It’s recommended that you do not stop taking ursodiol without talking with your doctor first. They can help you decide whether you should stop the drug and explain how to do so safely.

What brand names are available for ursodiol?

Ursodiol comes in different brand-name versions depending on the form. The brand-name version of ursodiol oral capsules is called Actigall. Ursodiol oral tablets come in the brand-name versions Urso 250 and Urso Forte.

If you’re interested in taking a brand-name version of ursodiol, talk with your doctor or pharmacist.

Are there alternatives for ursodiol, including a natural alternative?

Yes, there are alternatives to taking ursodiol. For gallstones, another bile acid medication called chenodiol is available. Another example of a treatment option is shock wave therapy.

For primary biliary cholangitis, there is another medication your doctor may suggest called obeticholic acid (Ocaliva).

Ursodiol is a naturally occurring bile acid, so it could be considered natural in some respects. But you may be looking for a natural remedy as an alternative to taking ursodiol. To learn about whether there are natural remedies that can help with your condition, talk with your doctor.

Can ursodiol be used for cholestasis?

Possibly. Cholestasis is a slowing or stopping of bile flow. (Bile is a substance the liver makes.)

Ursodiol doesn’t have approval from the Food and Drug Administration (FDA) to treat cholestasis. But doctors may choose to prescribe it off-label for this use. With off-label use, doctors prescribe a drug for a condition other than what the FDA approves it for.

Talk with your doctor to find out more about taking ursodiol for cholestasis.

Ursodiol may cause mild or serious side effects. More common mild side effects of ursodiol and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about ursodiol’s side effects, ask your doctor or pharmacist. You can also read the prescribing information* for ursodiol.

* To view ursodiol’s prescribing information, see the “Article resources” section below.

Mild side effects

More common mild side effects reported with the different forms of ursodiol are listed below. These side effects may differ based on the form of ursodiol you take.

This article doesn’t include all possible mild side effects of the drug. To learn more about ursodiol’s side effects based on the form, see the prescribing information* for ursodiol.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Ursodiol oral capsule’s mild side effects include:

• diarrhea
• headache
• indigestion (upset stomach)
• nausea
• mild allergic reaction†

Ursodiol oral tablet’s mild side effects include:

• abdominal pain or discomfort
• diarrhea
• indigestion
• nausea
• mild allergic reaction†

* To view ursodiol’s prescribing information, see the “Article resources” section below.
† For details about this side effect, see the “Interactions and warnings for ursodiol” section below.

Serious side effects

Serious side effects of ursodiol are listed below. These side effects may differ based on the form of ursodiol you take.

This article doesn’t include all possible serious side effects of the drug. To learn more about ursodiol’s side effects based on the form, see the prescribing information* for ursodiol.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, ursodiol’s serious side effects include:

• abnormal results in liver function tests, which can be a sign of liver problems
• changes in blood cell counts
• esophagitis (inflammation of the esophagus)
• increased blood sugar
• ulcer of the stomach or intestine (a painful sore in the lining of your stomach or intestine)
• severe allergic reaction†

* To view ursodiol’s prescribing information, see the “Article resources” section below.
† For details about this side effect, see the “Interactions and warnings for ursodiol” section below.

The Food and Drug Administration (FDA) approves prescription drugs such as ursodiol for certain conditions. Approved uses for ursodiol are described below. These uses differ based on the form of ursodiol prescribed.

Use for gallstones

Doctors may prescribe ursodiol oral capsule for treating or helping prevent gallstones. It’s used for this purpose in adults. It’s usually prescribed as a long-term treatment.

The gallbladder stores and releases bile to help with digestion. With gallstones, hardened “stone-like” masses form in this organ.

Most people don’t have symptoms of gallstones. But gallstones can block a duct where bile usually flows. This can cause severe pain in the upper right part of your abdomen. Nausea and vomiting may also occur.

Doctors may not prescribe ursodiol oral capsule in certain situations, such as when gallstones look a certain way on imaging exams or when surgery is a better option.

Use for a certain type of liver disease

Doctors may prescribe ursodiol oral tablet for treating primary biliary cholangitis. It’s used for this purpose in adults. It’s usually prescribed as a long-term treatment.

Primary biliary cholangitis is an autoimmune disorder of the liver. With this condition, your immune system attacks your liver. This causes damage to the liver’s bile ducts and can destroy them. The condition eventually results in liver failure.

Ursodiol can help slow the progression of primary biliary cholangitis and delay the need for a liver transplant.

Doctors may not prescribe ursodiol oral tablet in certain situations, such as when bile ducts are completely blocked, or liver disease is very advanced.

The dosage of ursodiol your doctor prescribes may vary based on your condition and certain other factors. Talk with your doctor about the dosage you should take.

Taking ursodiol

Ursodiol oral capsule is taken by mouth, with or without food.

Ursodiol oral tablet is taken by mouth, with food.

Your doctor will talk with you about how to take ursodiol. They’ll explain how much to take and how often. Always follow your doctor’s recommendation.

Overdose of ursodiol

You should not take more ursodiol than your doctor prescribes. For some drugs, doing so may lead to serious side effects or overdose.

If you think you’ve taken too much ursodiol, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Below, you’ll find information about ursodiol’s possible interactions and warnings.

Interactions of ursodiol

For some medications, certain things may affect how the drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take ursodiol, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription medications
• over-the-counter medications
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for ursodiol” section below.

Warnings for ursodiol

Some people should not take ursodiol, and others should take it cautiously.

Ursodiol could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether ursodiol is a safe option for you. These warnings may differ based on the form of ursodiol you take.

Ask your doctor about specific warnings for ursodiol, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Ursodiol can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to ursodiol or any of its ingredients, your doctor will likely not prescribe ursodiol. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to ursodiol, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Pregnancy or breastfeeding and ursodiol

Information about ursodiol and pregnancy and breastfeeding is described below.

Ursodiol and pregnancy

It’s not known whether ursodiol should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

Ursodiol and breastfeeding

It’s not known whether ursodiol should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

You may be able to save money on your prescription for ursodiol by using our Perks discount coupons. They can be found at the end of this article.

If you have questions about how to pay for ursodiol, talk with your doctor or pharmacist.

Note: Optum Perks coupons cannot be used with insurance copays or benefits.

This article describes ursodiol’s uses and side effects, ways to save on cost, and more. Let your doctor know if you have questions about ursodiol or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• Can I break the ursodiol tablet in half?
• What should I do if I miss a dose of ursodiol?
• How long will I need to take ursodiol?

• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
• Ursodiol- ursodiol capsule. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/31ff3961-3ef1-4ec3-b742-beb4b96de795/spl-doc
• Ursodiol- ursodiol tablet, film coated. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/46cfd68f-9a6e-4a00-a3e7-11d130b571fe/spl-doc

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.