Ursodeoxycholic Acid (Ursodiol, bile acid)

Ursodeoxycholic acid or ursodiol is a type of bile acid. It is a generic drug that may have different brand names. This drug is available with a physician’s prescription.

Know the basics

What is ursodeoxycholic acid used for?

• Dissolving cholesterol-rich gallstones
• Biliary reflux gastritis
• Cholestatic liver disease
• Primary biliary cirrhosis
• Intrahepatic cholestasis of pregnancy
• Cystic fibrosis (in children)

How should I take ursodeoxycholic acid?

Read the directions on the packaging for complete information. Check the label and expiration date.

For oral dosage forms, swallow it whole without chewing, crushing, or dissolving it in liquid. Take it with meals.

How do I store ursodeoxycholic acid?

Store this product at room temperature away from direct light and moisture. To prevent drug damage, you should not store it in the bathroom or the freezer. 

There may be different brands of this drug that may have different storage needs. So, it is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush this product down the toilet or pour them into a drain unless instructed to do so. Additionally, it is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Know the precautions & warnings

What should I know before using ursodeoxycholic acid?

Before using this drug, tell your doctor if you are/have:

• Pregnant or breastfeeding.
• Taking any other medicines. This includes any prescription, OTC, and herbal remedies.
• An allergy to any of the ingredients of this product.
• Any other illnesses, disorders, or medical conditions.

Is it safe to take ursodeoxycholic acid during pregnancy or breastfeeding?

This drug may be prescribed to pregnant women with intrahepatic cholestasis of pregnancy. It is a first-line treatment for this condition during the second and third trimester. However, there is not enough information on its effects on the fetus during pregnancy, especially the first trimester. Traces of ursodeoxycholic acid are present in breast milk, however, there are no reported adverse events.

Talk to your doctor or OB-GYN before starting or stopping any medication during pregnancy or if you plan to become pregnant.

Know the side effects

What are the side effects of ursodeoxycholic acid?

Like all drugs, this product may have side effects. If they occur, side effects are generally mild and resolve once treatment is finished or the dose is lowered. Some reported side effects include:

• Headache
• Dizziness
• Diarrhea
• Constipation
• Dyspepsia
• Nausea
• Back pain
• Upper respiratory tract infection
• Other infections
• Alopecia (hair loss)
• Skin rash
• Allergic reaction

However, not everyone experiences these side effects. In addition, some people may experience other side effects. So, if you have any concerns about a side effect, please consult your doctor or pharmacist.

Know the interactions

What drugs may interact with ursodeoxycholic acid?

This medication may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. 

To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. 

Drugs with known interactions:

• Aluminum hydroxide
• Bile acid sequestrants
• Ciclosporin
• Ciprofloxacin
• Estrogen derivatives
• Fibric acid derivatives
• Nitrendipine
• Rosuvastatin
• Sincalide

If you experience an adverse drug interaction, inform your doctor immediately to reevaluate your treatment plan. Approaches include dose adjustment, drug substitution, or ending therapy.

Does food or alcohol interact with ursodeoxycholic acid?

This drug may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with ursodeoxycholic acid?

Ursodeoxycholic acid may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Understand the dosage

The information provided is not a substitute for any medical advice. Therefore, you should always consult with your doctor or pharmacist before using any medication.

What is the dose for an adult?

Gallstone prevention

Take 600 mg per day in 1 or 2 divided doses.

Dissolution of cholesterol gallstones

Take 8 to 10 mg per kilogram of body weight per day, in 2 to 3 divided doses.

Biliary reflux gastritis

Take 1 capsule at bedtime for 10 to 14 days.

Primary biliary cirrhosis

Take 1 capsule 3 times a day for the first 3 months. If you liver function tests improve, you can take one dose per day.

Intrahepatic cholestasis of pregnancy

Take 10 to 15 mg per kilogram of body weight per day, in 2 to 3 divided doses – OR – 500 mg twice a day and gradually increasing by 500 mg (up to 2000 mg per day). Continue taking it until delivery.

What is the dose of ursodeoxycholic acid for a child?

Children with cystic fibrosis aged 6 years to less than 18 years: 

Give 20 mg per kg of body weight per day in 2 to 3 divided doses. Increase to 30 mg per kg per day, if necessary.

How is ursodeoxycholic acid available?

Ursodeoxycholic acid is available in the following dosage forms and strengths:

• Film-coated tablet 250 mg, 500 mg
• Capsule 250 mg, 300 mg, 400 mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to the nearest emergency room.

What should I do if I miss a dose?

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.