Ursodiol (Oral)

Ursodiol is a natural acid that works to decrease the formation of gallstones by dissolving cholesterol, and suppresses the production of cholesterol in the liver and absorption in the intestines.

Overview

Ursodiol is a prescription medication used to dissolve gallstones in patients where a surgery to remove the gallbladder is either unnecessary or not recommended due to other medical problems the patient may have. In addition to dissolving stones, ursodiol is often used to prevent the formation of gallstones in overweight patients who are on a rapid weight-loss program. However, ursodiol only works in patients whose gallstones are made of cholesterol and works best when these stones are small and are floating.

Ursodiol is also used to treat patients with primary biliary cirrhosis (PBC). Primary biliary cirrhosis is an autoimmune disorder that causes a patient's liver to malfunction and not work properly.

Take this medicine exactly as directed by your doctor. The dosage is based on your specific medical condition and the therapy prescribed.

This medicine is only available with your doctor's prescription.

Conditions Treated

  • Gallstones
  • Gallstone prevention
  • Primary Biliary Cirrhosis

Type of Medicine

  • Cholesterol Medication
  • Gastrointestinal Agent
  • Bile Acid

Side Effects

When taking a prescribed medicine, some side effects may emerge alongside the intended effects of the medicine. Although these unwanted effects may not occur, if they occur they require medical attention. Contact your doctor immediately if any of the following side effects occur:

More Common Side Effects:

  • Bladder pain
  • Bloody or cloudy urine
  • Burning, painful or difficult urination
  • Dizziness
  • Fast heartbeat
  • Frequent urge to urinate
  • Indigestion
  • Lower back or side pain
  • Severe nausea
  • Skin rash or itching over the entire body
  • Stomach pain
  • Vomiting
  • Weakness

Less Common Side Effects:

  • Black, tarry stools
  • Chest pain
  • Chills or fever
  • Cough
  • Pinpoint red spots on skin
  • Severe or continuing stomach pain
  • Sore throat or swollen glands
  • Sores, ulcers, or white spots on the lips on in the mouth
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness

Incidence Not Known:

  • Clay-colored stools
  • Dark urine
  • Difficulty with swallowing
  • Headache
  • Hives or welts
  • Hoarseness
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Loss of appetite
  • Nausea
  • Redness of the skin
  • Slow or irregular breathing
  • Tightness in the chest
  • Unpleasant breath odor
  • Yellow eyes or skin

Some side effects of Ursodiol may occur that do not necessarily require medical attention. These side effects may go away as your body adjusts to the medicine over the course of treatment. Also, your doctor may be able to inform you of ways to prevent or reduce some of these side effects. Check with your doctor if any of the following side effects continue or are bothersome, or if you have any questions about them:

More Common Side Effects:

  • Back pain
  • Body aches or pain
  • Congestion
  • Constipation
  • General feeling of discomfort or illness
  • Heartburn
  • Loss of voice
  • Muscle aches
  • Muscle or bone pain
  • Pain, swelling, or redness in the joints
  • Runny nose
  • Sweating
  • Trouble sleeping

Less Common Side Effects:

  • Diarrhea

Rare Side Effects:

  • Worsening psoriasis

Incidence Not Known:

  • Acid or sour stomach
  • Belching, bloating or swelling of face, arms, hands, lower legs, or feet
  • Difficulty with moving
  • Rapid weight gain
  • Stomach discomfort or upset
  • Tingling of the hands or feet
  • Unusual weight gain or loss

Ask your doctor or pharmacist for more information about possible side effects. You may also report side effects that are not listed here to the FDA at 1-800-FDA-1088 or by filling out an online form on the FDA's website.

Dosage

  • Take this medicine exactly as directed by your doctor. Do not take more of it or take it more often, and do not take this medicine for a longer time than your doctor prescribes. Altering dosage may increase the chance of side effects.
  • It is best to take ursodiol with meals, unless otherwise directed by your doctor.
  • Take this medicine for the full time of treatment, even if symptoms begin to disappear or you being feeling better. Prematurely ending treatment can result in gallstones dissolving slower than normal or not at all.
  • The dosage of ursodiol will be different for different patients. The amount of medicine that you take depends on the strength of the medicine, as well as the number of doses you take each day, the time between doses, and the duration of your treatment.
  • Follow your doctor's recommendations concerning dosage or the directions on the label. The following amounts are average doses of this medicine. If your dose is different, do not adjust your dose unless your doctor tells you to do so.

For Oral Dosage:

For Gallstone disease:

  • Adults and children 12 years of age and older: Your dose is based on your body weight and must be determined by your doctor. The average dose is usually 8 to 10 milligrams (mg) per kilogram (kg) of body weight per day, divided up into two or three doses.
  • Children younger than 12 years of age-Use and dose must be determined by your doctor.

For prevention of gallstones:

  • Adults and children 12 years of age and older-300 milligrams (mg) two times a day.
  • Children younger than 12 years of age-Use and dose must be determined by your doctor.

For Primary Biliary Cirrhosis:

  • Adults and children 12 years of age and older-Dose is based on body weight and must be determined by your doctor. The dose is usually 13 to 15 milligrams (mg) per kilogram (kg) of body weight per day, divided up into two to four doses. Your dosage may be adjusted by your doctor as needed.
  • Children younger than 12 years of age-Use and dose must be determined by your doctor.

If a dose is missed:

  • Call your doctor or pharmacist for instructions on next steps.
  • Take the missed dose as soon as you remember it. However, if it is nearly time for your next regularly scheduled dose, skip the missed dose and continue along your regular dosing schedule. Do not take a double dose of the medicine as to make up for the missed dose.

Interactions

Certain medicines may interact with ursodiol in an adverse or undesired way. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any vitamins, minerals or other dietary supplements. Be sure to also include any aluminum-containing antacids (Rolaids, Mylanta, or Maalox), birth control pills, cholesterol medications, cholestyramine (Questran, LoCHOLEST, Prevalite), clofibrate (Atromid-S), colestipol (Colestid), and estrogen (hormone replacements).

If you are using any of these medicines prior to using ursodiol, you may not be able to use ursodiol or you may need dosage adjustments or special tests during treatment. Discuss the interactions with the previously mentioned drugs and possible dosage changes with your doctor or pharmacist.

You should bring this list with you every time you visit a doctor or are admitted to a hospital. Carry this list with you in case of emergencies.

Your doctor or pharmacist may already be aware of any possible drug interactions and may already be monitoring you for them. Do not alter the dosage of any medicine in any way before checking with your doctor or pharmacist first. Ask your doctor or pharmacist for more information on other drugs that may possibly interact with ursodiol.

Do not take other medicines without discussing them with your doctor first. This includes prescription or nonprescription medicines and herbal, vitamin, or dietary supplements.

Certain medicines should not be used at or around the time of eating food or certain types of food as some interactions may occur. Additionally, the use of alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your doctor the use of ursodiol with food, alcohol or tobacco.

Warnings

Tell your doctor before taking ursodiol if you are allergic to it or other bile acids or if you have any other allergies. This product may contain inactive ingredients that could possibly cause allergic reactions or other problems.

This medicine should not be used if you have calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. If you have any of these stones, consult with your doctor about possible options.

This medicine should not be used if you have certain medical conditions. Consult your doctor before using this medicine if you have certain gallbladder or bile duct problems (acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, biliary-gastrointestinal fistula).

If you have had a history of liver disease (liver damage, liver transplant, ascites, variceal bleeding, hepatic encephalopathy) tell your doctor before using this medicine.

If you are pregnant, ursodiol should only be used if clearly needed. Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking ursodiol, call your doctor.

Tell your doctor if you are breast-feeding before taking ursodiol. You will need to talk about any risks to your baby.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness while using ursodiol, until you are sure you can perform such activities safely.

Do not share this medication with others. This has been prescribed for you alone, and different people will react differently to this medication.

In case of emergency or overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is no longer breathing, call local emergency services at 911.

Precautions

It is important that your progress is checked by your doctor at regular visits. While you are taking ursodiol, blood tests should be done every few months to make sure that the gallstones are dissolving and your liver is functioning properly. Your doctor may perform ultrasound examinations of your gallbladder on a regular basis as well to be sure this medication is helping your condition.

To treat gallstones, you may have to take this medicine for an extended amount of time, and all gallstones may not completely dissolve. Some patients that take ursodiol may develop gallstones again within several years after the treatment is completed. Discuss the risk of repeated gallstones with your doctor.

If severe abdominal or stomach pain occurs, especially towards the upper right side, or if severe nausea and vomiting occur, check with your doctor immediately. Such symptoms may mean that your gallstone condition requires your doctor's attention, or that you have other medical problems that may require attention as well.

Storage

Store the medicine in the original, closed container at room temperature, away from excess heat, moisture and direct light. Keep from freezing. Do not keep outdated medicine or keep medicine longer than needed. Ask your doctor about how you should dispose of any medicine that remains after your treatment has ended.

Keep out of reach of children.

Half-tablets (500mg scored tablets that are broken in half) may be used for up to 28 days when stored in their original packaging at room temperature. They should be stored separately from whole tablets.

Summary

Ursodiol is a naturally occurring bile acid that is used to dissolve gallstones in patients who do not want surgery or cannot have surgery to remove the gallstones. ursodiol is used to prevent the formation of gallstones in overweight patients who are on weight loss programs. Additionally, this medicine is used to treat patients with primary biliary cirrhosis.

Make sure to notify your doctor of your medical history before considering using ursodiol. Prior medical conditions and existing conditions, especially considering the liver, could complicate or worsen with the use of this medicine. Additionally, notify your doctor of any and all medications, vitamins and supplements you are currently taking before considering using ursodiol.

Never modify dosage of ursodiol or duration of treatment without first consulting your doctor. This medicine affects each patiently differently in different ways, and modifying treatment may result in more or worsened side effects.

Check with your doctor regularly concerning side effects, especially if they worsen or change in any way. Be sure to report side effects that have not been listed here to your doctor and the FDA as soon as they occur.

Resources
Last Reviewed:
December 22, 2017
Last Updated:
April 05, 2018
Content Source: