Side effects of ursodiol

Contents

Urso

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following table summarizes the adverse reactions observed in two placebo-controlled clinical trials.

In a randomized, cross-over study in sixty PBC patients, seven patients (11.6%) reported nine adverse reactions: abdominal pain and asthenia (1 patient), nausea (3 patients), dyspepsia (2 patients) and anorexia and esophagitis (1 patient each). One patient on the twice a day regimen (total dose 1000 mg) withdrew due to nausea. All of these nine adverse reactions except esophagitis were observed with the twice a day regimen at a total daily dose of 1000 mg or greater. However, an adverse reaction may occur at any dose.

Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during postapproval use of ursodiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Gastrointestinal disorders: abdominal discomfort, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.
  • General disorders and administration site conditions: malaise, peripheral edema, pyrexia.
  • Hepatobiliary disorders: jaundice (or aggravation of preexisting jaundice).
  • Immune System Disorders: Drug hypersensitivity to include facial edema, urticaria, angioedema and laryngeal edema.
  • Abnormal Laboratory Tests: ALT increased, AST increased, blood alkaline phosphatase increased, blood bilirubin increased, γ-GT increased, hepatic enzyme increased, liver function test abnormal, transaminases increased.
  • Musculoskeletal and connective tissue disorders: myalgia
  • Nervous system disorders: dizziness, headache.
  • Respiratory, thoracic and mediastinal disorders: cough.
  • Skin and subcutaneous tissue disorder: alopecia, pruritus, rash.

Read the entire FDA prescribing information for Urso (Ursodiol)

Generic Name: ursodiol (ur so DY all)
Brand Name: Actigall, Urso, Urso Forte, Urso DS

Medically reviewed by Drugs.com on Nov 4, 2019 – Written by Cerner Multum

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is ursodiol?

Ursodiol is a bile acid that decreases the amount of cholesterol produced by the liver and absorbed by the intestines. Ursodiol helps break down cholesterol that has formed into stones in the gallbladder. Ursodiol also increases bile flow in patients with primary biliary cirrhosis.

Ursodiol is used to treat primary biliary cirrhosis.

Ursodiol capsules are used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol capsules are not for treating gallstones that are calcified

Ursodiol may also be used for purposes not listed in this medication guide.

Important Information

You should not use ursodiol if you have an obstruction in your liver or gallbladder.

Before taking this medicine

You should not use ursodiol if you are allergic to it, or if you have an obstruction in your liver or gallbladder.

To make sure ursodiol is safe for you, tell your doctor if:

  • you have been coughing up blood; or

  • you have gained weight rapidly, especially in your face and midsection.

FDA pregnancy category B. Ursodiol is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ursodiol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take ursodiol?

Follow all directions on your prescription label. Do not take ursodiol in larger or smaller amounts or for longer than recommended.

Take the ursodiol tablet with food.

You may need to break a tablet in half to get your correct dose. Each tablet is scored in the middle and should break apart easily.

Swallow the tablet piece whole with a glass of water. A broken tablet can have a bitter taste.

Use ursodiol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To treat gallstones, you may have to take ursodiol for several months before your gallstones dissolve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Not all gallstones completely dissolve with ursodiol treatment, and you may develop new gallstones within 5 years after treatment. Talk to your doctor about your specific risks.

While using ursodiol, you may need gallbladder ultrasound exams, or frequent blood tests to check your liver function. Your doctor may also want to check your liver function every 6 months after you stop using ursodiol.

Store at room temperature away from moisture and heat. Tablets that are broken in half can be kept at room temperature for up to 28 days.

If you split your tablets, keep them separate from any whole tablets.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ursodiol?

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb ursodiol.

If you also take cholestyramine or colestipol, avoid taking ursodiol at the same time. Ask your doctor how many hours apart you should take your medicines.

Ursodiol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • liver problems–nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • signs of a new infection–sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, skin sores, trouble swallowing.

Common side effects may include:

  • headache, dizziness;

  • mild stomach pain or discomfort;

  • nausea, diarrhea, constipation;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • hair loss; or

  • mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ursodiol dosing information

Usual Adult Dose for Biliary Cirrhosis:

Tablets: 13 to 15 mg/kg orally per day, given in 2 to 4 divided doses with food

-The dose should be adjusted to the patient’s needs.
-Scored tablets may be broken in half to provide recommended doses.
Use: Treatment of patients with primary biliary cirrhosis (PBC)

Usual Adult Dose for Gallbladder Disease:

Capsules:
Gallstone dissolution: 8 to 10 mg/kg orally per day, given in 2 to 3 divided doses
Gallstone prevention: 300 mg orally 2 times a day
-Maximum dose: 600 mg/day

-Safety in the dissolution of gallstones has not been established in patients using this drug beyond 24 months.
-Ultrasound images should be obtained every 6 months for the first year.
-If gallstones appear to have dissolved, treatment should be continued, and dissolution should be confirmed on a repeat ultrasound in 1 to 3 months.
-Most patients who achieve complete dissolution show partial or complete dissolution at the first on-treatment reevaluation.
-If partial stone dissolution is not observed after 12 months of treatment, the likelihood of treatment is significantly reduced.
Uses:
-Patients with radiolucent, noncalcified gallbladder stones less than 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to advanced age, idiosyncratic reaction to general anesthesia, systemic disease, or those who refuse surgery
-For the prevention of gallstone formation in obese patients experiencing rapid weight loss

What other drugs will affect ursodiol?

Other drugs may interact with ursodiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 4.01.

Medical Disclaimer

More about ursodiol

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Compare Alternatives
  • Support Group
  • Pricing & Coupons
  • En Español
  • 17 Reviews
  • Drug class: gallstone solubilizing agents

Consumer resources

  • Ursodiol
  • Ursodiol (Advanced Reading)

Other brands: Actigall, Urso, Urso Forte

Professional resources

  • Ursodiol (AHFS Monograph)
  • … +3 more

Related treatment guides

  • Nonalcoholic Fatty Liver Disease
  • Gallbladder Disease
  • Primary Biliary Cholangitis

GENERIC NAME: URSODIOL – ORAL (UR-soe-DYE-ol)

BRAND NAME(S): Actigall, Urso

Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage

USES: Ursodiol is used to dissolve certain types of gallstones, to prevent gallstones from forming in obese patients who are losing weight rapidly, and to treat a certain type of liver disease (primary biliary cirrhosis). Ursodiol is a bile acid.

HOW TO USE: Take this medication exactly as directed by your doctor.Dosage is based on your medical condition and response to therapy.Do not increase your dose or take this medication more often without your doctor’s approval. Your condition will not improve any faster, and the risk of serious side effects may be increased.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

SIDE EFFECTS: Stomach upset, nausea, diarrhea, dizziness, back pain, hair loss, or cough may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: weakness, swelling of the ankles/feet, increased thirst/urination, signs of infection (e.g., fever, persistent sore throat), easy bleeding/bruising.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ursodiol, tell your doctor or pharmacist if you are allergic to it; or to other bile acids; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain gallbladder/bile duct problems (e.g., acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, biliary-gastrointestinal fistula).Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (e.g., ascites, variceal bleeding, hepatic encephalopathy).This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

(Picture Credit: Getty Images)

Ursodiol for dogs is a bile acid used to treat liver disease and dissolve or prevent gallstones. Some people also know it by the brand names Actigall and Urso.

Ursodiol works by reducing the amount of cholesterol made by the liver, decreasing the amount of cholesterol absorbed by food, and also increasing the rate at which the body breaks down cholesterol. While it is not FDA approved for veterinary use, it is commonly prescribed by veterinarians for certain canine conditions.

The main ingredient in ursodiol is ursodeoxycholic acid, which is a natural component of the bile that a dog’s body normally produces. For that reason, dogs usually tolerate it well, but some side effects can occur. If your veterinarian prescribes ursodiol for use in your dog, then follow their instructions closely.

Here’s what you should know about the uses, dosage, and side effects of ursodiol in dogs.

Uses Of Ursodiol For Dogs

(Picture Credit: Getty Images)

Ursodiol for dogs is used to treat a variety of liver and gallbladder conditions. The liver and gallbladder are two organs that are highly affected by cholesterol, and the drug’s ability to reduce cholesterol in the body is beneficial to these organs.

Cholesterol is sometimes a component of gallstones, and ursodiol can help prevent these stones from forming. Ursodiol also helps increase the flow of bile acid, which helps reduce toxic buildup of acid in the body.

Here are several of the conditions that a veterinarian might treat with a prescription for ursodiol:

  • Primary sclerosing cholangitis
  • Chronic hepatitis
  • Non-alcoholic fatty liver disease
  • Gallstones
  • Congenital portosystemic shunts
  • Juvenile fibrosing liver disease

Dosage Of Ursodiol For Dogs

(Picture Credit: Getty Images)

The usual dosage of ursodiol for dogs is 2.5 to 7 mg per pound of body weight given orally twice a day. You should give it to your dog with food, as this increases absorption. Ursodiol is available in 300 mg capsules and 250 mg tablets. Do not give it to your dog without your veterinarian’s approval.

Your vet will give you further instructions on proper dosage. They may also wish to adjust the dosage based on your dog’s condition and individual response to the drug.

The duration of the prescription can vary, but you should continue to administer the drug to your dog until your veterinarian instructs you to stop, as ending treatment early could result in relapse.

Side Effects Of Ursodiol For Dogs

(Picture Credit: Getty Images)

The side effects of ursodiol in dogs are generally mild if they appear at all. The main ingredient in ursodiol naturally exists in dogs’ bile, so dogs usually tolerate it well.

There are, however, some side effects that may appear, and if these are cause for concern, you should contact your veterinarian, as they may wish to alter the dosage or seek an alternative form of treatment.

Here are a few of the side effects of ursodiol in dogs:

  • Headache
  • Nausea
  • Upset stomach
  • Diarrhea
  • Worsening of liver disease

Make sure your veterinarian is aware of any other medical conditions your dog has, as well as any other medications your dog takes, especially Tylenol, antacids, and vitamin supplements, as these may react poorly with ursodiol.

As with all drugs, there is a risk of allergic reaction that could lead to anaphylaxis, a potentially life-threatening condition. If you see the signs of an allergic reaction, including hives, swelling, difficulty breathing, sneezing, or other symptoms, then contact your veterinarian right away.

Has your dog ever taken ursodiol? Did it help with their condition? Then let us know in the comments below!

Ursodiol Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 8, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

In Summary

Commonly reported side effects of ursodiol include: back pain. Other side effects include: arthralgia, alopecia, arthritis, and pharyngitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ursodiol: oral capsule, oral tablet

Along with its needed effects, ursodiol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ursodiol:

More common

  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful 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

  • Black, tarry stools
  • chest pain
  • chills or fever
  • cough
  • pinpoint red spots on the skin
  • severe or continuing stomach pain
  • sore throat or swollen glands
  • sores, ulcers, or white spots on the lips or 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 usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • 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

  • Diarrhea

Rare

  • 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

For Healthcare Professionals

Applies to ursodiol: oral capsule, oral tablet

General

The most commonly reported side effects included abdominal pain, diarrhea, constipation, and headache.

Gastrointestinal

Common (1% to 10%): Cholecystitis, flatulence, gastrointestinal disorder, pasty stools, peptic ulcer

Very rare (less than 0.01%): Calcification of gallstones, severe upper right abdominal pain

Frequency not reported: Esophagitis

Postmarketing reports: Abdominal discomfort

Calcification of gallstones may result in surgery, as bile acid therapy alone may not be able to dissolve the calcifications.

Severe upper right abdominal pain occurred in patients with primary biliary cirrhosis.

Nervous system

Very common (10% or more): Headache (up to 24.8%), dizziness (up to 16.5%)

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 15.5%), sinusitis (up to 11%)

Common (1% to 10%): Bronchitis, coughing, pharyngitis, rhinitis

Postmarketing reports: Cough, laryngeal edema

Immunologic

Very common (10% or more): Viral infection (up to 19.4%)

Common (1% to 10%): Influenza-like symptoms

Musculoskeletal

Very common (10% or more): Back pain (up to 11.8%)

Common (1% to 10%): Arthralgia, arthritis, musculoskeletal pain, myalgia

Dermatologic

Common (1% to 10%): Alopecia, skin rash/rash

Very rare (less than 0.01%): Urticaria

Frequency not reported: Increased pruritus/pruritus

Postmarketing reports: Facial edema

Hematologic

Common (1% to 10%): Leukopenia, thrombocytopenia

Genitourinary

Common (1% to 10%): Dysmenorrhea, urinary tract infection

Other

Common (1% to 10%): Fatigue

Frequency not reported: Asthenia, fever, other toxicity

Postmarketing reports: Malaise, pyrexia

Hypersensitivity

Drug hypersensitivity reactions included angioedema, facial edema, laryngeal edema, and urticaria.

Common (1% to 10%): Allergy

Frequency not reported: Allergic reactions

Postmarketing reports: Angioedema, drug hypersensitivity

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Sleep disturbance

Metabolic

Common (1% to 10%): Elevated blood glucose

Frequency not reported: Anorexia

Cardiovascular

Common (1% to 10%): Chest pain

Postmarketing reports: Peripheral edema

Renal

Common (1% to 10%): Elevated creatinine

Hepatic

Very rare (less than 0.01%): Decompensation of hepatic cirrhosis

Frequency not reported: Increased cholestasis

Postmarketing reports: Aggravation of pre-existing jaundice/jaundice, ALT increased, AST increased, blood alkaline phosphatase increased, blood bilirubin increased, GGT increased, hepatic enzyme increased, liver function tests abnormal, transaminases increased

Decompensation of hepatic cirrhosis occurred in patients with advanced stages of primary biliary cirrhosis. The condition partially regressed after treatment was discontinued.

1. “Product Information. Urso (ursodiol)” Scandipharm Inc, Birmingham, AL.

2. Cerner Multum, Inc. “Australian Product Information.” O 0

3. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

4. “Product Information. Actigall capsules (ursodiol).” Novartis Pharmaceutical, Research Triangle Pk, NC.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Compare Alternatives
  • Support Group
  • Pricing & Coupons
  • En Español
  • 17 Reviews
  • Drug class: gallstone solubilizing agents
  • Ursodiol
  • Ursodiol (Advanced Reading)

Other brands: Actigall, Urso, Urso Forte

  • Ursodiol (AHFS Monograph)
  • … +3 more
  • Nonalcoholic Fatty Liver Disease
  • Gallbladder Disease
  • Primary Biliary Cholangitis

This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Actigall; Urso 250; Urso Forte

Brand Names: Canada

DOM-Ursodiol C; JAMP-Ursodiol; PHL-Ursodiol C ; PMS-Ursodiol; PMS-Ursodiol C; Urso; Urso DS

What is this drug used for?

  • It is used to treat or prevent gallstones.
  • It is used to treat a type of liver disease caused by bile duct problems in the liver (biliary cirrhosis).

What do I need to tell my doctor BEFORE I take this drug?

  • If you have an allergy to ursodiol or any other part of this drug.
  • If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have a biliary tract block.
  • If you have a certain bile duct problem (cholangitis).
  • If you have any of these health problems: Abnormal opening in the biliary and GI (gastrointestinal) tracts, pancreatitis, or swelling of the gallbladder (cholecystitis).

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Dizziness.
  • Back pain.
  • Diarrhea or constipation.
  • Upset stomach or throwing up.
  • Stomach pain or heartburn.
  • Muscle or joint pain.
  • Signs of a common cold.
  • Hair loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

  • Some other drugs may need to be taken at some other time than this drug. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than this drug.

Tablets:

  • Take with food.
  • Some products may be broken in half. If you are not sure if you can break this product in half, talk with the doctor.
  • If you break the tablet in half, use the other half of the tablet for the next dose, as told by the doctor. Throw away half-tablets not used within 28 days.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

All products:

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Tablets:

  • If you break the tablet in half, store the half-tablets apart from the whole tablets.

General drug facts

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Last Reviewed Date

Copyright

Ursodiol by Par Pharm

What is Ursodiol?
Ursodiol treats liver and gall bladder disease in dogs and cats. Ursodiol requires a prescription from your veterinarian.
For: Cats and dogs

Benefits:

  • Dissolves certain types of bladder stones
  • Removes toxic bile acids
  • May also be helpful for treating cirrhosis and chronic active hepatitis
  • No serious side effects

How it works:
Ursodiol (Ursodeoxycholic acid) can restore healthy liver function by improving the flow of bile through the tiny ducts into the gall bladder and improving the flow of bile from the gall bladder into the intestine. It also prevents a potentially toxic build up of bile.

Ursodiol decreases the amount of cholesterol in bile by reducing the amount of cholesterol the liver produces. Ursodiol also reduces the amount of cholesterol absorbed from food and increases its breakdown, especially cholesterol that has formed into gallbladder stones.

Cautions:
Tell your veterinarian if your pet has any medical conditions. Don’t give your pet over-the-counter antacids that contain aluminum, such as Maalox or Mylanta, unless your veterinarian approves. Aluminum may decrease the effectiveness of this medication.

What is the most important information I should know about Ursodiol:
Ursodiol is a prescription medication not FDA approved for use in animals; however, it is a commonly accepted practice for veterinarians to use this medication in dogs and cats. Ursodiol is available as 300mg capsules. The usual dose for dogs and cats depends on the condition and the severity of symptoms. Do not give over the counter antacids that contain aluminum, such as Maalox or Mylanta unless your veterinarian approves. Aluminum may decrease the effectiveness of this medication. Ursodiol may need to be taken for a long period of time. Do not stop giving ursodiol to your pet unless told to by your veterinarian.

What is Ursodiol:
Ursodiol decreases the amount of cholesterol in bile and bile stones, by reducing the amount of cholesterol the liver produces. Ursodiol reduces the amount of cholesterol that is absorbed from food and also increases the breakdown of cholesterol, especially cholesterol that has formed into gallbladder stones. Ursodiol is not used to treat gallstones that are calcified. Ursodiol may also be used for purposes other than those listed in this guide.

What should I discuss with my veterinarian before giving Ursodiol to my pet:
Tell your veterinarian if your pet has cholecystitis, biliary obstruction, gallstone pancreatitis or biliary-gastrointestinal fistula. Also tell your veterinarian if your pet has any other medical conditions, especially heart, liver or kidney disease. Tell your veterinarian if your pet is pregnant or lactating.

How should this medication be given:
Give this medication exactly as directed by your veterinarian. If you do not understand the directions ask the pharmacist or veterinarian to explain them to you. Allow pet to drink plenty of water. Store Ursodiol at room temperature, away from moisture and heat. Keep this medication away from children and pets.

What happens if I miss giving a dose:
Give the missed dose as soon as you remember. However, if is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not give a double dose of the medication.

What happens if I overdose the pet:
Seek emergency veterinary medical treatment. Symptoms of ursodiol overdose are unknown but may include diarrhea.

What should I avoid while giving Ursodiol to my pet:
You should avoid giving your pet any over the counter antacids that contain aluminum. Examples include Maalox or Mylanta.

What are the possible side effects of Ursodiol:
If any of the following serious side effects occur, stop giving ursodiol and seek emergency veterinary medical attention; an allergic reaction (difficulty breathing; swelling of the lips; tongue or face; hives). Other less serious side effects may occur. Continue giving ursodiol and talk to your veterinarian if your pet experiences nausea or upset stomach, diarrhea or headache. Other side effects may also occur. Talk to your veterinarian about any side effect that seems unusual or bothersome to the animal.

What other drugs will affect Ursodiol:
Tell your veterinarian if your pet is being given an antacid containing aluminum as this may decrease the amount of ursodiol being absorbed. Estrogens (D.E.S. or diethylstilbesterol) may increase the amount of cholesterol in the body which would decrease the effectiveness of Ursodiol. Drugs other than those listed may also interact with Ursodiol. Talk to your veterinarian before giving your pet any prescription or over the counter medicines.

CLINICAL PHARMACOLOGY

Mechanism of Action

Ursodiol, a naturally occurring hydrophilic bile acid, derived from cholesterol, is present as a minor fraction of the total human bile acid pool. Oral administration of ursodiol increases this fraction in a dose related manner, to become the major biliary acid, replacing/displacing toxic concentrations of endogenous hydrophobic bile acids that tend to accumulate in cholestatic liver disease. In addition to the replacement and displacement of toxic bile acids, other mechanisms of action include cytoprotection of the injured bile duct epithelial cells (cholangiocytes) against toxic effects of bile acids, inhibition of apotosis of hepatocytes, immunomodulatory effects, and stimulation of bile secretion by hepatocytes and cholangiocytes.

Pharmacodynamics

Lithocholic acid, when administered chronically to animals, causes cholestatic liver injury that may lead to death from liver failure in certain species unable to form sulfate conjugates. Ursodiol is 7-dehydroxylated more slowly than chenodiol. For equimolar doses of ursodiol and chenodiol, steady state levels of lithocholic acid in biliary bile acids are lower during ursodiol administration than with chenodiol administration. Humans and chimpanzees can sulfate lithocholic acid. Although liver injury has not been associated with ursodiol therapy, a reduced capacity to sulfate may exist in some individuals.

Pharmacokinetics

Ursodiol (UDCA) is normally present as a minor fraction of the total bile acids in humans (about 5%). Following oral administration, the majority of ursodiol is absorbed by passive diffusion and its absorption is incomplete. Once absorbed, ursodiol undergoes hepatic extraction to the extent of about 50% in the absence of liver disease. As the severity of liver disease increases, the extent of extraction decreases. In the liver, ursodiol is conjugated with glycine or taurine, then secreted into bile. These conjugates of ursodiol are absorbed in the small intestine by passive and active mechanisms. The conjugates can also be deconjugated in the ileum by intestinal enzymes, leading to the formation of free ursodiol that can be reabsorbed and reconjugated in the liver. Nonabsorbed ursodiol passes into the colon where it is mostly 7-dehydroxylated to lithocholic acid. Some ursodiol is epimerized to chenodiol (CDCA) via a 7-oxo intermediate. Chenodiol also undergoes 7dehydroxylation to form lithocholic acid. These metabolites are poorly soluble and excreted in the feces. A small portion of lithocholic acid is reabsorbed, conjugated in the liver with glycine, or taurine and sulfated at the 3 position. The resulting sulfated lithocholic acid conjugates are excreted in bile and then lost in feces. In healthy subjects, at least 70% of ursodiol (unconjugated) is bound to plasma protein. No information is available on the binding of conjugated ursodiol to plasma protein in healthy subjects or PBC patients. Its volume of distribution has not been determined, but is expected to be small since the drug is mostly distributed in the bile and small intestine. Ursodiol is excreted primarily in the feces. With treatment, urinary excretion increases, but remains less than 1% except in severe cholestatic liver disease. During chronic administration of ursodiol, it becomes a major biliary and plasma bile acid. At a chronic dose of 13 to 15 mg/kg/day, ursodiol constitutes 30-50% of biliary and plasma bile acids.

Clinical Studies

Efficacy of Ursodeoxycholic Acid Administered at 13 to 15 mg/kg/day in 3 or 4 Divided Doses to PBC Patients

A U.S., multicenter, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of ursodeoxycholic acid at a dose of 13 to 15 mg/kg/day, administered in 3 or 4 divided doses in 180 patients with PBC (78% received four times a day dosage). Upon completion of the double-blind portion, all patients entered an open-label active treatment extension phase.

Treatment failure, the main efficacy end point measured during this study, was defined as death, need for liver transplantation, histologic progression by two stages or to cirrhosis, development of varices, ascites or encephalopathy, marked worsening of fatigue or pruritus, inability to tolerate the drug, doubling of serum bilirubin and voluntary withdrawal. After two years of double-blind treatment, the incidence of treatment failure was significantly (p < 0.01) reduced in the URSO 250 mg group (20 of 86 (23%)) as compared to the placebo group (40 of 86 (47%)). Time to treatment failure, which excluded doubling of serum bilirubin and voluntary withdrawal, was also significantly (p < 0.001) delayed in the URSO 250 treated group (n=86, 803.8±24.9 d vs. 641.1±24.4 d for the placebo group (n=86) on average) regardless of either histologic stage or baseline bilirubin levels ( > 1.8 or ≤ 1.8 mg/dl).

Using a definition of treatment failure, which excluded doubling of serum bilirubin and voluntary withdrawal, time to treatment failure was significantly delayed in the URSO 250 group. In comparison with placebo, treatment with URSO 250 resulted in a significant improvement in the following serum hepatic biochemistries when compared to baseline: total bilirubin, SGOT, alkaline phosphatase and IgM.

Efficacy of Ursodiol Administered at 14 mg/kg/day as a Once Daily Dose to PBC Patients

A second study conducted in Canada randomized 222 PBC patients to ursodiol, 14 mg/kg/day or placebo, administered as a once daily dose in a double-blind manner during a two-year period. At two years, a statistically significant (p < 0.001) difference between the two treatments (n=106 for the URSO 250 group and n=106 for the placebo group), in favor of ursodiol, was demonstrated in the following: reduction in the proportion of patients exhibiting a more than 50% increase in serum bilirubin; median percent decrease in bilirubin (-17.12% for the URSO 250 group vs. +20.00% for the placebo group), transaminases (-40.54% for the URSO 250 group vs. +5.71% for the placebo group) and alkaline phosphatase (-47.61% for the URSO 250 group vs. -5.69% for the placebo group); incidence of treatment failure; and time to treatment failure. The definition of treatment failure included: discontinuing the study for any reason; a total serum bilirubin level greater than or equal to 1.5 mg/dl or increasing to a level equal to or greater than two times the baseline level; and the development of ascites or encephalopathy. Evaluation of patients at 4 years or longer was inadequate due to the high drop out rate (n=10 withdrew from the URSO 250 group vs. n=15 from the placebo group) and small number of patients. Therefore, death, need for liver transplantation, histological progression by two stages or to cirrhosis, development of varices, ascites or encephalopathy, marked worsening of fatigue or pruritus, inability to tolerate the drug, doubling of serum bilirubin and voluntary withdrawal were not assessed.

Efficacy of URSO 250 Administered in Twice a Day Versus Four Times a Day Divided Dosing Schedules to PBC Patients

A randomized, two-period crossover study in fifty PBC patients compared efficacy of URSO 250 (ursodiol) in twice a day versus four times a day divided dosing schedules in 50 patients for 6 months in each crossover period. Mean percent changes from baseline in liver test results and Mayo risk score (n=46) and serum enrichment with UDCA (n=34) were not statistically significant with any dosage at any time interval. This study demonstrated that UDCA (13 to 15 mg/kg/day) given twice a day is equally effective to UDCA given four times a day. In addition, URSO 250 was given as a single versus three times a day dosing schedules in 10 patients. Due to the small number of patients in this arm of the study, it was not possible to conduct statistical comparisons between these regimens.

Ursodiol

What is Ursodiol?

Ursodiol is an oral medication containing bile acid that treats liver and gallbladder disease, and prevents and dissolves gallstones. It is also used in the treatment of chronic liver problems. Ursodiol can restore healthy liver function in cats and dogs by promoting regeneration of healthy liver tissue. Ursodiol requires a prescription from your veterinarian and is sold per capsule or tablet.

For:

Dogs and Cats

Benefits:

  • Treats liver and gallbladder disease and chronic liver problems
  • Prevents and dissolves gallstones
  • Restores healthy liver function

How does Ursodiol work?

Ursodiol for dogs and cats restores healthy liver function through improving the flow of bile into the gallbladder and improving the flow of bile from the gallbladder into the intestine. It also reduces the amount of cholesterol produced in the liver as well as cholesterol absorbed from food, which helps dissolve and prevent gallstones. In addition, Ursodiol prevents the build-up of toxic bile acids.

Cautions:

Tell your veterinarian if your pet has any medical conditions or is pregnant or lactating. Consult with your veterinarian before giving any other prescription or over-the-counter medications to your pet.

Brand Name:

Actigall

Generic Name:

Ursodiol

What is the most important thing I should know about Ursodiol?

Ursodiol is available as 250 mg tablets and 300 mg capsules. While the usual dose can depend on various factors, the usual dose for cats is 5-7 mg/lb (10-15 mg/kg) by mouth once daily. For dogs, the usual dose is 2.5-7 mg/lb (5-15 mg/kg) by mouth twice daily. Don’t stop giving Ursodiol to your pet unless directed by your veterinarian. Unless your veterinarian approves, don’t give your pet over-the-counter antacids that include aluminum because it can reduce the effectiveness of Ursodiol.

What should I discuss with my veterinarian before giving my pet Ursodiol?

Talk to your vet about check-ups that may be required while your pet is on Ursodiol. Tell your veterinarian if your pet is pregnant or lactating or has any other medical conditions.

How should Ursodiol be given to my dog or cat?

Administer Ursodiol to your pet exactly as instructed by your veterinarian. Give the capsule with food to increase absorption, and allow your pet to drink plenty of water. Actual dosage is determined by your veterinarian.

What are the potential side effects of Ursodiol to pets?

Possible side effects of Ursodiol can include nausea, upset stomach, or diarrhea. Stop giving Ursodiol to your pet and seek emergency veterinary treatment if your pet experiences an allergic reaction. Symptoms of an allergic reaction include difficulty breathing, hives, or swelling of the lips, tongue or face.

What happens if I miss giving a dose of Ursodiol to my pet?

Administer the missed dose as soon as you remember. If it is close to the next dose, skip the missed dose and resume the regular dosing schedule. Don’t give your pet two doses of Ursodiol at once.

What happens if I overdose my pet on Ursodiol?

Seek emergency veterinary treatment.

What should I avoid while giving Ursodiol to my pet?

Avoid giving your pet over-the-counter antacids that contain aluminum as it may reduce the effectiveness of Ursodiol. Talk to your veterinarian before giving your pet any other medication or supplement.

What other drugs will affect Ursodiol?

Ursodiol may react with acetaminophen, estrogens, and antacids containing aluminum.

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