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    Ursodiol

    Generic Name: Ursodiol (ur soe DYE ol)
    Brand Name: Actigall, Urso 250, Urso Forte
    Easy-to-read patient leaflet for Ursodiol. Includes indications, proper use, special instructions, precautions, and possible side effects.

    Average Savings for ursodiol (generic): 13.96%
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    Drug Information:
    This is not a list of all drugs or health problems that interact with ursodiol. 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 ursodiol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Use ursodiol as ordered by your doctor. Read all information given to you. Follow all instructions closely. Learn more

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    Ursodiol

    Generic Name: Ursodiol (ur soe DYE ol)
    Brand Name: Actigall, Urso 250, Urso Forte
    Uses of Ursodiol:
    • 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 Ursodiol?

    • If you have an allergy to ursodiol or any other part of ursodiol.
    • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
    • 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 ursodiol.

    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 ursodiol 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 Ursodiol?

    • Tell all of your health care providers that you take ursodiol. 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.

    How is this medicine (Ursodiol) best taken?

    Use ursodiol 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 ursodiol. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than ursodiol.

    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.

    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 Ursodiol?

    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.
    • Belly 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 the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

    If OVERDOSE is suspected:

    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.

    How do I store and/or throw out Ursodiol?

    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.

    Consumer information use

    • 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.
    • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
    • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
    • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ursodiol, 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.

    Further information

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

    Medical Disclaimer

    More about ursodiol

    • Side Effects
    • During Pregnancy or Breastfeeding
    • Dosage Information
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    • En Español
    • 17 Reviews
    • Drug class: gallstone solubilizing agents

    Consumer resources

    • Ursodiol

    Other brands: Actigall, Urso, Urso Forte

    Professional resources

    • ... +3 more

    Related treatment guides

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

    Editorial References and Review

    Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

    Source: Drugs.com Ursodiol (www.drugs.com/ursodiol.html).

    Ursodiol Side Effects

    Ursodiol Side Effects

    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

    Very common (10% or more): Abdominal pain (up to 43.2%), diarrhea (up to 27.1%), constipation (up to 26.4%), nausea (up to 17.4%), dyspepsia (up to 16.8%), vomiting (up to 13.7%)

    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.

    Editorial References and Review

    Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

    Source: Drugs.com Ursodiol (www.drugs.com/ursodiol.html).

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