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Ursodiol 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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Drug Interactions
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Pricing & Coupons
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

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.