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What Is Ursodiol (Actigall and Urso)?
Ursodiol is a prescription drug that's used to treat and prevent gallstones (hardened deposits of digestive fluid that can form in the gallbladder).
It's sold under the brand names Actigall and Urso.
This medicine is also used to treat primary biliary cirrhosis (an autoimmune disorder that affects the liver) and chronic liver disease.
In addition, it's sometimes used to help prevent organ rejection following a liver transplant.
Ursodiol is a bile acid that's naturally found in the body. It works by reducing the production of cholesterol and dissolving it in bile, so that it can't form stones.
The Food and Drug Administration (FDA) approved ursodiol in 1987. It's manufactured by different pharmaceutical companies.
Before taking Ursodiol, tell your doctor if you have, or have ever had:
- Any disease of the liver, gallbladder, pancreas, or bile duct
- A bile duct blockage
- Allergies to medications
Ursodiol must be taken for several months to have an effect. You may need to take the medicine for up to two years.
Continue to take ursodiol even if you feel well. Don't stop using the medicine without first talking to your doctor.
Your doctor will probably want to order frequent tests to check your body's response to ursodiol. Keep all appointments with your doctor's office and laboratory.
This drug should be used with extreme caution in children. Safety and effectiveness haven't been confirmed in this age group.
Pregnancy and Ursodiol
Ursodiol isn't believed to harm a fetus. Still, talk to your doctor if you're pregnant or plan to become pregnant during your treatment.
It's not known whether ursodiol passes into breast milk or could hurt a nursing baby. Talk to your doctor before breastfeeding while taking this medicine.
What is the most important information I should know about Actigall (ursodiol)?
You should not use ursodiol if you have an obstruction in your liver or gallbladder.
Before Using Actigall
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of ursodiol in the pediatric population. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of ursodiol in geriatric patients.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Ascites (accumulation of fluid in the abdominal or stomach cavity) or
- Bleeding varices (veins that enlarge and bleed) or
- Hepatic encephalopathy (brain disease due to liver failure) or
- Liver damage (from not having a certain chemical in your liver to break down a substance called lithocholate) or
- Liver transplant—Use with caution. May make these conditions worse.
- Biliary tract blockage—Should not be used in patients with this condition.
- Biliary tract problems or
- Pancreatitis (swelling or inflammation of the pancreas)—These conditions may make it necessary to have surgery since treatment with ursodiol would take too long.
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.
Watchful waiting has the advantage that no therapy may ever be required. For patients with silent or minimally symptomatic stones, the rate of development of moderate-to-severe symptoms or gallstone complications is estimated to be between 2% and 6% per year, leading to a cumulative rate of 7 to 27% in 5 years. Presumably the rate is higher for patients already having symptoms.
For patients with symptomatic gallstones, surgery offers the advantage of immediate and permanent stone removal, but carries a high risk in some patients. About 5% of cholecystectomized patients have residual symptoms or retained common duct stones. The spectrum of surgical risk varies as a function of age and the presence of disease other than cholelithiasis.
|Age (Yrs) ||Cholecystectomy ||Cholecystectomy |
+ Common Duct Exploration
|Low Risk Patients*|
|Women||0 - 49||.54||2.13|
|50 - 69||2.80||10.10|
|Men||0 - 49||1.04||4.12|
|50 - 69||5.41||19.23|
|High Risk Patients**|
|Women||0 - 49||12.66||47.62|
|50 - 69||17.24||58.82|
|Men||0 - 49||24.39||90.91|
|50 - 69||33.33||111.11|
|* In good health or with moderate systemic disease. |
** With severe or extreme systemic disease.
*** Includes both elective and emergency surgery.
Women in good health or who have only moderate systemic disease and are under 49 years of age have the lowest surgical mortality rate (0.054); men in all categories have a surgical mortality rate twice that of women. Common duct exploration quadruples the rates in all categories. The rates rise with each decade of life and increase tenfold or more in all categories with severe or extreme systemic disease.
Actigall Food Interactions
Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain food. In the case of Actigall, there are no specific foods that you must exclude from your diet when receiving this medication.
Before taking Actigall, tell your doctor about all of your medical conditions. Especially tell your doctor if you:
- are allergic to Actigall or to any of its ingredients
- have or have had diseases of the liver, gallbladder, pancreas, or bile duct
- are pregnant or breastfeeding
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Actigall and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Actigall falls into category B. There are no well-done studies that have been done in humans with Actigall. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication.
Gallstone complication requiring surgery
Known hepatocyte or bile ductal abnormalities, inflammatory bowel disease
Calcified gallstones, bile acid allergy, chronic hepatic disease
Billiary gastrointestinal fistula
Patients requiring cholecystectomy
Only use in radiolucent, non calcified, high cholesterol content gallstone
Chronic liver disease
Liver function tests (gamma-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored q3months x3 months after start of therapy, and q6months thereafter
Gallbladder stone dissolution may take several months
50% of cases have stone recurrence in 5 yr
Common side effects of Actigall include: back pain. Other side effects include: arthralgia, alopecia, arthritis, and pharyngitis. See below for a comprehensive list of adverse effects.
CAS Registry Number
Bile Acids and Salts
Cholagogues and Choleretics