URSO

Generic Name

ursodiol (ur so DY all)

 

Trade Name

Actigall
URSO

 

What is ursodiol?

Ursodiol is one of the naturally occurring bile salts. Bile salts are made in the liver and flow down the bile ducts to the intestine where they are needed to help digest the fats in the food we eat. There are a number of bile salts, some of which are toxic when retained in the liver. Ursodiol has low liver toxicity. When taken as a medication, it replaces some of the more toxic liver bile salts. Therefore, if bile is retained in the liver for some reason, there is less liver damage. The two main types of liver damage caused by bile salts being retained in the liver are primary biliary cirrhosis and primary sclerosing cholangitis.

 

What is it used for?

Ursodiol is approved by the FDA for the following:

  • Dissolving cholesterol gallstones
  • Preventing gallstone formation during rapid weight loss
  • Treatment of primary biliary cirrhosis

It is also used by physicians in the treatment of primary sclerosing cholangitis and other chronic disorders of the liver. Since one of the side effects is diarrhea, it occasionally is even used to treat difficult constipation.

 

How do I take it?

Follow your physician’s instructions carefully. You may take it on an empty stomach or with food to prevent stomach upset. Keep all medications away from children. Never share your medications with anyone else.

 

What do I do for a missed dose?

If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and return to your regular schedule. Do not double up on this medication.

 

Are there interactions with food or beverages?

There are no known interactions with food or beverages.

 

Are there interactions with other drugs?

An interaction generally means that one drug may increase or decrease the effect of another drug. Also, the more medications a person takes, the more likely there will be a drug interaction

Interaction with this drug may occur with the following:

  • antacids that contain aluminum (Alucaps, Rolaids)
  • cholesterol lowering medications (Lopid, Mevacor, Questran)
  • estrogens (Premarin)
  • birth control pills

 

Is there a problem if I have another disorder or disease?

At times, a drug may have a different or enhanced effect when other diseases are present. This drug has not been found to interact adversely with any other disease.

 

What about allergies?

People who have known allergies or asthma may be at an increased risk for a reaction from any new medication. The physician should always know a patient’s allergy history. Signs of an allergic reaction are skin rash, hives or itching. Of course, a person should not take ursodiol if there has been a previous reaction to this or a similar drug.

 

What if I’m pregnant, considering pregnancy or breast-feeding?

Most females now know that, if possible, no drug, including alcohol, should be taken during pregnancy or lactation. The potential danger, of course, is an injury to the baby. However, some drugs are much safer than others in this regard. So, the FDA has a grading system for each drug which reflects what is known medically. It ranks drugs from A, where medical studies show no evidence for danger to the fetus or mother, to B, C, D and X, where the medical evidence indicates that the risk to the fetus outweighs any benefit to the mother. Ursodiol is ranked B. Always consult your physician before taking any drug during or when planning pregnancy.

 

What are the effects on sexual function?

There are no known adverse effects on sexual function.

 

Are there other precautions?

It may take several weeks to months to see the full effect of this drug. Do not stop taking this medicine without checking with your doctor.

 

How long is it safe to take ursodiol?

The safety of using ursodiol beyond 24 months is not established. However, since it is a naturally occurring bile salt, it is likely safe to use it long-term. It is gastroenterologists’ experience that patients can safely stay on this drug for long periods.

 

How about side effects?

Adverse reactions can occur with any drug, even over-the-counter medications. Some of these are mild such as a stomach upset, which may be avoided by taking the medication with food. Minor reactions may go away on their own but if they persist, contact the physician. For major reactions, the patient should contact the physician immediately.

For ursodiol, the following are the observed side effects:

Minor:

  • diarrhea
  • nausea
  • vomiting
  • gas
  • metallic taste
  • constipation
  • rash
  • headache
  • muscle aches

Major:

  • severe itching
  • severe muscle or joint pain
  • persistent cough

 

A physician’s comment…

Gastroenterologists have been using ursodiol for years to treat primary biliary cirrhosis and primary sclerosing cholangitis because the drug lowers the abnormally elevated blood liver enzymes. It is assumed that this, in turn, results in less liver damage. Since the drug has a very good safety profile, physicians have been comfortable using it long-term. Data is coming into the medical literature that, indeed, there is significant benefit. People with these liver problems do seem to live longer and do not come to a liver transplant as soon as those who do not use it. Dissolving gallstones is almost never done anymore because laparoscopic gallbladder removal has become so easy. Dissolving gallstones takes a long time and, in many people, they may return when the drug is stopped. Still, for some who just don’t want surgery or where surgery is considered too dangerous, it can be used.