Brand Names: Actigall, Urso, Urso Forte

Generic Name: ursodiol (Pronunciation: ur so DY all)

• What is ursodiol (Urso)?
• What are the possible side effects of ursodiol (Urso)?
• What is the most important information I should know about ursodiol (Urso)?
• What should I discuss with my healthcare provider before taking ursodiol (Urso)?
• How should I take ursodiol (Urso)?
• What happens if I miss a dose (Urso)?
• What happens if I overdose (Urso)?
• What should I avoid while taking ursodiol (Urso)?
• What other drugs will affect ursodiol (Urso)?
• Where can I get more information?

What is ursodiol (Urso)?

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 small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol is also used to treat primary biliary cirrhosis.

Ursodiol is not for treating gallstones that are calcified.

Ursodiol may also be used for purposes other than those listed in this medication guide.

Actigall 300 mg

pink/white, imprinted with ACTIGALL, 300 MG

URS 250 mg

elliptical, white, imprinted with URS 785

Urso 250 mg

elliptical, white, imprinted with URS785

Urso Forte 500 mg

elliptical, white, imprinted with URS790

Ursodiol 300 mg-ACT

pink/white, imprinted with A-060

Ursodiol 300 mg-TEV

orange/white, imprinted with 93 9380

Ursodiol 300 mg-WAT

white, imprinted with Watson, 3159

What are the possible side effects of ursodiol (Urso)?

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

Other less serious side effects are more likely to occur, such as:

• fever, chills, body aches, flu symptoms;
• stomach pain, nausea, diarrhea, constipation;
• dizziness, tired feeling;
• back pain;
• runny or stuffy nose, cold symptoms; or
• headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ursodiol (Urso)?

Before taking ursodiol, tell your doctor if you are also taking cholestyramine (Questran), colestipol (Colestid), or estrogens (birth control pills or hormone replacement).

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb ursodiol.

To treat gallstones, you may have to take ursodiol for several months, and not all gallstones may completely dissolve. Many people who use this medicine will develop gallstones again within 5 years after treatment with ursodiol. Talk to your doctor about your specific risks for repeated gallstones.

To be sure this medication is helping your condition, your doctor may perform ultrasound examinations of your gallbladder on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.