Urso Forte

Name: Urso Forte

Urso Forte Overview

Urso Forte is a prescription medication used in the treatment of biliary cirrhosis, an autoimmune disease that affects the bile ducts in the liver.

Urso Forte is a bile acid, a natural substance produced by the liver. It helps to decrease the formation of gallstones by dissolving the cholesterol necessary to make gallstones and suppressing production of cholesterol in the liver and absorption in the intestines.

Urso Forte comes in oral tablet form. It is taken 2 to 4 times daily, with food.

Common side effects include stomach pain, diarrhea, and nausea. 

What should I discuss with my healthcare provider before taking Urso Forte (ursodiol)?

You should not use ursodiol if you are allergic to it, or if you have an obstruction in your liver or gallbladder.

To make sure ursodiol is safe for you, tell your doctor if:

  • you have been coughing up blood; or

  • you have gained weight rapidly, especially in your face and midsection.

FDA pregnancy category B. Ursodiol is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ursodiol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Urso Forte (ursodiol)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take the ursodiol tablet with food.

You may need to break a tablet in half to get your correct dose. Each tablet is scored in the middle and should break apart easily.

Swallow the tablet piece whole with a glass of water. A broken tablet can have a bitter taste.

Use ursodiol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To treat gallstones, you may have to take ursodiol for several months before your gallstones dissolve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Not all gallstones completely dissolve with ursodiol treatment, and you may develop new gallstones within 5 years after treatment. Talk to your doctor about your specific risks.

While using ursodiol, you may need gallbladder ultrasound exams, or frequent blood tests to check your liver function. Your doctor may also want to check your liver function every 6 months after you stop using ursodiol.

Store at room temperature away from moisture and heat. Tablets that are broken in half can be kept at room temperature for up to 28 days.

If you split your tablets, keep them separate from any whole tablets.

Urso Forte (ursodiol) side effects

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

Call your doctor at once if you have:

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • signs of a new infection--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, skin sores, trouble swallowing.

Common side effects may include:

  • headache, dizziness;

  • mild stomach pain or discomfort;

  • nausea, diarrhea, constipation;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • hair loss; or

  • mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How is this medicine (Urso Forte) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

  • To gain the most benefit, do not miss doses.
  • Keep taking Urso Forte as you have been told by your doctor or other health care provider, even if you feel well.
  • Some other drugs may need to be taken at some other time than this medicine. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Urso Forte.

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.

For Healthcare Professionals

Applies to ursodiol: oral capsule, oral tablet

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%): Flatulence (up to 7.7%), cholecystitis (5.2%), gastrointestinal disorder (3.9%), esophagitis (1.7%), peptic ulcer (1.3%)
Postmarketing reports: Abdominal discomfort, abdominal pain, diarrhea, constipation, dyspepsia, nausea, vomiting[Ref]

Nervous system

Very common (10% or more): Headache (up to 24.8%), dizziness (16.5%)
Common (1% to 10%): Insomnia (1.9%)
Postmarketing reports: Dizziness, headache[Ref]

Other

Very common (10% or more): Viral infection (up to 19.4%)
Common (1% to 10%): Fatigue (up to 7.8%), influenza-like symptoms (6.5%), chest pain (3.2%), asthenia (1.7%)
Postmarketing reports: Malaise, peripheral edema, pyrexia[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 15.5%), sinusitis (up to 11%)
Common (1% to 10%): Pharyngitis (up to 8.4%), coughing (7.1%), bronchitis (6.5%), rhinitis (5.2%)
Postmarketing reports: Cough[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 11.8%)
Common (1% to 10%): Arthralgia (7.7%), musculoskeletal pain (5.9%), arthritis (5.8%), myalgia (5.8%)
Postmarketing reports: Myalgia[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection (6.5%), dysmenorrhea (5.6%)[Ref]

Dermatologic

Common (1% to 10%): Alopecia (5.3%), skin rash (2.6%)
Postmarketing reports: Alopecia, pruritus, rash[Ref]

Hypersensitivity

Common (1% to 10%): Allergy (5.2%)
Postmarketing reports: Drug hypersensitivity (including facial edema, urticaria, angioedema, laryngeal edema)[Ref]

Hematologic

Common (1% to 10%): Leukopenia (2.6%), thrombocytopenia (1.3%)[Ref]

Metabolic

Common (1% to 10%): Anorexia (1.7%), elevated blood glucose (up to 1.3%)[Ref]

Renal

Common (1% to 10%): Elevated creatinine (1.3%)[Ref]

Hepatic

Postmarketing reports: Jaundice (or aggravation of preexisting jaundice), increased ALT, increased AST, increased blood alkaline phosphatase, increased blood bilirubin, increased gamma-glutamyltransferase, increased hepatic enzymes, abnormal liver function test, increased transaminases[Ref]

Some side effects of Urso Forte may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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