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Urso Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Urso (ursodiol) is a bile acid used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Urso is also used to treat primary biliary cirrhosis (PBC). Urso is available in generic form. Common side effects of Urso include stomach upset or pain, nausea, diarrhea, constipation, dizziness, tired feeling, back pain, hair loss, headache, fever, chills, body aches, flu symptoms, runny or stuffy nose, cough, or cold symptoms.
The recommended adult dosage for Urso in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient's need at the discretion of the physician. Urso may interact with cholestyramine, colestipol, estrogens (birth control pills or hormone replacement), or antacids that contain aluminum (such as Rolaids, Mylanta, or Maalox). Tell your doctor all medications you are taking. During pregnancy, Urso should be used only when prescribed. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Urso (ursodiol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Urso in Detail - Patient Information: Side Effects
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
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.
Read the entire detailed patient monograph for Urso (Ursodiol)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Urso Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: weakness, swelling of the ankles/feet, increased thirst/urination, signs of infection (e.g., fever, persistent sore throat), easy bleeding/bruising.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Urso (Ursodiol)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Urso FDA Prescribing Information: Side Effects
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The following table summarizes the adverse reactions observed in two placebo-controlled clinical trials.
|ADVERSE REACTIONS||VISIT AT 12 MONTHS||VISIT AT 24 MONTHS|
|Elevated creatinine||---||---||1 (1.32)||---|
|Elevated blood glucose||1 (1.18)||---||1 (1.32)||---|
|Peptic ulcer||---||---||1 (1.32)||---|
|Skin rash||---||---||2 (2.63)||---|
|Note: Those adverse reactions occurring at the same or
higher incidence in the placebo as in the UDCA group have been deleted from
this table (this includes diarrhea and thrombocytopenia at 12 months,
nausea/vomiting, fever and other toxicity).
UDCA = Ursodeoxycholic acid = Ursodiol
In a randomized, cross-over study in sixty PBC patients, seven patients (11.6%) reported nine adverse reactions: abdominal pain and asthenia (1 patient), nausea (3 patients), dyspepsia (2 patients) and anorexia and esophagitis (1 patient each). One patient on the twice a day regimen (total dose 1000 mg) withdrew due to nausea. All of these nine adverse reactions except esophagitis were observed with the twice a day regimen at a total daily dose of 1000 mg or greater. However, an adverse reaction may occur at any dose.
The following adverse reactions, presented by system organ class in alphabetical order, have been identified during postapproval use of ursodiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Gastrointestinal disorders: abdominal discomfort, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.
- General disorders and administration site conditions: malaise, peripheral edema, pyrexia.
- Hepatobiliary disorders: jaundice (or aggravation of preexisting jaundice).
- Immune System Disorders: Drug hypersensitivity to include facial edema, urticaria, angioedema and laryngeal edema.
- Abnormal Laboratory Tests: ALT increased, AST increased, blood alkaline phosphatase increased, blood bilirubin increased, γ-GT increased, hepatic enzyme increased, liver function test abnormal, transaminases increased.
- Musculoskeletal and connective tissue disorders: myalgia
- Nervous system disorders: dizziness, headache.
- Respiratory, thoracic and mediastinal disorders: cough.
- Skin and subcutaneous tissue disorder: alopecia, pruritus, rash.
Read the entire FDA prescribing information for Urso (Ursodiol)
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