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Urso

Last reviewed on RxList: 4/25/2019
Urso Side Effects Center

Last reviewed on RxList 4/25/2019

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.

Tell your doctor if you have unlikely but serious side effects of Urso include:

  • weakness,
  • swelling of the ankles or feet,
  • increased thirst or urination,
  • signs of infection (e.g., fever, persistent sore throat), or
  • easy bleeding or bruising.

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 breastfeeding.

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.

QUESTION

Hepatitis C virus causes an infection of the ______________. See Answer
Urso Consumer Information

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.

Read the entire detailed patient monograph for Urso (Ursodiol)

SLIDESHOW

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Urso Professional 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
UDCA
n (%)
Placebo
n (%)
UDCA
n (%)
Placebo
n (%)
Diarrhea --- --- 1 (1.32) ---
Elevated creatinine --- --- 1 (1.32) ---
Elevated blood glucose 1 (1.18) --- 1 (1.32) ---
Leukopenia --- --- 2 (2.63) ---
Peptic ulcer --- --- 1 (1.32) ---
Skin rash --- --- 2 (2.63) ---
Thrombocytopenia --- --- 1 (1.32) ---
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.

Postmarketing Experience

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)

Related Resources for Urso

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Read the Urso User Reviews »

© Urso Patient Information is supplied by Cerner Multum, Inc. and Urso Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Hepatitis C virus causes an infection of the ______________. See Answer

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