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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 Urso (ursodiol) Side Effects Center for a complete guide to possible side effects
Bile Acid Sequestering Agents
Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with URSO 250 and URSO Forte in the same manner as the bile acid sequestering agents.
Drugs Affecting Lipid Metabolism
Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of URSO 250 and URSO Forte.
Read the Urso Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 8/5/2013
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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