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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 = Urso (ursodiol) diol |
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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 urso (ursodiol) diol. 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.
Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of URSO 250 (urso (ursodiol) diol) and URSO (ursodiol) Forte by reducing its absorption.
Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with URSO 250 (urso (ursodiol) diol) and URSO (ursodiol) Forte in the same manner as the bile acid sequestering agents.
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 (urso (ursodiol) diol) and URSO (ursodiol) Forte.
Last reviewed on RxList: 12/28/2009
This monograph has been modified to include the generic and brand name in many instances.
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