Adverse Effects (AEs):

The following table summarizes the AEs observed in the two placebo-controlled clinical trials.

In a randomized, cross-over study in sixty PBC patients, four patients (6.7%) experienced one serious adverse event each (diabetes mellitus, cyst and breast neoplasm (experienced by two patients)). No deaths occurred in the study. Forty-three patients (43, 71.7%) experienced at least one treatment-emergent adverse event (TEAEs) during the study. The most common ( > 5%) TEAEs were asthenia (11.7%), dyspepsia (10%), peripheral edema (8.3%), hypertension (8.3%), nausea (8.3%), GI disorders (5%), chest pain (5%), and puritius (5%). Seven patients (11.6%) reported nine events that were judged as possibly or probably related to study medication. These nine TEAEs included abdominal pain and asthenia (1 patient), nausea (3 patients), dyspepsia (2 patients) and anorexia and esophagitis (1 patient each). One patient on the BID regimen (total dose 1000 mg) withdrew due to nausea. All of these nine TEAEs except esophagitis were observed with the BID regimen at a total daily dose of 1000 mg or greater.

Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of URSO 250® and URSO 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® and URSO 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® and URSO Forte®.

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