Common adverse reactions include diarrhea (33% EAIR), nausea (15-18%), pruritus (10%), vomiting (8%), and dizziness (4%).

Gastrointestinal and Systemic Adverse Events

In clinical trials, gastrointestinal effects (diarrhea, nausea, vomiting) were dose-dependent, typically occurring early and lasting weeks. Hepatobiliary events (cholelithiasis, acute cholecystitis) had low incidence (<1/100 PY). Lab abnormalities included transient ALT/AST elevations (≤13% >3x ULN) and decreased FT4 (17% at 100 mg). Serious risks included drug-induced autoimmune-like hepatitis (1 case) and statin-related myopathy. Hypersensitivity reactions (rash, urticaria) and rare arrhythmias were noted. Long-term safety in cirrhosis is not specified in the description.