Risk of liver test abnormalities; diarrhea, abdominal pain, & vomiting. Consider dose reduction or treatment interruption if liver abnormalities occur in the absence of other causes or if diarrhea, abdominal pain, &/or vomiting occur w/ no other etiologies found. May affect absorption of fat-soluble vit. Safety & effectiveness have not been established in patients <3 mth, elderly ≥65 yr, patients w/ clinically significant portal HTN & in patients w/ decompensated cirrhosis.