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warnings
WARNINGS Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis There have been rare postmarketing reports of ursodiol-treated patients who developed enteroliths (bezoars) resulting in obstructive symptoms that required surgical intervention. These patients had medical conditions that predisposed them to intestinal stenosis or stasis (e.g., surgical enteroanastomoses, Crohn's disease). If a patient presents with obstructive gastrointestinal symptoms, hold Actigall until a clinical evaluation has been conducted.
ADVERSE REACTIONS The nature and frequency of adverse experiences were similar across all groups. The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level To report SUSPECTED ADVERSE REACTIONS, Contact AvKARE at 1-855-361-3993 or go to www.avkare.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 1 1 Postmarketing Experience The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post-approval 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 : enteroliths (bezoars).