Review article: an analysis of safety profiles of treatments for diarrhoea-predominant irritable bowel syndrome

Aliment Pharmacol Ther. 2018 Oct;48(8):817-830. doi: 10.1111/apt.14948. Epub 2018 Sep 7.


Background: Irritable bowel syndrome (IBS) is multifactorial in nature, and a wide range of therapies is available to manage symptoms of this common disorder.

Aim: To provide an overview of the safety of interventions that may be used to manage patients with diarrhoea-predominant IBS (IBS-D).

Methods: Medline and Embase database searches (through 02 May 2018) to identify clinical studies that evaluated treatment safety and/or efficacy in adults with IBS-D.

Results: IBS-D treatments include dietary modification, probiotics, serotonin receptor antagonists, opioid receptor agonists and antagonists, nonsystemic antibiotics, bile acid sequestrants, antidepressants, and complementary and alternative therapies. These treatments vary in administration frequency (eg, daily; short-course therapy) and target various pathophysiologic factors. Safety profiles vary considerably by treatment among IBS-D therapies. The number needed to harm (defined as the number of patients treated to encounter an adverse event) was lowest (worse) for antidepressants (8.5) and highest (best) for probiotics (35), and the number needed to harm (defined as the number of patients who discontinued due to an adverse event) was lowest for tricyclic antidepressants (9) and highest for rifaximin (8971). Notable safety concerns with IBS-D treatments include pancreatitis with eluxadoline, ischaemic colitis and serious complications of constipation with alosetron, and cardiac adverse events with loperamide and tricyclic antidepressants. Treatment decisions need to account for medication risks and adverse events for each patient.

Conclusions: Multiple treatment options are now available for patients with IBS-D. However, the safety profiles of these agents vary widely by number needed to harm value. Providers should consider both safety and efficacy of a specific intervention when determining how best to manage patients' IBS-D symptoms.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Adult
  • Constipation / chemically induced
  • Diarrhea / etiology*
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Irritable Bowel Syndrome / drug therapy*
  • Irritable Bowel Syndrome / physiopathology
  • Pancreatitis / chemically induced


  • Gastrointestinal Agents