Am J Gastroenterol

Meta-analysis examines safety of IBS pharmacotherapy

June 12, 2025

Study details: This meta-analysis assessed the safety of IBS pharmacotherapies across 81 randomized controlled trials with over 22,000 patients. Researchers compared adverse event rates by drug class, focusing on number needed to harm (NNH) as the primary outcome. Secondary outcomes included relative risk of withdrawal and common adverse events.

Results: For IBS with constipation, tenapanor had the highest risk of adverse events (NNH: 16), while linaclotide, lubiprostone, plecanatide, and tegaserod had more favorable safety profiles (NNHs ranging from 35 to 59). In IBS with diarrhea, alosetron (NNH: 14) and eluxadoline (NNH: 32) showed higher risk, whereas rifaximin and ramosetron didn't significantly increase harm. For global IBS symptoms, tricyclic antidepressants had an NNH of 24. Most adverse events were mild and short-lived, with rifaximin emerging as the safest option overall.

Clinical impact: Tricyclic antidepressants (particularly at higher doses), tenapanor, and alosetron are associated with the greatest likelihood of discontinuing therapy due to adverse events, whereas rifaximin demonstrated the most favorable safety profile among the options evaluated.

Source:

Busam JA, et al. (2025, June 5). Am J Gastroenterol. The Safety of Pharmacotherapy for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. https://pubmed.ncbi.nlm.nih.gov/40471839/