Diarrhea-predominant irritable bowel syndrome treatment options eluxadoline, rifaximin, and alosetron: analysis of the FDA adverse event reporting system (FAERS) database

Adverse events (AEs) suspected to be associatedwith the three FDA approved medications (eluxadoline, rifaximin, and alosetron)for diarrhea-predominant irritable bowel syndrome (IBS-D) were examined. We analyzed all reports in the FDA Adverse EventReporting System (FAERS) database from each medication's date of FDA approvalthrough 30 June 2024. Reports were excluded if they contained other suspectedmedications or had a reason for use outside of IBS and/or diarrhea. Eluxadoline was associated with 1,002 AEs, mostcommonly abdominal pain (n = 257, 17.0%) and uniquely pancreatitis (n = 174, 11.5%)and sphincter of Oddi dysfunction (n = 39, 2.6%). Rifaximin was associated with652 AEs, most commonly abdominal pain (n = 64, 7.6%) and uniquely C. difficileand bacterial overgrowth (n = 3, 0.4% each). Alosetron was associated with 3,832AEs, most commonly constipation (n = 2,007, 23.1%) and uniquely colitis (n = 235,2.7%), ischemic colitis (n = 140, 1.6%), obstruction (n = 110, 1.3%), andperforation (n = 26, 0.3%). Our analysis of the FAERS database showed frequentreports of abdominal pain, constipation, and nausea/vomiting related to thethree FDA approved medications for IBS-D. Each raised concerns for distinct andserious AEs including pancreatitis (eluxadoline), C. difficileinfection (rifaximin), ischemic colitis (alosetron), and intestinalobstruction/perforation (alosetron).