Scoping review maps reported pancreatic and gallbladder adverse events with tirzepatide
A peer-reviewed scoping review in Diabetes, Metabolic Syndrome and Obesity mapped pancreatic and gallbladder adverse events reported with tirzepatide across 11 randomized trials, 5 observational studies, case reports and two pharmacovigilance databases. Trial rates of pancreatitis were low (0.2 to 3.7 percent across studies), while reporting databases captured a broader spectrum of events; the authors call for vigilant monitoring and standardized reporting.
Researchers from Macleods Pharmaceuticals, the University of Warwick, the University of Limerick and the Post Graduate Institute of Medical Education and Research published a scoping review in the journal Diabetes, Metabolic Syndrome and Obesity (published online October 23, 2026) mapping the existing evidence on pancreatic- and gallbladder-related adverse events with tirzepatide in obesity management. Following the Arksey and O'Malley framework with Joanna Briggs Institute guidance, the reviewers searched PubMed, EMBASE, the Cochrane Library, the FDA Adverse Event Reporting System (FAERS), EudraVigilance-based studies and ClinicalTrials.gov for evidence from December 2019 through September 2025, including 11 randomized controlled trials, 5 observational studies, 4 case reports, 1 EudraVigilance pharmacovigilance analysis and 575 FAERS reports.
In the randomized trials, pancreatobiliary events were infrequent. Pancreatitis was reported in 11 participants across five trials, with study-level frequencies ranging from 0.2 percent (3 of 1,896) to 3.7 percent (1 of 27, a small study). Cholelithiasis (gallstones) was reported in 73 participants across 11 trials, with frequencies from 0.3 percent to 3.7 percent. Observational studies reported pancreatitis proportions of 0.6 percent (63 of 10,002), 0.9 percent (1 of 110) and 2.1 percent (5,882 of 280,094); one retrospective cohort of 9,193 participants recorded incidence rates of 3.84 events per 1,000 person-years for pancreatitis and 11.89 per 1,000 person-years for cholelithiasis.
The pharmacovigilance sources captured a broader spectrum of reported events. In the EudraVigilance analysis, pancreatitis accounted for 363 reported adverse events (6.3 percent of all reports and 19.4 percent of gastrointestinal reports). In FAERS, pancreatitis represented 155 of 288 pancreatic-related reports (53.8 percent) and cholelithiasis 143 of 249 gallbladder-related reports (57.4 percent). Four case reports described six distinct events, including edematous, acute and necrotizing pancreatitis, acalculous cholecystitis, gallstones and gallbladder wall thickening.
The authors conclude that randomized trials generally reported low pancreatobiliary event frequencies while reporting databases captured a broader spectrum, and they caution that differences in study populations, comorbidity profiles and reporting methods, plus the absence of exposure denominators in spontaneous-report databases, prevent direct rate comparisons. They recommend vigilant monitoring and standardized adverse-event reporting. Context for patients: pancreatitis and gallbladder problems are established labeled warnings for tirzepatide (Mounjaro, Zepbound), and this review organizes existing reports rather than establishing new risk rates. Anyone taking tirzepatide who develops severe or persistent abdominal pain, with or without vomiting, should contact their prescriber promptly.