Plain Language Summary
One-year audit at a UK District General Hospital evaluating the frequency and clinical characteristics of pancreatitis presentations in patients prescribed tirzepatide (Mounjaro), comparing observed rates to FDA-reported clinical trial incidence of 0.32–0.39%. Documents real-world pancreatitis cases requiring clinical assessment and management. Provides UK-specific post-marketing pancreatitis surveillance data for tirzepatide—contributing to the evidence base for whether tirzepatide's real-world pancreatitis incidence aligns with controlled trial data and informing clinical monitoring protocols for NHS prescribers managing the rapidly expanding tirzepatide population.
Abstract
BACKGROUND: Tirzepatide (Mounjaro) is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist increasingly prescribed for type 2 diabetes and obesity due to its efficacy in weight loss and glycaemic control. In US FDA-reviewed clinical trials, pancreatitis occurred rarely, at rates of approximately 0.32-0.39% across all doses, comparable to placebo groups. Nevertheless, concerns remain about potential drug-associated pancreatitis, with case reports describing variable severity.
AIM: To determine the frequency and clinical characteristics of pancreatitis among patients receiving tirzepatide in a UK District General Hospital over a 12-month period.
METHODS: This retrospective single-centre audit reviewed 222 inpatient admissions coded as acute or chronic pancreatitis between February 2024 and February 2025. Demographics, comorbidities, drug history, imaging, and outcomes were extracted from electronic health records, focusing on anti-diabetic and anti-obesity medications. Acute and chronic cases were analysed separately to maintain the cohort context.
RESULTS: Of 222 patients, four (1.8%) were prescribed tirzepatide at admission. All were female with a body mass index (BMI) > 24 kg/m² (overweight to obese range), presenting with first-episode acute pancreatitis. All cases were mild, with no intensive care admission, necrosis, or pseudocyst formation. Confounding risk factors were frequent: two had gallstones, one reported alcohol intake, and one had no alternative cause identified. These findings align with the literature suggesting that rapid weight loss may increase gallstone-related pancreatitis risk.
CONCLUSION: In this single-centre audit, pancreatitis in patients receiving tirzepatide was rare, mild, and commonly associated with other aetiologies, such as gallstones or alcohol. No cases of chronic pancreatitis occurred among tirzepatide users. Although causality cannot be established, the overall risk appears low. Clinicians should remain vigilant during early treatment phases when weight loss is greatest. Further multicentre studies with prescribing denominator data are warranted to clarify incidence and potential preventive measures, such as short-term ursodeoxycholic acid prophylaxis in high-risk individuals.
Authors
Hossain, Asmita; Fahim, Muhammad; Abdalla, Moumn; Fozo, Khaldoun; Mon, Minthu; Kaholics, Botond; Veettil, Safana; Belgaumkar, Ajay; Carswell, Kirstin