UK regulator adds severe pancreatitis warnings to semaglutide and tirzepatide labels

The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medicines in the UK, rewrote the product information for all GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists on 29 January 2026 ^[2][3]. The new wording tells prescribers and patients that acute pancreatitis — inflammation of the pancreas — can occasionally be severe, with rare reports of necrotising and fatal cases ^[3].

The medicines covered are dulaglutide, exenatide, liraglutide, semaglutide (sold as Ozempic, Wegovy and Rybelsus) and tirzepatide (sold as Mounjaro and Zepbound) ^[3]. Exenatide is no longer marketed in the UK, and lixisenatide is no longer authorised there ^[3]. The agency acted on April 2025 advice from the Pharmacovigilance Expert Advisory Group of the Commission on Human Medicines, which wanted the warning worded consistently across the class ^[3].

What the reports show

Yellow Card, the UK system for reporting suspected side effects, logged 1,296 pancreatitis reports tied to these drugs between 2007 and October 2025 ^[3]. That count covers acute, chronic, autoimmune, hemorrhagic, necrotising, subacute and obstructive forms of pancreatitis ^[3]. Nineteen of the reports described a fatal outcome, and 24 were reported as necrotising pancreatitis ^[3].

For scale, the MHRA estimated that about 25.4 million packs of GLP-1 receptor agonists were dispensed in the UK over the previous five years, based on prescription data from the fourth quarter of 2020 through the third quarter of 2025 ^[3]. That estimate draws on retail and hospital pharmacy records and leaves out most online-only pharmacies ^[3]. The agency describes pancreatitis as a recognized but uncommon side effect, and says post-marketing experience shows some cases have been unusually serious ^[3].

MHRA chief safety officer Alison Cave said the risk of these severe outcomes is "very small" while urging patients and clinicians to stay alert to the symptoms ^[2].

Other research points in a different direction. EMJ, a medical publisher, reported that a large 2026 retrospective cohort study found no increased risk of acute pancreatitis among people with type 2 diabetes who used GLP-1 receptor agonists ^[4]. A 2025 case series described in the same article pointed to genetic predispositions in some patients who developed the condition ^[4].

Separately, University College London research cited by the MHRA estimated that 1.6 million adults in England, Wales and Scotland used GLP-1s such as semaglutide and tirzepatide to lose weight between early 2024 and early 2025 ^[2].

Why it matters for patients

Early pancreatitis is easy to misread, the MHRA says, because the first symptoms — stomach pain, nausea and vomiting — overlap with the common digestive side effects of these drugs, or with an infection ^[3]. The regulator's guidance tells patients to seek urgent medical attention for severe, persistent stomach pain that may spread to the back and may come with nausea and vomiting ^[2][3].

For clinicians, the updated advice is to stop the medicine immediately if pancreatitis is suspected, not to restart it if the diagnosis is confirmed, and to use these drugs with caution in anyone who has had pancreatitis before ^[3].

The MHRA also told prescribers that GLP-1s bought privately may not appear in a patient's medical history, so they should ask directly about GLP-1 or GLP-1/GIP use when someone arrives with these symptoms ^[3]. A similar record gap can exist in the US, where people obtain these drugs through telehealth, compounded versions or cash-pay channels, though the MHRA guidance governs UK practice only.

No change to US labeling has been reported in response, and it has not been disclosed whether the Food and Drug Administration is examining the same question.

What happens next

The MHRA and Genomics England are enrolling people who take GLP-1s in the Yellow Card Biobank, which is studying whether a person's genes affect the risk of pancreas inflammation ^[2]. The agency says the aim is to predict who faces the greatest risk, but no date has been announced for results or for any further label revisions ^[2]. Reports continue to be collected through the Yellow Card scheme ^[3].