GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal cases

The product information for all Glucagon-Like Peptide-1 (GLP-1) receptor agonists and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists has been further updated to highlight the potential risk of severe acute pancreatitis with these products, including rare reports of necrotising and fatal pancreatitis.

From: Medicines and Healthcare products Regulatory Agency Published 29 January 2026 Therapeutic area: Emergency medicine, Endocrinology, diabetology and metabolism, General practice, GI, hepatology and pancreatic disorders, Nutrition and dietetics and Pharmacy Published: 29 January 2026

Summary

The product information for all Glucagon-Like Peptide-1 (GLP-1) receptor agonists and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists (dulaglutide, exenatide, liraglutide, semaglutide and tirzepatide) has been further updated to highlight the potential risk of severe acute pancreatitis with these products, including rare reports of necrotising and fatal pancreatitis. Healthcare professionals should remain vigilant for signs and symptoms of acute pancreatitis in patients treated with GLP-1 and GLP-1/GIP receptor agonists.

Advice for Healthcare Professionals:

• be alert to the risk of acute pancreatitis in patients receiving Glucagon-Like Peptide-1 (GLP-1) receptor agonists and dual GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists. There have been rare reports of necrotising and fatal pancreatitis associated with GLP-1 and GLP-1/GIP receptor agonists
• advise patients to seek urgent medical attention if they develop severe and persistent abdominal pain that may radiate to the back and may be accompanied by nausea and vomiting
• privately prescribed GLP-1s and GLP-1/GIPs may not appear on the patient’s medical history so if a patient presents with these symptoms, enquire about GLP-1 or GLP-1/GIP use
• if pancreatitis is suspected, discontinue treatment with the GLP-1 or GLP-1/GIP receptor agonist immediately;
• do not restart therapy if the diagnosis of pancreatitis is confirmed
• GLP-1 and GLP-1/GIP receptor agonists should be used with caution in patients with a history of pancreatitis
• report suspected adverse drug reactions associated with this group of medications, including serious or fatal cases of pancreatitis, via the Yellow Card scheme.

Advice for Healthcare Professionals to Provide to Patients:

• pancreatitis (inflammation of the pancreas) is a possible side effect with GLP-1 receptor agonists and dual GLP-1/ GIP receptor agonists. In rare reports this can have serious or fatal outcomes
• seek urgent medical attention if you experience severe, persistent abdominal pain, that may radiate to your back and may be accompanied by nausea and vomiting, as this may be a sign of pancreatitis
• do not restart GLP-1 receptor agonist or GLP-1/GIP receptor agonist treatment if pancreatitis is confirmed
• report suspected side effects through the Yellow Card scheme.

Background

Glucagon-like peptide-1 (GLP-1) receptor agonists and dual GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists are used for the treatment of type 2 diabetes mellitus and, for some products, for weight management and cardiovascular risk reduction. The GLP-1 and GLP-1/GIP receptor agonists authorised in the UK include dulaglutide, exenatide, liraglutide, semaglutide and tirzepatide. Exenatide is no longer marketed in the UK and lixisenatide is no longer authorised.

Acute pancreatitis is a recognised side effect with GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists. Although the overall frequency remains uncommon, post-marketing experience has shown that some rare reports of acute pancreatitis have been particularly severe, including necrotising and fatal pancreatitis.

In the UK between 2007 and October 2025, the MHRA has received 1,296 Yellow Card reports of pancreatitis (including acute, autoimmune, chronic, haemorrhagic, necrotising, subacute and obstructive forms of pancreatitis) associated with GLP-1 receptor agonists or dual GLP-1/GIP receptor agonists. Of these, 19 reports were fatal and 24 were reported as necrotising pancreatitis. For context, in the past 5 years, it is estimated that roughly 25.4 million packs of the GLP-1 receptor agonists have been dispensed [1].

The Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines (CHM), has advised that the product information for all GLP-1 and dual GLP-1/GIP receptor agonists receptor agonists should be strengthened to highlight the potential severity of acute pancreatitis and to ensure consistency across the class of medicines.

Pancreatitis may be challenging to recognise in its early stages, as initial symptoms such as abdominal pain, nausea or vomiting may be attributed to other causes such as common gastrointestinal side effects of GLP-1 and GLP-1/GIP treatment or infection. Clinicians should remain vigilant for the possibility of pancreatitis in patients treated with GLP-1 or GLP-1/GIP receptor agonists and investigate in line with local clinical practice. Advise patients to seek urgent medical attention if they develop severe, persistent abdominal pain that may radiate to the back and may be accompanied by nausea and vomiting.

Product Information Update

The Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for all UK-authorised GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists have been updated to highlight reports of necrotising pancreatitis and reports with a fatal outcome and to advise that patients seek immediate medical attention if symptoms of acute pancreatitis occur.

Reporting advice

Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:

• the Yellow Card website
• the Yellow Card app; download from the Apple App Store or Google Play Store
• some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses) When reporting suspected adverse drug reactions, please provide as much information as possible, including information about medical history, any concomitant medication, onset timing, and treatment dates.

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GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal cases

Additional information

[1] - Data derived from IQVIA Prescription Based Services (PBS) and Hospital Pharmacy Audit (HPA) combined database, Extract from Q4 2020 to Q3 2025, analysed independently by the MHRA, January 2026. Drug = GLP-1 receptor agonists (liraglutide, semaglutide, tirzepatide, exenatide, lixisenatide, dulaglutide), Measure = Units. IQVIA PBS and HPA combined database captures the volume drug dispensed by prescription in UK retail and hospital pharmacies. Majority of online only pharmacies are not included.

References

• MHRA Pharmacovigilance Expert Advisory Group (PEAG) advice, April 2025
• Recommendations - Pancreatitis - Guidance - NICE

Stakeholder engagement:

1. Devolved administrations
2. NHS England
3. General Pharmaceutical Council
4. Gateshead Health NHS Foundation Trust You can sign up to receive email notifications for Drug Safety Updates.

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For any enquiries, please contact info@mhra.gov.uk

Article citation: MHRA Drug Safety Update volume 19, issue 6: January 2026: 3

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Published 29 January 2026 Contents