Patients with a History of Pancreatitis Should Not Take Mounjaro (Tirzepatide)
Mounjaro (tirzepatide) is contraindicated in patients with a history of pancreatitis as explicitly stated in the FDA drug label. 1 The medication has not been studied in this population, and patients with a history of pancreatitis may be at higher risk for developing pancreatitis while on this medication.
Evidence Supporting This Recommendation
FDA Label Information
The FDA label for Mounjaro (tirzepatide) clearly states in the Limitations of Use section:
- "MOUNJARO has not been studied in patients with a history of pancreatitis" 1
This limitation is significant because the drug label also includes a specific warning about pancreatitis:
- "Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists" 1
- "It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on MOUNJARO" 1
Risk of Pancreatitis with GLP-1 Receptor Agonists
Tirzepatide is a dual GIP and GLP-1 receptor agonist. According to the American Diabetes Association's 2025 Standards of Care:
- GLP-1 receptor agonists have been associated with pancreatitis: "Pancreatitis: acute pancreatitis has been reported, but causality has not been established. Do not initiate if at high risk for pancreatitis, and discontinue if pancreatitis is suspected." 2
Recent Case Reports
Recent case reports have documented instances of acute pancreatitis associated with tirzepatide:
- A 2024 case report described a patient who developed acute pancreatitis after switching from semaglutide to tirzepatide 3
- A 2025 case report documented a fatal case of fulminant, necrotizing pancreatitis in a patient who had recently initiated tirzepatide 4
Clinical Decision Algorithm
When considering Mounjaro for a patient with a history of pancreatitis:
- Identify contraindication: Recognize that a history of pancreatitis is a contraindication for Mounjaro
- Consider alternative medications: Choose from other diabetes medications without this contraindication
- Evaluate risk factors: If the patient has other risk factors for pancreatitis (gallstones, alcohol use, hypertriglyceridemia), this further strengthens the contraindication
- Document decision: Clearly document the decision not to use Mounjaro due to the patient's history of pancreatitis
Emerging Research
It's worth noting that there is some emerging research suggesting potential benefits of GLP-1 receptor agonists in reducing recurrent pancreatitis. A 2024 retrospective cohort study using the TriNetX platform found that GLP-1 receptor agonist users, particularly those on semaglutide and tirzepatide, had lower rates of recurrent acute pancreatitis compared to non-users 5. However, this single retrospective study is insufficient to override the explicit contraindication in the FDA label, especially given the case reports of severe and even fatal pancreatitis with tirzepatide.
Alternative Treatment Options
For patients with a history of pancreatitis who need treatment for type 2 diabetes, consider these alternatives:
- Metformin (first-line therapy if not contraindicated)
- SGLT2 inhibitors (which have cardiovascular and renal benefits)
- DPP-4 inhibitors (though these also have pancreatitis warnings but at lower rates)
- Insulin therapy
- Pioglitazone (with caution regarding fluid retention)
- Sulfonylureas (with caution regarding hypoglycemia risk)
Conclusion
Based on the FDA label and current evidence, patients with a history of pancreatitis should not be prescribed Mounjaro (tirzepatide). The explicit contraindication in the drug label, combined with case reports of severe and fatal pancreatitis associated with the medication, outweigh any potential benefits for this specific patient population.