Mounjaro Use in Patients with Known Gallstones
Mounjaro (tirzepatide) should be used with caution in patients with known gallstones due to the risk of acute gallbladder disease, and patients should be informed about this risk before starting treatment. 1
Risk Assessment for Gallbladder Disease with Mounjaro
According to the FDA label for Mounjaro, acute gallbladder disease (including cholelithiasis, biliary colic, and cholecystectomy) was reported in 0.6% of Mounjaro-treated patients compared to 0% of placebo-treated patients in clinical trials 1. This indicates a small but definite risk of gallbladder complications with tirzepatide use.
The risk appears to be similar to what has been observed with other GLP-1 receptor agonists, which as a class have been associated with biliary disease. The 2025 Diabetes Care standards specifically note that GLP-1 receptor agonists require evaluation for gallbladder disease if cholelithiasis or cholecystitis is suspected 2.
Decision Algorithm for Mounjaro Use in Patients with Gallstones
Assess symptom status of gallstones:
- Asymptomatic gallstones: May proceed with caution
- Symptomatic gallstones: Consider stone extraction before starting Mounjaro
Evaluate risk factors for gallstone complications:
- Size of stones (>3 cm increases risk)
- Calcified gallbladder
- History of biliary colic
- Recent episodes of right upper quadrant pain
Consider alternative medications if:
- Patient has had recent gallstone-related complications
- Patient has porcelain gallbladder
- Patient has contraindications to cholecystectomy if complications arise
Monitoring Recommendations
If proceeding with Mounjaro in a patient with known gallstones:
- Inform the patient about potential gallbladder-related side effects
- Monitor for symptoms of biliary colic or cholecystitis (right upper quadrant pain, nausea, vomiting)
- Consider baseline liver function tests before initiating therapy
- Educate patients to report any new or worsening abdominal pain promptly
Management of Gallstones in Patients on Mounjaro
The 2017 guidelines on common bile duct stones management recommend stone extraction for patients with symptomatic gallstones 2. For patients who develop gallstone symptoms while on Mounjaro:
- Promptly evaluate with ultrasound and liver function tests
- Consider discontinuing Mounjaro if gallstone complications occur
- Refer for appropriate intervention (typically laparoscopic cholecystectomy) if symptomatic
Safety Data on Gallstone Risk
A 2023 meta-analysis of tirzepatide clinical trials found that rates of cholelithiasis and cholecystitis were extremely low (≤1%) across all doses of tirzepatide 3. This suggests that while the risk exists, it is relatively uncommon.
Practical Recommendations
- For patients with asymptomatic gallstones: Mounjaro can be used with appropriate counseling about potential risks
- For patients with symptomatic gallstones: Consider addressing the gallstone disease (typically with cholecystectomy) before initiating Mounjaro
- For patients at high risk of gallstone complications: Consider alternative diabetes/weight management options
Pitfalls and Caveats
- Do not dismiss new right upper quadrant pain in patients on Mounjaro as simple dyspepsia - evaluate for gallbladder disease
- Avoid rapid weight loss protocols when starting Mounjaro, as this can independently increase gallstone formation risk
- Remember that GLP-1 receptor agonists can delay gastric emptying, which may mask or alter typical gallstone pain presentation
- Be aware that Mounjaro may affect oral medication absorption, including those used to manage gallstone symptoms 1
In conclusion, while Mounjaro is not absolutely contraindicated in patients with gallstones, the presence of gallstones should factor into the risk-benefit assessment when considering this medication. Patients should be informed about the small but definite risk of gallbladder complications, and appropriate monitoring should be implemented.