Does Ozempic Raise the Risk of Pancreatitis or Gallstones?

The short answer: Yes for gallstones, and probably not for pancreatitis. The Ozempic label reports gallstones in 1.5% of people on the 0.5 mg dose and 0.4% on the 1 mg dose, versus none on placebo. Pooled trial data show GLP-1 drugs raise gallbladder disease risk by about 37%. Pancreatitis carries a label warning, but randomized trials have not shown a clear increase. Both problems are uncommon, and both have warning signs you can learn.

What does the Ozempic label say about pancreatitis?

The FDA label for Ozempic carries a warning for acute pancreatitis in section 5.2. It states that acute pancreatitis, "including fatal and non-fatal hemorrhagic or necrotizing pancreatitis," has been observed in patients treated with GLP-1 receptor agonists, including Ozempic.

The label tells prescribers to watch for "persistent or severe abdominal pain (sometimes radiating to the back)," with or without nausea or vomiting. If pancreatitis is suspected, the label says to stop Ozempic and start treatment.

The label also gives numbers. In the glycemic control trials, adjudicated acute pancreatitis occurred in 7 Ozempic-treated patients (0.3 cases per 100 patient-years). The comparator groups had 3 cases (0.2 cases per 100 patient-years).

What does the Ozempic label say about gallstones?

Section 5.9 of the label covers acute gallbladder disease. It states that gallstones (cholelithiasis) and gallbladder inflammation (cholecystitis) have been reported in GLP-1 trials and after approval.

The placebo-controlled numbers are clearer than the pancreatitis numbers. Cholelithiasis was reported in 1.5% of patients on Ozempic 0.5 mg and 0.4% on Ozempic 1 mg. Cholelithiasis was not reported in any placebo-treated patient. The label advises gallbladder imaging and follow-up when gallstones are suspected.

The odd pattern (more gallstones on the lower dose) reflects small trial numbers, not a protective effect of higher doses. Larger pooled analyses, covered next, show the opposite: higher doses carry more risk.

Do the pooled trials confirm a gallbladder risk?

Yes. A 2022 meta-analysis in JAMA Internal Medicine by He and colleagues pooled 76 randomized trials with 103,371 participants. Randomization to a GLP-1 drug raised the risk of gallbladder or biliary disease by 37% (relative risk 1.37; 95% CI, 1.23 to 1.52). Gallstones rose 27% (RR 1.27) and cholecystitis rose 36% (RR 1.36).

The risk was not evenly spread. In weight-loss trials, the relative risk was 2.29. In diabetes trials it was 1.27. Higher doses carried a relative risk of 1.56, while lower doses showed no increase. Longer treatment also raised risk. The signal is strongest in the people losing the most weight.

An earlier 2017 review by Monami and colleagues reached the same conclusion from 113 trials. It found a 30% higher odds of cholelithiasis (odds ratio 1.30; 95% CI, 1.01 to 1.68).

Do the trials show more pancreatitis?

Not clearly. The same 2017 Monami review found no significant difference in pancreatitis between GLP-1 drugs and comparators (odds ratio 0.93; 95% CI, 0.65 to 1.34).

A 2025 meta-analysis of 62 randomized trials with 66,232 patients looked again with newer drugs included. The pooled risk of pancreatitis was 44% higher (RR 1.44; 95% CI, 1.09 to 1.89). But that increase disappeared when the authors stratified by background medication. They concluded that GLP-1 drugs carry "a slightly increased risk of pancreatitis, which is not significant when stratified by background medication use."

Observational data look more alarming. A 2023 study in JAMA by Sodhi and colleagues used insurance claims from 2006 to 2020. GLP-1 users had a hazard ratio of 9.09 for pancreatitis compared with bupropion-naltrexone users. The confidence interval ran from 1.25 to 66.00, which means very few events drove the estimate. Semaglutide users had 4.6 pancreatitis cases per 1,000 person-years, compared with 1.0 on the comparator. Biliary disease was not significantly different in that study (hazard ratio 1.50; 95% CI, 0.89 to 2.53).

The American College of Gastroenterology commentary on that study called it "hypothesis-generating" and listed its limits: most GLP-1 users had diabetes, diagnosis codes can misclassify events, and dose and duration data were missing. Randomized trials remain the better evidence, and they do not show a clear pancreatitis increase. Our page on Ozempic long-term side effects covers how these risks compare to more common problems.

Why does weight loss itself cause gallstones?

Part of the gallbladder risk has nothing to do with the drug. Fast weight loss causes gallstones on its own. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) explains the mechanism: "When you don't eat for a long period of time or you lose weight quickly, your liver releases extra cholesterol into the bile. Fast weight loss can also prevent the gallbladder from emptying properly."

Cholesterol-rich bile in a gallbladder that empties less often is the recipe for stones. NIDDK lists obesity and "certain kinds of dieting" as risk factors, and recommends a gradual target of 5 to 10 percent of starting weight over 6 months. Ozempic does two things at once. It slows stomach emptying and reduces appetite, so people eat less and lose weight quickly. GLP-1 drugs may also reduce gallbladder contraction directly. That is why the He meta-analysis found the highest risk in weight-loss trials.

The practical point: the more weight you lose and the faster you lose it, the higher your gallstone risk. This is true on Ozempic, on Mounjaro, after bariatric surgery, and on a very low-calorie diet.

What symptoms should you watch for?

Both conditions cause abdominal pain, but the pattern differs. NIDDK describes pancreatitis as "pain in your upper abdomen that may extend to your back," often with nausea, vomiting, fever, and a rapid pulse. The Ozempic label uses almost the same words: persistent or severe pain, sometimes radiating to the back.

A gallbladder attack usually causes pain in the upper right abdomen. Attacks "often follow heavy meals and usually occur in the evening or during the night," and can last several hours. NIDDK says to get care right away for pain lasting several hours, nausea and vomiting, fever, yellow skin or eyes, or dark urine and pale stools.

Mild nausea and stomach upset are expected in the first weeks and usually fade. Severe, constant, or worsening pain is different. Do not wait it out. Pancreatitis is diagnosed with a blood test and imaging, and gallstones with an ultrasound. If your main problem is nausea or bloating rather than pain, see our guides on Ozempic and gastroparesis and managing Ozempic nausea.

Who should be cautious?

Ozempic is not contraindicated for people with prior pancreatitis, but the trials largely excluded them. That means the safety data do not cover them well. Most prescribers weigh the history carefully and may choose another drug. Tell your prescriber if you have ever had pancreatitis, gallstones, or gallbladder surgery.

• Prior pancreatitis. The cause matters. Gallstone pancreatitis after gallbladder removal is a different situation than alcohol-related or unexplained pancreatitis.
• Known gallstones. Silent stones are common, and most never cause symptoms. Rapid weight loss can turn a silent stone into an attack.
• Heavy alcohol use. Alcohol is a leading cause of pancreatitis on its own. Combining it with a drug that carries a pancreatitis warning stacks the risk. See Ozempic and alcohol.
• Very high triglycerides. This is another independent pancreatitis cause worth treating before or alongside Ozempic.

If you do develop pancreatitis on Ozempic, the label says to stop the drug. Restarting is a case-by-case decision with your doctor. For gallstones, many people continue treatment after the stones are managed, since the gallbladder can be removed and the drug's benefits continue.

The bottom line

Ozempic raises the risk of gallstones and gallbladder disease. The label shows 1.5% and 0.4% versus 0% on placebo, and the largest meta-analysis shows a 37% relative increase, higher with weight loss and higher doses. Much of that risk comes from rapid weight loss itself. Pancreatitis carries a label warning and a small numeric excess in trials, but pooled randomized data do not show a clear increase. Learn the warning signs, share your history with your prescriber, and get severe abdominal pain checked the same day.

Last updated: August 2026. This article is for informational purposes only and does not constitute medical advice. Talk with your prescriber before starting or stopping Ozempic, especially if you have a history of pancreatitis or gallbladder disease.