GLP-1 pancreatitis and gallbladder warnings: what the labels report

Short answer: every US label for Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, Saxenda, Victoza and Trulicity warns about acute pancreatitis and acute gallbladder disease. In the trials they summarize, pancreatitis was rare (well under 1 case per 100 patient-years), while gallstones and gallbladder inflammation were reported more often on the drug than on placebo in most trials. All eight Canadian product monographs add one rule the US text does not: if pancreatitis is confirmed, the drug should not be restarted.

On this page: Pancreatitis rates · Symptoms · Canada: restart and history rules · Gallbladder rates · Lipase and amylase · What to log

Pancreatitis rates in the label trials

Section 5 of each US label says acute pancreatitis, "including fatal and non-fatal hemorrhagic or necrotizing pancreatitis", has been observed in patients treated with GLP-1 receptor agonists. Section 6 gives the trial counts below. "Adjudicated" means an independent committee confirmed the case. Trials differ in length, population and comparator, so compare each drug with its own comparator column, not across rows.

Medication	On the drug (US label)	Comparator or placebo	Canadian monograph
Ozempic (semaglutide)	Glycemic trials: 7 adjudicated cases, 0.3 per 100 patient-years	3 on comparators, 0.2 per 100 patient-years	Monograph adds SUSTAIN 6: 8 (0.27 per 100 patient-years) vs 10 on placebo (0.33)
Wegovy (semaglutide)	Weight trials: 4 adjudicated cases, 0.2 per 100 patient-years	1 on placebo, under 0.1 per 100 patient-years	Monograph adds SELECT: 17 (0.2%) vs 24 (0.3%) on placebo
Rybelsus / Ozempic tablets	Pooled trials: 6 serious cases, 0.1 events per 100 patient-years	1 on comparators, under 0.1	Monograph adds SOUL: 0.4% vs 0.4% on placebo
Mounjaro (tirzepatide)	14 events in 13 patients, 0.23 per 100 years of exposure	3 events in 3 patients, 0.11	Same figures (13 patients = 0.2%)
Zepbound (tirzepatide)	Weight trials: 0.2%, 0.14 per 100 years of exposure; sleep apnea trials: 0.84 per 100 years	Placebo 0.2%, 0.15; sleep apnea placebo 0	Same sleep apnea figure (SURMOUNT-OSA)
Saxenda (liraglutide)	9 of 3,291 (0.3%), plus 2 cases 74 and 124 days after the last dose	2 of 1,843 (0.1%)	Same figures
Victoza (liraglutide)	13 cases (9 acute, 4 chronic), 2.7 per 1,000 patient-years	1 on glimepiride, 0.5 per 1,000 patient-years	Not compared here
Trulicity (dulaglutide)	5 adjudicated cases, 1.4 per 1,000 patient-years; dose trial 0.2% (1.5 mg), 0.3% (3 mg), 0.5% (4.5 mg)	1 on non-incretin comparators, 0.88 per 1,000 patient-years	Not compared here

In the two largest placebo-controlled outcome trials quoted in the Canadian monographs, pancreatitis was not more common on semaglutide: SUSTAIN 6 (Ozempic) had 8 cases vs 10 on placebo, and SELECT (Wegovy) had 17 vs 24. The one clearly higher rate on a US label is the Zepbound sleep apnea trials, at 0.84 patients per 100 years of exposure vs 0 on placebo. In the Trulicity dose trial, the rate rose from 0.2% at 1.5 mg to 0.5% at 4.5 mg, though the numbers are small (1, 2 and 3 patients).

Symptoms the labels tell you to watch for

Pancreatitis: persistent or severe abdominal pain, sometimes radiating to the back, with or without nausea or vomiting (US section 5). The Saxenda and Victoza monographs say the pain may be persistent or intermittent.
Gallbladder disease: the US labels say gallbladder studies and clinical follow-up are indicated if cholelithiasis (gallstones) or cholecystitis (gallbladder inflammation) is suspected. The patient information leaflets list pain in the upper stomach, fever, yellowing of the skin or eyes (jaundice) and clay-coloured stools.

Every US label tells patients to stop the medication promptly and contact their healthcare provider if pancreatitis is suspected, and to contact their provider if gallbladder disease is suspected. Severe abdominal pain is a reason to get medical care right away.

Canada: the no-restart rule and pancreatitis history

The Canadian monographs (section 7, Warnings and Precautions) go further than the current US section 5 text in two ways. All eight say the drug should not be restarted once pancreatitis is confirmed, and most say something about people who have had pancreatitis before.

Monograph	"Should not be restarted" if confirmed	History of pancreatitis	Monograph date
Ozempic	Yes	Consider diabetes therapies other than Ozempic	2026-07-13
Wegovy	Yes	Not studied in chronic pancreatitis or acute pancreatitis in the past 6 months; caution	2025-12-10
Rybelsus	Yes	No history statement in the pancreatitis paragraph	2026-07-13
Mounjaro	Yes	Not evaluated in prior pancreatitis; use with caution	2026-06-23
Zepbound	Yes	Not evaluated in prior pancreatitis; use with caution	2026-06-11
Saxenda	Yes	Unknown whether the risk is higher; these patients were excluded from trials	2022-12-09 (revision)
Victoza	Yes	Studied in a limited number of patients; unknown whether the risk is higher	2022-12-09 (revision)
Trulicity	Yes	Not studied; consider other diabetes therapies	2024-07-05 (revision)

The Mounjaro and Zepbound monographs also say that, without other signs and symptoms, elevations in pancreatic enzymes alone are not predictive of pancreatitis. The Trulicity and Victoza monographs say other suspect medications should also be stopped and confirmatory tests done. We checked the US labels on DailyMed on November 4, 2026: their section 5 says to discontinue and start appropriate management if pancreatitis is suspected, and does not include the restart sentence.

Gallstones and gallbladder inflammation: label rates

The Wegovy and Zepbound US labels say treatment is associated with an increased occurrence of gallbladder disease. The Wegovy label adds that substantial or rapid weight loss can increase the risk of cholelithiasis, but that gallbladder disease was still more common on Wegovy than on placebo. The figures below are what each US label reports, with the trial they come from.

Medication	On the drug	Placebo	Trial
Ozempic	Cholelithiasis 1.5% (0.5 mg) and 0.4% (1 mg)	Not reported on placebo	Placebo-controlled glycemic trials
Wegovy (adults)	Cholelithiasis 1.6% injection, 2.5% tablets; cholecystitis 0.6% injection	Cholelithiasis 0.7% (injection placebo), 1% (tablet placebo); cholecystitis 0.2%	Weight-reduction trials
Wegovy (ages 12+)	Cholelithiasis 3.8%; cholecystitis 0.8%	0% and 0%	Pediatric weight-reduction trial
Rybelsus / Ozempic tablets	Cholelithiasis 1.1%; cholecystitis 1.1% (14 mg)	0.9% and 0.7%	4-year cardiovascular outcomes trial
Mounjaro	Acute gallbladder disease 0.6%	0%	Placebo-controlled adult trials
Zepbound	Cholelithiasis 1.1%; cholecystitis 0.7%; cholecystectomy 0.2%	1%, 0.2%, none	Pool of two weight-reduction trials
Saxenda	Cholelithiasis 2.2%; cholecystitis 0.8%	0.8% and 0.4%	Adult trials
Victoza	Any acute gallbladder event 3.1%; cholelithiasis 1.5%; acute cholecystitis 1.1%	1.9%, 1.1%, 0.7%	LEADER cardiovascular trial
Trulicity	Cholelithiasis 0.62 per 100 patient-years; serious acute cholecystitis 0.5%	0.56 per 100 patient-years; 0.3%	Cardiovascular outcomes trial, median 5.4 years

The Wegovy label says gallbladder events were more common in patients aged 12 and older than in adults (3.8% cholelithiasis vs 0% on placebo). The Wegovy tablet trials also showed a higher cholelithiasis rate (2.5%) than the injection trials (1.6%), each against its own placebo group.

Lipase and amylase rises

Blood tests during treatment often show higher pancreatic enzymes even without pancreatitis. The Wegovy, Mounjaro, Zepbound, Saxenda and Victoza labels say the clinical significance of these rises is unknown in the absence of other signs and symptoms of pancreatitis.

Medication	What the US label reports
Ozempic	Amylase +13%, lipase +22% (mean from baseline)
Wegovy	Amylase +15% to 16%, lipase +39%; MASH trial: lipase over 3× the upper limit of normal in 4.7% vs 1.3% on placebo
Rybelsus / Ozempic tablets	Amylase +10% (7 mg) and +13% (14 mg); lipase +30% and +34%
Mounjaro	Pancreatic amylase +33% to 38%, lipase +31% to 42% (placebo: amylase +4%, lipase unchanged)
Zepbound	Pancreatic amylase +20% to 25%, lipase +28% to 35% (placebo: +2.1% and +5.8%)
Saxenda	Lipase at least 3× the upper limit of normal at any time in 2.1% vs 1.0% on placebo
Victoza	LEADER: lipase at least 3× the upper limit in 7.9% vs 4.5%; amylase 1% vs 0.7%
Trulicity	Lipase and/or pancreatic amylase +14% to 20% (placebo up to +3%)

If a lab result shows high lipase, ask your prescriber what it means for you; the labels do not set a lipase level at which to stop.

What to log and tell your prescriber

Any past pancreatitis, gallstones or gallbladder problems, before you start.
Abdominal pain: the date, where it is, how severe, whether it spreads to the back and whether it comes with vomiting or fever.
Yellowing of the skin or eyes, or pale stools.
Dose changes, since the labels ask prescribers to observe patients after starting treatment (and, on the Victoza monograph, after dose increases).
Lab results you are given, such as lipase, so you can compare over time.

For severe GI rates and gastroparesis wording, see GLP-1 severe gastrointestinal adverse reactions warning. For the other class warnings, see GLP-1 thyroid warning and contraindications, GLP-1 aspiration risk under anesthesia, GLP-1 kidney and dehydration warning and GLP-1 side effects: rates and tracking.

Sources

This page summarizes official product labels as general information. It is not medical advice. Do not start, stop or change any medication without talking to your prescriber. Labels are updated; check the current version for your product.

Frequently asked questions

How common is pancreatitis on Ozempic, Wegovy, Mounjaro or Zepbound?

Rare in the trials summarized on the US labels. Ozempic: 7 adjudicated cases (0.3 per 100 patient-years) vs 3 on comparators (0.2). Wegovy: 4 cases (0.2 per 100 patient-years) vs 1 on placebo (under 0.1). Mounjaro: 14 events in 13 patients (0.23 patients per 100 years of exposure) vs 3 on comparators (0.11). Zepbound weight trials: 0.2% vs 0.2% on placebo (0.14 vs 0.15 per 100 years). These are trial counts, not a personal risk estimate.

What are the pancreatitis symptoms the labels list?

The US labels describe persistent or severe abdominal pain, sometimes radiating to the back, which may or may not come with nausea or vomiting. The labels tell patients to stop the medication promptly and contact their healthcare provider if pancreatitis is suspected.

Can you restart a GLP-1 after pancreatitis?

All eight Canadian product monographs covered here say that if pancreatitis is confirmed, the drug should not be restarted. The current US labels on DailyMed say to discontinue the drug and start appropriate management if pancreatitis is suspected; the restart sentence is not in the US section 5 text we checked on November 4, 2026. Any decision about restarting belongs to your prescriber.

Can I take a GLP-1 if I have had pancreatitis before?

The Canadian monographs handle this differently. Ozempic and Trulicity say to consider other diabetes therapies in people with a history of pancreatitis. Mounjaro and Zepbound say they were not evaluated in people with prior pancreatitis and should be used with caution. Wegovy says it was not studied in chronic pancreatitis or acute pancreatitis in the past 6 months. Saxenda and Victoza say it is unknown whether a history of pancreatitis raises the risk. Discuss your history with your prescriber.

Do GLP-1s cause gallstones?

The labels report more gallbladder events with the drug than with placebo in several trials. For example: Wegovy injection cholelithiasis 1.6% vs 0.7% placebo (adults), Saxenda 2.2% vs 0.8%, Zepbound cholecystitis 0.7% vs 0.2%, Mounjaro acute gallbladder disease 0.6% vs 0%. The Wegovy and Zepbound labels say treatment is associated with an increased occurrence of gallbladder disease.

Are gallbladder problems more common in teenagers on Wegovy?

Yes, according to the US Wegovy label. In the trial of patients aged 12 and older, cholelithiasis was reported by 3.8% on Wegovy injection vs 0% on placebo, and cholecystitis by 0.8% vs 0%. The label says the incidence was higher in pediatric patients than in adults.

Do high lipase or amylase levels mean I have pancreatitis?

Not on their own, according to the labels. Mean lipase rose from baseline by 22% with Ozempic, 39% with Wegovy, 31% to 42% with Mounjaro and 28% to 35% with Zepbound in trials. The Wegovy, Mounjaro, Zepbound, Saxenda and Victoza labels say the clinical significance of these rises is unknown without other signs and symptoms of pancreatitis, and the Mounjaro and Zepbound monographs say enzyme elevations alone are not predictive.

Which GLP-1 has the most gallbladder events on its label?

The labels report different trial designs, so the numbers are not a fair head-to-head comparison. The largest drug-vs-placebo gap on a US label is the Wegovy pediatric trial (3.8% vs 0% cholelithiasis). Among adult numbers, Victoza in the LEADER trial reported 3.1% vs 1.9% for any acute gallbladder event, and Saxenda reported 2.2% vs 0.8% cholelithiasis.

What should I track if I am worried about these side effects?

The symptoms the labels name: abdominal pain (where, how bad, whether it spreads to the back), nausea and vomiting, fever, yellowing of the skin or eyes, and clay-coloured stools for gallbladder problems. A GLP-1 tracker such as Glidedose lets you log these with dates so you can show your prescriber when they started.

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Delayed gastric emptying and pulmonary aspiration warnings from US labels and Canadian monographs for all 8 GLP-1s.GLP-1 kidney and dehydration warning
Acute kidney injury wording and trial rates from each label, severe GI rates, and Canada's ESRD rules.GLP-1 diabetic retinopathy warning
Retinopathy rates from each label, who should be monitored, and US vs Canada differences.GLP-1 thyroid warning and contraindications
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Week-by-week escalation for Ozempic, Wegovy, Mounjaro and Zepbound from the labels.