GLP-1 Medicines and Gallbladder Problems: Label Rates
[Answers · GLP-1 medicines]

Can GLP-1 medicines cause gallbladder problems?

From FDA labels, public health agencies and published studies · Reviewed

Short answer: Yes, though it is uncommon. All four US labels carry a warning for acute gallbladder disease. In the Wegovy weight-loss trials, gallstones were reported in 1.6% of adults on the injection versus 0.7% on placebo; in the Zepbound trials, gallbladder inflammation was reported in 0.7% versus 0.2%. A 2022 review of 76 trials found more risk at higher doses, with longer use and in weight-loss trials. Signs to report include upper stomach pain, fever and yellow skin or eyes.

How often it happened in the trials

Each label reports gallbladder events from its own placebo-controlled trials. Cholelithiasis means gallstones; cholecystitis means an inflamed gallbladder; cholecystectomy means surgery to remove it.

Gallbladder events in placebo-controlled trials, from each US label
Medicine and trialsOn the medicinePlacebo
Wegovy injection, adults, weight reduction: gallstones1.6%0.7%
Wegovy injection, adults, weight reduction: inflamed gallbladder0.6%0.2%
Wegovy tablets, adults, weight reduction: gallstones2.5%1%
Wegovy injection, ages 12 and up: gallstones3.8%0%
Zepbound, weight reduction (Studies 1 and 2): gallstones1.1%1%
Zepbound, weight reduction: inflamed gallbladder0.7%0.2%
Zepbound, weight reduction: gallbladder removed0.2%0%
Ozempic 0.5 mg and 1 mg, type 2 diabetes: gallstones1.5% and 0.4%0%
Mounjaro, type 2 diabetes: gallstones, biliary colic or gallbladder removal0.6%0%

The trials differ in who took part, which doses were used and how long they ran, so the rows are not a ranking of one medicine against another. The Wegovy label notes that rates were higher in teenagers aged 12 and older than in adults.

Is it the medicine or the weight loss?

Fast or large weight loss is a known cause of gallstones on its own, and both weight-loss labels speak to that. The Wegovy label says substantial or rapid weight loss can raise the risk, but that gallbladder disease was more common on Wegovy than on placebo "even after accounting for the degree of weight loss". The Zepbound label says the gallbladder events "were associated with weight reduction", and that gallstone rates were similar in its weight-loss and sleep apnea trials.

The Wegovy label also says gallbladder disease can happen without substantial or rapid weight loss.

What a 2022 review of 76 trials found

He and colleagues pooled 76 randomized trials with 103,371 adults that compared a GLP-1 medicine with placebo or another treatment. Being assigned a GLP-1 medicine was linked to a 37% higher relative risk of gallbladder or bile duct disease (relative risk 1.37), including gallstones (1.27) and an inflamed gallbladder (1.36).

The link was stronger in some settings than others:

  • Weight-loss trials: relative risk 2.29, against 1.27 in trials for type 2 diabetes and other conditions.
  • Higher doses: 1.56, while lower doses showed no clear rise (0.99).
  • Longer use: 1.40 with longer treatment, against no clear rise with shorter treatment (0.79).

A relative risk compares two groups; it does not say how many people are affected. Because these events are uncommon to begin with, the label tables above give a better sense of the actual numbers.

Signs the labels ask you to report

The Ozempic, Mounjaro and Zepbound leaflets say to tell your healthcare provider right away, and the Wegovy leaflet says to call your provider, if you get symptoms of gallbladder problems. The Wegovy leaflet adds that some gallbladder problems need surgery. The symptoms listed are:

  • Pain in the upper stomach (abdomen)
  • Fever
  • Yellowing of the skin or eyes (jaundice)
  • Clay-colored stools

For prescribers, the labels say that if gallstones or an inflamed gallbladder are suspected, gallbladder tests and follow-up are needed. Severe stomach pain that will not go away, sometimes spreading to the back, is listed separately as a sign of pancreatitis.

Logging when stomach pain started, what you ate and where you were in the dose schedule gives your provider a clear picture. Dose Track keeps side effects and weight alongside each dose.

Read more on Dose Track: Wegovy side effects · Zepbound side effects · Ozempic side effects · Mounjaro side effects · GLP-1 side effects week by week · GLP-1 receptor agonist (glossary)

General education drawn from labels, public health agencies and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your medicine are the final word. Questions for other users? Ask in the Dose Track community.

Frequently asked questions

How common are gallstones on Wegovy?+
In the Wegovy weight-reduction trials, gallstones were reported in 1.6% of adults on the injection compared with 0.7% on placebo, and in 2.5% on the tablets compared with 1% on placebo.
How common are gallbladder problems on Zepbound?+
In the Zepbound weight-reduction trials, gallstones were reported in 1.1% versus 1% on placebo, an inflamed gallbladder in 0.7% versus 0.2%, and gallbladder removal in 0.2% versus none.
Is the gallbladder risk only from losing weight fast?+
Not entirely. The Wegovy label says gallbladder disease was more common than on placebo even after accounting for weight loss, and can happen without rapid weight loss.
What are the signs of a gallbladder problem on a GLP-1?+
The label leaflets list pain in the upper stomach, fever, yellowing of the skin or eyes, and clay-colored stools, and say to contact your healthcare provider if you get them.