From each FDA label

Do GLP-1s cause gallbladder problems?

10 of the 10 current GLP-1 labels carry a warning on gallbladder problems. Wegovy's label says: "Treatment with Wegovy is associated with an increased occurrence of cholelithiasis and cholecystitis."

Read from each manufacturer's FDA label on DailyMed. The newest revision saying anything on this is Aug 28, 2026.

Word for word

What each label says about gallbladder problems

Sentences from each label's warnings and side effect sections. Only cross-references are removed.

Wegovy · Warning: Acute Gallbladder Disease

  • Treatment with Wegovy is associated with an increased occurrence of cholelithiasis and cholecystitis.
  • The incidence of cholelithiasis and cholecystitis was higher in Wegovy injection-treated pediatric patients aged 12 years and older than in Wegovy injection-treated adults.
  • In randomized clinical trials in adults for weight reduction, cholelithiasis was reported by 1.6% of Wegovy injection-treated patients and 0.7% of placebo injection-treated patients, and by 2.5% of Wegovy tablet-treated patients and 1% of placebo tablet-treated patients.
  • In Wegovy clinical trials in adults for weight reduction, cholelithiasis was reported by 1.6% of Wegovy injection-treated patients and 0.7% of placebo-treated patients and by 2.5% of Wegovy tablet-treated patients and 1% of placebo tablet-treated patients.

Label revised Jun 18, 2026. DailyMed

Ozempic · Warning: Acute Gallbladder Disease

  • Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing.
  • In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with Ozempic 0.5 mg and 1 mg, respectively.
  • Cholelithiasis was not reported in placebo-treated patients.

Label revised Jun 1, 2026. DailyMed

Rybelsus and Ozempic tablets · Warning: Acute Gallbladder Disease

  • Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing.
  • In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets (7 mg once daily).
  • In a 4-year CV outcomes trial (Trial 7), cholelithiasis was reported in 1.1% of patients treated with semaglutide tablets (14 mg once daily) and in 0.9% of placebo-treated patients.
  • Cholelithiasis: In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets 7 mg.

Label revised Jan 30, 2026. DailyMed

Zepbound · Warning: Acute Gallbladder Disease

  • Treatment with Zepbound and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease.
  • In a pool of two Zepbound clinical trials for weight reduction (Studies 1 and 2), cholelithiasis was reported in 1.1% of Zepbound-treated patients and 1% of placebo-treated patients, cholecystitis was reported in 0.7% of Zepbound-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of Zepbound-treated patients and no placebo-treated patients.
  • Acute gallbladder events were associated with weight reduction.
  • In a pool of Study 1 and 2, cholelithiasis was reported in 1.1% of Zepbound-treated patients and 1% of placebo-treated patients, cholecystitis was reported in 0.7% of Zepbound-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of Zepbound-treated patients and no placebo-treated patients.

Label revised Aug 28, 2026. DailyMed

Mounjaro · Warning: Acute Gallbladder Disease

  • Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing.
  • In Mounjaro placebo-controlled clinical trials in adults, acute gallbladder disease (cholelithiasis, biliary colic, and cholecystectomy) was reported by 0.6% of Mounjaro-treated patients and 0% of placebo-treated patients.
  • If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.
  • In the pool of placebo-controlled clinical trials in adults, acute gallbladder disease (cholelithiasis, biliary colic and cholecystectomy) was reported by 0.6% of Mounjaro-treated patients and 0% of placebo-treated patients.

Label revised Aug 27, 2026. DailyMed

Foundayo · Warning: Acute Gallbladder Disease

  • Treatment with Foundayo and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease.
  • In a pool of two clinical trials for weight reduction (Trials 1 and 2), cholelithiasis was reported in 1% of patients treated with orforglipron once daily and 0.7% of placebo-treated patients, and acute cholecystitis was reported in 0.4% of patients treated with orforglipron once daily and 0.3% of placebo-treated patients.
  • Acute gallbladder events were associated with weight reduction.
  • In a pool of Trials 1 and 2, cholelithiasis was reported in 1% of Foundayo-treated patients and 0.7% of placebo-treated patients, and acute cholecystitis was reported in 0.4% of Foundayo-treated patients and 0.3% of placebo-treated patients.

Label revised Jul 29, 2026. DailyMed

Trulicity · Warning: Acute Gallbladder Disease

  • Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing.
  • In a cardiovascular outcomes trial with a median follow up of 5.4 years, cholelithiasis occurred at a rate of 0.62/100 patient-years in Trulicity-treated patients and 0.56/100 patient-years in placebo-treated patients after adjusting for prior cholecystectomy.
  • Serious events of acute cholecystitis were reported in 0.5% and 0.3% of patients on Trulicity and placebo respectively.

Label revised Jun 16, 2026. DailyMed

Saxenda · Warning: Acute Gallbladder Disease

  • In Saxenda clinical trials in adults, 2.2% of Saxenda-treated patients reported adverse events of cholelithiasis versus 0.8% of placebo-treated patients.
  • The incidence of cholecystitis was 0.8% in Saxenda-treated patients versus 0.4% in placebo-treated patients.
  • The majority of Saxenda-treated patients with adverse events of cholelithiasis and cholecystitis required cholecystectomy.

Label revised Feb 25, 2026. DailyMed

Victoza · Warning: Acute Gallbladder Disease

  • Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing.
  • If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
  • In adult glycemic control trials of Victoza, the incidence of cholelithiasis was 0.3% in both Victoza-treated and placebo-treated patients.

Label revised Oct 14, 2025. DailyMed

Byetta · Warning: Acute Gallbladder Disease

  • Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing.
  • In a clinical study with exenatide, 1.9% of exenatide-treated patients and 1.4% of placebo-treated patients reported an acute event of gallbladder disease, such as cholelithiasis or cholecystitis.
  • If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

Label revised Sep 2, 2025. DailyMed

Not from trials

Reports to FDA about gallbladder problems

Counts of voluntary reports from patients and doctors. They cannot show that a medicine caused anything and cannot give a rate, and a brand used by more people draws more reports.

MedicineReports namingAll reports on it
MounjaroCholelithiasis: 599 · Cholecystitis: 213 · Gallbladder disorder: 192 · Cholecystitis acute: 10197,440
OzempicCholelithiasis: 559 · Cholecystitis: 321 · Gallbladder disorder: 152 · Cholecystitis acute: 4870,863
ByettaCholelithiasis: 359 · Gallbladder disorder: 97 · Cholecystitis: 71 · Cholecystitis acute: 3352,087
TrulicityCholelithiasis: 266 · Cholecystitis: 112 · Gallbladder disorder: 83 · Cholecystitis acute: 3387,279
VictozaCholelithiasis: 263 · Cholecystitis: 89 · Gallbladder disorder: 72 · Cholecystitis acute: 3641,462
WegovyCholelithiasis: 227 · Cholecystitis: 78 · Gallbladder disorder: 68 · Cholecystitis acute: 1925,993
ZepboundCholelithiasis: 194 · Gallbladder disorder: 118 · Cholecystitis: 44 · Cholecystitis acute: 1280,835
SaxendaCholelithiasis: 162 · Cholecystitis: 44 · Gallbladder disorder: 26 · Cholecystitis acute: 127,270
Rybelsus and Ozempic tabletsCholelithiasis: 61 · Cholecystitis: 39 · Cholecystitis acute: 13 · Gallbladder disorder: 127,758
FoundayoCholelithiasis: 3 · Gallbladder disorder: 3 · Cholecystitis: 1 · Cholecystitis acute: 13,050

Counted through openFDA from FDA's Adverse Event Reporting System, refreshed weekly. One report can name several terms.

Updated automatically

Latest FDA label updates

Written from each source's own record as it changes. Every change on GLPcompare

Questions

Gallbladder problems on a GLP-1: common questions

Does Wegovy cause gallbladder problems?

Its FDA label: Treatment with Wegovy is associated with an increased occurrence of cholelithiasis and cholecystitis. The incidence of cholelithiasis and cholecystitis was higher in Wegovy injection-treated pediatric patients aged 12 years and older than in Wegovy injection-treated adults.

Does Ozempic cause gallbladder problems?

Its FDA label: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with Ozempic 0.5 mg and 1 mg, respectively.

Does Rybelsus cause gallbladder problems?

Its FDA label: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets (7 mg once daily).

Does Zepbound cause gallbladder problems?

Its FDA label: Treatment with Zepbound and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease. In a pool of two Zepbound clinical trials for weight reduction (Studies 1 and 2), cholelithiasis was reported in 1.1% of Zepbound-treated patients and 1% of placebo-treated patients, cholecystitis was reported in 0.7% of Zepbound-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of Zepbound-treated patients and no placebo-treated patients.

Does Mounjaro cause gallbladder problems?

Its FDA label: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In Mounjaro placebo-controlled clinical trials in adults, acute gallbladder disease (cholelithiasis, biliary colic, and cholecystectomy) was reported by 0.6% of Mounjaro-treated patients and 0% of placebo-treated patients.

Does Foundayo cause gallbladder problems?

Its FDA label: Treatment with Foundayo and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease. In a pool of two clinical trials for weight reduction (Trials 1 and 2), cholelithiasis was reported in 1% of patients treated with orforglipron once daily and 0.7% of placebo-treated patients, and acute cholecystitis was reported in 0.4% of patients treated with orforglipron once daily and 0.3% of placebo-treated patients.

Does Trulicity cause gallbladder problems?

Its FDA label: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In a cardiovascular outcomes trial with a median follow up of 5.4 years, cholelithiasis occurred at a rate of 0.62/100 patient-years in Trulicity-treated patients and 0.56/100 patient-years in placebo-treated patients after adjusting for prior cholecystectomy.

Does Saxenda cause gallbladder problems?

Its FDA label: In Saxenda clinical trials in adults, 2.2% of Saxenda-treated patients reported adverse events of cholelithiasis versus 0.8% of placebo-treated patients. The incidence of cholecystitis was 0.8% in Saxenda-treated patients versus 0.4% in placebo-treated patients.

Does Victoza cause gallbladder problems?

Its FDA label: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

Other side effects

Trial rates describe groups, not what one person will feel. Talk to your clinician before starting, stopping or changing a medicine.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.