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Clinicalkey AI in action: Risk of gallstones when taking Ozempic?

| 2 min read

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ClinicalKey AI Query: What is the risk of gallstones when taking Ozempic?

Ozempic (semaglutide) has been associated with an increased risk of gallstones (cholelithiasis) in clinical studies.[1-2]

  • In clinical trials for type 2 diabetes mellitus (T2DM), cholelithiasis was reported in 1.5% of patients treated with Ozempic 0.5 mg and 0.4% of patients treated with Ozempic 1 mg subcutaneous injection.[1-2]

  • For weight management, the incidence of cholelithiasis was higher in Ozempic-treated pediatric patients 12 years and older compared to adult patients.[1]

  • In clinical trials of Ozempic injection for weight management in adults, cholelithiasis was reported in 1.6% of Ozempic-treated patients compared with 0.7% of placebo-treated patients.[1]

  • Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in Ozempic-treated patients than in placebo-treated patients, even after accounting for the degree of weight loss.[1]

  • Cholecystectomy has been reported during postmarketing use of Ozempic.[1]


  1. Semaglutide.opens in new tab/window  Elsevier ClinicalKey  Drug Monograph. Content last updated: March 20, 2024 

  2. Ozempic. Label via DailyMed.opens in new tab/window  Food and Drug Administration (DailyMed)  FDA 

Answer generated on April 2, 2024 

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