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There is no official FDA black box warning specifically linking tirzepatide to gallstones , but the prescribing information for both Mounjaro and Zepbound includes warnings about acute gallbladder disease, noting that cholelithiasis (gallstones) and cholecystitis (gallbladder inflammation) were observed in clinical trials

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Limitations In spontaneous reports, some cases were not confirmed by healthcare professionals and reporters could decide the primary suspect drugs themselves