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Mounjaro ® (tirzepatide) injection
2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Does Mounjaro® (tirzepatide) affect bone density and/or increase the risk of bone fracture?
There is no information available on the effect of tirzepatide on bone density. Risk of bone fracture is not included in the US Mounjaro prescribing information. Eli Lilly and Company reviews safety data for all our medicines on an ongoing basis.
See important safety information, including boxed warning, in the attached prescribing information.
Effect of Tirzepatide on Bone Density
There is no information available on the effect of tirzepatide on bone density or bone metabolism.
Tirzepatide and Risk of Bone Fracture
No information about a risk of bone fracture is included in the current US Mounjaro (tirzepatide) prescribing information.1 At the time of review, to the extent there was data available on risks of bone fracture from the tirzepatide clinical trials and postmarketing experience, it did not meet FDA's criteria for clinical significance, causality to the drug, or relevance to patient safety and treatment decisions.2
Patient safety is Eli Lilly and Company’s top priority and we actively engage in evaluating, monitoring, and reporting safety information for all our medicines. If new information indicates a new safety concern or signal for the product or the class, including postmarketing experience, the prescribing information will be properly updated in alignment with regulatory authorities.2
Enclosed Prescribing Information
Reference
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
2US Food and Drug Administration. Frequently asked questions about labeling for prescription medicines for healthcare professionals. Updated April 1, 2024. Accessed August 19, 2024. https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/frequently-asked-questions-about-labeling-prescription-medicines
Date of Last Review: September 20, 2024