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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.
What was the incidence of intestinal obstruction in adults with type 2 diabetes taking Mounjaro® (tirzepatide)?
In the completed tirzepatide phase 2 and 3 registration trials for type 2 diabetes, a total of 5 patients experienced an intestinal obstruction or ileus.
See important safety information, including boxed warning, in the attached prescribing information.
Incidence of Gastrointestinal Obstruction or Ileus During Tirzepatide Studies in Adults With Type 2 Diabetes
In the completed tirzepatide phase 2 and 3 registration trials for type 2 diabetes, intestinal obstruction or ileus was noted in
- 5 of the 5415 tirzepatide-treated participants (those who received at least one dose of tirzepatide), and
- 0 of the 2354 participants receiving placebo or active comparators.1
The specific preferred terms associated with intestinal obstruction or ileus included
- ileus (3 patients treated with tirzepatide)
- intestinal pseudo-obstruction (1 patient treated with tirzepatide), and
- large intestinal obstruction (1 patient treated with tirzepatide).1
For the 3 patients with reported ileus, no events were reported as serious adverse events.1
Related Gastrointestinal Adverse Reactions Reported in Postmarketing Experience
Ileus and intestinal obstruction have been reported during post-approval use of tirzepatide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.2
Background
The current literature presents mixed findings.
Eli Lilly and Company recognize that publications on this safety topic may exist in scientific literature. Publications authored by independent individuals or groups employing different research methodologies, may be subject to varying scientific rigor and interpretations. For this reason, Lilly primarily limits responses to data generated from our own sponsored research programs. We encourage the prescribing healthcare provider to exercise clinical judgement to obtain and evaluate external literature for sound scientific merit, clinical relevance, and generalizability.
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: February 16, 2026