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  1. Medical Information Right
  2. Diabetes Right
  3. Mounjaro (tirzepatide) injection Right
  4. What are the common adverse events with Mounjaro® (tirzepatide) in adults?
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Mounjaro ® (tirzepatide) injection

2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg

Full Prescribing Information

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 are the common adverse events with Mounjaro® (tirzepatide) in adults?

Gastrointestinal adverse reactions were most common adverse events with the use of Mounjaro.

US_cFAQ_TZP9006A_M_USPI_COMMON_AEs_T2D
US_cFAQ_TZP9006A_M_USPI_COMMON_AEs_T2Den-US

See important safety information, including boxed warning, in the attached prescribing information.

Mounjaro Common Adverse Events in Clinical Trials in Adults

Adverse Reactions in Pool of Placebo-Controlled Trials Reported in ≥5% of MOUNJARO-treated Adult Patients with Type 2 Diabetes Mellitus shows common adverse reactions, not including hypoglycemia, associated with the use of MOUNJARO in the pool of placebo-controlled trials in adults. These adverse reactions occurred more commonly on MOUNJARO than on placebo and occurred in at least 5% of patients treated with MOUNJARO.1

Adverse Reactions in Pool of Placebo-Controlled Trials Reported in ≥5% of MOUNJARO-treated Adult Patients with Type 2 Diabetes Mellitus1

Adverse Reaction, %a

Placebo
N=235

MOUNJARO 5 mg
N=237

MOUNJARO 10 mg
N=240

MOUNJARO 15 mg
N=241

Nausea

4

12

15

18

Diarrhea

9

12

13

17

Decreased appetite

1

5

10

11

Vomiting

2

5

5

9

Constipation

1

6

6

7

Dyspepsia

3

8

8

5

Abdominal pain

4

6

5

5

aPercentages reflect the number of patients who reported at least 1 occurrence of the adverse reaction.

In the pool of seven clinical trials in adults, the types and frequency of common adverse reactions, not including hypoglycemia, were similar to those listed in Adverse Reactions in Pool of Placebo-Controlled Trials Reported in ≥5% of MOUNJARO-treated Adult Patients with Type 2 Diabetes Mellitus.1

Gastrointestinal Adverse Reactions

In the pool of placebo-controlled trials in adults, gastrointestinal adverse reactions occurred more frequently among patients receiving MOUNJARO than placebo (placebo 20.4%, MOUNJARO 5 mg 37.1%, MOUNJARO 10 mg 39.6%, MOUNJARO 15 mg 43.6%). More patients receiving MOUNJARO 5 mg (3.0%), MOUNJARO 10 mg (5.4%), and MOUNJARO 15 mg (6.6%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.4%). The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation and decreased over time.

The following gastrointestinal adverse reactions were reported more frequently in MOUNJARO-treated adult patients than placebo-treated patients (frequencies listed, respectively, as: placebo; 5 mg; 10 mg; 15 mg): eructation (0.4%, 3.0%, 2.5%, 3.3%), flatulence (0%, 1.3%, 2.5%, 2.9%), gastroesophageal reflux disease (0.4%, 1.7%, 2.5%, 1.7%), abdominal distension (0.4%, 0.4%, 2.9%, 0.8%).1

Enclosed Prescribing Information

MOUNJARO® (tirzepatide) injection, for subcutaneous use, Lilly

Reference

1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.

Date of Last Review: January 13, 2026

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