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REPORTED SIGNALS

tirzepatide

Mounjaro · Zepbound

Registration status unknownDrugglp-1Eli Lilly and Company
SUBCUTANEOUS

1 INDICATIONS AND USAGE ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.

Mechanism. 12.1 Mechanism of Action Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It contains a C20 fatty diacid that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1. GLP-1 is a physiological regulator of appetite and caloric intake. Nonclinical studies suggest the addition of GIP may further contribute to the regulation of food intake. Both GIP receptors and GLP-1 receptors are found in areas of the brain involved in appetite regulation. Animal studies show that tirzepatide distributes to and activates neurons in brain regions involved in regulation of appetite and food intake.

FDA BOXED WARNING

FDA requires a boxed warning on this label. See full prescribing information.

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140,435
reports (FAERS)
17.1%
reported as serious
725
fatal reports (0.5%)
30
signals above threshold
2022
first approved
2026-07
last updated
TIMELINE · FDA MILESTONES
Approved
2022
2021
2026
SIGNAL RANKING · ROR

What stands out in the reports.

On the labelNew signalUnknown & frequent
Symptom
0.1110100
ROR [95% CI]
Therapeutic Response Changed
72.8 [68.977.0]
Accidental Underdose
70.5 [68.073.0]
Injection SITE Injury
52.4 [49.255.7]
Extra DOSE Administered
47.2 [46.148.4]
Incorrect DOSE Administered
26.6 [26.227.0]
Eructation
23.4 [22.424.4]
Impaired Gastric Emptying
20.4 [19.321.5]
Hunger
20.3 [19.321.5]
Injection SITE Haemorrhage
10.4 [10.110.7]
Accidental Overdose
8.8 [8.49.2]
Injection SITE RASH
8.0 [7.68.4]
Injection SITE MASS
7.5 [7.27.9]
Injection SITE PAIN
7.4 [7.37.5]
Injection SITE Bruising
6.6 [6.46.8]
Injection SITE Pruritus
6.2 [5.96.4]

ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.

INTERPRETATION
Auto-generated

Tirzepatide reports show higher-than-average reporting for accidental overdose, underdose, and changed therapeutic response. These are logical given it’s an injectable medication requiring precise dosing. Injection site reactions like rash, mass, pain, bruising, and itching are also disproportionately reported, which is expected for any injectable drug. Remember, "frequently reported" does not mean "frequently caused." This does not replace medical advice.

This does not replace medical advice.

LABEL VERSUS REPORT
On the label

No signals currently mapped to the label.

Newly reported
Therapeutic Response Changed
Accidental Underdose
Injection SITE Injury
Extra DOSE Administered
Incorrect DOSE Administered
Eructation
Impaired Gastric Emptying
Hunger
REPORTS OVER TIME

Report volume per quarter.

2022202320242025
RECALL HISTORY · 0 ON RECORD

No recalls on record.

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SOURCE & CITATION
HealthProves. tirzepatide — reported signals. Retrieved 2026-07-04. Source: openFDA (FAERS). healthproves.com/tirzepatide/
FAERS140,435 records
Retrieved2026-07-04
MethodROR / disproportionality