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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

Wat opvalt in de meldingen.

In bijsluiterNieuw signaalOnbekend & frequent
Symptoom
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-schaal). Een waarde boven 1 betekent dat het symptoom vaker wordt gemeld voor dit product dan voor alle andere producten samen. Dit meet hoeveel het opvalt in meldingen — geen causaliteit, geen risico.

INTERPRETATION
Auto-gegenereerd

Tirzepatide wordt vaak gemeld met bijwerkingen rond de injectieplaats, zoals uitslag, pijn, jeuk, blauwe plekken en een massa. Dit is logisch, omdat het middel via injectie wordt toegediend. Ook worden overdosering, onderdosering en verandering van therapeutische respons relatief vaak gemeld. Dit kan komen door de complexe dosering of de aard van de ziekte. 'Vaak gemeld' is niet hetzelfde als 'vaak veroorzaakt'. Dit vervangt geen medisch advies.

Dit vervangt geen medisch advies.

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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BRON & CITATIE
HealthProves. tirzepatide — reported signals. Retrieved 2026-07-04. Source: openFDA (FAERS). healthproves.com/tirzepatide/
FAERS140,435 records
Opgehaald2026-07-04
MethodeROR / disproportionaliteit