Mounjaro Kwikpentirzepatide
According to the FDA label: 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.
87,221 adverse event reports submitted to the FDA (2016–2026)
Top Reported Adverse Events
The most frequently reported events in association with Mounjaro Kwikpen in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Incorrect Dose Administered 16,761 reports
A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Nausea 8,946 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Injection Site Pain 8,917 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Off Label Use 7,479 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Diarrhoea 5,387 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Extra Dose Administered 5,015 reports
A report that more doses of a medication were taken than directed. This is a usage category.
Full definition in the glossary →Vomiting 4,629 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Injection Site Haemorrhage 3,464 reports
Bleeding at the spot where a medication was injected. Also spelled hemorrhage in American English.
Full definition in the glossary →Constipation 3,302 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →Injection Site Erythema 2,968 reports
Redness of the skin at the spot where a medication was injected. Erythema means skin redness.
Full definition in the glossary →Product Dose Omission Issue 2,911 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Blood Glucose Increased 2,756 reports
A blood test result showing a higher than normal blood sugar level.
Full definition in the glossary →Fatigue 2,256 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 2,208 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Decreased Appetite 2,207 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 52,581 |
| Male | 19,748 |
| Unknown | 5 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 55 |
| 18-34 | 4,642 |
| 35-49 | 15,007 |
| 50-64 | 23,349 |
| 65-74 | 11,249 |
| 75+ | 4,009 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Mounjaro Kwikpen. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 66,466 |
| Other Serious | 15,249 |
| Hospitalization | 7,507 |
| Life-Threatening | 1,026 |
| Disability | 844 |
| Death | 688 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Mounjaro Kwikpen. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2016 | 5 |
| 2017 | 6 |
| 2018 | 3 |
| 2019 | 22 |
| 2020 | 29 |
| 2021 | 30 |
| 2022 | 5,036 |
| 2023 | 20,761 |
| 2024 | 22,618 |
| 2025 | 31,662 |
| 2026 (partial) | 7,049 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Mounjaro Kwikpen
In FDA adverse event reports that mention Mounjaro Kwikpen, these medications appeared most often in the same report.
- Metformin (4,552 reports)
- Empagliflozin (1,759 reports)
- Semaglutide (1,579 reports)
- Insulin Glargine (1,549 reports)
- Omeprazole (1,235 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026