Zepboundtirzepatide
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.
56,007 adverse event reports submitted to the FDA (2015–2026)
Top Reported Adverse Events
The most frequently reported events in association with Zepbound 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 11,467 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 5,707 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 4,333 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Extra Dose Administered 4,017 reports
A report that more doses of a medication were taken than directed. This is a usage category.
Full definition in the glossary →Drug Ineffective 3,303 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 →Diarrhoea 3,153 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 →Accidental Underdose 2,611 reports
A report that less of a medication was taken than intended, by accident. This is a usage category.
Full definition in the glossary →Vomiting 2,535 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Constipation 2,086 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →- Therapeutic Response Changed 1,860 reports
Injection Site Erythema 1,849 reports
Redness of the skin at the spot where a medication was injected. Erythema means skin redness.
Full definition in the glossary →Fatigue 1,733 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Injection Site Haemorrhage 1,592 reports
Bleeding at the spot where a medication was injected. Also spelled hemorrhage in American English.
Full definition in the glossary →Weight Increased 1,350 reports
Injection Site Bruising 1,304 reports
Bruising at the spot where a medication was injected.
Full definition in the glossary →
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 | 34,324 |
| Male | 8,606 |
| Unknown | 66 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 25 |
| 18-34 | 4,089 |
| 35-49 | 11,386 |
| 50-64 | 15,286 |
| 65-74 | 7,415 |
| 75+ | 2,708 |
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 Zepbound. 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 | 51,309 |
| Other Serious | 2,987 |
| Hospitalization | 1,814 |
| Disability | 192 |
| Life-Threatening | 183 |
| Death | 131 |
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 Zepbound. 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 |
|---|---|
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 6 |
| 2020 | 3 |
| 2021 | 12 |
| 2022 | 31 |
| 2023 | 115 |
| 2024 | 11,190 |
| 2025 | 32,072 |
| 2026 (partial) | 12,574 |
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.
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