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This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Zepbound Kwikpen (tirzepatide)

glp-1 receptor agonist
Last updated: June 18, 2026
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Zepbound Kwikpen is the brand name for tirzepatide, a glp-1 receptor agonist. According to the FDA-approved 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 condit. FAERS contains 140,435 submissions naming this drug from 2015 through 2026; the top three reactions cited are incorrect dose administered, nausea, and injection site pain.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Zepbound Kwikpen. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

INCORRECT DOSE ADMINISTERED 28,115 (20.0%) NAUSEA 14,290 (10.2%) INJECTION SITE PAIN 13,177 (9.4%) EXTRA DOSE ADMINISTERED 9,000 (6.4%) DIARRHOEA 8,305 (5.9%) OFF LABEL USE 8,291 (5.9%) VOMITING 6,887 (4.9%) DRUG INEFFECTIVE 5,415 (3.9%) CONSTIPATION 5,248 (3.7%) INJECTION SITE HAEMORRHAGE 5,035 (3.6%) INJECTION SITE ERYTHEMA 4,771 (3.4%) ACCIDENTAL UNDERDOSE 4,607 (3.3%) PRODUCT DOSE OMISSION ISSUE 4,162 (3.0%) FATIGUE 3,845 (2.7%) INJECTION SITE BRUISING 3,266 (2.3%)

Patient Demographics

Patient sex and age across the FAERS submissions that named Zepbound Kwikpen. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

Female Male Unknown

By Age Group

0-17 18-44 45-64 65+

Severity Outcomes

Severity flags recorded across the 140,435 FAERS submissions that named Zepbound Kwikpen. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

DEATH 775 (0.6%) HOSPITALIZATION 8,670 (6.2%) LIFE-THREATENING 1,090 (0.8%) DISABLING 956 (0.7%)

Submissions Per Quarter

Quarterly count of FAERS submissions that named Zepbound Kwikpen. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Zepbound Kwikpen. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

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 no...

Adverse Reactions (from label)

6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.3 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.4 )] Acute Pancreatitis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Hypoglycemia [see Warnings and Precautions ( 5.7 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] The most common adverse reactions, reported in ≥5% of patients treated with ZEPBOUND are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, gastroesophageal reflux disease. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545...

FDA label effective date: 2026-04-22

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.