35/100 · Moderate
Manufactured by Eli Lilly and Company
Tirzepatide Adverse Events Show Mostly Non-Serious Reactions
196,029 FDA adverse event reports analyzed
Last updated: 2026-05-12
TIRZEPATIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Eli Lilly and Company. Based on analysis of 196,029 FDA adverse event reports, TIRZEPATIDE has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for TIRZEPATIDE include INCORRECT DOSE ADMINISTERED, INJECTION SITE PAIN, NAUSEA, EXTRA DOSE ADMINISTERED, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TIRZEPATIDE.
Tirzepatide has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 196,029 adverse event reports for this medication, which is primarily manufactured by Eli Lilly And Company.
The most commonly reported adverse events include Incorrect Dose Administered, Injection Site Pain, Nausea. Of classified reports, 16.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most reactions were non-serious, with the majority being gastrointestinal issues.
Incorrect dose administration was a common issue, indicating potential misuse. Serious adverse events were relatively low, but injection site reactions were frequent.
Patients taking Tirzepatide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are not commonly reported, but patients should be cautious with off-label use and ensure correct dosing. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tirzepatide received a safety concern score of 35/100 (moderate concern). This is based on a 16.7% serious event ratio across 120,871 classified reports. The score accounts for 196,029 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 74,456, Male: 24,157, Unknown: 71. The most frequently reported age groups are age 55 (2,571 reports), age 54 (2,391 reports), age 53 (2,327 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 120,871 classified reports for TIRZEPATIDE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Drug interactions are not commonly reported, but patients should be cautious with off-label use and ensure correct dosing.
If you are taking Tirzepatide, here are important things to know. The most commonly reported side effects include incorrect dose administered, injection site pain, nausea, extra dose administered, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow the prescribed dose and administration instructions. Report any unusual symptoms to your healthcare provider promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety profile of Tirzepatide, and patients should report any adverse events to their healthcare provider.
The FDA has received approximately 196,029 adverse event reports associated with Tirzepatide. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Tirzepatide include Incorrect Dose Administered, Injection Site Pain, Nausea, Extra Dose Administered, Off Label Use. By volume, the top reported reactions are: Incorrect Dose Administered (25,919 reports), Injection Site Pain (12,325 reports), Nausea (12,028 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tirzepatide.
Out of 120,871 classified reports, 20,206 (16.7%) were classified as serious and 100,665 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Tirzepatide break down by patient sex as follows: Female: 74,456, Male: 24,157, Unknown: 71. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Tirzepatide adverse events are: age 55: 2,571 reports, age 54: 2,391 reports, age 53: 2,327 reports, age 56: 2,287 reports, age 57: 2,222 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Tirzepatide adverse event reports is Eli Lilly And Company. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Tirzepatide include: Diarrhoea, Vomiting, Injection Site Haemorrhage, Accidental Underdose, Injection Site Erythema. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Tirzepatide to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Tirzepatide has a safety concern score of 35 out of 100 (moderate concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Most reactions were non-serious, with the majority being gastrointestinal issues.
Key safety signals identified in Tirzepatide's adverse event data include: Incorrect dose administration. Injection site pain and hemorrhage. Gastrointestinal issues like nausea and diarrhea. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are not commonly reported, but patients should be cautious with off-label use and ensure correct dosing. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tirzepatide.
Always follow the prescribed dose and administration instructions. Report any unusual symptoms to your healthcare provider promptly.
Tirzepatide has 196,029 adverse event reports on file with the FDA. Incorrect dose administration was a common issue, indicating potential misuse. The volume of reports for Tirzepatide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of Tirzepatide, and patients should report any adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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