45/100 · Moderate
Manufactured by Eli Lilly and Company
Dulaglutide Adverse Events: Common Nausea and Injection Site Issues
151,183 FDA adverse event reports analyzed
Last updated: 2026-05-12
DULAGLUTIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Eli Lilly and Company. Based on analysis of 151,183 FDA adverse event reports, DULAGLUTIDE has a safety score of 45 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for DULAGLUTIDE include NAUSEA, INJECTION SITE PAIN, BLOOD GLUCOSE INCREASED, DIARRHOEA, INCORRECT DOSE ADMINISTERED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DULAGLUTIDE.
Dulaglutide has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 151,183 adverse event reports for this medication, which is primarily manufactured by Eli Lilly And Company.
The most commonly reported adverse events include Nausea, Injection Site Pain, Blood Glucose Increased. Of classified reports, 25.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and injection site pain are the most common adverse events.
Serious adverse events account for 25.3% of total reports. Weight decrease and decreased appetite are reported but less frequently.
Patients taking Dulaglutide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Dulaglutide can cause injection site hemorrhage and bruising. Ensure proper injection technique and monitor for these issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dulaglutide received a safety concern score of 45/100 (moderate concern). This is based on a 25.3% serious event ratio across 85,620 classified reports. The score accounts for 151,183 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: 44,406, Male: 32,394, Unknown: 11. The most frequently reported age groups are age 65 (1,452 reports), age 60 (1,279 reports), age 66 (1,233 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 85,620 classified reports for DULAGLUTIDE:
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.
Dulaglutide can cause injection site hemorrhage and bruising. Ensure proper injection technique and monitor for these issues.
If you are taking Dulaglutide, here are important things to know. The most commonly reported side effects include nausea, injection site pain, blood glucose increased, diarrhoea, incorrect dose administered. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for injection site issues such as pain, hemorrhage, and bruising. Follow prescribed dosing instructions to avoid incorrect dose administration. 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 dulaglutide for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 151,183 adverse event reports associated with Dulaglutide. 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 Dulaglutide include Nausea, Injection Site Pain, Blood Glucose Increased, Diarrhoea, Incorrect Dose Administered. By volume, the top reported reactions are: Nausea (9,986 reports), Injection Site Pain (9,796 reports), Blood Glucose Increased (9,762 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dulaglutide.
Out of 85,620 classified reports, 21,653 (25.3%) were classified as serious and 63,967 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 Dulaglutide break down by patient sex as follows: Female: 44,406, Male: 32,394, Unknown: 11. 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 Dulaglutide adverse events are: age 65: 1,452 reports, age 60: 1,279 reports, age 66: 1,233 reports, age 62: 1,229 reports, age 64: 1,207 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 Dulaglutide 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 Dulaglutide include: Vomiting, Inappropriate Schedule Of Product Administration, Drug Ineffective, Weight Decreased, Decreased Appetite. 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 Dulaglutide 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.
Dulaglutide has a safety concern score of 45 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. Nausea and injection site pain are the most common adverse events.
Key safety signals identified in Dulaglutide's adverse event data include: Injection site hemorrhage and bruising are key safety signals.. Incorrect dose administration and drug ineffectiveness are significant issues.. Serious adverse events such as death and acute kidney injury are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Dulaglutide can cause injection site hemorrhage and bruising. Ensure proper injection technique and monitor for these issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dulaglutide.
Monitor for injection site issues such as pain, hemorrhage, and bruising. Follow prescribed dosing instructions to avoid incorrect dose administration.
Dulaglutide has 151,183 adverse event reports on file with the FDA. Serious adverse events account for 25.3% of total reports. The volume of reports for Dulaglutide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor dulaglutide for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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