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Trulicity ® (dulaglutide) injection
0.75 mg/0.5 mL, 1.5 mg/0.5 mL, 3mg/0.5mL, 4.5mg/0.5mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Is Trulicity® (dulaglutide) treatment associated with major depressive disorder or suicide?
No information about major depressive disorder, depression, self-injury, self-harm, suicidal behavior and ideation, or suicide is included in the current US Trulicity (dulaglutide) prescribing information.
See important safety information, including boxed warning, in the attached prescribing information.
Approved Indication
Dulaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) indicated
- as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes, and
- to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors.1
Dulaglutide and Major Depressive Disorder, Depression, Self-Injury, Self-Harm, Suicidal Behavior and Ideation, or Suicide
No information about major depressive disorder, depression, self-injury, self-harm, suicidal behavior and ideation, or suicide is included in the current US Trulicity (dulaglutide) prescribing information.1
Patient safety is Eli Lilly and Company’s top priority, and we actively engage in evaluating, monitoring, and reporting safety information for all our medicines. If new information indicates a new safety concern or signal for the product or the class, including postmarketing experience, the prescribing information will be properly updated in alignment with regulatory authorities.2
Enclosed Prescribing Information
References
1Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
2US Food and Drug Administration. Frequently asked questions about labeling for prescription medicines for healthcare professionals. Updated April 1, 2024. Accessed August 19, 2024. https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/frequently-asked-questions-about-labeling-prescription-medicines
Date of Last Review: August 13, 2024