Dulaglutide Side Effects: Common, Serious & FDA Warnings
Based on 86,000+ FDA adverse event reports, the most-reported dulaglutide reactions include nausea, injection site pain, and blood glucose increased. No active recalls are on record. The FDA-approved label carries a boxed warning.
WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), and Nonclinical Toxicology ( 13.1 )] . TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of TRULICITY and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with TRULICITY [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Dulaglutide causes thyroid C-cell tumors in rats. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).
Common Side Effects of Dulaglutide
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for dulaglutide. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Nausea | 10,199 | 11.8% |
| Injection Site Pain | 9,872 | 11.4% |
| Blood Glucose Increased | 9,831 | 11.3% |
| Diarrhoea | 5,948 | 6.9% |
| Vomiting | 5,608 | 6.5% |
| Incorrect Dose Administered | 5,535 | 6.4% |
| Inappropriate Schedule Of Product Administration | 3,831 | 4.4% |
| Weight Decreased | 3,390 | 3.9% |
| Decreased Appetite | 3,227 | 3.7% |
| Extra Dose Administered | 3,140 | 3.6% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
From the FDA-approved label, Section 5.1: Risk of Thyroid C-cell
Tumors In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure [see Nonclinical Toxicology ( 13.1 )] . Glucagon-like peptide-1 (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether TRULICITY will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.Show full Section 5.1
One case of MTC was reported in a patient treated with TRULICITY in a clinical trial. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). An additional case of C-cell hyperplasia with elevated calcitonin levels following treatment was reported in the cardiovascular outcomes trial (REWIND). Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. TRULICITY is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of TRULICITY and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with TRULICITY. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
From the FDA-approved label, Section 5.4: Hypersensitivity Reactions
There have been postmarketing reports of serious hypersensitivity reactions including anaphylactic reactions and angioedema in patients treated with TRULICITY [see Adverse Reactions ( 6.2 )] . If a hypersensitivity reaction occurs, discontinue TRULICITY; treat promptly per standard of care, and monitor until signs and symptoms resolve. TRULICITY is contraindicated in patients with a previous serious hypersensitivity reaction to dulaglutide or to any of the components of TRULICITY. Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with TRULICITY.
Dulaglutide Recalls
FDA enforcement actions matched to dulaglutide via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
No recalls are on record for this drug in the FDA enforcement database.
Show 2 closed recalls (2021 to 2022)
Includes resolved and terminated recalls matched to dulaglutide. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2022-05-25 | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions Cardinal Health Inc. | Class II | 1 box | Resolved |
| 2021-09-01 | Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product. Eli Lilly & Company | Class II | 119,539 4-packs | Terminated |
Dulaglutide Shortages
FDA-listed shortages of dulaglutide products. Strength and dosage-form level detail.
Is Dulaglutide Safe?
Dulaglutide is FDA-approved. The label's Warnings and Precautions section covers risk of thyroid c-cell (Section 5.1), pancreatitis (Section 5.2), hypoglycemia with concomitant use of insulin secretagogues or insulin patients receiving (Section 5.3), hypersensitivity reactions (Section 5.4), acute kidney (Section 5.5), severe gastrointestinal disease use of (Section 5.6), diabetic retinopathy complications in patients with a history of (Section 5.7), acute gallbladder disease (Section 5.8).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Dulaglutide is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
TRULICITY ® is 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 mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.Show full Indications and Usage
TRULICITY ® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated ( 1 ): 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 mellitus. To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. Limitations of Use: Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients ( 1 , 5.2 ). Not for treatment of type 1 diabetes mellitus ( 1 ). Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis ( 1 , 5.6 ). Limitations of Use TRULICITY: Has not been studied in patients with a history of pancreatitis [see Warnings and Precautions ( 5.2 )] . Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients [see Warnings and Precautions ( 5.6 )] .
Frequently Asked Questions
What are the most-reported side effects of dulaglutide?
Is dulaglutide the same as Trulicity?
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Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.