Trulicity side effects
In Trulicity's FDA label (revised Jun 16, 2026), the most common side effects at 1.5 mg were nausea (21.1% vs 5.3% on placebo), vomiting (12.7% vs 2.3%) and diarrhea (12.6% vs 6.7%).
Source: FDA label on DailyMed (Eli Lilly and Company), revised , version 62. Read every day: a new FDA version updates this page by itself.
How often Trulicity side effects happened
Table 1: Adverse Reactions in Pool of Placebo-Controlled Trials That Occurred in ≥5% of TRULICITY-Treated Adult Patients with Type 2 Diabetes Mellitus
| Side effect | Trulicity 1.5 mg | Placebo |
|---|---|---|
| Nausea | 21.1% | 5.3% |
| Vomiting | 12.7% | 2.3% |
| Diarrhea | 12.6% | 6.7% |
| Abdominal pain | 9.4% | 4.9% |
| Decreased appetite | 8.6% | 1.6% |
| Indigestion | 5.8% | 2.3% |
| Fatigue | 5.6% | 2.6% |
People in the trial reporting each side effect, as FDA prints it. The placebo column is the rate among people given no medication, which is why a side effect can be common on both.
Boxed warning
- 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)] .
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
What the label warns about
Section 5 of the label, word for word.
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.
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.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
Acute Pancreatitis
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including TRULICITY [see Adverse Reactions (6)] .
After initiation of TRULICITY, observe patients carefully for signs and symptoms of acute pancreatitis which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue TRULICITY and initiate appropriate management.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
Patients receiving TRULICITY in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse Reactions (6.1) and Drug Interactions (7)].
The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
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.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
Acute Kidney Injury Due to Volume Depletion
There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, including TRULICITY [see Adverse Reactions (6.2)] . The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions (6.1)] . Monitor renal function in patients reporting adverse reactions to TRULICITY that could lead to volume depletion, especially during dosage initiation and escalation of TRULICITY.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
Severe Gastrointestinal Adverse Reactions
Use of TRULICITY has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)] . In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving TRULICITY (0.75 mg 2.2%, 1.5 mg 4.3%) than placebo (1.4%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.
TRULICITY is not recommended in patients with severe gastroparesis.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy
In a cardiovascular outcomes trial with a median follow up of 5.4 years involving patients with type 2 diabetes with established cardiovascular disease or multiple cardiovascular risk factors, diabetic retinopathy complications occurred in patients treated with TRULICITY 1.5 mg (1.9%) and placebo (1.5%). These events were prospectively ascertained as a secondary composite endpoint. The proportion of patients with diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline (TRULICITY 8.5%, placebo 6.2%) than among patients without a known history of diabetic retinopathy (TRULICITY 1%, placebo 1%).
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
Acute Gallbladder Disease
Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In a cardiovascular outcomes trial with a median follow up of 5.4 years, cholelithiasis occurred at a rate of 0.62/100 patient-years in TRULICITY-treated patients and 0.56/100 patient-years in placebo-treated patients after adjusting for prior cholecystectomy. Serious events of acute cholecystitis were reported in 0.5% and 0.3% of patients on TRULICITY and placebo respectively. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
Pulmonary Aspiration During General Anesthesia or Deep Sedation
TRULICITY delays gastric emptying [see Clinical Pharmacology (12.2)] . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.
Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking TRULICITY, including whether modifying preoperative fasting recommendations or temporarily discontinuing TRULICITY could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking TRULICITY.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
Who should not take Trulicity
TRULICITY is contraindicated in patients with:
- Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)] .
- Serious hypersensitivity reaction to dulaglutide or to any of the product components. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with TRULICITY [see Warnings and Precautions (5.4)] .
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
Trulicity, pregnancy and breastfeeding
Pregnancy
Risk Summary
Limited data with TRULICITY in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see Clinical Considerations]. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. TRULICITY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 6-times human exposure at the maximum recommended human dose (MRHD) of 4.5 mg/week. In pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 5-times human exposure at the MRHD. Adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide [see Data] .
The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an HbA1c >7% and has been reported to be as high as 20–25% in women with an HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
Clinical Considerations
Disease-associated maternal and/or embryo/fetal risk
Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.
Data
Animal Data
Pregnant rats given subcutaneous doses of 0.49, 1.63, or 4.89 mg/kg dulaglutide every 3 days during organogenesis had systemic exposures 2-, 6-, and 18-times human exposure at the maximum recommended human dose (MRHD) of 4.5 mg/week, respectively, based on plasma area under the time-concentration curve (AUC) comparison. Reduced fetal weights associated with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide were observed at ≥1.63 mg/kg. Irregular skeletal ossifications and increases in post-implantation loss also were observed at 4.89 mg/kg.
In pregnant rabbits given subcutaneous doses of 0.04, 0.12, or 0.41 mg/kg dulaglutide every 3 days during organogenesis, systemic exposures in pregnant rabbits were 0.5-, 2-, and 5-times human exposure at the MRHD, based on plasma AUC comparison. Fetal visceral malformation of lung lobular agenesis and skeletal malformations of the vertebrae and/or ribs were observed in conjunction with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide at 0.41 mg/kg.
In a prenatal-postnatal study in F 0 maternal rats given subcutaneous doses of 0.2, 0.49, or 1.63 mg/kg every third day from implantation through lactation, systemic exposures in pregnant rats were 1-, 2-, and 7-times human exposure at the MRHD, based on plasma AUC comparison. F 1 pups from F 0 maternal rats given 1.63 mg/kg dulaglutide had statistically significantly lower mean body weight from birth through postnatal day 63 for males and postnatal day 84 for females. F 1 offspring from F 0 maternal rats receiving 1.63 mg/kg dulaglutide had decreased forelimb and hindlimb grip strength and males had delayed balano-preputial separation. Females had decreased startle response. These physical findings may relate to the decreased size of the offspring relative to controls as they appeared at early postnatal assessments but were not observed at a later assessment. F 1 female offspring of the F 0 maternal rats given 1.63 mg/kg of dulaglutide had a longer mean escape time and a higher mean number of errors relative to concurrent control during 1 of 2 trials in the memory evaluation portion of the Biel water maze. These findings occurred in conjunction with decreased F 0 maternal food intake and decreased weight gain attributed to the pharmacologic activity at 1.63 mg/kg. The human relevance of these memory deficits in the F 1 female rats is not known.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
Breastfeeding
Risk Summary
There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The presence of dulaglutide in milk of treated lactating animals was not determined. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TRULICITY and any potential adverse effects on the breastfed infant from TRULICITY or from the underlying maternal condition.
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
What Trulicity interacts with
Oral Medications
TRULICITY delays gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. The delay in gastric emptying is dose-dependent but is attenuated with the recommended dose escalation to higher doses of TRULICITY [see Dosage and Administration (2.1)] . The delay is largest after the first dose and diminishes with subsequent doses. In clinical pharmacology studies, TRULICITY 1.5 mg did not affect the absorption of the tested orally administered medications to a clinically relevant degree [see Clinical Pharmacology (12.3)] . There is limited experience with the use of concomitant medications in clinical trials with TRULICITY doses of 3 mg and 4.5 mg.
Monitor drug levels of oral medications with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with TRULICITY.
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When initiating TRULICITY, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
All side-effect tables and trial data in the label
Everything the label reports under adverse reactions, in its own order.
The following serious reactions are described below or elsewhere in the prescribing information:
- Risk of Thyroid C-cell Tumors [see Warnings and Precautions (5.1)]
- Acute Pancreatitis [see Warnings and Precautions (5.2)]
- Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions (5.3)]
- Hypersensitivity Reactions [see Warnings and Precautions (5.4)]
- Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions (5.5)]
- Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.6)]
- Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy [see Warnings and Precautions (5.7)]
- Acute Gallbladder Disease [see Warnings and Precautions (5.8)]
- Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.9)]
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Adverse Reactions in the Clinical Trials in Adults with Type 2 Diabetes Mellitus
Pool of Adult Placebo-Controlled Trials for TRULICITY 0.75 mg and 1.5 mg Doses
The data in Table 1 are derived from a pool of placebo-controlled trials and include 1,670 adult patients with type 2 diabetes mellitus exposed to TRULICITY with a mean duration of exposure of 23.8 weeks [see Clinical Studies (14)] . The mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8 years, a mean HbA1c of 8.0%, and 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 mL/min/1.73 m 2 ) in 96%.
Table 1 shows adverse reactions, excluding hypoglycemia, occurring in ≥5% of TRULICITY treated adult patients and more commonly than placebo in a pool of placebo-controlled trials.
| Adverse Reaction | Placebo (N=568) % | TRULICITY 0.75 mg (N=836) % | TRULICITY 1.5 mg (N=834) % |
|---|---|---|---|
| Nausea | 5.3 | 12.4 | 21.1 |
| Diarrhea | 6.7 | 8.9 | 12.6 |
| Vomiting | 2.3 | 6.0 | 12.7 |
| Abdominal Pain | 4.9 | 6.5 | 9.4 |
| Decreased Appetite | 1.6 | 4.9 | 8.6 |
| Dyspepsia | 2.3 | 4.1 | 5.8 |
| Fatigue | 2.6 | 4.2 | 5.6 |
a Includes diarrhea, fecal volume increased, frequent bowel movements.
b Includes retching, vomiting, vomiting projectile.
c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain.
d Includes fatigue, asthenia, malaise.
Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction.
Gastrointestinal Adverse Reactions
In the pool of placebo-controlled trials, gastrointestinal (GI) adverse reactions occurred more frequently among patients who received TRULICITY compared to patients who received placebo (placebo 21%, 0.75 mg 32%, 1.5 mg 41%). A higher percentage of patients who received TRULICITY 0.75 mg (1.3%) and TRULICITY 1.5 mg (3.5%) discontinued treatment due to GI adverse reactions than patients who received placebo (0.2%). Investigators graded the severity of GI adverse reactions that occurred in those treated with 0.75 mg and 1.5 mg of TRULICITY as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 42% of cases, respectively, or “severe” in 7% and 11% of cases, respectively.
The following GI adverse reactions were reported more frequently in TRULICITY-treated patients than placebo -treated patients (frequencies listed, respectively, as: placebo; 0.75 mg; 1.5 mg): constipation (0.7%, 3.9%, 3.7%), flatulence (1.4%, 1.4%, 3.4%), abdominal distension (0.7%, 2.9%, 2.3%), gastroesophageal reflux disease (0.5%, 1.7%, 2.0%), and eructation (0.2%, 0.6%, 1.6%).
Adult Dose Ranging Trial for TRULICITY 3 mg and 4.5 mg Doses
Table 2 shows adverse reactions occurring ≥5% in any of the treatment groups through 36 weeks in a clinical trial with 1842 adult patients with type 2 diabetes mellitus treated with TRULICITY 1.5 mg, 3 mg, or 4.5 mg subcutaneously once weekly as an add-on to metformin [see Clinical Studies (14.3)] . The adverse reaction profile is consistent with previous clinical trials in adults.
| Adverse Reaction | TRULICITY 1.5 mg (N=612) % | TRULICITY 3 mg (N=616) % | TRULICITY 4.5 mg (N=614) % |
|---|---|---|---|
| Nausea | 13.4 | 15.6 | 16.4 |
| Diarrhea | 7.0 | 11.4 | 10.7 |
| Vomiting | 5.6 | 8.3 | 9.3 |
| Dyspepsia | 2.8 | 5.0 | 2.6 |
a Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction.
Other Adverse Reactions in Adults
Hypoglycemia
Table 3 summarizes the incidence of hypoglycemia in the placebo-controlled clinical studies in adult patients with type 2 diabetes mellitus: episodes with a glucose level <54 mg/dL with or without symptoms, and severe hypoglycemia, defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
| Placebo | TRULICITY 0.75 mg | TRULICITY 1.5 mg | |
| Add-on to Metformin | Add-on to Metformin | Add-on to Metformin | Add-on to Metformin |
| (26 weeks) | N=177 | N=302 | N=304 |
| Hypoglycemia with a glucose level <54 mg/dL | 0 | 0.3 | 0.7 |
| Severe hypoglycemia | 0 | 0 | 0 |
| Add-on to Metformin + Pioglitazone | Add-on to Metformin + Pioglitazone | Add-on to Metformin + Pioglitazone | Add-on to Metformin + Pioglitazone |
| (26 weeks) | N=141 | N=280 | N=279 |
| Hypoglycemia with a glucose level <54 mg/dL | 1.4 | 2.1 | 0 |
| Severe hypoglycemia | 0 | 0 | 0 |
| Add-on to Glimepiride | Add-on to Glimepiride | Add-on to Glimepiride | Add-on to Glimepiride |
| (24 weeks) | N=60 | - | N=239 |
| Hypoglycemia with a glucose level <54 mg/dL | 0 | - | 3.3 |
| Severe hypoglycemia | 0 | - | 0 |
| In Combination with Insulin Glargine ± Metformin | In Combination with Insulin Glargine ± Metformin | In Combination with Insulin Glargine ± Metformin | In Combination with Insulin Glargine ± Metformin |
| (28 weeks) | N=150 | - | N=150 |
| Hypoglycemia with a glucose level <54 mg/dL | 9.3 | - | 14.7 |
| Severe hypoglycemia | 0 | - | 0.7 |
| Add-on to SGLT2i ± Metformin | Add-on to SGLT2i ± Metformin | Add-on to SGLT2i ± Metformin | Add-on to SGLT2i ± Metformin |
| (24 weeks) | N=140 | N=141 | N=142 |
| Hypoglycemia with a glucose level <54 mg/dL | 0.7 | 0.7 | 0.7 |
| Severe hypoglycemia | 0 | 0.7 | 0 |
Hypoglycemia was more frequent when TRULICITY was used in combination with a sulfonylurea or insulin than when used with non-secretagogues. In a 78-week adult clinical trial, hypoglycemia (glucose level <54 mg/dL) occurred in 20% and 21% of patients when TRULICITY 0.75 mg and 1.5 mg, respectively, were co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when TRULICITY 0.75 mg and 1.5 mg, respectively, were co-administered with a sulfonylurea. In a 52-week adult clinical trial, hypoglycemia (glucose level <54 mg/dL) occurred in 77% and 69% of patients when TRULICITY 0.75 mg and 1.5 mg, respectively, were co-administered with prandial insulin. Severe hypoglycemia occurred in 2.7% and 3.4% of patients when TRULICITY 0.75 mg and 1.5 mg, respectively, were co-administered with prandial insulin. Refer to Table 3 for the incidence of hypoglycemia in patients treated in combination with basal insulin glargine.
In the clinical trial with adult patients on TRULICITY 1.5 mg, TRULICITY 3 mg, or TRULICITY 4.5 mg once weekly, as add-on to metformin, incidences of hypoglycemia (glucose level <54 mg/dL) through 36 weeks were 1.1%, 0.3%, and 1.1%, respectively, and incidences of severe hypoglycemia were 0.2%, 0%, and 0.2%, respectively.
Cholelithiasis and Cholecystitis
In a cardiovascular outcomes trial in adult patients with type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple cardiovascular risk factors with a median follow up of 5.4 years [see Clinical Studies 14.5] , cholelithiasis occurred at a rate of 0.62/100 patient-years in TRULICITY-treated patients and 0.56/100 patient-years in placebo-treated patients after adjusting for prior cholecystectomy. Serious events of acute cholecystitis were reported in 0.5% and 0.3% of patients on TRULICITY and placebo respectively.
Heart Rate Increase and Tachycardia-Related Adverse Reactions
In adult patients, TRULICITY 0.75 mg and 1.5 mg resulted in a mean increase in heart rate (HR) of 2-4 beats per minute (bpm).
Adverse reactions of sinus tachycardia were reported more frequently in patients exposed to TRULICITY. Sinus tachycardia was reported in 3.0%, 2.8%, and 5.6% of patients treated with placebo, TRULICITY 0.75 mg and TRULICITY 1.5 mg, respectively. Persistence of sinus tachycardia (reported at more than 2 visits) was reported in 0.2%, 0.4% and 1.6% of patients treated with placebo, TRULICITY 0.75 mg and TRULICITY 1.5 mg, respectively. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of ≥15 beats per minute, were reported in 0.7%, 1.3% and 2.2% of patients treated with placebo, TRULICITY 0.75 mg and TRULICITY 1.5 mg, respectively.
Hypersensitivity
Systemic hypersensitivity adverse reactions, sometimes severe (e.g., severe urticaria, systemic rash, facial edema, lip swelling), occurred in 0.5% of adult patients on TRULICITY in clinical studies.
Injection-site Reactions
In the placebo-controlled studies in adults, injection-site reactions (e.g., injection-site rash, erythema) were reported in 0.5% of TRULICITY-treated patients and in 0.0% of placebo-treated patients.
PR Interval Prolongation and Adverse Reactions of First-Degree Atrioventricular (AV) Block
A mean increase from baseline in PR interval of 2-3 milliseconds was observed in TRULICITY-treated adult patients in contrast to a mean decrease of 0.9 milliseconds in placebo-treated patients. The adverse reaction of first-degree AV block occurred more frequently in patients treated with TRULICITY than placebo (0.9%, 1.7% and 2.3% for placebo, TRULICITY 0.75 mg and TRULICITY 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5% and 3.2% of patients treated with placebo, TRULICITY 0.75 mg and TRULICITY 1.5 mg, respectively.
Acute Pancreatitis
In a pooled analysis from the original registration studies, 12 (3.4 cases per 1,000 patient years) pancreatitis-related adverse reactions were reported in patients exposed to TRULICITY versus 3 in non-incretin comparators (2.7 cases per 1000 patient years). An analysis of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to TRULICITY (1.4 cases per 1,000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1,000 patient years).
Based on an analysis of adjudicated events in a clinical trial evaluating Trulicity 1.5 mg, 3 mg, or 4.5 mg once weekly, pancreatitis occurred in 1 patient exposed to TRULICITY 1.5 mg (0.2%), in 2 patients exposed to TRULICITY 3 mg (0.3%), and 3 patients exposed to TRULICITY 4.5 mg (0.5%).
Amylase and Lipase Increase
Adult patients exposed to TRULICITY had mean increases from baseline in lipase and/or pancreatic amylase of 14% to 20%, while placebo-treated patients had mean increases of up to 3%.
Adverse Reactions in the Clinical Trial of Pediatric Patients 10 Years of Age and Older with Type 2 Diabetes Mellitus
TRULICITY was administered to 150 pediatric patients 10 years of age and older with type 2 diabetes mellitus for a mean duration of 41.3 weeks [ see Clinical Studies (14.6) ]. The mean age was 14.5 years and 71% of patients were female. Overall, 55% were White, 15% were Black or African American, 12% were Asian, 10% were American Indian or Alaska Native, 5% were other races, and 3% had unknown race. Additionally, 55% were Hispanic or Latino, 42% were not Hispanic or Latino, and 3% had unknown ethnicity. At baseline, the mean duration of type 2 diabetes mellitus was 2 years, mean HbA1c was 8.1%, mean weight was 90.5 kg and mean BMI was 34.1 kg/m 2 .
The safety profile in pediatric patients treated with TRULICITY 0.75 mg and 1.5 mg subcutaneously once-weekly was consistent with that described above for adult patients with type 2 diabetes mellitus with the exception of injection site reactions. In pediatric patients, the incidence of injection site reactions was 3.9% (2 patients) in the TRULICITY 0.75 mg group, 3.8% (2 patients) in the TRULICITY 1.5 mg group, and 2.0% (1 patient) in the placebo group.
Postmarketing Experience
The following additional adverse reactions have been reported during post-approval use of TRULICITY. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Gastrointestinal: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death, ileus, intestinal obstruction, severe constipation including fecal impaction
- Hepatobiliary: cholecystitis, cholelithiasis requiring cholecystectomy, cholestasis, elevation of liver enzymes, hepatitis
- Hypersensitivity: anaphylactic reactions, angioedema
- Neurologic : dysgeusia, dysesthesia
- Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation
- Renal: acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis
- Skin and Subcutaneous Tissue: alopecia
Source: Trulicity prescribing information (FDA label on DailyMed), revised 2026-06-16
What changed for Dulaglutide
- FDA labelFDA label updated: Trulicity (Eli Lilly and Company), effective 2026-06-16
- FDAFDA approved a labeling supplement for Trulicity
- FDAFDA approved a labeling supplement for Trulicity
Written from each source's own record as it changes. Every change on GLPcompare
What people have reported to FDA about Trulicity
87,279 reports name Trulicity, 21,756 of them marked serious, in FDA's file of Oct 28, 2026. Anyone can file a report and a report names every medicine the person took, so these counts cannot show that Trulicity caused a problem or how often it happens. For how often, use the trial rates above.
Symptoms reported most
- Nausea10,397
- Injection site pain9,978
- Blood glucose increased9,865
- Diarrhea6,065
- Vomiting5,813
- Weight decreased3,360
- Decreased appetite3,210
- Bleeding at the injection site3,164
- Glycosylated haemoglobin increased2,917
- Upper abdominal pain2,479
- Fatigue2,421
- Abdominal pain2,388
Pen, dose and use problems reported most
- Incorrect dose administered5,645
- Inappropriate schedule of product administration3,831
- Drug ineffective3,676
- Extra dose administered3,197
- Accidental underdose2,369
- Product dose omission issue2,312
- Off label use1,904
- Accidental overdose1,885
- Drug dose omission1,332
- Underdose1,065
- Overdose962
- Product dose omission723
Counted through openFDA from FDA's Adverse Event Reporting System. One report can list several problems.
Trulicity side effects: common questions
What are the most common side effects of Trulicity?
In Trulicity's FDA label (revised Jun 16, 2026), the most common side effects at 1.5 mg were nausea (21.1% vs 5.3% on placebo), vomiting (12.7% vs 2.3%) and diarrhea (12.6% vs 6.7%). These come from FDA's table of placebo-controlled trials (Table 1: Adverse Reactions in Pool of Placebo-Controlled Trials That Occurred in ≥5% of TRULICITY-Treated Adult Patients with Type 2 Diabetes Mellitus).
Does Trulicity cause fatigue?
In its FDA label, 5.6% of people taking Trulicity at 1.5 mg reported fatigue, against 2.6% on placebo.
Does Trulicity cause hair loss?
Its FDA label lists alopecia among side effects reported after approval, without a rate: reports like these come from people using it in practice, so they cannot say how often it happens or prove the medicine caused it.
What serious side effects does the Trulicity label warn about?
Its Warnings and Precautions section covers Risk of Thyroid C-cell Tumors; Acute Pancreatitis; Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin; Hypersensitivity Reactions; Acute Kidney Injury Due to Volume Depletion; Severe Gastrointestinal Adverse Reactions; Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy; Acute Gallbladder Disease; and Pulmonary Aspiration During General Anesthesia or Deep Sedation.
Does Trulicity have a boxed warning?
Yes. 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...
Can you take Trulicity while pregnant?
Limited data with TRULICITY in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage.
Can you take Trulicity while breastfeeding?
There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production.
Should you stop Trulicity before surgery?
Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking TRULICITY, including whether modifying preoperative fasting recommendations or temporarily discontinuing TRULICITY could reduce the incidence of retained gastric contents.
Does Trulicity cause withdrawal symptoms?
The warnings and side effect sections of its FDA label do not list any. What trials do show after people stop a GLP-1 is weight coming back. What happens when you stop a GLP-1
Who should not take Trulicity?
TRULICITY is contraindicated in patients with: Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Serious hypersensitivity reaction to dulaglutide or to any of the product components. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with TRULICITY.
How many side effect reports has FDA received about Trulicity?
FDA's adverse event system holds 87,279 reports that name Trulicity, 21,756 of them marked serious. The most reported symptoms are nausea, injection site pain, blood glucose increased. Anyone can file a report and a report names every medicine the person took, so these cannot show that Trulicity caused a problem or how often it happens. The trial rates in its label do that.
Trial rates describe groups, not what one person will feel. Talk to your clinician before starting, stopping or changing a medicine. Label revised Jun 16, 2026.