Skip to main content

What the label lists and what reports show

Dulaglutide side effects

Dulaglutide's FDA label: “Most common adverse reactions (incidence ≥5%) are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite ( 6.1 ).” FAERS holds 88,160 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (10,405 reports).

  • No generic listed
  • Boxed warning

Check it at the source: the dulaglutide FDA label on DailyMed (effective June 16, 2026, Eli Lilly and Company); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of TRULICITY?

TRULICITY may cause serious side effects, including: See “ What is the most important information I should know about TRULICITY? ” inflammation of your pancreas (pancreatitis). Stop using TRULICITY and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use TRULICITY with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or light-headedness sweating confusion or drowsiness headache blurred vision slurred speech shakiness fast heartbeat anxiety, irritability, or mood changes hunger weakness feeling jittery serious allergic reactions. […]

Source: FDA drug label, Eli Lilly and Company, effective June 16, 2026 (SPL set 463050bd-2b1c-40f5-b3c3-0a04bb433309), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence ≥5%) are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite ( 6.1 ).

Table 3: Incidence (%) of Hypoglycemia in Adult Patients with Type 2 Diabetes Mellitus in Placebo-Controlled Trials

(26 weeks)Placebo N=177TRULICITY 0.75 mg N=302TRULICITY 1.5 mg N=304
Hypoglycemia with a glucose level <54 mg/dL00.30.7
Severe hypoglycemia000
Hypoglycemia with a glucose level <54 mg/dL1.42.10
Severe hypoglycemia000
Hypoglycemia with a glucose level <54 mg/dL0-3.3
Severe hypoglycemia0-0
Hypoglycemia with a glucose level <54 mg/dL9.3-14.7
Severe hypoglycemia0-0.7
Hypoglycemia with a glucose level <54 mg/dL0.70.70.7
Severe hypoglycemia00.70

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

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 )] Most common adverse reactions (incidence ≥5%) are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Source: FDA drug label, Eli Lilly and Company, effective June 16, 2026 (SPL set 463050bd-2b1c-40f5-b3c3-0a04bb433309), via openFDA; the full label on DailyMed

What do FAERS reports show?

88,160 reports list dulaglutide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,676 are coded as a death and 10,732 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Nausea (named in the label)10,405
  • Injection Site Pain9,956
  • Blood Glucose Increased9,904
  • Diarrhoea (named in the label)6,090
  • Vomiting (named in the label)5,787
  • Incorrect Dose Administered (a use or a product term, not a reaction)5,598
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)3,838
  • Drug Ineffective (a use or a product term, not a reaction)3,678
  • Weight Decreased3,419
  • Decreased Appetite (named in the label)3,255
  • Extra Dose Administered3,170
  • Injection Site Haemorrhage3,164
  • Glycosylated Haemoglobin Increased2,954
  • Abdominal Pain Upper (named in the label)2,473
  • Fatigue (named in the label)2,470
  • Accidental Underdose (a use or a product term, not a reaction)2,367
  • Constipation (named in the label)2,342
  • Abdominal Pain (named in the label)2,333
  • Product Dose Omission Issue (a use or a product term, not a reaction)2,278
  • Malaise (named in the label)2,082
  • Injection Site Bruising1,951
  • Off Label Use (a use or a product term, not a reaction)1,910
  • Accidental Overdose (a use or a product term, not a reaction)1,888
  • Dizziness (named in the label)1,874
  • Blood Glucose Decreased1,847

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Dulaglutide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions