{
 "query": "dulaglutide",
 "ingredient": "dulaglutide",
 "slug": "dulaglutide",
 "rxcui": "1551291",
 "brands": [
  "Trulicity"
 ],
 "names": [
  "dulaglutide"
 ],
 "classes": [
  {
   "id": "A10BJ",
   "name": "Glucagon-like peptide-1 (GLP-1) analogues"
  }
 ],
 "alternatives": [
  "albiglutide",
  "exenatide",
  "liraglutide",
  "lixisenatide",
  "semaglutide"
 ],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 7
  },
  "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. Dulaglutid...",
  "indications_and_usage": "\u00ae 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. TRULICITY \u00ae 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.",
  "contraindications": "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 )] . Patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 ( 4 ). Patients with a serious hypersensitivity reaction to dulaglutide or any of the product components ( 4 ).",
  "warnings_and_cautions": "Thyroid C-cell Tumors: See Boxed Warning ( 5.1 ). Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including TRULICITY. Discontinue if pancreatitis is suspected ( 5.2 ). Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary ( 5.3 ). Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) have occurred. Discontinue TRULICITY and promptly seek medical advice ( 5.4 ). Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion ( 5.5 ). Severe Gastrointestinal Adverse Reactions: Use may be associated with gastrointestinal adverse reactions, sometimes severe. TRULICITY is not recommended in patients with severe gastroparesis ( 5.6 ). Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy ( 5.7 ). Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected...",
  "warnings": "",
  "adverse_reactions": "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 \u22655%) 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. 6.1 Clinical Trials Experience Because clinical studies are condu...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions Severe Gastrointestinal Adverse Reactions ( 5.6 ) 03/2026",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) . Risk of Thyroid C-cell Tumors Inform patients that TRULICITY causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician [see Boxed Warning and Warnings and Precautions ( 5.1 )] . Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue TRULICITY promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions ( 5.2 )] . Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin Inform patients that the risk of hypoglycemia may be increased when TRULICITY is used in combination with an insulin secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions ( 5.3 )] ....",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: March 2026 TRU-0012-MG-20260312 Medication Guide TRULICITY \u00ae (TRU-li-si-tee) (dulaglutide) injection, for subcutaneous use Read this Medication Guide before you start using TRULICITY and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about TRULICITY? TRULICITY may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats or mice, TRULICITY and medicines that work like TRULICITY caused thyroid tumors, including thyroid cancer. It is not known if TRULICITY will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not use TRULICITY if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if ...",
  "clinical_studies": "14.1 Overview of Clinical Trials TRULICITY has been studied in adults as monotherapy and in combination with metformin, sulfonylurea, metformin and sulfonylurea, metformin and thiazolidinedione, sodium-glucose co-transporter-2 inhibitors (SGLT2i) with or without metformin, basal insulin with or without metformin, and prandial insulin with or without metformin. TRULICITY has also been studied in patients with type 2 diabetes mellitus and moderate to severe renal impairment. Dose escalation was performed in one trial in adults with TRULICITY doses up to 4.5 mg added to metformin. All other clinical studies in adults evaluated TRULICITY 0.75 mg and 1.5 mg without dose escalation; patients were initiated and maintained on either 0.75 mg or 1.5 mg for the duration of the trials [see Clinical Studies ( 14.2 , 14.3 , 14.4 )] . TRULICITY 0.75 mg and 1.5 mg was studied in pediatric patients 10 years of age and older with type 2 diabetes in combination with or without metformin and/or basal insulin treatment [see Clinical Studies ( 14.6 )] . In patients with type 2 diabetes mellitus, TRULICITY produced reductions from baseline in HbA1c compared to placebo. No overall differences in glycemic ...",
  "brand_name": "Trulicity",
  "manufacturer": "Eli Lilly and Company",
  "application_number": "BLA125469",
  "pharm_class_epc": [
   "GLP-1 Receptor Agonist [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260616",
  "set_id": "463050bd-2b1c-40f5-b3c3-0a04bb433309",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 88268,
  "serious": 22950,
  "death": 1674,
  "hospitalization": 10772,
  "primary_suspect": 88141,
  "top_reactions": [
   [
    "Nausea",
    10432
   ],
   [
    "Injection Site Pain",
    9959
   ],
   [
    "Blood Glucose Increased",
    9910
   ],
   [
    "Diarrhoea",
    6110
   ],
   [
    "Vomiting",
    5815
   ],
   [
    "Incorrect Dose Administered",
    5599
   ],
   [
    "Inappropriate Schedule Of Product Administration",
    3840
   ],
   [
    "Drug Ineffective",
    3680
   ],
   [
    "Weight Decreased",
    3425
   ],
   [
    "Decreased Appetite",
    3260
   ],
   [
    "Extra Dose Administered",
    3172
   ],
   [
    "Injection Site Haemorrhage",
    3165
   ],
   [
    "Glycosylated Haemoglobin Increased",
    2955
   ],
   [
    "Abdominal Pain Upper",
    2477
   ],
   [
    "Fatigue",
    2471
   ]
  ],
  "by_year": {
   "2019": 9349,
   "2020": 10730,
   "2021": 12646,
   "2022": 11152,
   "2023": 9509,
   "2024": 7283,
   "2025": 5871,
   "2026": 2469
  },
  "by_year_primary": {
   "2019": 9349,
   "2020": 10730,
   "2021": 12636,
   "2022": 11128,
   "2023": 9467,
   "2024": 7266,
   "2025": 5857,
   "2026": 2449
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220405",
   "reason": "TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions",
   "firm": "Cardinal Health Inc.",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20210819",
   "reason": "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.",
   "firm": "Eli Lilly & Company",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "20140918",
  "rems": false,
  "rems_last": "20171212",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "ELI LILLY AND CO"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/18/2014"
 },
 "trials": {
  "total": 143,
  "completed": 102,
  "terminated": 3,
  "with_results": 61,
  "industry": 82,
  "phase3": 36,
  "results_share": 0.5980392156862745,
  "terminated_share": 0.02097902097902098
 },
 "pubmed": {
  "rct": 115,
  "meta": 18,
  "recent_rct": 51,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 68374.89,
  "records": 3313,
  "by_name": [
   [
    "Trulicity",
    68374.89
   ]
  ],
  "names_checked": [
   "dulaglutide",
   "Trulicity"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4305141,
  "beneficiaries": 788716,
  "spend": 5454134725.1,
  "by_brand": [
   {
    "brand": "Trulicity",
    "claims": 4305141,
    "per_claim": 1266.8887558,
    "is_generic": false
   }
  ],
  "per_claim": 1266.888755815431
 },
 "mdl": [
  {
   "number": "3094",
   "title": "Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Products Liability Litigation",
   "judge": "Marston, Karen S.",
   "court": "PAE",
   "docket": "2:24-md-3094",
   "actions": "",
   "matched": "glp-1"
  },
  {
   "number": "3163",
   "title": "Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation",
   "judge": "Marston, Karen S.",
   "court": "PAE",
   "docket": "2:25-md-3163",
   "actions": "",
   "matched": "glp-1"
  }
 ],
 "dsc": [
  {
   "date": "20260113",
   "title": "FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications",
   "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp",
   "kind": "class",
   "matched": "glucagon-like peptide"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "dulaglutide",
  "matched": "dulaglutide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15572,
  "fills": 4305141,
  "per_million": 3617.0708462278003,
  "ratio": 1.306297032395174,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 64,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 1 Drug Safety Communication(s) about this drug's class since 2010 (-4)",
    "3,617 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-2)",
    "Death share in reports is near or below the FAERS average (0.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 60,
   "letter": "D",
   "why": [
    "115 randomized trials and 18 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III (-6)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 60,
   "letter": "D",
   "why": [
    "Pharma paid doctors $68,375 tied to this drug last year: negligible",
    "Named in 2 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 67,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are nausea, injection site pain, blood glucose increased, diarrhoea. How would we recognize and handle those?",
  "Why this one over albiglutide, exenatide, liraglutide? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}