{
 "query": "tirzepatide",
 "ingredient": "tirzepatide",
 "slug": "tirzepatide",
 "rxcui": "2601723",
 "brands": [
  "Mounjaro",
  "Zepbound"
 ],
 "names": [
  "tirzepatide"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 8
  },
  "boxed_warning": "WARNING: RISK OF THYROID C-CELL TUMORS In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND 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 ZEPBOUND [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. In rats, tirzepatide causes thyroid C-cell...",
  "indications_and_usage": "\u00ae is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.",
  "contraindications": "is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions ( 5.1 )] . Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.2 )] . Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 ( 4 ) Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND ( 4 )",
  "warnings_and_cautions": "Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. ZEPBOUND is not recommended in patients with severe gastroparesis. ( 5.2 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.3 ) Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated. ( 5.4 ) Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND. Discontinue if pancreatitis is suspected. ( 5.5 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue ZEPBOUND. ( 5.6 ) Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.3 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.4 )] Acute Pancreatitis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Hypoglycemia [see Warnings and Precautions ( 5.7 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] The most common adverse reactions, reported in \u22655% of patients treated with ZEPBOUND are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, gastroesophageal reflux disease. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-8...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.4 ) 01/2026 Warnings and Precautions Severe Gastrointestinal Adverse Reactions ( 5.2 ) 02/2026 Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus ( 5.8 ) 08/2026 Suicidal Behavior and Ideation (Removed) 02/2026 Never Share a ZEPBOUND KwikPen Between Patients ( 5.10 ) 01/2026",
  "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 ZEPBOUND causes 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 healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1 )] . Severe Gastrointestinal Adverse Reactions Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions ( 5.2 )] . Acute Kidney Injury Due to Volume Depletion Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea...",
  "spl_medguide": "PATIENT MEDICATION GUIDE This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 08/2026 Medication Guide ZEPBOUND \u00ae (ZEHP-bownd) (tirzepatide) injection, for subcutaneous use Do not share your ZEPBOUND KwikPen or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. What is the most important information I should know about ZEPBOUND? ZEPBOUND 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, ZEPBOUND and medicines that work like ZEPBOUND caused thyroid tumors, including thyroid cancer. It is not known if ZEPBOUND will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not use ZEPBOUND if you or any of your family have ever had a type of thyroid cancer called MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). What is ...",
  "clinical_studies": "14.1 Weight Reduction and Long-Term Maintenance Studies in Adults with Obesity or Overweight Weight Reduction in Adults with Obesity or Overweight, with or without Type 2 Diabetes Mellitus (Study 1 and Study 2) Overview of Study 1 and Study 2 The efficacy of ZEPBOUND for weight reduction in conjunction with a reduced-calorie diet and increased physical activity was studied in two randomized, double-blind, placebo-controlled fixed-dosage trials (Study 1 and Study 2) in adults aged 18 years and older. In Studies 1 and 2, all patients received a standard lifestyle intervention which included instruction on a reduced-calorie diet (approximately 500 kcal/day deficit) and increased physical activity counseling (recommended minimum of 150 min/week) that began with the first dose of study medication or placebo and continued throughout the trial. Patients also received counseling on behavior modification strategies to adhere to diet and exercise recommendations. In both trials, weight reduction was assessed after 72 weeks of treatment (at least 52 weeks at maintenance dose). Study 1 (NCT04184622) was a 72-week trial that enrolled 2,539 adult patients with obesity (BMI \u226530 kg/m 2 ), or with ...",
  "brand_name": "Zepbound",
  "manufacturer": "Eli Lilly and Company",
  "application_number": "NDA217806",
  "pharm_class_epc": [
   "Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]",
   "GLP-1 Receptor Agonist [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260828",
  "set_id": "487cd7e7-434c-4925-99fa-aa80b1cc776b",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 160657,
  "serious": 28499,
  "death": 889,
  "hospitalization": 10230,
  "primary_suspect": 160195,
  "top_reactions": [
   [
    "Incorrect Dose Administered",
    29672
   ],
   [
    "Nausea",
    17091
   ],
   [
    "Injection Site Pain",
    13905
   ],
   [
    "Diarrhoea",
    10006
   ],
   [
    "Extra Dose Administered",
    9608
   ],
   [
    "Off Label Use",
    8941
   ],
   [
    "Vomiting",
    8267
   ],
   [
    "Drug Ineffective",
    6965
   ],
   [
    "Constipation",
    6502
   ],
   [
    "Injection Site Haemorrhage",
    5281
   ],
   [
    "Injection Site Erythema",
    5210
   ],
   [
    "Fatigue",
    4771
   ],
   [
    "Accidental Underdose",
    4609
   ],
   [
    "Product Dose Omission Issue",
    4474
   ],
   [
    "Abdominal Pain Upper",
    3709
   ]
  ],
  "by_year": {
   "2019": 27,
   "2020": 33,
   "2021": 35,
   "2022": 5051,
   "2023": 20800,
   "2024": 33045,
   "2025": 62302,
   "2026": 39347
  },
  "by_year_primary": {
   "2019": 27,
   "2020": 33,
   "2021": 35,
   "2022": 5041,
   "2023": 20778,
   "2024": 32983,
   "2025": 62119,
   "2026": 39162
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 2,
  "nda": 2,
  "anda": 0,
  "first_approval": "20220513",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 19,
  "labeling_recent": 17,
  "sponsors": [
   "ELI LILLY AND CO"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/13/2022"
 },
 "trials": {
  "total": 307,
  "completed": 91,
  "terminated": 6,
  "with_results": 47,
  "industry": 144,
  "phase3": 60,
  "results_share": 0.5164835164835165,
  "terminated_share": 0.019543973941368076
 },
 "pubmed": {
  "rct": 126,
  "meta": 91,
  "recent_rct": 123,
  "cochrane": [
   {
    "pmid": "41161687",
    "title": "Tirzepatide for adults living with obesity",
    "year": "2025"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 17446962.580000002,
  "records": 262958,
  "by_name": [
   [
    "Mounjaro",
    12625760.55
   ],
   [
    "Zepbound",
    4821202.03
   ]
  ],
  "names_checked": [
   "tirzepatide",
   "Mounjaro",
   "Zepbound"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 5105750,
  "beneficiaries": 894826,
  "spend": 6337329984.15,
  "by_brand": [
   {
    "brand": "Mounjaro",
    "claims": 5105397,
    "per_claim": 1241.2242654,
    "is_generic": false
   },
   {
    "brand": "Zepbound",
    "claims": 353,
    "per_claim": 1097.2902266,
    "is_generic": false
   }
  ],
  "per_claim": 1241.2143140870587
 },
 "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": "glucagon-like peptide"
  },
  {
   "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": "glucagon-like peptide"
  }
 ],
 "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": "tirzepatide",
  "matched": "tirzepatide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 134264,
  "fills": 5105750,
  "per_million": 26296.62635264163,
  "ratio": 9.496967692044226,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 51,
   "letter": "D",
   "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)",
    "26,297 FDA reports naming it as the suspect drug per million Medicare fills, 9.5x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 75,
   "letter": "B",
   "why": [
    "126 randomized trials and 91 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 77,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "17 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)",
    "Approved within the last 5 years: long-term safety is not yet known (-10)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 15,
   "letter": "F",
   "why": [
    "Pharma paid doctors $17,446,963 tied to this drug last year (-45)",
    "Named in 2 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 54,
 "grade": "D",
 "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 incorrect dose administered, nausea, injection site pain, diarrhoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}