{
 "query": "liraglutide",
 "ingredient": "liraglutide",
 "slug": "liraglutide",
 "rxcui": "475968",
 "brands": [
  "Saxenda",
  "Victoza"
 ],
 "names": [
  "liraglutide"
 ],
 "classes": [
  {
   "id": "A10BJ",
   "name": "Glucagon-like peptide-1 (GLP-1) analogues"
  }
 ],
 "alternatives": [
  "albiglutide",
  "dulaglutide",
  "exenatide",
  "lixisenatide",
  "semaglutide"
 ],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 19
  },
  "boxed_warning": "WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )] . Liraglutide injection 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 liraglutide injection 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 liraglutide injection [see Contraindications ( 4 ) , Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warnin...",
  "indications_and_usage": "Liraglutide injection 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 and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established. Liraglutide injection is a 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 and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. ( 1 ) Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: Coadministration with other lir...",
  "contraindications": "Liraglutide injection is contraindicated in: Patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1) ]. Patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in liraglutide injection. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with liraglutide injection [see Warnings and Precautions (5.7) ] . Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. ( 4 ) Hypersensitivity to liraglutide or any excipients in liraglutide injection. ( 4 )",
  "warnings_and_cautions": "Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including liraglutide injection. Discontinue if pancreatitis is suspected. ( 5.2 ) Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. ( 5.3 ) Hypoglycemia: Can occur in adults when liraglutide injection is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin. The risk may be lowered by a reduction in the dose of concomitantly administered insulin secretagogues or insulin. In the pediatric clinical trial, patients did not have type 2 diabetes. Hypoglycemia occurred in liraglutide injection-treated pediatric patients. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. ( 5.4 ) Heart Rate Increase: Monitor heart rate at regular intervals. ( 5.5 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.6 ) Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. Liraglutide injection is not recommended in patien...",
  "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) ] Acute Pancreatitis [see Warnings and Precautions (5.2) ] Acute Gallbladder Disease [see Warnings and Precautions (5.3) ] Risk for Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy [see Warnings and Precautions (5.4) ] Heart Rate Increase [see Warnings and Precautions (5.5) ] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions (5.6) ] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.9) ] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.10) ] Most common adverse reactions, reported in greater than or equal to 5% are: nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, pyrexia, and gastroenteritis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bio...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u202605/2025 Dosage and Administration, Patient Selection (2.1)...\u2026(Removed) 05/2025 Contraindications, Pregnancy (4)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026(Removed) 05/2025 Warnings and Precautions, Severe Gastrointestinal Adverse Reactions (5.7)\u2026\u2026\u2026\u2026\u2026\u202610/2025 Pulmonary Aspiration During General Anesthesia or Deep Sedation (5.10)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..11/2024",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Instructions Advise patients to take liraglutide injection exactly as prescribed. Instruct patients to follow the dose escalation schedule and to not take more than the recommended dose. Instruct adult patients to discontinue liraglutide injection if they have not achieved 4% weight loss by 16 weeks of treatment. Instruct pediatric patients 12 years of age and older to discontinue liraglutide injection if they have not achieved a BMI reduction of 1% from baseline after 12 weeks on the maintenance dose. Risk of Thyroid C-cell Tumors Inform patients that liraglutide causes benign and malignant thyroid C-cell tumors in mice and 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, hoarseness, dysphagia or dyspnea) to their health care provider [see Boxed Warning , 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 accomp...",
  "spl_medguide": "MEDICATION GUIDE Liraglutide (lir\u02ba a gloo\u00b4 tide) injection, for subcutaneous use What is the most important information I should know about liraglutide injection? Serious side effects may happen in people who take liraglutide injection, 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 and mice, liraglutide injection and medicines that work like liraglutide injection caused thyroid tumors, including thyroid cancer. It is not known if liraglutide injection will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not use liraglutide injection if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). What is liraglutide injection? Liraglutide injection is an injectable prescription medicine used for adults with obesity or overweight (excess weight) who also have weight related medical p...",
  "clinical_studies": "14.1 Weight Management Trials in Adults with Overweight or Obesity The safety and efficacy of liraglutide for chronic weight management in conjunction with reduced caloric intake and increased physical activity were studied in three 56-week, randomized, double-blind, placebo-controlled trials. In all studies, liraglutide was titrated to 3 mg daily during a 4-week period. All patients received instruction for a reduced-calorie diet (approximately 500 kcal/day deficit) and physical activity counseling (recommended increase in physical activity of minimum 150 mins/week) that began with the first dose of study medication or placebo and continued throughout the trial. Study 1 enrolled 3731 patients with obesity (BMI greater than or equal to 30 kg/m 2 ) or with overweight (BMI 27-29.9 kg/m 2 ) and at least one weight-related comorbid condition such as treated or untreated dyslipidemia or hypertension; patients with type 2 diabetes mellitus were excluded. Patients were randomized in a 2:1 ratio to either liraglutide or placebo. Patients were stratified based on the presence or absence of abnormal blood glucose measurements at randomization. All patients were treated for up to 56 weeks. Th...",
  "brand_name": "Liraglutide",
  "manufacturer": "Biocon Pharma Inc.",
  "application_number": "ANDA217063",
  "pharm_class_epc": [
   "GLP-1 Receptor Agonist [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20251016",
  "set_id": "0b898330-eca1-f60a-71d2-b91716e336ed",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 36160,
  "serious": 19504,
  "death": 1520,
  "hospitalization": 8858,
  "primary_suspect": 36068,
  "top_reactions": [
   [
    "Nausea",
    4413
   ],
   [
    "Vomiting",
    2567
   ],
   [
    "Blood Glucose Increased",
    2487
   ],
   [
    "Diarrhoea",
    2285
   ],
   [
    "Off Label Use",
    1799
   ],
   [
    "Pancreatitis",
    1553
   ],
   [
    "Fatigue",
    1329
   ],
   [
    "Headache",
    1318
   ],
   [
    "Drug Ineffective",
    1316
   ],
   [
    "Decreased Appetite",
    1191
   ],
   [
    "Weight Decreased",
    1189
   ],
   [
    "Constipation",
    1153
   ],
   [
    "Dizziness",
    1136
   ],
   [
    "Weight Increased",
    1047
   ],
   [
    "Abdominal Pain Upper",
    1022
   ]
  ],
  "by_year": {
   "2019": 3068,
   "2020": 2759,
   "2021": 2313,
   "2022": 1876,
   "2023": 1925,
   "2024": 1678,
   "2025": 1992,
   "2026": 1221
  },
  "by_year_primary": {
   "2019": 3067,
   "2020": 2759,
   "2021": 2298,
   "2022": 1869,
   "2023": 1905,
   "2024": 1653,
   "2025": 1979,
   "2026": 1210
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260424",
   "reason": "Presence of particulate matter: a white thread-like structure in the cartridge",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210322",
   "reason": "Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.",
   "firm": "Novo Nordisk Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210322",
   "reason": "Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.",
   "firm": "Novo Nordisk Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 13,
  "nda": 2,
  "anda": 11,
  "first_approval": "20100125",
  "rems": false,
  "rems_last": "20181204",
  "labeling_supplements": 29,
  "labeling_recent": 14,
  "sponsors": [
   "BIOCON PHARMA",
   "FRESENIUS KABI USA",
   "HIKMA",
   "LUPIN",
   "MYLAN INSTITUTIONAL",
   "NANJING KING FRIEND",
   "NOVO",
   "NOVO NORDISK INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/25/2010"
 },
 "trials": {
  "total": 515,
  "completed": 366,
  "terminated": 38,
  "with_results": 144,
  "industry": 261,
  "phase3": 112,
  "results_share": 0.39344262295081966,
  "terminated_share": 0.07378640776699029
 },
 "pubmed": {
  "rct": 431,
  "meta": 78,
  "recent_rct": 124,
  "cochrane": [
   {
    "pmid": "41161684",
    "title": "Liraglutide for adults living with obesity",
    "year": "2025"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 508541.88,
  "records": 3042,
  "by_name": [
   [
    "Victoza",
    377495.64
   ],
   [
    "Saxenda",
    131046.24
   ]
  ],
  "names_checked": [
   "liraglutide",
   "Saxenda",
   "Victoza"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 351843,
  "beneficiaries": 128285,
  "spend": 328991595.9,
  "by_brand": [
   {
    "brand": "Victoza 3-Pak",
    "claims": 181068,
    "per_claim": 1121.4739787,
    "is_generic": false
   },
   {
    "brand": "Victoza 2-Pak",
    "claims": 108521,
    "per_claim": 717.21345306,
    "is_generic": false
   },
   {
    "brand": "Liraglutide",
    "claims": 62254,
    "per_claim": 772.57404167,
    "is_generic": true
   }
  ],
  "per_claim": 935.0522701886921
 },
 "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": "liraglutide",
  "matched": "liraglutide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4842,
  "fills": 351843,
  "per_million": 13761.819902627023,
  "ratio": 4.970050425721284,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 47,
   "letter": "F",
   "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)",
    "13,762 FDA reports naming it as the suspect drug per million Medicare fills, 5.0x the median drug on this site (-14)",
    "Death share in reports is near or below the FAERS average (0.5x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 76,
   "letter": "B",
   "why": [
    "431 randomized trials and 78 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",
    "Only 39% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 83,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 11 generic makers (-4)",
    "14 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 45,
   "letter": "F",
   "why": [
    "Pharma paid doctors $508,542 tied to this drug last year (-15)",
    "Named in 2 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (11 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 65,
 "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, vomiting, blood glucose increased, 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?",
  "Why this one over albiglutide, dulaglutide, exenatide? What would make you pick one of those instead?",
  "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.)"
 ]
}