{
 "query": "semaglutide",
 "ingredient": "semaglutide",
 "slug": "semaglutide",
 "rxcui": "1991302",
 "brands": [
  "Ozempic",
  "Rybelsus",
  "Wegovy"
 ],
 "names": [
  "semaglutide"
 ],
 "classes": [
  {
   "id": "A10BJ",
   "name": "Glucagon-like peptide-1 (GLP-1) analogues"
  }
 ],
 "alternatives": [
  "albiglutide",
  "dulaglutide",
  "exenatide",
  "liraglutide",
  "lixisenatide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "SUBCUTANEOUS": 4,
   "ORAL": 1
  },
  "boxed_warning": "WARNING: RISK OF THYROID C-CELL TUMORS \u2022 In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . \u2022 RYBELSUS and OZEMPIC tablets are 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 RYBELSUS or OZEMPIC tablets 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 RYBELSUS or OZEMPIC tablets [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing in...",
  "indications_and_usage": "and OZEMPIC tablets are indicated: \u2022 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. \u2022 to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. RYBELSUS and OZEMPIC tablets are glucagon-like peptide-1 (GLP-1) receptor agonists indicated: \u2022 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) \u2022 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 are at high risk for these events. ( 1 )",
  "contraindications": "and OZEMPIC tablets are contraindicated in patients with: \u2022 A 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 )] . \u2022 A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS or OZEMPIC tablets. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with semaglutide tablets [see Warnings and Precautions ( 5.7 )] . \u2022 Personal or family history of MTC or in patients with MEN 2 syndrome type 2 ( 4 ) \u2022 Prior serious hypersensitivity reaction to semaglutide or any of the excipients in OZEMPIC ( 4 )",
  "warnings_and_cautions": "\u2022 Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including RYBELSUS or OZEMPIC tablets. Discontinue if pancreatitis is suspected. ( 5.2 ) \u2022 Diabetic Retinopathy Complications : Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored. ( 5.3 ) \u2022 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin : May increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin secretagogue or insulin may be necessary. ( 5.4 ) \u2022 Acute Kidney Injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.5 ) \u2022 Severe Gastrointestinal Adverse Reactions : Use of RYBELSUS or OZEMPIC tablets has been associated with gastrointestinal adverse reactions, sometimes severe. RYBELSUS and OZEMPIC tablets are not recommended in patients with severe gastroparesis. ( 5.6 ) \u2022 Hypersensitivity Reactions : Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue RYBELSUS or OZEMPIC tablets if hypersensitivity react...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described below or elsewhere in the prescribing information: \u2022 Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] \u2022 Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] \u2022 Diabetic Retinopathy Complications [see Warnings and Precautions ( 5.3 )] \u2022 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.4 )] \u2022 Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] \u2022 Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] \u2022 Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] \u2022 Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] \u2022 Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence \u22655%) are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-833-457-7455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying condit...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1 ) \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.\u2026\u2026..10/2025 Dosage and Administration ( 2 )\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..\u2026\u2026\u2026..12/2025 Warnings and Precautions Acute Pancreatitis ( 5.2 )\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..\u202610/2025 Acute Kidney Injury Due to Volume Depletion ( 5.5 ) \u2026\u2026\u2026..10/2025 Severe Gastrointestinal Adverse Reactions ( 5.6 ) \u2026.\u2026\u2026\u2026\u2026.10/2025 Acute Gallbladder Disease ( 5.8 )\u2026\u2026\u2026\u2026\u2026.\u2026\u2026\u2026..\u2026\u2026\u2026.10/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risk of Thyroid C-cell Tumors Inform patients that semaglutide causes thyroid C-cell tumors in rodents 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 physician [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 accompanied by nausea or vomiting. Instruct patients to discontinue RYBELSUS or OZEMPIC tablets promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions ( 5.2 )] . Diabetic Retinopathy Complications Inform patients to contact their physician if changes in vision are experienced during treatment with RYBELSUS or OZEMPIC tablets [see Warnings and Precautions ( 5.3 )] . Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin Inform patients that the risk of hypoglycemia is increased when RYBELSUS or OZEMPIC tablets are use...",
  "spl_medguide": "Medication Guide MEDICATION GUIDE RYBELSUS \u00ae (reb-EL-sus) (semaglutide) tablets, for oral use OZEMPIC \u00ae (oh-ZEM-pick) (semaglutide) tablets, for oral use Read this Medication Guide before you start using RYBELSUS or OZEMPIC tablets 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 RYBELSUS and OZEMPIC tablets? RYBELSUS and OZEMPIC tablets may cause serious side effects, including: \u2022 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 rodents, RYBELSUS and OZEMPIC tablets and other medicines that work like RYBELSUS and OZEMPIC tablets caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS and OZEMPIC tablets will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. \u2022 Do not use RYBELSUS or OZEMPIC tablets if you or any of your family have ever ...",
  "clinical_studies": "14.1 Overview of Clinical Studies The effectiveness of OZEMPIC tablets (1.5 mg, 4 mg and 9 mg strengths) [see Dosage and Administration ( 2.2 )] and RYBELSUS (3 mg, 7, mg and 14 mg strengths) [see Dosage and Administration ( 2.3 )] has been established as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus based on adequate and well-controlled studies of RYBELSUS in adult patients with type 2 diabetes mellitus [see Clinical Pharmacology ( 12.3 )] . Below is a display of the efficacy results of the adequate and well-controlled studies of RYBELSUS, referred to below as semaglutide tablets, in adult patients with type 2 diabetes mellitus. Semaglutide tablets have been studied as monotherapy and in combination with metformin, sulfonylureas, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, insulins, and thiazolidinediones in patients with type 2 diabetes mellitus. The efficacy of semaglutide tablets was compared with placebo, empagliflozin, sitagliptin and liraglutide. Semaglutide tablets have also been studied in patients with type 2 diabetes mellitus with mild and moderate renal impairment. In patients with type 2 diabetes mellitus, ...",
  "brand_name": "OZEMPIC",
  "manufacturer": "Novo Nordisk Pharmaceutical Industries, LP",
  "application_number": "NDA213051",
  "pharm_class_epc": [
   "GLP-1 Receptor Agonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260130",
  "set_id": "27f15fac-7d98-4114-a2ec-92494a91da98",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 100515,
  "serious": 50502,
  "death": 1597,
  "hospitalization": 19475,
  "primary_suspect": 100153,
  "top_reactions": [
   [
    "Nausea",
    14414
   ],
   [
    "Vomiting",
    9561
   ],
   [
    "Off Label Use",
    8778
   ],
   [
    "Diarrhoea",
    8165
   ],
   [
    "Constipation",
    5962
   ],
   [
    "Decreased Appetite",
    5752
   ],
   [
    "Weight Decreased",
    5136
   ],
   [
    "Fatigue",
    4352
   ],
   [
    "Headache",
    4139
   ],
   [
    "Weight Increased",
    3936
   ],
   [
    "Impaired Gastric Emptying",
    3873
   ],
   [
    "Product Use In Unapproved Indication",
    3849
   ],
   [
    "Abdominal Pain Upper",
    3783
   ],
   [
    "Dizziness",
    3568
   ],
   [
    "Blood Glucose Increased",
    3548
   ]
  ],
  "by_year": {
   "2019": 1832,
   "2020": 3961,
   "2021": 5514,
   "2022": 8069,
   "2023": 11841,
   "2024": 19086,
   "2025": 27462,
   "2026": 21528
  },
  "by_year_primary": {
   "2019": 1832,
   "2020": 3961,
   "2021": 5511,
   "2022": 8042,
   "2023": 11800,
   "2024": 19039,
   "2025": 27384,
   "2026": 21362
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 6,
  "nda": 5,
  "anda": 0,
  "first_approval": "20171205",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 31,
  "labeling_recent": 28,
  "sponsors": [
   "APOTEX INC",
   "NOVO",
   "NOVO NORDISK INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/05/2017"
 },
 "trials": {
  "total": 790,
  "completed": 353,
  "terminated": 25,
  "with_results": 110,
  "industry": 410,
  "phase3": 185,
  "results_share": 0.311614730878187,
  "terminated_share": 0.03164556962025317
 },
 "pubmed": {
  "rct": 266,
  "meta": 133,
  "recent_rct": 219,
  "cochrane": [
   {
    "pmid": "41161683",
    "title": "Semaglutide for adults living with obesity",
    "year": "2025"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 15071226.22,
  "records": 423428,
  "by_name": [
   [
    "Wegovy",
    6861639.65
   ],
   [
    "Ozempic",
    5531973.0
   ],
   [
    "Rybelsus",
    2677613.57
   ]
  ],
  "names_checked": [
   "semaglutide",
   "Ozempic",
   "Rybelsus",
   "Wegovy"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 11880490,
  "beneficiaries": 2315591,
  "spend": 15161661664.4,
  "by_brand": [
   {
    "brand": "Ozempic",
    "claims": 10417182,
    "per_claim": 1245.0868524,
    "is_generic": false
   },
   {
    "brand": "Rybelsus",
    "claims": 1251733,
    "per_claim": 1509.9721953,
    "is_generic": false
   },
   {
    "brand": "Wegovy",
    "claims": 211575,
    "per_claim": 1424.0023226,
    "is_generic": false
   }
  ],
  "per_claim": 1276.1815097188753
 },
 "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": "semaglutide",
  "matched": "semaglutide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 67785,
  "fills": 11880490,
  "per_million": 5705.572749945499,
  "ratio": 2.0605548158232514,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 55,
   "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)",
    "5,706 FDA reports naming it as the suspect drug per million Medicare fills, 2.1x the median drug on this site (-6)",
    "Death share in reports is near or below the FAERS average (0.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 68,
   "letter": "C",
   "why": [
    "266 randomized trials and 133 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 31% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "28 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": 15,
   "letter": "F",
   "why": [
    "Pharma paid doctors $15,071,226 tied to this drug last year (-45)",
    "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": 59,
 "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 nausea, vomiting, 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?",
  "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.)"
 ]
}