{
 "query": "dapagliflozin",
 "ingredient": "dapagliflozin",
 "slug": "dapagliflozin",
 "rxcui": "1488564",
 "brands": [
  "Farxiga"
 ],
 "names": [
  "dapagliflozin",
  "dapagliflozin 2,3-butanediol monohydrate",
  "dapagliflozin propanediol"
 ],
 "classes": [
  {
   "id": "A10BK",
   "name": "Sodium-glucose co-transporter 2 (SGLT2) inhibitors"
  }
 ],
 "alternatives": [
  "bexagliflozin",
  "canagliflozin",
  "empagliflozin",
  "ertugliflozin",
  "sotagliflozin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 29
  },
  "boxed_warning": "",
  "indications_and_usage": "are indicated: \u2022 To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. \u2022 To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. \u2022 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. \u2022 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use \u2022 DAPAGLIFLOZIN TABLETS are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ]. \u2022 DAPAGLIFLOZIN TABLETS are not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. DAPAGLIFLOZIN TABLETS are likely to be ineffective in this setting based upon its mechanism of action. \u2022 DAPAGLIFLOZIN TABLETS are not recommended for the treatment of chronic kidney disease in patients with polycy...",
  "contraindications": "\u2022 History of a serious hypersensitivity reaction to dapagliflozin, such as anaphylactic reactions or angioedema [see Adverse Reactions (6.1) ] . \u2022 History of serious hypersensitivity reaction to dapagliflozin. (4)",
  "warnings_and_cautions": "\u2022 Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue DAPAGLIFLOZIN TABLETS if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. (5.1) \u2022 Volume depletion: Before initiating DAPAGLIFLOZIN TABLETS, assess volume status and renal function in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. ( 5.2 ) \u2022 Urosepsis and Pyelonephritis: Evaluate for signs and symptoms of urinary tract infections and treat promptly, if indicated. (5.3) \u2022 Hypoglycemia: Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with DAPAGLIFLOZIN TABLETS. (5.4) \u2022 Necrotizing Fasciitis of the Perineum (Fournier\u2019s Gangrene): Serious, life-threatening cases have occurred in patients with diabetes, both females and males. Assess patients prese...",
  "warnings": "",
  "adverse_reactions": "The following important adverse reactions are described below and elsewhere in the labeling: \u2022 Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] \u2022 Volume Depletion [see Warnings and Precautions (5.2) ] \u2022 Urosepsis and Pyelonephritis [see Warnings and Precautions (5.3) ] \u2022 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.4) ] \u2022 Necrotizing Fasciitis of the Perineum (Fournier\u2019s Gangrene) [see Warnings and Precautions (5.5) ] \u2022 Genital Mycotic Infections [see Warnings and Precautions (5.6) ] \u2022 Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 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 conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in cli...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage (1) 09/2023 Dosage and Administration (2.3) 09/2023 Warnings and Precautions (5.1) 09/2023",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, inform them that using DAPAGLIFLOZIN TABLETS can increase their risk of life-threatening diabetic ketoacidosis. For all other patients, inform them that DAPAGLIFLOZIN TABLETS can cause potentially fatal ketoacidosis and that type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are risk factors. Educate all patients on precipitating factors (such as insulin dose reduction or missed insulin doses, infection, reduced caloric intake, ketogenic diet, surgery, dehydration, and alcohol abuse) and symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing). Inform patients that blood glucose may be normal even in the presence of ketoacidosis. Advise patients that they may be asked to monitor ketones. If symptoms of ketoacidosis occur, instruct patients to discontinue DAPAGLIFLOZIN TABLETS and seek medical attention immediately [see Warnings and Precautions (5.1) ] . Volume Depletion Inform...",
  "spl_medguide": "MEDICATION GUIDE DAPAGLIFLOZIN [dap-a-gli-FLO-zin] TABLETS for oral use What is the most important information I should know about DAPAGLIFLOZIN TABLETS? DAPAGLIFLOZIN TABLETS can cause serious side effects, including: \u2022 Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis . DAPAGLIFLOZIN TABLETS can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop tak...",
  "clinical_studies": "14.1 Glycemic Control in Patients with Type 2 Diabetes Mellitus Overview of Clinical Studies of dapagliflozin for Type 2 Diabetes Mellitus Dapagliflozin has been studied as monotherapy, in combination with metformin, pioglitazone, sulfonylurea (glimepiride), sitagliptin (with or without metformin), metformin plus a sulfonylurea, or insulin (with or without other oral antidiabetic therapy), compared to a sulfonylurea (glipizide), and in combination with a GLP-1 receptor agonist (exenatide extended-release) added-on to metformin. Dapagliflozin has also been studied in patients with type 2 diabetes mellitus and moderate renal impairment. Treatment with dapagliflozin as monotherapy and in combination with metformin, glimepiride, pioglitazone, sitagliptin, or insulin produced statistically significant improvements in mean change from baseline at Week 24 in HbA1c compared to control. Reductions in HbA1c were seen across subgroups including gender, age, race, duration of disease, and baseline body mass index (BMI). Monotherapy A total of 840 treatment-naive patients with inadequately controlled type 2 diabetes mellitus participated in 2 placebo-controlled studies to evaluate the safety an...",
  "brand_name": "DAPAGLIFLOZIN",
  "manufacturer": "A-S Medication Solutions",
  "application_number": "NDA202293",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240628",
  "set_id": "82cdd5ad-df2b-4bdd-a3a6-a059040100b4",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 63930,
  "serious": 50351,
  "death": 10461,
  "hospitalization": 19624,
  "primary_suspect": 63529,
  "top_reactions": [
   [
    "Death",
    8288
   ],
   [
    "Nausea",
    2739
   ],
   [
    "Fatigue",
    2690
   ],
   [
    "Diarrhoea",
    2525
   ],
   [
    "Dizziness",
    2506
   ],
   [
    "Diabetic Ketoacidosis",
    2494
   ],
   [
    "Dyspnoea",
    2337
   ],
   [
    "Off Label Use",
    2291
   ],
   [
    "Weight Decreased",
    2250
   ],
   [
    "Blood Glucose Increased",
    2245
   ],
   [
    "Acute Kidney Injury",
    2118
   ],
   [
    "Vomiting",
    2037
   ],
   [
    "Headache",
    1823
   ],
   [
    "Malaise",
    1705
   ],
   [
    "Dehydration",
    1622
   ]
  ],
  "by_year": {
   "2019": 2273,
   "2020": 2596,
   "2021": 3674,
   "2022": 5198,
   "2023": 8771,
   "2024": 12092,
   "2025": 13106,
   "2026": 6204
  },
  "by_year_primary": {
   "2019": 2272,
   "2020": 2595,
   "2021": 3669,
   "2022": 5135,
   "2023": 8693,
   "2024": 12024,
   "2025": 12978,
   "2026": 6148
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 22,
  "nda": 1,
  "anda": 15,
  "first_approval": "20140108",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 12,
  "labeling_recent": 4,
  "sponsors": [
   "AIZANT",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "APOTEX INC",
   "ASTRAZENECA AB",
   "AUROBINDO PHARMA",
   "BIOCON PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/08/2014"
 },
 "trials": {
  "total": 760,
  "completed": 386,
  "terminated": 42,
  "with_results": 135,
  "industry": 311,
  "phase3": 182,
  "results_share": 0.34974093264248707,
  "terminated_share": 0.05526315789473684
 },
 "pubmed": {
  "rct": 480,
  "meta": 63,
  "recent_rct": 290,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 5900612.77,
  "records": 145657,
  "by_name": [
   [
    "Farxiga",
    5900612.77
   ]
  ],
  "names_checked": [
   "dapagliflozin",
   "Farxiga"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 6026406,
  "beneficiaries": 1492285,
  "spend": 5492482710.54,
  "by_brand": [
   {
    "brand": "Farxiga",
    "claims": 5634650,
    "per_claim": 938.93124922,
    "is_generic": false
   },
   {
    "brand": "Dapagliflozin",
    "claims": 391756,
    "per_claim": 515.45795633,
    "is_generic": false
   }
  ],
  "per_claim": 911.4027017993809
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20160614",
   "title": "FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm505860.htm",
   "kind": "drug",
   "matched": "dapagliflozin"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "dapagliflozin",
  "matched": "dapagliflozin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 31150,
  "fills": 6026406,
  "per_million": 5168.918257415779,
  "ratio": 1.8667432481719828,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 83,
   "letter": "B",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-8)",
    "5,169 FDA reports naming it as the suspect drug per million Medicare fills, 1.9x the median drug on this site (-5)",
    "Death appears in 1.8x the share of reports seen across all of FAERS (-4)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "480 randomized trials and 63 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)",
    "Only 35% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "4 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $5,900,613 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (15 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 79,
 "grade": "B",
 "questions": [
  "In 2016 the FDA issued a safety communication about this drug (FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are death, nausea, fatigue, diarrhoea. How would we recognize and handle those?",
  "Why this one over bexagliflozin, canagliflozin, empagliflozin? What would make you pick one of those instead?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}