{
 "query": "empagliflozin",
 "ingredient": "empagliflozin",
 "slug": "empagliflozin",
 "rxcui": "1545653",
 "brands": [
  "Jardiance"
 ],
 "names": [
  "empagliflozin"
 ],
 "classes": [
  {
   "id": "A10BK",
   "name": "Sodium-glucose co-transporter 2 (SGLT2) inhibitors"
  }
 ],
 "alternatives": [
  "bexagliflozin",
  "canagliflozin",
  "dapagliflozin",
  "ertugliflozin",
  "sotagliflozin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 13
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. ( 1 ) To reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. ( 1 ) To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and o...",
  "contraindications": "is contraindicated in patients: with a hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5.8) ] . Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE. ( 4 )",
  "warnings_and_cautions": "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 JARDIANCE if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. ( 5.1 ) Volume Depletion: Before initiating JARDIANCE, assess volume status and renal function in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for signs and symptoms during therapy. ( 5.2 ) Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated. ( 5.3 ) Hypoglycemia: Adult patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher regardless of insulin use. Consider lowering the dosage of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating JARDIANCE. ( 5.4 ) Necrotizing Fasciitis of t...",
  "warnings": "",
  "adverse_reactions": "The following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] Volume Depletion [see Warnings and Precautions (5.2) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.3) ] Hypoglycemia [see Warnings and Precautions (5.4) ] Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) [see Warnings and Precautions (5.5) ] Genital Mycotic Infections [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] Most common adverse reactions (5% or greater incidence) were urinary tract infections and female genital mycotic infections ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 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 pract...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1 ) 9/2023 Dosage and Administration ( 2.2 ) 9/2023 Dosage and Administration ( 2.3 ) 6/2023 Dosage and Administration ( 2.4 ) 9/2023 Warnings and Precautions ( 5.1 ) 9/2023 Warnings and Precautions ( 5.4 ) 6/2023 Warnings and Precautions ( 5.7 ) 9/2023",
  "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 JARDIANCE can increase their risk of life-threatening diabetic ketoacidosis and that fatal ketoacidosis has occurred. For all other patients, inform them that JARDIANCE 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 JARDIANCE and seek medical attention immediately [see Warnings and Precautions (5.1) ] . Volume Depletion I...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: September 2023 MEDICATION GUIDE JARDIANCE \u00ae (jar DEE ans) (empagliflozin tablets) for oral use What is the most important information I should know about JARDIANCE? JARDIANCE can cause serious side effects, including: Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. JARDIANCE 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 ...",
  "clinical_studies": "14.1 Glycemic Control Trials in Adults with Type 2 Diabetes Mellitus JARDIANCE has been studied as monotherapy and in combination with metformin, sulfonylurea, pioglitazone, linagliptin, and insulin. JARDIANCE has also been studied in patients with type 2 diabetes mellitus with mild or moderate renal impairment. In adult patients with type 2 diabetes mellitus, treatment with JARDIANCE reduced hemoglobin A1c (HbA1c), compared to placebo. The reduction in HbA1c for JARDIANCE compared with placebo was observed across subgroups including sex, race, geographic region, baseline BMI and duration of disease. Monotherapy A total of 986 patients with type 2 diabetes mellitus participated in a double-blind, placebo-controlled trial to evaluate the efficacy of JARDIANCE monotherapy. Treatment-na\u00efve patients with inadequately controlled type 2 diabetes mellitus entered an open-label placebo run-in for 2 weeks. At the end of the run-in period, patients who remained inadequately controlled and had an HbA1c between 7% and 10% were randomized to placebo, JARDIANCE 10 mg, JARDIANCE 25 mg, or a reference comparator. At Week 24, treatment with JARDIANCE 10 mg or 25 mg daily provided statistically sign...",
  "brand_name": "Jardiance",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "NDA204629",
  "pharm_class_epc": [
   "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260617",
  "set_id": "334f1b3d-5670-6685-e063-6294a90a7e47",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 67251,
  "serious": 40865,
  "death": 3357,
  "hospitalization": 22246,
  "primary_suspect": 67027,
  "top_reactions": [
   [
    "Diabetic Ketoacidosis",
    3902
   ],
   [
    "Nausea",
    3595
   ],
   [
    "Diarrhoea",
    3254
   ],
   [
    "Blood Glucose Increased",
    3199
   ],
   [
    "Weight Decreased",
    2928
   ],
   [
    "Fatigue",
    2888
   ],
   [
    "Off Label Use",
    2788
   ],
   [
    "Vomiting",
    2712
   ],
   [
    "Dizziness",
    2669
   ],
   [
    "Dyspnoea",
    2390
   ],
   [
    "Drug Ineffective",
    2378
   ],
   [
    "Fungal Infection",
    2155
   ],
   [
    "Euglycaemic Diabetic Ketoacidosis",
    2049
   ],
   [
    "Urinary Tract Infection",
    2024
   ],
   [
    "Headache",
    1939
   ]
  ],
  "by_year": {
   "2019": 5491,
   "2020": 5459,
   "2021": 6244,
   "2022": 7533,
   "2023": 9172,
   "2024": 9862,
   "2025": 9604,
   "2026": 5000
  },
  "by_year_primary": {
   "2019": 5491,
   "2020": 5459,
   "2021": 6237,
   "2022": 7512,
   "2023": 9120,
   "2024": 9821,
   "2025": 9529,
   "2026": 4972
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20230309",
   "reason": "Labeling: Label Mix-up",
   "firm": "Boehringer Ingelheim Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 11,
  "nda": 2,
  "anda": 2,
  "first_approval": "20140801",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 13,
  "labeling_recent": 6,
  "sponsors": [
   "AIZANT",
   "AJANTA PHARMA LTD",
   "ALKEM LABS LTD",
   "ANNORA PHARMA",
   "AUROBINDO PHARMA LIMITED",
   "BOEHRINGER INGELHEIM",
   "INVAGEN PHARMS",
   "LAURUS GENERICS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/01/2014"
 },
 "trials": {
  "total": 640,
  "completed": 340,
  "terminated": 32,
  "with_results": 131,
  "industry": 254,
  "phase3": 123,
  "results_share": 0.38529411764705884,
  "terminated_share": 0.05
 },
 "pubmed": {
  "rct": 408,
  "meta": 47,
  "recent_rct": 279,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 14327290.7,
  "records": 238298,
  "by_name": [
   [
    "Jardiance",
    14327290.7
   ]
  ],
  "names_checked": [
   "empagliflozin",
   "Jardiance"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 11368280,
  "beneficiaries": 2543331,
  "spend": 11435997421.0,
  "by_brand": [
   {
    "brand": "Jardiance",
    "claims": 11368280,
    "per_claim": 1005.9566989,
    "is_generic": false
   }
  ],
  "per_claim": 1005.9566989025604
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "empagliflozin",
  "matched": "empagliflozin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 24322,
  "fills": 11368280,
  "per_million": 2139.4617303585064,
  "ratio": 0.7726618106485239,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "2,139 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.5x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 68,
   "letter": "C",
   "why": [
    "408 randomized trials and 47 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 39% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III (-6)",
    "6 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": 55,
   "letter": "D",
   "why": [
    "Pharma paid doctors $14,327,291 tied to this drug last year (-45)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (2 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are diabetic ketoacidosis, nausea, diarrhoea, blood glucose increased. How would we recognize and handle those?",
  "Why this one over bexagliflozin, canagliflozin, dapagliflozin? 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.)"
 ]
}