{
 "query": "glipizide",
 "ingredient": "glipizide",
 "slug": "glipizide",
 "rxcui": "4821",
 "brands": [
  "Glucotrol"
 ],
 "names": [
  "glipizide"
 ],
 "classes": [
  {
   "id": "A10BB",
   "name": "Sulfonylureas"
  }
 ],
 "alternatives": [
  "acetohexamide",
  "carbutamide",
  "chlorpropamide",
  "glibornuride",
  "gliclazide",
  "glimepiride",
  "gliquidone",
  "glyburide",
  "tolazamide",
  "tolbutamide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 106
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. GLUCOTROL XL is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis 1.1 Limitations of Use GLUCOTROL XL is not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.",
  "contraindications": "Glipizide is contraindicated in patients with: \u2022 Known hypersensitivity to glipizide or any of the product's ingredients. \u2022 Hypersensitivity to sulfonamide derivatives. \u25aa Known hypersensitivity to glipizide or any of the product's ingredients ( 4 ). \u25aa Hypersensitivity to sulfonamide derivatives ( 4 ).",
  "warnings_and_cautions": "\u25aa Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications ( 5.1 ). \u25aa Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative ( 5.2 ). \u25aa Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives ( 5.3 ). \u25aa Macrovascular Outcomes: No clinical studies have established conclusive evidence of macrovascular risk reduction with GLUCOTROL XL or any other anti-diabetic drug ( 5.4 ). 5.1 Hypoglycemia All sulfonylurea drugs, including GLUCOTROL XL, are capable of producing severe hypoglycemia [see Adverse Reactions (6) ] . Concomitant use of GLUCOTROL XL with other anti-diabetic medication can increase the risk of hypoglycemia. A lower dose of GLUCOTROL XL may be required to minimize the risk of hypoglycemia when combining it with other anti-diabetic medications. Educate patients to recognize and manage hypoglycemia. When initiating and increasing GLUCOTROL XL in patients who may be predisposed to hypo...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling: \u2022 Hypoglycemia [see Warnings and Precautions (5.1) ] \u2022 Hemolytic anemia [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence > 3%) are dizziness, diarrhea, nervousness, tremor, hypoglycemia and flatulence ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 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 practice. In clinical trials, 580 patients from 31 to 87 years of age received GLUCOTROL XL in doses from 5 mg to 60 mg in both controlled and open trials. The dosages above 20 mg are not recommended dosages. In these trials, approximately 180 patients were treated with GLUCOTROL XL for at least 6 months. Table 1 summarizes the incidence of adverse reactions, other than hypoglycemia, that were reported in pooled double-blind, placebo-co...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the potential adverse reactions of GLUCOTROL XL including hypoglycemia. Explain the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development to patients and responsible family members. Also inform patients about the importance of adhering to dietary instructions, of a regular exercise program, and of regular testing of glycemic control. Inform patients that GLUCOTROL XL should be swallowed whole. Inform patients that they should not chew, divide or crush tablets and they may occasionally notice in their stool something that looks like a tablet. In the GLUCOTROL XL tablet, the medication is contained within a non-dissolvable shell that has been specially designed to slowly release the drug so the body can absorb it. Pregnancy Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1) ]. Lactation Advise breastfeeding women taking GLUCOTROL XL to monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, hypothermia, excessive sleepiness, p...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Glucotrol XL",
  "manufacturer": "Roerig",
  "application_number": "NDA020329",
  "pharm_class_epc": [
   "Sulfonylurea [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260721",
  "set_id": "eed99b60-d043-4249-9b2a-f05e46fb588d",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 39991,
  "serious": 22130,
  "death": 3573,
  "hospitalization": 11103,
  "primary_suspect": 39903,
  "top_reactions": [
   [
    "Blood Glucose Increased",
    3145
   ],
   [
    "Diarrhoea",
    2395
   ],
   [
    "Drug Ineffective",
    2367
   ],
   [
    "Nausea",
    2269
   ],
   [
    "Fatigue",
    2176
   ],
   [
    "Chronic Kidney Disease",
    1671
   ],
   [
    "Death",
    1661
   ],
   [
    "Acute Kidney Injury",
    1586
   ],
   [
    "Off Label Use",
    1466
   ],
   [
    "Dyspnoea",
    1455
   ],
   [
    "Dizziness",
    1398
   ],
   [
    "Headache",
    1297
   ],
   [
    "Pain",
    1273
   ],
   [
    "Weight Decreased",
    1222
   ],
   [
    "Asthenia",
    1215
   ]
  ],
  "by_year": {
   "2019": 4225,
   "2020": 3462,
   "2021": 2767,
   "2022": 2263,
   "2023": 1960,
   "2024": 1982,
   "2025": 2073,
   "2026": 935
  },
  "by_year_primary": {
   "2019": 4223,
   "2020": 3461,
   "2021": 2755,
   "2022": 2250,
   "2023": 1933,
   "2024": 1977,
   "2025": 2062,
   "2026": 920
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 23,
  "nda": 2,
  "anda": 21,
  "first_approval": "19840508",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 19,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "AIPING PHARM INC",
   "ANI PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA USA",
   "BARR LABS INC",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/08/1984"
 },
 "trials": {
  "total": 49,
  "completed": 40,
  "terminated": 1,
  "with_results": 22,
  "industry": 29,
  "phase3": 14,
  "results_share": 0.55,
  "terminated_share": 0.02040816326530612
 },
 "pubmed": {
  "rct": 78,
  "meta": 1,
  "recent_rct": 0,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "glipizide",
   "Glucotrol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7812781,
  "beneficiaries": 2029090,
  "spend": 90777417.50999999,
  "by_brand": [
   {
    "brand": "Glipizide",
    "claims": 4523542,
    "per_claim": 9.5454387955,
    "is_generic": true
   },
   {
    "brand": "Glipizide ER",
    "claims": 3267396,
    "per_claim": 14.452478561,
    "is_generic": false
   },
   {
    "brand": "Glipizide XL",
    "claims": 20942,
    "per_claim": 15.484521536,
    "is_generic": false
   },
   {
    "brand": "Glucotrol XL",
    "claims": 901,
    "per_claim": 57.687813541,
    "is_generic": false
   }
  ],
  "per_claim": 11.619091525796
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4959,
  "fills": 7812781,
  "per_million": 634.7291700612112,
  "ratio": 0.22923101771432458,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "635 FDA reports naming it as the suspect drug per million Medicare fills, 0.2x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 43,
   "letter": "F",
   "why": [
    "78 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (21 applications)",
    "10 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 86,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are blood glucose increased, diarrhoea, nausea. How would we recognize and handle those?",
  "Why this one over acetohexamide, carbutamide, chlorpropamide? What would make you pick one of those instead?",
  "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.)"
 ]
}