{
 "query": "glimepiride",
 "ingredient": "glimepiride",
 "slug": "glimepiride",
 "rxcui": "25789",
 "brands": [],
 "names": [
  "glimepiride"
 ],
 "classes": [
  {
   "id": "A10BB",
   "name": "Sulfonylureas"
  }
 ],
 "alternatives": [
  "acetohexamide",
  "carbutamide",
  "chlorpropamide",
  "glibornuride",
  "gliclazide",
  "glipizide",
  "gliquidone",
  "glyburide",
  "tolazamide",
  "tolbutamide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 72
  },
  "boxed_warning": "",
  "indications_and_usage": "Glimepiride Tablet, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1 )] ]. Glimepiride Tablet USP is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1.1 ). Important Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1.1 ). 1.1 Important Limitations of Use Glimepiride should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
  "contraindications": "Glimepiride is contraindicated in patients with a history of a hypersensitivity reaction to: Glimepiride or any of the product's ingredients [ see Warnings and Precautions ( 5.2 ) ]. Sulfonamide derivatives: Patients who have developed an allergic reaction to sulfonamide derivatives may develop an allergic reaction to Glimepiride. Do not use glimepiride in patients who have a history of an allergic reaction to sulfonamide derivatives. Reported hypersensitivity reactions include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g. anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea) [ see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 ) ]. Hypersensitivity to glimepiride or any of the product's ingredients ( 4 ) Hypersensitivity to sulfonamide derivatives ( 4 )",
  "warnings_and_cautions": "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 ). Hypersensitivity Reactions: Post-marketing reports include anaphylaxis, angioedema and Stevens-Johnson Syndrome. Promptly discontinue glimepiride, assess for other causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes ( 5.2 ). Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative. ( 5.3 ). Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives ( 5.4 ). Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction with glimepiride or any other anti-diabetic drug ( 5.5 ). 5.1 Hypoglycemia All sulfonylureas, including glimepiride, can cause severe hypoglycemia [see Adverse Reactions ( 6.1 ) ]. The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. These impairments may present a risk in situati...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions ( 5.1 ) ] Hemolytic anemia [see Warnings and Precautions ( 5.3 ) ] In clinical trials, the most common adverse reactions with glimepiride were hypoglycemia, dizziness, asthenia, headache, and nausea. Common adverse reactions in clinical trials (\u22655% and more common than with placebo) include hypoglycemia, headache, nausea, and dizziness ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Carlsbad Technology, Inc. at (760) 431-8284 or contact 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. Approximately 2,800 patients with type 2 diabetes have been treated with glimepiride in the controlled clinical trials. In these trials, approximately 1,700 patients were treated with glimepiride for at least 1 year. Table 1 summarizes adverse events, other th...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "17.1 Information for Patients Inform patients about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose. Inform patients about the potential side effects of glimepiride including hypoglycemia and weight gain. Explain the symptoms and treatment of hypoglycemia as well as conditions that predispose to hypoglycemia. Patients should be informed that the ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Patients with diabetes should be advised to inform their healthcare provider if they are pregnant, contemplating pregnancy, breastfeeding, or contemplating breastfeeding. Rx Only Manufactured and Distributed by: Carlsbad Technology, Inc. 5923 Balfour Court, Carlsbad, CA 92008 Marketed/ Packaged by: GSMS, Inc. Camarillo, CA 93012 USA Revised 11/2013 CTI-16 Rev. D",
  "spl_medguide": "",
  "clinical_studies": "14.1 Monotherapy A total of 304 patients with type 2 diabetes already treated with sulfonylurea therapy participated in a 14-week, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of glimepiride monotherapy. Patients discontinued their sulfonylurea therapy then entered a 3-week placebo washout period followed by randomization into 1 of 4 treatment groups: placebo (n=74), glimepiride 1 mg (n=78), glimepiride 4 mg (n=76) and glimepiride 8 mg (n=76). All patients randomized to glimepiride started 1 mg daily. Patients randomized to glimepiride 4 mg or 8 mg had blinded, forced titration of the glimepiride dose at weekly intervals, first to 4 mg and then to 8 mg, as long as the dose was tolerated, until the randomized dose was reached. Patients randomized to the 4 mg dose reached the assigned dose at Week 2. Patients randomized to the 8 mg dose reached the assigned dose at Week 3. Once the randomized dose level was reached, patients were to be maintained at that dose until Week 14. Approximately 66% of the placebo-treated patients completed the trial compared to 81% of patients treated with glimepiride 1 mg and 92% of patients treated wit...",
  "brand_name": "Glimepiride",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA077911",
  "pharm_class_epc": [
   "Sulfonylurea [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20190213",
  "set_id": "00b9e312-921e-41e6-ad27-0a6ce87f8298",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 40203,
  "serious": 27085,
  "death": 3727,
  "hospitalization": 14745,
  "primary_suspect": 40054,
  "top_reactions": [
   [
    "Blood Glucose Increased",
    2584
   ],
   [
    "Diarrhoea",
    2325
   ],
   [
    "Nausea",
    2178
   ],
   [
    "Hypoglycaemia",
    1971
   ],
   [
    "Fatigue",
    1887
   ],
   [
    "Drug Ineffective",
    1827
   ],
   [
    "Acute Kidney Injury",
    1699
   ],
   [
    "Dyspnoea",
    1338
   ],
   [
    "Dizziness",
    1319
   ],
   [
    "Vomiting",
    1311
   ],
   [
    "Off Label Use",
    1265
   ],
   [
    "Asthenia",
    1228
   ],
   [
    "Death",
    1223
   ],
   [
    "Weight Decreased",
    1172
   ],
   [
    "Fall",
    1165
   ]
  ],
  "by_year": {
   "2019": 4231,
   "2020": 3350,
   "2021": 2715,
   "2022": 2193,
   "2023": 2013,
   "2024": 1840,
   "2025": 1711,
   "2026": 771
  },
  "by_year_primary": {
   "2019": 4228,
   "2020": 3342,
   "2021": 2707,
   "2022": 2159,
   "2023": 1979,
   "2024": 1796,
   "2025": 1700,
   "2026": 764
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20240118",
   "reason": "Misprint on tablet",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240118",
   "reason": "Misprint on tablet",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230316",
   "reason": "CGMP Deviations",
   "firm": "Northwind Pharmaceuticals LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230316",
   "reason": "CGMP Deviations",
   "firm": "Northwind Pharmaceuticals LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20141009",
   "reason": "Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.",
   "firm": "Micro Labs Usa, Inc                                    S",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 18,
  "nda": 1,
  "anda": 16,
  "first_approval": "19951130",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 11,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS LABS FL INC",
   "AUROBINDO PHARMA LTD",
   "CARLSBAD",
   "CHARTWELL MOLECULAR",
   "DR REDDYS LABS LTD",
   "EPIC PHARMA LLC",
   "HIKMA PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/30/1995"
 },
 "trials": {
  "total": 273,
  "completed": 207,
  "terminated": 31,
  "with_results": 94,
  "industry": 194,
  "phase3": 102,
  "results_share": 0.45410628019323673,
  "terminated_share": 0.11355311355311355
 },
 "pubmed": {
  "rct": 218,
  "meta": 2,
  "recent_rct": 26,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "glimepiride"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4597334,
  "beneficiaries": 1162408,
  "spend": 41415754.15,
  "by_brand": [
   {
    "brand": "Glimepiride",
    "claims": 4597334,
    "per_claim": 9.008645913,
    "is_generic": true
   }
  ],
  "per_claim": 9.008645913044386
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4260,
  "fills": 4597334,
  "per_million": 926.6239955591653,
  "ratio": 0.3346481799789618,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "927 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "218 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 45% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 2 Class III across 16 generic makers (-7)"
   ],
   "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 (16 applications)",
    "10 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are blood glucose increased, diarrhoea, nausea, hypoglycaemia. 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.)"
 ]
}