{
 "query": "gemfibrozil",
 "ingredient": "gemfibrozil",
 "slug": "gemfibrozil",
 "rxcui": "4719",
 "brands": [
  "Lopid"
 ],
 "names": [
  "gemfibrozil"
 ],
 "classes": [
  {
   "id": "C10AB",
   "name": "Fibrates"
  }
 ],
 "alternatives": [
  "bezafibrate",
  "choline fenofibrate",
  "ciprofibrate",
  "clofibrate",
  "etofibrate",
  "fenofibrate"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 43
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE LOPID (gemfibrozil tablets, USP) is indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. LOPID therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of LOPID therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug t...",
  "contraindications": "CONTRAINDICATIONS 1. Hepatic or severe renal dysfunction, including primary biliary cirrhosis. 2. Preexisting gallbladder disease (see WARNINGS ). 3. Hypersensitivity to gemfibrozil. 4. Combination therapy of gemfibrozil with simvastatin (see WARNINGS and PRECAUTIONS ). 5. Combination therapy of gemfibrozil with repaglinide (see PRECAUTIONS ). 6. Combination therapy of gemfibrozil with dasabuvir (see PRECAUTIONS ). 7. Combination therapy of gemfibrozil with selexipag (see PRECAUTIONS ).",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS 1. Because of chemical, pharmacological, and clinical similarities between gemfibrozil and clofibrate, the adverse findings with clofibrate in two large clinical studies may also apply to gemfibrozil. In the first of those studies, the Coronary Drug Project, 1000 subjects with previous myocardial infarction were treated for five years with clofibrate. There was no difference in mortality between the clofibrate-treated subjects and 3000 placebo-treated subjects, but twice as many clofibrate-treated subjects developed cholelithiasis and cholecystitis requiring surgery. In the other study, conducted by the World Health Organization (WHO), 5000 subjects without known coronary heart disease were treated with clofibrate for five years and followed one year beyond. There was a statistically significant (44%) higher age-adjusted total mortality in the clofibrate-treated group than in a comparable placebo-treated control group during the trial period. The excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, post-cholecystectomy complications, and pancreatitis. The higher risk of clofibrate-treated subjects for gallbladder disease was confir...",
  "adverse_reactions": "ADVERSE REACTIONS In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received LOPID for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the LOPID group: LOPID (N = 2046) PLACEBO (N = 2035) Frequency in percent of subjects Gastrointestinal reactions 34.2 23.8 Dyspepsia 19.6 11.9 Abdominal pain 9.8 5.6 Acute appendicitis 1.2 0.6 (histologically confirmed in most cases where data were available) Atrial fibrillation 0.7 0.1 Adverse events reported by more than 1% of subjects, but without a significant difference between groups: Diarrhea 7.2 6.5 Fatigue 3.8 3.5 Nausea/Vomiting 2.5 2.1 Eczema 1.9 1.2 Rash 1.7 1.3 Vertigo 1.5 1.3 Constipation 1.4 1.3 Headache 1.2 1.1 Gallbladder surgery was performed in 0.9% of LOPID and 0.5% of placebo subjects in the primary prevention component, a 64% excess, which is not statistically different from the excess of gallbladder surgery observed in the clofibrate group compared to the placebo group of the WHO study. Gallbladder surgery was also performed more frequently in the LOPID group compared to the placebo group (1.9% ver...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Lopid",
  "manufacturer": "Parke-Davis Div of Pfizer Inc",
  "application_number": "NDA018422",
  "pharm_class_epc": [
   "Peroxisome Proliferator Receptor alpha Agonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260521",
  "set_id": "c48855b7-215e-453b-b3b1-a0f9dee7221f",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 7924,
  "serious": 5003,
  "death": 624,
  "hospitalization": 2472,
  "primary_suspect": 7889,
  "top_reactions": [
   [
    "Chronic Kidney Disease",
    487
   ],
   [
    "Fatigue",
    482
   ],
   [
    "Acute Kidney Injury",
    456
   ],
   [
    "Drug Ineffective",
    445
   ],
   [
    "Diarrhoea",
    431
   ],
   [
    "Nausea",
    399
   ],
   [
    "Renal Failure",
    359
   ],
   [
    "Pain",
    349
   ],
   [
    "Headache",
    319
   ],
   [
    "Drug Hypersensitivity",
    317
   ],
   [
    "Off Label Use",
    305
   ],
   [
    "Asthenia",
    264
   ],
   [
    "Dizziness",
    258
   ],
   [
    "Dyspnoea",
    256
   ],
   [
    "Death",
    245
   ]
  ],
  "by_year": {
   "2019": 951,
   "2020": 665,
   "2021": 453,
   "2022": 352,
   "2023": 324,
   "2024": 303,
   "2025": 269,
   "2026": 131
  },
  "by_year_primary": {
   "2019": 951,
   "2020": 663,
   "2021": 446,
   "2022": 335,
   "2023": 322,
   "2024": 302,
   "2025": 268,
   "2026": 129
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 21,
  "nda": 1,
  "anda": 17,
  "first_approval": "19811221",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 21,
  "labeling_recent": 0,
  "sponsors": [
   "APOTEX",
   "ASCENT PHARMS INC",
   "AUROBINDO PHARMA LTD",
   "CADILA",
   "CADILA PHARMS LTD",
   "CHARTWELL MOLECULES",
   "CHARTWELL RX",
   "EPIC PHARMA LLC"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/21/1981"
 },
 "trials": {
  "total": 43,
  "completed": 33,
  "terminated": 6,
  "with_results": 8,
  "industry": 28,
  "phase3": 3,
  "results_share": 0.24242424242424243,
  "terminated_share": 0.13953488372093023
 },
 "pubmed": {
  "rct": 178,
  "meta": 0,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "gemfibrozil",
   "Lopid"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 754049,
  "beneficiaries": 185735,
  "spend": 14192377.35,
  "by_brand": [
   {
    "brand": "Gemfibrozil",
    "claims": 754028,
    "per_claim": 18.819027516,
    "is_generic": true
   },
   {
    "brand": "Lopid",
    "claims": 21,
    "per_claim": 109.69857143,
    "is_generic": false
   }
  ],
  "per_claim": 18.821558479621352
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 699,
  "fills": 754049,
  "per_million": 926.9954605072085,
  "ratio": 0.33478233371271393,
  "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 (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 31,
   "letter": "F",
   "why": [
    "178 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 24% of completed registered trials posted results (-15)"
   ],
   "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 (17 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are chronic kidney disease, fatigue, acute kidney injury. How would we recognize and handle those?",
  "Why this one over bezafibrate, choline fenofibrate, ciprofibrate? 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.)"
 ]
}