{
 "query": "fenofibrate",
 "ingredient": "fenofibrate",
 "slug": "fenofibrate",
 "rxcui": "8703",
 "brands": [
  "Lipofen",
  "Antara",
  "Fenoglide",
  "Tricor"
 ],
 "names": [
  "fenofibrate",
  "fenofibrate micronized"
 ],
 "classes": [
  {
   "id": "C10AB",
   "name": "Fibrates"
  }
 ],
 "alternatives": [
  "bezafibrate",
  "choline fenofibrate",
  "ciprofibrate",
  "clofibrate",
  "etofibrate",
  "gemfibrozil"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 132
  },
  "boxed_warning": "",
  "indications_and_usage": "Fenofibrate capsules are indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Fenofibrate capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL) ( 1 ) to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible ( 1 ) Limitations of Use: Markedly elevated levels of serum TG (e.g., >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined ( 1 ). Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus. ( 1 ) Limitations of Use Markedly elevated levels of seru...",
  "contraindications": "Fenofibrate capsules are contraindicated in patients with: Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis [see Clinical Pharmacology (12.3) ] . Active liver disease, including those with unexplained persistent liver function abnormalities [see Warnings and Precautions (5.2) ] . Pre-existing gallbladder disease [see Warnings and Precautions (5.5) ] . Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients in fenofibrate capsules. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with fenofibrate [see Warnings and Precautions (5.9) ] . Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis ( 4 ) Active liver disease, including those with unexplained persistent liver function abnormalities ( 4 ) Pre-existing gallbladder disease ( 4 ) Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients in fenofibrate capsules ( 4 )",
  "warnings_and_cautions": "Hepatotoxicity : Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibrates. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy. Discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist ( 5.2 ) Myopathy and Rhabdomyolysis : Have been reported in patients taking fenofibrates. Risks are increased during co-administration with a statin, in geriatric patients and in patients with renal impairment, or hypothyroidism. Discontinue fenofibrate if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Temporarily discontinue fenofibrate in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the fenofibrate dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. ( 5.3 ) Increases in Serum Creatinine : Monitor renal function in patients with ren...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions (5.1) ] Hepatoxicity [see Warnings and Precautions (5.2) ] Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.3) ] Increases in Serum Creatinine [see Warnings and Precautions (5.4) ] Cholelithiasis [see Warnings and Precautions (5.5) ] Increased Bleeding Risk with Coumarin Anticoagulants [see Warnings and Precautions (5.6) ] Pancreatitis [see Warnings and Precautions (5.7) ] Hematologic Changes [see Warnings and Precautions (5.8) ] Hypersensitivity reactions [see Warnings and Precautions (5.9) ] Venothromboembolic disease [see Warnings and Precautions (5.10) ] Paradoxical Decreases in HDL Cholesterol Levels [see Warnings and Precautions (5.11) ] Adverse reactions (\u2265 2% and greater than placebo): abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varyi...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1 ) 6/2025 Dosage and Administration ( 2 ) 6/2025 Warnings and Precautions, Mortality and Coronary Heart Disease Morbidity ( 5.1 ) 6/2025",
  "information_for_patients": "Hepatotoxicity Inform patients that fenofibrate capsules may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Contraindications (4) and Warnings and Precautions (5.2) ] . Myopathy and Rhabdomyolysis Advise patients that fenofibrate capsules may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to inform other healthcare providers prescribing a new medication or increasing the dosage of an existing medication that they are taking fenofibrate capsules. Instruct patients to promptly report any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.3) and Drug Interactions (7) ] . Increased Bleeding Risk with Coumarin Anticoagulants Inform patients that the concomitant use of fenofibrate capsules with coumarin-type anticoagulants may increase the risk of bleeding. Advise patients if they ar...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Overview of Clinical Trials The effectiveness of fenofibrate has been established in adults with hypertriglyceridemia or primary hyperlipidemia based on adequate and well-controlled trials of other formulations of fenofibrate, referenced below as \"fenofibrate.\" Dosages of fenofibrate used in these trials were comparable to fenofibrate 150 mg per day [see Clinical Pharmacology (12.3) ] . 14.2 Clinical Trials in Adults with Hypertriglyceridemia The effects of fenofibrate on serum TG were studied in two randomized, double-blind, placebo-controlled clinical trials of 147 patients with hypertriglyceridemia. Patients were treated for 8 weeks under protocols that differed only in that one entered patients with baseline TG levels of 500 to 1,500 mg/dL, and the other TG levels of 350 to 499 mg/dL. In patients with hypertriglyceridemia and normal cholesterolemia with or without hyperchylomicronemia, treatment with fenofibrate decreased primarily very low density lipoprotein (VLDL), TG, and VLDL cholesterol (VLDL-C). Treatment of patients with elevated TG often results in an increase of LDL-C (see Table 5 ). Table 5: Effects of Fenofibrate in Patients with Hypertriglyceridemia Trial 1 Pl...",
  "brand_name": "Fenofibrate",
  "manufacturer": "ANI Pharmaceuticals, Inc.",
  "application_number": "NDA021612",
  "pharm_class_epc": [
   "Peroxisome Proliferator Receptor alpha Agonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260512",
  "set_id": "3a69e15a-eda6-4a6e-8934-6881e4370521",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 35949,
  "serious": 24731,
  "death": 2813,
  "hospitalization": 12462,
  "primary_suspect": 35815,
  "top_reactions": [
   [
    "Fatigue",
    2287
   ],
   [
    "Diarrhoea",
    2248
   ],
   [
    "Nausea",
    2043
   ],
   [
    "Drug Ineffective",
    1878
   ],
   [
    "Acute Kidney Injury",
    1670
   ],
   [
    "Headache",
    1584
   ],
   [
    "Dyspnoea",
    1567
   ],
   [
    "Off Label Use",
    1517
   ],
   [
    "Chronic Kidney Disease",
    1479
   ],
   [
    "Dizziness",
    1443
   ],
   [
    "Fall",
    1392
   ],
   [
    "Pain",
    1389
   ],
   [
    "Asthenia",
    1331
   ],
   [
    "Vomiting",
    1226
   ],
   [
    "Arthralgia",
    1189
   ]
  ],
  "by_year": {
   "2019": 3636,
   "2020": 3093,
   "2021": 2628,
   "2022": 2389,
   "2023": 2319,
   "2024": 2198,
   "2025": 2457,
   "2026": 1291
  },
  "by_year_primary": {
   "2019": 3632,
   "2020": 3086,
   "2021": 2622,
   "2022": 2362,
   "2023": 2301,
   "2024": 2171,
   "2025": 2425,
   "2026": 1282
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260528",
   "reason": "CGMP Deviations",
   "firm": "Ajanta Pharma USA Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180912",
   "reason": "Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.",
   "firm": "Hetero Labs, Ltd. - Unit III",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 55,
  "nda": 7,
  "anda": 48,
  "first_approval": "19931231",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 54,
  "labeling_recent": 12,
  "sponsors": [
   "ABBVIE",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "AMNEAL",
   "ANI PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/31/1993"
 },
 "trials": {
  "total": 226,
  "completed": 147,
  "terminated": 26,
  "with_results": 65,
  "industry": 116,
  "phase3": 64,
  "results_share": 0.4421768707482993,
  "terminated_share": 0.11504424778761062
 },
 "pubmed": {
  "rct": 320,
  "meta": 18,
  "recent_rct": 31,
  "cochrane": [
   {
    "pmid": "37310870",
    "title": "Fenofibrate for diabetic retinopathy",
    "year": "2023"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 129.88,
  "records": 1,
  "by_name": [
   [
    "Tricor",
    129.88
   ]
  ],
  "names_checked": [
   "fenofibrate",
   "Lipofen",
   "Antara",
   "Fenoglide",
   "Tricor"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2044078,
  "beneficiaries": 516663,
  "spend": 59076308.06,
  "by_brand": [
   {
    "brand": "Fenofibrate",
    "claims": 2043799,
    "per_claim": 28.82317132,
    "is_generic": true
   },
   {
    "brand": "Lipofen",
    "claims": 279,
    "per_claim": 600.49942652,
    "is_generic": false
   }
  ],
  "per_claim": 28.901200472780396
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Cardiology",
  "names": [
   "bezafibrate",
   "ciprofibrate",
   "fenofibrate"
  ],
  "reason": "Bezafibrate, ciprofibrate and fenofibrate are cholesterol-lowering drugs that have not been shown to prevent cardiovascular events. Y et they all have numerous adverse effects, including cutaneous, haematological and renal disorders ( Prescrire Int n\u00b0 85, 117 , 174). When the use of a fibrate is justified, gemfibrozil is the only one shown to have a degree of efficacy against the cardiovascular complications of hypercholesterolaemia, provided that renal function and serum creatine phosphokinase levels are closely monitored.",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "fenofibrate"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5878,
  "fills": 2044078,
  "per_million": 2875.6241200189033,
  "ratio": 1.0385252083691425,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 90,
   "letter": "A",
   "why": [
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "2,876 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 55,
   "letter": "D",
   "why": [
    "320 randomized trials and 18 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "1 independent Cochrane review(s) exist",
    "Only 44% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 82,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 1 Class III across 48 generic makers (-5)",
    "12 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": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $130 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 (48 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, nausea. 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.)"
 ]
}