{
 "query": "atorvastatin",
 "ingredient": "atorvastatin",
 "slug": "atorvastatin",
 "rxcui": "83367",
 "brands": [
  "Lipitor",
  "Atorvaliq"
 ],
 "names": [
  "atorvastatin",
  "atorvastatin calcium",
  "atorvastatin calcium anhydrous",
  "atorvastatin calcium propylene glycol solvate",
  "atorvastatin calcium trihydrate"
 ],
 "classes": [
  {
   "id": "C10AA",
   "name": "HMG CoA reductase inhibitors"
  }
 ],
 "alternatives": [
  "cerivastatin",
  "fluvastatin",
  "lovastatin",
  "pitavastatin",
  "pravastatin",
  "rosuvastatin",
  "simvastatin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 253
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated: \u2022 To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. \u2022 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). \u2022 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). \u2022 As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia. ATORVALIQ is an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): \u2022 To reduce the risk of: o Myocardial ...",
  "contraindications": "is contraindicated in patients with: \u2022 Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] \u2022 Hypersensitivity to atorvastatin or any excipients in ATORVALIQ. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions (6.2) ] . \u2022 Acute liver failure or decompensated cirrhosis ( 4 ). \u2022 Hypersensitivity to atorvastatin or any excipient in ATORVALIQ ( 4 ).",
  "warnings_and_cautions": "\u2022 Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher ATORVALIQ dosage. Discontinue ATORVALIQ if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue ATORVALIQ 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 ATORVALIQ dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever ( 2.5 , 5.1 , 7.1 , 8.5 , 8.6 ). \u2022 Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue ATORVALIQ if IMNM is suspected ( 5.2 ). \u2022 Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical sy...",
  "warnings": "",
  "adverse_reactions": "The following important adverse reactions are described below and elsewhere in the labeling: \u2022 Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] \u2022 Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] \u2022 Hepatic Dysfunction [see Warnings and Precautions (5.3) ] \u2022 Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence \u22655%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc. at 1-844-321-1443, 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, the 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. The safety of ATORVALIQ has been established in adequate and well-controlled trials of atorvastatin calcium tablets, referenced below as \u201catorvastatin\u201d [see Clinical Studies (14) ]. In the atorvastatin placebo-controlled clinical tri...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct patients or caregivers to use an oral dosing syringe or oral dosing cup to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes and cups may be obtained from their pharmacy [see Dosage and Administration (2.1) ]. Myopathy and Rhabdomyolysis Advise patients that ATORVALIQ may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication or consuming large quantities of grapefruit juice and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . Hepatic Dysfunction Inform patients that ATORVALIQ 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 Warnings and Precautions (5.3) ] . Increases in HbA1c and Fasting Seru...",
  "spl_medguide": "",
  "clinical_studies": "The effectiveness of ATORVALIQ has been established in adequate and well-controlled trials of atorvastatin calcium tablets, referenced below as \u201catorvastatin.\u201d Prevention of Cardiovascular Disease In the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), the effect of atorvastatin on fatal and non-fatal coronary heart disease was assessed in 10,305 patients with hypertension, 40-80 years of age (mean of 63 years; 19% women; 95% White, 3% Black, 1% South Asian, 1% other), without a previous myocardial infarction and with total cholesterol (TC) levels \u2264251 mg/dL. Additionally, all patients had at least 3 of the following cardiovascular risk factors: male gender (81%), age >55 years (85%), smoking (33%), diabetes (24%), history of CHD in a first-degree relative (26%), TC:HDL >6 (14%), peripheral vascular disease (5%), left ventricular hypertrophy (14%), prior cerebrovascular event (10%), specific ECG abnormality (14%), proteinuria/albuminuria (62%). In this double-blind, placebo-controlled trial, patients were treated with anti-hypertensive therapy (goal BP <140/90 mm Hg for patients without diabetes; <130/80 mm Hg for patients with diabetes) and allocated to either atorvastatin 10 mg...",
  "brand_name": "ATORVALIQ",
  "manufacturer": "CMP Pharma, Inc.",
  "application_number": "NDA213260",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240427",
  "set_id": "41fca2d8-7f3f-45b9-8974-81b89accc211",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 413983,
  "serious": 300465,
  "death": 33420,
  "hospitalization": 148709,
  "primary_suspect": 411705,
  "top_reactions": [
   [
    "Fatigue",
    24502
   ],
   [
    "Diarrhoea",
    21784
   ],
   [
    "Nausea",
    20009
   ],
   [
    "Dyspnoea",
    19767
   ],
   [
    "Drug Ineffective",
    19088
   ],
   [
    "Off Label Use",
    17223
   ],
   [
    "Dizziness",
    16102
   ],
   [
    "Headache",
    15330
   ],
   [
    "Acute Kidney Injury",
    14663
   ],
   [
    "Pain",
    14131
   ],
   [
    "Fall",
    14004
   ],
   [
    "Asthenia",
    13874
   ],
   [
    "Death",
    13097
   ],
   [
    "Arthralgia",
    12537
   ],
   [
    "Vomiting",
    11858
   ]
  ],
  "by_year": {
   "2019": 41206,
   "2020": 39088,
   "2021": 33711,
   "2022": 32253,
   "2023": 32234,
   "2024": 32710,
   "2025": 35516,
   "2026": 17729
  },
  "by_year_primary": {
   "2019": 41179,
   "2020": 39041,
   "2021": 33560,
   "2022": 31747,
   "2023": 31758,
   "2024": 32342,
   "2025": 35103,
   "2026": 17485
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250919",
   "reason": "Failed Dissolution Specifications",
   "firm": "Ascend Laboratories, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250919",
   "reason": "Failed Dissolution Specifications",
   "firm": "Ascend Laboratories, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250919",
   "reason": "Failed Dissolution Specifications",
   "firm": "Ascend Laboratories, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250919",
   "reason": "Failed Dissolution Specifications",
   "firm": "Ascend Laboratories, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250317",
   "reason": "Failed dissolution specifications: lower than specifications",
   "firm": "BIOCON PHARMA INC",
   "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": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20220316",
   "reason": "Failed Impurities/Degradation Specifications: Out of Specification results for related substance.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20210604",
   "reason": "Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 28,
 "drugsfda": {
  "applications": 35,
  "nda": 2,
  "anda": 33,
  "first_approval": "19961217",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 29,
  "labeling_recent": 3,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ALKEM LABS LTD",
   "APOTEX",
   "APOTEX INC",
   "AUROBINDO PHARMA LTD",
   "BIOCON PHARMA",
   "CADILA PHARMS LTD",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/17/1996"
 },
 "trials": {
  "total": 1198,
  "completed": 746,
  "terminated": 107,
  "with_results": 241,
  "industry": 502,
  "phase3": 277,
  "results_share": 0.3230563002680965,
  "terminated_share": 0.08931552587646077
 },
 "pubmed": {
  "rct": 1178,
  "meta": 76,
  "recent_rct": 110,
  "cochrane": [
   {
    "pmid": "33482034",
    "title": "Effect of atorvastatin on testosterone levels",
    "year": "2021"
   },
   {
    "pmid": "25760954",
    "title": "Lipid-lowering efficacy of atorvastatin",
    "year": "2015"
   },
   {
    "pmid": "23235655",
    "title": "Lipid lowering efficacy of atorvastatin",
    "year": "2012"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 5470.57,
  "records": 98,
  "by_name": [
   [
    "Lipitor",
    3384.0
   ],
   [
    "Atorvaliq",
    2086.57
   ]
  ],
  "names_checked": [
   "atorvastatin",
   "Lipitor",
   "Atorvaliq"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 73374921,
  "beneficiaries": 17838516,
  "spend": 784217807.95,
  "by_brand": [
   {
    "brand": "Atorvastatin Calcium",
    "claims": 73349032,
    "per_claim": 10.313531866,
    "is_generic": true
   },
   {
    "brand": "Lipitor",
    "claims": 23269,
    "per_claim": 1151.6690489,
    "is_generic": false
   },
   {
    "brand": "Atorvaliq",
    "claims": 2620,
    "per_claim": 355.74122519,
    "is_generic": false
   }
  ],
  "per_claim": 10.687818089098863
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "atorvastatin",
  "matched": "atorvastatin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 84930,
  "fills": 73374921,
  "per_million": 1157.4799514945985,
  "ratio": 0.4180212912531596,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,157 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 75,
   "letter": "B",
   "why": [
    "1178 randomized trials and 76 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "3 independent Cochrane review(s) exist",
    "Only 32% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 16 Class II, 12 Class III across 33 generic makers (-7)",
    "3 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $5,471 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 (33 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 92,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, nausea, dyspnoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over cerivastatin, fluvastatin, lovastatin? 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.)"
 ]
}