{
 "query": "rosuvastatin",
 "ingredient": "rosuvastatin",
 "slug": "rosuvastatin",
 "rxcui": "301542",
 "brands": [
  "Crestor",
  "Ezallor"
 ],
 "names": [
  "rosuvastatin",
  "rosuvastatin calcium"
 ],
 "classes": [
  {
   "id": "C10AA",
   "name": "HMG CoA reductase inhibitors"
  }
 ],
 "alternatives": [
  "atorvastatin",
  "cerivastatin",
  "fluvastatin",
  "lovastatin",
  "pitavastatin",
  "pravastatin",
  "simvastatin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 162
  },
  "boxed_warning": "",
  "indications_and_usage": "Rosuvastatin tablets are indicated: To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP \u22652 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce LDL-C in adults with primary hyperlipidemia. Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). 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 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: ( 1 ) To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at incre...",
  "contraindications": "Rosuvastatin tablets are contraindicated in the following conditions: Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets [see Adverse Reactions (6.1) ] . Acute liver failure or decompensated cirrhosis. ( 4 ) Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. ( 4 )",
  "warnings_and_cautions": "Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher rosuvastatin tablets dosage. Asian patients may be at higher risk for myopathy. Discontinue rosuvastatin tablets if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue rosuvastatin tablets 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 rosuvastatin tablets dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. ( 5.1 , 7.1 , 8.5 , 8.6 , 8.8 ) Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue rosuvastatin tablets if IMNM is suspected. ( 5.2 ) 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 i...",
  "warnings": "",
  "adverse_reactions": "The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Proteinuria and Hematuria [see Warnings and Precautions (5.4) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.5) ] Most frequent adverse reactions (rate \u2265 2%) are headache, nausea, myalgia, asthenia, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc., at 1-855-724-3436 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 clinical practice. Adverse reactions reported in \u22652% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 2. These studies had a treatment duration of up to 12...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration Modifications Due to Drug Interactions ( 2.6 ) 07/2023 Contraindications, Pregnancy and Lactation ( 4 ) Removed 01/2023 Warnings and Precautions ( 5.2 ) 01/2023 Warnings and Precautions, Concomitant Coumarin Anticoagulants ( 5.4 ) Removed 01/2023",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Myopathy and Rhabdomyolysis Advise patients that rosuvastatin 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 promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1) , and Drug Interactions (7.1) ]. Hepatic Dysfunction Inform patients that rosuvastatin 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 Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with rosuvastatin. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.5) ] . ...",
  "spl_medguide": "",
  "clinical_studies": "Primary Prevention of Cardiovascular Disease In the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, the effect of Atorvastatin on the occurrence of major cardiovascular (CV) disease events was assessed in 17,802 men (\u226550 years) and women (\u226560 years) who had no clinically evident cardiovascular disease, LDL-C levels <130 mg/dL and hsCRP levels \u22652 mg/L. The study population had an estimated baseline coronary heart disease risk of 11.6% over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58%), low HDL-C levels (23%), cigarette smoking (16%), or a family history of premature CHD (12%). Patients had a median baseline LDL-C of 108 mg/dL and hsCRP of 4.3 mg/L. Patients were randomly assigned to placebo (n=8901) or rosuvastatin 20 mg once daily (n=8901) and were followed for a mean duration of 2 years. The JUPITER study was stopped early by the Data Safety Monitoring Board due to meeting predefined stopping rules for efficacy in rosuvastatin-treated subjects. The primary end point was a composite end point consisting of the...",
  "brand_name": "Rosuvastatin",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA206381",
  "pharm_class_epc": [
   "HMG-CoA Reductase Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240306",
  "set_id": "11701a6e-9b34-4939-e063-6294a90a09c9",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 173310,
  "serious": 123793,
  "death": 11334,
  "hospitalization": 58290,
  "primary_suspect": 172299,
  "top_reactions": [
   [
    "Fatigue",
    12399
   ],
   [
    "Dyspnoea",
    10108
   ],
   [
    "Drug Ineffective",
    9993
   ],
   [
    "Nausea",
    9954
   ],
   [
    "Diarrhoea",
    9695
   ],
   [
    "Off Label Use",
    9666
   ],
   [
    "Pain",
    8814
   ],
   [
    "Headache",
    8179
   ],
   [
    "Arthralgia",
    7283
   ],
   [
    "Dizziness",
    7262
   ],
   [
    "Asthenia",
    6722
   ],
   [
    "Myalgia",
    6454
   ],
   [
    "Cough",
    6305
   ],
   [
    "Vomiting",
    6243
   ],
   [
    "Acute Kidney Injury",
    6198
   ]
  ],
  "by_year": {
   "2019": 14225,
   "2020": 14559,
   "2021": 15240,
   "2022": 15315,
   "2023": 15823,
   "2024": 15873,
   "2025": 20198,
   "2026": 10442
  },
  "by_year_primary": {
   "2019": 14218,
   "2020": 14537,
   "2021": 15160,
   "2022": 15142,
   "2023": 15614,
   "2024": 15741,
   "2025": 19949,
   "2026": 10320
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20251231",
   "reason": "Out of specification for dissolution.",
   "firm": "AvKARE",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "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"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 31,
  "nda": 2,
  "anda": 29,
  "first_approval": "20030812",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 31,
  "labeling_recent": 9,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS CO",
   "APOTEX",
   "ASTRAZENECA",
   "AUROBINDO PHARMA LTD",
   "BIOCON PHARMA",
   "CADILA PHARMS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/12/2003"
 },
 "trials": {
  "total": 904,
  "completed": 607,
  "terminated": 56,
  "with_results": 134,
  "industry": 558,
  "phase3": 191,
  "results_share": 0.22075782537067545,
  "terminated_share": 0.061946902654867256
 },
 "pubmed": {
  "rct": 579,
  "meta": 52,
  "recent_rct": 66,
  "cochrane": [
   {
    "pmid": "25415541",
    "title": "Lipid-lowering efficacy of rosuvastatin",
    "year": "2014"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "rosuvastatin",
   "Crestor",
   "Ezallor"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 30868104,
  "beneficiaries": 8225223,
  "spend": 468525712.78000003,
  "by_brand": [
   {
    "brand": "Rosuvastatin Calcium",
    "claims": 30813501,
    "per_claim": 14.169110086,
    "is_generic": true
   },
   {
    "brand": "Crestor",
    "claims": 54565,
    "per_claim": 584.98740218,
    "is_generic": false
   },
   {
    "brand": "Ezallor Sprinkle",
    "claims": 38,
    "per_claim": 157.56263158,
    "is_generic": false
   }
  ],
  "per_claim": 15.178311981195867
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 46010,
  "fills": 30868104,
  "per_million": 1490.5353435377824,
  "ratio": 0.538303499909081,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,491 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.7x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 69,
   "letter": "C",
   "why": [
    "579 randomized trials and 52 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 22% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 6 Class II, 0 Class III across 29 generic makers (-6)",
    "9 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 $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 (29 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 89,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, dyspnoea, nausea. 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 atorvastatin, cerivastatin, fluvastatin? 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.)"
 ]
}