{
 "query": "simvastatin",
 "ingredient": "simvastatin",
 "slug": "simvastatin",
 "rxcui": "36567",
 "brands": [
  "Zocor",
  "Flolipid"
 ],
 "names": [
  "simvastatin"
 ],
 "classes": [
  {
   "id": "C10AA",
   "name": "HMG CoA reductase inhibitors"
  }
 ],
 "alternatives": [
  "atorvastatin",
  "cerivastatin",
  "fluvastatin",
  "lovastatin",
  "pitavastatin",
  "pravastatin",
  "rosuvastatin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 119
  },
  "boxed_warning": "",
  "indications_and_usage": "\u00ae is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. ZOCOR is an HMG-CoA reductase inhibitor indicated: ( 1 ) To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease,...",
  "contraindications": "is contraindicated in the following conditions: Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) [see Drug Interactions (7.1) ] . Concomitant use of cyclosporine, danazol or gemfibrozil [see Drug Interactions (7.1) ] . Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . Hypersensitivity to simvastatin or any excipients in ZOCOR. Hypersensitivity reactions, including anaphylaxis, angioedema and Stevens-Johnson syndrome, have been reported [see Adverse Reactions (6.2) ] . Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) ( 4 , 7.1 ) Concomitant use of cyclosporine, danazol or gemfibrozil ( 4 , 7.1 ) Acute liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to simvastatin or any excipient in ZOCOR ( 4 , 6.2 )",
  "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 ZOCOR dosage. Chinese patients may be at higher risk for myopathy. Discontinue ZOCOR if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue ZOCOR 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 ZOCOR 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. Discontinue ZOCOR 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 enzyme before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with c...",
  "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) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence \u22655%) are upper respiratory infection, headache, abdominal pain, constipation, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical studies, 2,423 adult patients were exposed to ZOCOR with a median duration of follow-up of approximately 18 months. The most commonly reported adverse reactions (incidence \u22655%) in these ZOCOR clinical studies ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.1 ) 3/2023",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Myopathy and Rhabdomyolysis Advise patients that ZOCOR may cause myopathy and rhabdomyolysis. Inform patients taking an 80 mg daily dose of ZOCOR that they are at an increased risk. Inform patients that the risk is also increased when taking certain types of medication or consuming grapefruit juice 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 dose of an existing medication that they are taking ZOCOR. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Contraindications (4) , Warnings and Precautions (5.1) , and Drug Interactions (7.1) ] . Hepatic Dysfunction Inform patients that ZOCOR 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 Level...",
  "spl_medguide": "",
  "clinical_studies": "Adults at High Risk of Coronary Heart Disease Events In a randomized, double-blind, placebo-controlled, multi-centered study [the Scandinavian Simvastatin Survival Study (Study 4S)], the effect of therapy with ZOCOR on total mortality was assessed in 4,444 adult patients with CHD (history of angina and/or a previous myocardial infarction) and baseline total cholesterol (total-C) between 212 and 309 mg/dL who were on a lipid-lowering diet. In Study 4S, patients were treated with standard care, including lipid-lowering diet, and randomized to either ZOCOR 20-40 mg/day (n=2,221) or placebo (n=2,223) for a median duration of 5.4 years. ZOCOR significantly reduced the risk of mortality by 30% (p=0.0003, 182 deaths in the ZOCOR group vs 256 deaths in the placebo group). The risk of CHD mortality was significantly reduced by 42% (p=0.00001, 111 deaths in the ZOCOR group vs 189 deaths in the placebo group). There was no statistically significant difference between groups in non-cardiovascular mortality. ZOCOR significantly reduced the risk for the secondary composite endpoint (time to first occurrence of CHD death, definite or probable hospital verified non-fatal MI, silent MI verified by ...",
  "brand_name": "ZOCOR",
  "manufacturer": "Organon LLC",
  "application_number": "NDA019766",
  "pharm_class_epc": [
   "HMG-CoA Reductase Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250328",
  "set_id": "8f55d5de-5a4f-4a39-8c84-c53976dd6af9",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 164399,
  "serious": 119344,
  "death": 15113,
  "hospitalization": 62302,
  "primary_suspect": 163604,
  "top_reactions": [
   [
    "Fatigue",
    10177
   ],
   [
    "Diarrhoea",
    8884
   ],
   [
    "Nausea",
    8536
   ],
   [
    "Dyspnoea",
    8276
   ],
   [
    "Drug Ineffective",
    7808
   ],
   [
    "Dizziness",
    7210
   ],
   [
    "Acute Kidney Injury",
    7036
   ],
   [
    "Off Label Use",
    6429
   ],
   [
    "Fall",
    6424
   ],
   [
    "Headache",
    6246
   ],
   [
    "Asthenia",
    5929
   ],
   [
    "Pain",
    5864
   ],
   [
    "Malaise",
    5515
   ],
   [
    "Vomiting",
    5501
   ],
   [
    "Arthralgia",
    5303
   ]
  ],
  "by_year": {
   "2019": 18211,
   "2020": 14369,
   "2021": 10546,
   "2022": 9127,
   "2023": 7677,
   "2024": 6670,
   "2025": 6151,
   "2026": 2789
  },
  "by_year_primary": {
   "2019": 18169,
   "2020": 14332,
   "2021": 10483,
   "2022": 8910,
   "2023": 7550,
   "2024": 6572,
   "2025": 6041,
   "2026": 2725
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "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 II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200318",
   "reason": "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190729",
   "reason": "Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20171222",
   "reason": "Presence of foreign substance: metallic razor blade was found in one bottle.",
   "firm": "Hetero Labs, Ltd. - Unit III",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 20,
  "nda": 3,
  "anda": 16,
  "first_approval": "19911223",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 50,
  "labeling_recent": 4,
  "sponsors": [
   "ACCORD HLTHCARE",
   "AUROBINDO PHARMA",
   "BIOCON PHARMA",
   "CHARTWELL RX",
   "HETERO LABS LTD III",
   "INVAGEN PHARMS",
   "IVAX SUB TEVA PHARMS",
   "LUPIN"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/23/1991"
 },
 "trials": {
  "total": 681,
  "completed": 455,
  "terminated": 76,
  "with_results": 171,
  "industry": 275,
  "phase3": 180,
  "results_share": 0.3758241758241758,
  "terminated_share": 0.11160058737151249
 },
 "pubmed": {
  "rct": 932,
  "meta": 31,
  "recent_rct": 60,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "simvastatin",
   "Zocor",
   "Flolipid"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 15055272,
  "beneficiaries": 3669172,
  "spend": 128001839.55,
  "by_brand": [
   {
    "brand": "Simvastatin",
    "claims": 15052578,
    "per_claim": 8.3994403743,
    "is_generic": true
   },
   {
    "brand": "Zocor",
    "claims": 2681,
    "per_claim": 583.84894815,
    "is_generic": false
   },
   {
    "brand": "Flolipid",
    "claims": 13,
    "per_claim": 254.54846154,
    "is_generic": false
   }
  ],
  "per_claim": 8.502127331209957
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20111215",
   "title": "Zocor (simvastatin) - Revised dose limitation for Zocor (simvastatin) when taken with amiodarone",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm283137.htm",
   "kind": "drug",
   "matched": "zocor"
  },
  {
   "date": "20110608",
   "title": "Simvastatin - New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm256581.htm",
   "kind": "drug",
   "matched": "zocor"
  }
 ],
 "settlements": [
  {
   "year": 2008,
   "company": "Merck",
   "amount_usd": 650000000.0,
   "amount_text": "$650 million",
   "violations": "Medicare fraud, kickbacks",
   "products": "Zocor, Vioxx, Pepsid",
   "laws": "False Claims Act, Medicaid Rebate Statute",
   "urls": [
    "https://www.justice.gov/opa/pr/2008/February/08_civ_094.html"
   ],
   "matched": "zocor"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "simvastatin",
  "matched": "simvastatin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15338,
  "fills": 15055272,
  "per_million": 1018.7793352388452,
  "ratio": 0.36792987443857683,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 84,
   "letter": "B",
   "why": [
    "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2011 (-16)",
    "1,019 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 (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 72,
   "letter": "C",
   "why": [
    "932 randomized trials and 31 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 38% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 84,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 6 Class II, 2 Class III across 16 generic makers (-7)",
    "4 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Maker paid $650 million in 2008 to settle federal allegations naming this drug (Medicare fraud, kickbacks) (-15)",
    "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)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "In 2011 the FDA issued a safety communication about this drug (Zocor (simvastatin) - Revised dose limitation for Zocor (simvastatin) when taken with amiodarone). Does that risk apply to me?",
  "The maker paid $650 million in 2008 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, nausea, dyspnoea. How would we recognize and handle those?",
  "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.)"
 ]
}