{
 "query": "pravastatin",
 "ingredient": "pravastatin",
 "slug": "pravastatin",
 "rxcui": "42463",
 "brands": [
  "Pravachol"
 ],
 "names": [
  "pravastatin",
  "pravastatin sodium"
 ],
 "classes": [
  {
   "id": "C10AA",
   "name": "HMG CoA reductase inhibitors"
  }
 ],
 "alternatives": [
  "atorvastatin",
  "cerivastatin",
  "fluvastatin",
  "lovastatin",
  "pitavastatin",
  "rosuvastatin",
  "simvastatin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 118
  },
  "boxed_warning": "",
  "indications_and_usage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Pravastatin sodium is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 7. Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. ( 1.1 ) 8. Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD. ( 1.1 ) 9. Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. ( 1.2 ) 10. Reduce elevated serum TG levels in patients with hypertriglyceridemia. ( 1.2 ) 11. Treat patients with primary dysbetalipoproteinemia who are not responding to diet. ( 1.2 ) 12. Treat childr...",
  "contraindications": "5. Hypersensitivity to any component of this medication. ( 4.1 , 6.2 , 11 ) 6. Active liver disease or unexplained, persistent elevations of serum transaminases. ( 4.2 , 5.2 ) 7. Pregnancy ( 4.3 , 8.1, 8.3 ) 8. Lactation ( 4.4 , 8.2 ) 4.1 Hypersensitivity Hypersensitivity to any component of this medication. 4.2 Liver Active liver disease or unexplained, persistent elevations of serum transaminases [see Warnings and Precautions (5.2) ]. 4.3 Pregnancy Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they are contraindicated during pregnancy and in nursing mothers. PRAVASTATIN SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN INFORMED OF THE POTENTIAL HAZARDS. If the patient beco...",
  "warnings_and_cautions": "3. Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): predisposing factors include advanced age (\u226565), uncontrolled hypothyroidism, and renal impairment. Patients should be advised to promptly report to their physician any unexplained and/or persistent muscle pain, tenderness, or weakness. Pravastatin therapy should be discontinued if myopathy is diagnosed or suspected. ( 5.1 , 8.5 ) 4. Liver enzyme abnormalities: persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter. ( 5.2 ) 5.1 Skeletal Muscle Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with pravastatin and other drugs in this class . A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects. Uncomplicated myalgia has also been reported in pravastatin-treated patients [see Adverse Reactions ( 6 ) ]. Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values to greater than 10 times the ULN, was rare (<0.1%) in pra...",
  "warnings": "",
  "adverse_reactions": "Pravastatin is generally well tolerated; adverse reactions have usually been mild and transient. In 4-month-long placebo-controlled trials, 1.7% of pravastatin-treated patients and 1.2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant. In short-term clinical trials, the most commonly reported adverse reactions (\u22652% and > placebo) regardless of causality were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Adverse Clinical Events Short-Term Controlled Trials In the pravastatin sodium placebo-controlled clinical trials database of 1313 patients (age range 20 to 76 years, 32.4% women, 93.5% Caucasians, 5% Blacks, 0.9% Hispanics, 0.4% Asians, 0.2% Others) with a median treatment duration of 14 weeks, 3.3% of patients on pravastatin sodium and 1.2% patients on placebo discontinued due to adverse events regardless of causality. The most common adverse reactions that led to treatment disc...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration Patients with Renal Impairment (2.3) 7/2016 Contraindications Pregnancy (4.3), Lactation (4.4) 7/2016",
  "information_for_patients": "Muscle Pain Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing pravastatin [see Warnings and Precautions (5.1) ]. Liver Enzymes It is recommended that liver enzyme tests be performed before the initiation of pravastatin, and thereafter when clinically indicated. All patients treated with pravastatin should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.2) ]. Embryofetal Toxicity Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications( 4.3 ) , Use in Specific Populations ( 8.1 , 8.3 ) ]. Lactation Advise women not to breastfeed during treatment with pravastatin sodium tablets [see Contraindications( 4.4 ),Use in Specific Populations ( 8.2 ) ]. APOTEX INC. PRAVASTATIN SODIUM TABLETS, USP 10 mg, 20 mg, 40 mg and 80 mg Manufactured by...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Prevention of Coronary Heart Disease In the Pravastatin Primary Prevention Study (WOS), 3 the effect of pravastatin sodium on fatal and nonfatal CHD was assessed in 6595 men 45 to 64 years of age, without a previous MI, and with LDL-C levels between 156 to 254 mg/dL (4 to 6.7 mmol/L). In this randomized, double-blind, placebo-controlled study, patients were treated with standard care, including dietary advice, and either pravastatin sodium 40 mg daily (N=3302) or placebo (N=3293) and followed for a median duration of 4.8 years. Median (25 th , 75 th percentile) percent changes from baseline after 6 months of pravastatin treatment in Total-C, LDL-C, TG, and HDL-C were \u221220.3 (\u221226.9, \u221211.7), \u221227.7 (\u221236.0, \u221216.9), \u22129.1 (\u221227.6, 12.5), and 6.7 (\u22122.1, 15.6), respectively. Pravastatin sodium significantly reduced the rate of first coronary events (either CHD death or nonfatal MI) by 31% (248 events in the placebo group [CHD death=44, nonfatal MI=204] versus 174 events in the pravastatin sodium group [CHD death=31, nonfatal MI=143], p=0.0001 [see figure below]). The risk reduction with pravastatin sodium was similar and significant throughout the entire range of baseline LDL cholestero...",
  "brand_name": "PRAVASTATIN SODIUM",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA076341",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20220301",
  "set_id": "2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 63898,
  "serious": 42410,
  "death": 5776,
  "hospitalization": 20894,
  "primary_suspect": 63635,
  "top_reactions": [
   [
    "Fatigue",
    4220
   ],
   [
    "Diarrhoea",
    3658
   ],
   [
    "Nausea",
    3166
   ],
   [
    "Acute Kidney Injury",
    2966
   ],
   [
    "Chronic Kidney Disease",
    2964
   ],
   [
    "Drug Ineffective",
    2914
   ],
   [
    "Dyspnoea",
    2877
   ],
   [
    "Off Label Use",
    2809
   ],
   [
    "Headache",
    2675
   ],
   [
    "Pain",
    2604
   ],
   [
    "Fall",
    2531
   ],
   [
    "Dizziness",
    2418
   ],
   [
    "Arthralgia",
    2249
   ],
   [
    "Death",
    2204
   ],
   [
    "Asthenia",
    2195
   ]
  ],
  "by_year": {
   "2019": 8001,
   "2020": 6478,
   "2021": 5104,
   "2022": 4506,
   "2023": 4062,
   "2024": 3903,
   "2025": 3644,
   "2026": 1845
  },
  "by_year_primary": {
   "2019": 7992,
   "2020": 6468,
   "2021": 5083,
   "2022": 4457,
   "2023": 4004,
   "2024": 3872,
   "2025": 3606,
   "2026": 1806
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240628",
   "reason": "Failed Dissolution Specifications: results below specifications",
   "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"
  },
  {
   "class": "Class II",
   "date": "20190325",
   "reason": "Presence Of  Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20171117",
   "reason": "Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.",
   "firm": "Lupin Limited",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20170711",
   "reason": "Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20130405",
   "reason": "Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.",
   "firm": "Glenmark Generics Inc., USA",
   "status": "Terminated"
  }
 ],
 "recall_total": 11,
 "drugsfda": {
  "applications": 19,
  "nda": 1,
  "anda": 16,
  "first_approval": "19911031",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 19,
  "labeling_recent": 1,
  "sponsors": [
   "ACCORD HLTHCARE",
   "APOTEX",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA USA",
   "BIOCON PHARMA",
   "BRISTOL MYERS SQUIBB",
   "CHARTWELL RX",
   "CIPLA"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/31/1991"
 },
 "trials": {
  "total": 192,
  "completed": 143,
  "terminated": 20,
  "with_results": 43,
  "industry": 74,
  "phase3": 35,
  "results_share": 0.3006993006993007,
  "terminated_share": 0.10416666666666667
 },
 "pubmed": {
  "rct": 515,
  "meta": 19,
  "recent_rct": 13,
  "cochrane": [
   {
    "pmid": "37721222",
    "title": "Pravastatin for lowering lipids",
    "year": "2023"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "pravastatin",
   "Pravachol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 9395079,
  "beneficiaries": 2344151,
  "spend": 126966414.24,
  "by_brand": [
   {
    "brand": "Pravastatin Sodium",
    "claims": 9395079,
    "per_claim": 13.514140141,
    "is_generic": true
   }
  ],
  "per_claim": 13.514140140812014
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "pravastatin",
  "matched": "pravastatin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 9284,
  "fills": 9395079,
  "per_million": 988.1768955854443,
  "ratio": 0.35687787191974857,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "988 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": 62,
   "letter": "D",
   "why": [
    "515 randomized trials and 19 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 independent Cochrane review(s) exist",
    "Only 30% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 9 Class II, 1 Class III across 16 generic makers (-6)",
    "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 (16 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, diarrhoea, nausea, acute kidney injury. 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.)"
 ]
}