{
 "query": "ranolazine",
 "ingredient": "ranolazine",
 "slug": "ranolazine",
 "rxcui": "35829",
 "brands": [
  "Aspruzyo",
  "Ranexa"
 ],
 "names": [
  "ranolazine"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 30
  },
  "boxed_warning": "",
  "indications_and_usage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. Ranolazine extended-release tablets are an antianginal indicated for the treatment of chronic angina. ( 1 )",
  "contraindications": "Ranolazine is contraindicated in patients: \u2022 Taking strong inhibitors of CYP3A [see Drug Interactions (7.1) ] \u2022 Taking inducers of CYP3A [see Drug Interactions (7.1) ] \u2022 With liver cirrhosis [see Use in Specific Populations (8.6) ] \u2022 Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nelfinavir) ( 4 , 7.1 ) \u2022 CYP3A inducers (e.g., rifampin, phenobarbital, St. John\u2019s wort) ( 4 , 7.1 ) \u2022 Liver cirrhosis ( 4 , 8.6 )",
  "warnings_and_cautions": "\u2022 QT interval prolongation: Can occur with ranolazine. Little data available on high doses, long exposure, use with QT interval-prolonging drugs, potassium channel variants causing prolonged QT interval, in patients with a family history of (or congenital) long QT syndrome, or in patients with known acquired QT interval prolongation. ( 5.1 ) \u2022 Renal failure: Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment (CrCL<60 mL/min). If acute renal failure develops, discontinue ranolazine extended-release tablets. ( 5.2 ) 5.1 QT Interval Prolongation Ranolazine blocks I Kr and prolongs the QTc interval in a dose-related manner. Clinical experience in an acute coronary syndrome population did not show an increased risk of proarrhythmia or sudden death [see Clinical Studies (14.2) ] . However, there is little experience with high doses (>1,000 mg twice daily) or exposure, other QT-prolonging drugs, potassium channel variants resulting in a long QT interval, in patients with a family history of (or congenital) long QT syndrome, or in patients with known acquired QT interval prolongation. 5.2 Renal Failure Acute renal failure has been ...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions (>4% and more common than with placebo) are dizziness, headache, constipation, nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 practice. A total of 2,018 patients with chronic angina were treated with ranolazine in controlled clinical trials. Of the patients treated with ranolazine, 1,026 were enrolled in three double-blind, placebo-controlled, randomized studies (CARISA, ERICA, MARISA) of up to 12 weeks\u2019 duration. In addition, upon study completion, 1,251 patients received treatment with ranolazine in open-label, long-term studies; 1,227 patients were exposed to ranolazine for more than 1 year, 613 patients for more than 2 years, 531 patients for more than 3 years, and 326 patients for more than 4 years. At recommended doses, about 6% of patients disconti...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients that ranolazine extended-release tablets will not abate an acute angina episode. Strong CY3PA Inhibitors, CYP3A Inducers, Liver Cirrhosis \u2022 Inform patients that ranolazine extended-release tablets should not be used with drugs that are strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir) [(see Contraindications (4) , Drug Interactions (7.1) ]. \u2022 Inform patients that ranolazine extended-release tablets should not be used with drugs that are inducers of CYP3A (e.g., rifampin, rifabutin, rifapentine, barbiturates, carbamazepine, phenytoin, St. John\u2019s wort) [(see Contraindications (4) , Drug Interactions (7.1) ]. \u2022 Inform patients that ranolazine extended-release tablets should not be used in patients with liver cirrhosis [(see Contraindications (4) , Use in Specific Populations (8.6) ]. Moderate CYP3A Inhibitors, P-gp Inhibitors, Grapefruit Products \u2022 Advise patients to inform their physician if they are receiving drugs that are moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin) [see Drug Interactions (7) ]. \u2022 Advise patients to inform th...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Chronic Stable Angina CARISA (Combination Assessment of Ranolazine In Stable Angina) was a study in 823 chronic angina patients randomized to receive 12 weeks of treatment with twice-daily ranolazine 750 mg, 1000 mg, or placebo, who also continued on daily doses of atenolol 50 mg, amlodipine 5 mg, or diltiazem CD 180 mg. Sublingual nitrates were used in this study as needed. In this trial, statistically significant (p <0.05) increases in modified Bruce treadmill exercise duration and time to angina were observed for each ranolazine dose versus placebo, at both trough (12 hours after dosing) and peak (4 hours after dosing) plasma levels, with minimal effects on blood pressure and heart rate. The changes versus placebo in exercise parameters are presented in Table 1. Exercise treadmill results showed no increase in effect on exercise at the 1000 mg dose compared to the 750 mg dose. Table 1 Exercise Treadmill Results (CARISA) Mean Difference from Placebo (sec) Study CARISA (N=791) Ranolazine Twice-daily Dose 750 mg 1000 mg Exercise Duration Trough 24 a 24 a Peak 34 b 26 a Time to Angina Trough 30 a 26 a Peak 38 b 38 b Time to 1 mm ST-Segment Depression Trough 20 21 Peak 41 b 35 b...",
  "brand_name": "Ranolazine",
  "manufacturer": "Glenmark Pharmaceuticals Inc., USA",
  "application_number": "ANDA211082",
  "pharm_class_epc": [
   "Anti-anginal [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260123",
  "set_id": "0cf58732-c242-49b0-8e3f-248778b4458d",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 17103,
  "serious": 13315,
  "death": 1723,
  "hospitalization": 6555,
  "primary_suspect": 17013,
  "top_reactions": [
   [
    "Death",
    973
   ],
   [
    "Dizziness",
    954
   ],
   [
    "Chest Pain",
    914
   ],
   [
    "Dyspnoea",
    884
   ],
   [
    "Myocardial Infarction",
    796
   ],
   [
    "Angina Pectoris",
    730
   ],
   [
    "Nausea",
    679
   ],
   [
    "Fall",
    634
   ],
   [
    "Fatigue",
    626
   ],
   [
    "Stent Placement",
    615
   ],
   [
    "Off Label Use",
    562
   ],
   [
    "Asthenia",
    498
   ],
   [
    "Diarrhoea",
    493
   ],
   [
    "Headache",
    492
   ],
   [
    "Malaise",
    471
   ]
  ],
  "by_year": {
   "2019": 1830,
   "2020": 895,
   "2021": 660,
   "2022": 618,
   "2023": 655,
   "2024": 692,
   "2025": 813,
   "2026": 396
  },
  "by_year_primary": {
   "2019": 1828,
   "2020": 888,
   "2021": 658,
   "2022": 602,
   "2023": 644,
   "2024": 686,
   "2025": 792,
   "2026": 374
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260917",
   "reason": "Failed Dissolution Specifications: below specification",
   "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": "20231023",
   "reason": "Failed Dissolution Specifications: Out of specification for dissolution.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 30,
  "nda": 2,
  "anda": 27,
  "first_approval": "20060127",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 11,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "AJANTA PHARMA LTD",
   "ALKEM LABS LTD",
   "AMNEAL",
   "ANI PHARMS",
   "AUROBINDO PHARMA",
   "CADILA"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/27/2006"
 },
 "trials": {
  "total": 91,
  "completed": 52,
  "terminated": 22,
  "with_results": 48,
  "industry": 58,
  "phase3": 17,
  "results_share": 0.9230769230769231,
  "terminated_share": 0.24175824175824176
 },
 "pubmed": {
  "rct": 87,
  "meta": 12,
  "recent_rct": 8,
  "cochrane": [
   {
    "pmid": "28178363",
    "title": "Ranolazine for stable angina pectoris",
    "year": "2017"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ranolazine",
   "Aspruzyo",
   "Ranexa"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1248804,
  "beneficiaries": 301059,
  "spend": 111440668.18,
  "by_brand": [
   {
    "brand": "Ranolazine ER",
    "claims": 1248783,
    "per_claim": 89.235561727,
    "is_generic": false
   },
   {
    "brand": "Aspruzyo Sprinkle",
    "claims": 21,
    "per_claim": 229.31904762,
    "is_generic": false
   }
  ],
  "per_claim": 89.2379173833524
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Cardiology",
  "names": [
   "ranolazine"
  ],
  "reason": "Ranolazine, authorised as an antianginal agent but with a poorly elucidated mechanism, has disproportionate adverse effects given its minimal efficacy in reducing the frequency of angina attacks, including: gastrointestinal disorders, neuropsychiatric disorders, palpitations, bradycardia, hypotension, QT prolongation and peripheral oedema (Prescrire Int n\u00b0 102; Rev Prescrire n\u00b0 350; Interactions M\u00e9dicamenteuses Prescrire ). Main changes in the 2026 update of Prescrire\u2019s drugs to avoid P rescrire updates its review of drugs to avoid every year, in the interest of improving patient care. The mai...",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "ranolazine"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1852,
  "fills": 1248804,
  "per_million": 1483.0189525337844,
  "ratio": 0.5355889721377811,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 90,
   "letter": "A",
   "why": [
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "1,483 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 (1.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 43,
   "letter": "F",
   "why": [
    "87 randomized trials and 12 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",
    "24% of registered trials were terminated, withdrawn, or suspended (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 27 generic makers (-4)"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (27 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 79,
 "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 death, dizziness, chest pain, dyspnoea. How would we recognize and handle those?",
  "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.)"
 ]
}