{
 "query": "verapamil",
 "ingredient": "verapamil",
 "slug": "verapamil",
 "rxcui": "11170",
 "brands": [
  "Calan",
  "Isoptin",
  "Verelan"
 ],
 "names": [
  "verapamil",
  "verapamil hydrochloride"
 ],
 "classes": [
  {
   "id": "C08DA",
   "name": "Phenylalkylamine derivatives"
  }
 ],
 "alternatives": [
  "etripamil",
  "gallopamil"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 56,
   "INTRAVENOUS": 37
  },
  "boxed_warning": "",
  "indications_and_usage": "Verapamil Hydrochloride Extended-release Capsules (PM) for oral use is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it ...",
  "contraindications": "Verapamil is contraindicated in: Severe left ventricular dysfunction [ see Warnings and Precautions (5.1) ]. Hypotension (less than 90 mm Hg systolic pressure) or cardiogenic shock. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker). Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) [ see Warnings and Precautions (5.4) ]. Severe left ventricular dysfunction (4) Hypotension (<90 mmHg systolic pressure) or cardiogenic shock (4) Sick sinus syndrome (except in patients with pacemaker) (4) 2nd- or 3rd-degree AV block (except in patients with pacemaker) (4) Atrial flutter or atrial fibrillation and an accessory bypass tract",
  "warnings_and_cautions": "Congestive heart failure or pulmonary edema may develop ( 5.1 ) Hypotension/dizziness may occur ( 5.2 ) Elevated transaminases have occurred; monitor liver function ( 5.3 ) Ventricular fibrillation has occurred in patients with atrial flutter or atrial fibrillation and an accessory bypass tract ( 5.4 ) Reduce dose or discontinue therapy if marked first-degree AV block or progression to second- or third-degree AV block occurs ( 5.5 ) Sinus bradycardia, pulmonary edema, severe hypotension, second-degree AV block, sinus arrest, and death occurred in patients with hypertrophic cardiomyopathy ( 5.6 ) 5.1 Heart Failure Verapamil has a negative inotropic effect which, in most patients, is compensated by its afterload reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance. In previous clinical experience with 4,954 patients primarily with immediate-release verapamil, 87 (1.8%) developed congestive heart failure or pulmonary edema. Avoid verapamil in patients with severe left ventricular dysfunction (e.g., ejection fraction less than 30% or moderate to severe symptoms of cardiac failure) and in patients with any degree of ventricula...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions (incidence \u2265 3% and more common than in patients treated with placebo) are headache, infection, constipation, flu syndrome, peripheral edema, dizziness, pharyngitis, and sinusitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-877-495-6856 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 practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose. See Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4 , 5.5 ) for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinua...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Verapamil Hydrochloride Extended-release Capsules (PM) SHOULD NOT BE CRUSHED OR CHEWED. Verapamil Hydrochloride Extended-release Capsules (PM) ARE TO BE SWALLOWED WHOLE OR THE ENTIRE CONTENTS OF THE CAPSULE SPRINKLED ONTO APPLESAUCE [ see Dosage and Administration (2.2) ]. When the sprinkle method of administration is prescribed, explain the details of the proper technique to the patient. [ See Dosage and Administration (2.2) ].",
  "spl_medguide": "",
  "clinical_studies": "Verapamil Hydrochloride Extended-release Capsules (PM) was evaluated in two placebo-controlled, parallel design, double-blind studies of patients with mild to moderate hypertension. In the clinical trials, 413 evaluable patients were randomized to either placebo, 100 mg, 200 mg, 300 mg, or 400 mg and treated for up to 8 weeks. Verapamil Hydrochloride Extended-release Capsules (PM) or placebo was given once daily between 9 pm and 11 pm (nighttime) and blood pressure changes were measured with 36-hour ambulatory blood pressure monitoring (ABPM). The results of these studies demonstrate that Verapamil Hydrochloride Extended-release Capsules (PM), at 200, 300, and 400 mg, is a consistently and significantly more effective antihypertensive agent than placebo in reducing ambulatory blood pressures. Over this dose range, the placebo-subtracted net decreases in diastolic BP at trough (averaged over 6-10 pm) were dose-related, and ranged from 3.8 to 10.0 mm Hg after 8 weeks of therapy. Although Verapamil Hydrochloride Extended-release Capsules (PM) 100 mg was not effective in reducing diastolic BP at trough when measured by ABPM, efficacy was demonstrated in reducing diastolic BP when measu...",
  "brand_name": "Verapamil Hydrochloride",
  "manufacturer": "Wilshire Pharmaceuticals, Inc.",
  "application_number": "NDA020943",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241127",
  "set_id": "5f665d08-e1e4-422a-88c2-d8834abf9e1a",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 30221,
  "serious": 22208,
  "death": 4322,
  "hospitalization": 11343,
  "primary_suspect": 29970,
  "top_reactions": [
   [
    "Drug Ineffective",
    2005
   ],
   [
    "Dyspnoea",
    1803
   ],
   [
    "Fatigue",
    1739
   ],
   [
    "Nausea",
    1666
   ],
   [
    "Headache",
    1503
   ],
   [
    "Off Label Use",
    1494
   ],
   [
    "Dizziness",
    1426
   ],
   [
    "Diarrhoea",
    1406
   ],
   [
    "Completed Suicide",
    1261
   ],
   [
    "Hypotension",
    1236
   ],
   [
    "Toxicity To Various Agents",
    1214
   ],
   [
    "Drug Interaction",
    1188
   ],
   [
    "Malaise",
    1152
   ],
   [
    "Fall",
    1139
   ],
   [
    "Asthenia",
    1063
   ]
  ],
  "by_year": {
   "2019": 3350,
   "2020": 2970,
   "2021": 2229,
   "2022": 1976,
   "2023": 1846,
   "2024": 1731,
   "2025": 1501,
   "2026": 712
  },
  "by_year_primary": {
   "2019": 3350,
   "2020": 2955,
   "2021": 2206,
   "2022": 1918,
   "2023": 1797,
   "2024": 1692,
   "2025": 1441,
   "2026": 708
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20240702",
   "reason": "Cross contamination with other products.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240702",
   "reason": "Cross contamination with other products.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 77,
  "nda": 9,
  "anda": 62,
  "first_approval": "19810812",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 76,
  "labeling_recent": 1,
  "sponsors": [
   "ABRAXIS PHARM",
   "ACTAVIS ELIZABETH",
   "AMNEAL",
   "APOTEX CORP",
   "ASPIRO",
   "AZURITY",
   "BEDFORD",
   "CADILA PHARMS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/12/1981"
 },
 "trials": {
  "total": 176,
  "completed": 110,
  "terminated": 19,
  "with_results": 29,
  "industry": 57,
  "phase3": 16,
  "results_share": 0.2636363636363636,
  "terminated_share": 0.10795454545454546
 },
 "pubmed": {
  "rct": 624,
  "meta": 27,
  "recent_rct": 13,
  "cochrane": [
   {
    "pmid": "25985145",
    "title": "Adenosine and verapamil for no-reflow during primary percutaneous coronary intervention in people with acute myocardial infarction",
    "year": "2015"
   },
   {
    "pmid": "23736949",
    "title": "Adenosine and verapamil for no-reflow during primary percutaneous coronary intervention in people with acute myocardial infarction",
    "year": "2013"
   },
   {
    "pmid": "10796323",
    "title": "Diltiazem, nifedipine, nimodipine or verapamil for neuroleptic-induced tardive dyskinesia",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "verapamil",
   "Calan",
   "Isoptin",
   "Verelan"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1616837,
  "beneficiaries": 413685,
  "spend": 84717419.14999999,
  "by_brand": [
   {
    "brand": "Verapamil ER",
    "claims": 1065275,
    "per_claim": 29.73130265,
    "is_generic": false
   },
   {
    "brand": "Verapamil SR",
    "claims": 266884,
    "per_claim": 115.20326509,
    "is_generic": false
   },
   {
    "brand": "Verapamil HCl",
    "claims": 232510,
    "per_claim": 12.167136725,
    "is_generic": true
   },
   {
    "brand": "Verapamil ER PM",
    "claims": 51938,
    "per_claim": 372.75524163,
    "is_generic": false
   },
   {
    "brand": "Verelan PM",
    "claims": 230,
    "per_claim": 479.80356522,
    "is_generic": false
   }
  ],
  "per_claim": 52.39700671743657
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "verapamil",
  "matched": "verapamil",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3841,
  "fills": 1616837,
  "per_million": 2375.62599074613,
  "ratio": 0.8579520041828543,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "2,376 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Death appears in 1.6x the FAERS average share of reports (within the margin this measure deserves)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 61,
   "letter": "D",
   "why": [
    "624 randomized trials and 27 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 26% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 98,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 2 Class III across 62 generic makers (-2)"
   ],
   "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": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (62 applications)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 89,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, 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 etripamil, gallopamil? 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.)"
 ]
}