{
 "query": "diltiazem",
 "ingredient": "diltiazem",
 "slug": "diltiazem",
 "rxcui": "3443",
 "brands": [
  "Tiazac",
  "Cardizem",
  "Cartia",
  "Dilt",
  "Diltzac",
  "Matzim",
  "Taztia",
  "Tiadylt"
 ],
 "names": [
  "diltiazem",
  "diltiazem hydrochloride",
  "diltiazem malate"
 ],
 "classes": [
  {
   "id": "C05AE",
   "name": "Muscle relaxants"
  },
  {
   "id": "C08DB",
   "name": "Benzothiazepine derivatives"
  }
 ],
 "alternatives": [
  "isosorbide dinitrate",
  "nitroglycerin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 100,
   "INTRAVENOUS": 11
  },
  "boxed_warning": "",
  "indications_and_usage": "Diltiazem Hydrochloride Extended-Release Tablet is a nondihydropyridine calcium channel blocker indicated for: treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. ( 1.1 ) improving exercise tolerance in patients with chronic stable angina. ( 1.2 ) 1.1 Hypertension Diltiazem Hydrochloride Extended-Release Tablets are 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...",
  "contraindications": "Diltiazem hydrochloride extended-release tablets are contraindicated in: Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. Patients with hypotension (less than 90 mm Hg systolic). Patients who have demonstrated hypersensitivity to the drug. Patients with acute myocardial infarction and pulmonary. Sick sinus syndrome except in the presence of a functioning ventricular pacemaker. ( 4 ) Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. ( 4 ) Hypotension (less than 90 mm Hg systolic). ( 4 ) Hypersensitivity to the drug. ( 4 ) Acute myocardial infarction and pulmonary. ( 4 )",
  "warnings_and_cautions": "Bradycardia, second- or third- degree AV block: Monitor heart rate and rhythm. ( 5.1 ) Heart failure: Monitor for signs and symptoms. ( 5.2 ) Increased liver enzymes and acute hepatic injury. ( 5.3 ) Severe skin reactions. ( 5.4 ) 5.1 Bradycardia or AV Block Diltiazem hydrochloride extended-release tablets may cause abnormally slow heart rates or second- or third-degree AV block. Patients with sick sinus syndrome are at increased risk of bradycardia. Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal's angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem [see Adverse Reactions (6) ] . Monitor for effects on heart rate and cardiac conduction. 5.2 Heart Failure Worsening of heart failure has been reported in patients with impairment of ventricular function. Experience with the use of diltiazem in combination with beta-blockers in patients with impaired ventricular function is limited. 5.3 Acute Hepatic Injury Significant elevations in liver enzymes such as alkaline phosphatase, LDH, AST (SGOT), ALT (SGPT) and signs of acute hepatic injury have been repo...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described in greater detail, in other sections: Bradycardia and AV block [see Warnings and Precautions (5.1) ] Heart failure [see Warnings and Precautions (5.2) ] Acute hepatic injury [see Warnings and Precautions (5.3) ] Severe skin reactions [see Warnings and Precautions (5.4) ] The most common adverse reactions ( > 2% ) are lower limb edema, sinus congestion and rash in patients treated for hypertension, and lower limb edema, headache, dizziness, fatigue, bradycardia, first-degree AV block and cough in patients treated for angina. ( 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 practice. For the hypertension studies, the following table presents adverse reactions more common on diltiazem than on placebo (but excluding events with no plausible relationship to t...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise patients: That the diltiazem hydrochloride extended-release tablets should be swallowed whole and not chewed or crushed. To consult the physician who prescribed diltiazem hydrochloride extended-release tablets before taking or stopping any other medications, including over-the-counter products or nutritional supplements, such as St John\u2019s wort. To contact the physician who prescribed diltiazem hydrochloride extended-release tablets or any other physician immediately if they experience possible adverse reactions, including bradycardia, arrhythmias, symptoms indicative of hypotension or heart failure, hepatic and skin reactions. To consult their physician if they become pregnant while taking diltiazem hydrochloride extended-release tablets or plan to become pregnant. Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, USA. Rev. 7/2025",
  "spl_medguide": "",
  "clinical_studies": "14.1 Hypertension In a randomized, double-blind, parallel-group, dose-response study involving 478 patients with essential hypertension, evening doses of diltiazem hydrochloride extended-release tablets 120 mg, 240 mg, 360 mg, and 540 mg were compared to placebo and to 360 mg administered in the morning. The mean reductions in diastolic blood pressure by ABPM at roughly 24 hours after the morning (4 AM to 8 AM) or evening (6 PM to 10 PM) administration (i.e., the time corresponding to expected trough serum concentrations) are shown in the table below: Mean Change in Trough Diastolic Pressure by ABPM Evening Dosing Morning Dosing 120 mg 240 mg 360 mg 540 mg 360 mg -2.0 -4.4 -4.4 -8.1 -6.4 A second randomized, double-blind, parallel-group, dose-response study (N=258) evaluated diltiazem hydrochloride extended-release tablets following morning doses of placebo or 120 mg, 180 mg, 300 mg, or 540 mg. Diastolic blood pressure measured by supine office cuff sphygmomanometer at trough (7 AM to 9 AM) decreased in an apparently linear manner over the dosage range studied. Group mean changes for placebo, 120 mg, 180 mg, 300 mg and 540 mg were -2.6 mm Hg, -1.9 mm Hg, -5.4 mm Hg, -6.1 mm Hg, and...",
  "brand_name": "DILTIAZEM HYDROCHLORIDE",
  "manufacturer": "ScieGen Pharmaceuticals, Inc.",
  "application_number": "ANDA216327",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251016",
  "set_id": "1ca03c9e-edc8-4c7f-89ee-f2346ea8c067",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 68537,
  "serious": 50774,
  "death": 10695,
  "hospitalization": 28838,
  "primary_suspect": 68131,
  "top_reactions": [
   [
    "Dyspnoea",
    6171
   ],
   [
    "Fatigue",
    4971
   ],
   [
    "Diarrhoea",
    4216
   ],
   [
    "Nausea",
    3963
   ],
   [
    "Drug Ineffective",
    3823
   ],
   [
    "Headache",
    3738
   ],
   [
    "Dizziness",
    3538
   ],
   [
    "Pain",
    3392
   ],
   [
    "Fall",
    3358
   ],
   [
    "Off Label Use",
    3347
   ],
   [
    "Pneumonia",
    3284
   ],
   [
    "Death",
    3168
   ],
   [
    "Hypotension",
    2807
   ],
   [
    "Asthenia",
    2778
   ],
   [
    "Arthralgia",
    2755
   ]
  ],
  "by_year": {
   "2019": 6510,
   "2020": 6460,
   "2021": 5345,
   "2022": 5101,
   "2023": 4536,
   "2024": 4304,
   "2025": 4246,
   "2026": 2051
  },
  "by_year_primary": {
   "2019": 6499,
   "2020": 6455,
   "2021": 5318,
   "2022": 5006,
   "2023": 4415,
   "2024": 4245,
   "2025": 4207,
   "2026": 2015
  }
 },
 "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": "20241101",
   "reason": "cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20241101",
   "reason": "cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20241101",
   "reason": "cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240417",
   "reason": "Failed Dissolution Specifications",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240326",
   "reason": "Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230113",
   "reason": "Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190130",
   "reason": "Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.",
   "firm": "Valeant Pharmaceuticals North America LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190130",
   "reason": "Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.",
   "firm": "Valeant Pharmaceuticals North America LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190130",
   "reason": "Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.",
   "firm": "Valeant Pharmaceuticals North America LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190130",
   "reason": "Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.",
   "firm": "Valeant Pharmaceuticals North America LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 11,
 "drugsfda": {
  "applications": 72,
  "nda": 12,
  "anda": 59,
  "first_approval": "19821105",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 52,
  "labeling_recent": 5,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "ACTAVIS LABS FL INC",
   "ADAPTIS",
   "ALEMBIC",
   "ALLERGAN",
   "AMTA",
   "APOTEX"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/05/1982"
 },
 "trials": {
  "total": 136,
  "completed": 83,
  "terminated": 19,
  "with_results": 31,
  "industry": 47,
  "phase3": 21,
  "results_share": 0.37349397590361444,
  "terminated_share": 0.13970588235294118
 },
 "pubmed": {
  "rct": 606,
  "meta": 15,
  "recent_rct": 13,
  "cochrane": [
   {
    "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": [
   "diltiazem",
   "Tiazac",
   "Cardizem",
   "Cartia",
   "Dilt",
   "Diltzac",
   "Matzim",
   "Taztia",
   "Tiadylt"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 6482880,
  "beneficiaries": 1873419,
  "spend": 233533357.62000003,
  "by_brand": [
   {
    "brand": "Diltiazem 24hr ER (Cd)",
    "claims": 3662791,
    "per_claim": 28.202183013,
    "is_generic": false
   },
   {
    "brand": "Diltiazem HCl",
    "claims": 707541,
    "per_claim": 23.777329865,
    "is_generic": true
   },
   {
    "brand": "Diltiazem 24hr ER",
    "claims": 629074,
    "per_claim": 31.514187981,
    "is_generic": false
   },
   {
    "brand": "Dilt-XR",
    "claims": 383212,
    "per_claim": 36.495371361,
    "is_generic": false
   },
   {
    "brand": "Cartia Xt",
    "claims": 258636,
    "per_claim": 28.760769344,
    "is_generic": false
   },
   {
    "brand": "Diltiazem 24hr ER (XR)",
    "claims": 209383,
    "per_claim": 36.697361343,
    "is_generic": false
   },
   {
    "brand": "Tiadylt ER",
    "claims": 200287,
    "per_claim": 32.383277147,
    "is_generic": false
   },
   {
    "brand": "Diltiazem 12hr ER",
    "claims": 189166,
    "per_claim": 171.70803442,
    "is_generic": false
   },
   {
    "brand": "Diltiazem 24hr ER (La)",
    "claims": 189131,
    "per_claim": 86.493931243,
    "is_generic": false
   },
   {
    "brand": "Matzim La",
    "claims": 47025,
    "per_claim": 94.712673472,
    "is_generic": false
   },
   {
    "brand": "Cardizem La",
    "claims": 2968,
    "per_claim": 229.67121631,
    "is_generic": false
   },
   {
    "brand": "Taztia Xt",
    "claims": 1724,
    "per_claim": 29.299019722,
    "is_generic": false
   },
   {
    "brand": "Cardizem CD",
    "claims": 1422,
    "per_claim": 2634.0527989,
    "is_generic": false
   },
   {
    "brand": "Tiazac",
    "claims": 424,
    "per_claim": 181.17436321,
    "is_generic": false
   },
   {
    "brand": "Cardizem",
    "claims": 96,
    "per_claim": 1501.9783333,
    "is_generic": false
   }
  ],
  "per_claim": 36.02308813675404
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 10467,
  "fills": 6482880,
  "per_million": 1614.5601954686806,
  "ratio": 0.5830947973174646,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 97,
   "letter": "A",
   "why": [
    "1,615 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death appears in 1.7x the share of reports seen across all of FAERS (-3)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 69,
   "letter": "C",
   "why": [
    "606 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 37% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 85,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 7 Class II, 4 Class III across 59 generic makers (-7)",
    "5 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "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 (59 applications)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 88,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, diarrhoea, nausea. How would we recognize and handle those?",
  "Why this one over isosorbide dinitrate, nitroglycerin? 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.)"
 ]
}