{
 "query": "nifedipine",
 "ingredient": "nifedipine",
 "slug": "nifedipine",
 "rxcui": "7417",
 "brands": [
  "Procardia"
 ],
 "names": [
  "nifedipine"
 ],
 "classes": [
  {
   "id": "C08CA",
   "name": "Dihydropyridine derivatives"
  }
 ],
 "alternatives": [
  "amlodipine",
  "clevidipine",
  "felodipine",
  "isradipine",
  "lacidipine",
  "lercanidipine",
  "levamlodipine",
  "manidipine",
  "mepirodipine",
  "nicardipine",
  "nilvadipine",
  "nimodipine",
  "nisoldipine",
  "nitrendipine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 87
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
  "contraindications": "CONTRAINDICATIONS Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (See PRECAUTIONS: Drug Interactions. ) Nifedipine must not be used in cases of cardiogenic shock. Nifedipine extended-release tablets are contraindicated in patients with a known hypersensitivity to any component of the tablet.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Excessive Hypotension Although in most patients the hypotensive effect of nifedipine is modest and well tolerated, occasional patients have had excessive and poorly tolerated hypotension. These responses have usually occurred during initial titration or at the time of subsequent upward dosage adjustment, and may be more likely in patients using concomitant beta-blockers. Severe hypotension and/or increased fluid volume requirements have been reported in patients who received immediate-release capsules together with a beta-blocking agent and who underwent coronary artery bypass surgery using high-dose fentanyl anesthesia. The interaction with high-dose fentanyl appears to be due to the combination of nifedipine and a beta-blocker, but the possibility that it may occur with nifedipine alone, with low doses of fentanyl, in other surgical procedures, or with other narcotic analgesics cannot be ruled out. In nifedipine-treated patients where surgery using high-dose fentanyl anesthesia is contemplated, the physician should be aware of these potential problems and, if the patient\u2019s condition permits, sufficient time (at least 36 hours) should be allowed for nifedipine to be washe...",
  "adverse_reactions": "ADVERSE REACTIONS The incidence of adverse events during treatment with nifedipine extended-release tablets in doses up to 90 mg daily were derived from multi-center, placebo-controlled clinical trials in 370 hypertensive patients. Atenolol 50 mg once daily was used concomitantly in 187 of the 370 patients on nifedipine extended-release tablets and in 64 of the 126 patients on placebo. All adverse events reported during nifedipine extended-release tablets therapy were tabulated independently of their causal relationship to medication. The most common adverse event reported with nifedipine extended-release tablets was peripheral edema. This was dose related, and the frequency was 18% on nifedipine extended-release tablets 30 mg daily, 22% on nifedipine extended-release tablets 60 mg daily, and 29% on nifedipine extended-release tablets 90 mg daily versus 10% on placebo. Other common adverse events reported in the above placebo-controlled trials include: Adverse Event NIFEDIPINE EXTENDED-RELEASE TABLETS (%) (n=370) PLACEBO (%) (n=126) Headache 19 13 Flushing/heat sensation 4 0 Dizziness 4 2 Fatigue/asthenia 4 4 Nausea 2 1 Constipation 1 0 Where the frequency of adverse events with ni...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Nifedipine extended-release tablets are an extended-release tablet and should be swallowed whole and taken on an empty stomach. It should not be administered with food. Do not chew, divide, or crush tablets.",
  "spl_medguide": "",
  "clinical_studies": "Clinical Studies Nifedipine extended-release tablets produced dose-related decreases in systolic and diastolic blood pressure as demonstrated in two double-blind, randomized, placebo-controlled trials in which over 350 patients were treated with nifedipine extended-release tablets, 30, 60, or 90 mg once daily for 6 weeks. In the first study, nifedipine extended-release tablet was given as monotherapy and in the second study, nifedipine extended-release tablet was added to a beta-blocker in patients not controlled on a beta-blocker alone. The mean trough (24 hours post-dose) blood pressure results from these studies are shown below: MEAN REDUCTIONS IN TROUGH SUPINE BLOOD PRESSURE (mmHg) SYSTOLIC/DIASTOLIC NIFEDIPINE EXTENDED-RELEASE DOSE N MEAN TROUGH REDUCTION Placebo response subtracted. STUDY 1 30 mg 60 5.3/2.9 60 mg 57 8.0/4.1 90 mg 55 12.5/8.1 STUDY 2 30 mg 58 7.6/3.8 60 mg 63 10.1/5.3 90 mg 62 10.2/5.8 The trough/peak ratios estimated from 24 hour blood pressure monitoring ranged from 41% to 78% for diastolic and 46% to 91% for systolic blood pressure.",
  "brand_name": "Nifedipine",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA076070",
  "pharm_class_epc": [
   "Dihydropyridine Calcium Channel Blocker [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20180507",
  "set_id": "36b07283-fc0e-4a14-b78f-1d2ab80e7f31",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 43114,
  "serious": 33936,
  "death": 4879,
  "hospitalization": 17950,
  "primary_suspect": 42852,
  "top_reactions": [
   [
    "Off Label Use",
    2329
   ],
   [
    "Drug Ineffective",
    2322
   ],
   [
    "Diarrhoea",
    2300
   ],
   [
    "Fatigue",
    2265
   ],
   [
    "Dyspnoea",
    2195
   ],
   [
    "Nausea",
    1979
   ],
   [
    "Headache",
    1895
   ],
   [
    "Acute Kidney Injury",
    1786
   ],
   [
    "Hypertension",
    1608
   ],
   [
    "Dizziness",
    1545
   ],
   [
    "Death",
    1499
   ],
   [
    "Pneumonia",
    1487
   ],
   [
    "Pain",
    1425
   ],
   [
    "Chronic Kidney Disease",
    1387
   ],
   [
    "Asthenia",
    1287
   ]
  ],
  "by_year": {
   "2019": 4489,
   "2020": 3873,
   "2021": 3407,
   "2022": 3125,
   "2023": 3189,
   "2024": 3224,
   "2025": 2955,
   "2026": 1472
  },
  "by_year_primary": {
   "2019": 4486,
   "2020": 3870,
   "2021": 3390,
   "2022": 3065,
   "2023": 3117,
   "2024": 3177,
   "2025": 2922,
   "2026": 1449
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20210702",
   "reason": "Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.",
   "firm": "The Harvard Drug Group",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 36,
  "nda": 4,
  "anda": 32,
  "first_approval": "19811231",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 40,
  "labeling_recent": 1,
  "sponsors": [
   "ACELLA",
   "ACTAVIS ELIZABETH",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA USA",
   "BAYER PHARMS",
   "CHASE LABS NJ"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/31/1981"
 },
 "trials": {
  "total": 196,
  "completed": 107,
  "terminated": 23,
  "with_results": 26,
  "industry": 50,
  "phase3": 39,
  "results_share": 0.24299065420560748,
  "terminated_share": 0.11734693877551021
 },
 "pubmed": {
  "rct": 1201,
  "meta": 42,
  "recent_rct": 27,
  "cochrane": [
   {
    "pmid": "34921554",
    "title": "Nifedipine for primary dysmenorrhoea",
    "year": "2021"
   },
   {
    "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": [
   "nifedipine",
   "Procardia"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3861285,
  "beneficiaries": 932043,
  "spend": 100748953.69999999,
  "by_brand": [
   {
    "brand": "Nifedipine ER",
    "claims": 3845740,
    "per_claim": 25.757997186,
    "is_generic": false
   },
   {
    "brand": "Nifedipine",
    "claims": 14331,
    "per_claim": 49.66867839,
    "is_generic": true
   },
   {
    "brand": "Procardia XL",
    "claims": 1214,
    "per_claim": 806.08877265,
    "is_generic": false
   }
  ],
  "per_claim": 26.092079113559343
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "nifedipine",
  "matched": "nifedipine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 7548,
  "fills": 3861285,
  "per_million": 1954.7896619907624,
  "ratio": 0.7059679068985751,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "1,955 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 72,
   "letter": "C",
   "why": [
    "1201 randomized trials and 42 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "2 independent Cochrane review(s) exist",
    "Only 24% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 32 generic makers (-1)"
   ],
   "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 (32 applications)",
    "14 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 91,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are diarrhoea, fatigue. 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 amlodipine, clevidipine, felodipine? 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.)"
 ]
}