{
 "query": "calcitriol",
 "ingredient": "calcitriol",
 "slug": "calcitriol",
 "rxcui": "1894",
 "brands": [
  "Vectical",
  "Rocaltrol"
 ],
 "names": [
  "calcitriol"
 ],
 "classes": [
  {
   "id": "A11CC",
   "name": "Vitamin D and analogues"
  }
 ],
 "alternatives": [
  "alfacalcidol",
  "calcifediol",
  "cholecalciferol",
  "dihydrotachysterol",
  "ergocalciferol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 27,
   "INTRAVENOUS": 2,
   "TOPICAL": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of \u2265 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
  "contraindications": "CONTRAINDICATIONS Calcitriol should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of Calcitriol in patients with known hypersensitivity to calcitriol (or drugs of the same class) or any of the inactive ingredients is contraindicated.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Overdosage of any form of vitamin D is dangerous (see OVERDOSAGE ). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis and other soft-tissue calcification. The serum calcium times phosphate (Ca \u00d7 P) product should not be allowed to exceed 70 mg 2 /dL 2 . Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition. Calcitriol is the most potent metabolite of vitamin D available. The administration of Calcitriol to patients in excess of their daily requirements can cause hypercalcemia, hypercalciuria, and hyperphosphatemia. Therefore, pharmacologic doses of vitamin D and its derivatives should be withheld during Calcitriol treatment to avoid possible additive effects and hypercalcemia. If treatment is switched from ergocalciferol (vitamin D 2 ) to calcitriol, it may take several months for the ergocalciferol level in the blood to return to the baseline value (see OVERDOSAGE ). Calcitriol increases inorganic phosphate levels in serum. While this is desirable in pati...",
  "adverse_reactions": "ADVERSE REACTIONS Since Calcitriol is believed to be the active hormone which exerts vitamin D activity in the body, adverse effects are, in general, similar to those encountered with excessive vitamin D intake, ie, hypercalcemia syndrome or calcium intoxication, depending on the severity and duration of hypercalcemia (see WARNINGS ). Because of the short biological half-life of calcitriol, pharmacokinetic investigations have shown normalization of elevated serum calcium within a few days of treatment withdrawal, ie, much faster than in treatment with vitamin D3 preparations. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include: Early: weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia, abdominal pain or stomach ache. Late: polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT (AST) and SGPT (ALT), ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, senso...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients The patient and his or her caregivers should be informed about compliance with dosage instructions, adherence to instructions about diet and calcium supplementation, and avoidance of the use of unapproved nonprescription drugs. Patients and their caregivers should also be carefully informed about the symptoms of hypercalcemia (see ADVERSE REACTIONS ). The effectiveness of Calcitriol therapy is predicated on the assumption that each patient is receiving an adequate daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Calcitriol",
  "manufacturer": "Patrin Pharma, Inc",
  "application_number": "ANDA203973",
  "pharm_class_epc": [
   "Vitamin D3 Analog [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20231002",
  "set_id": "c5c37779-0c26-438f-b1ca-61cf9915d233",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 20212,
  "serious": 15699,
  "death": 2612,
  "hospitalization": 8717,
  "primary_suspect": 20158,
  "top_reactions": [
   [
    "Nausea",
    1415
   ],
   [
    "Off Label Use",
    1288
   ],
   [
    "Chronic Kidney Disease",
    1280
   ],
   [
    "Diarrhoea",
    1191
   ],
   [
    "Acute Kidney Injury",
    1148
   ],
   [
    "Renal Failure",
    1110
   ],
   [
    "Fatigue",
    1032
   ],
   [
    "Dyspnoea",
    1023
   ],
   [
    "Vomiting",
    1012
   ],
   [
    "Death",
    932
   ],
   [
    "Drug Hypersensitivity",
    885
   ],
   [
    "End Stage Renal Disease",
    824
   ],
   [
    "Headache",
    792
   ],
   [
    "Drug Ineffective",
    775
   ],
   [
    "Constipation",
    759
   ]
  ],
  "by_year": {
   "2019": 2716,
   "2020": 1876,
   "2021": 1671,
   "2022": 1296,
   "2023": 1313,
   "2024": 1542,
   "2025": 1312,
   "2026": 710
  },
  "by_year_primary": {
   "2019": 2715,
   "2020": 1874,
   "2021": 1661,
   "2022": 1277,
   "2023": 1307,
   "2024": 1537,
   "2025": 1306,
   "2026": 706
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20140501",
   "reason": "Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point",
   "firm": "Boehringer Ingelheim Roxane Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 23,
  "nda": 4,
  "anda": 19,
  "first_approval": "19780817",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 18,
  "labeling_recent": 0,
  "sponsors": [
   "ABBVIE",
   "AM REGENT",
   "AMNEAL PHARMS",
   "ANDA REPOSITORY",
   "BIONPHARMA",
   "ESJAY PHARMA",
   "FRESENIUS KABI USA",
   "FRESENIUS MEDCL"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/17/1978"
 },
 "trials": {
  "total": 187,
  "completed": 115,
  "terminated": 32,
  "with_results": 54,
  "industry": 47,
  "phase3": 20,
  "results_share": 0.46956521739130436,
  "terminated_share": 0.1711229946524064
 },
 "pubmed": {
  "rct": 216,
  "meta": 8,
  "recent_rct": 23,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "calcitriol",
   "Vectical",
   "Rocaltrol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1333054,
  "beneficiaries": 336700,
  "spend": 27436400.810000002,
  "by_brand": [
   {
    "brand": "Calcitriol",
    "claims": 1328365,
    "per_claim": 19.890219405,
    "is_generic": true
   },
   {
    "brand": "Vectical",
    "claims": 4615,
    "per_claim": 216.1608299,
    "is_generic": false
   },
   {
    "brand": "Rocaltrol",
    "claims": 74,
    "per_claim": 234.4227027,
    "is_generic": false
   }
  ],
  "per_claim": 20.58161245530939
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "calcitriol",
  "matched": "calcitriol",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3549,
  "fills": 1333054,
  "per_million": 2662.307753474353,
  "ratio": 0.9614864805075987,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,662 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.4x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 52,
   "letter": "D",
   "why": [
    "216 randomized trials and 8 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 47% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "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 (19 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 86,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are nausea, chronic kidney disease, diarrhoea. 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 alfacalcidol, calcifediol, cholecalciferol? 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.)"
 ]
}