{
 "query": "ergocalciferol",
 "ingredient": "ergocalciferol",
 "slug": "ergocalciferol",
 "rxcui": "4018",
 "brands": [
  "Calcidol",
  "Drisdol"
 ],
 "names": [
  "ergocalciferol"
 ],
 "classes": [
  {
   "id": "A11CC",
   "name": "Vitamin D and analogues"
  }
 ],
 "alternatives": [
  "alfacalcidol",
  "calcifediol",
  "calcitriol",
  "cholecalciferol",
  "dihydrotachysterol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 37,
   "INTRAVENOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
  "contraindications": "CONTRAINDICATIONS Ergocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases vitamin D must be strictly restricted. Keep out of the reach of children.",
  "adverse_reactions": "ADVERSE REACTIONS Hypervitaminosis D is characterized by effects on the following organ system: Renal: Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death. CNS: Mental retardation. Soft Tissues: Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Skeletal: Bone demineralization (osteoporosis) in adults occurs concomitantly. Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism), vague aches, stiffness, and weakness. Gastrointestinal: Nausea, anorexia, constipation. Metabolic: Mild acidosis, anemia, weight loss. AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com ; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Ergocalciferol",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA080704",
  "pharm_class_epc": [
   "Provitamin D2 Compound [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20181218",
  "set_id": "2841b0ba-3b09-4f03-a060-9fb7f1af8344",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 64633,
  "serious": 44083,
  "death": 5930,
  "hospitalization": 20543,
  "primary_suspect": 64534,
  "top_reactions": [
   [
    "Fatigue",
    7644
   ],
   [
    "Drug Ineffective",
    6538
   ],
   [
    "Pain",
    6360
   ],
   [
    "Nausea",
    6221
   ],
   [
    "Headache",
    6075
   ],
   [
    "Off Label Use",
    5915
   ],
   [
    "Dyspnoea",
    5802
   ],
   [
    "Diarrhoea",
    5741
   ],
   [
    "Arthralgia",
    4835
   ],
   [
    "Vomiting",
    4674
   ],
   [
    "Pneumonia",
    4109
   ],
   [
    "Asthenia",
    4086
   ],
   [
    "Condition Aggravated",
    4076
   ],
   [
    "Malaise",
    4005
   ],
   [
    "Dizziness",
    3958
   ]
  ],
  "by_year": {
   "2019": 6772,
   "2020": 6107,
   "2021": 5512,
   "2022": 5124,
   "2023": 4690,
   "2024": 5376,
   "2025": 5157,
   "2026": 2186
  },
  "by_year_primary": {
   "2019": 6768,
   "2020": 6106,
   "2021": 5506,
   "2022": 5105,
   "2023": 4670,
   "2024": 5361,
   "2025": 5147,
   "2026": 2165
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 14,
  "nda": 1,
  "anda": 10,
  "first_approval": "19410111",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 10,
  "labeling_recent": 0,
  "sponsors": [
   "BIONPHARMA",
   "CHARTWELL MOLECULAR",
   "CHARTWELL RX",
   "CHASE CHEM",
   "ESJAY PHARMA",
   "EVERYLIFE",
   "IMPAX LABS",
   "LILLY"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/11/1941"
 },
 "trials": {
  "total": 157,
  "completed": 109,
  "terminated": 22,
  "with_results": 39,
  "industry": 14,
  "phase3": 15,
  "results_share": 0.3577981651376147,
  "terminated_share": 0.14012738853503184
 },
 "pubmed": {
  "rct": 34,
  "meta": 1,
  "recent_rct": 5,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ergocalciferol",
   "Calcidol",
   "Drisdol"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "ergocalciferol",
  "matched": "ergocalciferol",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 29,
   "letter": "F",
   "why": [
    "34 randomized trials and 1 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 36% 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 (10 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, pain, 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 alfacalcidol, calcifediol, calcitriol? 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.)"
 ]
}