pharmacopeia
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Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Enzyme Interactions; Structural Macromolecules.

Indications

Sourced from openFDA
  • Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

Contraindications

Sourced from openFDA
  • Ergocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.contraindicated

Dosage & administration

Sourced from openFDA

THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. Vitamin D Resistant Rickets: 12,000 to 500,000 USP units daily. Hypoparathyroidism: 50,000 to 200,000 USP units daily concomitantly with calcium lactate 4 g, six times per day. DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION. Calcium intake should be adequate. Blood calcium and phosphorous determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.

Warnings & precautions

Sourced from openFDA

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

Sourced from openFDA

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. To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy Category C Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation. For the protection of the fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific, unique case outweigh the significant hazards involved. The safety in excess of 400 USP units of vitamin D daily during pregnancy has not been established.

Overdosage

Sourced from openFDA

The effects of administered vitamin D can persist for two or more months after cessation of treatment. Hypervitaminosis D is characterized by: Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and stiffness, constipation, mental retardation, anemia, and mild acidosis. 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. Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. 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). The treatment of hypervitaminosis D with hypercalcemia consists in immediate withdrawal of the vitamin, a low calcium diet, generous intake of fluids, along with symptomatic and supportive treatment. Hypercalcemic crisis with dehydration, stupor, coma, and azotemia requires more vigorous treatment. The first step should be hydration of the patient.

Approval history

Sourced from openFDA
  • Jan 11, 1941NDANDA003444Esjay Pharma
  • Oct 16, 1978ANDAANDA080704Bionpharma
  • May 20, 2009ANDAANDA040833Chartwell Rx
  • Aug 3, 2010ANDAANDA090455Onesource Specialty
  • Dec 7, 2018ANDAANDA204276Puracap Pharm Llc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
374,046 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue37,1169.9%
  2. 2Nausea27,5787.4%
  3. 3Diarrhoea26,4227.1%
  4. 4Headache25,3276.8%
  5. 5Drug Ineffective25,0736.7%
  6. 6Pain23,6916.3%
  7. 7Off Label Use22,5346.0%
  8. 8Dyspnoea19,9055.3%
  9. 9Arthralgia19,6745.3%
  10. 10Dizziness19,1275.1%
  11. 11Asthenia16,8674.5%
  12. 12Fall16,7264.5%
  13. 13Vomiting15,4684.1%
  14. 14Pain In Extremity14,6473.9%
  15. 15Malaise14,4613.9%

Literature

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Recent PubMed references pinned to Ergocalciferol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 155 ClinicalTrials.gov registrations naming Ergocalciferol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ergocalciferol work?
Mechanism-of-action classes: Enzyme Interactions; Structural Macromolecules.
What is Ergocalciferol used for?
According to FDA labeling, Ergocalciferol carries indications including: Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ergocalciferol?
Ergocalciferol is classified as Vitamin D and analogues, Provitamin D2 Compound, Enzyme Interactions, Structural Macromolecules, Bone Resorption Inhibition, Decreased Distal Tubule PO4-- Excretion, Decreased Proximal Tubule PO4-- Excretion, Decreased PTH Secretion, Decreased Renal Ca++ Excretion, Inorganic Ion Absorption Alteration, Stimulation Small Intestine Fluid/Electrolyte Absorption, Vitamin Uptake and Modification Alteration.
What are the brand names for Ergocalciferol?
Ergocalciferol is marketed under brand names including Calcidol, Drisdol.
What are the contraindications for Ergocalciferol?
Ergocalciferol labeling lists contraindications including: Ergocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.. Always consult the full prescribing information and a clinician.
Note. Data for ergocalciferol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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