Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Alfacalcidol
Drug ID BADD_D02610
Description Alfacalcidol, or 1-alpha-hydroxycholecalciferol or 1-alpha-hydroxyvitamin D3, is a non-endogenous analogue of [vitamin D].[A234044] It plays an essential function in calcium homeostasis and bone metabolism. Alfacaldisol is activated by the enzyme 25-hydroxylase in the liver to mediate its effects in the body, or most importantly, the kidneys and bones. The pharmacological actions of alfacalcidol are prolonged than vitamin D because a negative feedback mechanism regulates the final activation step of vitamin D in the kidneys.[A175348,A175351] Alfacalcidol is available in oral and intravenous formulations. In Canada, it is marketed as ONE-ALPHA, which manages hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in adults with chronic renal failure.[L33284] In approving European countries, alfacalcidol is also indicated for managing nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.[L33364,L33369]
Indications and Usage Alfacalcidol is indicated in adult patients with chronic renal failure for the management of hypocalcemia, secondary hyperparathyroidism, or osteodystrophy.[L33284] Alfacalcidol is indicated in the management of nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.[L33364,L33369]
Marketing Status approved; nutraceutical
ATC Code A11CC03
DrugBank ID DB01436
KEGG ID D01518
MeSH ID C008088
PubChem ID 5282181
TTD Drug ID Not Available
NDC Product Code Not Available
UNII URQ2517572
Synonyms alfacalcidol | 1 alpha-hydroxyvitamin D3 | 1-alpha-oxycholecalciferol | 1-hydroxycholecalciferol | alphacalcidol | 1 alpha-hydroxycholecalciferol | 1alpha-OHD3 | 1-hydroxycholecalciferol, (1beta)-(5Z)-isomer | 1-hydroxycholecalciferol, (1beta,3beta-(5E,7E))-isomer | 1-hydroxycholecalciferol, aluminum salt | Oksidevit | Bondiol | Eenalfadrie | Etalpha | Un-Alfa | EinsAlpha | One-Alpha | 1-hydroxycholecalciferol, (1alpha,3alpha-(5Z,7E))-isomer | AlfaD
Chemical Information
Molecular Formula C27H44O2
CAS Registry Number 41294-56-8
SMILES CC(C)CCCC(C)C1CCC2C1(CCCC2=CC=C3CC(CC(C3=C)O)O)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Calcinosis08.03.04.002--Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.001--
Depressed level of consciousness17.02.04.002--
Dyspnoea02.11.05.003; 22.02.01.004--
Haemolysis01.06.04.002--
Hypertension24.08.02.001--
Hypoxia22.02.02.003--
Myocardial infarction24.04.04.009; 02.02.02.007--
Nausea07.01.07.001--
Pericardial effusion02.06.01.002--
Pulmonary haemorrhage22.12.01.009; 24.07.01.016--
Pulmonary oedema22.01.03.003; 02.05.02.003--
Pyrexia08.05.02.003--
Therapeutic response decreased08.06.01.016--Not Available
Thrombocytopenia01.08.01.002--Not Available
Vomiting07.01.07.003--
Spherocytic anaemia01.06.05.002--Not Available
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