Cholecalciferol
Adrovance, Alendronic Acid / Colecalciferol, Fosamax D, Fosavance, Infuvite, Vantavo (cholecalciferol) is a small molecule pharmaceutical. Cholecalciferol was first approved as Infuvite adult on 2000-05-18. It is used to treat cardiovascular diseases, chronic kidney failure, crohn disease, familial hypophosphatemic rickets, and hypoparathyroidism amongst others in the USA. It has been approved in Europe to treat postmenopausal osteoporosis.
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Commercial
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Drug Products
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New Drug Application (NDA)
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Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 3 pack family dollar instant hand sanitizers | OTC monograph not final | 2014-11-28 |
| a and d | OTC monograph final | 2020-01-07 |
| a and d plus e | C200263 | 2024-08-08 |
| adult infuvite multiple vitamins | New Drug Application | 2019-05-14 |
| adult infuvite multiple vitamins for infusion pharmacy bulk | New Drug Application | 2013-01-01 |
| ag international | OTC monograph final | 2019-07-23 |
| ameriderm | OTC monograph final | 2022-01-13 |
| animi-3 | unapproved drug other | 2013-02-06 |
| animi-3 with vitamin d | unapproved drug other | 2011-05-23 |
| anubis barcelona | OTC monograph final | 2023-09-01 |
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ATC Codes
A: Alimentary tract and metabolism drugs
— A11: Vitamins
— A11C: Vitamin a and d, incl. combinations of the two
— A11CC: Vitamin d and analogues
— A11CC05: Colecalciferol
— A11CC55: Colecalciferol, combinations
M: Musculo-skeletal system drugs
— M05: Drugs for treatment of bone diseases
— M05B: Drugs affecting bone structure and mineralization
— M05BB: Bisphosphonates, combinations affecting bone structure and mineralization
— M05BB03: Alendronic acid and colecalciferol
— M05BB04: Risedronic acid, calcium and colecalciferol, sequential
— M05BB05: Alendronic acid, calcium and colecalciferol, sequential
— M05BB07: Risedronic acid and colecalciferol
— M05BB08: Zoledronic acid, calcium and colecalciferol, sequential
— M05BB09: Ibandronic acid and colecalciferol
— M05BX: Other drugs affecting bone structure and mineralization in atc
— M05BX53: Strontium ranelate and colecalciferol
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Clinical
Clinical Trials
4398 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | 50 | 79 | 76 | 99 | 500 | 779 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | 14 | 29 | 59 | 50 | 100 | 248 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 9 | 25 | 22 | 37 | 57 | 142 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 12 | 32 | 21 | 16 | 67 | 136 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 9 | 8 | 13 | 94 | 125 |
| Covid-19 | D000086382 | — | — | 8 | 20 | 19 | 11 | 65 | 119 |
| Chronic renal insufficiency | D051436 | — | N18 | 9 | 20 | 20 | 31 | 38 | 111 |
| Leukemia | D007938 | — | C95 | 30 | 55 | 28 | 3 | 8 | 108 |
| Healthy volunteers/patients | — | — | — | 35 | 4 | 3 | 2 | 56 | 99 |
| Syndrome | D013577 | — | — | 12 | 29 | 10 | 14 | 41 | 96 |
Show 381 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 13 | 30 | 18 | — | 15 | 63 |
| Myeloid leukemia | D007951 | — | C92 | 18 | 22 | 3 | — | 1 | 35 |
| Aging | D000375 | GO_0007568 | R41.81 | 3 | 3 | 2 | — | 24 | 31 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 12 | 17 | 3 | — | 4 | 29 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 2 | 1 | 4 | — | 22 | 29 |
| Melanoma | D008545 | — | — | 8 | 9 | 3 | — | 8 | 24 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 6 | 4 | — | 15 | 24 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 6 | 7 | 8 | — | 3 | 22 |
| Hepatitis d | D003699 | EFO_0007304 | — | 1 | 8 | 3 | — | 7 | 19 |
| Bone density | D015519 | EFO_0003923 | M85 | 1 | 2 | 1 | — | 16 | 19 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | 2 | — | — | 18 | 21 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 8 | 6 | — | — | 3 | 14 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 2 | 1 | — | — | 10 | 12 |
| Ulcer | D014456 | MPATH_579 | — | 2 | 1 | — | — | 10 | 12 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 8 | 5 | — | — | — | 11 |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | 1 | 1 | — | — | 9 | 11 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | 10 | 11 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 1 | — | — | 8 | 9 |
| Exercise | D015444 | EFO_0000483 | — | — | 1 | — | — | 8 | 9 |
| Autoimmune diseases | D001327 | HP_0002960 | M30-M36 | — | 4 | — | — | 4 | 8 |
Show 269 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | HP_0003124 | — | 1 | — | — | — | 8 | 9 |
| Periodontal diseases | D010510 | — | K05.6 | 1 | — | — | — | 7 | 8 |
| Heart disease risk factors | D000082742 | — | — | 2 | — | — | — | 5 | 7 |
| Nutritional status | D009752 | — | — | 1 | — | — | — | 5 | 6 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | — | — | — | 5 | 6 |
| Gingivitis | D005891 | HP_0000230 | K05.10 | 1 | — | — | — | 5 | 6 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 3 | — | — | — | 2 | 5 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | 1 | 4 |
| Diet therapy | D004035 | — | — | 1 | — | — | — | 3 | 4 |
| Gastrointestinal microbiome | D000069196 | — | — | 2 | — | — | — | 2 | 4 |
Show 56 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-acute covid-19 syndrome | D000094024 | — | — | — | — | — | — | 9 | 9 |
| Healthy diet | D000072001 | — | — | — | — | — | — | 9 | 9 |
| Cerebral palsy | D002547 | — | G80 | — | — | — | — | 8 | 8 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | — | 8 | 8 |
| Urinary incontinence | D014549 | HP_0000020 | R32 | — | — | — | — | 7 | 7 |
| Body weight changes | D001836 | — | — | — | — | — | — | 6 | 6 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 6 | 6 |
| Enuresis | D004775 | — | R32 | — | — | — | — | 6 | 6 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | — | — | — | 6 | 6 |
| Myopia | D009216 | EFO_0003927 | H52.1 | — | — | — | — | 6 | 6 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cholecalciferol |
| INN | colecalciferol |
| Description | Fosamax Plus D (cholecalciferol) is a small molecule pharmaceutical. Cholecalciferol was first approved as Fosamax plus d on 2005-04-07. It is used to treat cardiovascular diseases, chronic kidney failure, crohn disease, familial hypophosphatemic rickets, and hypoparathyroidism amongst others in the USA. |
| Classification | Small molecule |
| Drug class | vitamin D analogs |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=C1CC[C@H](O)C/C1=C/C=C1\CCC[C@@]2(C)[C@H]1CC[C@@H]2[C@H](C)CCCC(C)C |
Identifiers
| PDB | — |
| CAS-ID | 67-97-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1042 |
| ChEBI ID | 28940 |
| PubChem CID | 5280795 |
| DrugBank | DB00169 |
| UNII ID | 1C6V77QF41 (ChemIDplus, GSRS) |
Target
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Safety
Black-box Warning
Black-box warning for: Citranatal, Citranatal 90 dha, Citranatal assure, Citranatal b-calm, Citranatal dha, Citranatal essence, Citranatal harmony, Citranatal harmony 2.1, Citranatal harmony 3.0, Citranatal medley, Citranatal rx, Healthy mamabe well rounded, Marnatal f, Moms choice rx, Natafort, Nestabs, Nestabs dha, Nestabs one, O-cal prenatal vitamin, Omega-3 well pack, Pnv prenatal plus multivitamin, Pnv prenatal vitamin, Pnv-dha, Pnv-omega, Pnv-select, Pr natal 400, Pr natal 400 ec, Pr natal 430, Pr natal 430 ec, Pre-tabs dha, Prenaissance, Prenaissance plus, Prenata, Prenatal plus multivitamin plus dha minicaps, Prenate dha, Prenate elite, Prenate enhance, Prenate essential, Prenate mini, Prenate pixie, Prenate restore, Primacare, Select ob, Select-ob plus dha, Tricare prenatal, Tristart dha, Vitafol, Vitafol fe plus, Vitafol ob, Vitafol-ob plus dha
Adverse Events
Top Adverse Reactions
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16,909 adverse events reported
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