ergocalciferol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
Vitamin D analogues/derivatives	2838	50-14-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ergocalciferol vitamin D2 calciferol ercalciol ergorone	Molecular weight: 396.66 Formula: C28H44O CLOGP: 9.39 LIPINSKI: 1 HAC: 1 HDO: 1 TPSA: 20.23 ALOGS: -5.96 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ergocalciferol
vitamin D2
calciferol
ercalciol
ergorone

Molecular weight: 396.66
Formula: C28H44O
CLOGP: 9.39
LIPINSKI: 1
HAC: 1
HDO: 1
TPSA: 20.23
ALOGS: -5.96
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.86 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
Jan. 11, 1941	FDA	SANOFI AVENTIS US

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Toxicity to various agents	997.33	10.22	326	486142	246924	62755630
Completed suicide	720.72	10.22	124	486344	145549	62857005
Drug interaction	439.52	10.22	672	485796	228459	62774095
Drug abuse	435.46	10.22	31	486437	72487	62930067
Intentional overdose	396.93	10.22	50	486418	74102	62928452
Drug ineffective	370.43	10.22	5713	480755	1039052	61963502
Multiple sclerosis relapse	348.41	10.22	986	485482	47492	62955062
Overdose	325.98	10.22	243	486225	114835	62887719
Product dose omission issue	312.70	10.22	2952	483516	231361	62771193
Acute kidney injury	305.31	10.22	1017	485451	262398	62740156

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Toxicity to various agents	447.28	10.32	187	162621	200175	34593948
Fatigue	413.11	10.32	3042	159766	367611	34426512
Drug interaction	337.76	10.32	333	162475	225613	34568510
Completed suicide	267.84	10.32	64	162744	98104	34696019
Product dose omission issue	264.18	10.32	1181	161627	118530	34675593
Drug abuse	261.87	10.32	69	162739	99027	34695096
Multiple sclerosis relapse	208.78	10.32	281	162527	12852	34781271
Acute kidney injury	199.34	10.32	740	162068	304248	34489875
Infective pulmonary exacerbation of cystic fibrosis	154.15	10.32	174	162634	6627	34787496
Intentional overdose	139.47	10.32	19	162789	43655	34750468

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Toxicity to various agents	1452.05	9.73	415	496750	421125	78826098
Completed suicide	985.93	9.73	172	496993	245595	79001628
Drug interaction	797.20	9.73	848	496317	414335	78832888
Drug abuse	721.91	9.73	84	497081	162607	79084616
Acute kidney injury	614.41	9.73	1465	495700	517939	78729284
Fatigue	520.43	9.73	8402	488763	921325	78325898
Multiple sclerosis relapse	498.67	9.73	976	496189	45557	79201666
Product dose omission issue	469.42	9.73	2892	494273	244645	79002578
Intentional overdose	464.32	9.73	57	497108	105903	79141320
Overdose	425.36	9.73	316	496849	183890	79063333

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A11CC01	ALIMENTARY TRACT AND METABOLISM VITAMINS VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO Vitamin D and analogues
CHEBI has role	CHEBI:33288	rodenticides
CHEBI has role	CHEBI:50646	antiosteoporotic
CHEBI has role	CHEBI:50733	Dietary Supplement
CHEBI has role	CHEBI:76924	plant metabolites
FDA CS	M0007651	Ergocalciferols
FDA EPC	N0000175909	Provitamin D2 Compound
MeSH PA	D050071	Bone Density Conservation Agents
MeSH PA	D000077264	Calcium-Regulating Hormones and Agents
MeSH PA	D018977	Micronutrients

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Osteomalacia	indication	4598005	DOID:10573
Hypocalcemia	indication	5291005
Vitamin D deficiency	indication	34713006
Hypoparathyroidism	indication	36976004	DOID:11199
Rickets	indication	41345002	DOID:10609
Osteoporosis	indication	64859006	DOID:11476
Familial x-linked hypophosphatemic vitamin D refractory rickets	indication	82236004
Vitamin deficiency	indication	85670002
Postmenopausal osteoporosis	indication	102447009
Prevention of dental caries	indication	426482000

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Bioact source	MoA source
Vitamin D3 receptor	Nuclear hormone receptor	P11473	VDR_HUMAN	AGONIST	WOMBAT-PK	CHEMBL
25-hydroxyvitamin D-1 alpha hydroxylase, mitochondrial	Enzyme	O15528	CP27B_HUMAN		WOMBAT-PK
Vitamin D 25-hydroxylase	Enzyme	Q6VVX0	CP2R1_HUMAN		WOMBAT-PK

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External reference:

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ID	Source
D2V	PDB_CHEM_ID
001013	NDDF
1067	MMSL
11253	RXNORM
11563006	SNOMEDCT_US
23433006	SNOMEDCT_US
30178006	SNOMEDCT_US
315714	MMSL
335232	MMSL
3554	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
DRISDOL	HUMAN PRESCRIPTION DRUG LABEL	1	30698-493	CAPSULE, LIQUID FILLED	1.25 mg	ORAL	NDA	19 sections
DRISDOL	HUMAN PRESCRIPTION DRUG LABEL	1	30698-493	CAPSULE, LIQUID FILLED	1.25 mg	ORAL	NDA	19 sections
Ergocalciferol	HUMAN PRESCRIPTION DRUG LABEL	1	10544-527	CAPSULE	1.25 mg	ORAL	ANDA	19 sections
Ergocalciferol	HUMAN PRESCRIPTION DRUG LABEL	1	33261-730	CAPSULE	1.25 mg	ORAL	ANDA	19 sections
Ergocalciferol	HUMAN PRESCRIPTION DRUG LABEL	1	42291-266	CAPSULE, LIQUID FILLED	1.25 mg	ORAL	ANDA	20 sections
Ergocalciferol	HUMAN PRESCRIPTION DRUG LABEL	1	42794-006	CAPSULE, LIQUID FILLED	1.25 mg	ORAL	ANDA	19 sections
Ergocalciferol	HUMAN PRESCRIPTION DRUG LABEL	1	43063-711	CAPSULE, LIQUID FILLED	1.25 mg	ORAL	ANDA	18 sections
Ergocalciferol	HUMAN PRESCRIPTION DRUG LABEL	1	43063-711	CAPSULE, LIQUID FILLED	1.25 mg	ORAL	ANDA	18 sections
Ergocalciferol	HUMAN PRESCRIPTION DRUG LABEL	1	43063-711	CAPSULE, LIQUID FILLED	1.25 mg	ORAL	ANDA	18 sections
Ergocalciferol	HUMAN PRESCRIPTION DRUG LABEL	1	43063-711	CAPSULE, LIQUID FILLED	1.25 mg	ORAL	ANDA	18 sections

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