biotin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	373	58-85-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: biotin coenzyme R D-Biotin	A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk. Molecular weight: 244.31 Formula: C10H16N2O3S CLOGP: -0.08 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 78.43 ALOGS: -2.30 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

biotin
coenzyme R
D-Biotin

A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk.

Molecular weight: 244.31
Formula: C10H16N2O3S
CLOGP: -0.08
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 78.43
ALOGS: -2.30
ROTB: 5

Status: OFP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.22 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	43 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Feb. 20, 1953	FDA	HOSPIRA

FDA Adverse Event Reporting System (Female)

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
Alopecia	115.31	12.13	268	25566	162146	46498082
Toxicity to various agents	82.79	12.13	10	25824	211756	46448472
Pleural thickening	81.44	12.13	36	25798	2559	46657669
Fatigue	78.82	12.13	590	25244	608107	46052121
Blood magnesium increased	76.14	12.13	36	25798	2991	46657237
Presbyacusis	75.42	12.13	35	25799	2787	46657441
Pleural fibrosis	70.51	12.13	36	25798	3533	46656695
Deafness neurosensory	68.12	12.13	38	25796	4456	46655772
Epigastric discomfort	62.36	12.13	39	25795	5645	46654583
Cyst	57.26	12.13	50	25784	12050	46648178
Dry eye	51.18	12.13	73	25761	30249	46629979
Drug interaction	48.47	12.13	26	25808	203068	46457160
Blood potassium increased	41.38	12.13	49	25785	16918	46643310
Product dose omission issue	40.10	12.13	192	25642	168328	46491900
Osteopenia	36.53	12.13	46	25788	16915	46643313
Acute kidney injury	33.64	12.13	49	25785	235806	46424422
Onychoclasis	32.18	12.13	25	25809	5119	46655109
General physical health deterioration	28.82	12.13	14	25820	115755	46544473
Diarrhoea	27.87	12.13	449	25385	559153	46101075
Bone cyst	27.48	12.13	16	25818	2035	46658193
Osteoarthritis	27.37	12.13	86	25748	61939	46598289
Flatulence	25.36	12.13	52	25782	28826	46631402
Headache	24.60	12.13	386	25448	477966	46182262
Full blood count decreased	24.43	12.13	44	25790	22167	46638061
Product compounding quality issue	24.36	12.13	7	25827	138	46660090
Synovitis	23.55	12.13	3	25831	61072	46599156
Cardio-respiratory arrest	22.94	12.13	3	25831	59866	46600362
Muscle spasms	22.86	12.13	131	25703	122982	46537246
Skin lesion	22.17	12.13	47	25787	26666	46633562
Weight increased	21.94	12.13	161	25673	164312	46495916
Feeling abnormal	21.88	12.13	131	25703	124929	46535299
Osteosclerosis	21.80	12.13	17	25817	3499	46656729
Hyponatraemia	21.33	12.13	15	25819	101317	46558911
Febrile neutropenia	21.28	12.13	13	25821	94614	46565614
Pruritus	21.19	12.13	216	25618	242136	46418092
Pre-existing condition improved	21.13	12.13	22	25812	6590	46653638
Maternal exposure during pregnancy	20.52	12.13	16	25818	102533	46557695
Back pain	20.21	12.13	191	25643	209848	46450380
C-reactive protein increased	20.07	12.13	4	25830	58586	46601642
Hypokalaemia	19.92	12.13	12	25822	88012	46572216
Sinusitis	19.63	12.13	131	25703	129637	46530591
White blood cell count decreased	19.27	12.13	117	25717	112114	46548114
Leukopenia	19.03	12.13	7	25827	68336	46591892
Hot flush	18.88	12.13	60	25774	43457	46616771
Constipation	18.62	12.13	162	25672	173935	46486293
Contraindicated product administered	17.95	12.13	11	25823	79936	46580292
Nail disorder	17.94	12.13	22	25812	7874	46652354
Exostosis	17.74	12.13	25	25809	10238	46649990
Migraine	17.51	12.13	81	25753	69945	46590283
Dizziness	17.19	12.13	274	25560	340140	46320088
Cardiac arrest	16.98	12.13	15	25819	90384	46569844
Overdose	16.78	12.13	19	25815	101960	46558268
Cardiac failure	16.60	12.13	12	25822	79936	46580292
Neutropenia	16.51	12.13	34	25800	143170	46517058
Hospitalisation	16.35	12.13	74	25760	63311	46596917
Eosinophilic pleural effusion	16.25	12.13	4	25830	42	46660186
Hypoaesthesia	16.21	12.13	117	25717	118752	46541476
Memory impairment	15.48	12.13	84	25750	77253	46582975
Weight decreased	15.23	12.13	181	25653	210668	46449560
Bradycardia	15.06	12.13	9	25825	66289	46593939
Gastrointestinal disorder	14.96	12.13	69	25765	59507	46600721
Pain in extremity	14.90	12.13	213	25621	258467	46401761
Multiple sclerosis relapse	14.69	12.13	54	25780	42071	46618157
Thrombocytopenia	14.64	12.13	30	25804	126551	46533677
Gastrooesophageal reflux disease	14.37	12.13	80	25754	74264	46585964
Drug ineffective	13.70	12.13	279	25555	677559	45982669
Nausea	13.43	12.13	485	25349	686969	45973259
Increased tendency to bruise	13.39	12.13	21	25813	9453	46650775
Burning sensation	13.10	12.13	54	25780	44357	46615871
Depressed level of consciousness	13.03	12.13	5	25829	47564	46612664
Flushing	12.81	12.13	70	25764	64544	46595684
Injection site erythema	12.39	12.13	77	25757	74350	46585878
Dyspepsia	12.14	12.13	72	25762	68400	46591828

FDA Adverse Event Reporting System (Male)

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
Peritonitis bacterial	31.03	18.25	18	3327	11360	29937773
Fatigue	28.26	18.25	89	3256	320584	29628549
Memory impairment	18.89	18.25	22	3323	37152	29911981
Laboratory test interference	18.28	18.25	5	3340	425	29948708

Pharmacologic Action:

Source	Code	Description
ATC	A11HA05	ALIMENTARY TRACT AND METABOLISM VITAMINS OTHER PLAIN VITAMIN PREPARATIONS Other plain vitamin preparations
CHEBI has role	CHEBI:23354	coenzymes
CHEBI has role	CHEBI:23357	cofactor
CHEBI has role	CHEBI:26348	prosthetic groups
CHEBI has role	CHEBI:50733	nutritional supplement
CHEBI has role	CHEBI:75769	vitamin b
CHEBI has role	CHEBI:75771	mus musculus metabolite
CHEBI has role	CHEBI:75772	baker's yeast metabolite
CHEBI has role	CHEBI:76971	e.coli metabolites
CHEBI has role	CHEBI:77746	h. sapiens metabolites
MeSH PA	D018977	Micronutrients
MeSH PA	D014803	Vitamin B Complex
MeSH PA	D014815	Vitamins

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Biotin deficiency disease	indication	49607006
Biotinidase deficiency	off-label use	8808004	DOID:856
Propionic acidemia	off-label use	69080001	DOID:14701
Holocarboxylase synthase deficiency	off-label use	360369003	DOID:859
Constipation	contraindication	14760008	DOID:2089
Sarcoidosis	contraindication	31541009	DOID:11335
Dehydration	contraindication	34095006
Hypercalcemia	contraindication	66931009	DOID:12678
Hyperparathyroidism	contraindication	66999008	DOID:13543
Kidney disease	contraindication	90708001	DOID:557
Kidney stone	contraindication	95570007
Osteolysis	contraindication	203522001

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.79	acidic
pKa2	13.37	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Insulin-degrading enzyme	Enzyme	P14735	IDE_HUMAN		EC50	5.60		CHEMBL

External reference:

ID	Source
6SO6U10H04	UNII
4017638	VUID
N0000146018	NUI
D00029	KEGG_DRUG
4017638	VANDF
4020110	VANDF
C0005575	UMLSCUI
CHEBI:15956	CHEBI
BTN	PDB_CHEM_ID
CHEMBL857	ChEMBL_ID
DB00121	DRUGBANK_ID
D001710	MESH_DESCRIPTOR_UI
1203	INN_ID
171548	PUBCHEM_CID
4787	IUPHAR_LIGAND_ID
1588	RXNORM
11819	MMSL
118935	MMSL
118941	MMSL
d06867	MMSL
001035	NDDF
13813003	SNOMEDCT_US
8919000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Strovite Forte Caplet	HUMAN PRESCRIPTION DRUG LABEL	19	0642-0204	TABLET, COATED	0.15 mg	ORAL	UNULLPPROVED DRUG OTHER	15 sections
Strovite One Caplets	HUMAN PRESCRIPTION DRUG LABEL	20	0642-0207	TABLET	100 ug	ORAL	UNULLPPROVED DRUG OTHER	14 sections
BACMIN	HUMAN PRESCRIPTION DRUG LABEL	19	0682-3001	TABLET, COATED	150 ug	ORAL	UNULLPPROVED DRUG OTHER	10 sections
Dialyvite Supreme D	HUMAN PRESCRIPTION DRUG LABEL	13	10542-009	TABLET, COATED	300 ug	ORAL	Unapproved drug other	7 sections
Dialyvite	HUMAN PRESCRIPTION DRUG LABEL	9	10542-010	TABLET, COATED	300 ug	ORAL	Unapproved drug other	7 sections
Dialyvite 5000	HUMAN PRESCRIPTION DRUG LABEL	12	10542-011	TABLET, COATED	300 ug	ORAL	Unapproved drug other	7 sections
Dialyvite with Zinc	HUMAN PRESCRIPTION DRUG LABEL	10	10542-012	TABLET, COATED	300 ug	ORAL	Unapproved drug other	7 sections
Dialyvite 3000	HUMAN PRESCRIPTION DRUG LABEL	12	10542-014	TABLET, COATED	300 ug	ORAL	Unapproved drug other	7 sections
Quflora FE Pediatric Drops	HUMAN PRESCRIPTION DRUG LABEL	14	15370-102	LIQUID	3 ug	ORAL	UNULLPPROVED DRUG OTHER	11 sections
Dialyvite	HUMAN PRESCRIPTION DRUG LABEL	9	17856-0010	TABLET, COATED	300 ug	ORAL	Unapproved drug other	8 sections
PNV-Select	HUMAN PRESCRIPTION DRUG LABEL	18	42192-320	TABLET, FILM COATED	300 ug	ORAL	unapproved drug other	10 sections
PNV-Omega	HUMAN PRESCRIPTION DRUG LABEL	13	42192-332	CAPSULE, GELATIN COATED	250 ug	ORAL	unapproved drug other	12 sections
HairQ-Plus	HUMAN OTC DRUG LABEL	1	49658-2001	SHAMPOO	0.06 mL	TOPICAL	unapproved drug other	8 sections
HairQ-Plus	HUMAN OTC DRUG LABEL	1	49658-4001	SOLUTION	0.06 mL	TOPICAL	unapproved drug other	8 sections
Bonogenhair care shampoo	HUMAN OTC DRUG LABEL	4	50653-1001	SHAMPOO	0.06 g	TOPICAL	unapproved drug other	2 sections
Bonogen Plushair care shampoo	HUMAN OTC DRUG LABEL	4	50653-2001	SHAMPOO	0.06 g	TOPICAL	unapproved drug other	2 sections
Bonogen Activatorhair loss treatment	HUMAN OTC DRUG LABEL	1	50653-3001	LIQUID	0.00 mL	TOPICAL	unapproved drug other	3 sections
Born Hair	HUMAN OTC DRUG LABEL	4	50653-4001	SHAMPOO	0.06 g	TOPICAL	unapproved drug other	7 sections
Doll Lash	HUMAN OTC DRUG LABEL	4	51329-1001	LIQUID	0.06 mL	TOPICAL	unapproved drug other	8 sections
Concept OB	HUMAN PRESCRIPTION DRUG LABEL	15	52747-620	CAPSULE	300 ug	ORAL	unapproved drug other	13 sections
Concept DHA	HUMAN PRESCRIPTION DRUG LABEL	15	52747-621	CAPSULE, LIQUID FILLED	300 ug	ORAL	unapproved drug other	7 sections
Integra Plus	HUMAN PRESCRIPTION DRUG LABEL	10	52747-712	CAPSULE	300 ug	ORAL	unapproved drug other	12 sections
Floriva	HUMAN PRESCRIPTION DRUG LABEL	16	52796-173	TABLET, CHEWABLE	40 ug	ORAL	UNULLPPROVED DRUG OTHER	6 sections
Floriva	HUMAN PRESCRIPTION DRUG LABEL	16	52796-174	TABLET, CHEWABLE	40 ug	ORAL	UNULLPPROVED DRUG OTHER	6 sections
Floriva	HUMAN PRESCRIPTION DRUG LABEL	16	52796-177	TABLET, CHEWABLE	40 ug	ORAL	UNULLPPROVED DRUG OTHER	7 sections
PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION	HUMAN PRESCRIPTION DRUG LABEL	13	54643-5646	INJECTION, SOLUTION	20 ug	INTRAVENOUS	NDA	19 sections
Adult Infuvite Multiple Vitamins for Infusion	HUMAN PRESCRIPTION DRUG LABEL	13	54643-5649	INJECTION, SOLUTION	60 ug	INTRAVENOUS	NDA	17 sections
Adult Infuvite Multiple Vitamins for Infusion	HUMAN PRESCRIPTION DRUG LABEL	13	54643-5649	INJECTION, SOLUTION	60 ug	INTRAVENOUS	NDA	17 sections
Infuvite Adult Multiple Vitamins	HUMAN PRESCRIPTION DRUG LABEL	13	54643-5650	INJECTION, SOLUTION	60 ug	INTRAVENOUS	NDA	20 sections
Adult Infuvite Multiple Vitamins	HUMAN PRESCRIPTION DRUG LABEL	13	54643-7862	INJECTION, SOLUTION	60 ug	INTRAVENOUS	NDA	20 sections