biotin 🐶 Veterinary Use | 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
Fatigue	89.21	12.90	670	26722	706931	49870801
Toxicity to various agents	88.64	12.90	7	27385	212492	50365240
Pleural thickening	82.15	12.90	36	27356	2563	50575169
Blood magnesium increased	78.60	12.90	36	27356	2844	50574888
Presbyacusis	76.71	12.90	35	27357	2741	50574991
Pleural fibrosis	73.07	12.90	36	27356	3348	50574384
Alopecia	69.16	12.90	289	27103	244758	50332974
Deafness neurosensory	68.85	12.90	38	27354	4463	50573269
Epigastric discomfort	61.99	12.90	39	27353	5831	50571901
Dry eye	58.09	12.90	79	27313	32016	50545716
Cyst	57.90	12.90	50	27342	12137	50565595
Synovitis	54.80	12.90	3	27389	123862	50453870
Product dose omission issue	50.39	12.90	215	27177	183623	50394109
Maternal exposure during pregnancy	48.95	12.90	13	27379	159765	50417967
Contraindicated product administered	47.81	12.90	11	27381	148947	50428785
Hand deformity	42.60	12.90	3	27389	100196	50477536
Diarrhoea	41.43	12.90	493	26899	587983	49989749
Glossodynia	40.28	12.90	7	27385	115562	50462170
Drug interaction	39.72	12.90	30	27362	199591	50378141
General physical health deterioration	39.29	12.90	14	27378	142420	50435312
Onychoclasis	39.17	12.90	28	27364	5168	50572564
Headache	39.04	12.90	432	26960	506103	50071629
COVID-19	37.54	12.90	80	27312	46582	50531150
Osteopenia	37.21	12.90	46	27346	16972	50560760
Systemic lupus erythematosus	36.82	12.90	15	27377	140607	50437125
White blood cell count decreased	35.48	12.90	141	27251	116581	50461151
Blood potassium increased	35.34	12.90	44	27348	16354	50561378
Muscle spasms	34.49	12.90	147	27245	125406	50452326
Acute kidney injury	34.17	12.90	44	27348	228014	50349718
Back pain	30.09	12.90	213	27179	219817	50357915
Flatulence	29.07	12.90	55	27337	29403	50548329
Feeling abnormal	28.55	12.90	139	27253	125353	50452379
Bone cyst	28.00	12.90	16	27376	2008	50575724
Osteoarthritis	26.86	12.90	90	27302	68516	50509216
Skin lesion	25.27	12.90	49	27343	26678	50551054
Multiple sclerosis relapse	25.10	12.90	65	27327	42899	50534833
Drug ineffective	25.05	12.90	304	27088	819029	49758703
Hot flush	24.96	12.90	66	27326	44103	50533629
Full blood count decreased	23.65	12.90	43	27349	22303	50555429
Sinusitis	23.23	12.90	165	27227	170393	50407339
C-reactive protein increased	23.21	12.90	4	27388	66470	50511262
Osteosclerosis	22.34	12.90	17	27375	3450	50574282
Migraine	22.11	12.90	90	27302	75190	50502542
Constipation	22.09	12.90	174	27218	185534	50392198
Pre-existing condition improved	22.01	12.90	23	27369	7074	50570658
Hypoaesthesia	21.52	12.90	130	27262	127127	50450605
Gastrooesophageal reflux disease	21.37	12.90	90	27302	76338	50501394
Hyponatraemia	21.04	12.90	13	27379	96126	50481606
Weight decreased	20.42	12.90	196	27196	221049	50356683
Dizziness	20.35	12.90	281	27111	346088	50231644
Cardiac arrest	20.20	12.90	10	27382	83641	50494091
Psoriasis	19.87	12.90	82	27310	68918	50508814
Exposure during pregnancy	19.54	12.90	22	27370	120993	50456739
Febrile neutropenia	19.00	12.90	15	27377	97652	50480080
Nausea	18.88	12.90	507	26885	704891	49872841
Memory impairment	18.83	12.90	89	27303	79271	50498461
Multiple sclerosis	18.68	12.90	37	27355	20456	50557276
Lower respiratory tract infection	18.04	12.90	15	27377	95186	50482546
Exostosis	17.14	12.90	26	27366	11627	50566105
Increased tendency to bruise	16.88	12.90	23	27369	9333	50568399
Hypokalaemia	16.51	12.90	14	27378	87978	50489754
Dry skin	16.32	12.90	56	27336	43135	50534597
Hepatic enzyme increased	16.27	12.90	31	27361	137349	50440383
Pruritus	16.21	12.90	229	27163	283339	50294393
Eosinophilic pleural effusion	16.01	12.90	4	27388	46	50577686
Pain in extremity	15.86	12.90	221	27171	272644	50305088
Infusion related reaction	15.47	12.90	44	27348	169513	50408219
Death	15.39	12.90	108	27284	325271	50252461
Dysgeusia	15.18	12.90	51	27341	38865	50538867
Overdose	15.16	12.90	19	27373	99708	50478024
Bradycardia	15.11	12.90	8	27384	64418	50513314
Surgery	14.94	12.90	43	27349	30162	50547570
Injection site erythema	14.93	12.90	80	27312	74856	50502876
Nail disorder	14.76	12.90	22	27370	9686	50568046
Depressed level of consciousness	14.50	12.90	5	27387	51948	50525784
Paraesthesia	14.47	12.90	113	27279	120130	50457602
Wound	14.24	12.90	22	27370	105772	50471960
Dry mouth	14.06	12.90	64	27328	56114	50521618
Burning sensation	13.87	12.90	55	27337	45391	50532341
Injection site pain	13.73	12.90	105	27287	110919	50466813
Dyspepsia	13.36	12.90	77	27315	74020	50503712
Cardiac failure	13.19	12.90	13	27379	76027	50501705
Foreign body in reproductive tract	12.99	12.90	6	27386	483	50577249

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
Fractional exhaled nitric oxide increased	80.65	21.25	16	2995	360	29571156
Sensation of foreign body	55.82	21.25	16	2995	1774	29569742
Myoglobin blood increased	54.11	21.25	16	2995	1979	29569537
Secretion discharge	53.53	21.25	19	2992	4191	29567325
Plantar fasciitis	51.63	21.25	14	2997	1267	29570249
Brain natriuretic peptide increased	42.31	21.25	16	2995	4214	29567302
Dyspnoea exertional	36.49	21.25	30	2981	36460	29535056
Fatigue	31.08	21.25	86	2925	316735	29254781
Dysphonia	30.88	21.25	21	2990	19175	29552341
Memory impairment	30.37	21.25	27	2984	36443	29535073
Obstructive airways disorder	27.68	21.25	16	2995	11000	29560516
Sleep apnoea syndrome	25.37	21.25	18	2993	17581	29553935
Muscle spasms	23.56	21.25	31	2980	65051	29506465
Needle fatigue	21.59	21.25	6	3005	594	29570922

FDA Adverse Event Reporting System (Geriatric)

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	141.71	13.79	228	22488	165462	64310554
Fatigue	105.97	13.79	531	22185	748199	63727817
Toxicity to various agents	101.01	13.79	7	22709	363506	64112510
Presbyacusis	79.41	13.79	31	22685	2544	64473472
Pleural thickening	77.87	13.79	31	22685	2679	64473337
Blood magnesium increased	72.61	13.79	31	22685	3200	64472816
Pleural fibrosis	65.89	13.79	31	22685	4019	64471997
Cyst	58.62	13.79	42	22674	11985	64464031
Acute kidney injury	58.20	13.79	44	22672	449196	64026820
Epigastric discomfort	55.93	13.79	33	22683	6778	64469238
Deafness neurosensory	55.29	13.79	32	22684	6342	64469674
Drug interaction	54.32	13.79	30	22686	362053	64113963
Headache	53.06	13.79	343	22373	529124	63946892
Dry eye	49.52	13.79	56	22660	28963	64447053
Product dose omission issue	47.76	13.79	164	22552	194583	64281433
Onychoclasis	42.36	13.79	24	22692	4568	64471448
Multiple sclerosis relapse	41.23	13.79	61	22655	41074	64434942
Osteopenia	41.13	13.79	38	22678	15502	64460514
Feeling abnormal	34.03	13.79	114	22602	133488	64342528
Bone cyst	33.24	13.79	16	22700	2181	64473835
Nausea	32.41	13.79	420	22296	785380	63690636
Osteoarthritis	31.27	13.79	69	22647	63267	64412749
Blood potassium increased	31.18	13.79	42	22674	25938	64450078
White blood cell count decreased	31.18	13.79	124	22592	157713	64318303
Burning sensation	27.86	13.79	57	22659	49607	64426409
Sinusitis	27.51	13.79	113	22603	145815	64330201
Back pain	27.39	13.79	166	22550	250005	64226011
Memory impairment	27.26	13.79	79	22637	85603	64390413
Diarrhoea	26.76	13.79	379	22337	722325	63753691
Multiple sclerosis	26.45	13.79	33	22683	18908	64457108
Osteosclerosis	26.31	13.79	16	22700	3470	64472546
Migraine	26.24	13.79	64	22652	62613	64413403
COVID-19	25.67	13.79	65	22651	65075	64410941
Dizziness	25.44	13.79	247	22469	429916	64046100
Skin lesion	24.28	13.79	45	22671	36437	64439579
Injection site pain	24.01	13.79	90	22626	111318	64364698
Weight decreased	23.14	13.79	176	22540	285563	64190453
General physical health deterioration	22.80	13.79	23	22693	204402	64271614
Dyspepsia	22.67	13.79	71	22645	80241	64395775
Hypoaesthesia	22.59	13.79	103	22613	139005	64337011
Urinary tract infection	22.44	13.79	149	22567	231447	64244569
Injection site erythema	22.25	13.79	65	22651	70735	64405281
Muscle spasms	21.86	13.79	103	22613	140920	64335096
Hot flush	21.29	13.79	49	22667	46186	64429830
Pain in extremity	20.39	13.79	179	22537	302906	64173110
Dry skin	20.10	13.79	51	22665	51110	64424906
Flatulence	20.08	13.79	41	22675	35625	64440391
Relapsing-remitting multiple sclerosis	19.64	13.79	9	22707	1099	64474917
Gastrooesophageal reflux disease	19.46	13.79	69	22647	83074	64392942
Pancytopenia	18.55	13.79	14	22702	143295	64332721
Renal failure	18.54	13.79	22	22694	181666	64294350
Deformity	17.84	13.79	16	22700	6281	64469735
Pruritus	17.76	13.79	178	22538	312222	64163794
Cardiac failure	17.04	13.79	13	22703	132360	64343656
Hypokalaemia	16.98	13.79	11	22705	121892	64354124
Febrile neutropenia	16.83	13.79	25	22691	187632	64288384
Depressed level of consciousness	16.82	13.79	4	22712	81432	64394584
Overdose	16.62	13.79	19	22697	159547	64316469
Balance disorder	16.61	13.79	66	22650	83860	64392156
Cardiac arrest	16.43	13.79	18	22698	154046	64321970
Injection site bruising	16.14	13.79	38	22678	36335	64439681
Exostosis	16.08	13.79	20	22696	11418	64464598
Paraesthesia	15.82	13.79	91	22625	134431	64341585
Dysgeusia	15.56	13.79	44	22672	47003	64429013
Arthralgia	15.14	13.79	229	22487	442031	64033985
Hyponatraemia	15.09	13.79	18	22698	148321	64327695
Injection site mass	15.03	13.79	24	22692	17246	64458770
Dry mouth	14.88	13.79	51	22665	60367	64415649
Interstitial lung disease	14.76	13.79	8	22708	97724	64378292
Thrombocytopenia	14.65	13.79	36	22680	223765	64252251
Milk allergy	14.59	13.79	4	22712	106	64475910
Neutropenia	14.57	13.79	40	22676	239584	64236432
Needle fatigue	14.41	13.79	6	22710	582	64475434
Pain	14.36	13.79	274	22442	553237	63922779
Neck pain	14.34	13.79	51	22665	61482	64414534
Vitamin D deficiency	14.18	13.79	19	22697	11673	64464343
Confusional state	14.15	13.79	46	22670	261098	64214918
Bone hypertrophy	13.99	13.79	5	22711	321	64475695
Respiratory failure	13.94	13.79	22	22694	161161	64314855
Fall	13.94	13.79	215	22501	416611	64059405
Psoriasis	13.87	13.79	56	22660	71647	64404369

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A11HA05	ALIMENTARY TRACT AND METABOLISM VITAMINS OTHER PLAIN VITAMIN PREPARATIONS Other plain vitamin preparations
MeSH PA	D018977	Micronutrients
MeSH PA	D014803	Vitamin B Complex
MeSH PA	D014815	Vitamins
CHEBI has role	CHEBI:23354	coenzymes
CHEBI has role	CHEBI:23357	cofactor
CHEBI has role	CHEBI:26348	prosthetic groups
CHEBI has role	CHEBI:50733	Dietary Supplement
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:75772	S. cerevisiae metabolites
CHEBI has role	CHEBI:76971	Escherichia coli metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:78675	fundamental metabolites

Drug Use | Suggest Off label Use Form| |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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
4017638	VUID
N0000146018	NUI
D00029	KEGG_DRUG
1588	RXNORM
C0005575	UMLSCUI
CHEBI:57586	CHEBI
BTN	PDB_CHEM_ID
CHEMBL857	ChEMBL_ID
DB00121	DRUGBANK_ID
D001710	MESH_DESCRIPTOR_UI
171548	PUBCHEM_CID
4787	IUPHAR_LIGAND_ID
1203	INN_ID
6SO6U10H04	UNII
11819	MMSL
118935	MMSL
118941	MMSL
d06867	MMSL
001035	NDDF
13813003	SNOMEDCT_US
8919000	SNOMEDCT_US
4017638	VANDF
4020110	VANDF

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	UNAPPROVED DRUG OTHER	15 sections
Strovite One Caplets	HUMAN PRESCRIPTION DRUG LABEL	20	0642-0207	TABLET	100 ug	ORAL	UNAPPROVED DRUG OTHER	14 sections
BACMIN	HUMAN PRESCRIPTION DRUG LABEL	19	0682-3001	TABLET, COATED	150 ug	ORAL	UNAPPROVED 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	UNAPPROVED 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	UNAPPROVED DRUG OTHER	6 sections
Floriva	HUMAN PRESCRIPTION DRUG LABEL	16	52796-174	TABLET, CHEWABLE	40 ug	ORAL	UNAPPROVED DRUG OTHER	6 sections
Floriva	HUMAN PRESCRIPTION DRUG LABEL	16	52796-177	TABLET, CHEWABLE	40 ug	ORAL	UNAPPROVED 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