biotin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
373 58-85-5

Description:

MoleculeDescription

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:

PropertyValueReference
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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Feb. 20, 1953 FDA HOSPIRA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Insulin-degrading enzyme Enzyme EC50 5.60 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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