biotin 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 ┬ÁM/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
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 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
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:

SourceCodeDescription
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)

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

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
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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