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

Stem definitionDrug idCAS RN
347 590-46-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • betaine
  • oxyneurine
  • betafin
  • glycine betaine
  • betaine anhydrous
  • betaine hydrochloride
  • betaine chloride
  • cystadane
  • betaine HCl
A naturally occurring compound that has been of interest for its role in osmoregulation. As a drug, betaine hydrochloride has been used as a source of hydrochloric acid in the treatment of hypochlorhydria. Betaine has also been used in the treatment of liver disorders, for hyperkalemia, for homocystinuria, and for gastrointestinal disturbances. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1341)
  • Molecular weight: 117.15
  • Formula: C5H11NO2
  • CLOGP: -8.17
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 40.13
  • ALOGS: -1.96
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1 g O
6 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ
S (Water solubility) 1570 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Feb. 14, 2007 EMA Orphan Europe S.A.R.L.
Oct. 25, 1996 FDA RARE DIS THERAP

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
Hypermethioninaemia 81.92 28.90 9 386 51 63488576
Brain oedema 42.31 28.90 11 384 14184 63474443
Intracranial pressure increased 36.16 28.90 8 387 5219 63483408

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
Overdose 78.37 46.55 27 200 91032 34865672

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
Hypermethioninaemia 105.92 34.50 12 588 75 79743713
Overdose 86.99 34.50 37 563 184169 79559619
Intracranial pressure increased 51.25 34.50 12 588 8310 79735478
Brain oedema 46.54 34.50 14 586 25249 79718539
Treatment noncompliance 43.89 34.50 16 584 52252 79691536

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A09AB02 ALIMENTARY TRACT AND METABOLISM
DIGESTIVES, INCL. ENZYMES
DIGESTIVES, INCL. ENZYMES
Acid preparations
ATC A16AA06 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Amino acids and derivatives
MeSH PA D000963 Antimetabolites
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
MeSH PA D008082 Lipotropic Agents
FDA MoA N0000175804 Methylating Activity
FDA EPC N0000175805 Methylating Agent
CHEBI has role CHEBI:78675 fundamental metabolites

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

DiseaseRelationSNOMED_IDDOID
Homocystinuria indication 11282001 DOID:9263
Cystitis indication 38822007 DOID:1679
Klebsiella cystitis indication 60867007
Infective cystitis indication 236620008
Escherichia coli urinary tract infection indication 301011002
Bacterial urinary infection indication 312124009
Urinary tract infection caused by Klebsiella indication 369001000119100
E. Coli Pyelonephritis indication
Enterococcus Complicated UTI indication
Complicated Proteus UTI indication
Complicated UTI with Pseudomonas Aeruginosa indication
Cerebral edema contraindication 2032001
Achilles tendinitis contraindication 11654001
Lowered convulsive threshold contraindication 19260006
Short bowel syndrome contraindication 26629001 DOID:10605
Torsades de pointes contraindication 31722008
Transplantation of heart contraindication 32413006
Crohn's disease contraindication 34000006
Tendinitis contraindication 34840004 DOID:971
Hypermethioninemia contraindication 43123004
Hypokalemia contraindication 43339004
Transplant of kidney contraindication 70536003
Epilepsy contraindication 84757009 DOID:1826
Transplant of lung contraindication 88039007
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Prolonged QT interval contraindication 111975006
Gastrointestinal obstruction contraindication 126765001
Acute pancreatitis contraindication 197456007 DOID:2913
Meconium ileus contraindication 206523001
Peripheral nerve disease contraindication 302226006
Operation on gastrointestinal tract contraindication 386621005
Pseudomembranous enterocolitis contraindication 397683000
Traumatic rupture of tendon contraindication 415749005
Congenital long QT syndrome contraindication 442917000
Shoulder Tendonitis contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 1.89 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4019632 VUID
N0000147725 NUI
D03103 KEGG_DRUG
1512 RXNORM
C0005304 UMLSCUI
CHEBI:17750 CHEBI
BET PDB_CHEM_ID
CHEMBL95889 ChEMBL_ID
247 PUBCHEM_CID
DB06756 DRUGBANK_ID
CHEMBL1182 ChEMBL_ID
CHEMBL1201130 ChEMBL_ID
D001622 MESH_DESCRIPTOR_UI
4550 IUPHAR_LIGAND_ID
3SCV180C9W UNII
11810 MMSL
14793 MMSL
167417 MMSL
167421 MMSL
46863 MMSL
d04875 MMSL
391841000 SNOMEDCT_US
413645006 SNOMEDCT_US
43356007 SNOMEDCT_US
4018110 VANDF
4019632 VANDF
107-43-7 SECONDARY_CAS_RN
001115 NDDF
004543 NDDF
006281 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Betaine Human Prescription Drug Label 1 0713-0352 POWDER, FOR SOLUTION 1 g ORAL ANDA 23 sections
FACE IT HD PERFECT BB SPF30 PA 01 HUMAN OTC DRUG LABEL 5 51523-103 CREAM 2 mL TOPICAL OTC monograph not final 7 sections
FACE IT HD PERFECT BB SPF30 PA 02 HUMAN OTC DRUG LABEL 5 51523-104 CREAM 2 mL TOPICAL OTC monograph not final 7 sections
Cystadane HUMAN PRESCRIPTION DRUG LABEL 1 52276-400 POWDER, FOR SOLUTION 1 g ORAL NDA 16 sections
Cystadane HUMAN PRESCRIPTION DRUG LABEL 1 52276-400 POWDER, FOR SOLUTION 1 g ORAL NDA 16 sections
Cystadane HUMAN PRESCRIPTION DRUG LABEL 1 52276-401 POWDER, FOR SOLUTION 1 g ORAL Unapproved drug for use in drug shortage 3 sections
Betaine Anhydrous For Oral Solution HUMAN PRESCRIPTION DRUG LABEL 1 55792-002 POWDER, FOR SOLUTION 1 g ORAL ANDA 16 sections
EnBrace HR HUMAN PRESCRIPTION DRUG LABEL 16 64661-650 CAPSULE, DELAYED RELEASE PELLETS 500 ug ORAL UNAPPROVED DRUG OTHER 11 sections
EnBrace HR HUMAN PRESCRIPTION DRUG LABEL 16 64661-650 CAPSULE, DELAYED RELEASE PELLETS 500 ug ORAL UNAPPROVED DRUG OTHER 11 sections
EnBrace HR HUMAN PRESCRIPTION DRUG LABEL 16 64661-650 CAPSULE, DELAYED RELEASE PELLETS 500 ug ORAL UNAPPROVED DRUG OTHER 11 sections
EnLyte HUMAN PRESCRIPTION DRUG LABEL 18 64661-711 CAPSULE, DELAYED RELEASE PELLETS 500 ug ORAL unapproved drug other 12 sections
Cystadane HUMAN PRESCRIPTION DRUG LABEL 1 66621-4000 POWDER, FOR SOLUTION 6 g ORAL NDA 16 sections
ATONO2 Oxygen Baby HUMAN OTC DRUG LABEL 1 70993-0005 LOTION 0.20 g TOPICAL unapproved drug other 6 sections
Wizyoung Vitamin Collagen Essence Mask Pack HUMAN OTC DRUG LABEL 2 71102-100 PATCH 0.75 g TOPICAL unapproved drug other 8 sections
Wizyoung Diamond Collagen Essence Mask Pack HUMAN OTC DRUG LABEL 2 71102-101 PATCH 0.75 g TOPICAL unapproved drug other 8 sections
Betaine Anhydrous HUMAN PRESCRIPTION DRUG LABEL 1 71863-115 POWDER, FOR SOLUTION 1 g ORAL ANDA 15 sections
Betaine Anhydrous for Oral Solution HUMAN PRESCRIPTION DRUG LABEL 1 72647-900 FOR SOLUTION 1 g ORAL ANDA 24 sections
Betaine Anhydrous for Oral Solution HUMAN PRESCRIPTION DRUG LABEL 1 72647-900 FOR SOLUTION 1 g ORAL ANDA 24 sections
CELRAUM PHEROMONE FRAGRANCE LOVELY PERFUME HUMAN OTC DRUG LABEL 6 75368-040 SHAMPOO 1.50 g TOPICAL unapproved drug other 9 sections
HWASAMONG Dr.All Scalp HealingShampoo HUMAN OTC DRUG LABEL 2 76678-0001 SHAMPOO 0.50 g TOPICAL unapproved drug other 7 sections
Anubis Barcelona Total Hydrating HUMAN OTC DRUG LABEL 10 83021-692 LOTION 5 g TOPICAL OTC monograph final 9 sections
Anubis Barcelona Total Hydrating HUMAN OTC DRUG LABEL 10 83021-692 LOTION 5 g TOPICAL OTC monograph final 9 sections
Dr.Jucre Rebirth Activating Toner HUMAN OTC DRUG LABEL 1 83071-020 LIQUID 0.00 g TOPICAL unapproved drug other 10 sections