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betaine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 347 | 590-46-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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)
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 1 | g | O |
| 6 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,ITK,JAK1,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIK3CG,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70 | 58 | |||
| kinase-selectivity-class | ACVR2B,AXL,BRAF,CAMK2D,CDK4,DDR1,DYRK1B,EPHB4,FLT3,GRK2,MAPK7,STK33,TTK | 13 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 25, 1996 | FDA | RARE DIS THERAP | |
| Feb. 14, 2007 | EMA | Orphan Europe S.A.R.L. |
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 |
|---|---|---|---|---|---|---|
| Hypermethioninaemia | 83.09 | 30.11 | 9 | 485 | 51 | 90627902 |
| Brain oedema | 41.51 | 30.11 | 11 | 483 | 17374 | 90610579 |
| Intracranial pressure increased | 35.09 | 30.11 | 8 | 486 | 6803 | 90621150 |
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 |
|---|---|---|---|---|---|---|
| Overdose | 73.14 | 44.86 | 27 | 261 | 105237 | 42515810 |
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 |
|---|---|---|---|---|---|---|
| Hypermethioninaemia | 107.76 | 34.79 | 12 | 709 | 74 | 110588504 |
| Overdose | 83.42 | 34.79 | 37 | 684 | 233757 | 110354821 |
| Intracranial pressure increased | 50.13 | 34.79 | 12 | 709 | 10523 | 110578055 |
| Treatment noncompliance | 48.09 | 34.79 | 18 | 703 | 72972 | 110515606 |
| Brain oedema | 45.62 | 34.79 | 14 | 707 | 31084 | 110557494 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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 | D000960 | Hypolipidemic Agents |
| MeSH PA | D000963 | Antimetabolites |
| MeSH PA | D005765 | Gastrointestinal Agents |
| MeSH PA | D008082 | Lipotropic Agents |
| MeSH PA | D057847 | Lipid Regulating Agents |
| FDA MoA | N0000175804 | Methylating Activity |
| FDA EPC | N0000175805 | Methylating Agent |
| CHEBI has role | CHEBI:78675 | fundamental metabolite |
Related Drugs by ATC class:
A09AB Acid preparations 3 drugs
A16AA Amino acids and derivatives 6 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (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:
| ID | Source |
|---|---|
| 4019632 | VUID |
| N0000147725 | NUI |
| D03103 | KEGG_DRUG |
| 1512 | RXNORM |
| C0005304 | UMLSCUI |
| CHEBI:17750 | CHEBI |
| 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 |
| BET | PDB_CHEM_ID |
| 107-43-7 | SECONDARY_CAS_RN |
| 4018110 | VANDF |
| 4019632 | VANDF |
| 001115 | NDDF |
| 004543 | NDDF |
| 006281 | NDDF |
| 391841000 | SNOMEDCT_US |
| 413645006 | SNOMEDCT_US |
| 43356007 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 | 52276-401 | 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 |
| PaxLyte | HUMAN PRESCRIPTION DRUG LABEL | 18 | 64661-217 | CAPSULE | 500 mg | ORAL | unapproved drug other | 9 sections |
| EnBrace HR | HUMAN PRESCRIPTION DRUG LABEL | 16 | 64661-650 | CAPSULE, DELAYED RELEASE PELLETS | 500 ug | ORAL | UNAPPROVED DRUG OTHER | 11 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 | 16 sections |
| Betaine Anhydrous | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71863-115 | POWDER, FOR SOLUTION | 1 g | ORAL | ANDA | 16 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 |
| Dr.Jucre Rebirth Activating Toner | HUMAN OTC DRUG LABEL | 1 | 83071-020 | LIQUID | 0.00 g | TOPICAL | unapproved drug other | 10 sections |
| YVTYVT MICRODERMABRASION FACIAL SCRUB | HUMAN OTC DRUG LABEL | 4 | 85212-0018 | OINTMENT | 2 g | EXTRACORPOREAL | OTC Monograph Drug | 8 sections |
| YVTYVT COPPER PEPTIDES FACIAL SERUM | HUMAN OTC DRUG LABEL | 4 | 85212-0020 | CREAM | 5 g | EXTRACORPOREAL | OTC Monograph Drug | 10 sections |
| Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g) | HUMAN OTC DRUG LABEL | 12 | 85514-7538 | CREAM | 1 g | TOPICAL | unapproved drug other | 9 sections |