albendazole Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
anthelminthics, tiabendazole derivatives 103 54965-21-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • albendazole
  • albamelin
  • albendol
  • albenza
A benzimidazole broad-spectrum anthelmintic structurally related to MEBENDAZOLE that is effective against many diseases. (From Martindale, The Extra Pharmacopoeia, 30th ed, p38)
  • Molecular weight: 265.33
  • Formula: C12H15N3O2S
  • CLOGP: 3.46
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 67.01
  • ALOGS: -4.07
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.40 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 56.53 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 5 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
June 11, 1996 FDA AMEDRA PHARMS

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
Strongyloidiasis 60.52 39.00 11 887 854 46684310
Congenital absence of cranial vault 57.77 39.00 7 891 28 46685136
Neural tube defect 45.58 39.00 7 891 193 46684971

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
Strongyloidiasis 152.11 35.60 32 1284 2314 29948848
Conjunctival haemorrhage 48.24 35.60 13 1303 2687 29948475
Gastritis 40.23 35.60 19 1297 20179 29930983

Pharmacologic Action:

SourceCodeDescription
ATC P02CA03 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ANTHELMINTICS
ANTINEMATODAL AGENTS
Benzimidazole derivatives
FDA EPC N0000175481 Anthelmintic
MeSH PA D000871 Anthelmintics
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000923 Anticestodal Agents
MeSH PA D050256 Antimitotic Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000980 Antiplatyhelmintic Agents
MeSH PA D000981 Antiprotozoal Agents
MeSH PA D050257 Tubulin Modulators
CHEBI has role CHEBI:35443 anthelminthic
CHEBI has role CHEBI:60832 tubulin modulators
CHEBI has role CHEBI:61951 microtubule destabilising role
FDA MoA N0000191624 Cytochrome P450 1A Inducers

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Echinococcus granulosus infection of liver indication 20790006
Echinococcus granulosus infection indication 75006000 DOID:1495
Echinococcus granulosus infection of lung indication 75388006
Cerebral cysticercosis indication 230215006
Echinococcus Granulosus Infection of the Peritoneum indication
Immunosuppression contraindication 38013005
Pancytopenia contraindication 127034005 DOID:12450
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Neutropenic disorder contraindication 303011007 DOID:1227
Aplastic anemia contraindication 306058006 DOID:12449

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.03 acidic
pKa2 4.04 Basic

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
Tubulin Structural INHIBITOR CHEMBL CHEMBL
Tubulin Structural INHIBITOR CHEMBL CHEMBL
Tubulin alpha chain Structural WOMBAT-PK

External reference:

IDSource
F4216019LN UNII
4020995 VUID
N0000148464 NUI
D00134 KEGG_DRUG
C0001911 UMLSCUI
CHEBI:16664 CHEBI
CHEMBL1483 ChEMBL_ID
DB00518 DRUGBANK_ID
D015766 MESH_DESCRIPTOR_UI
2082 PUBCHEM_CID
3967 INN_ID
151717 RXNORM
4141 MMSL
5968 MMSL
72826 MMSL
d03806 MMSL
004079 NDDF
387558006 SNOMEDCT_US
96119002 SNOMEDCT_US
4020995 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Albendazole HUMAN PRESCRIPTION DRUG LABEL 1 0115-1701 TABLET, FILM COATED 200 mg ORAL NDA 25 sections
Albendazole HUMAN PRESCRIPTION DRUG LABEL 1 0591-2712 TABLET, FILM COATED 200 mg ORAL ANDA 23 sections
Albendazole HUMAN PRESCRIPTION DRUG LABEL 1 16714-907 TABLET, FILM COATED 200 mg ORAL ANDA 25 sections
Albendazole200 mg HUMAN PRESCRIPTION DRUG LABEL 1 31722-935 TABLET, FILM COATED 200 mg ORAL ANDA 21 sections
Albendazole200 mg HUMAN PRESCRIPTION DRUG LABEL 1 42291-093 TABLET, FILM COATED 200 mg ORAL ANDA 21 sections
Albendazole Human Prescription Drug Label 1 42799-110 TABLET 200 mg ORAL ANDA 24 sections
Albendazole HUMAN PRESCRIPTION DRUG LABEL 1 43598-452 TABLET, FILM COATED 200 mg ORAL ANDA 23 sections
Albendazole HUMAN PRESCRIPTION DRUG LABEL 1 51407-258 TABLET 200 mg ORAL ANDA 24 sections
Albendazole HUMAN PRESCRIPTION DRUG LABEL 1 54505-055 TABLET, FILM COATED 200 mg ORAL NDA 23 sections
Albendazole200 mg HUMAN PRESCRIPTION DRUG LABEL 1 63629-1221 TABLET, FILM COATED 200 mg ORAL ANDA 21 sections
ALBENZA HUMAN PRESCRIPTION DRUG LABEL 1 64896-693 TABLET, FILM COATED 200 mg ORAL NDA 24 sections
ALBENDAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 69097-237 TABLET 200 mg ORAL ANDA 21 sections
Albendazole Human Prescription Drug Label 1 69539-151 TABLET 200 mg ORAL ANDA 23 sections
Albendazole HUMAN PRESCRIPTION DRUG LABEL 1 70710-1021 TABLET, FILM COATED 200 mg ORAL ANDA 25 sections
Albendazole HUMAN PRESCRIPTION DRUG LABEL 1 70771-1103 TABLET, FILM COATED 200 mg ORAL ANDA 1 sections
Albendazole Human Prescription Drug Label 1 72205-051 TABLET 200 mg ORAL ANDA 23 sections
ZENTEL HUMAN OTC DRUG LABEL 1 72689-0036 TABLET 400 mg ORAL unapproved drug other 7 sections
ALBENZA HUMAN PRESCRIPTION DRUG LABEL 1 76413-145 TABLET, FILM COATED 200 mg ORAL NDA 25 sections
Albendazole Human Prescription Drug Label 1 78482-110 TABLET 200 mg ORAL ANDA 22 sections