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

Stem definition	Drug id	CAS RN
anthelminthics, tiabendazole derivatives	103	54965-21-8

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.40	g	O

ADMET properties:

Property	Value	Reference
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 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	5 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
June 11, 1996	FDA	AMEDRA PHARMS

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
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 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
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:

Source	Code	Description
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)

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (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:

Target	Class	UniProt	Action	Bioact source	MoA source
Tubulin	Structural	C4PKY4_ECHGR C4PKZ2_ECHGR C4PKZ6_ECHGR	INHIBITOR	CHEMBL	CHEMBL
Tubulin	Structural	F1L005_ASCSU F1L4P8_ASCSU F1L5G6_ASCSU F1L7U3_ASCSU F1L7Y0_ASCSU F1L8A5_ASCSU F1LCS0_ASCSU	INHIBITOR	CHEMBL	CHEMBL
Tubulin alpha chain	Structural	TBA_HAECO		WOMBAT-PK

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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