albendazole 🐶 Veterinary Use | 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
S (Water solubility)	0.00 mg/mL	Bocci G, Oprea TI, Benet LZ

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
Catarrh	103.99	42.30	21	2234	1528	63485239
Steroid dependence	101.27	42.30	21	2234	1743	63485024
Burns second degree	98.87	42.30	21	2234	1957	63484810
Hypopnoea	85.19	42.30	21	2234	3785	63482982
Rhinitis	70.50	42.30	23	2232	11343	63475424
Gingival pain	69.32	42.30	21	2234	8141	63478626
Parosmia	65.98	42.30	19	2236	6187	63480580
Impaired quality of life	58.52	42.30	21	2234	13762	63473005
Cardiac murmur	57.41	42.30	21	2234	14531	63472236
Congenital absence of cranial vault	57.04	42.30	7	2248	14	63486753
Bronchiectasis	55.28	42.30	21	2234	16121	63470646
Tubulointerstitial nephritis	54.44	42.30	22	2233	19881	63466886
Impaired work ability	53.66	42.30	21	2234	17454	63469313
Nightmare	51.75	42.30	21	2234	19173	63467594
Accidental overdose	51.09	42.30	22	2233	23287	63463480
Frequent bowel movements	48.07	42.30	21	2234	23001	63463766

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
Steroid dependence	154.40	37.89	33	2591	1484	34952823
Bronchiectasis	89.65	37.89	32	2592	9769	34944538
Impaired work ability	80.29	37.89	27	2597	6903	34947404
Frequent bowel movements	77.86	37.89	31	2593	12756	34941551
Impaired quality of life	76.74	37.89	25	2599	5793	34948514
Medication error	57.33	37.89	31	2593	25534	34928773
Stress	55.01	37.89	32	2592	30315	34923992
Strongyloidiasis	49.75	37.89	15	2609	2696	34951611
Rectal haemorrhage	49.09	37.89	33	2591	40216	34914091
Burns second degree	47.55	37.89	12	2612	1117	34953190
Haematochezia	47.04	37.89	34	2590	46500	34907807
Haemosiderosis	44.78	37.89	9	2615	297	34954010
Catarrh	43.94	37.89	11	2613	991	34953316
Loss of personal independence in daily activities	42.37	37.89	28	2596	33151	34921156
Product use in unapproved indication	40.74	37.89	47	2577	117452	34836855
Conjunctival haemorrhage	39.75	37.89	13	2611	3042	34951265
Hypopnoea	39.15	37.89	12	2612	2277	34952030
Parosmia	38.47	37.89	12	2612	2413	34951894

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
Steroid dependence	223.13	31.55	47	4538	2583	79737220
Bronchiectasis	120.01	31.55	46	4539	22340	79717463
Burns second degree	113.24	31.55	27	4558	2601	79737202
Catarrh	112.93	31.55	26	4559	2152	79737651
Impaired quality of life	112.27	31.55	39	4546	14347	79725456
Frequent bowel movements	104.37	31.55	45	4540	29494	79710309
Impaired work ability	100.35	31.55	39	4546	19642	79720161
Hypopnoea	94.31	31.55	27	4558	5302	79734501
Parosmia	86.99	31.55	27	4558	6987	79732816
Gingival pain	80.38	31.55	27	4558	8971	79730832
Rhinitis	77.81	31.55	30	4555	14777	79725026
Rectal haemorrhage	73.85	31.55	49	4536	76251	79663552
Medication error	71.11	31.55	46	4539	68596	79671207
Cardiac murmur	68.94	31.55	28	4557	15796	79724007
Haematochezia	67.70	31.55	49	4536	87596	79652207
Stress	64.91	31.55	46	4539	79566	79660237
Strongyloidiasis	56.84	31.55	17	4568	3881	79735922
Nightmare	52.84	31.55	27	4558	25834	79713969
Product use in unapproved indication	52.29	31.55	68	4517	250291	79489512
Accidental overdose	49.73	31.55	30	4555	39551	79700252
Vertigo	49.66	31.55	37	4548	69045	79670758
Inappropriate schedule of product administration	47.81	31.55	48	4537	133580	79606223
Loss of personal independence in daily activities	46.49	31.55	42	4543	102538	79637265
Tinnitus	41.72	31.55	28	4557	44305	79695498
Eczema	41.37	31.55	27	4558	40791	79699012
Intentional product use issue	40.94	31.55	47	4538	152065	79587738
Tubulointerstitial nephritis	40.49	31.55	26	4559	38209	79701594
Swollen tongue	40.33	31.55	27	4558	42543	79697260
Dysgeusia	39.70	31.55	30	4555	57147	79682656
Deep vein thrombosis	38.83	31.55	41	4544	120878	79618925
Conjunctival haemorrhage	38.52	31.55	14	4571	5851	79733952
Drug ineffective	37.35	31.55	141	4444	1080772	78659031
Haemosiderosis	36.65	31.55	8	4577	519	79739284
Echinococciasis	35.39	31.55	5	4580	22	79739781
Condition aggravated	35.03	31.55	84	4501	501040	79238763
Off label use	31.81	31.55	119	4466	907096	78832707
Adverse drug reaction	31.68	31.55	28	4557	66364	79673439

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	P02CA03	ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS ANTHELMINTICS ANTINEMATODAL AGENTS Benzimidazole derivatives
FDA EPC	N0000175481	Anthelmintic
FDA MoA	N0000191624	Cytochrome P450 1A Inducers
CHEBI has role	CHEBI:35443	anthelmintics
CHEBI has role	CHEBI:60832	tubulin modulators
CHEBI has role	CHEBI:61951	microtubule destabilizing role
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

Drug Use | Suggest Off label Use Form| |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

🐶 Veterinary Drug Use

Species	Use	Relation
Cattle	Removal of adult liver flukes, Fasciola hepatica	Indication
Cattle	Removal of heads and segments of tapeworms, Moniezia benedeni	Indication
Cattle	Removal of brown stomach worms, Ostertagia ostertagi (adult and 4th stage larvae)	Indication
Cattle	Removal of barberpole worms, Haemonchus contortus	Indication
Cattle	Removal of small stomach worms, Trichostrongylus axei	Indication
Cattle	Removal of thread-necked intestinal worms, Nematodirus spathiger (adult and 4th stage larvae)	Indication
Cattle	Removal of small intestinal worms, Cooperia punctata	Indication
Cattle	Removal of hookworms, Bunostomum phlebotomum (adult)	Indication
Cattle	Removal of bankrupt worms, Trichostrongylus colubriformis	Indication
Cattle	Removal of nodular worms, Oesophagostomum radiatum	Indication
Cattle	Removal of lungworms, Dictyocaulus viviparus (adult and 4th stage larvae)	Indication
Cattle	Removal of thread-necked intestinal worms, N helvetianus (adult and 4th stage larvae)	Indication
Cattle	Removal of small intestinal worms, C oncophora	Indication
Cattle	Removal of heads and segments of tapeworms, M expansa	Indication
Cattle	Removal of barberpole worms, H placei	Indication
Goats	Treatment of adult liver flukes (Fasciola hepatica)	Indication
Sheep	Removal of adult liver flukes, Fasciola hepatica	Indication
Sheep	Removal of heads and segments of common tapeworms, Moniezia expansa	Indication
Sheep	Removal of fringed tapeworms, Thysanosoma actinoides	Indication
Sheep	Removal of brown stomach worms, Ostertagia circumcincta (adult and fourth stage larvae)	Indication
Sheep	Removal of barberpole worms, Haemonchus contortus	Indication
Sheep	Removal of small stomach worms, Trichostrongylus axei	Indication
Sheep	Removal of thread-necked intestinal worms, Nematodirus spathiger (adult and fourth stage larvae)	Indication
Sheep	Removal of Coopers worms, Cooperia oncophora	Indication
Sheep	Removal of bankrupt worms, Trichostrongylus colubriformis	Indication
Sheep	Removal of nodular worms, Oesophagostomum columbianum	Indication
Sheep	Removal of large-mouth bowel worm, Chabertia ovina	Indication
Sheep	Removal of lungworms, Dictyocaulus filaria (adult and larval stages)	Indication
Sheep	Removal of adult liver flukes, Fascioloides magna	Indication
Sheep	Removal of thread-necked intestinal worms, N filicollis	Indication
Sheep	Removal of brown stomach worms, Marshallagia marshalli	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Valbazen	Zoetis Inc.	1
Valbazen	Zoetis Inc.	1
Valbazen	Zoetis Inc.	1

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

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	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	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	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
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
Albendazole200 mg	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1221	TABLET, FILM COATED	200 mg	ORAL	ANDA	21 sections
Albendazole200 mg	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1221	TABLET, FILM COATED	200 mg	ORAL	ANDA	21 sections
Albendazole200 mg	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1221	TABLET, FILM COATED	200 mg	ORAL	ANDA	21 sections
Albendazole200 mg	HUMAN PRESCRIPTION DRUG LABEL	1	63629-9278	TABLET, FILM COATED	200 mg	ORAL	ANDA	21 sections
Albendazole200 mg	HUMAN PRESCRIPTION DRUG LABEL	1	63629-9278	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
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	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	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	70771-1103	TABLET, FILM COATED	200 mg	ORAL	ANDA	1 sections
Albendazole200 mg	HUMAN PRESCRIPTION DRUG LABEL	1	72162-1309	TABLET, FILM COATED	200 mg	ORAL	ANDA	21 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