albendazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.385 High 0.83
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.764 High 0.83
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 74.473 10^-6 cm/s High 0.83
dh-clint Dog hepatocyte intrinsic clearance 28.642 uL/min/10^6 cells High 0.83
dppb Dog plasma protein binding (% unbound) 5.720 % High 0.83
fcs-ppb Fetal calf serum protein binding (% unbound) 14.750 % High 0.83
herg hERG pIC50 4.731 pIC50 High 0.83
hh-clint Human hepatocyte intrinsic clearance 14.997 uL/min/10^6 cells High 0.83
hlm-clint Human liver microsomal intrinsic clearance 71.614 uL/min/mg protein High 0.83
hppb Human plasma protein binding (% unbound) 4.590 % High 0.83
kinase-safety-class ACVR2A,ACVR2B,ALK,AURKA,AURKB,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK5,CDK9,CSF1R,DDR1,DYRK1B,EIF2AK3,ERBB2,FLT3,GRK2,GSK3B,IRAK1,ITK,JAK1,JAK2,KIT,MAP3K1,MAP3K10,MAP3K11,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK10,MAPK7,MARK4,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ULK2 57
kinase-selectivity-class ACVR2A,ACVR2B,AURKA,AXL,BRAF,CAMK2D,CDK1,CDK9,CSF1R,DDR1,DYRK1B,FLT3,GRK2,IRAK1,JAK1,MAP2K6,MAP3K1,MAP3K21,MAP4K1,MAPK7,MARK4,PDK1,PDK4,PRKDC,SIK2,SIK3,STK33,ULK1 28
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.067 High 0.83
mh-clint Mouse hepatocyte intrinsic clearance 101.391 High 0.83
mppb Mouse plasma protein binding (% unbound) 6 High 0.83
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.944 High 0.83
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 11.810 % High 0.83
rh-clint Rat hepatocyte intrinsic clearance 56.364 uL/min/10^6 cells High 0.83
rh-fuinc Rat hepatocyte fraction unbound in incubation 48.450 % High 0.83
rppb Rat plasma protein binding (% unbound) 4.060 % High 0.83
solubility-dd Solubility at pH 7.4 in DMSO 8.892 uM High 0.83

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
Catarrh 108.35 40.82 21 2456 1613 90624357
Burns second degree 104.33 40.82 21 2456 1959 90624011
Steroid dependence 101.47 40.82 21 2456 2248 90623722
Hypopnoea 87.48 40.82 21 2456 4410 90621560
Rhinitis 72.40 40.82 23 2454 13549 90612421
Gingival pain 71.27 40.82 21 2456 9631 90616339
Parosmia 68.45 40.82 19 2458 7050 90618920
Congenital absence of cranial vault 58.87 40.82 7 2470 14 90625956
Cardiac murmur 58.19 40.82 21 2456 18173 90607797
Impaired work ability 56.95 40.82 21 2456 19305 90606665
Tubulointerstitial nephritis 54.87 40.82 22 2455 25321 90600649
Nightmare 54.56 40.82 21 2456 21704 90604266
Bronchiectasis 54.00 40.82 21 2456 22309 90603661
Impaired quality of life 53.27 40.82 21 2456 23123 90602847
Accidental overdose 52.54 40.82 22 2455 28251 90597719
Tinnitus 43.66 40.82 22 2455 43080 90582890
Neural tube defect 42.83 40.82 7 2470 201 90625769

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
Steroid dependence 301.28 53.60 85 5746 6637 42608867
Burns second degree 232.49 53.60 68 5763 6028 42609476
Catarrh 229.29 53.60 67 5764 5919 42609585
Hypopnoea 215.26 53.60 68 5763 7814 42607690
Parosmia 212.73 53.60 67 5764 7624 42607880
Bronchiectasis 211.90 53.60 83 5748 17936 42597568
Gingival pain 210.26 53.60 68 5763 8426 42607078
Impaired work ability 209.36 53.60 74 5757 12017 42603487
Systemic lupus erythematosus 208.03 53.60 69 5762 9255 42606249
Frequent bowel movements 198.06 53.60 83 5748 21324 42594180
Rhinitis 191.11 53.60 69 5762 11908 42603596
Cardiac murmur 186.77 53.60 69 5762 12706 42602798
Impaired quality of life 172.63 53.60 67 5764 14110 42601394
Medication error 154.63 53.60 80 5751 33074 42582430
Swollen tongue 146.53 53.60 67 5764 21164 42594340
Stress 140.94 53.60 83 5748 44129 42571375
Nightmare 139.06 53.60 68 5763 24944 42590560
Migraine 138.03 53.60 68 5763 25346 42590158
Vertigo 137.89 53.60 75 5756 34272 42581232
Alcohol poisoning 137.34 53.60 48 5783 7526 42607978
Rectal haemorrhage 137.17 53.60 85 5746 49521 42565983
Tinnitus 132.53 53.60 69 5762 28869 42586635
Accidental overdose 131.03 53.60 68 5763 28262 42587242
Haematochezia 126.82 53.60 86 5745 58350 42557154
Dysgeusia 124.45 53.60 70 5761 34119 42581385
Eczema 121.93 53.60 69 5762 34017 42581487
Loss of personal independence in daily activities 119.38 53.60 78 5753 49738 42565766
Tubulointerstitial nephritis 115.92 53.60 65 5766 31483 42584021
Adverse drug reaction 108.15 53.60 66 5765 37368 42578136
Arthritis 106.01 53.60 68 5763 41997 42573507
Palpitations 103.65 53.60 72 5759 50725 42564779
Intentional product use issue 98 53.60 80 5751 71753 42543751
Product use in unapproved indication 91.55 53.60 119 5712 184337 42431167
Inappropriate schedule of product administration 81.80 53.60 82 5749 95820 42519684
Deep vein thrombosis 79.22 53.60 73 5758 76884 42538620
Abdominal discomfort 76.71 53.60 71 5760 75184 42540320
Haemosiderosis 71.66 53.60 15 5816 326 42615178
Somnolence 68.29 53.60 90 5741 141015 42474489
Strongyloidiasis 63.15 53.60 22 5809 3409 42612095

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
Steroid dependence 414.95 39.12 101 7971 8368 110572859
Burns second degree 337.23 39.12 84 7988 7649 110573578
Catarrh 336.58 39.12 83 7989 7252 110573975
Hypopnoea 305.04 39.12 84 7988 11296 110569931
Parosmia 288.36 39.12 83 7989 13097 110568130
Gingival pain 278.13 39.12 84 7988 15652 110565575
Bronchiectasis 262.17 39.12 99 7973 36394 110544833
Rhinitis 256.33 39.12 86 7986 22459 110558768
Impaired work ability 246.78 39.12 87 7985 26332 110554895
Cardiac murmur 245.00 39.12 85 7987 24543 110556684
Impaired quality of life 217.62 39.12 82 7990 29935 110551292
Nightmare 203.86 39.12 84 7988 38779 110542448
Frequent bowel movements 198.25 39.12 99 7973 71291 110509936
Accidental overdose 183.72 39.12 85 7987 51749 110529478
Tinnitus 171.15 39.12 85 7987 60455 110520772
Tubulointerstitial nephritis 170.79 39.12 82 7990 54202 110527025
Alcohol poisoning 167.31 39.12 50 8022 8970 110572257
Swollen tongue 165.47 39.12 83 7989 60279 110520948
Haematochezia 163.76 39.12 103 7969 115421 110465806
Vertigo 163.57 39.12 93 7979 86777 110494450
Dysgeusia 162.34 39.12 86 7986 69899 110511328
Stress 162.18 39.12 99 7973 105249 110475978
Rectal haemorrhage 160.30 39.12 103 7969 119730 110461497
Medication error 157.05 39.12 97 7975 105269 110475958
Eczema 156.92 39.12 85 7987 72208 110509019
Product use in unapproved indication 119.99 39.12 155 7917 447222 110134005
Adverse drug reaction 119.97 39.12 82 7990 105477 110475750
Loss of personal independence in daily activities 117.32 39.12 93 7979 149927 110431300
Palpitations 114.55 39.12 94 7978 159118 110422109
Deep vein thrombosis 109.97 39.12 87 7985 139800 110441427
Inappropriate schedule of product administration 109.79 39.12 102 7970 203535 110377692
Arthritis 92.34 39.12 85 7987 167501 110413726
Migraine 88.68 39.12 84 7988 171568 110409659
Cerebrovascular accident 88.53 39.12 86 7986 181198 110400029
Intentional product use issue 86.05 39.12 98 7974 247808 110333419
Haemosiderosis 78.90 39.12 16 8056 568 110580659
Strongyloidiasis 76.93 39.12 24 8048 4962 110576265
Pulmonary embolism 69.72 39.12 82 7990 214392 110366835
COVID-19 68.80 39.12 87 7985 244973 110336254
Somnolence 68.76 39.12 96 7976 297353 110283874
Systemic lupus erythematosus 63.16 39.12 85 7987 254253 110326974
Condition aggravated 59.52 39.12 151 7921 734685 109846542
Drug ineffective 58.72 39.12 242 7830 1520298 109060929
Iron overload 58.16 39.12 16 8056 2135 110579092
Disseminated strongyloidiasis 55.23 39.12 12 8060 597 110580630
Weight decreased 54.33 39.12 111 7961 467946 110113281
Vanishing bile duct syndrome 52.04 39.12 16 8056 3152 110578075
Depression 51.55 39.12 87 7985 317248 110263979
Enterococcal sepsis 51.34 39.12 16 8056 3296 110577931
Hepatitis toxic 49.58 39.12 18 8054 5903 110575324
Hepatorenal syndrome 46.18 39.12 16 8056 4581 110576646
Abdominal discomfort 44.01 39.12 92 7980 393766 110187461
Pyrexia 42.70 39.12 153 7919 898112 109683115
Dyspnoea 40.80 39.12 15 8057 1106857 109474370

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC P02CA03 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ANTHELMINTICS
ANTINEMATODAL AGENTS
Benzimidazole derivatives
ATC P02CA53 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 D000977 Antiparasitic Agents
MeSH PA D000980 Antiplatyhelmintic Agents
MeSH PA D000981 Antiprotozoal Agents
MeSH PA D050256 Antimitotic Agents
MeSH PA D050257 Tubulin Modulators
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35443 anthelminthic drug
CHEBI has role CHEBI:38068 antimalarial
CHEBI has role CHEBI:55324 gastrointestinal drug
CHEBI has role CHEBI:60832 tubulin modulator
CHEBI has role CHEBI:61951 microtubule-destabilising agent
CHEBI has role CHEBI:64946 anti-HIV agent
FDA MoA N0000191624 Cytochrome P450 1A Inducers

Related Drugs by ATC class:

P02CA Benzimidazole derivatives 6 drugs
ciclobendazolefenbendazoleflubendazoleivermectinmebendazolethiabendazole

Drug Use | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

SpeciesUseRelation
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

ProductApplicantIngredients
Valbazen Zoetis Inc. 1
Valbazen Zoetis Inc. 1
Valbazen Zoetis Inc. 1

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
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
4141 MMSL
5968 MMSL
72826 MMSL
d03806 MMSL
4020995 VANDF
004079 NDDF
387558006 SNOMEDCT_US
96119002 SNOMEDCT_US

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
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 46708-681 TABLET, FILM COATED 200 mg ORAL ANDA 24 sections
Albendazole HUMAN PRESCRIPTION DRUG LABEL 1 51407-258 TABLET 200 mg ORAL ANDA 24 sections
Albendazole Human Prescription Drug Label 1 62332-681 TABLET, FILM COATED 200 mg ORAL ANDA 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 72162-2359 TABLET 200 mg ORAL ANDA 23 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