albendazole ๐Ÿถ Veterinary Use | 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 ยตM/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:

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 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 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 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 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 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:

SourceCodeDescription
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|

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




๐Ÿถ 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

๐Ÿถ 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
387558006 SNOMEDCT_US
96119002 SNOMEDCT_US
4020995 VANDF
4141 MMSL
5968 MMSL
72826 MMSL
d03806 MMSL
004079 NDDF

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 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