benzonatate ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
326 104-31-4

Description:

MoleculeDescription

Synonyms:

  • tessalon
  • benzonatate
  • benzononantin
  • benzononatine
  • Molecular weight:
  • Formula: C12H17NO2(C2H4O)7-9
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.60 g O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 14.20 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Hosey CM, Chan R, Benet LZ
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Feb. 10, 1958 FDA PFIZER

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
Pneumonia 179.69 13.32 400 17797 456367 63014458
Bronchitis 134.24 13.32 172 18025 124763 63346062
COVID-19 88.87 13.32 134 18063 112969 63357856
Cough 81.40 13.32 225 17972 292518 63178307
Drug ineffective 77.29 13.32 113 18084 1044652 62426173
Upper respiratory tract infection 74.31 13.32 104 18093 81943 63388882
Completed suicide 70.19 13.32 139 18058 145534 63325291
Product dose omission issue 67.98 13.32 183 18014 234130 63236695
Dyspnoea 49.44 13.32 341 17856 660972 62809853
Asthma 46.77 13.32 109 18088 127452 63343373
Hypoxia 45.72 13.32 70 18127 59722 63411103
Maternal exposure during pregnancy 45.49 13.32 5 18192 220057 63250768
Influenza 44.43 13.32 97 18100 108625 63362200
Chronic obstructive pulmonary disease 43.24 13.32 70 18127 62616 63408209
Death 40.65 13.32 213 17984 374168 63096657
Synovitis 39.26 13.32 4 18193 186914 63283911
Angiokeratoma 39.14 13.32 9 18188 141 63470684
Cardiac arrest 37.16 13.32 82 18115 92463 63378362
Glossodynia 37.13 13.32 4 18193 178872 63291953
Systemic lupus erythematosus 35.85 13.32 8 18189 208910 63261915
Treatment failure 35.43 13.32 7 18190 199036 63271789
Therapy interrupted 32.16 13.32 43 18154 32412 63438413
Drug intolerance 28.36 13.32 28 18169 308633 63162192
Wound 26.54 13.32 7 18190 163256 63307569
Hospitalisation 26.17 13.32 68 18129 85013 63385812
Acute respiratory failure 25.83 13.32 40 18157 34445 63436380
Joint swelling 25.47 13.32 34 18163 327632 63143193
Therapeutic product effect decreased 25.07 13.32 12 18185 193175 63277650
Pericarditis 24.77 13.32 4 18193 131575 63339250
Rheumatoid arthritis 24.51 13.32 22 18175 253797 63217028
COVID-19 pneumonia 24.45 13.32 25 18172 14184 63456641
Off label use 24.44 13.32 105 18092 674357 62796468
Drug interaction 23.17 13.32 19 18178 229112 63241713
Exposure during pregnancy 22.88 13.32 8 18189 155539 63315286
Seasonal allergy 22.69 13.32 29 18168 20921 63449904
White blood cell count decreased 22.41 13.32 89 18108 139015 63331810
Arthropathy 21.90 13.32 21 18176 234771 63236054
Respiratory arrest 21.88 13.32 36 18161 32609 63438216
Viral infection 20.84 13.32 37 18160 35626 63435199
Pulmonary embolism 20.71 13.32 77 18120 116607 63354218
Hepatic enzyme increased 20.18 13.32 17 18180 202311 63268514
Impaired quality of life 19.74 13.32 22 18175 13761 63457064
Infusion related reaction 19.56 13.32 25 18172 245496 63225329
General physical health deterioration 18.79 13.32 18 18179 201384 63269441
Respiratory tract infection 18.06 13.32 38 18159 41445 63429380
Illness 18.04 13.32 42 18155 49017 63421808
Productive cough 17.90 13.32 49 18148 63159 63407666
C-reactive protein increased 17.55 13.32 3 18194 94704 63376121
Lower respiratory tract infection 17.50 13.32 8 18189 132299 63338526
Haemoptysis 17.04 13.32 30 18167 28696 63442129
Blister 16.93 13.32 8 18189 129806 63341019
Full blood count decreased 16.51 13.32 28 18169 25996 63444829
Multiple allergies 16.37 13.32 20 18177 13782 63457043
Drug hypersensitivity 15.83 13.32 147 18050 310540 63160285
Pneumothorax 15.28 13.32 21 18176 16240 63454585
Swelling 14.72 13.32 36 18161 275342 63195483
Fatigue 14.68 13.32 345 17852 887683 62583142
Palmar erythema 14.59 13.32 8 18189 1759 63469066
Therapy cessation 14.56 13.32 29 18168 30428 63440397
Pulse absent 14.18 13.32 12 18185 5362 63465463
Infusion site erythema 13.98 13.32 17 18180 11662 63459163
Sinusitis 13.49 13.32 111 18086 226542 63244283

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
Pneumonia 134.57 17.23 266 7499 362361 34586805
Death 67.33 17.23 217 7548 397832 34551334
Cough 50.27 17.23 106 7659 150034 34799132
Bronchitis 48.56 17.23 53 7712 41910 34907256
Therapy interrupted 28.64 17.23 24 7741 13673 34935493
Hypoxia 25.90 17.23 45 7720 55050 34894116
Dyspnoea 25.17 17.23 156 7609 376626 34572540
Fatigue 25.10 17.23 154 7611 370499 34578667
Acute respiratory failure 24.15 17.23 32 7733 30896 34918270
Pneumonitis 21.88 17.23 32 7733 33846 34915320
COVID-19 21.66 17.23 51 7714 77499 34871667
Product dose omission issue 21.61 17.23 67 7698 119644 34829522
Respiratory failure 20.75 17.23 62 7703 108510 34840656
Non-small cell lung cancer 20.30 17.23 12 7753 3928 34945238
Liver function test increased 19.69 17.23 20 7745 14545 34934621
Drug ineffective 17.72 17.23 48 7717 456703 34492463

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
Pneumonia 231.39 13.27 522 20317 659724 79063825
Bronchitis 114.00 13.27 155 20684 130489 79593060
Death 84.18 13.27 331 20508 566183 79157366
Cough 75.71 13.27 239 20600 366550 79356999
COVID-19 72.68 13.27 140 20699 157534 79566015
Hypoxia 68.94 13.27 108 20731 103135 79620414
Completed suicide 63.94 13.27 174 20665 245593 79477956
Product dose omission issue 62.16 13.27 173 20666 247364 79476185
Drug ineffective 62.12 13.27 118 20721 1080795 78642754
Dyspnoea 57.30 13.27 401 20438 856624 78866925
Acute respiratory failure 50.90 13.27 70 20769 59471 79664078
Chronic obstructive pulmonary disease 47.10 13.27 82 20757 85337 79638212
Upper respiratory tract infection 42.03 13.27 81 20758 91087 79632462
Influenza 39.03 13.27 97 20742 129509 79594040
Hypervolaemia 36.20 13.27 50 20789 42640 79680909
Angiokeratoma 35.87 13.27 9 20830 228 79723321
Cardiac arrest 34.36 13.27 111 20728 171985 79551564
Pulmonary embolism 32.73 13.27 109 20730 171545 79552004
Pneumonitis 31.70 13.27 57 20782 60803 79662746
Off label use 29.85 13.27 129 20710 907086 78816463
Synovitis 28.70 13.27 3 20836 150731 79572818
Therapy interrupted 28.53 13.27 38 20801 31303 79692246
Respiratory failure 27.76 13.27 107 20732 180804 79542745
Therapy cessation 27.45 13.27 41 20798 37521 79686028
COVID-19 pneumonia 26.29 13.27 35 20804 28814 79694735
Drug intolerance 25.57 13.27 19 20820 264100 79459449
Productive cough 25.42 13.27 65 20774 88266 79635283
Maternal exposure during pregnancy 25.28 13.27 3 20836 136535 79587014
Fatigue 24.45 13.27 359 20480 929368 78794181
General physical health deterioration 23.93 13.27 22 20817 275216 79448333
Haemoptysis 23.68 13.27 48 20791 55951 79667598
Treatment failure 22.85 13.27 8 20831 170478 79553071
Hospice care 22.77 13.27 20 20819 10304 79713245
Therapeutic product effect decreased 21.43 13.27 8 20831 163855 79559694
Asthma 20.80 13.27 80 20759 135015 79588534
Joint swelling 19.74 13.27 28 20811 288618 79434931
Drug interaction 18.33 13.27 52 20787 415131 79308418
Hospitalisation 18.09 13.27 60 20779 94176 79629373
Pulmonary arterial hypertension 17.98 13.27 29 20810 28337 79695212
Rheumatoid arthritis 17.71 13.27 17 20822 208453 79515096
Pericarditis 17.64 13.27 3 20836 104233 79619316
Non-small cell lung cancer 17.50 13.27 14 20825 6346 79717203
Lower respiratory tract infection 17.42 13.27 6 20833 129214 79594335
Infusion related reaction 17.10 13.27 21 20818 230216 79493333
Pleural effusion 16.90 13.27 79 20760 145183 79578366
Sarcomatoid carcinoma of the lung 15.52 13.27 3 20836 21 79723528
Glossodynia 15.38 13.27 4 20835 103333 79620216
Pneumothorax 15.35 13.27 27 20812 28296 79695253
Drug hypersensitivity 14.91 13.27 131 20708 298785 79424764
Exposure during pregnancy 14.89 13.27 4 20835 101128 79622421
Non-cardiac chest pain 14.44 13.27 15 20824 9509 79714040
Respiratory arrest 14.18 13.27 40 20799 57510 79666039
Systemic lupus erythematosus 14.11 13.27 7 20832 121142 79602407
Atrial fibrillation 13.93 13.27 94 20745 197792 79525757
Pulse absent 13.70 13.27 15 20824 10088 79713461
Rhabdomyolysis 13.54 13.27 5 20834 103126 79620423
Failure to thrive 13.38 13.27 16 20823 11828 79711721

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R05DB01 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
Other cough suppressants
FDA PE N0000009010 Decreased Tracheobronchial Stretch Receptor Activity
CHEBI has role CHEBI:38867 anaesthetic
CHEBI has role CHEBI:51177 anti-tussive
MeSH PA D000996 Antitussive Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D019141 Respiratory System Agents
FDA EPC N0000175796 Non-narcotic Antitussive

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Cough indication 49727002




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

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
Sodium channel protein type 5 subunit alpha Ion channel WOMBAT-PK

External reference:

IDSource
D00242 KEGG_DRUG
18993 RXNORM
C0053229 UMLSCUI
CHEBI:3032 CHEBI
CHEMBL1374379 ChEMBL_ID
DB00868 DRUGBANK_ID
C029755 MESH_SUPPLEMENTAL_RECORD_UI
7611 IUPHAR_LIGAND_ID
651 INN_ID
5P4DHS6ENR UNII
7699 PUBCHEM_CID
3024 MMSL
41691 MMSL
4260 MMSL
d00796 MMSL
31801005 SNOMEDCT_US
386030001 SNOMEDCT_US
4018542 VANDF
32760-16-0 SECONDARY_CAS_RN
001663 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tessalon HUMAN PRESCRIPTION DRUG LABEL 1 0069-0122 CAPSULE 100 mg ORAL NDA 18 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 0440-1185 CAPSULE 100 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8194 CAPSULE 100 mg ORAL ANDA 16 sections
Benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8403 CAPSULE 100 mg ORAL ANDA 16 sections
Benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6564 CAPSULE 100 mg ORAL ANDA 15 sections
Benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6564 CAPSULE 100 mg ORAL ANDA 15 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6657 CAPSULE 100 mg ORAL ANDA 17 sections
Benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 0904-7153 CAPSULE 100 mg ORAL ANDA 17 sections
Benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 10135-632 CAPSULE 200 mg ORAL ANDA 17 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 10544-094 CAPSULE 100 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 10544-123 CAPSULE 200 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 10544-129 CAPSULE 100 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 11788-027 CAPSULE 200 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 11788-027 CAPSULE 200 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 11788-027 CAPSULE 200 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 11788-028 CAPSULE 100 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 11788-028 CAPSULE 100 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 11788-028 CAPSULE 100 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 11788-029 CAPSULE 150 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 11788-029 CAPSULE 150 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 11788-029 CAPSULE 150 mg ORAL ANDA 16 sections
Benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 12634-826 CAPSULE, LIQUID FILLED 100 mg ORAL ANDA 12 sections
Benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 16590-031 CAPSULE 100 mg ORAL ANDA 11 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 21695-191 CAPSULE 100 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 21695-760 CAPSULE 200 mg ORAL ANDA 16 sections
Benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 31722-956 CAPSULE 100 mg ORAL ANDA 11 sections
Benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 31722-957 CAPSULE 150 mg ORAL ANDA 11 sections
Benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 31722-958 CAPSULE 200 mg ORAL ANDA 11 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 33261-147 CAPSULE 100 mg ORAL ANDA 16 sections
benzonatate HUMAN PRESCRIPTION DRUG LABEL 1 33261-634 CAPSULE 200 mg ORAL ANDA 16 sections