benzonatate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	326	104-31-4

Description:

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

Molecule

Description

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:

Dose	Unit	Route
0.60	g	O

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	14.20 µM/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:

Date	Agency	Company	Orphan
Feb. 10, 1958	FDA	PFIZER

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
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 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
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 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
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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
Cough	indication	49727002

🐶 Veterinary Drug Use

None

🐶 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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Sodium channel protein type 5 subunit alpha	Ion channel	Q14524	SCN5A_HUMAN					WOMBAT-PK

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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