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

Stem definition	Drug id	CAS RN
	4191	286930-02-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fesoterodine toviaz fesoterodine fumarate	a muscarinic antagonist for treatment of overactive bladder Molecular weight: 411.59 Formula: C26H37NO3 CLOGP: 4.36 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 49.77 ALOGS: -5.30 ROTB: 11 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fesoterodine
toviaz
fesoterodine fumarate

a muscarinic antagonist for treatment of overactive bladder

Molecular weight: 411.59
Formula: C26H37NO3
CLOGP: 4.36
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 49.77
ALOGS: -5.30
ROTB: 11

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
4	mg	O
3.50	mg	O

ADMET properties:

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Property	Value	Reference
S (Water solubility)	256 mg/mL	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.33 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

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Date	Agency	Company
April 20, 2007	EMA	Pfizer Europe MA EEIG
Dec. 25, 2012	PMDA	PFIZER JAPAN INC.
Oct. 31, 2008	FDA	PFIZER

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FDA Adverse Event Reporting System (Female)

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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
Urinary retention	252.06	16.81	107	8054	30194	63450667
Dry mouth	219.40	16.81	132	8029	77731	63403130
Brain injury	105.00	16.81	38	8123	7005	63473856
Fall	95.39	16.81	176	7985	392158	63088703
Pulseless electrical activity	77.52	16.81	31	8130	7490	63473371
Urinary incontinence	74.15	16.81	48	8113	31966	63448895
Multiple fractures	73.44	16.81	31	8130	8587	63472274
Electrocardiogram QRS complex prolonged	63.02	16.81	25	8136	5913	63474948
Catarrh	54.40	16.81	16	8145	1533	63479328
Dysuria	48.88	16.81	38	8123	33700	63447161

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FDA Adverse Event Reporting System (Male)

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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
Urinary retention	415.46	21.92	149	3249	36139	34917394
Dry mouth	106.63	21.92	54	3344	30111	34923422
Dysuria	48.13	21.92	31	3367	27121	34926412
Fall	41.37	21.92	72	3326	202813	34750720
Catarrh	41.11	21.92	11	3387	991	34952542
Burns second degree	39.81	21.92	11	3387	1118	34952415
Steroid dependence	36.60	21.92	11	3387	1506	34952027
Hypertonic bladder	34.37	21.92	11	3387	1853	34951680
Dementia	32.82	21.92	19	3379	13729	34939804
Gingival pain	32.72	21.92	12	3386	3040	34950493

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FDA Adverse Event Reporting System (Geriatric)

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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
Urinary retention	308.05	16.71	146	9533	56484	79678225
Dry mouth	191.35	16.71	124	9555	87895	79646814
Fall	124.10	16.71	216	9463	487413	79247296
Brain injury	88.97	16.71	38	9641	11479	79723230
Catarrh	80.01	16.71	23	9656	2155	79732554
Multiple fractures	77.29	16.71	31	9648	7995	79726714
Burns second degree	71.48	16.71	22	9657	2606	79732103
Steroid dependence	71.47	16.71	22	9657	2608	79732101
Pulseless electrical activity	66.28	16.71	33	9646	14127	79720582
Urinary incontinence	59.24	16.71	45	9634	40864	79693845

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	G04BD11	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs for urinary frequency and incontinence
ATC	G04BD13	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs for urinary frequency and incontinence
MeSH PA	D018678	Cholinergic Agents
MeSH PA	D018680	Cholinergic Antagonists
MeSH PA	D018727	Muscarinic Antagonists
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D064804	Urological Agents

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

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Disease	Relation	SNOMED_ID	DOID
Urgent desire to urinate	indication	75088002
Urge incontinence of urine	indication	87557004
Bladder muscle dysfunction - overactive	indication	236633002
Increased Urinary Frequency	indication
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Myasthenia gravis	contraindication	91637004	DOID:437
Acute constipation	contraindication	197119006
Bladder outflow obstruction	contraindication	236645006
Retention of urine	contraindication	267064002

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.64	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
4MG	TOVIAZ	PFIZER	N022030	Oct. 31, 2008	RX	TABLET, EXTENDED RELEASE	ORAL	7807715	June 7, 2027	TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY
4MG	TOVIAZ	PFIZER	N022030	Oct. 31, 2008	RX	TABLET, EXTENDED RELEASE	ORAL	8088398	June 7, 2027	TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY
8MG	TOVIAZ	PFIZER	N022030	Oct. 31, 2008	RX	TABLET, EXTENDED RELEASE	ORAL	7807715	June 7, 2027	TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY
8MG	TOVIAZ	PFIZER	N022030	Oct. 31, 2008	RX	TABLET, EXTENDED RELEASE	ORAL	8088398	June 7, 2027	TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
4MG	TOVIAZ	PFIZER	N022030	Oct. 31, 2008	RX	TABLET, EXTENDED RELEASE	ORAL	June 17, 2024	TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING GREATER THAN 25 KG
4MG	TOVIAZ	PFIZER	N022030	Oct. 31, 2008	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 17, 2024	PEDIATRIC EXCLUSIVITY
8MG	TOVIAZ	PFIZER	N022030	Oct. 31, 2008	RX	TABLET, EXTENDED RELEASE	ORAL	June 17, 2024	TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING GREATER THAN 25 KG
8MG	TOVIAZ	PFIZER	N022030	Oct. 31, 2008	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 17, 2024	PEDIATRIC EXCLUSIVITY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN	ANTAGONIST	Ki	6.40	WOMBAT-PK	CHEMBL
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN	ANTAGONIST	Ki	6.27	WOMBAT-PK	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	6.39	WOMBAT-PK
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	6.19	WOMBAT-PK
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	5.98	WOMBAT-PK

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External reference:

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ID	Source
012671	NDDF
012672	NDDF
10020	INN_ID
137285	MMSL
207679-81-0	SECONDARY_CAS_RN
25992	MMSL
286930-03-8	SECONDARY_CAS_RN
358891	MMSL
4028101	VUID
4028101	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Fesoterodine fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	43598-247	TABLET, EXTENDED RELEASE	4 mg	ORAL	ANDA	26 sections
Fesoterodine fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	43598-248	TABLET, EXTENDED RELEASE	8 mg	ORAL	ANDA	26 sections
Fesoterodine Fumarate	Human Prescription Drug Label	1	46708-175	TABLET, EXTENDED RELEASE	4 mg	ORAL	ANDA	27 sections
Fesoterodine Fumarate	Human Prescription Drug Label	1	46708-176	TABLET, EXTENDED RELEASE	8 mg	ORAL	ANDA	27 sections
Fesoterodine fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	51407-661	TABLET, EXTENDED RELEASE	4 mg	ORAL	ANDA	26 sections
Fesoterodine fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	51407-662	TABLET, EXTENDED RELEASE	8 mg	ORAL	ANDA	26 sections
Fesoterodine Fumarate	Human Prescription Drug Label	1	62332-175	TABLET, EXTENDED RELEASE	4 mg	ORAL	ANDA	27 sections
Fesoterodine Fumarate	Human Prescription Drug Label	1	62332-176	TABLET, EXTENDED RELEASE	8 mg	ORAL	ANDA	27 sections
Fesoterodine Fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	62559-376	TABLET, FILM COATED, EXTENDED RELEASE	8 mg	ORAL	ANDA	28 sections
Fesoterodine Fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	65162-369	TABLET, EXTENDED RELEASE	4 mg	ORAL	ANDA	20 sections

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