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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:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	256 mg/mL	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)	0.33 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

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

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
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
Steroid dependence	48.12	16.81	15	8146	1749	63479112
Burns second degree	46.43	16.81	15	8146	1963	63478898
Colitis ulcerative	39.13	16.81	30	8131	26061	63454800
Hypopnoea	36.85	16.81	15	8146	3791	63477070
Gait disturbance	36.77	16.81	76	8085	183102	63297759
Frequent bowel movements	35.69	16.81	27	8134	22995	63457866
Bradycardia	34.90	16.81	45	8116	73182	63407679
Constipation	34.69	16.81	84	8077	224859	63256002
Gingival pain	34.23	16.81	18	8143	8144	63472717
Vertigo	32.04	16.81	39	8122	59848	63421013
Nocturia	28.70	16.81	16	8145	8125	63472736
Bladder spasm	27.97	16.81	10	8151	1778	63479083
Tubulointerstitial nephritis	27.92	16.81	22	8139	19881	63460980
Micturition urgency	26.23	16.81	16	8145	9595	63471266
Dry throat	25.78	16.81	14	8147	6751	63474110
Loss of consciousness	24.85	16.81	50	8111	118071	63362790
Rectal haemorrhage	24.73	16.81	31	8130	48999	63431862
Swollen tongue	24.26	16.81	26	8135	34774	63446087
Parosmia	24.09	16.81	13	8148	6193	63474668
Tinnitus	23.76	16.81	26	8135	35602	63445259
Stress	22.67	16.81	35	8126	67132	63413729
Rhinitis	21.41	16.81	15	8146	11351	63469510
Impaired quality of life	21.00	16.81	16	8145	13767	63467094
Product blister packaging issue	20.77	16.81	5	8156	221	63480640
Therapeutic product effect incomplete	20.65	16.81	48	8113	125008	63355853
Feeling abnormal	20.31	16.81	53	8108	148339	63332522
Nightmare	20.25	16.81	18	8143	19176	63461685
Cardiac murmur	20.23	16.81	16	8145	14536	63466325
Overdose	18.81	16.81	44	8117	115034	63365827
Bronchiectasis	18.77	16.81	16	8145	16126	63464735
Anticholinergic syndrome	18.41	16.81	8	8153	2374	63478487
Palpitations	18.30	16.81	43	8118	112727	63368134
Pollakiuria	17.95	16.81	20	8141	27917	63452944
Multiple sclerosis relapse	17.40	16.81	26	8135	48452	63432409
Vision blurred	17.09	16.81	37	8124	91887	63388974
Balance disorder	16.87	16.81	35	8126	84387	63396474

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
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
Hypopnoea	32.15	21.92	11	3387	2278	34951255
Parosmia	31.53	21.92	11	3387	2414	34951119
Benign prostatic hyperplasia	29.31	21.92	18	3380	14477	34939056
Cystitis interstitial	29.22	21.92	6	3392	169	34953364
Systemic lupus erythematosus	26.93	21.92	11	3387	3713	34949820
Swollen tongue	26.66	21.92	17	3381	14588	34938945
Confusional state	26.53	21.92	49	3349	144111	34809422
Vertigo	22.19	21.92	19	3379	25517	34928016

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
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
Gingival pain	57.54	16.71	26	9653	8972	79725737
Hypopnoea	56.26	16.71	22	9657	5307	79729402
Dysuria	54.59	16.71	47	9632	50904	79683805
Parosmia	50.42	16.71	22	9657	6992	79727717
Vertigo	47.75	16.71	50	9629	69032	79665677
Electrocardiogram QRS complex prolonged	47.05	16.71	24	9655	10809	79723900
Colitis ulcerative	45.47	16.71	36	9643	34706	79700003
Frequent bowel movements	43.88	16.71	33	9646	29506	79705203
Swollen tongue	39.10	16.71	36	9643	42534	79692175
Gait disturbance	38.97	16.71	81	9598	207425	79527284
Rectal haemorrhage	37.06	16.71	46	9633	76254	79658455
Hypertonic bladder	36.25	16.71	15	9664	4186	79730523
Cardiac murmur	36.05	16.71	23	9656	15801	79718908
Impaired quality of life	35.51	16.71	22	9657	14364	79720345
Rhinitis	34.92	16.71	22	9657	14785	79719924
Nightmare	30.04	16.71	25	9654	25836	79708873
Urinary tract infection	29.01	16.71	86	9593	274426	79460283
Bronchiectasis	28.87	16.71	23	9656	22363	79712346
Cystitis interstitial	27.01	16.71	9	9670	1374	79733335
Tinnitus	25.26	16.71	29	9650	44304	79690405
Stress	25.12	16.71	39	9640	79573	79655136
Impaired work ability	24.90	16.71	20	9659	19661	79715048
Dementia	24.90	16.71	22	9657	24637	79710072
Benign prostatic hyperplasia	24.29	16.71	16	9663	11596	79723113
Nocturia	24.22	16.71	17	9662	13664	79721045
Therapeutic product effect incomplete	23.93	16.71	53	9626	141592	79593117
Constipation	23.81	16.71	82	9597	282968	79451741
Tubulointerstitial nephritis	23.47	16.71	26	9653	38209	79696500
Confusional state	23.25	16.71	88	9591	317909	79416800
Micturition urgency	23.06	16.71	16	9663	12625	79722084
Bladder spasm	22.38	16.71	9	9670	2334	79732375
Loss of consciousness	22.07	16.71	57	9622	167886	79566823
Toxicity to various agents	21.84	16.71	12	9667	421528	79313181
Accidental overdose	21.06	16.71	25	9654	39556	79695153
Product blister packaging issue	20.97	16.71	5	9674	225	79734484
Body height decreased	20.87	16.71	13	9666	8567	79726142
Drug ineffective	20.79	16.71	211	9468	1080702	78654007
Urine flow decreased	20.72	16.71	7	9672	1114	79733595
Completed suicide	19.98	16.71	3	9676	245764	79488945
Bradycardia	19.90	16.71	48	9631	135509	79599200
Intentional product use issue	19.34	16.71	51	9628	152061	79582648
Palpitations	18.76	16.71	45	9634	126565	79608144
Cystitis	18.29	16.71	27	9652	52705	79682004
Colitis ischaemic	18.15	16.71	15	9664	15344	79719365
Bladder disorder	17.66	16.71	12	9667	9153	79725556
Eczema	17.28	16.71	23	9656	40795	79693914
Arthritis	17.20	16.71	41	9638	114839	79619870
Product prescribing error	17.08	16.71	24	9655	44789	79689920
Medication error	16.79	16.71	30	9649	68612	79666097

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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
Gastric retention	contraindication	307227006
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Gastrointestinal hypomotility	contraindication	421807004
Poor metabolizer due to cytochrome p450 CYP2D6 variant	contraindication	423629005
Aggravated Glaucoma	contraindication

🐶 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)

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

Orange Book exclusivity data (new drug applications)

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
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
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	Dec. 17, 2024	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

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

External reference:

ID	Source
4028101	VUID
N0000179802	NUI
D07226	KEGG_DRUG
286930-03-8	SECONDARY_CAS_RN
4028101	VANDF
4028102	VANDF
C2343853	UMLSCUI
CHEBI:135920	CHEBI
CHEMBL1201764	ChEMBL_ID
CHEMBL1201765	ChEMBL_ID
DB06702	DRUGBANK_ID
C526675	MESH_SUPPLEMENTAL_RECORD_UI
7473	IUPHAR_LIGAND_ID
8068	INN_ID
621G617227	UNII
6918558	PUBCHEM_CID
DB15578	DRUGBANK_ID
797195	RXNORM
137285	MMSL
25992	MMSL
358891	MMSL
d07162	MMSL
012671	NDDF
012672	NDDF
432254002	SNOMEDCT_US
432255001	SNOMEDCT_US
441469003	SNOMEDCT_US
C4301611	UMLSCUI
CHEMBL3348932	ChEMBL_ID
10020	INN_ID
207679-81-0	SECONDARY_CAS_RN
9819382	PUBCHEM_CID
YU871O78GR	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0242	TABLET, FILM COATED, EXTENDED RELEASE	4 mg	ORAL	NDA	32 sections
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0242	TABLET, FILM COATED, EXTENDED RELEASE	4 mg	ORAL	NDA	32 sections
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0242	TABLET, FILM COATED, EXTENDED RELEASE	4 mg	ORAL	NDA	32 sections
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0244	TABLET, FILM COATED, EXTENDED RELEASE	8 mg	ORAL	NDA	32 sections
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0244	TABLET, FILM COATED, EXTENDED RELEASE	8 mg	ORAL	NDA	32 sections
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0244	TABLET, FILM COATED, EXTENDED RELEASE	8 mg	ORAL	NDA	32 sections
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
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6156	TABLET, FILM COATED, EXTENDED RELEASE	4 mg	ORAL	NDA	29 sections
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6175	TABLET, FILM COATED, EXTENDED RELEASE	8 mg	ORAL	NDA	29 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
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	63539-183	TABLET, FILM COATED, EXTENDED RELEASE	8 mg	ORAL	NDA	32 sections
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	63539-183	TABLET, FILM COATED, EXTENDED RELEASE	8 mg	ORAL	NDA	32 sections
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	63539-242	TABLET, FILM COATED, EXTENDED RELEASE	4 mg	ORAL	NDA	32 sections
Toviaz	HUMAN PRESCRIPTION DRUG LABEL	1	63539-242	TABLET, FILM COATED, EXTENDED RELEASE	4 mg	ORAL	NDA	32 sections
Fesoterodine Fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	65162-369	TABLET, EXTENDED RELEASE	4 mg	ORAL	ANDA	20 sections
Fesoterodine Fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	65162-370	TABLET, EXTENDED RELEASE	8 mg	ORAL	ANDA	20 sections
FESOTERODINE FUMARATE	Human Prescription Drug Label	1	65862-766	TABLET, FILM COATED, EXTENDED RELEASE	4 mg	ORAL	ANDA	27 sections
FESOTERODINE FUMARATE	Human Prescription Drug Label	1	65862-766	TABLET, FILM COATED, EXTENDED RELEASE	4 mg	ORAL	ANDA	27 sections
FESOTERODINE FUMARATE	Human Prescription Drug Label	1	65862-767	TABLET, FILM COATED, EXTENDED RELEASE	8 mg	ORAL	ANDA	27 sections
FESOTERODINE FUMARATE	Human Prescription Drug Label	1	65862-767	TABLET, FILM COATED, EXTENDED RELEASE	8 mg	ORAL	ANDA	27 sections
Fesoterodine Fumarate	Human Prescription Drug Label	1	67877-064	TABLET, EXTENDED RELEASE	4 mg	ORAL	ANDA	26 sections
Fesoterodine Fumarate	Human Prescription Drug Label	1	67877-068	TABLET, EXTENDED RELEASE	8 mg	ORAL	ANDA	26 sections
fesoterodine fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	68180-618	TABLET, EXTENDED RELEASE	4 mg	ORAL	ANDA	27 sections