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

Stem definition	Drug id	CAS RN
muscarinic receptors antagonists	2457	242478-37-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: YM-67905 YM-905 solifenacin solifenacin succinate vesicare	A quinuclidine and tetrahydroisoquinoline derivative and selective M3 MUSCARINIC ANTAGONIST. It is used as a UROLOGIC AGENT in the treatment of URINARY INCONTINENCE. Molecular weight: 362.47 Formula: C23H26N2O2 CLOGP: 4.68 LIPINSKI: 0 HAC: 4 HDO: 0 TPSA: 32.78 ALOGS: -3.70 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

YM-67905
YM-905
solifenacin
solifenacin succinate
vesicare

A quinuclidine and tetrahydroisoquinoline derivative and selective M3 MUSCARINIC ANTAGONIST. It is used as a UROLOGIC AGENT in the treatment of URINARY INCONTINENCE.

Molecular weight: 362.47
Formula: C23H26N2O2
CLOGP: 4.68
LIPINSKI: 0
HAC: 4
HDO: 0
TPSA: 32.78
ALOGS: -3.70
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
5	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	12.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.30 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	90 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	8.20 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.02 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	52 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Nov. 19, 2004	FDA	ASTELLAS

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
Dry mouth	172.48	11.55	183	25243	77680	63385916
Multiple sclerosis relapse	136.85	11.55	130	25296	48348	63415248
Fall	118.20	11.55	385	25041	391949	63071647
Urinary retention	116.90	11.55	97	25329	30204	63433392
Urinary tract infection	85.24	11.55	266	25160	264418	63199178
Urinary incontinence	84.94	11.55	83	25343	31931	63431665
Vision blurred	71.00	11.55	130	25296	91794	63371802
Dementia	70.07	11.55	59	25367	18735	63444861
Residual urine volume increased	63.20	11.55	12	25414	45	63463551
Multiple sclerosis	62.44	11.55	62	25364	24310	63439286
Maternal exposure during pregnancy	61.06	11.55	8	25418	220054	63243542
Gait disturbance	60.66	11.55	186	25240	182992	63280604
Synovitis	53.81	11.55	6	25420	186912	63276684
Joint abscess	52.82	11.55	15	25411	397	63463199
Drug intolerance	52.74	11.55	29	25397	308632	63154964
Hand deformity	51.76	11.55	3	25423	159454	63304142
Contraindicated product administered	51.48	11.55	12	25414	217636	63245960
Arteriovenous fistula occlusion	49.50	11.55	14	25412	365	63463231
Fear of eating	49.03	11.55	14	25412	378	63463218
Blue toe syndrome	48.51	11.55	14	25412	393	63463203
Genital pain	47.09	11.55	14	25412	437	63463159
Constipation	46.67	11.55	196	25230	224747	63238849
Infusion related reaction	46.60	11.55	20	25406	245501	63218095
Treatment failure	45.08	11.55	12	25414	199031	63264565
Lymphocyte count decreased	40.35	11.55	55	25371	30202	63433394
Glossodynia	40.10	11.55	11	25415	178865	63284731
Discomfort	38.07	11.55	10	25416	167364	63296232
Genital ulceration	38.01	11.55	13	25413	642	63462954
Hallucination	35.52	11.55	72	25354	54745	63408851
Dopamine transporter scintigraphy abnormal	34.83	11.55	8	25418	87	63463509
Therapeutic product effect decreased	34.68	11.55	17	25409	193170	63270426
Cerebellar syndrome	34.36	11.55	20	25406	3519	63460077
Swelling	32.98	11.55	37	25389	275341	63188255
Cutaneous T-cell dyscrasia	31.67	11.55	7	25419	63	63463533
Dyskinesia	30.91	11.55	50	25376	31952	63431644
Cutaneous lupus erythematosus	30.85	11.55	17	25409	2695	63460901
Exposure during pregnancy	30.58	11.55	12	25414	155535	63308061
Bladder sphincter atony	30.44	11.55	8	25418	157	63463439
Balance disorder	30.05	11.55	88	25338	84334	63379262
Pericarditis	29.65	11.55	8	25418	131571	63332025
Renal pain	29.42	11.55	23	25403	6576	63457020
Bladder disorder	29.12	11.55	26	25400	8920	63454676
Nodular rash	28.72	11.55	8	25418	197	63463399
Joint swelling	28.51	11.55	55	25371	327611	63135985
Disorientation	28.19	11.55	54	25372	39398	63424198
Acute kidney injury	27.43	11.55	190	25236	263225	63200371
Rheumatoid arthritis	27.34	11.55	37	25389	253782	63209814
Dry throat	26.79	11.55	22	25404	6743	63456853
Arthropathy	26.55	11.55	33	25393	234759	63228837
Dysuria	26.38	11.55	48	25378	33690	63429906
Cystitis	25.27	11.55	63	25363	54928	63408668
Toxicity to various agents	24.70	11.55	38	25388	247212	63216384
Sinus arrest	24.35	11.55	13	25413	1936	63461660
Abdominal discomfort	23.67	11.55	59	25367	320826	63142770
Hyponatraemia	23.55	11.55	98	25328	111802	63351794
Confusional state	23.14	11.55	168	25258	236212	63227384
Malaise	22.96	11.55	261	25165	415693	63047903
Sinus node dysfunction	22.35	11.55	17	25409	4668	63458928
Poliomyelitis	21.88	11.55	5	25421	53	63463543
Lower respiratory tract infection	21.75	11.55	13	25413	132294	63331302
Wound	21.73	11.55	20	25406	163243	63300353
Hypertonic bladder	21.62	11.55	15	25411	3573	63460023
Hepatic enzyme increased	21.27	11.55	30	25396	202298	63261298
Pain	20.45	11.55	194	25232	740434	62723162
Pyelonephritis	20.28	11.55	30	25396	17748	63445848
Micturition urgency	20.21	11.55	22	25404	9589	63454007
Airway remodelling	20.10	11.55	5	25421	78	63463518
Hallucination, visual	19.80	11.55	31	25395	19267	63444329
Blood potassium decreased	19.15	11.55	48	25378	41978	63421618
Renal function test abnormal	19.09	11.55	14	25412	3639	63459957
Labelled drug-drug interaction medication error	18.84	11.55	25	25401	13374	63450222
Dyspepsia	18.83	11.55	86	25340	102110	63361486
Cognitive disorder	18.73	11.55	57	25369	55758	63407838
Colitis ischaemic	18.27	11.55	22	25404	10686	63452910
Visual impairment	17.80	11.55	74	25352	84372	63379224
Heat stroke	17.62	11.55	8	25418	840	63462756
Upper gastrointestinal haemorrhage	17.59	11.55	29	25397	18823	63444773
Oscillopsia	17.41	11.55	5	25421	138	63463458
Lower urinary tract symptoms	17.29	11.55	4	25422	45	63463551
Drug interaction	17.06	11.55	153	25273	228978	63234618
Muscular weakness	16.94	11.55	95	25331	122258	63341338
Incontinence	16.82	11.55	22	25404	11610	63451986
Muscle injury	16.68	11.55	3	25423	65342	63398254
Arthralgia	16.67	11.55	147	25279	569563	62894033
Dizziness	16.29	11.55	252	25174	429673	63033923
Pollakiuria	16.12	11.55	35	25391	27902	63435694
Torsade de pointes	15.91	11.55	23	25403	13328	63450268
Infective myositis	15.87	11.55	4	25422	66	63463530
Neurogenic bladder	15.85	11.55	12	25414	3273	63460323
Atrial fibrillation	15.77	11.55	90	25336	116546	63347050
Arthritis bacterial	15.74	11.55	16	25410	6447	63457149
Thalamus haemorrhage	15.72	11.55	7	25419	702	63462894
Skin burning sensation	15.27	11.55	22	25404	12712	63450884
Disease progression	15.22	11.55	16	25410	122742	63340854
Wrong technique in product usage process	15.04	11.55	57	25369	62283	63401313
Liver injury	14.98	11.55	3	25423	60517	63403079
Blister	14.92	11.55	18	25408	129796	63333800
Feeling abnormal	14.81	11.55	106	25320	148286	63315310
Oral pain	14.62	11.55	34	25392	28360	63435236
Nocturia	14.34	11.55	17	25409	8124	63455472
Gastrointestinal disorder	14.25	11.55	19	25407	131220	63332376
Varicose ulceration	14.14	11.55	6	25420	535	63463061
Hypotonic urinary bladder	14.12	11.55	3	25423	22	63463574
Muscle strain	14.12	11.55	17	25409	8257	63455339
Blood viscosity increased	13.96	11.55	5	25421	283	63463313
Loss of consciousness	13.96	11.55	88	25338	118033	63345563
Vasculitic rash	13.91	11.55	8	25418	1376	63462220
Psoriatic arthropathy	13.68	11.55	10	25416	91510	63372086
Drug ineffective	13.63	11.55	317	25109	1044448	62419148
Hypersensitivity	13.36	11.55	66	25360	292619	63170977
Poverty of speech	13.33	11.55	5	25421	323	63463273
Subacute hepatic failure	13.18	11.55	4	25422	134	63463462
Memory impairment	13.16	11.55	79	25347	104179	63359417
Dry eye	13.09	11.55	41	25385	40720	63422876
Product use issue	13.01	11.55	45	25381	220475	63243121
Food poisoning	12.98	11.55	12	25414	4304	63459292
Benign renal neoplasm	12.95	11.55	3	25423	34	63463562
Language disorder	12.95	11.55	9	25417	2151	63461445
Infection	12.70	11.55	48	25378	229125	63234471
Intentional overdose	12.59	11.55	7	25419	74145	63389451
Cerebral haematoma	12.58	11.55	11	25415	3672	63459924
Hereditary angioedema with C1 esterase inhibitor deficiency	12.50	11.55	3	25423	40	63463556
Blood sodium decreased	12.44	11.55	29	25397	24223	63439373
Posture abnormal	12.33	11.55	9	25417	2323	63461273
Stomatitis	12.29	11.55	23	25403	138702	63324894
Excessive cerumen production	12.22	11.55	5	25421	407	63463189
Nodal rhythm	12.21	11.55	8	25418	1735	63461861
Drug abuse	12.09	11.55	7	25419	72511	63391085
Escherichia urinary tract infection	11.97	11.55	19	25407	11943	63451653
Freezing phenomenon	11.85	11.55	7	25419	1265	63462331
Fibromyalgia	11.74	11.55	9	25417	80411	63383185
Dysgraphia	11.70	11.55	10	25416	3236	63460360

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	106.94	14.32	90	10990	36198	34909653
Confusional state	79.34	14.32	154	10926	144006	34801845
Dry mouth	79.08	14.32	70	11010	30095	34915756
Hallucination	62.07	14.32	79	11001	51419	34894432
Fall	59.10	14.32	169	10911	202716	34743135
Constipation	54.13	14.32	128	10952	136854	34808997
Duplicate therapy error	41.67	14.32	10	11070	171	34945680
Urinary incontinence	40.15	14.32	39	11041	18835	34927016
Urinary tract infection	38.09	14.32	83	10997	83998	34861853
Gastrointestinal hypomotility	34.71	14.32	13	11067	1060	34944791
Faecaloma	33.46	14.32	21	11059	5356	34940495
Urosepsis	30.17	14.32	28	11052	12771	34933080
Hallucination, visual	29.22	14.32	32	11048	17759	34928092
Dysuria	28.58	14.32	39	11041	27113	34918738
Hyponatraemia	27.06	14.32	72	11008	82619	34863232
Dementia	24.82	14.32	26	11054	13722	34932129
Epilepsy	24.34	14.32	32	11048	21463	34924388
Delirium	24.10	14.32	47	11033	43944	34901907
Pneumonia aspiration	23.24	14.32	45	11035	41858	34903993
Cognitive disorder	22.66	14.32	36	11044	28657	34917194
Product name confusion	21.97	14.32	5	11075	67	34945784
Enterocolitis bacterial	21.93	14.32	7	11073	353	34945498
Micturition urgency	20.89	14.32	17	11063	6508	34939343
Malaise	20.32	14.32	114	10966	185711	34760140
Pollakiuria	20.31	14.32	28	11052	19646	34926205
Volvulus	20.14	14.32	10	11070	1622	34944229
Haematuria	19.95	14.32	47	11033	50019	34895832
Duodenitis haemorrhagic	19.73	14.32	5	11075	108	34945743
Bladder cancer	19.63	14.32	25	11055	16253	34929598
Cerebral hypoperfusion	19.36	14.32	7	11073	517	34945334
Completed suicide	18.94	14.32	4	11076	98164	34847687
Hypertonic bladder	18.88	14.32	10	11070	1854	34943997
Upper respiratory tract irritation	18.56	14.32	4	11076	41	34945810
Bladder discomfort	17.92	14.32	5	11075	158	34945693
Pancreatitis acute	17.82	14.32	32	11048	28109	34917742
Body temperature decreased	17.29	14.32	21	11059	13013	34932838
Toxicity to various agents	17.22	14.32	23	11057	200339	34745512
Cataract	16.87	14.32	30	11050	26156	34919695
Foetal heart rate disorder	16.37	14.32	4	11076	74	34945777
Incontinence	16.17	14.32	14	11066	5833	34940018
Lower urinary tract symptoms	15.98	14.32	5	11075	236	34945615
Dizziness	15.89	14.32	121	10959	218400	34727451
Blood pressure systolic increased	15.70	14.32	27	11053	22925	34922926
Polyuria	15.09	14.32	16	11064	8558	34937293
Somnolence	14.77	14.32	72	11008	111044	34834807

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
Fall	141.99	11.28	454	29556	487175	79227203
Urinary retention	139.46	11.28	137	29873	56493	79657885
Dry mouth	125.38	11.28	160	29850	87859	79626519
Multiple sclerosis relapse	107.96	11.28	109	29901	46424	79667954
Urinary tract infection	91.24	11.28	268	29742	274244	79440134
Urinary incontinence	89.76	11.28	93	29917	40816	79673562
Confusional state	76.41	11.28	278	29732	317719	79396659
Hallucination	66.10	11.28	117	29893	85628	79628750
Multiple sclerosis	64.54	11.28	59	29951	22223	79692155
Constipation	61.77	11.28	240	29770	282810	79431568
Fear of eating	60.69	11.28	17	29993	456	79713922
Genital pain	59.74	11.28	19	29991	795	79713583
Vision blurred	57.87	11.28	125	29885	105773	79608605
Arteriovenous fistula occlusion	53.72	11.28	16	29994	536	79713842
Residual urine volume increased	53.18	11.28	10	30000	38	79714340
Dementia	52.19	11.28	55	29955	24604	79689774
Gait disturbance	49.42	11.28	181	29829	207325	79507053
Malaise	46.85	11.28	330	29680	489539	79224839
Toxicity to various agents	46.63	11.28	54	29956	421486	79292892
Genital ulceration	46.58	11.28	17	29993	1083	79713295
Hyponatraemia	46.52	11.28	160	29850	177688	79536690
Joint abscess	45.41	11.28	14	29996	528	79713850
Blue toe syndrome	44.22	11.28	14	29996	577	79713801
Dysuria	41.17	11.28	71	29939	50880	79663498
Dyskinesia	38.30	11.28	64	29946	44709	79669669
Treatment failure	37.53	11.28	9	30001	170477	79543901
Hallucination, visual	36.69	11.28	53	29957	32676	79681702
Duplicate therapy error	34.73	11.28	10	30000	297	79714081
Systemic lupus erythematosus	34.46	11.28	3	30007	121146	79593232
Disorientation	34.16	11.28	74	29936	62702	79651676
Infusion related reaction	33.21	11.28	23	29987	230214	79484164
Synovitis	33.10	11.28	8	30002	150726	79563652
Renal pain	32.24	11.28	26	29984	8270	79706108
Cutaneous T-cell dyscrasia	32.10	11.28	7	30003	63	79714315
Drug abuse	31.38	11.28	11	29999	162680	79551698
Gastrointestinal hypomotility	30.83	11.28	15	29995	1958	79712420
Balance disorder	30.39	11.28	94	29916	98763	79615615
Cutaneous lupus erythematosus	30.22	11.28	17	29993	2986	79711392
Urosepsis	29.84	11.28	43	29967	26452	79687926
Hypertonic bladder	29.83	11.28	19	29991	4182	79710196
Lower urinary tract symptoms	28.98	11.28	8	30002	203	79714175
Maternal exposure during pregnancy	28.54	11.28	8	30002	136530	79577848
Cystitis	28.51	11.28	62	29948	52670	79661708
Hand deformity	28.43	11.28	3	30007	103916	79610462
Micturition urgency	28.19	11.28	29	29981	12612	79701766
Dizziness	28.03	11.28	312	29698	526129	79188249
Cerebellar syndrome	27.51	11.28	20	29990	5460	79708918
Incontinence	27.17	11.28	30	29980	14134	79700244
Faecaloma	26.64	11.28	27	29983	11537	79702841
Volvulus	25.91	11.28	15	29995	2781	79711597
Nodular rash	25.67	11.28	8	30002	313	79714065
Food poisoning	25.30	11.28	18	29992	4751	79709627
Pollakiuria	25.06	11.28	48	29962	37269	79677109
Acute kidney injury	24.17	11.28	300	29710	519104	79195274
Cognitive disorder	23.86	11.28	69	29941	69857	79644521
Delirium	22.86	11.28	77	29933	84550	79629828
Therapeutic product effect decreased	22.80	11.28	17	29993	163846	79550532
Poliomyelitis	21.86	11.28	5	30005	57	79714321
Sinus node dysfunction	21.54	11.28	20	29990	7681	79706697
Lymphocyte count decreased	20.51	11.28	51	29959	47238	79667140
Drug intolerance	20.42	11.28	43	29967	264076	79450302
Neurogenic bladder	20.30	11.28	15	29995	4197	79710181
Renal function test abnormal	20.14	11.28	16	29994	4982	79709396
Sinus arrest	19.98	11.28	14	29996	3608	79710770
Arthralgia	19.79	11.28	130	29880	571673	79142705
Freezing phenomenon	19.71	11.28	11	29999	1903	79712475
Dyspepsia	19.60	11.28	87	29923	108600	79605778
Liver function test abnormal	19.52	11.28	61	29949	64414	79649964
Completed suicide	19.01	11.28	40	29970	245727	79468651
Bladder discomfort	18.98	11.28	8	30002	748	79713630
Blood potassium decreased	18.96	11.28	49	29961	46463	79667915
Discomfort	18.84	11.28	12	29998	125605	79588773
Rheumatoid arthritis	18.71	11.28	31	29979	208439	79505939
Pericarditis	18.52	11.28	8	30002	104228	79610150
Drug hypersensitivity	18.19	11.28	55	29955	298861	79415517
Haematuria	18.03	11.28	62	29948	68774	79645604
Oral pain	17.89	11.28	38	29972	31760	79682618
Epilepsy	17.65	11.28	44	29966	40816	79673562
Duodenitis haemorrhagic	17.28	11.28	5	30005	151	79714227
Memory impairment	16.91	11.28	85	29925	111649	79602729
Neutropenia	16.76	11.28	54	29956	287656	79426722
On and off phenomenon	16.66	11.28	12	29998	3228	79711150
Pain	16.65	11.28	177	29833	703625	79010753
Enterocolitis bacterial	16.63	11.28	7	30003	652	79713726
Product name confusion	16.55	11.28	5	30005	176	79714202
Off label use	16.29	11.28	242	29768	906973	78807405
Disease progression	16.00	11.28	28	29982	184334	79530044
Dry throat	15.97	11.28	17	29993	7689	79706689
Oscillopsia	15.86	11.28	5	30005	203	79714175
Gastrointestinal pain	15.75	11.28	19	29991	9836	79704542
Labelled drug-drug interaction medication error	15.50	11.28	33	29977	27617	79686761
Arthritis bacterial	15.19	11.28	18	29992	9148	79705230
Thalamus haemorrhage	15.04	11.28	9	30001	1773	79712605
Fibromyalgia	14.96	11.28	3	30007	64337	79650041
Hypophagia	14.74	11.28	44	29966	45323	79669055
Upper respiratory tract irritation	14.71	11.28	5	30005	258	79714120
Exposure during pregnancy	14.71	11.28	10	30000	101122	79613256
Pyelonephritis	14.65	11.28	27	29983	20361	79694017
Muscular weakness	14.56	11.28	107	29903	160622	79553756
Cystitis interstitial	14.38	11.28	8	30002	1375	79713003
Secondary progressive multiple sclerosis	14.31	11.28	8	30002	1389	79712989
Bladder cancer	14.21	11.28	26	29984	19500	79694878
Loss of consciousness	14.20	11.28	110	29900	167833	79546545
Airway remodelling	14.17	11.28	5	30005	289	79714089
Stoma site pain	13.99	11.28	8	30002	1450	79712928
Acute disseminated encephalomyelitis	13.86	11.28	5	30005	308	79714070
Electrocardiogram QT prolonged	13.84	11.28	69	29941	90317	79624061
Drug ineffective	13.84	11.28	306	29704	1080607	78633771
Atrial fibrillation	13.74	11.28	124	29886	197762	79516616
Joint swelling	13.66	11.28	59	29951	288587	79425791
Bladder disorder	13.57	11.28	17	29993	9148	79705230
Blood viscosity increased	13.37	11.28	5	30005	341	79714037
Lactic acidosis	13.15	11.28	5	30005	70354	79644024
Swelling	13.09	11.28	40	29970	216671	79497707
Muscle strain	13.01	11.28	17	29993	9538	79704840
Infection	12.96	11.28	47	29963	241665	79472713
Benign renal neoplasm	12.90	11.28	3	30007	37	79714341
Oral mucosal eruption	12.69	11.28	6	30004	735	79713643
Hereditary angioedema with C1 esterase inhibitor deficiency	12.62	11.28	3	30007	41	79714337
Infective myositis	12.52	11.28	4	30006	170	79714208
Escherichia urinary tract infection	12.14	11.28	20	29990	13805	79700573
Cerebral ventricular rupture	11.99	11.28	5	30005	455	79713923
Dementia with Lewy bodies	11.94	11.28	6	30004	840	79713538
Speech disorder	11.70	11.28	46	29964	54399	79659979
Radiation inflammation	11.55	11.28	6	30004	899	79713479
Hepatic enzyme increased	11.54	11.28	33	29977	182577	79531801
Blood sodium decreased	11.52	11.28	33	29977	33222	79681156
Somnolence	11.49	11.28	139	29871	238842	79475536
Paralysis	11.48	11.28	19	29991	13158	79701220
Pseudomembranous colitis	11.39	11.28	12	29998	5362	79709016
Nightmare	11.33	11.28	28	29982	25833	79688545

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	G04BD08	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs for urinary frequency and incontinence
ATC	G04CA53	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Alpha-adrenoreceptor antagonists
FDA MoA	N0000000125	Cholinergic Muscarinic Antagonists
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
FDA EPC	N0000175700	Cholinergic Muscarinic Antagonist

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
Torsades de pointes	contraindication	31722008
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Prolonged QT interval	contraindication	111975006
Gastrointestinal obstruction	contraindication	126765001
Disease of liver	contraindication	235856003	DOID:409
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
Congenital long QT syndrome	contraindication	442917000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.21	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
1MG/ML	VESICARE LS	ASTELLAS	N209529	May 26, 2020	RX	SUSPENSION	ORAL	May 26, 2023	NEW PRODUCT
1MG/ML	VESICARE LS	ASTELLAS	N209529	May 26, 2020	RX	SUSPENSION	ORAL	Nov. 26, 2023	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN	ANTAGONIST	IC50	6.88	CHEMBL	CHEMBL
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN	ANTAGONIST	IC50	6.24	CHEMBL	CHEMBL
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN	ANTAGONIST	Ki	7.20	IUPHAR
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		IC50	7.20	CHEMBL
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN	ANTAGONIST	Ki	6.80	IUPHAR
Muscarinic acetylcholine receptor M2	GPCR		ACM2_RAT		Ki	6.92	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR		ACM1_RAT		Ki	8	CHEMBL
Muscarinic acetylcholine receptor M3	GPCR		ACM3_RAT		Ki	8	CHEMBL

External reference:

ID	Source
4024390	VUID
N0000022393	NUI
D01269	KEGG_DRUG
242478-38-2	SECONDARY_CAS_RN
4021510	VANDF
4024390	VANDF
C1099677	UMLSCUI
CHEBI:135530	CHEBI
CHEMBL1734	ChEMBL_ID
CHEMBL1200803	ChEMBL_ID
DB01591	DRUGBANK_ID
D000069464	MESH_DESCRIPTOR_UI
154059	PUBCHEM_CID
7483	IUPHAR_LIGAND_ID
8155	INN_ID
A8910SQJ1U	UNII
322167	RXNORM
19082	MMSL
256920	MMSL
63797	MMSL
d05413	MMSL
008712	NDDF
008713	NDDF
407030007	SNOMEDCT_US
407031006	SNOMEDCT_US
426324001	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Solifenacin Succinate	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1933	TABLET, FILM COATED	5 mg	ORAL	ANDA	26 sections
Solifenacin Succinate	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1934	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
Solifenacin succinate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3795	TABLET, FILM COATED	5 mg	ORAL	ANDA	26 sections
Solifenacin succinate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3795	TABLET, FILM COATED	5 mg	ORAL	ANDA	26 sections
Solifenacin succinate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3795	TABLET, FILM COATED	5 mg	ORAL	ANDA	26 sections
Solifenacin succinate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3796	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
Solifenacin succinate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3796	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
Solifenacin succinate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3796	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
solifenacin succinate	Human Prescription Drug Label	1	27241-037	TABLET, FILM COATED	5 mg	ORAL	ANDA	26 sections
solifenacin succinate	Human Prescription Drug Label	1	27241-038	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
Solifenacin Succinate	HUMAN PRESCRIPTION DRUG LABEL	1	29300-328	TABLET, FILM COATED	5 mg	ORAL	ANDA	19 sections
Solifenacin Succinate	HUMAN PRESCRIPTION DRUG LABEL	1	29300-329	TABLET, FILM COATED	10 mg	ORAL	ANDA	19 sections
solifenacin succinate	HUMAN PRESCRIPTION DRUG LABEL	1	31722-027	TABLET, FILM COATED	5 mg	ORAL	ANDA	27 sections
solifenacin succinate	HUMAN PRESCRIPTION DRUG LABEL	1	31722-028	TABLET, FILM COATED	10 mg	ORAL	ANDA	27 sections
Solifenacin Succinate	HUMAN PRESCRIPTION DRUG LABEL	1	35561-285	TABLET, FILM COATED	5 mg	ORAL	ANDA	26 sections
Solifenacin Succinate	HUMAN PRESCRIPTION DRUG LABEL	1	35561-286	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
Solifenacin Succinate	HUMAN PRESCRIPTION DRUG LABEL	1	42291-739	TABLET, FILM COATED	5 mg	ORAL	ANDA	18 sections
Solifenacin Succinate	HUMAN PRESCRIPTION DRUG LABEL	1	42291-740	TABLET, FILM COATED	10 mg	ORAL	ANDA	18 sections
Solifenacin Succinate	Human Prescription Drug Label	1	46708-192	TABLET, COATED	5 mg	ORAL	ANDA	27 sections
Solifenacin Succinate	Human Prescription Drug Label	1	46708-193	TABLET, COATED	10 mg	ORAL	ANDA	27 sections
SOLIFENACIN SUCCINATE	HUMAN PRESCRIPTION DRUG LABEL	1	50228-427	TABLET, FILM COATED	5 mg	ORAL	ANDA	27 sections
SOLIFENACIN SUCCINATE	HUMAN PRESCRIPTION DRUG LABEL	1	50228-428	TABLET, FILM COATED	10 mg	ORAL	ANDA	27 sections
VESIcare	HUMAN PRESCRIPTION DRUG LABEL	1	51248-150	TABLET, FILM COATED	5 mg	ORAL	NDA	26 sections
VESIcare	HUMAN PRESCRIPTION DRUG LABEL	1	51248-150	TABLET, FILM COATED	5 mg	ORAL	NDA	26 sections
VESIcare	HUMAN PRESCRIPTION DRUG LABEL	1	51248-150	TABLET, FILM COATED	5 mg	ORAL	NDA	26 sections
VESIcare	HUMAN PRESCRIPTION DRUG LABEL	1	51248-150	TABLET, FILM COATED	5 mg	ORAL	NDA	26 sections
VESIcare	HUMAN PRESCRIPTION DRUG LABEL	1	51248-151	TABLET, FILM COATED	10 mg	ORAL	NDA	26 sections
VESIcare	HUMAN PRESCRIPTION DRUG LABEL	1	51248-151	TABLET, FILM COATED	10 mg	ORAL	NDA	26 sections
VESIcare	HUMAN PRESCRIPTION DRUG LABEL	1	51248-151	TABLET, FILM COATED	10 mg	ORAL	NDA	26 sections
VESIcare	HUMAN PRESCRIPTION DRUG LABEL	1	51248-151	TABLET, FILM COATED	10 mg	ORAL	NDA	26 sections