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

Stem definition	Drug id	CAS RN
spasmolytics with a papaverine-like action	2028	5633-20-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: oxybutynin hydrochloride oxybutynin oxybutynin chloride oxytrol ditropan kentera oxybutynin HCl	Oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. Oxybutynin is a racemic (50:50) mixture of R- and S-isomers. Antimuscarinic activity resides predominantly in the R-isomer. The R-isomer of oxybutynin shows greater selectivity for the M1 and M3 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the M2 subtype (predominant in cardiac tissue). Molecular weight: 357.49 Formula: C22H31NO3 CLOGP: 4.69 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 49.77 ALOGS: -4.55 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

oxybutynin hydrochloride
oxybutynin
oxybutynin chloride
oxytrol
ditropan
kentera
oxybutynin HCl

Oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. Oxybutynin is a racemic (50:50) mixture of R- and S-isomers. Antimuscarinic activity resides predominantly in the R-isomer. The R-isomer of oxybutynin shows greater selectivity for the M1 and M3 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the M2 subtype (predominant in cardiac tissue).

Molecular weight: 357.49
Formula: C22H31NO3
CLOGP: 4.69
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 49.77
ALOGS: -4.55
ROTB: 10

Status: OFP

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

Drug dosage:

Dose	Unit	Route
15	mg	O
3.90	mg	TD

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.80 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.93 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	6 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.85 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	5.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.00 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	7.20 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
July 16, 1975	FDA

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 tract infection	258.69	10.89	563	40323	223457	50340781
Multiple sclerosis relapse	236.32	10.89	228	40658	42736	50521502
Fall	213.69	10.89	674	40212	334258	50229980
Multiple sclerosis	165.02	10.89	135	40751	20358	50543880
Urinary incontinence	117.55	10.89	129	40757	28079	50536159
Dry mouth	105.41	10.89	174	40712	56004	50508234
Application site erythema	97.65	10.89	55	40831	4483	50559755
Systemic lupus erythematosus	87.25	10.89	7	40879	140615	50423623
Maternal exposure during pregnancy	81.96	10.89	15	40871	159763	50404475
Gait disturbance	71.81	10.89	275	40611	149730	50414508
Joint swelling	70.39	10.89	57	40829	245229	50319009
Synovitis	67.14	10.89	10	40876	123855	50440383
Balance disorder	64.29	10.89	162	40724	70428	50493810
Glossodynia	63.41	10.89	9	40877	115560	50448678
Urine analysis abnormal	60.81	10.89	40	40846	4310	50559928
Exposure during pregnancy	56.65	10.89	14	40872	121001	50443237
Micturition urgency	51.42	10.89	47	40839	8217	50556021
Application site pruritus	48.77	10.89	33	40853	3726	50560512
Abdominal discomfort	48.48	10.89	70	40816	231571	50332667
Drug intolerance	48.07	10.89	64	40822	219040	50345198
Neurogenic bladder	46.71	10.89	29	40857	2828	50561410
Laboratory test abnormal	46.38	10.89	74	40812	23134	50541104
Secondary progressive multiple sclerosis	43.49	10.89	21	40865	1245	50562993
Treatment failure	43.31	10.89	29	40857	137608	50426630
Bladder disorder	43.26	10.89	41	40845	7502	50556736
Infusion related reaction	43.13	10.89	44	40842	169513	50394725
Hepatic enzyme increased	41.83	10.89	30	40856	137350	50426888
Pollakiuria	40.90	10.89	71	40815	23780	50540458
Mental status changes	40.33	10.89	90	40796	36182	50528056
Product adhesion issue	39.75	10.89	31	40855	4361	50559877
Off label use	39.29	10.89	224	40662	474202	50090036
Hypertonic bladder	38.12	10.89	26	40860	2974	50561264
Pericarditis	37.02	10.89	9	40877	78680	50485558
Muscular weakness	36.60	10.89	163	40723	94850	50469388
Depression	35.47	10.89	242	40644	165181	50399057
White blood cells urine positive	34.43	10.89	29	40857	4549	50559689
Wound	32.33	10.89	23	40863	105771	50458467
Urine leukocyte esterase positive	32.00	10.89	23	40863	2860	50561378
Hallucination	31.48	10.89	96	40790	46561	50517677
Escherichia urinary tract infection	30.84	10.89	40	40846	10355	50553883
Culture urine positive	30.46	10.89	24	40862	3427	50560811
Bladder spasm	29.87	10.89	17	40869	1413	50562825
Malignant neoplasm progression	29.77	10.89	9	40877	68115	50496123
Incontinence	28.97	10.89	38	40848	9947	50554291
Application site rash	28.94	10.89	20	40866	2337	50561901
Asthenia	28.65	10.89	388	40498	318654	50245584
Cerebral atrophy	28.30	10.89	26	40860	4575	50559663
Dysuria	27.60	10.89	67	40819	28437	50535801
Urinary retention	26.92	10.89	63	40823	26127	50538111
Muscle spasticity	26.69	10.89	49	40837	17135	50547103
Gait inability	26.69	10.89	78	40808	36949	50527289
Arthralgia	26.49	10.89	227	40659	438475	50125763
Rheumatoid arthritis	26.48	10.89	80	40806	202470	50361768
Band neutrophil percentage increased	26.46	10.89	9	40877	212	50564026
Arthropathy	26.37	10.89	55	40831	157851	50406387
Duodenal ulcer perforation	26.34	10.89	3	40883	45608	50518630
Monocyte percentage increased	26.21	10.89	14	40872	1027	50563211
Confusional state	26.17	10.89	247	40639	185681	50378557
Cystitis	25.79	10.89	87	40799	44477	50519761
Swelling	25.79	10.89	80	40806	200792	50363446
Hallucination, visual	25.40	10.89	47	40839	16535	50547703
Vaginal flatulence	25.30	10.89	9	40877	243	50563995
Febrile neutropenia	25.21	10.89	25	40861	97642	50466596
Product use issue	25.01	10.89	52	40834	149423	50414815
Bacterial test	24.83	10.89	14	40872	1143	50563095
Urinary sediment present	24.70	10.89	17	40869	1974	50562264
Red blood cells urine positive	23.85	10.89	19	40867	2756	50561482
Urine abnormality	23.36	10.89	27	40859	6211	50558027
Injection site scar	23.03	10.89	12	40874	837	50563401
Myelocyte percentage increased	22.85	10.89	8	40878	206	50564032
Stomatitis	22.81	10.89	29	40857	101315	50462923
Band neutrophil count increased	22.40	10.89	9	40877	342	50563896
Urine oxalate increased	22.05	10.89	8	40878	229	50564009
Lymphocyte percentage decreased	21.82	10.89	18	40868	2742	50561496
Head injury	21.72	10.89	55	40831	23965	50540273
Crystal urine present	21.69	10.89	14	40872	1460	50562778
Dysmetropsia	21.18	10.89	6	40880	75	50564163
Retinal depigmentation	20.70	10.89	8	40878	274	50563964
Amnesia	20.61	10.89	78	40808	42182	50522056
Lymphocyte count decreased	20.50	10.89	57	40829	26250	50537988
Nephrolithiasis	20.31	10.89	68	40818	34625	50529613
Muscle injury	20.09	10.89	3	40883	37108	50527130
Rash	19.93	10.89	242	40644	437229	50127009
Prescription drug used without a prescription	19.88	10.89	14	40872	1686	50562552
Food refusal	19.67	10.89	8	40878	314	50563924
Thrombocytopenia	19.25	10.89	47	40839	127626	50436612
Psychotic symptom	19.05	10.89	12	40874	1200	50563038
Urinary tract infection bacterial	19.04	10.89	20	40866	4139	50560099
Myelocyte count increased	18.96	10.89	8	40878	345	50563893
Decubitus ulcer	18.77	10.89	30	40856	9388	50554850
Memory impairment	18.74	10.89	119	40767	79241	50484997
Chronic papillomatous dermatitis	18.40	10.89	5	40881	53	50564185
Therapeutic product effect decreased	18.30	10.89	53	40833	135997	50428241
Application site irritation	18.19	10.89	13	40873	1602	50562636
Application site vesicles	17.83	10.89	12	40874	1343	50562895
Dizziness	17.80	10.89	385	40501	345984	50218254
Injection related reaction	17.74	10.89	9	40877	594	50563644
Blister	17.65	10.89	26	40860	85392	50478846
Lymphopenia	17.63	10.89	39	40847	15582	50548656
Faecaloma	17.52	10.89	25	40861	7083	50557155
Alopecia	17.48	10.89	121	40765	244926	50319312
Product administered at inappropriate site	17.40	10.89	15	40871	2428	50561810
Abortion spontaneous	17.40	10.89	6	40880	41766	50522472
Impaired self-care	17.25	10.89	13	40873	1738	50562500
Peripheral swelling	17.10	10.89	97	40789	205839	50358399
Nocturia	17.08	10.89	24	40862	6706	50557532
Discomfort	17.05	10.89	39	40847	108341	50455897
Dementia	17.01	10.89	39	40847	15958	50548280
Lagophthalmos	16.92	10.89	7	40879	287	50563951
Specific gravity urine decreased	16.63	10.89	9	40877	678	50563560
Dermatitis contact	16.50	10.89	27	40859	8619	50555619
Urine odour abnormal	16.45	10.89	21	40865	5352	50558886
Porphyria acute	16.34	10.89	8	40878	489	50563749
Resting tremor	16.16	10.89	9	40877	717	50563521
Proctitis	16.14	10.89	13	40873	1915	50562323
Lower respiratory tract infection	16.02	10.89	33	40853	95168	50469070
Cerebrovascular accident	16.01	10.89	131	40755	94549	50469689
Urinary tract infection pseudomonal	15.42	10.89	9	40877	784	50563454
Stress urinary incontinence	15.36	10.89	13	40873	2052	50562186
Pyelonephritis	15.34	10.89	36	40850	14953	50549285
Pain	15.27	10.89	354	40532	578549	49985689
Peroneal nerve palsy	15.15	10.89	18	40868	4265	50559973
Constipation	14.69	10.89	221	40665	185487	50378751
Drug abuse	14.67	10.89	16	40870	59830	50504408
Body height decreased	14.60	10.89	26	40860	8882	50555356
Product complaint	14.52	10.89	30	40856	11436	50552802
Nasopharyngitis	14.38	10.89	94	40792	192833	50371405
Therapeutic product effect incomplete	14.34	10.89	33	40853	91482	50472756
Thyroglobulin increased	14.19	10.89	4	40882	49	50564189
Neutrophil percentage increased	14.09	10.89	14	40872	2713	50561525
Neutropenia	13.79	10.89	67	40819	147898	50416340
Urinary tract disorder	13.77	10.89	13	40873	2367	50561871
Repetitive strain injury	13.41	10.89	5	40881	155	50564083
Cardiac failure congestive	13.33	10.89	115	40771	84267	50479971
Somnolence	13.26	10.89	187	40699	154798	50409440
Open fracture	13.05	10.89	6	40880	318	50563920
Vertigo	13.04	10.89	79	40807	51753	50512485
Hip fracture	12.75	10.89	48	40838	25883	50538355
Pregnancy	12.75	10.89	4	40882	29573	50534665
Haemoglobin urine present	12.72	10.89	8	40878	798	50563440
Red blood cell sedimentation rate increased	12.64	10.89	4	40882	29412	50534826
Anaemia folate deficiency	12.60	10.89	5	40881	184	50564054
Product closure removal difficult	12.54	10.89	3	40883	18	50564220
Chronic obstructive pulmonary disease	12.54	10.89	80	40806	53355	50510883
Seizure	12.52	10.89	148	40738	117726	50446512
Hallucinations, mixed	12.50	10.89	16	40870	4087	50560151
Drug withdrawal syndrome neonatal	12.50	10.89	11	40875	1830	50562408
Mixed incontinence	12.37	10.89	4	40882	80	50564158
Female genital tract fistula	12.30	10.89	15	40871	3651	50560587
Device expulsion	12.25	10.89	4	40882	28818	50535420
Hypersensitivity	12.21	10.89	113	40773	215048	50349190
Coordination abnormal	12.13	10.89	28	40858	11506	50552732
Incision site pruritus	11.69	10.89	3	40883	25	50564213
Klebsiella test positive	11.67	10.89	8	40878	923	50563315
Basophil count decreased	11.65	10.89	4	40882	97	50564141
Radiculopathy	11.63	10.89	17	40869	4924	50559314
Anaphylactic reaction	11.62	10.89	16	40870	54039	50510199
Hepatic function abnormal	11.52	10.89	6	40880	32675	50531563
Bone marrow failure	11.45	10.89	4	40882	27620	50536618
Bladder pain	11.41	10.89	10	40876	1654	50562584
Dysarthria	11.38	10.89	60	40826	37343	50526895
Interstitial lung disease	11.17	10.89	16	40870	53160	50511078
Intentional overdose	11.08	10.89	21	40865	62483	50501755
Therapy cessation	11.06	10.89	46	40840	25965	50538273
Urge incontinence	11.06	10.89	7	40879	706	50563532
Product use in unapproved indication	11.05	10.89	52	40834	115767	50448471

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 tract infection	162.49	12.79	188	14247	72166	29487926
Dry mouth	94.28	12.79	81	14354	21703	29538389
Confusional state	75.69	12.79	182	14253	127695	29432397
Multiple sclerosis relapse	69.78	12.79	52	14383	11367	29548725
Fall	67.87	12.79	215	14220	176963	29383129
Multiple sclerosis	57.28	12.79	35	14400	5519	29554573
Bladder spasm	43.18	12.79	16	14419	817	29559275
Muscle spasticity	40.94	12.79	27	14408	4856	29555236
Urinary retention	40.71	12.79	63	14372	31835	29528257
Constipation	31.88	12.79	125	14310	114035	29446057
Disorganised speech	31.34	12.79	12	14423	671	29559421
Completed suicide	24.52	12.79	98	14337	90148	29469944
Daydreaming	24.04	12.79	9	14426	473	29559619
Hallucination	20.56	12.79	58	14377	44654	29515438
Dysuria	20.25	12.79	38	14397	22402	29537690
Micturition urgency	19.89	12.79	18	14417	5155	29554937
Urosepsis	19.30	12.79	25	14410	10721	29549371
Escherichia urinary tract infection	18.92	12.79	14	14421	3025	29557067
Urinary incontinence	18.88	12.79	31	14404	16450	29543642
Interstitial lung disease	18.47	12.79	3	14432	57715	29502377
Nephrolithiasis	18.19	12.79	39	14396	25295	29534797
Decubitus ulcer	18.05	12.79	20	14415	7291	29552801
Perthes disease	17.80	12.79	3	14432	3	29560089
Syncope	17.23	12.79	82	14353	81289	29478803
Gait disturbance	17.07	12.79	76	14359	73273	29486819
Delirium	17.04	12.79	50	14385	39347	29520745
Dizziness	16.57	12.79	153	14282	189531	29370561
Neurogenic bladder	16.34	12.79	10	14425	1580	29558512
Cystitis interstitial	15.88	12.79	5	14430	155	29559937
Intestinal pseudo-obstruction	15.58	12.79	9	14426	1279	29558813
Cognitive disorder	15.54	12.79	35	14400	23464	29536628
Amnesia	15.28	12.79	34	14401	22609	29537483
Rib hypoplasia	15.05	12.79	3	14432	12	29560080
Implant site erosion	14.71	12.79	4	14431	73	29560019
Vision blurred	14.61	12.79	48	14387	40128	29519964
Pollakiuria	14.46	12.79	28	14407	16888	29543204
Pulmonary hypoplasia	14.38	12.79	6	14429	420	29559672
Localised oedema	14.18	12.79	12	14423	3144	29556948
Granulocytopenia	14.12	12.79	16	14419	5978	29554114
Haemorrhage urinary tract	13.80	12.79	9	14426	1587	29558505
Haematuria	13.67	12.79	50	14385	44089	29516003
Tongue haemorrhage	13.50	12.79	6	14429	490	29559602
Bladder catheterisation	13.38	12.79	6	14429	501	29559591
Hepatitis acute	13.14	12.79	16	14419	6446	29553646
Hallucination, tactile	13.14	12.79	5	14430	275	29559817
Balance disorder	12.96	12.79	43	14392	36127	29523965
Mental status changes	12.94	12.79	42	14393	34885	29525207

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 tract infection	358.43	10.46	600	43641	230996	64223495
Multiple sclerosis relapse	254.31	10.46	217	44024	40918	64413573
Fall	214.65	10.46	700	43541	416126	64038365
Multiple sclerosis	162.13	10.46	121	44120	18820	64435671
Dry mouth	141.01	10.46	190	44051	60228	64394263
Urinary incontinence	77.27	10.46	109	44132	36042	64418449
Confusional state	68.00	10.46	356	43885	260788	64193703
Urine analysis abnormal	63.65	10.46	43	44198	5713	64448778
Application site erythema	61.55	10.46	39	44202	4650	64449841
Laboratory test abnormal	53.57	10.46	74	44167	23989	64430502
Neurogenic bladder	52.30	10.46	32	44209	3587	64450904
Gait disturbance	51.35	10.46	244	43997	171911	64282580
Bladder spasm	49.28	10.46	25	44216	1947	64452544
Escherichia urinary tract infection	48.33	10.46	50	44191	11987	64442504
Muscle spasticity	47.64	10.46	58	44183	16611	64437880
Micturition urgency	47.04	10.46	46	44195	10313	64444178
Application site pruritus	45.37	10.46	29	44212	3510	64450981
Treatment failure	43.54	10.46	13	44228	116803	64337688
Mental status changes	41.97	10.46	114	44127	61048	64393443
Urinary retention	41.34	10.46	99	44142	49102	64405389
Dysuria	41.29	10.46	90	44151	41967	64412524
Balance disorder	41.18	10.46	139	44102	83787	64370704
Synovitis	38.84	10.46	10	44231	99080	64355411
Joint swelling	37.51	10.46	56	44185	215326	64239165
Off label use	37.14	10.46	268	43973	632538	63821953
Nephrolithiasis	36.81	10.46	88	44153	43595	64410896
White blood cells urine positive	36.48	10.46	30	44211	5368	64449123
Bladder disorder	36.22	10.46	35	44206	7732	64446759
Drug intolerance	33.59	10.46	48	44193	187944	64266547
Hallucination	33.47	10.46	118	44123	72670	64381821
Maternal exposure during pregnancy	33.39	10.46	12	44229	95872	64358619
Culture urine positive	32.17	10.46	25	44216	4126	64450365
Gait inability	32.15	10.46	82	44159	42286	64412205
Systemic lupus erythematosus	32.06	10.46	7	44234	77605	64376886
Muscular weakness	31.98	10.46	172	44069	127166	64327325
Urine leukocyte esterase positive	31.96	10.46	23	44218	3380	64451111
Depression	31.21	10.46	224	44017	183067	64271424
Pollakiuria	30.41	10.46	67	44174	31463	64423028
Cystitis	29.73	10.46	80	44161	42595	64411896
Urinary tract infection bacterial	29.56	10.46	26	44215	5095	64449396
Infusion related reaction	29.37	10.46	42	44199	164425	64290066
Secondary progressive multiple sclerosis	28.87	10.46	15	44226	1228	64453263
Interstitial lung disease	28.14	10.46	16	44225	97716	64356775
Hypertonic bladder	27.39	10.46	21	44220	3397	64451094
Hallucination, visual	26.68	10.46	59	44182	27775	64426716
Incontinence	26.66	10.46	37	44204	12044	64442447
Exposure during pregnancy	26.57	10.46	10	44231	77665	64376826
Bacterial test	26.42	10.46	14	44227	1193	64453298
Urinary sediment present	25.44	10.46	17	44224	2217	64452274
Hepatic enzyme increased	25.43	10.46	31	44210	129912	64324579
Impaired self-care	24.91	10.46	17	44224	2296	64452195
Intestinal pseudo-obstruction	24.68	10.46	16	44225	1984	64452507
Drug abuse	24.44	10.46	33	44208	132341	64322150
Hepatic function abnormal	24.24	10.46	7	44234	64306	64390185
Malignant neoplasm progression	24.19	10.46	25	44216	112846	64341645
Asthenia	24.16	10.46	420	43821	427624	64026867
Decubitus ulcer	23.77	10.46	37	44204	13342	64441149
Amnesia	23.71	10.46	80	44161	48189	64406302
Urine oxalate increased	23.57	10.46	8	44233	222	64454269
Cerebral atrophy	23.55	10.46	27	44214	7258	64447233
Thrombocytopenia	23.45	10.46	77	44164	223724	64230767
Dementia	23.37	10.46	47	44194	20719	64433772
Urine abnormality	23.32	10.46	27	44214	7335	64447156
Granulocytopenia	23.08	10.46	32	44209	10408	64444083
Myelocyte percentage increased	22.88	10.46	8	44233	243	64454248
Band neutrophil percentage increased	22.65	10.46	9	44232	393	64454098
Application site rash	22.57	10.46	15	44226	1939	64452552
Hallucinations, mixed	22.27	10.46	24	44217	6028	64448463
Dizziness	21.78	10.46	415	43826	429748	64024743
Dysmetropsia	21.46	10.46	6	44235	85	64454406
Retinal depigmentation	20.94	10.46	8	44233	314	64454177
Febrile neutropenia	20.75	10.46	63	44178	187594	64266897
Pyelonephritis	20.54	10.46	40	44201	17226	64437265
Constipation	20.50	10.46	244	43997	229093	64225398
Crystal urine present	20.35	10.46	14	44227	1915	64452576
Faecaloma	20.29	10.46	29	44212	9699	64444792
Stress urinary incontinence	20.25	10.46	13	44228	1585	64452906
Urosepsis	20.24	10.46	46	44195	22048	64432443
Monocyte percentage increased	19.89	10.46	14	44227	1986	64452505
Disorganised speech	19.87	10.46	13	44228	1637	64452854
Specific gravity urine decreased	19.78	10.46	10	44231	773	64453718
Glossodynia	19.49	10.46	10	44231	64686	64389805
Daydreaming	19.46	10.46	10	44231	800	64453691
Renal impairment	19.06	10.46	40	44201	134977	64319514
Bladder pain	18.97	10.46	13	44228	1768	64452723
Red blood cells urine positive	18.70	10.46	19	44222	4459	64450032
Band neutrophil count increased	18.43	10.46	9	44232	646	64453845
Injection related reaction	18.27	10.46	9	44232	658	64453833
Food refusal	18.26	10.46	8	44233	447	64454044
Body height decreased	17.98	10.46	24	44217	7530	64446961
General physical health deterioration	17.72	10.46	76	44165	204349	64250142
Dermatitis contact	17.56	10.46	26	44215	8974	64445517
Product adhesion issue	17.32	10.46	14	44227	2445	64452046
Abdominal discomfort	16.92	10.46	66	44175	182256	64272235
Psychotic symptom	16.84	10.46	13	44228	2125	64452366
Dysarthria	16.82	10.46	83	44158	59323	64395168
Neutropenia	16.79	10.46	96	44145	239528	64214963
Perthes disease	16.78	10.46	3	44238	3	64454488
Lagophthalmos	16.77	10.46	7	44234	347	64454144
Bone marrow failure	16.69	10.46	6	44235	47946	64406545
Urinary tract infection pseudomonal	16.54	10.46	11	44230	1423	64453068
Product use in unapproved indication	16.34	10.46	64	44177	176554	64277937
Lymphocyte percentage decreased	16.34	10.46	18	44223	4631	64449860
Multiple organ dysfunction syndrome	16.10	10.46	28	44213	101385	64353106
Syncope	16.02	10.46	172	44069	157463	64297028
Abnormal behaviour	15.88	10.46	55	44186	33567	64420924
Urge incontinence	15.41	10.46	9	44232	927	64453564
Wound	15.22	10.46	18	44223	76459	64378032
Application site vesicles	14.91	10.46	10	44231	1312	64453179
Urine odour abnormal	14.89	10.46	18	44223	5118	64449373
Porphyria acute	14.77	10.46	8	44233	712	64453779
Hydronephrosis	14.75	10.46	31	44210	14094	64440397
Memory impairment	14.73	10.46	105	44136	85577	64368914
Prescription drug used without a prescription	14.61	10.46	13	44228	2587	64451904
Repetitive strain injury	14.49	10.46	5	44236	146	64454345
Product administered at inappropriate site	14.48	10.46	14	44227	3096	64451395
Myelocyte count increased	14.45	10.46	8	44233	744	64453747
Urinary tract disorder	14.26	10.46	14	44227	3152	64451339
Rash	14.25	10.46	225	44016	458324	63996167
Thyroglobulin increased	14.22	10.46	4	44237	58	64454433
Toxic epidermal necrolysis	14.09	10.46	4	44237	37162	64417329
Drug reaction with eosinophilia and systemic symptoms	14.06	10.46	10	44231	54207	64400284
Visual impairment	14.05	10.46	93	44148	73984	64380507
Progressive multiple sclerosis	14.02	10.46	8	44233	788	64453703
Delirium	13.81	10.46	88	44153	69106	64385385
Vision blurred	13.45	10.46	107	44134	90209	64364282
Haemoglobin urine present	13.42	10.46	8	44233	855	64453636
Product use issue	13.39	10.46	56	44185	151659	64302832
Head injury	13.21	10.46	51	44190	32791	64421700
Shock	12.95	10.46	5	44236	38235	64416256
Open fracture	12.93	10.46	6	44235	384	64454107
Wrist fracture	12.92	10.46	24	44217	9977	64444514
Stomatitis	12.69	10.46	36	44205	109569	64344922
Duodenal ulcer perforation	12.63	10.46	4	44237	34621	64419870
Product dose omission issue	12.39	10.46	195	44046	194552	64259939
Cytomegalovirus infection	12.37	10.46	5	44236	37194	64417297
Somnolence	12.24	10.46	202	44039	203443	64251048
Nocturia	12.24	10.46	25	44216	11140	64443351
Product complaint	12.21	10.46	26	44215	11928	64442563
Toxicity to various agents	12.10	10.46	176	44065	363337	64091154
Injection site scar	12.09	10.46	7	44234	709	64453782
Anaemia folate deficiency	12.04	10.46	5	44236	245	64454246
Kidney infection	11.98	10.46	33	44208	17805	64436686
Ascites	11.91	10.46	15	44226	61986	64392505
Speech disorder	11.86	10.46	65	44176	48376	64406115
Folliculitis	11.85	10.46	3	44238	30074	64424417
Lymphocyte count decreased	11.62	10.46	57	44184	40642	64413849
Incision site pruritus	11.59	10.46	3	44238	31	64454460
Cystitis interstitial	11.44	10.46	8	44233	1124	64453367
Blood urine present	11.41	10.46	33	44208	18307	64436184
Swelling	11.32	10.46	64	44177	160154	64294337
Liver disorder	11.22	10.46	12	44229	53339	64401152
Arthropathy	11.08	10.46	44	44197	120923	64333568
Salivary gland disorder	10.91	10.46	5	44236	311	64454180
Tongue haemorrhage	10.88	10.46	7	44234	856	64453635
Cerebrovascular accident	10.83	10.46	143	44098	137440	64317051
Red blood cell sedimentation rate increased	10.72	10.46	4	44237	31231	64423260
Ankle fracture	10.67	10.46	28	44213	14682	64439809
Lactic acidosis	10.64	10.46	16	44225	61394	64393097
Haematocrit decreased	10.59	10.46	69	44172	54586	64399905
Anticholinergic syndrome	10.56	10.46	11	44230	2658	64451833
Vertigo	10.54	10.46	73	44168	58938	64395553

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	G04BD04	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs for urinary frequency and incontinence
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	D010276	Parasympatholytics
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D064804	Urological Agents
CHEBI has role	CHEBI:36333	local anesthetics
CHEBI has role	CHEBI:38215	calcium channel blockers
CHEBI has role	CHEBI:48876	muscarinic antagonists
CHEBI has role	CHEBI:50370	parasympatholytics
CHEBI has role	CHEBI:51371	muscle relaxants
CHEBI has role	CHEBI:53784	antispasmodics
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
Neurogenic bladder	indication	398064005
Increased Urinary Frequency	indication
Sinus tachycardia	contraindication	11092001
Severe chronic ulcerative colitis	contraindication	14311001
Toxic megacolon	contraindication	28536002	DOID:1770
Atony of colon	contraindication	29479008
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763
Conduction disorder of the heart	contraindication	44808001
Chronic heart failure	contraindication	48447003
Paralytic ileus	contraindication	55525008	DOID:8442
Ulcerative colitis	contraindication	64766004	DOID:8577
Hiatal hernia	contraindication	84089009	DOID:12642
Kidney disease	contraindication	90708001	DOID:557
Myasthenia gravis	contraindication	91637004	DOID:437
Gastrointestinal obstruction	contraindication	126765001
Gastroesophageal reflux disease	contraindication	235595009	DOID:8534
Disease of liver	contraindication	235856003	DOID:409
Bladder outflow obstruction	contraindication	236645006
Benign prostatic hyperplasia	contraindication	266569009
Retention of urine	contraindication	267064002
Drowsy	contraindication	271782001
Gastric retention	contraindication	307227006
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Disorder of coronary artery	contraindication	414024009
Gastrointestinal hypomotility	contraindication	421807004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	7.67	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
10% (100MG/PACKET)	GELNIQUE	ALLERGAN	N022204	Jan. 27, 2009	RX	GEL	TRANSDERMAL	10449173	Nov. 6, 2029	TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE WITH A SINGLE UNIT DOSE OF 10% OXYBUTYNIN CHLORIDE GEL
10% (100MG/PACKET)	GELNIQUE	ALLERGAN	N022204	Jan. 27, 2009	RX	GEL	TRANSDERMAL	9259388	Nov. 6, 2029	TREATMENT OF OVERACTIVE BLADDER BY APPLICATION OF OXYBUTYNIN CHLORIDE GEL TO SKIN
10% (100MG/PACKET)	GELNIQUE	ALLERGAN	N022204	Jan. 27, 2009	RX	GEL	TRANSDERMAL	8920392	March 26, 2031	TREATMENT OF OVERACTIVE BLADDER BY APPLICATION OF OXYBUTYNIN CHLORIDE GEL TO SKIN

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN	ANTAGONIST	Ki	9	CHEMBL	DRUG LABEL
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN	ANTAGONIST	Ki	9.11	CHEMBL	DRUG LABEL
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	6.30	DRUG MATRIX
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	6.84	DRUG MATRIX
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN	ANTAGONIST	Ki	8.09	CHEMBL
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	8.44	CHEMBL
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	7.85	CHEMBL
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	7.99	DRUG MATRIX
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	6.22	DRUG MATRIX
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	7.17	DRUG MATRIX
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.59	DRUG MATRIX
Membrane-associated progesterone receptor component 1	Membrane receptor		PGRC1_RAT		Ki	6.09	DRUG MATRIX
Muscarinic acetylcholine receptor M2	GPCR		ACM2_RAT		Ki	8.16	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR		ACM1_RAT		Ki	8.23	CHEMBL
Muscarinic acetylcholine receptor M3	GPCR		ACM3_RAT		Ki	9.02	CHEMBL

External reference:

ID	Source
4018815	VUID
N0000147118	NUI
D00465	KEGG_DRUG
1508-65-2	SECONDARY_CAS_RN
4018815	VANDF
4019869	VANDF
C0069805	UMLSCUI
CHEBI:7856	CHEBI
CHEMBL1231	ChEMBL_ID
CHEMBL1133	ChEMBL_ID
DB01062	DRUGBANK_ID
C005419	MESH_SUPPLEMENTAL_RECORD_UI
4634	PUBCHEM_CID
359	IUPHAR_LIGAND_ID
1354	INN_ID
K9P6MC7092	UNII
151651	RXNORM
180	MMSL
28244	MMSL
4610	MMSL
46359	MMSL
5214	MMSL
d00328	MMSL
001768	NDDF
004715	NDDF
31815007	SNOMEDCT_US
35768004	SNOMEDCT_US
372717000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
GELNIQUE	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5812	GEL	100 mg	TRANSDERMAL	NDA	27 sections
GELNIQUE	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5861	GEL	100 mg	TRANSDERMAL	NDA	27 sections
OXYTROL	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6153	PATCH	3.90 mg	TRANSDERMAL	NDA	27 sections
Oxytrol for Women	HUMAN OTC DRUG LABEL	1	0023-9637	PATCH	3.90 mg	TRANSDERMAL	NDA	14 sections
OXYBUTYNIN CHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0671	SYRUP	5 mg	ORAL	ANDA	18 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0603-4975	TABLET	5 mg	ORAL	ANDA	24 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0603-4975	TABLET	5 mg	ORAL	ANDA	24 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-3512	TABLET	5 mg	ORAL	ANDA	21 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-3512	TABLET	5 mg	ORAL	ANDA	21 sections
oxybutynin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8219	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	ANDA	24 sections
Oxybutynin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8220	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	ANDA	24 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0832-0038	TABLET	5 mg	ORAL	ANDA	23 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-2821	TABLET	5 mg	ORAL	ANDA	21 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6570	TABLET, EXTENDED RELEASE	5 mg	ORAL	ANDA	25 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7027	TABLET	5 mg	ORAL	ANDA	20 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	10135-609	TABLET, EXTENDED RELEASE	5 mg	ORAL	ANDA	29 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	10135-610	TABLET, EXTENDED RELEASE	10 mg	ORAL	ANDA	29 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	10135-611	TABLET, EXTENDED RELEASE	15 mg	ORAL	ANDA	29 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	10135-640	TABLET	5 mg	ORAL	ANDA	23 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	10544-518	TABLET	5 mg	ORAL	ANDA	24 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	10544-559	TABLET	5 mg	ORAL	ANDA	21 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	10702-201	TABLET	5 mg	ORAL	ANDA	22 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	14539-653	TABLET	5 mg	ORAL	ANDA	13 sections
oxybutynin chloride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-317	TABLET, EXTENDED RELEASE	5 mg	ORAL	ANDA	26 sections
oxybutynin chloride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-318	TABLET, EXTENDED RELEASE	10 mg	ORAL	ANDA	26 sections
oxybutynin chloride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-319	TABLET, EXTENDED RELEASE	15 mg	ORAL	ANDA	26 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	17856-0092	SYRUP	5 mg	ORAL	ANDA	17 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	17856-0149	SYRUP	5 mg	ORAL	ANDA	21 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	17856-1491	SOLUTION	5 mg	ORAL	ANDA	23 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	21695-406	TABLET	5 mg	ORAL	ANDA	23 sections