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
March 27, 2023	PMDA	Hisamitsu Pharmaceutical Co., 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 tract infection	288.10	10.65	607	45169	264077	63179169
Multiple sclerosis relapse	265.56	10.65	244	45532	48234	63395012
Fall	239.53	10.65	722	45054	391612	63051634
Multiple sclerosis	191.56	10.65	151	45625	24221	63419025
Contraindicated product administered	138.50	10.65	4	45772	217644	63225602
Urinary incontinence	135.59	10.65	140	45636	31874	63411372
Systemic lupus erythematosus	122.38	10.65	7	45769	208911	63234335
Application site erythema	100.24	10.65	55	45721	4780	63438466
Maternal exposure during pregnancy	99.56	10.65	19	45757	220043	63223203
Synovitis	98.93	10.65	10	45766	186908	63256338
Vaginal flatulence	95.71	10.65	47	45729	3246	63440000
Dry mouth	94.34	10.65	187	45589	77676	63365570
Glossodynia	93.56	10.65	10	45766	178866	63264380
Joint swelling	87.69	10.65	65	45711	327601	63115645
Proctitis	83.76	10.65	51	45725	5390	63437856
Gait disturbance	82.67	10.65	305	45471	182873	63260373
Balance disorder	74.02	10.65	178	45598	84244	63359002
Female genital tract fistula	73.03	10.65	53	45723	7506	63435740
Radiculopathy	71.21	10.65	55	45721	8556	63434690
Abdominal discomfort	71.02	10.65	76	45700	320809	63122437
Drug intolerance	67.31	10.65	74	45702	308587	63134659
Treatment failure	66.70	10.65	30	45746	199013	63244233
Pericarditis	64.75	10.65	9	45767	131570	63311676
Urine analysis abnormal	62.18	10.65	41	45735	4975	63438271
Exposure during pregnancy	61.32	10.65	18	45758	155529	63287717
Hepatic enzyme increased	61.05	10.65	35	45741	202293	63240953
Vaginal discharge	59.69	10.65	51	45725	9147	63434099
Micturition urgency	55.76	10.65	50	45726	9561	63433685
Neurogenic bladder	53.69	10.65	32	45744	3253	63439993
Arthropathy	51.48	10.65	56	45720	234736	63208510
Duodenal ulcer perforation	50.79	10.65	3	45773	87206	63356040
Application site pruritus	50.45	10.65	33	45743	3951	63439295
Pollakiuria	49.14	10.65	79	45697	27858	63415388
Laboratory test abnormal	48.57	10.65	77	45699	26835	63416411
Off label use	48.39	10.65	287	45489	674175	62769071
Wound	48.17	10.65	29	45747	163234	63280012
Mental status changes	47.81	10.65	95	45681	39504	63403742
Secondary progressive multiple sclerosis	46.41	10.65	22	45754	1405	63441841
Bladder disorder	45.04	10.65	43	45733	8903	63434343
Hypertonic bladder	43.68	10.65	29	45747	3559	63439687
Depression	40.92	10.65	262	45514	196230	63247016
Product adhesion issue	40.91	10.65	31	45745	4688	63438558
Swelling	40.73	10.65	86	45690	275292	63167954
Product use issue	40.63	10.65	60	45716	220460	63222786
Muscular weakness	38.85	10.65	183	45593	122170	63321076
Infusion related reaction	38.60	10.65	74	45702	245447	63197799
White blood cells urine positive	36.36	10.65	30	45746	5128	63438118
Muscle injury	35.87	10.65	3	45773	65342	63377904
Colitis ulcerative	35.68	10.65	66	45710	26025	63417221
Therapeutic product effect decreased	35.16	10.65	53	45723	193134	63250112
Arthralgia	34.94	10.65	254	45522	569456	62873790
Rheumatoid arthritis	34.49	10.65	83	45693	253736	63189510
Hallucination	34.27	10.65	102	45674	54715	63388531
Culture urine positive	33.69	10.65	25	45751	3662	63439584
Escherichia urinary tract infection	33.13	10.65	42	45734	11920	63431326
Constipation	33.07	10.65	276	45500	224667	63218579
Urinary retention	32.22	10.65	69	45707	30232	63413014
Blister	31.85	10.65	28	45748	129786	63313460
Oral candidiasis	31.59	10.65	58	45718	22740	63420506
Malignant neoplasm progression	31.45	10.65	10	45766	82111	63361135
Discomfort	31.35	10.65	45	45731	167329	63275917
Incontinence	30.89	10.65	40	45736	11592	63431654
Cerebral atrophy	30.67	10.65	27	45749	5039	63438207
Stomatitis	30.48	10.65	33	45743	138692	63304554
Cystitis	30.37	10.65	98	45678	54893	63388353
Application site rash	29.95	10.65	20	45756	2478	63440768
Urine leukocyte esterase positive	29.90	10.65	23	45753	3556	63439690
Dysuria	29.40	10.65	71	45705	33667	63409579
Bacterial test	28.97	10.65	15	45761	1159	63442087
Muscle spasticity	28.39	10.65	54	45722	21740	63421506
Bladder spasm	28.14	10.65	17	45759	1771	63441475
Hallucination, visual	27.89	10.65	50	45726	19248	63423998
Rash	27.60	10.65	265	45511	560606	62882640
Asthenia	27.39	10.65	408	45368	383196	63060050
Urinary sediment present	27.29	10.65	18	45758	2185	63441061
Urine abnormality	26.70	10.65	29	45747	6990	63436256
Band neutrophil percentage increased	26.45	10.65	9	45767	239	63443007
Monocyte percentage increased	26.42	10.65	14	45762	1134	63442112
Lower respiratory tract infection	26.36	10.65	34	45742	132273	63310973
Nephrolithiasis	26.13	10.65	78	45698	41906	63401340
Alopecia	26.07	10.65	140	45636	337396	63105850
Red blood cells urine positive	25.92	10.65	20	45756	3106	63440140
Febrile neutropenia	25.12	10.65	29	45747	118420	63324826
Anorectal malformation	24.94	10.65	4	45772	0	63443246
Decubitus ulcer	24.60	10.65	34	45742	10486	63432760
Lymphocyte count decreased	24.59	10.65	62	45714	30195	63413051
Lymphocyte percentage decreased	24.54	10.65	19	45757	2966	63440280
Frequent bowel movements	23.99	10.65	52	45724	22970	63420276
Myelocyte percentage increased	23.74	10.65	8	45768	206	63443040
Cerebrovascular accident	23.68	10.65	146	45630	107878	63335368
Peripheral swelling	22.41	10.65	107	45669	265835	63177411
Rectal haemorrhage	22.37	10.65	82	45694	48948	63394298
Band neutrophil count increased	22.36	10.65	9	45767	386	63442860
Injection site scar	22.27	10.65	12	45764	1006	63442240
Urine oxalate increased	22.16	10.65	8	45768	254	63442992
General physical health deterioration	22.07	10.65	73	45703	201329	63241917
Crystal urine present	21.68	10.65	14	45762	1640	63441606
Dysmetropsia	21.64	10.65	6	45770	78	63443168
Confusional state	21.62	10.65	263	45513	236117	63207129
Retinal depigmentation	21.29	10.65	8	45768	285	63442961
Head injury	21.09	10.65	55	45721	27341	63415905
Psoriatic arthropathy	20.97	10.65	21	45755	91499	63351747
Thrombocytopenia	20.85	10.65	49	45727	151108	63292138
Hypersensitivity	20.13	10.65	126	45650	292559	63150687
Nocturia	20.08	10.65	27	45749	8114	63435132
Psychotic symptom	19.94	10.65	13	45763	1548	63441698
Nasopharyngitis	19.87	10.65	105	45671	254152	63189094
Impaired healing	19.76	10.65	27	45749	102515	63340731
Myelocyte count increased	19.47	10.65	8	45768	362	63442884
Red blood cell sedimentation rate increased	19.44	10.65	4	45772	43978	63399268
Food refusal	19.37	10.65	8	45768	367	63442879
Urinary tract infection bacterial	19.20	10.65	21	45755	5101	63438145
Resting tremor	18.84	10.65	10	45766	813	63442433
Application site irritation	18.59	10.65	13	45763	1737	63441509
Application site vesicles	18.45	10.65	12	45764	1423	63441823
Cardiac failure congestive	18.45	10.65	122	45654	92311	63350935
Peroneal nerve palsy	18.43	10.65	20	45756	4815	63438431
Chronic papillomatous dermatitis	18.32	10.65	5	45771	61	63443185
Amnesia	18.26	10.65	84	45692	55501	63387745
Memory impairment	18.10	10.65	133	45643	104125	63339121
Dizziness	18.00	10.65	421	45355	429504	63013742
Impaired self-care	17.81	10.65	13	45763	1857	63441389
Faecaloma	17.58	10.65	25	45751	7916	63435330
Lymphopenia	17.53	10.65	40	45736	18287	63424959
Drug abuse	17.35	10.65	16	45760	72502	63370744
Pyelonephritis	17.22	10.65	39	45737	17739	63425507
Prescription drug used without a prescription	17.07	10.65	14	45762	2372	63440874
Mixed incontinence	17.01	10.65	5	45771	81	63443165
Urine odour abnormal	17.01	10.65	22	45754	6367	63436879
Product dose omission issue	16.99	10.65	250	45526	234063	63209183
Chronic sinusitis	16.95	10.65	32	45744	12811	63430435
Dementia	16.86	10.65	40	45736	18754	63424492
Gait inability	16.64	10.65	79	45697	52880	63390366
Specific gravity urine decreased	16.50	10.65	9	45767	773	63442473
Neutrophil percentage increased	16.46	10.65	15	45761	2928	63440318
Injection related reaction	16.21	10.65	9	45767	800	63442446
Lagophthalmos	16.14	10.65	7	45769	363	63442883
Somnolence	15.98	10.65	198	45578	178487	63264759
Chronic obstructive pulmonary disease	15.85	10.65	88	45688	62598	63380648
Urinary tract infection pseudomonal	15.77	10.65	9	45767	844	63442402
Product administered at inappropriate site	15.59	10.65	15	45761	3134	63440112
Gastrointestinal disorder	15.47	10.65	46	45730	131193	63312053
Speech disorder	15.32	10.65	64	45712	40565	63402681
Dermatitis contact	15.24	10.65	28	45748	10980	63432266
Stress urinary incontinence	15.16	10.65	13	45763	2342	63440904
Hallucinations, mixed	15.06	10.65	18	45758	4811	63438435
Intentional product use issue	14.95	10.65	45	45731	127847	63315399
Central nervous system lesion	14.66	10.65	27	45749	10608	63432638
Thyroglobulin increased	14.64	10.65	4	45772	49	63443197
Product complaint	14.59	10.65	30	45746	12779	63430467
Urinary tract disorder	14.55	10.65	14	45762	2927	63440319
Vertigo	14.44	10.65	83	45693	59804	63383442
Body height decreased	14.42	10.65	26	45750	10052	63433194
Anaphylactic reaction	14.21	10.65	16	45760	66084	63377162
Seizure	14.10	10.65	152	45624	132482	63310764
Device expulsion	13.83	10.65	4	45772	34918	63408328
Repetitive strain injury	13.64	10.65	5	45771	166	63443080
Dysarthria	13.63	10.65	64	45712	42647	63400599
Haematochezia	13.43	10.65	75	45701	53469	63389777
Product use in unapproved indication	13.41	10.65	75	45701	179005	63264241
Haemoglobin urine present	13.41	10.65	8	45768	815	63442431
Pregnancy	13.21	10.65	5	45771	36831	63406415
Hip fracture	13.20	10.65	49	45727	29425	63413821
Talipes	13.09	10.65	10	45766	1530	63441716
Abortion spontaneous	13.07	10.65	9	45767	47186	63396060
Product closure removal difficult	12.88	10.65	3	45773	18	63443228
Swollen joint count increased	12.76	10.65	5	45771	36049	63407197
Feeling abnormal	12.65	10.65	163	45613	148229	63295017
Weight decreased	12.48	10.65	274	45502	276524	63166722
Drug withdrawal syndrome neonatal	12.42	10.65	11	45765	2070	63441176
Therapy cessation	12.30	10.65	49	45727	30408	63412838
Bladder operation	12.24	10.65	8	45768	956	63442290
Pneumonia influenzal	12.23	10.65	10	45766	1687	63441559
Anaemia folate deficiency	12.20	10.65	5	45771	225	63443021
Neutropenia	12.19	10.65	75	45701	174930	63268316
Visual impairment	12.06	10.65	103	45673	84343	63358903
Incision site pruritus	12.02	10.65	3	45773	25	63443221
Coordination abnormal	12.01	10.65	29	45747	13744	63429502
Myocardial infarction	11.81	10.65	117	45659	99776	63343470
Hepatic function abnormal	11.81	10.65	6	45770	37136	63406110
Open fracture	11.67	10.65	6	45770	457	63442789
Kidney infection	11.63	10.65	40	45736	23136	63420110
Sinusitis	11.57	10.65	106	45670	226547	63216699
On and off phenomenon	11.55	10.65	10	45766	1825	63441421
Liver disorder	11.53	10.65	13	45763	53674	63389572
Bladder pain	11.44	10.65	11	45765	2297	63440949
Skin irritation	11.31	10.65	23	45753	9718	63433528
Interstitial lung disease	11.23	10.65	17	45759	61891	63381355
Nitrite urine	11.19	10.65	3	45773	34	63443212
Haematocrit decreased	11.16	10.65	57	45719	39283	63403963
Anticholinergic syndrome	11.15	10.65	11	45765	2371	63440875
Congenital uterine anomaly	11.11	10.65	4	45772	126	63443120
Blood thyroid stimulating hormone decreased	10.98	10.65	15	45761	4575	63438671
Hip arthroplasty	10.83	10.65	11	45765	47635	63395611
Porphyria acute	10.80	10.65	8	45768	1169	63442077
Klebsiella test positive	10.74	10.65	8	45768	1179	63442067

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	170.12	12.88	200	15682	83881	34857168
Confusional state	87.10	12.88	198	15684	143962	34797087
Dry mouth	85.82	12.88	86	15796	30079	34910970
Fall	74.01	12.88	231	15651	202654	34738395
Multiple sclerosis relapse	70.99	12.88	54	15828	13079	34927970
Multiple sclerosis	56.28	12.88	36	15846	6609	34934440
Urinary retention	47.79	12.88	70	15812	36218	34904831
Muscle spasticity	47.65	12.88	31	15851	5857	34935192
Bladder spasm	42.88	12.88	16	15866	896	34940153
Constipation	30.40	12.88	133	15749	136849	34804200
Delirium	29.37	12.88	63	15819	43928	34897121
Neurogenic bladder	29.36	12.88	15	15867	1798	34939251
Disorganised speech	28.90	12.88	12	15870	893	34940156
Completed suicide	23.84	12.88	98	15784	98070	34842979
Daydreaming	23.35	12.88	9	15873	551	34940498
Hallucination	22.85	12.88	63	15819	51435	34889614
Urosepsis	20.29	12.88	27	15855	12772	34928277
Escherichia urinary tract infection	20.08	12.88	15	15867	3531	34937518
Urinary incontinence	20.07	12.88	33	15849	18841	34922208
Amnesia	20.03	12.88	40	15842	26523	34914526
Interstitial lung disease	19.81	12.88	3	15879	65279	34875770
Micturition urgency	19.27	12.88	19	15863	6506	34934543
Dysuria	18.25	12.88	39	15843	27113	34913936
Perthes disease	18.01	12.88	3	15879	3	34941046
Decubitus ulcer	17.61	12.88	21	15861	8900	34932149
Syncope	17.45	12.88	85	15797	91366	34849683
Pollakiuria	16.51	12.88	31	15851	19643	34921406
Nephrolithiasis	16.43	12.88	40	15842	30293	34910756
Bladder catheterisation	16.33	12.88	7	15875	564	34940485
Anticholinergic syndrome	16.31	12.88	9	15873	1260	34939789
Cystitis interstitial	15.79	12.88	5	15877	170	34940879
Haematuria	15.46	12.88	54	15828	50012	34891037
Vision blurred	15.45	12.88	51	15831	45912	34895137
Gait disturbance	15.44	12.88	78	15804	85062	34855987
Rib hypoplasia	15.27	12.88	3	15879	12	34941037
Implant site erosion	14.60	12.88	4	15878	81	34940968
Mental status changes	14.39	12.88	44	15838	38039	34903010
Pulmonary hypoplasia	13.91	12.88	6	15876	491	34940558
Dizziness	13.88	12.88	156	15726	218365	34722684
Granulocytopenia	13.86	12.88	16	15866	6551	34934498
Lumbar puncture abnormal	13.74	12.88	3	15879	22	34941027
Localised oedema	13.71	12.88	12	15870	3536	34937513
Intestinal pseudo-obstruction	13.61	12.88	9	15873	1747	34939302
Abnormal behaviour	13.60	12.88	33	15849	24936	34916113
Balance disorder	13.57	12.88	45	15837	40609	34900440
Posturing	13.49	12.88	6	15876	528	34940521
C-reactive protein increased	13.33	12.88	4	15878	54094	34886955
Injection site inflammation	13.16	12.88	7	15875	911	34940138
Haemorrhage urinary tract	13.08	12.88	9	15873	1865	34939184
Tongue haemorrhage	12.92	12.88	6	15876	584	34940465
Agitation	12.91	12.88	56	15826	57343	34883706

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	392.84	10.72	647	48453	273865	79421423
Multiple sclerosis relapse	276.04	10.72	229	48871	46304	79648984
Fall	236.17	10.72	747	48353	486882	79208406
Multiple sclerosis	169.47	10.72	127	48973	22155	79673133
Dry mouth	123.50	10.72	206	48894	87813	79607475
Urinary incontinence	95.76	10.72	122	48978	40787	79654501
Contraindicated product administered	80.33	10.72	4	49096	157534	79537754
Confusional state	72.85	10.72	387	48713	317610	79377678
Neurogenic bladder	69.32	10.72	39	49061	4173	79691115
Urine analysis abnormal	65.38	10.72	44	49056	6476	79688812
Application site erythema	62.34	10.72	39	49061	5071	79690217
Treatment failure	60.87	10.72	15	49085	170471	79524817
Synovitis	60.60	10.72	10	49090	150724	79544564
Gait disturbance	56.29	10.72	265	48835	207241	79488047
Escherichia urinary tract infection	54.30	10.72	54	49046	13771	79681517
Laboratory test abnormal	53.92	10.72	76	49024	27972	79667316
Urinary retention	53.63	10.72	112	48988	56518	79638770
Muscle spasticity	53.36	10.72	66	49034	21409	79673879
Systemic lupus erythematosus	51.08	10.72	7	49093	121142	79574146
Mental status changes	50.57	10.72	121	48979	66838	79628450
Drug intolerance	49.21	10.72	54	49046	264065	79431223
Off label use	48.79	10.72	343	48757	906872	78788416
Bladder spasm	47.76	10.72	25	49075	2318	79692970
Joint swelling	47.47	10.72	65	49035	288581	79406707
Micturition urgency	47.12	10.72	48	49052	12593	79682695
Application site pruritus	46.28	10.72	29	49071	3781	79691507
Balance disorder	45.34	10.72	149	48951	98708	79596580
Maternal exposure during pregnancy	41.57	10.72	16	49084	136522	79558766
Dysuria	40.57	10.72	94	49006	50857	79644431
Nephrolithiasis	38.84	10.72	95	49005	53196	79642092
White blood cells urine positive	38.31	10.72	31	49069	6044	79689244
Culture urine positive	37.60	10.72	27	49073	4408	79690880
Hallucination	37.33	10.72	127	48973	85618	79609670
Pollakiuria	35.55	10.72	74	49026	37243	79658045
Vaginal flatulence	34.85	10.72	21	49079	2554	79692734
Bladder disorder	34.52	10.72	35	49065	9130	79686158
Hepatic enzyme increased	34.37	10.72	37	49063	182573	79512715
Depression	33.81	10.72	239	48861	216551	79478737
Hallucination, visual	33.67	10.72	67	49033	32662	79662626
Muscular weakness	33.64	10.72	191	48909	160538	79534750
Glossodynia	33.35	10.72	11	49089	103326	79591962
Cystitis	33.25	10.72	89	49011	52643	79642645
Hypertonic bladder	32.06	10.72	24	49076	4177	79691111
Incontinence	31.19	10.72	41	49059	14123	79681165
Urinary tract infection bacterial	30.64	10.72	28	49072	6428	79688860
Bacterial test	30.63	10.72	15	49085	1208	79694080
Exposure during pregnancy	30.54	10.72	12	49088	101120	79594168
Urine leukocyte esterase positive	30.39	10.72	23	49077	4068	79691220
General physical health deterioration	30.26	10.72	79	49021	275159	79420129
Constipation	30.07	10.72	286	48814	282764	79412524
Interstitial lung disease	29.90	10.72	16	49084	112584	79582704
Secondary progressive multiple sclerosis	28.74	10.72	15	49085	1382	79693906
Decubitus ulcer	27.94	10.72	41	49059	15646	79679642
Urinary sediment present	27.58	10.72	18	49082	2517	79692771
Abdominal discomfort	27.53	10.72	72	49028	250655	79444633
Duodenal ulcer perforation	27.50	10.72	4	49096	66207	79629081
Drug abuse	27.37	10.72	36	49064	162655	79532633
Radiculopathy	26.70	10.72	30	49070	8794	79686494
Female genital tract fistula	26.59	10.72	25	49075	5950	79689338
Syncope	26.34	10.72	195	48905	179254	79516034
Delirium	25.85	10.72	112	48988	84515	79610773
Cerebral atrophy	25.37	10.72	28	49072	8047	79687241
Hallucinations, mixed	25.36	10.72	26	49074	6873	79688415
Proctitis	25.03	10.72	25	49075	6407	79688881
Hepatic function abnormal	25.00	10.72	7	49093	73100	79622188
Urine abnormality	24.97	10.72	28	49072	8191	79687097
Amnesia	24.52	10.72	90	49010	62967	79632321
Arthropathy	24.26	10.72	45	49055	177066	79518222
Asthenia	24.25	10.72	446	48654	511243	79184045
Thrombocytopenia	24.21	10.72	83	49017	265176	79430112
Impaired self-care	24.15	10.72	17	49083	2690	79692598
Folliculitis	23.82	10.72	3	49097	55377	79639911
Urine oxalate increased	23.79	10.72	8	49092	241	79695047
Gait inability	23.68	10.72	85	49015	58832	79636456
Vaginal discharge	23.66	10.72	26	49074	7437	79687851
Myelocyte percentage increased	23.64	10.72	8	49092	246	79695042
Granulocytopenia	23.51	10.72	32	49068	11399	79683889
Urosepsis	23.46	10.72	51	49049	26444	79668844
Febrile neutropenia	23.37	10.72	69	49031	230930	79464358
Pericarditis	23.32	10.72	18	49082	104218	79591070
Band neutrophil percentage increased	23.02	10.72	9	49091	420	79694868
Application site rash	22.85	10.72	15	49085	2117	79693171
Pyelonephritis	22.51	10.72	43	49057	20345	79674943
Dementia	22.44	10.72	48	49052	24611	79670677
Infusion related reaction	22.42	10.72	70	49030	230167	79465121
Intestinal pseudo-obstruction	22.39	10.72	16	49084	2593	79692695
Malignant neoplasm progression	21.96	10.72	31	49069	135959	79559329
Dysmetropsia	21.72	10.72	6	49094	91	79695197
Product use issue	21.72	10.72	62	49038	209760	79485528
Retinal depigmentation	21.71	10.72	8	49092	317	79694971
Wound	21.35	10.72	24	49076	116155	79579133
Macular degeneration	20.81	10.72	30	49070	11266	79684022
Red blood cells urine positive	20.63	10.72	20	49080	4943	79690345
Monocyte percentage increased	20.40	10.72	14	49086	2127	79693161
Crystal urine present	20.29	10.72	14	49086	2146	79693142
Faecaloma	20.27	10.72	30	49070	11534	79683754
Stress urinary incontinence	19.82	10.72	13	49087	1833	79693455
Specific gravity urine decreased	19.72	10.72	10	49090	868	79694420
Swelling	19.64	10.72	68	49032	216643	79478645
Dysarthria	19.52	10.72	88	49012	67534	79627754
Bladder pain	19.29	10.72	14	49086	2323	79692965
Daydreaming	19.14	10.72	10	49090	923	79694365
Dizziness	19.05	10.72	441	48659	526000	79169288
Chronic sinusitis	18.94	10.72	31	49069	12995	79682293
Band neutrophil count increased	18.91	10.72	9	49091	681	79694607
Lymphocyte percentage decreased	18.74	10.72	19	49081	4957	79690331
Rash	18.50	10.72	248	48852	578110	79117178
Neutropenia	18.35	10.72	103	48997	287607	79407681
Renal impairment	18.33	10.72	44	49056	157739	79537549
Disorganised speech	18.20	10.72	13	49087	2104	79693184
Therapeutic product effect decreased	18.02	10.72	47	49053	163816	79531472
Stomatitis	17.79	10.72	40	49060	146717	79548571
Abnormal behaviour	17.69	10.72	56	49044	36365	79658923
Body height decreased	17.61	10.72	24	49076	8556	79686732
Blister	17.59	10.72	29	49071	119447	79575841
Psychotic symptom	17.51	10.72	14	49086	2683	79692605
Food refusal	17.50	10.72	8	49092	552	79694736
Product adhesion issue	17.48	10.72	14	49086	2690	79692598
Product dose omission issue	17.12	10.72	230	48870	247307	79447981
Cerebrovascular accident	17.01	10.72	158	48942	155134	79540154
Multiple organ dysfunction syndrome	16.96	10.72	30	49070	120216	79575072
Product use in unapproved indication	16.86	10.72	88	49012	250271	79445017
Liver disorder	16.85	10.72	12	49088	72405	79622883
Red blood cell sedimentation rate increased	16.47	10.72	4	49096	45938	79649350
Vision blurred	16.06	10.72	116	48984	105782	79589506
Lagophthalmos	15.99	10.72	7	49093	436	79694852
Speech disorder	15.82	10.72	71	49029	54374	79640914
Dermatitis contact	15.69	10.72	26	49074	11007	79684281
Bone marrow failure	15.53	10.72	6	49094	51101	79644187
Injection related reaction	15.46	10.72	9	49091	1027	79694261
Urinary tract infection pseudomonal	15.37	10.72	11	49089	1787	79693501
Rheumatoid arthritis	15.35	10.72	71	49029	208399	79486889
Urine odour abnormal	15.14	10.72	19	49081	6254	79689034
Application site vesicles	15.12	10.72	10	49090	1430	79693858
Myelocyte count increased	15.09	10.72	8	49092	761	79694527
Memory impairment	15.03	10.72	119	48981	111615	79583673
Urge incontinence	14.90	10.72	9	49091	1099	79694189
Repetitive strain injury	14.83	10.72	5	49095	152	79695136
Hydronephrosis	14.78	10.72	33	49067	17421	79677867
Drug ineffective	14.35	10.72	533	48567	1080380	78614908
Lower respiratory tract infection	14.25	10.72	37	49063	129183	79566105
Wrist fracture	14.23	10.72	26	49074	11895	79683393
Somnolence	14.11	10.72	216	48884	238765	79456523
Nocturia	14.06	10.72	28	49072	13653	79681635
Completed suicide	13.70	10.72	220	48880	245547	79449741
Perthes disease	13.65	10.72	3	49097	16	79695272
Intentional product use issue	13.59	10.72	48	49052	152064	79543224
Urinary tract disorder	13.57	10.72	14	49086	3728	79691560
Blood urine present	13.48	10.72	36	49064	21261	79674027
Haemoglobin urine present	13.47	10.72	8	49092	947	79694341
Ascites	13.46	10.72	16	49084	75546	79619742
Shock	13.42	10.72	5	49095	43543	79651745
Arthralgia	13.34	10.72	260	48840	571543	79123745
Central nervous system lesion	13.31	10.72	27	49073	13341	79681947
Thyroglobulin increased	13.31	10.72	4	49096	83	79695205
Impaired healing	13.16	10.72	21	49079	87634	79607654
Cystitis interstitial	13.07	10.72	9	49091	1374	79693914
Cytomegalovirus infection	12.97	10.72	5	49095	42639	79652649
Product administered at inappropriate site	12.89	10.72	14	49086	3951	79691337
Kidney infection	12.89	10.72	36	49064	21815	79673473
Visual impairment	12.88	10.72	99	49001	92032	79603256
C-reactive protein increased	12.71	10.72	39	49061	128988	79566300
Head injury	12.61	10.72	51	49049	37318	79657970
Neutrophil percentage increased	12.61	10.72	15	49085	4674	79690614
Lymphocyte count decreased	12.51	10.72	60	49040	47229	79648059
Clonus	12.36	10.72	18	49082	6822	79688466
Toxic epidermal necrolysis	12.33	10.72	6	49094	44575	79650713
Resting tremor	12.30	10.72	9	49091	1512	79693776
Lethargy	12.29	10.72	89	49011	81203	79614085
Haematocrit decreased	12.25	10.72	72	49028	61240	79634048
Anticholinergic syndrome	12.18	10.72	13	49087	3598	79691690
Product complaint	12.17	10.72	26	49074	13323	79681965
Open fracture	12.07	10.72	6	49094	499	79694789
Injection site scar	11.81	10.72	7	49093	826	79694462
Progressive multiple sclerosis	11.69	10.72	8	49092	1209	79694079
Incision site pruritus	11.66	10.72	3	49097	34	79695254
Neuralgia	11.62	10.72	46	49054	33338	79661950
Lumbar puncture abnormal	11.59	10.72	3	49097	35	79695253
Anaemia folate deficiency	11.54	10.72	5	49095	304	79694984
Psoriatic arthropathy	11.42	10.72	19	49081	77980	79617308
Cytokine release syndrome	11.32	10.72	4	49096	35994	79659294
Hepatotoxicity	11.32	10.72	9	49091	51343	79643945
Skin ulcer	11.31	10.72	10	49090	54140	79641148
Dysphagia	11.30	10.72	120	48980	122016	79573272
Gastrointestinal disorder	11.30	10.72	38	49062	122167	79573121
Vulvovaginal mycotic infection	11.29	10.72	14	49086	4552	79690736
Bladder operation	11.24	10.72	7	49093	902	79694386
Eosinophilia	11.24	10.72	7	49093	45338	79649950
Salivary gland disorder	11.23	10.72	5	49095	324	79694964
Ankle fracture	11.06	10.72	29	49071	16940	79678348
Therapy cessation	10.92	10.72	49	49051	37513	79657775
Seizure	10.88	10.72	170	48930	188664	79506624
Prescription drug used without a prescription	10.87	10.72	13	49087	4072	79691216
Dyspnoea	10.82	10.72	425	48675	856600	78838688
Haematuria	10.78	10.72	76	49024	68760	79626528
Mixed incontinence	10.77	10.72	3	49097	47	79695241

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
Hyperhidrosis of palms	indication	303090009
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	ABBVIE	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	ABBVIE	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	ABBVIE	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	0023-5812	GEL	100 mg	TRANSDERMAL	NDA	27 sections
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
GELNIQUE	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5861	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	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	16 sections
Oxytrol for Women	HUMAN OTC DRUG LABEL	1	0023-9637	PATCH	3.90 mg	TRANSDERMAL	NDA	16 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	0615-8428	TABLET	5 mg	ORAL	ANDA	20 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8428	TABLET	5 mg	ORAL	ANDA	20 sections
Oxybutynin Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0832-0038	TABLET	5 mg	ORAL	ANDA	23 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	0904-2821	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	0904-6570	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