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	268.39	10.51	576	42350	239937	56009204
Multiple sclerosis relapse	260.12	10.51	239	42687	44664	56204477
Fall	231.07	10.51	696	42230	356814	55892327
Multiple sclerosis	157.10	10.51	146	42780	27656	56221485
Urinary incontinence	138.28	10.51	140	42786	29445	56219696
Contraindicated product administered	127.71	10.51	3	42923	186283	56062858
Systemic lupus erythematosus	109.68	10.51	7	42919	180071	56069070
Rheumatoid arthritis	107.48	10.51	81	42845	382523	55866618
Dry mouth	104.82	10.51	181	42745	64024	56185117
Application site erythema	99.92	10.51	55	42871	4545	56244596
Maternal exposure during pregnancy	93.52	10.51	16	42910	189537	56059604
Synovitis	88.06	10.51	10	42916	161295	56087846
Glossodynia	84.37	10.51	9	42917	152449	56096692
Gait disturbance	80.83	10.51	291	42635	163030	56086111
Joint swelling	80.48	10.51	62	42864	289738	55959403
Vaginal flatulence	71.95	10.51	25	42901	668	56248473
Balance disorder	67.09	10.51	167	42759	76353	56172788
Urine analysis abnormal	62.39	10.51	41	42885	4676	56244465
Abdominal discomfort	62.10	10.51	72	42854	277202	55971939
Micturition urgency	59.27	10.51	51	42875	8730	56240411
Treatment failure	57.56	10.51	29	42897	170363	56078778
Drug intolerance	56.92	10.51	71	42855	264747	55984394
Exposure during pregnancy	56.27	10.51	17	42909	136325	56112816
Pollakiuria	54.79	10.51	81	42845	25121	56224020
Neurogenic bladder	54.44	10.51	32	42894	2997	56246144
Pericarditis	54.12	10.51	9	42917	108914	56140227
Hepatic enzyme increased	52.38	10.51	33	42893	171351	56077790
Infusion related reaction	51.52	10.51	50	42876	208881	56040260
Proctitis	51.21	10.51	29	42897	2531	56246610
Application site pruritus	50.03	10.51	33	42893	3786	56245355
Hypertonic bladder	49.97	10.51	31	42895	3201	56245940
Laboratory test abnormal	48.91	10.51	76	42850	24619	56224522
Bladder disorder	46.98	10.51	43	42883	7981	56241160
Off label use	44.50	10.51	246	42680	555934	55693207
Mental status changes	44.15	10.51	92	42834	37409	56211732
Secondary progressive multiple sclerosis	42.99	10.51	21	42905	1354	56247787
Wound	42.03	10.51	27	42899	138777	56110364
Arthropathy	41.66	10.51	55	42871	200220	56048921
Product adhesion issue	40.78	10.51	31	42895	4452	56244689
Female genital tract fistula	40.72	10.51	31	42895	4461	56244680
Duodenal ulcer perforation	40.58	10.51	3	42923	68339	56180802
Muscular weakness	40.16	10.51	172	42754	104280	56144861
Radiculopathy	38.43	10.51	33	42893	5632	56243509
White blood cells urine positive	36.77	10.51	30	42896	4772	56244369
Depression	36.63	10.51	249	42677	179868	56069273
Bladder spasm	34.85	10.51	19	42907	1540	56247601
Product use issue	33.90	10.51	56	42870	185985	56063156
Hallucination	33.72	10.51	98	42828	49051	56200090
Swelling	33.62	10.51	84	42842	239687	56009454
Culture urine positive	33.43	10.51	25	42901	3503	56245638
Arthralgia	32.81	10.51	236	42690	501433	55747708
Escherichia urinary tract infection	32.53	10.51	41	42885	10934	56238207
Incontinence	31.66	10.51	40	42886	10695	56238446
Urine leukocyte esterase positive	31.51	10.51	23	42903	3105	56246036
Asthenia	31.29	10.51	399	42527	342574	55906567
Urinary retention	30.87	10.51	67	42859	28007	56221134
Malignant neoplasm progression	30.67	10.51	9	42917	73578	56175563
Dysuria	30.06	10.51	70	42856	30659	56218482
Application site rash	29.49	10.51	20	42906	2403	56246738
Muscle injury	29.28	10.51	3	42923	52497	56196644
Cystitis	29.16	10.51	93	42833	48945	56200196
Therapeutic product effect decreased	29.05	10.51	53	42873	169399	56079742
Cerebral atrophy	28.83	10.51	26	42900	4734	56244407
Stomatitis	28.51	10.51	30	42896	120780	56128361
Vaginal discharge	28.48	10.51	29	42897	6134	56243007
Discomfort	28.39	10.51	40	42886	141721	56107420
Bacterial test	28.19	10.51	15	42911	1158	56247983
Urinary sediment present	27.28	10.51	18	42908	2066	56247075
Muscle spasticity	27.12	10.51	52	42874	19908	56229233
Blister	26.88	10.51	26	42900	108861	56140280
Urine abnormality	26.47	10.51	29	42897	6670	56242471
Band neutrophil percentage increased	26.47	10.51	9	42917	225	56248916
Febrile neutropenia	26.29	10.51	25	42901	105520	56143621
Monocyte percentage increased	26.21	10.51	14	42912	1089	56248052
Red blood cells urine positive	25.92	10.51	20	42906	2936	56246205
Hallucination, visual	25.59	10.51	47	42879	17421	56231720
Decubitus ulcer	25.06	10.51	34	42892	9741	56239400
Rash	24.56	10.51	249	42677	492798	55756343
Lymphocyte count decreased	24.49	10.51	61	42865	27878	56221263
Lymphocyte percentage decreased	24.35	10.51	19	42907	2835	56246306
Alopecia	23.83	10.51	129	42797	293329	55955812
Gait inability	23.68	10.51	78	42848	41740	56207401
Constipation	23.32	10.51	246	42680	201697	56047444
Myelocyte percentage increased	23.30	10.51	8	42918	206	56248935
Nephrolithiasis	23.30	10.51	72	42854	37263	56211878
Injection site scar	22.99	10.51	12	42914	891	56248250
Band neutrophil count increased	22.42	10.51	9	42917	362	56248779
Confusional state	22.39	10.51	250	42676	207905	56041236
Lower respiratory tract infection	22.38	10.51	33	42893	114761	56134380
Head injury	22.26	10.51	55	42871	25011	56224130
Urine oxalate increased	21.90	10.51	8	42918	248	56248893
Dysmetropsia	21.52	10.51	6	42920	75	56249066
Crystal urine present	21.44	10.51	14	42912	1579	56247562
Retinal depigmentation	21.04	10.51	8	42918	278	56248863
Peripheral swelling	20.85	10.51	100	42826	234626	56014515
Amnesia	20.75	10.51	80	42846	46242	56202899
Memory impairment	20.23	10.51	124	42802	86433	56162708
Nocturia	20.20	10.51	26	42900	7080	56242061
Cerebrovascular accident	20.01	10.51	137	42789	99133	56150008
Dizziness	20.01	10.51	400	42526	375740	55873401
Thrombocytopenia	19.64	10.51	47	42879	136177	56112964
Food refusal	19.56	10.51	8	42918	338	56248803
Myelocyte count increased	19.04	10.51	8	42918	362	56248779
Prescription drug used without a prescription	18.69	10.51	14	42912	1966	56247175
Urinary tract infection bacterial	18.69	10.51	20	42906	4480	56244661
Application site irritation	18.60	10.51	13	42913	1639	56247502
Nasopharyngitis	18.55	10.51	96	42830	220863	56028278
Chronic papillomatous dermatitis	18.43	10.51	5	42921	56	56249085
Application site vesicles	18.38	10.51	12	42914	1353	56247788
Psychotic symptom	18.35	10.51	12	42914	1357	56247784
Impaired self-care	17.76	10.51	13	42913	1763	56247378
Faecaloma	17.75	10.51	25	42901	7416	56241725
Injection related reaction	17.73	10.51	9	42917	630	56248511
Lymphopenia	17.28	10.51	39	42887	16735	56232406
Cardiac failure congestive	17.06	10.51	120	42806	87600	56161541
Hypersensitivity	17.01	10.51	120	42806	256288	55992853
Product administered at inappropriate site	16.99	10.51	15	42911	2655	56246486
Drug abuse	16.85	10.51	16	42910	67594	56181547
Mixed incontinence	16.74	10.51	5	42921	81	56249060
Dementia	16.69	10.51	39	42887	17119	56232022
Resting tremor	16.65	10.51	9	42917	717	56248424
Specific gravity urine decreased	16.43	10.51	9	42917	736	56248405
Neutrophil percentage increased	16.31	10.51	15	42911	2801	56246340
Pyelonephritis	16.22	10.51	37	42889	15987	56233154
Red blood cell sedimentation rate increased	16.16	10.51	4	42922	36619	56212522
Lagophthalmos	15.98	10.51	7	42919	351	56248790
General physical health deterioration	15.93	10.51	71	42855	169939	56079202
Urine odour abnormal	15.93	10.51	21	42905	5853	56243288
Urinary tract infection pseudomonal	15.80	10.51	9	42917	794	56248347
Dermatitis contact	15.72	10.51	27	42899	9500	56239641
Psoriatic arthropathy	15.70	10.51	20	42906	73988	56175153
Somnolence	15.67	10.51	192	42734	163221	56085920
Stress urinary incontinence	15.52	10.51	13	42913	2145	56246996
Peroneal nerve palsy	15.39	10.51	18	42908	4443	56244698
Product complaint	15.20	10.51	30	42896	11730	56237411
Body height decreased	15.11	10.51	26	42900	9159	56239982
Impaired healing	15.02	10.51	27	42899	86814	56162327
Therapeutic product effect incomplete	14.95	10.51	37	42889	105994	56143147
Thyroglobulin increased	14.42	10.51	4	42922	49	56249092
Hip fracture	14.11	10.51	49	42877	26924	56222217
Abortion spontaneous	13.95	10.51	8	42918	43745	56205396
Product dose omission issue	13.77	10.51	226	42700	204527	56044614
Repetitive strain injury	13.69	10.51	5	42921	155	56248986
Urinary tract disorder	13.41	10.51	13	42913	2591	56246550
Seizure	13.31	10.51	150	42776	124969	56124172
Vertigo	13.27	10.51	79	42847	54493	56194648
Chronic obstructive pulmonary disease	13.25	10.51	82	42844	57333	56191808
Feeling abnormal	13.25	10.51	158	42768	133444	56115697
Open fracture	13.23	10.51	6	42920	327	56248814
Haemoglobin urine present	13.10	10.51	8	42918	803	56248338
Visual impairment	12.99	10.51	99	42827	74103	56175038
Anaemia folate deficiency	12.73	10.51	5	42921	190	56248951
Product closure removal difficult	12.72	10.51	3	42923	18	56249123
Skin irritation	12.70	10.51	23	42903	8432	56240709
Coordination abnormal	12.62	10.51	29	42897	12592	56236549
Pain	12.52	10.51	398	42528	662786	55586355
Anaphylactic reaction	12.46	10.51	16	42910	58979	56190162
Central nervous system lesion	12.42	10.51	25	42901	9913	56239228
Speech disorder	12.34	10.51	59	42867	37434	56211707
Hallucinations, mixed	12.28	10.51	16	42910	4408	56244733
Porphyria acute	12.22	10.51	8	42918	906	56248235
Device expulsion	12.19	10.51	4	42922	30445	56218696
Drug withdrawal syndrome neonatal	12.19	10.51	11	42915	2005	56247136
Dysarthria	12.14	10.51	61	42865	39489	56209652
Pregnancy	12.11	10.51	5	42921	33028	56216113
Myocardial infarction	12.09	10.51	116	42810	92754	56156387
Neutropenia	12.02	10.51	71	42855	158096	56091045
Intentional overdose	11.94	10.51	21	42905	68096	56181045
Sinusitis	11.89	10.51	95	42831	197486	56051655
Incision site pruritus	11.86	10.51	3	42923	25	56249116
Gastrointestinal disorder	11.85	10.51	45	42881	112657	56136484
Klebsiella test positive	11.80	10.51	8	42918	960	56248181
Oral candidiasis	11.53	10.51	36	42890	18727	56230414
Interstitial lung disease	11.52	10.51	16	42910	57047	56192094
Hepatic function abnormal	11.48	10.51	6	42920	34552	56214589
Basophil count decreased	11.47	10.51	4	42922	108	56249033
Therapy cessation	11.33	10.51	46	42880	27218	56221923
Nitrite urine	11.03	10.51	3	42923	34	56249107
Blood thyroid stimulating hormone decreased	11.00	10.51	15	42911	4318	56244823
Bladder pain	10.98	10.51	10	42916	1844	56247297
Progressive multiple sclerosis	10.85	10.51	7	42919	774	56248367
Bone marrow failure	10.83	10.51	4	42922	28282	56220859
Haematocrit decreased	10.74	10.51	56	42870	36773	56212368
Intestinal pseudo-obstruction	10.72	10.51	7	42919	790	56248351
Magnetic resonance imaging abnormal	10.62	10.51	12	42914	2854	56246287
Anticholinergic syndrome	10.62	10.51	10	42916	1924	56247217
Tri-iodothyronine increased	10.52	10.51	4	42922	139	56249002

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	170.33	12.71	196	14898	76673	31605577
Dry mouth	91.81	12.71	83	15011	24375	31657875
Confusional state	82.29	12.71	190	14904	133144	31549106
Multiple sclerosis relapse	68.44	12.71	52	15042	11995	31670255
Fall	64.71	12.71	215	14879	185874	31496376
Multiple sclerosis	48.55	12.71	36	15058	8001	31674249
Bladder spasm	46.99	12.71	17	15077	831	31681419
Urinary retention	43.42	12.71	66	15028	33659	31648591
Muscle spasticity	40.37	12.71	28	15066	5607	31676643
Disorganised speech	30.32	12.71	12	15082	752	31681498
Constipation	28.70	12.71	126	14968	123865	31558385
Delirium	27.65	12.71	61	15033	41360	31640890
Completed suicide	25.92	12.71	99	14995	91415	31590835
Urinary incontinence	25.32	12.71	36	15058	17284	31664966
Micturition urgency	24.50	12.71	21	15073	5739	31676511
Daydreaming	23.64	12.71	9	15085	508	31681742
Hallucination	22.07	12.71	60	15034	46350	31635900
Neurogenic bladder	21.44	12.71	12	15082	1647	31680603
Escherichia urinary tract infection	21.13	12.71	15	15079	3115	31679135
Hypertonic bladder	20.97	12.71	12	15082	1718	31680532
Nephrolithiasis	20.24	12.71	42	15052	27297	31654953
Anticholinergic syndrome	20.12	12.71	10	15084	1078	31681172
Dysuria	19.99	12.71	39	15055	24255	31657995
Urosepsis	19.60	12.71	26	15068	11694	31670556
Interstitial lung disease	19.43	12.71	3	15091	61400	31620850
Perthes disease	17.87	12.71	3	15091	3	31682247
Syncope	17.77	12.71	84	15010	85098	31597152
Decubitus ulcer	17.28	12.71	20	15074	7836	31674414
Vision blurred	16.84	12.71	51	15043	41864	31640386
Gait disturbance	16.59	12.71	77	15017	77418	31604832
Bladder catheterisation	16.46	12.71	7	15087	527	31681723
Pollakiuria	16.29	12.71	30	15064	17872	31664378
Cystitis interstitial	15.67	12.71	5	15089	166	31682084
Dizziness	15.62	12.71	154	14940	198993	31483257
Rib hypoplasia	15.13	12.71	3	15091	12	31682238
Amnesia	15.09	12.71	34	15060	23368	31658882
Implant site erosion	14.81	12.71	4	15090	73	31682177
Cognitive disorder	14.74	12.71	35	15059	24888	31657362
Mental status changes	14.67	12.71	44	15050	35924	31646326
Granulocytopenia	14.21	12.71	16	15078	6083	31676167
Pulmonary hypoplasia	14.11	12.71	6	15088	452	31681798
Intestinal pseudo-obstruction	14.08	12.71	9	15085	1574	31680676
Localised oedema	13.96	12.71	12	15082	3290	31678960
Haematuria	13.84	12.71	51	15043	46263	31635987
Balance disorder	13.61	12.71	44	15050	37378	31644872
Abnormal behaviour	13.59	12.71	33	15061	23795	31658455
Haemorrhage urinary tract	13.28	12.71	9	15085	1736	31680514
Agitation	13.24	12.71	56	15038	54113	31628137
Bladder disorder	13.20	12.71	11	15083	2891	31679359
Hallucination, tactile	13.19	12.71	5	15089	279	31681971
Tongue haemorrhage	13.16	12.71	6	15088	534	31681716
Hepatitis acute	12.98	12.71	16	15078	6693	31675557

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	369.55	10.71	615	45586	248154	70634089
Multiple sclerosis relapse	276.34	10.71	227	45974	42790	70839453
Fall	220.53	10.71	712	45489	443384	70438859
Multiple sclerosis	142.92	10.71	124	46077	25161	70857082
Dry mouth	139.08	10.71	199	46002	70258	70811985
Urinary incontinence	94.68	10.71	120	46081	37722	70844521
Contraindicated product administered	74.64	10.71	3	46198	134609	70747634
Confusional state	68.83	10.71	366	45835	284032	70598211
Urine analysis abnormal	65.44	10.71	44	46157	6110	70876133
Application site erythema	62.85	10.71	39	46162	4722	70877521
Neurogenic bladder	60.09	10.71	35	46166	3778	70878465
Bladder spasm	57.74	10.71	28	46173	2085	70880158
Gait disturbance	56.77	10.71	255	45946	184851	70697392
Micturition urgency	55.05	10.71	51	46150	11263	70870980
Escherichia urinary tract infection	54.06	10.71	53	46148	12554	70869689
Laboratory test abnormal	53.97	10.71	75	46126	25748	70856495
Synovitis	52.93	10.71	10	46191	129218	70753025
Treatment failure	51.45	10.71	15	46186	144127	70738116
Rheumatoid arthritis	51.32	10.71	69	46132	291736	70590507
Urinary retention	48.14	10.71	106	46095	52414	70829829
Mental status changes	47.61	10.71	118	46083	62983	70819260
Hypertonic bladder	47.45	10.71	30	46171	3753	70878490
Muscle spasticity	46.98	10.71	61	46140	19628	70862615
Application site pruritus	46.28	10.71	29	46172	3572	70878671
Systemic lupus erythematosus	43.67	10.71	7	46194	101895	70780348
Joint swelling	43.38	10.71	61	46140	253150	70629093
Off label use	42.84	10.71	296	45905	742764	70139479
Dysuria	42.62	10.71	93	46108	45701	70836542
Balance disorder	42.21	10.71	142	46059	89986	70792257
Bladder disorder	41.56	10.71	38	46163	8251	70873992
Drug intolerance	40.03	10.71	53	46148	225634	70656609
Nephrolithiasis	39.46	10.71	92	46109	47231	70835012
Maternal exposure during pregnancy	39.37	10.71	13	46188	115332	70766911
White blood cells urine positive	38.80	10.71	31	46170	5609	70876634
Pollakiuria	37.06	10.71	73	46128	33388	70848855
Hallucination	36.46	10.71	121	46080	76139	70806104
Culture urine positive	35.08	10.71	26	46175	4211	70878032
Infusion related reaction	34.41	10.71	47	46154	197487	70684756
Incontinence	33.67	10.71	42	46159	12986	70869257
Muscular weakness	33.37	10.71	178	46023	138158	70744085
Depression	31.64	10.71	230	45971	198744	70683499
Urine leukocyte esterase positive	31.61	10.71	23	46178	3622	70878621
Cystitis	31.50	10.71	84	46117	46857	70835386
Hepatic enzyme increased	30.87	10.71	34	46167	156956	70725287
Bacterial test	29.83	10.71	15	46186	1208	70881035
Gait inability	29.24	10.71	82	46119	47093	70835150
Urinary tract infection bacterial	29.16	10.71	26	46175	5465	70876778
Glossodynia	29.07	10.71	10	46191	86477	70795766
Interstitial lung disease	29.02	10.71	16	46185	104669	70777574
Secondary progressive multiple sclerosis	28.25	10.71	15	46186	1352	70880891
Asthenia	28.08	10.71	436	45765	457230	70425013
Urinary sediment present	27.92	10.71	18	46183	2329	70879914
Decubitus ulcer	27.85	10.71	40	46161	14151	70868092
Hallucination, visual	26.64	10.71	59	46142	29278	70852965
Exposure during pregnancy	26.43	10.71	12	46189	87705	70794538
Syncope	25.45	10.71	190	46011	165519	70716724
Impaired self-care	25.43	10.71	17	46184	2337	70879906
Urine abnormality	24.76	10.71	28	46173	7810	70874433
Hepatic function abnormal	24.39	10.71	7	46194	67989	70814254
Malignant neoplasm progression	24.34	10.71	26	46175	121713	70760530
Cerebral atrophy	23.91	10.71	27	46174	7520	70874723
Granulocytopenia	23.87	10.71	32	46169	10615	70871628
General physical health deterioration	23.56	10.71	77	46124	235954	70646289
Urine oxalate increased	23.54	10.71	8	46193	235	70882008
Amnesia	23.38	10.71	81	46120	52074	70830169
Intestinal pseudo-obstruction	23.21	10.71	16	46185	2314	70879929
Myelocyte percentage increased	23.19	10.71	8	46193	246	70881997
Delirium	22.99	10.71	103	46098	74511	70807732
Application site rash	22.90	10.71	15	46186	1994	70880249
Band neutrophil percentage increased	22.82	10.71	9	46192	406	70881837
Dementia	22.63	10.71	47	46154	22318	70859925
Dizziness	22.58	10.71	426	45775	463715	70418528
Thrombocytopenia	22.51	10.71	80	46121	239030	70643213
Hallucinations, mixed	22.30	10.71	24	46177	6338	70875905
Abdominal discomfort	22.15	10.71	69	46132	214589	70667654
Dysmetropsia	21.76	10.71	6	46195	85	70882158
Pyelonephritis	21.60	10.71	41	46160	18248	70863995
Urosepsis	21.56	10.71	48	46153	23901	70858342
Febrile neutropenia	21.56	10.71	65	46136	204253	70677990
Retinal depigmentation	21.34	10.71	8	46193	314	70881929
Faecaloma	21.31	10.71	30	46171	10421	70871822
Constipation	20.97	10.71	254	45947	252184	70630059
Duodenal ulcer perforation	20.83	10.71	4	46197	51108	70831135
Red blood cells urine positive	20.57	10.71	20	46181	4689	70877554
Stress urinary incontinence	20.27	10.71	13	46188	1667	70880576
Monocyte percentage increased	20.27	10.71	14	46187	2031	70880212
Crystal urine present	20.16	10.71	14	46187	2048	70880195
Specific gravity urine decreased	19.59	10.71	10	46191	831	70881412
Daydreaming	19.54	10.71	10	46191	836	70881407
Disorganised speech	19.44	10.71	13	46188	1788	70880455
Wound	18.73	10.71	22	46179	98710	70783533
Arthropathy	18.66	10.71	44	46157	150013	70732230
Band neutrophil count increased	18.59	10.71	9	46192	668	70881575
Lymphocyte percentage decreased	18.48	10.71	19	46182	4760	70877483
Body height decreased	18.39	10.71	24	46177	7759	70874484
Bladder pain	18.19	10.71	13	46188	1991	70880252
Folliculitis	18.06	10.71	3	46198	42567	70839676
Renal impairment	18.06	10.71	42	46159	143895	70738348
Food refusal	17.86	10.71	8	46193	497	70881746
Product adhesion issue	17.63	10.71	14	46187	2510	70879733
Rash	17.50	10.71	231	45970	510331	70371912
Abnormal behaviour	17.41	10.71	56	46145	34653	70847590
Injection related reaction	17.23	10.71	9	46192	785	70881458
Product use issue	17.07	10.71	60	46141	179877	70702366
Pericarditis	17.03	10.71	18	46183	84687	70797556
Dermatitis contact	17.00	10.71	26	46175	9723	70872520
Dysarthria	16.98	10.71	83	46118	62230	70820013
Vision blurred	16.96	10.71	113	46088	94871	70787372
Multiple organ dysfunction syndrome	16.78	10.71	28	46173	108487	70773756
Stomatitis	16.53	10.71	37	46164	128474	70753769
Memory impairment	16.42	10.71	110	46091	92531	70789712
Urinary tract infection pseudomonal	16.35	10.71	11	46190	1528	70880715
Drug abuse	16.14	10.71	46	46155	147210	70735033
Product use in unapproved indication	16.02	10.71	75	46126	207403	70674840
Neutropenia	15.97	10.71	100	46101	257056	70625187
Lagophthalmos	15.95	10.71	7	46194	414	70881829
Psychotic symptom	15.92	10.71	13	46188	2425	70879818
Bone marrow failure	15.90	10.71	6	46195	49004	70833239
Swelling	15.86	10.71	66	46135	188473	70693770
Hydronephrosis	15.39	10.71	32	46169	15210	70867033
Application site vesicles	15.31	10.71	10	46191	1323	70880920
Visual impairment	15.26	10.71	97	46104	80153	70802090
Nocturia	15.21	10.71	28	46173	12176	70870067
Product dose omission issue	15.19	10.71	212	45989	217256	70664987
Urge incontinence	14.76	10.71	9	46192	1056	70881187
Repetitive strain injury	14.74	10.71	5	46196	146	70882097
Myelocyte count increased	14.69	10.71	8	46193	759	70881484
Blister	14.58	10.71	27	46174	100499	70781744
Drug reaction with eosinophilia and systemic symptoms	14.50	10.71	10	46191	58003	70824240
Thyroglobulin increased	14.42	10.71	4	46197	58	70882185
Toxic epidermal necrolysis	14.32	10.71	4	46197	39553	70842690
Urine odour abnormal	14.27	10.71	18	46183	5625	70876618
Urinary tract disorder	14.25	10.71	14	46187	3323	70878920
Speech disorder	14.23	10.71	68	46133	50512	70831731
Somnolence	14.18	10.71	208	45993	215398	70666845
Progressive multiple sclerosis	14.13	10.71	8	46193	818	70881425
Product administered at inappropriate site	14.12	10.71	14	46187	3362	70878881
Therapeutic product effect decreased	14.03	10.71	47	46154	142971	70739272
Red blood cell sedimentation rate increased	13.82	10.71	4	46197	38638	70843605
Haemoglobin urine present	13.77	10.71	8	46193	859	70881384
Cystitis interstitial	13.71	10.71	9	46192	1200	70881043
Anticholinergic syndrome	13.66	10.71	13	46188	2967	70879276
Liver disorder	13.63	10.71	12	46189	61556	70820687
Prescription drug used without a prescription	13.60	10.71	13	46188	2984	70879259
Head injury	13.58	10.71	51	46150	34090	70848153
Perthes disease	13.48	10.71	3	46198	16	70882227
Open fracture	13.10	10.71	6	46195	393	70881850
Cerebrovascular accident	13.07	10.71	147	46054	143323	70738920
Shock	13.03	10.71	5	46196	40420	70841823
Wrist fracture	12.95	10.71	24	46177	10492	70871751
Arthralgia	12.77	10.71	241	45960	503149	70379094
Product complaint	12.72	10.71	26	46175	12205	70870038
Cytomegalovirus infection	12.68	10.71	5	46196	39753	70842490
Lymphocyte count decreased	12.59	10.71	59	46142	43480	70838763
Lethargy	12.53	10.71	88	46113	75162	70807081
Blood urine present	12.35	10.71	34	46167	19319	70862924
Neutrophil percentage increased	12.31	10.71	15	46186	4527	70877716
Lower respiratory tract infection	12.23	10.71	35	46166	111878	70770365
Kidney infection	12.23	10.71	34	46167	19421	70862822
Injection site scar	12.17	10.71	7	46194	738	70881505
Occupational exposure to product	12.08	10.71	7	46194	748	70881495
Haematocrit decreased	12.02	10.71	71	46130	57187	70825056
Drug ineffective	11.94	10.71	496	45705	939256	69942987
Ascites	11.82	10.71	16	46185	67531	70814712
Incision site pruritus	11.75	10.71	3	46198	31	70882212
Acute myeloid leukaemia	11.44	10.71	3	46198	30937	70851306
Anaemia folate deficiency	11.34	10.71	5	46196	299	70881944
Insomnia	11.29	10.71	202	45999	217604	70664639
Central nervous system lesion	11.25	10.71	25	46176	12428	70869815
Skin ulcer	11.13	10.71	9	46192	48136	70834107
Salivary gland disorder	11.07	10.71	5	46196	317	70881926
Hip fracture	11.06	10.71	42	46159	28221	70854022
Porphyria acute	10.93	10.71	8	46193	1271	70880972
Ankle fracture	10.84	10.71	28	46173	15316	70866927
Tongue haemorrhage	10.77	10.71	7	46194	918	70881325

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
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.59	DRUG MATRIX
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
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	7.17	DRUG MATRIX
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	6.22	DRUG MATRIX
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
Muscarinic acetylcholine receptor M1	GPCR		ACM1_RAT		Ki	8.23	CHEMBL
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 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	0023-5861	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 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	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	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
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