oxybutynin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
spasmolytics with a papaverine-like action 2028 5633-20-5

Description:

MoleculeDescription

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:

DoseUnitRoute
15 mg O
3.90 mg TD

ADMET properties:

PropertyValueReference
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 ยตM/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:

DateAgencyCompanyOrphan
July 16, 1975 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.67 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M1 GPCR ANTAGONIST Ki 9 CHEMBL DRUG LABEL
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 9.11 CHEMBL DRUG LABEL
Sodium-dependent noradrenaline transporter Transporter Ki 5.59 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 6.30 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 6.84 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR ANTAGONIST Ki 8.09 CHEMBL
Muscarinic acetylcholine receptor M4 GPCR Ki 8.44 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 7.17 DRUG MATRIX
Cytochrome P450 2C19 Enzyme IC50 6.22 DRUG MATRIX
Muscarinic acetylcholine receptor M5 GPCR Ki 7.85 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7.99 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 8.23 CHEMBL
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 6.09 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR Ki 8.16 CHEMBL
Muscarinic acetylcholine receptor M3 GPCR Ki 9.02 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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