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
March 27, 2023 PMDA Hisamitsu Pharmaceutical Co., Inc.

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 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 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 170.12 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 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 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:

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
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




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 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:

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
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
Muscarinic acetylcholine receptor M5 GPCR Ki 7.85 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7.99 DRUG MATRIX
Cytochrome P450 2C19 Enzyme IC50 6.22 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 7.17 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.59 DRUG MATRIX
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 M1 GPCR Ki 8.23 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 0023-5812 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