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

FDA Adverse Event Reporting System (Male)

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

FDA Adverse Event Reporting System (Geriatric)

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

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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