ursodiol Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
2797 128-13-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • urosiol
  • ursodiol
  • ursocol
  • ursodeoxycholic acid
  • ursodesoxycholic acid
  • ursolvan
  • ursacholic acid
  • deoxyursocholic acid
An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic.
  • Molecular weight: 392.58
  • Formula: C24H40O4
  • CLOGP: 4.51
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 3
  • TPSA: 77.76
  • ALOGS: -4.30
  • ROTB: 4

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.75 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 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) 38.21 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Dec. 31, 1987 FDA ACTAVIS LABS UT 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
Hepatic function abnormal 370.23 12.05 241 28078 34180 46623563
Blood bilirubin increased 223.71 12.05 177 28142 34007 46623736
Ascites 194.64 12.05 168 28151 36416 46621327
Hepatic encephalopathy 182.22 12.05 99 28220 10058 46647685
Pruritus 182.13 12.05 432 27887 241920 46415823
Hepatic failure 170.79 12.05 150 28169 33266 46624477
Liver disorder 156.83 12.05 150 28169 37096 46620647
Aspartate aminotransferase increased 136.11 12.05 201 28118 78499 46579244
Platelet count decreased 133.68 12.05 227 28092 99797 46557946
Jaundice 119.20 12.05 115 28204 28730 46629013
Alanine aminotransferase increased 115.87 12.05 199 28120 88252 46569491
Primary biliary cholangitis 113.96 12.05 38 28281 1133 46656610
Hepatocellular carcinoma 113.49 12.05 48 28271 2791 46654952
Graft versus host disease 109.31 12.05 61 28258 6527 46651216
Venoocclusive liver disease 106.83 12.05 52 28267 4199 46653544
Cholangitis 99.25 12.05 51 28268 4623 46653120
Infective pulmonary exacerbation of cystic fibrosis 97.69 12.05 68 28251 10739 46647004
Hepatic cirrhosis 95.50 12.05 78 28241 15654 46642089
Rheumatoid arthritis 92.48 12.05 17 28302 240198 46417545
Drug ineffective 86.82 12.05 176 28143 677662 45980081
Cytomegalovirus infection 85.83 12.05 78 28241 18066 46639677
Disseminated intravascular coagulation 82.74 12.05 78 28241 18927 46638816
Blood alkaline phosphatase increased 81.50 12.05 110 28209 39499 46618244
Drug hypersensitivity 75.24 12.05 27 28292 243798 46413945
Pain 73.51 12.05 110 28209 476838 46180905
Cholestasis 73.37 12.05 86 28233 26807 46630936
Completed suicide 72.25 12.05 4 28315 145916 46511827
Hepatic cancer 69.27 12.05 35 28284 3062 46654681
Thrombotic microangiopathy 67.54 12.05 49 28270 8257 46649486
Febrile neutropenia 66.83 12.05 165 28154 94462 46563281
Hyperbilirubinaemia 65.98 12.05 53 28266 10385 46647358
Interstitial lung disease 64.91 12.05 117 28202 53832 46603911
Renal impairment 62.69 12.05 139 28180 74233 46583510
Pyrexia 62.52 12.05 393 27926 348409 46309334
Cholestasis of pregnancy 62.16 12.05 24 28295 1100 46656643
Oesophageal varices haemorrhage 60.19 12.05 24 28295 1199 46656544
Acute graft versus host disease in skin 58.90 12.05 31 28288 2951 46654792
Neutrophil count decreased 58.51 12.05 99 28220 43327 46614416
Acute graft versus host disease 55.35 12.05 33 28286 3997 46653746
Autoimmune hepatitis 54.39 12.05 42 28277 7772 46649971
Cholangitis sclerosing 53.74 12.05 21 28298 994 46656749
Total bile acids increased 52.40 12.05 13 28306 128 46657615
Decreased appetite 51.27 12.05 243 28076 193593 46464150
Gamma-glutamyltransferase increased 50.44 12.05 78 28241 31662 46626081
Cytomegalovirus viraemia 49.66 12.05 32 28287 4446 46653297
Liver transplant rejection 47.47 12.05 21 28298 1362 46656381
Varices oesophageal 46.48 12.05 26 28293 2793 46654950
Venoocclusive disease 46.38 12.05 23 28296 1933 46655810
Stomatitis 46.00 12.05 117 28202 68180 46589563
Chronic graft versus host disease 44.57 12.05 25 28294 2700 46655043
Drug-induced liver injury 42.65 12.05 64 28255 25304 46632439
Drug intolerance 42.48 12.05 18 28301 147031 46510712
Joint swelling 42.41 12.05 24 28295 166049 46491694
Portal hypertension 41.39 12.05 26 28293 3457 46654286
Cytomegalovirus test positive 41.11 12.05 24 28295 2796 46654947
Anaemia 40.74 12.05 280 28039 255499 46402244
Pulmonary malformation 40.63 12.05 10 28309 95 46657648
Liver transplant 39.06 12.05 22 28297 2395 46655348
Hypoproteinaemia 38.81 12.05 20 28299 1823 46655920
Cystitis haemorrhagic 38.48 12.05 25 28294 3522 46654221
Contraindicated product administered 37.18 12.05 3 28316 79944 46577799
Pain in extremity 35.67 12.05 64 28255 258616 46399127
Adenoviral hepatitis 35.65 12.05 11 28308 254 46657489
Pancytopenia 35.54 12.05 123 28196 84935 46572808
Cystic fibrosis 35.20 12.05 24 28295 3664 46654079
White blood cell count decreased 34.35 12.05 147 28172 112084 46545659
Bile duct stone 34.13 12.05 23 28296 3444 46654299
Hepatomegaly 34.08 12.05 38 28281 11215 46646528
Sepsis 33.39 12.05 167 28152 135847 46521896
Respiratory tract malformation 32.99 12.05 8 28311 71 46657672
Injection site pain 32.77 12.05 12 28307 107140 46550603
Hypoalbuminaemia 32.06 12.05 35 28284 10092 46647651
Blood lactate dehydrogenase increased 32.04 12.05 50 28269 20450 46637293
Splenomegaly 31.57 12.05 34 28285 9654 46648089
Treatment failure 30.98 12.05 9 28310 93078 46564665
Therapy interrupted 30.24 12.05 35 28284 10756 46646987
Lung cyst 29.87 12.05 8 28311 109 46657634
Tonsillar haemorrhage 29.84 12.05 9 28310 192 46657551
Cardiac failure 29.48 12.05 111 28208 79837 46577906
Palmar-plantar erythrodysaesthesia syndrome 29.38 12.05 48 28271 20403 46637340
Hypersensitivity 29.03 12.05 29 28290 150292 46507451
Coagulation test abnormal 28.91 12.05 12 28307 665 46657078
Aplastic anaemia 28.56 12.05 28 28291 7125 46650618
Multiple organ dysfunction syndrome 28.21 12.05 82 28237 51628 46606115
Blood alkaline phosphatase abnormal 28.12 12.05 10 28309 363 46657380
Therapeutic product effect decreased 27.46 12.05 8 28311 82593 46575150
Staphylococcal sepsis 27.34 12.05 28 28291 7504 46650239
Pneumonia cytomegaloviral 26.79 12.05 16 28303 1944 46655799
Enterococcal sepsis 26.66 12.05 14 28305 1326 46656417
Bacterial sepsis 26.65 12.05 20 28299 3547 46654196
Hepatitis cholestatic 26.40 12.05 26 28293 6651 46651092
Hepatic necrosis 26.33 12.05 24 28295 5577 46652166
Intentional overdose 26.27 12.05 4 28315 64940 46592803
Acute graft versus host disease in intestine 26.24 12.05 15 28304 1680 46656063
Venous haemorrhage 26.04 12.05 8 28311 182 46657561
Hyperuricaemia 25.74 12.05 22 28297 4695 46653048
Pleural effusion 25.64 12.05 109 28210 82843 46574900
Vanishing bile duct syndrome 25.63 12.05 11 28308 663 46657080
Hepatitis fulminant 25.25 12.05 19 28300 3383 46654360
Hepatic fibrosis 25.10 12.05 18 28301 2977 46654766
Candida test positive 25.10 12.05 12 28307 931 46656812
Ammonia increased 25.09 12.05 21 28298 4356 46653387
Arthralgia 25.00 12.05 125 28194 364478 46293265
Haemophagocytic lymphohistiocytosis 24.97 12.05 28 28291 8314 46649429
Haemorrhage subcutaneous 23.30 12.05 17 28302 2889 46654854
Coma hepatic 23.25 12.05 10 28309 606 46657137
Engraftment syndrome 22.85 12.05 8 28311 277 46657466
Muscle spasms 22.36 12.05 25 28294 123088 46534655
Abdominal discomfort 22.09 12.05 36 28283 151129 46506614
Hepatitis C 22.06 12.05 23 28296 6295 46651448
Hyperammonaemia 21.76 12.05 20 28299 4696 46653047
Alopecia 21.63 12.05 41 28278 162373 46495370
Premature baby 21.41 12.05 39 28280 18073 46639670
Histoplasmosis 21.05 12.05 13 28306 1677 46656066
Cardiac tamponade 20.77 12.05 19 28300 4435 46653308
Enterocolitis 20.72 12.05 22 28297 6146 46651597
Chest pain 20.56 12.05 48 28271 176276 46481467
Overdose 20.46 12.05 19 28300 101960 46555783
Therapy cessation 20.45 12.05 48 28271 26581 46631162
Aspergillus infection 20.41 12.05 23 28296 6867 46650876
Injection site erythema 20.10 12.05 10 28309 74417 46583326
Spider naevus 20.07 12.05 6 28313 124 46657619
Loss of personal independence in daily activities 20.02 12.05 5 28314 57178 46600565
Maternal exposure during breast feeding 19.43 12.05 15 28304 2774 46654969
Adenovirus infection 19.24 12.05 15 28304 2815 46654928
Blood creatine phosphokinase increased 19.18 12.05 48 28271 27676 46630067
Cholangitis acute 19.13 12.05 8 28311 452 46657291
Altered state of consciousness 18.93 12.05 43 28276 23305 46634438
Osteoarthritis 18.87 12.05 7 28312 62018 46595725
Cytokine release syndrome 18.82 12.05 21 28298 6202 46651541
Swelling 18.81 12.05 29 28290 124482 46533261
Faeces soft 18.65 12.05 16 28303 3432 46654311
Arthritis 18.56 12.05 12 28307 77304 46580439
Chronic obstructive pulmonary disease 18.40 12.05 6 28313 57627 46600116
Premature labour 18.27 12.05 28 28291 11271 46646472
Fatigue 18.25 12.05 260 28059 608437 46049306
Blood albumin abnormal 18.10 12.05 7 28312 322 46657421
Acute myeloid leukaemia recurrent 18.06 12.05 11 28308 1385 46656358
Sinusitis 17.95 12.05 32 28287 129736 46528007
Enterocolitis bacterial 17.56 12.05 6 28313 193 46657550
Amylase increased 17.51 12.05 19 28300 5440 46652303
Hyperamylasaemia 17.31 12.05 7 28312 363 46657380
Asthma 17.28 12.05 18 28301 91524 46566219
Toxicity to various agents 17.27 12.05 68 28251 211698 46446045
Mucosal disorder 17.25 12.05 12 28307 1892 46655851
Foetor hepaticus 17.15 12.05 3 28316 3 46657740
Cholecystitis acute 17.14 12.05 22 28297 7516 46650227
Injection site reaction 17.11 12.05 4 28315 47845 46609898
Fixed eruption 17.11 12.05 9 28310 856 46656887
Spinal compression fracture 16.82 12.05 29 28290 12874 46644869
Hallucination, tactile 16.68 12.05 6 28313 225 46657518
Migraine 16.63 12.05 11 28308 70015 46587728
Acute graft versus host disease in liver 16.59 12.05 8 28311 632 46657111
Gait disturbance 16.57 12.05 40 28279 145223 46512520
Anxiety 16.43 12.05 56 28263 181901 46475842
Transfusion 16.29 12.05 29 28290 13202 46644541
Liver carcinoma ruptured 16.29 12.05 3 28316 5 46657738
Acute lymphocytic leukaemia recurrent 16.22 12.05 12 28307 2083 46655660
Ocular icterus 15.95 12.05 15 28304 3625 46654118
Anion gap normal 15.93 12.05 3 28316 6 46657737
Cerebrovascular accident 15.77 12.05 23 28296 101016 46556727
Hepatitis B 15.77 12.05 15 28304 3678 46654065
Depression 15.60 12.05 52 28267 170052 46487691
Cholelithiasis 15.34 12.05 55 28264 38626 46619117
Gastrointestinal mucosal disorder 15.32 12.05 8 28311 749 46656994
Injection site swelling 15.17 12.05 3 28316 40324 46617419
Myocarditis 15.16 12.05 21 28298 7718 46650025
Epstein-Barr virus associated lymphoproliferative disorder 15.01 12.05 10 28309 1469 46656274
Intraventricular haemorrhage neonatal 14.90 12.05 5 28314 152 46657591
Septic shock 14.84 12.05 72 28247 57821 46599922
Drug eruption 14.83 12.05 37 28282 21292 46636451
Oedema 14.81 12.05 80 28239 66991 46590752
Cholangitis infective 14.78 12.05 5 28314 156 46657587
Pregnancy 14.76 12.05 43 28276 27094 46630649
Liver injury 14.71 12.05 31 28288 15970 46641773
Hepatitis 14.69 12.05 48 28271 32167 46625576
Renal tubular disorder 14.49 12.05 12 28307 2453 46655290
Sopor 14.42 12.05 35 28284 19793 46637950
Pelvic venous thrombosis 14.31 12.05 10 28309 1587 46656156
Bronchopulmonary aspergillosis 14.18 12.05 20 28299 7476 46650267
Transposition of the great vessels 14.18 12.05 5 28314 177 46657566
Graft versus host disease in gastrointestinal tract 14.13 12.05 12 28307 2538 46655205
Dyspnoea 14.12 12.05 224 28095 515324 46142419
Viral haemorrhagic cystitis 13.92 12.05 7 28312 606 46657137
Hyponatraemia 13.82 12.05 107 28212 101225 46556518
Transplantation complication 13.80 12.05 4 28315 74 46657669
Musculoskeletal stiffness 13.70 12.05 24 28295 97969 46559774
Wrong technique in product usage process 13.68 12.05 8 28311 54414 46603329
Hepatic artery stenosis 13.54 12.05 3 28316 17 46657726
Biliary cirrhosis 13.50 12.05 4 28315 80 46657663
Immunosuppressant drug level increased 13.39 12.05 13 28306 3269 46654474
Myositis 13.36 12.05 20 28299 7884 46649859
Hepatic mass 13.32 12.05 9 28310 1353 46656390
Urine uric acid increased 13.26 12.05 3 28316 19 46657724
Septic arthritis staphylococcal 13.25 12.05 6 28313 411 46657332
Systemic lupus erythematosus 13.24 12.05 12 28307 65168 46592575
Portal hypertensive gastropathy 13.24 12.05 7 28312 672 46657071
Upper respiratory tract inflammation 13.18 12.05 12 28307 2783 46654960
Hypokalaemia 13.16 12.05 95 28224 87929 46569814
Haematuria 13.14 12.05 41 28278 26817 46630926
Renal glycosuria 13.13 12.05 3 28316 20 46657723
Off label use 13.11 12.05 312 28007 379529 46278214
Biliary tract disorder 13.08 12.05 7 28312 689 46657054
Dizziness 12.96 12.05 138 28181 340276 46317467
Serum ferritin increased 12.94 12.05 16 28303 5267 46652476
Erythema multiforme 12.90 12.05 22 28297 9682 46648061
Graft versus host disease in skin 12.84 12.05 11 28308 2356 46655387
Caesarean section 12.82 12.05 30 28289 16573 46641170
Epstein-Barr virus infection 12.68 12.05 18 28301 6766 46650977
VIIIth nerve lesion 12.65 12.05 3 28316 24 46657719
Myocardial infarction 12.65 12.05 25 28294 97503 46560240
Mucosal inflammation 12.64 12.05 52 28267 38924 46618819
Lower respiratory tract infection 12.62 12.05 9 28310 55080 46602663
Bile duct stenosis 12.53 12.05 8 28311 1093 46656650
Pneumonia fungal 12.51 12.05 14 28305 4146 46653597
Neutropenia 12.33 12.05 137 28182 143067 46514676
Feeling abnormal 12.32 12.05 37 28282 125023 46532720
Psoriasis 12.16 12.05 18 28301 78586 46579157
Corynebacterium sepsis 12.14 12.05 3 28316 29 46657714
Right atrial dilatation 12.09 12.05 6 28313 505 46657238

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
Hepatic function abnormal 407.81 11.62 323 26806 41622 29883727
Hepatic encephalopathy 219.52 11.62 145 26984 14047 29911302
Hepatic cancer 185.77 11.62 99 27030 6449 29918900
Blood bilirubin increased 168.23 11.62 186 26943 36450 29888899
Hepatic failure 165.30 11.62 178 26951 33865 29891484
Liver disorder 154.21 11.62 161 26968 29561 29895788
Ascites 148.98 11.62 173 26956 35748 29889601
Infective pulmonary exacerbation of cystic fibrosis 145.83 11.62 93 27036 8479 29916870
Cholangitis 136.09 11.62 86 27043 7716 29917633
Venoocclusive liver disease 136.05 11.62 81 27048 6532 29918817
Palmar-plantar erythrodysaesthesia syndrome 118.13 11.62 102 27027 14768 29910581
Pyrexia 105.45 11.62 535 26594 293954 29631395
Hepatocellular carcinoma 95.31 11.62 75 27054 9535 29915814
Graft versus host disease 89.61 11.62 74 27055 10076 29915273
Platelet count decreased 89.40 11.62 254 26875 105875 29819474
Aspartate aminotransferase increased 82.17 11.62 179 26950 63243 29862106
Interstitial lung disease 80.39 11.62 172 26957 60025 29865324
Graft versus host disease in skin 74.58 11.62 43 27086 3264 29922085
Acute graft versus host disease in skin 74.33 11.62 48 27081 4468 29920881
Jaundice 74.07 11.62 117 27012 32369 29892980
Completed suicide 70.79 11.62 5 27124 99487 29825862
Acute graft versus host disease 69.71 11.62 51 27078 5813 29919536
Renal impairment 64.62 11.62 195 26934 83989 29841360
Cholangitis sclerosing 64.30 11.62 26 27103 894 29924455
Death 61.19 11.62 147 26982 357136 29568213
Cystitis haemorrhagic 60.02 11.62 43 27086 4744 29920605
Alanine aminotransferase increased 58.83 11.62 174 26955 74102 29851247
Disseminated intravascular coagulation 57.80 11.62 85 27044 22086 29903263
Cytomegalovirus infection 57.78 11.62 88 27041 23586 29901763
Toxicity to various agents 57.25 11.62 46 27083 177137 29748212
Chronic graft versus host disease 56.29 11.62 39 27090 4080 29921269
Myocardial infarction 55.79 11.62 22 27107 125603 29799746
Decreased appetite 55.22 11.62 275 26854 149635 29775714
Cytomegalovirus viraemia 53.15 11.62 43 27086 5686 29919663
Thrombotic microangiopathy 52.61 11.62 51 27078 8559 29916790
Dyspnoea 51.75 11.62 144 26985 333151 29592198
Gamma-glutamyltransferase increased 50.13 11.62 93 27036 29257 29896092
Oesophageal varices haemorrhage 49.16 11.62 32 27097 3019 29922330
Venoocclusive disease 48.82 11.62 30 27099 2560 29922789
Drug abuse 48.58 11.62 8 27121 82064 29843285
Febrile neutropenia 48.32 11.62 208 26921 106485 29818864
Acute graft versus host disease in liver 47.33 11.62 23 27106 1231 29924118
Drug-induced liver injury 46.25 11.62 75 27054 21199 29904150
Fatigue 45.81 11.62 144 26985 320529 29604820
Drug ineffective 45.78 11.62 157 26972 340230 29585119
Bile duct stone 44.15 11.62 27 27102 2284 29923065
Blood alkaline phosphatase increased 43.18 11.62 91 27038 31396 29893953
Engraftment syndrome 43.06 11.62 19 27110 814 29924535
White blood cell count decreased 42.98 11.62 170 26959 83777 29841572
Liver transplant rejection 42.81 11.62 26 27103 2172 29923177
Cholangitis acute 42.05 11.62 18 27111 716 29924633
Acute graft versus host disease in intestine 40.66 11.62 26 27103 2379 29922970
Hepatitis C 39.39 11.62 54 27075 13151 29912198
Hepatic cirrhosis 38.37 11.62 59 27070 15940 29909409
Hyperbilirubinaemia 35.84 11.62 59 27070 16883 29908466
Neutrophil count decreased 35.06 11.62 101 27028 42353 29882996
Dizziness 34.19 11.62 79 27050 194830 29730519
Cerebral infarction 33.61 11.62 74 27055 26299 29899050
Glomerulosclerosis 33.47 11.62 15 27114 667 29924682
Product dose omission issue 33.21 11.62 21 27108 91610 29833739
Amylase increased 30.90 11.62 32 27097 5809 29919540
Stomatitis 30.12 11.62 88 27041 37191 29888158
Liver carcinoma ruptured 29.62 11.62 9 27120 129 29925220
Pain 29.45 11.62 71 27058 172570 29752779
Hyperammonaemia 28.77 11.62 30 27099 5490 29919859
Anaemia 28.68 11.62 301 26828 207691 29717658
Cholelithiasis 28.36 11.62 59 27070 20166 29905183
Cerebrovascular accident 27.76 11.62 21 27108 83456 29841893
Blood lactate dehydrogenase increased 27.61 11.62 59 27070 20542 29904807
Intentional overdose 27.01 11.62 3 27126 41478 29883871
Eosinophilic colitis 26.88 11.62 9 27120 179 29925170
Hyperhidrosis 26.26 11.62 14 27115 67076 29858273
Altered state of consciousness 25.50 11.62 56 27073 19863 29905486
Hypoalbuminaemia 25.33 11.62 40 27089 11052 29914297
Cystic fibrosis related diabetes 25.28 11.62 8 27121 132 29925217
Graft versus host disease in liver 25.22 11.62 14 27115 988 29924361
Liver abscess 25.13 11.62 22 27107 3240 29922109
Anxiety 24.66 11.62 27 27102 89844 29835505
Overdose 24.65 11.62 24 27105 84313 29841036
Graft versus host disease in gastrointestinal tract 24.25 11.62 21 27108 3048 29922301
Liver transplant 23.83 11.62 20 27109 2782 29922567
Hepatorenal syndrome 23.61 11.62 19 27110 2492 29922857
Cardiac failure congestive 23.56 11.62 25 27104 84382 29840967
Coronary artery disease 23.23 11.62 8 27121 49704 29875645
Hyperuricaemia 23.21 11.62 31 27098 7363 29917986
Human herpesvirus 6 infection 23.20 11.62 17 27112 1941 29923408
Cytomegalovirus test positive 23.04 11.62 22 27107 3623 29921726
Fall 22.95 11.62 86 27043 181786 29743563
Joint swelling 22.92 11.62 7 27122 46939 29878410
Bile duct stenosis 22.54 11.62 14 27115 1217 29924132
Pleural effusion 22.50 11.62 129 27000 73937 29851412
Hemivertebra 22.50 11.62 7 27122 109 29925240
Enterocolitis 22.48 11.62 29 27100 6658 29918691
Discharge 22.15 11.62 7 27122 115 29925234
Stem cell transplant 21.92 11.62 17 27112 2114 29923235
Syncope 21.69 11.62 27 27102 84876 29840473
Viral haemorrhagic cystitis 21.59 11.62 12 27117 849 29924500
Aplasia 21.14 11.62 22 27107 4015 29921334
Drug eruption 21.01 11.62 48 27081 17478 29907871
Cystic fibrosis 20.95 11.62 17 27112 2257 29923092
Kidney fibrosis 20.08 11.62 16 27113 2069 29923280
Blood urea increased 19.77 11.62 68 27061 31313 29894036
Pulmonary alveolar haemorrhage 19.76 11.62 27 27102 6554 29918795
Peripheral swelling 19.50 11.62 16 27113 61058 29864291
Mucosal disorder 19.47 11.62 14 27115 1553 29923796
Autoimmune hepatitis 19.42 11.62 20 27109 3607 29921742
Haemobilia 19.41 11.62 8 27121 289 29925060
Hypoaldosteronism 19.30 11.62 7 27122 178 29925171
Pain in extremity 19.03 11.62 45 27084 110176 29815173
Pouchitis 18.81 11.62 10 27119 647 29924702
Hypotension 18.66 11.62 106 27023 200459 29724890
Rheumatoid arthritis 18.62 11.62 7 27122 41190 29884159
Adenovirus infection 18.41 11.62 21 27108 4247 29921102
Prothrombin level decreased 18.07 11.62 12 27117 1170 29924179
Proctitis haemorrhagic 18.02 11.62 3 27126 0 29925349
Blood albumin decreased 17.96 11.62 37 27092 12555 29912794
Psoriasis 17.95 11.62 8 27121 42498 29882851
Hepatic cancer recurrent 17.80 11.62 8 27121 358 29924991
Hyperplasia 17.69 11.62 9 27120 532 29924817
Cardiac disorder 17.66 11.62 7 27122 39886 29885463
Dilatation intrahepatic duct acquired 17.58 11.62 5 27124 56 29925293
Chronic obstructive pulmonary disease 17.50 11.62 10 27119 46116 29879233
Intentional product misuse 17.23 11.62 5 27124 34662 29890687
Erythema multiforme 17.14 11.62 28 27101 7957 29917392
C-reactive protein increased 16.83 11.62 81 27048 43392 29881957
Capillary leak syndrome 16.47 11.62 13 27116 1659 29923690
Varices oesophageal 16.40 11.62 18 27111 3491 29921858
Multiple organ dysfunction syndrome 16.38 11.62 106 27023 63381 29861968
Bronchopulmonary aspergillosis 16.25 11.62 35 27094 12249 29913100
Epstein-Barr virus associated lymphoproliferative disorder 16.09 11.62 13 27116 1715 29923634
Asthenia 16.05 11.62 126 27003 221164 29704185
Biliary tract infection 16.01 11.62 8 27121 455 29924894
Arthralgia 15.97 11.62 66 27063 135725 29789624
Cystitis viral 15.94 11.62 8 27121 459 29924890
Cholecystitis 15.90 11.62 30 27099 9549 29915800
Chest pain 15.90 11.62 54 27075 117573 29807776
Portal vein occlusion 15.89 11.62 5 27124 81 29925268
Oesophageal atresia 15.83 11.62 8 27121 466 29924883
Drug interaction 15.72 11.62 111 27018 199457 29725892
Memory impairment 15.69 11.62 7 27122 37167 29888182
Porphyria non-acute 15.58 11.62 8 27121 482 29924867
Faecalith 15.49 11.62 3 27126 4 29925345
Epstein-Barr virus infection 15.06 11.62 24 27105 6682 29918667
Portal vein thrombosis 14.87 11.62 17 27112 3447 29921902
Acute lymphocytic leukaemia recurrent 14.81 11.62 15 27114 2652 29922697
Feeling abnormal 14.54 11.62 18 27111 56738 29868611
Bacterial infection 14.52 11.62 34 27095 12576 29912773
Escherichia sepsis 14.50 11.62 18 27111 3976 29921373
Macroglossia 14.40 11.62 6 27123 223 29925126
Drug hypersensitivity 14.36 11.62 25 27104 68494 29856855
Pulmonary embolism 14.21 11.62 31 27098 78104 29847245
Antimitochondrial antibody positive 14.05 11.62 4 27125 45 29925304
Pancreatic enzymes increased 13.97 11.62 8 27121 599 29924750
Polychromasia 13.71 11.62 5 27124 129 29925220
Hepatic vein occlusion 13.68 11.62 5 27124 130 29925219
Staphylococcal sepsis 13.67 11.62 28 27101 9463 29915886
Tumour embolism 13.38 11.62 4 27125 54 29925295
Acute myocardial infarction 13.34 11.62 17 27112 52922 29872427
Vision blurred 13.29 11.62 11 27118 41805 29883544
Depression 13.27 11.62 40 27089 90397 29834952
Engraft failure 13.27 11.62 7 27122 446 29924903
Vanishing bile duct syndrome 13.26 11.62 8 27121 660 29924689
Cholestasis 13.13 11.62 51 27078 24899 29900450
Neonatal respiratory distress 13.05 11.62 7 27122 461 29924888
Cytomegalovirus duodenitis 12.93 11.62 4 27125 61 29925288
Bone marrow transplant 12.84 11.62 9 27120 959 29924390
Cytokine release syndrome 12.79 11.62 28 27101 9905 29915444
Haemophilic arthropathy 12.76 11.62 5 27124 158 29925191
Jaundice cholestatic 12.66 11.62 18 27111 4533 29920816
Headache 12.65 11.62 105 27024 182201 29743148
Hepatic vein stenosis 12.50 11.62 3 27126 16 29925333
Red blood cell schistocytes present 12.47 11.62 6 27123 314 29925035
Immunosuppressant drug level increased 12.21 11.62 18 27111 4684 29920665
Melanoderma 12.15 11.62 5 27124 180 29925169
Suicidal ideation 12.11 11.62 9 27120 36105 29889244
Drug intolerance 11.99 11.62 14 27115 45277 29880072
Musculoskeletal stiffness 11.95 11.62 9 27120 35872 29889477
Post transplant lymphoproliferative disorder 11.93 11.62 19 27110 5287 29920062
Transplant rejection 11.91 11.62 26 27103 9180 29916169
Lethargy 11.83 11.62 11 27118 39508 29885841
Cystic fibrosis hepatic disease 11.68 11.62 3 27126 22 29925327
Biliary tract disorder 11.63 11.62 8 27121 827 29924522

Pharmacologic Action:

SourceCodeDescription
ATC A05AA02 ALIMENTARY TRACT AND METABOLISM
BILE AND LIVER THERAPY
BILE THERAPY
Bile acids and derivatives
FDA CS M0002475 Bile Acids and Salts
FDA EPC N0000175802 Bile Acid
MeSH PA D002756 Cholagogues and Choleretics
MeSH PA D005765 Gastrointestinal Agents
CHEBI has role CHEBI:75771 mus musculus metabolite
CHEBI has role CHEBI:77746 h. sapiens metabolites

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Primary biliary cirrhosis indication 31712002 DOID:12236
Calculus in biliary tract indication 266474003
Cholelithiasis Prevention indication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.92 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Bile acid receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme WOMBAT-PK
G-protein coupled bile acid receptor 1 GPCR EC50 5.62 CHEMBL
M1-family alanyl aminopeptidase Unclassified IC50 5.59 CHEMBL

External reference:

IDSource
4019318 VUID
N0000147507 NUI
D00734 KEGG_DRUG
4019318 VANDF
C0042105 UMLSCUI
CHEBI:9907 CHEBI
CHEMBL1551 ChEMBL_ID
D014580 MESH_DESCRIPTOR_UI
4920 INN_ID
DB01586 DRUGBANK_ID
724L30Y2QR UNII
31401 PUBCHEM_CID
7104 IUPHAR_LIGAND_ID
11065 RXNORM
31954 MMSL
5659 MMSL
d01005 MMSL
001212 NDDF
108669000 SNOMEDCT_US
41143004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Actigall HUMAN PRESCRIPTION DRUG LABEL 1 0023-6145 CAPSULE 300 mg ORAL NDA 18 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-1730 CAPSULE 300 mg ORAL ANDA 18 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0527-1326 CAPSULE 300 mg ORAL ANDA 19 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-2998 TABLET 250 mg ORAL NDA AUTHORIZED GENERIC 24 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-3005 TABLET 500 mg ORAL NDA AUTHORIZED GENERIC 24 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-3159 CAPSULE 300 mg ORAL NDA authorized generic 18 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0615-1374 CAPSULE 300 mg ORAL NDA 17 sections
Ursodiol 200 mg HUMAN PRESCRIPTION DRUG LABEL 1 0722-7143 CAPSULE 200 mg ORAL ANDA 19 sections
Ursodiol 400 mg HUMAN PRESCRIPTION DRUG LABEL 1 0722-7144 CAPSULE 400 mg ORAL ANDA 19 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6221 CAPSULE 300 mg ORAL ANDA 12 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6890 TABLET, FILM COATED 250 mg ORAL ANDA 24 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 10135-543 CAPSULE 300 mg ORAL ANDA 18 sections
URSODIOL HUMAN PRESCRIPTION DRUG LABEL 1 16590-349 CAPSULE 300 mg ORAL NDA 17 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 24658-780 CAPSULE 300 mg ORAL ANDA 12 sections
Ursodiol Human Prescription Drug Label 1 42385-946 CAPSULE 300 mg ORAL ANDA 17 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 42806-503 CAPSULE 300 mg ORAL ANDA 12 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 49884-412 TABLET, FILM COATED 250 mg ORAL ANDA 24 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 49884-413 TABLET, FILM COATED 500 mg ORAL ANDA 24 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 50268-796 CAPSULE 300 mg ORAL ANDA 12 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 50268-797 CAPSULE 300 mg ORAL ANDA 17 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 51079-383 CAPSULE 300 mg ORAL ANDA 18 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 51224-151 CAPSULE 300 mg ORAL ANDA 19 sections
BAMBOO SALT Eunganggo Jook Yeom Toothpaste HUMAN OTC DRUG LABEL 7 53208-459 PASTE 0.02 g DENTAL OTC monograph not final 4 sections
BAMBOO SALT Eunganggo Jook Yeom HUMAN OTC DRUG LABEL 7 53208-505 PASTE 0.02 g DENTAL OTC monograph not final 8 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 54868-5033 CAPSULE 300 mg ORAL NDA AUTHORIZED GENERIC 17 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 55154-3355 CAPSULE 300 mg ORAL ANDA 12 sections
Urso 250 HUMAN PRESCRIPTION DRUG LABEL 1 58914-785 TABLET, FILM COATED 250 mg ORAL NDA 25 sections
Urso Forte HUMAN PRESCRIPTION DRUG LABEL 1 58914-790 TABLET, FILM COATED 500 mg ORAL NDA 25 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 60429-662 CAPSULE 300 mg ORAL ANDA 18 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 60687-100 CAPSULE 300 mg ORAL ANDA 19 sections