ursodiol ๐Ÿถ Veterinary Use | 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 ยตM/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 315.24 11.95 212 29787 32469 50542656
Blood bilirubin increased 198.17 11.95 159 29840 31879 50543246
Hepatic encephalopathy 197.87 11.95 102 29897 9534 50565591
Ascites 192.67 11.95 164 29835 35697 50539428
Hepatic failure 178.27 11.95 150 29849 32133 50542992
Pruritus 173.62 11.95 461 29538 283107 50292018
Liver disorder 140.97 11.95 140 29859 37082 50538043
Platelet count decreased 139.01 11.95 229 29770 100497 50474628
Infective pulmonary exacerbation of cystic fibrosis 134.93 11.95 74 29925 7835 50567290
Aspartate aminotransferase increased 132.25 11.95 195 29804 77803 50497322
Hepatocellular carcinoma 130.89 11.95 48 29951 1951 50573174
Jaundice 124.12 11.95 112 29887 26317 50548808
Hepatic cirrhosis 123.30 11.95 94 29905 17483 50557642
Venoocclusive liver disease 117.01 11.95 55 29944 4206 50570919
Graft versus host disease 111.60 11.95 60 29939 6106 50569019
Pain 102.23 11.95 116 29883 578787 49996338
Drug ineffective 101.76 11.95 209 29790 819124 49756001
Alanine aminotransferase increased 99.85 11.95 184 29815 88175 50486950
Febrile neutropenia 96.37 11.95 192 29807 97475 50477650
Blood alkaline phosphatase increased 96.31 11.95 115 29884 37411 50537714
Disseminated intravascular coagulation 95.34 11.95 80 29919 17055 50558070
Cholangitis 89.77 11.95 47 29952 4532 50570593
Cytomegalovirus infection 82.13 11.95 75 29924 17887 50557238
Pulmonary malformation 82.00 11.95 20 29979 187 50574938
Primary biliary cholangitis 80.90 11.95 29 29970 1103 50574022
Cholestasis 80.74 11.95 87 29912 25314 50549811
Drug hypersensitivity 74.27 11.95 28 29971 250982 50324143
Cholestasis of pregnancy 73.46 11.95 27 29972 1104 50574021
Interstitial lung disease 72.07 11.95 120 29879 53056 50522069
Contraindicated product administered 72.04 11.95 4 29995 148954 50426171
Joint swelling 71.51 11.95 28 29971 245258 50329867
Hepatic cancer 68.18 11.95 35 29964 3240 50571885
Drug intolerance 65.55 11.95 24 29975 219080 50356045
Renal impairment 63.22 11.95 139 29860 75522 50499603
Rheumatoid arthritis 62.62 11.95 21 29978 202529 50372596
Completed suicide 62.39 11.95 4 29995 131885 50443240
Neutrophil count decreased 61.21 11.95 103 29896 45923 50529202
Oesophageal varices haemorrhage 61.08 11.95 23 29976 1007 50574118
Hyperbilirubinaemia 60.21 11.95 48 29951 9522 50565603
Varices oesophageal 58.62 11.95 30 29969 2759 50572366
Portal hypertension 58.58 11.95 32 29967 3360 50571765
Aplastic anaemia 58.02 11.95 43 29956 7660 50567465
Pyrexia 55.36 11.95 400 29599 379803 50195322
Thrombotic microangiopathy 55.10 11.95 44 29955 8747 50566378
Lung cyst 54.86 11.95 14 29985 160 50574965
Acute graft versus host disease 51.38 11.95 31 29968 3927 50571198
Systemic lupus erythematosus 50.17 11.95 11 29988 140611 50434514
Decreased appetite 49.63 11.95 243 29756 200680 50374445
Alopecia 48.88 11.95 44 29955 245003 50330122
Total bile acids increased 48.29 11.95 12 29987 122 50575003
Blood alkaline phosphatase abnormal 48.17 11.95 15 29984 366 50574759
Autoimmune hepatitis 47.91 11.95 38 29961 7481 50567644
Anaemia 47.26 11.95 283 29716 252173 50322952
Sepsis 46.83 11.95 179 29820 132746 50442379
Treatment failure 46.67 11.95 12 29987 137625 50437500
Cytomegalovirus viraemia 46.43 11.95 31 29968 4678 50570447
Therapeutic product effect decreased 45.87 11.95 12 29987 136038 50439087
Drug-induced liver injury 45.78 11.95 69 29930 28026 50547099
Splenomegaly 45.45 11.95 41 29958 9619 50565506
Swelling 45.16 11.95 32 29967 200840 50374285
Chronic graft versus host disease 43.92 11.95 25 29974 2842 50572283
Cholangitis sclerosing 43.70 11.95 19 29980 1210 50573915
Hepatomegaly 43.45 11.95 42 29957 10751 50564374
Pancytopenia 42.72 11.95 128 29871 83902 50491223
Respiratory tract malformation 41.64 11.95 10 29989 87 50575038
Hypersensitivity 41.29 11.95 40 29959 215121 50360004
Cystic fibrosis 41.28 11.95 24 29975 2840 50572285
Abdominal discomfort 41.15 11.95 46 29953 231595 50343530
Acute graft versus host disease in skin 40.11 11.95 24 29975 2994 50572131
Hepatic fibrosis 38.80 11.95 24 29975 3178 50571947
Bile duct stone 38.09 11.95 24 29975 3283 50571842
Gamma-glutamyltransferase increased 37.67 11.95 65 29934 29558 50545567
Tonsillar haemorrhage 36.66 11.95 11 29988 236 50574889
Adenoviral hepatitis 36.62 11.95 11 29988 237 50574888
Liver transplant rejection 36.24 11.95 17 29982 1293 50573832
Arthralgia 36.16 11.95 136 29863 438566 50136559
Pain in extremity 35.85 11.95 67 29932 272798 50302327
Cystitis haemorrhagic 35.61 11.95 24 29975 3678 50571447
Sinusitis 34.74 11.95 30 29969 170528 50404597
Cardiac failure 34.18 11.95 111 29888 75929 50499196
Hypoproteinaemia 33.64 11.95 18 29981 1813 50573312
Hypoalbuminaemia 33.50 11.95 35 29964 9825 50565300
Maternal exposure during breast feeding 33.49 11.95 22 29977 3232 50571893
White blood cell count decreased 33.06 11.95 147 29852 116575 50458550
Venoocclusive disease 33.05 11.95 18 29981 1878 50573247
Portal hypertensive gastropathy 32.94 11.95 13 29986 647 50574478
Exposure via breast milk 32.94 11.95 17 29982 1591 50573534
Palmar-plantar erythrodysaesthesia syndrome 32.23 11.95 49 29950 20049 50555076
Multiple organ dysfunction syndrome 31.80 11.95 83 29916 50254 50524871
CFTR gene mutation 31.71 11.95 8 29991 87 50575038
Premature baby 31.25 11.95 46 29953 18291 50556834
Lower respiratory tract infection 30.95 11.95 9 29990 95192 50479933
Pericarditis 30.51 11.95 5 29994 78684 50496441
Cytokine release syndrome 29.97 11.95 31 29968 8603 50566522
Pneumonia cytomegaloviral 29.93 11.95 17 29982 1924 50573201
Hepatitis fulminant 29.78 11.95 20 29979 3048 50572077
Coagulation test abnormal 29.20 11.95 12 29987 664 50574461
Fatigue 29.14 11.95 274 29725 707327 49867798
Discomfort 28.96 11.95 14 29985 108366 50466759
Liver transplant 28.45 11.95 17 29982 2115 50573010
Hepatic necrosis 28.15 11.95 24 29975 5224 50569901
Infusion related reaction 26.61 11.95 37 29962 169520 50405605
Vanishing bile duct syndrome 26.47 11.95 11 29988 626 50574499
Candida test positive 26.36 11.95 12 29987 852 50574273
Blood lactate dehydrogenase increased 26.29 11.95 44 29955 19518 50555607
Hyperammonaemia 26.16 11.95 22 29977 4702 50570423
Ammonia increased 26.10 11.95 21 29978 4220 50570905
Lactation disorder 25.55 11.95 9 29990 325 50574800
Spider naevus 25.43 11.95 7 29992 109 50575016
Cytomegalovirus test positive 25.40 11.95 17 29982 2575 50572550
Therapy interrupted 25.33 11.95 44 29955 20108 50555017
Venous haemorrhage 25.24 11.95 8 29991 207 50574918
Hepatitis cholestatic 24.99 11.95 24 29975 6093 50569032
Pleural effusion 24.91 11.95 105 29894 81349 50493776
Haemorrhage subcutaneous 24.77 11.95 17 29982 2684 50572441
Faeces soft 24.66 11.95 20 29979 4064 50571061
Bacterial sepsis 24.62 11.95 19 29980 3593 50571532
Neutropenia 24.58 11.95 161 29838 147804 50427321
Adenovirus infection 24.57 11.95 18 29981 3150 50571975
Transfusion 24.38 11.95 34 29965 12871 50562254
Hyperuricaemia 24.29 11.95 21 29978 4659 50570466
Bronchopulmonary aspergillosis 24.11 11.95 26 29973 7566 50567559
Product prescribing error 24.08 11.95 44 29955 20917 50554208
Impaired healing 23.81 11.95 6 29993 69780 50505345
Enterocolitis 23.55 11.95 24 29975 6543 50568582
Septic shock 23.50 11.95 81 29918 57094 50518031
Injection site pain 23.25 11.95 19 29980 111005 50464120
Therapy cessation 23.09 11.95 49 29950 25962 50549163
Haemophagocytic lymphohistiocytosis 23.03 11.95 27 29972 8606 50566519
Alagille syndrome 22.96 11.95 4 29995 4 50575121
Aspergillus infection 22.79 11.95 24 29975 6797 50568328
Foetal exposure during pregnancy 22.53 11.95 50 29949 27309 50547816
Staphylococcal sepsis 22.18 11.95 24 29975 7012 50568113
Mucosal inflammation 22.16 11.95 63 29936 40079 50535046
Loss of personal independence in daily activities 22.08 11.95 7 29992 70043 50505082
Intentional overdose 22.06 11.95 5 29994 62499 50512626
Enterococcal sepsis 21.94 11.95 12 29987 1263 50573862
Hepatitis C 21.44 11.95 20 29979 4897 50570228
Musculoskeletal stiffness 21.20 11.95 27 29972 128454 50446671
Wound 21.06 11.95 19 29980 105775 50469350
Histoplasmosis 20.85 11.95 13 29986 1746 50573379
Premature delivery 20.34 11.95 44 29955 23619 50551506
Coma hepatic 20.21 11.95 9 29990 607 50574518
Cardiac tamponade 19.98 11.95 18 29981 4214 50570911
Cholangitis acute 19.81 11.95 8 29991 423 50574702
Graft versus host disease in gastrointestinal tract 19.77 11.95 15 29984 2766 50572359
Stomatitis 19.15 11.95 114 29885 101230 50473895
Altered state of consciousness 19.13 11.95 41 29958 21869 50553256
Epstein-Barr virus infection 18.86 11.95 22 29977 6975 50568150
Hyponatraemia 18.72 11.95 109 29890 96030 50479095
Gait disturbance 18.66 11.95 38 29961 149967 50425158
Serum ferritin increased 18.64 11.95 19 29980 5183 50569942
Premature labour 18.43 11.95 28 29971 11448 50563677
Irritable bowel syndrome 18.38 11.95 4 29995 51437 50523688
Blood creatine phosphokinase increased 18.23 11.95 45 29954 26322 50548803
Myocarditis 18.19 11.95 23 29976 7924 50567201
Engraftment syndrome 18.12 11.95 7 29992 329 50574796
Osteoarthritis 18.11 11.95 9 29990 68597 50506528
Enterocolitis bacterial 18.06 11.95 6 29993 181 50574944
Haematuria 18.01 11.95 44 29955 25569 50549556
Nasopharyngitis 17.73 11.95 57 29942 192870 50382255
Spinal compression fracture 17.72 11.95 29 29970 12627 50562498
Gestational diabetes 17.71 11.95 22 29977 7443 50567682
Fixed eruption 17.56 11.95 9 29990 830 50574295
Allergic sinusitis 17.53 11.95 8 29991 571 50574554
Overdose 17.47 11.95 20 29979 99707 50475418
Bicytopenia 17.32 11.95 12 29987 1924 50573201
Foetor hepaticus 17.22 11.95 3 29996 3 50575122
Acute lymphocytic leukaemia recurrent 17.10 11.95 12 29987 1963 50573162
Hallucination, tactile 17.00 11.95 6 29993 218 50574907
Pregnancy 16.89 11.95 47 29952 29530 50545595
Hepatitis B 16.88 11.95 15 29984 3451 50571674
Ocular icterus 16.84 11.95 15 29984 3460 50571665
Cystic fibrosis lung 16.54 11.95 5 29994 110 50575015
Gastrointestinal disorder 16.48 11.95 19 29980 94437 50480688
Pre-eclampsia 16.41 11.95 22 29977 8022 50567103
Mobility decreased 16.34 11.95 14 29985 79934 50495191
Blister 16.22 11.95 16 29983 85402 50489723
Amylase increased 16.21 11.95 18 29981 5412 50569713
Peripheral swelling 16.17 11.95 65 29934 205871 50369254
Pelvic venous thrombosis 16.17 11.95 10 29989 1324 50573801
Product administered to patient of inappropriate age 16.13 11.95 13 29986 2617 50572508
Hepatitis 16.05 11.95 48 29951 31405 50543720
Blood albumin abnormal 16.04 11.95 7 29992 450 50574675
Anion gap normal 16.00 11.95 3 29996 6 50575119
Congenital cystic lung 15.98 11.95 4 29995 42 50575083
Eczema 15.97 11.95 39 29960 22663 50552462
Biliary tract disorder 15.90 11.95 8 29991 710 50574415
Cardiac failure high output 15.84 11.95 6 29993 267 50574858
Blood bilirubin abnormal 15.71 11.95 8 29991 728 50574397
Chronic obstructive pulmonary disease 15.71 11.95 6 29993 53429 50521696
Lip pruritus 15.64 11.95 8 29991 735 50574390
Arthritis 15.62 11.95 17 29982 86704 50488421
Liver carcinoma ruptured 15.40 11.95 3 29996 8 50575117
Pancreatitis relapsing 15.30 11.95 8 29991 769 50574356
Oedema 15.27 11.95 82 29917 70099 50505026
Mucosal disorder 15.22 11.95 11 29988 1884 50573241
Contusion 15.19 11.95 27 29972 112156 50462969
Off label use 15.17 11.95 378 29621 474048 50101077
Upper respiratory tract inflammation 15.06 11.95 12 29987 2377 50572748
Low birth weight baby 15.04 11.95 18 29981 5863 50569262
Syndactyly 14.68 11.95 6 29993 327 50574798
Transposition of the great vessels 14.62 11.95 5 29994 165 50574960
Hepatic vein occlusion 14.32 11.95 4 29995 66 50575059
Iron deficiency anaemia 14.12 11.95 31 29968 16803 50558322
Injection site reaction 14.08 11.95 6 29993 50026 50525099
Pneumonia fungal 14.08 11.95 15 29984 4305 50570820
Epstein-Barr virus associated lymphoproliferative disorder 14.02 11.95 10 29989 1679 50573446
Necrotising gastritis 13.99 11.95 4 29995 72 50575053
Muscle spasms 13.82 11.95 34 29965 125519 50449606
Biliary cirrhosis 13.74 11.95 4 29995 77 50575048
Gallbladder enlargement 13.58 11.95 7 29992 653 50574472
Cerebrovascular accident 13.54 11.95 22 29977 94658 50480467
Cerebral haemorrhage 13.53 11.95 41 29958 27011 50548114
Pulmonary arterial hypertension 13.34 11.95 34 29965 20285 50554840
Renal glycosuria 13.33 11.95 3 29996 19 50575106
Poor sucking reflex 13.32 11.95 5 29994 217 50574908
Aspartate aminotransferase abnormal 13.30 11.95 8 29991 1008 50574117
Migraine 13.29 11.95 15 29984 75265 50499860
Viral haemorrhagic cystitis 13.26 11.95 7 29992 686 50574439
Abdominal pain 13.23 11.95 205 29794 236023 50339102
Cholelithiasis 13.23 11.95 51 29948 37922 50537203
Gastrointestinal mucosal disorder 13.22 11.95 7 29992 690 50574435
Hospitalisation 13.20 11.95 77 29922 67860 50507265
Erythema multiforme 13.03 11.95 21 29978 9029 50566096
Liver sarcoidosis 12.72 11.95 3 29996 24 50575101
Abscess rupture 12.53 11.95 5 29994 256 50574869
Transplantation complication 12.53 11.95 4 29995 106 50575019
Wheezing 12.52 11.95 11 29988 62036 50513089
Gastrointestinal infection 12.42 11.95 18 29981 7056 50568069
Diffuse large B-cell lymphoma 12.35 11.95 16 29983 5646 50569479
Dyspnoea 12.26 11.95 240 29759 547368 50027757
Pulmonary haemorrhage neonatal 12.21 11.95 3 29996 29 50575096
Cystic fibrosis respiratory infection suppression 12.19 11.95 5 29994 275 50574850
Forced expiratory volume decreased 12.15 11.95 14 29985 4380 50570745
Hypoaesthesia 12.10 11.95 37 29962 127220 50447905
Acute graft versus host disease in intestine 12.01 11.95 9 29990 1630 50573495
Culture stool positive 11.97 11.95 5 29994 288 50574837
Pneumothorax 11.95 11.95 26 29973 14008 50561117

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 320.13 12.06 280 28125 38979 29507143
Hepatic encephalopathy 240.34 12.06 152 28253 12883 29533239
Hepatic cancer 178.86 12.06 98 28307 6358 29539764
Hepatic failure 173.38 12.06 181 28224 31331 29514791
Infective pulmonary exacerbation of cystic fibrosis 170.94 12.06 94 28311 6142 29539980
Blood bilirubin increased 150.56 12.06 174 28231 33719 29512403
Cholangitis 144.19 12.06 90 28315 7447 29538675
Hepatocellular carcinoma 142.15 12.06 87 28318 6951 29539171
Venoocclusive liver disease 135.87 12.06 84 28321 6833 29539289
Ascites 134.92 12.06 171 28234 36448 29509674
Palmar-plantar erythrodysaesthesia syndrome 125.64 12.06 108 28297 14651 29531471
Liver disorder 120.78 12.06 141 28264 27608 29518514
Pyrexia 102.86 12.06 545 27860 287077 29259045
Platelet count decreased 91.89 12.06 264 28141 104408 29441714
Aspartate aminotransferase increased 90.46 12.06 186 28219 59539 29486583
Interstitial lung disease 87.70 12.06 180 28225 57538 29488584
Jaundice 75.17 12.06 115 28290 29181 29516941
Renal impairment 68.30 12.06 202 28203 81131 29464991
Decreased appetite 68.03 12.06 298 28107 145044 29401078
Completed suicide 64.77 12.06 6 28399 90240 29455882
Alanine aminotransferase increased 63.21 12.06 180 28225 70764 29475358
Graft versus host disease in skin 61.24 12.06 39 28366 3340 29542782
Toxicity to various agents 59.26 12.06 48 28357 173613 29372509
Cholangitis sclerosing 59.11 12.06 26 28379 1041 29545081
Acute graft versus host disease 58.66 12.06 47 28358 5777 29540345
Graft versus host disease 55.96 12.06 57 28348 9571 29536551
Cystitis haemorrhagic 55.10 12.06 42 28363 4800 29541322
Gamma-glutamyltransferase increased 55.04 12.06 95 28310 26642 29519480
Oesophageal varices haemorrhage 53.53 12.06 33 28372 2669 29543453
Disseminated intravascular coagulation 53.47 12.06 80 28325 19900 29526222
Death 53.21 12.06 161 28244 341923 29204199
Myocardial infarction 52.72 12.06 20 28385 110276 29435846
Acute graft versus host disease in skin 52.08 12.06 40 28365 4624 29541498
Febrile neutropenia 51.60 12.06 229 28176 112011 29434111
Drug abuse 50.72 12.06 8 28397 79875 29466247
Drug ineffective 50.23 12.06 180 28225 362990 29183132
Dyspnoea 49.22 12.06 156 28249 326576 29219546
Venoocclusive disease 45.25 12.06 29 28376 2510 29543612
Cholangitis acute 44.93 12.06 19 28386 690 29545432
Aplastic anaemia 44.62 12.06 45 28360 7465 29538657
Organic brain syndrome 42.57 12.06 14 28391 247 29545875
Blood alkaline phosphatase increased 42.40 12.06 88 28317 28318 29517804
Cytomegalovirus infection 42.03 12.06 78 28327 23137 29522985
Fatigue 41.81 12.06 160 28245 316661 29229461
Bile duct stone 40.93 12.06 26 28379 2216 29543906
Drug-induced liver injury 40.77 12.06 74 28331 21581 29524541
White blood cell count decreased 39.74 12.06 172 28233 83190 29462932
Product dose omission issue 39.05 12.06 22 28383 96361 29449761
Cytomegalovirus viraemia 37.79 12.06 38 28367 6282 29539840
Stomatitis 36.83 12.06 98 28307 37015 29509107
Liver transplant rejection 36.31 12.06 23 28382 1951 29544171
Hepatic cirrhosis 36.05 12.06 56 28349 14388 29531734
Hepatitis C 35.00 12.06 43 28362 8867 29537255
Urge incontinence 33.65 12.06 14 28391 488 29545634
Engraftment syndrome 32.55 12.06 16 28389 827 29545295
Philadelphia positive chronic myeloid leukaemia 32.51 12.06 9 28396 85 29546037
Amylase increased 32.03 12.06 32 28373 5248 29540874
Hyperbilirubinaemia 31.96 12.06 54 28351 14880 29531242
Glomerulosclerosis 31.85 12.06 15 28390 705 29545417
Neutrophil count decreased 31.69 12.06 103 28302 43464 29502658
Bladder hypertrophy 31.18 12.06 14 28391 589 29545533
Aplasia 31.09 12.06 28 28377 4035 29542087
Anxiety 29.82 12.06 23 28382 85342 29460780
Cerebrovascular accident 29.12 12.06 19 28386 76892 29469230
Cystic fibrosis related diabetes 28.72 12.06 9 28396 135 29545987
Mucosal disorder 28.68 12.06 18 28387 1502 29544620
Cerebral infarction 28.47 12.06 69 28336 24606 29521516
Anaemia 28.26 12.06 306 28099 200645 29345477
Dizziness 28.16 12.06 91 28314 189593 29356529
Retinitis viral 28.14 12.06 8 28397 84 29546038
Thrombotic microangiopathy 27.99 12.06 38 28367 8643 29537479
Fall 27.72 12.06 83 28322 177095 29369027
Liver carcinoma ruptured 27.51 12.06 9 28396 156 29545966
Joint swelling 27.27 12.06 7 28398 49623 29496499
Hyperammonaemia 26.68 12.06 30 28375 5633 29540489
Hyperuricaemia 26.66 12.06 33 28372 6856 29539266
Intentional overdose 26.49 12.06 3 28402 38525 29507597
Liver transplant 26.16 12.06 20 28385 2296 29543826
Overdose 26.02 12.06 23 28382 79796 29466326
Hypoalbuminaemia 25.78 12.06 40 28365 10265 29535857
Hyperhidrosis 25.74 12.06 15 28390 64525 29481597
Chronic graft versus host disease 25.52 12.06 25 28380 4004 29542118
Eosinophilic colitis 25.39 12.06 9 28396 201 29545921
Bile duct stenosis 25.12 12.06 15 28390 1145 29544977
Altered state of consciousness 24.44 12.06 57 28348 19832 29526290
Cholelithiasis 23.48 12.06 54 28351 18618 29527504
Graft versus host disease in liver 23.40 12.06 14 28391 1072 29545050
Hypotension 23.15 12.06 102 28303 194252 29351870
Acute graft versus host disease in liver 23.15 12.06 15 28390 1323 29544799
Oesophagitis 22.76 12.06 41 28364 11882 29534240
Viral haemorrhagic cystitis 22.58 12.06 13 28392 927 29545195
Peripheral swelling 22.47 12.06 17 28388 63722 29482400
Hemivertebra 22.28 12.06 7 28398 106 29546016
Hepatorenal syndrome 21.93 12.06 18 28387 2288 29543834
Liver abscess 21.68 12.06 21 28384 3317 29542805
Mucosal inflammation 21.46 12.06 73 28332 31522 29514600
Dilatation intrahepatic duct acquired 21.46 12.06 6 28399 59 29546063
Enterocolitis 21.22 12.06 29 28376 6637 29539485
Coronary artery disease 21.11 12.06 8 28397 44182 29501940
Graft versus host disease in gastrointestinal tract 20.23 12.06 20 28385 3238 29542884
Pain in extremity 20.07 12.06 48 28357 110385 29435737
Asthenia 19.99 12.06 123 28282 215127 29330995
Cytokine release syndrome 19.99 12.06 41 28364 13078 29533044
Portal vein thrombosis 19.97 12.06 20 28385 3289 29542833
Acute graft versus host disease in intestine 19.64 12.06 17 28388 2324 29543798
Cardiac failure congestive 19.53 12.06 27 28378 76554 29469568
Kidney fibrosis 19.52 12.06 16 28389 2031 29544091
Cystic fibrosis 19.35 12.06 14 28391 1478 29544644
Hypoaldosteronism 19.12 12.06 7 28398 172 29545950
Discharge 18.97 12.06 7 28398 176 29545946
Pruritus allergic 18.89 12.06 7 28398 178 29545944
Intentional product misuse 18.83 12.06 5 28400 34656 29511466
Haemobilia 18.68 12.06 8 28397 300 29545822
Memory impairment 18.46 12.06 6 28399 36464 29509658
Adenovirus infection 18.34 12.06 22 28383 4425 29541697
Pleural effusion 18.28 12.06 125 28280 71783 29474339
Blood urea increased 18.26 12.06 64 28341 28048 29518074
Biliary tract infection 18.00 12.06 9 28396 483 29545639
Proctitis haemorrhagic 17.85 12.06 3 28402 0 29546122
Cytomegalovirus test positive 17.62 12.06 19 28386 3404 29542718
Gallbladder polyp 17.48 12.06 8 28397 352 29545770
Cardiac disorder 17.38 12.06 7 28398 37256 29508866
Blood lactate dehydrogenase increased 17.33 12.06 49 28356 19160 29526962
Folliculitis 17.25 12.06 20 28385 3880 29542242
Hyperplasia 17.25 12.06 9 28396 528 29545594
Chronic obstructive pulmonary disease 17.08 12.06 9 28396 40946 29505176
Heart rate increased 17.08 12.06 8 28397 38930 29507192
Acute lymphocytic leukaemia recurrent 16.66 12.06 16 28389 2500 29543622
Erythema multiforme 16.64 12.06 28 28377 7689 29538433
Pancreatic enzymes increased 16.54 12.06 9 28396 575 29545547
Capillary leak syndrome 16.36 12.06 14 28391 1885 29544237
Prothrombin level decreased 16.22 12.06 11 28394 1047 29545075
Arthralgia 16.17 12.06 74 28331 139543 29406579
Pouchitis 16.13 12.06 9 28396 604 29545518
Colitis ulcerative 16.13 12.06 37 28368 12732 29533390
Porphyria non-acute 15.60 12.06 8 28397 453 29545669
Oesophageal atresia 15.40 12.06 8 28397 465 29545657
Drug eruption 15.39 12.06 43 28362 16698 29529424
Varicella zoster virus infection 15.11 12.06 12 28393 1456 29544666
Vision blurred 15.10 12.06 10 28395 40166 29505956
C-reactive protein increased 15.07 12.06 83 28322 44180 29501942
Benign hepatic neoplasm 14.56 12.06 3 28402 6 29546116
Musculoskeletal stiffness 14.52 12.06 9 28396 37449 29508673
Jaundice cholestatic 14.39 12.06 19 28386 4207 29541915
Adjustment disorder 14.38 12.06 10 28395 991 29545131
Antimitochondrial antibody positive 14.33 12.06 4 28401 39 29546083
Cholecystitis 14.32 12.06 29 28376 9168 29536954
Wheezing 14.31 12.06 7 28398 33233 29512889
Cataract subcapsular 14.27 12.06 7 28398 360 29545762
Peroneal nerve palsy 14.21 12.06 15 28390 2624 29543498
Suicidal ideation 13.94 12.06 8 28397 34708 29511414
Pain 13.88 12.06 102 28303 171330 29374792
Stem cell transplant 13.85 12.06 13 28392 1974 29544148
Escherichia sepsis 13.83 12.06 18 28387 3931 29542191
Tumour embolism 13.82 12.06 4 28401 45 29546077
Blood albumin decreased 13.81 12.06 33 28372 11662 29534460
Chest pain 13.78 12.06 58 28347 111915 29434207
Paraesthesia 13.71 12.06 19 28386 53826 29492296
Varices oesophageal 13.69 12.06 16 28389 3130 29542992
Polychromasia 13.65 12.06 5 28400 123 29545999
Initial insomnia 13.58 12.06 15 28390 2760 29543362
Psoriasis 13.56 12.06 7 28398 32220 29513902
Pulmonary alveolar haemorrhage 13.55 12.06 23 28382 6357 29539765
Syncope 13.52 12.06 37 28368 81334 29464788
Rheumatoid arthritis 13.50 12.06 7 28398 32145 29513977
Liver function test increased 13.46 12.06 33 28372 11852 29534270
Muscle twitching 13.32 12.06 26 28379 8000 29538122
Lethargy 13.27 12.06 10 28395 37570 29508552
Toxic epidermal necrolysis 13.26 12.06 43 28362 18110 29528012
Organising pneumonia 13.19 12.06 20 28385 5028 29541094
Cystic fibrosis lung 13.15 12.06 4 28401 54 29546068
Bacterial disease carrier 13.12 12.06 7 28398 430 29545692
Feeling abnormal 13.09 12.06 20 28385 54425 29491697
Sweat test abnormal 13.03 12.06 3 28402 12 29546110
Drug interaction 13.01 12.06 124 28281 197261 29348861
Cytomegalovirus duodenitis 12.95 12.06 4 28401 57 29546065
Rectal tenesmus 12.94 12.06 8 28397 650 29545472
Headache 12.93 12.06 106 28299 173901 29372221
Oedema due to hepatic disease 12.66 12.06 3 28402 14 29546108
Taste disorder 12.59 12.06 19 28386 4757 29541365
Pulmonary embolism 12.56 12.06 35 28370 76499 29469623
Portal vein occlusion 12.53 12.06 4 28401 64 29546058
Gallbladder enlargement 12.51 12.06 9 28396 942 29545180
Enteritis infectious 12.48 12.06 10 28395 1229 29544893
Hepatic cancer recurrent 12.47 12.06 6 28399 296 29545826
Acute myocardial infarction 12.42 12.06 17 28388 48421 29497701
Drug intolerance 12.39 12.06 17 28388 48362 29497760
Antithrombin III decreased 12.32 12.06 6 28399 304 29545818
Injection site pain 12.29 12.06 8 28397 32438 29513684
Hepatitis C RNA positive 12.24 12.06 5 28400 166 29545956
Drug hypersensitivity 12.21 12.06 30 28375 68376 29477746

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
Hepatic function abnormal 500.02 11.18 410 50289 63903 64384130
Hepatic encephalopathy 410.73 11.18 237 50462 20829 64427204
Hepatic failure 315.49 11.18 296 50403 55098 64392935
Blood bilirubin increased 294.63 11.18 290 50409 57263 64390770
Ascites 287.31 11.18 296 50403 61705 64386328
Infective pulmonary exacerbation of cystic fibrosis 246.77 11.18 139 50560 11657 64436376
Venoocclusive liver disease 245.38 11.18 131 50568 9884 64438149
Hepatic cancer 218.62 11.18 110 50589 7338 64440695
Platelet count decreased 218.26 11.18 436 50263 167275 64280758
Hepatocellular carcinoma 211.75 11.18 112 50587 8291 64439742
Liver disorder 210.59 11.18 234 50465 53117 64394916
Cholangitis 198.52 11.18 117 50582 10685 64437348
Aspartate aminotransferase increased 167.36 11.18 321 50378 119467 64328566
Jaundice 155.10 11.18 191 50508 48321 64399712
Completed suicide 140.90 11.18 9 50690 224405 64223628
Palmar-plantar erythrodysaesthesia syndrome 130.54 11.18 136 50563 28683 64419350
Hepatic cirrhosis 127.99 11.18 129 50570 26169 64421864
Pyrexia 125.80 11.18 809 49890 557835 63890198
Interstitial lung disease 119.75 11.18 248 50451 97484 64350549
Alanine aminotransferase increased 116.67 11.18 304 50395 138727 64309306
Disseminated intravascular coagulation 114.26 11.18 134 50565 32214 64415819
Graft versus host disease 113.39 11.18 91 50608 13722 64434311
Renal impairment 112.04 11.18 294 50405 134723 64313310
Decreased appetite 110.74 11.18 476 50223 280813 64167220
Drug ineffective 101.19 11.18 332 50367 839915 63608118
Febrile neutropenia 98.60 11.18 348 50351 187309 64260724
Aplastic anaemia 98.21 11.18 84 50615 13836 64434197
Pruritus 95.37 11.18 491 50208 311909 64136124
Cytomegalovirus infection 94.80 11.18 131 50568 37068 64410965
Blood alkaline phosphatase increased 93.96 11.18 163 50536 56116 64391917
Pain 93.36 11.18 184 50515 553327 63894706
Oesophageal varices haemorrhage 90.38 11.18 48 50651 3581 64444452
Toxicity to various agents 89.85 11.18 92 50607 363421 64084612
Cystitis haemorrhagic 86.51 11.18 62 50637 7894 64440139
Joint swelling 85.86 11.18 31 50668 215351 64232682
Drug intolerance 80.30 11.18 24 50675 187968 64260065
Hyperbilirubinaemia 76.81 11.18 89 50610 21116 64426917
Venoocclusive disease 75.41 11.18 44 50655 3941 64444092
Anaemia 75.13 11.18 532 50167 378148 64069885
Neutrophil count decreased 74.38 11.18 178 50521 77018 64371015
Gamma-glutamyltransferase increased 72.63 11.18 134 50565 48376 64399657
Drug-induced liver injury 71.83 11.18 132 50567 47511 64400522
Primary biliary cholangitis 68.74 11.18 27 50672 994 64447039
Cholestasis 68.51 11.18 125 50574 44747 64403286
Rheumatoid arthritis 66.57 11.18 23 50676 164271 64283762
Contraindicated product administered 65.67 11.18 5 50694 107824 64340209
Cholangitis sclerosing 64.23 11.18 31 50668 1888 64446145
Cholestasis of pregnancy 64.17 11.18 25 50674 900 64447133
Bile duct stone 64.00 11.18 43 50656 4935 64443098
Drug hypersensitivity 63.60 11.18 56 50643 237759 64210274
Acute graft versus host disease 62.42 11.18 54 50645 9030 64439003
Hepatitis C 60.99 11.18 58 50641 10957 64437076
Fatigue 60.41 11.18 344 50355 748386 63699647
White blood cell count decreased 60.37 11.18 265 50434 157572 64290461
Acute graft versus host disease in skin 60.20 11.18 47 50652 6808 64441225
Cytomegalovirus viraemia 56.16 11.18 55 50644 10773 64437260
Varices oesophageal 53.54 11.18 39 50660 5091 64442942
Pulmonary malformation 53.18 11.18 14 50685 134 64447899
Arthralgia 52.82 11.18 175 50524 442085 64005948
Pain in extremity 51.62 11.18 100 50599 302985 64145048
Dyspnoea 50.76 11.18 344 50355 718330 63729703
Drug abuse 49.51 11.18 21 50678 132353 64315680
Therapeutic product effect decreased 48.74 11.18 15 50684 115336 64332697
Graft versus host disease in skin 47.69 11.18 37 50662 5310 64442723
Pancytopenia 46.96 11.18 230 50469 143079 64304954
Liver transplant rejection 46.15 11.18 29 50670 2970 64445063
Thrombotic microangiopathy 45.99 11.18 61 50638 16594 64431439
Myocardial infarction 45.59 11.18 38 50661 165783 64282250
Intentional overdose 45.31 11.18 8 50691 89936 64358097
Hypoalbuminaemia 44.65 11.18 62 50637 17612 64430421
Sinusitis 44.54 11.18 30 50669 145898 64302135
Chronic graft versus host disease 44.53 11.18 38 50661 6238 64441795
Hyperuricaemia 44.19 11.18 47 50652 10144 64437889
Hyperammonaemia 43.52 11.18 46 50653 9858 64438175
Autoimmune hepatitis 42.83 11.18 46 50653 10038 64437995
Portal hypertension 42.79 11.18 37 50662 6182 64441851
Mucosal inflammation 42.70 11.18 127 50572 62457 64385576
Cystic fibrosis 42.56 11.18 29 50670 3405 64444628
Swelling 42.48 11.18 38 50661 160180 64287853
Liver transplant 42.46 11.18 31 50668 4061 64443972
Cholangitis acute 40.98 11.18 20 50679 1248 64446785
Overdose 40.94 11.18 39 50660 159527 64288506
Altered state of consciousness 40.44 11.18 91 50608 37811 64410222
Engraftment syndrome 40.36 11.18 19 50680 1094 64446939
Cytokine release syndrome 39.65 11.18 64 50635 20765 64427268
Stomatitis 39.61 11.18 181 50518 109424 64338609
Glossodynia 39.39 11.18 3 50696 64693 64383340
Amylase increased 39.07 11.18 43 50656 9642 64438391
Splenomegaly 38.09 11.18 58 50641 17903 64430130
Lung cyst 37.85 11.18 11 50688 156 64447877
Musculoskeletal stiffness 35.41 11.18 27 50672 123179 64324854
Lower respiratory tract infection 35.39 11.18 15 50684 94599 64353434
Multiple organ dysfunction syndrome 34.82 11.18 165 50534 101248 64346785
Enterocolitis 34.70 11.18 45 50654 11973 64436060
Pleural effusion 34.47 11.18 193 50506 126366 64321667
Sepsis 34.22 11.18 303 50396 230038 64217995
Adenovirus infection 34.22 11.18 35 50664 7220 64440813
Acute lymphocytic leukaemia recurrent 34.05 11.18 27 50672 3999 64444034
Injection site pain 33.86 11.18 23 50676 111385 64336648
Blood alkaline phosphatase abnormal 33.72 11.18 15 50684 757 64447276
Cerebrovascular accident 33.72 11.18 35 50664 137548 64310485
Liver carcinoma ruptured 33.17 11.18 10 50689 162 64447871
Hypersensitivity 32.40 11.18 66 50633 196386 64251647
Vanishing bile duct syndrome 32.11 11.18 17 50682 1260 64446773
Bile duct stenosis 31.93 11.18 19 50680 1765 64446268
Anxiety 31.81 11.18 70 50629 202579 64245454
Cholelithiasis 31.66 11.18 93 50606 45413 64402620
Oesophagitis 31.43 11.18 59 50640 21571 64426462
Hepatorenal syndrome 31.42 11.18 25 50674 3721 64444312
Philadelphia positive chronic myeloid leukaemia 30.94 11.18 9 50690 128 64447905
Erythema multiforme 30.92 11.18 49 50650 15652 64432381
Peripheral swelling 30.62 11.18 75 50624 209078 64238955
Pericarditis 30.54 11.18 6 50693 62510 64385523
Hepatomegaly 29.61 11.18 50 50649 16832 64431201
Systemic lupus erythematosus 29.52 11.18 12 50687 77600 64370433
Blood lactate dehydrogenase increased 29.42 11.18 74 50625 33004 64415029
Gastrointestinal infection 29.35 11.18 34 50665 8062 64439971
Dizziness 28.75 11.18 209 50490 429954 64018079
Cystic fibrosis related diabetes 28.47 11.18 9 50690 172 64447861
Retinitis viral 28.38 11.18 8 50691 101 64447932
Viral haemorrhagic cystitis 28.19 11.18 17 50682 1618 64446415
Graft versus host disease in gastrointestinal tract 28.16 11.18 28 50671 5584 64442449
Cerebral infarction 27.72 11.18 83 50616 40961 64407072
Mobility decreased 27.06 11.18 17 50682 85823 64362210
Headache 27.02 11.18 276 50423 529191 63918842
Chronic obstructive pulmonary disease 27.00 11.18 11 50688 71037 64376996
Coma hepatic 26.95 11.18 14 50685 998 64447035
Hepatitis cholestatic 26.84 11.18 40 50659 12115 64435918
Wheezing 26.76 11.18 15 50684 80564 64367469
Adenoviral hepatitis 26.75 11.18 11 50688 457 64447576
Ammonia increased 26.47 11.18 30 50669 6947 64441086
CFTR gene mutation 25.80 11.18 7 50692 76 64447957
Hepatitis fulminant 25.56 11.18 28 50671 6246 64441787
Abdominal discomfort 25.43 11.18 67 50632 182255 64265778
Gallbladder enlargement 25.43 11.18 15 50684 1371 64446662
Impaired healing 25.29 11.18 8 50691 60465 64387568
Bronchopulmonary aspergillosis 25.21 11.18 50 50649 19035 64428998
Nasopharyngitis 25.17 11.18 75 50624 195998 64252035
Portal hypertensive gastropathy 25.02 11.18 14 50685 1158 64446875
Maternal exposure during breast feeding 24.93 11.18 17 50682 1999 64446034
Biliary tract infection 24.88 11.18 13 50686 938 64447095
Hepatic fibrosis 24.77 11.18 26 50673 5526 64442507
Glomerulosclerosis 24.70 11.18 13 50686 952 64447081
Cytomegalovirus test positive 24.59 11.18 25 50674 5119 64442914
Fall 24.37 11.18 210 50489 416616 64031417
Septic shock 24.34 11.18 154 50545 105283 64342750
Hyperhidrosis 24.15 11.18 38 50661 124882 64323151
Exposure via breast milk 24.10 11.18 12 50687 782 64447251
Lactation disorder 23.96 11.18 8 50691 183 64447850
Acute graft versus host disease in intestine 23.88 11.18 21 50678 3588 64444445
Faeces soft 23.63 11.18 26 50673 5829 64442204
Aplasia 23.22 11.18 28 50671 6925 64441108
Spider naevus 22.96 11.18 7 50692 118 64447915
Coagulation test abnormal 22.89 11.18 13 50686 1106 64446927
Discomfort 22.88 11.18 18 50681 80860 64367173
Mucosal disorder 22.67 11.18 19 50680 3043 64444990
Haemorrhage subcutaneous 22.33 11.18 22 50677 4339 64443694
Liver abscess 22.27 11.18 24 50675 5256 64442777
Alopecia 22.27 11.18 62 50637 165628 64282405
Cystic fibrosis lung 22.18 11.18 7 50692 133 64447900
Coronary artery disease 21.94 11.18 10 50689 60423 64387610
Intentional product misuse 21.87 11.18 15 50684 72280 64375753
Cholecystitis acute 21.75 11.18 35 50664 11325 64436708
Tonsillar haemorrhage 21.69 11.18 8 50691 247 64447786
Portal vein thrombosis 21.60 11.18 23 50676 4968 64443065
Haemobilia 21.57 11.18 9 50690 388 64447645
Blood urea increased 21.54 11.18 80 50619 44073 64403960
Graft versus host disease in liver 21.48 11.18 14 50685 1527 64446506
Eosinophilic colitis 21.44 11.18 9 50690 394 64447639
Venous haemorrhage 21.37 11.18 8 50691 258 64447775
Treatment failure 21.22 11.18 37 50662 116779 64331254
Candida test positive 20.74 11.18 12 50687 1058 64446975
Pneumonia cytomegaloviral 20.58 11.18 21 50678 4318 64443715
Organic brain syndrome 20.33 11.18 9 50690 449 64447584
Vision blurred 19.92 11.18 25 50674 90291 64357742
Diarrhoea 19.91 11.18 724 49975 721980 63726053
Antimitochondrial antibody positive 19.91 11.18 6 50693 97 64447936
Respiratory tract malformation 19.90 11.18 5 50694 39 64447994
Sputum increased 19.86 11.18 19 50680 3616 64444417
Balance disorder 19.83 11.18 22 50677 83904 64364129
Arthritis 19.77 11.18 22 50677 83792 64364241
Blood pressure fluctuation 19.76 11.18 8 50691 51863 64396170
Urge incontinence 19.49 11.18 11 50688 925 64447108
Ocular icterus 19.48 11.18 22 50677 5076 64442957
Pancreatic enzymes increased 19.46 11.18 12 50687 1189 64446844
Death 19.44 11.18 265 50434 482440 63965593
Loss of personal independence in daily activities 19.42 11.18 17 50682 72437 64375596
Blood creatine phosphokinase increased 19.17 11.18 94 50605 58464 64389569
Hypoproteinaemia 19.09 11.18 18 50681 3364 64444669
Biliary obstruction 18.88 11.18 19 50680 3845 64444188
Forced expiratory volume decreased 18.72 11.18 25 50674 6842 64441191
Toxic epidermal necrolysis 18.68 11.18 68 50631 37098 64410935
Transaminases increased 18.67 11.18 77 50622 44517 64403516
Bladder hypertrophy 18.54 11.18 9 50690 555 64447478
Hypotension 18.42 11.18 201 50498 380773 64067260
Sedation 18.23 11.18 5 50694 41457 64406576
Injection site reaction 18.10 11.18 7 50692 46657 64401376
Chest pain 18.07 11.18 110 50589 235870 64212163
Drug eruption 18.06 11.18 66 50633 36070 64411963
Acute graft versus host disease in liver 18.00 11.18 13 50686 1674 64446359
Gestational diabetes 17.84 11.18 22 50677 5568 64442465
Psoriasis 17.83 11.18 18 50681 71685 64376348
Biliary tract disorder 17.83 11.18 12 50687 1381 64446652
Wrong technique in product usage process 17.71 11.18 15 50684 64959 64383074
Duodenal ulcer perforation 17.61 11.18 3 50696 34622 64413411
Asthenia 17.59 11.18 234 50465 427810 64020223
Psychotic disorder 17.57 11.18 3 50696 34575 64413458
Spinal compression fracture 17.49 11.18 37 50662 14738 64433295
Muscle spasms 17.34 11.18 55 50644 140968 64307065
Unresponsive to stimuli 17.28 11.18 9 50690 50384 64397649
Eczema 17.22 11.18 57 50642 29663 64418370
Bacterial sepsis 17.13 11.18 25 50674 7432 64440601
Aspergillus infection 17.11 11.18 39 50660 16340 64431693
Gallbladder polyp 17.07 11.18 10 50689 902 64447131
Neck pain 17.02 11.18 14 50685 61519 64386514
Infusion related reaction 16.99 11.18 69 50630 164398 64283635
Burning sensation 16.84 11.18 9 50690 49655 64398378
Drug dependence 16.69 11.18 3 50696 33309 64414724
Biliary dilatation 16.64 11.18 14 50685 2254 64445779
Bile duct cancer 16.62 11.18 10 50689 948 64447085
Iron overload 16.59 11.18 12 50687 1550 64446483
Contusion 16.56 11.18 41 50658 113924 64334109
Porphyria non-acute 16.45 11.18 9 50690 712 64447321
Migraine 16.44 11.18 15 50684 62662 64385371
Hypophosphataemia 16.44 11.18 36 50663 14684 64433349
Heart rate increased 16.38 11.18 33 50666 98642 64349391
Foetor hepaticus 16.37 11.18 3 50696 3 64448030
Cytopenia 16.34 11.18 37 50662 15434 64432599
Staphylococcal sepsis 16.09 11.18 33 50666 12866 64435167
Hepatic necrosis 16.08 11.18 26 50673 8447 64439586
Colitis ulcerative 15.96 11.18 47 50652 22981 64425052
Histoplasmosis 15.91 11.18 13 50686 2009 64446024
Blood bilirubin abnormal 15.73 11.18 10 50689 1045 64446988
Memory impairment 15.69 11.18 27 50672 85655 64362378
Epstein-Barr virus infection 15.64 11.18 32 50667 12456 64435577
Hospitalisation 15.62 11.18 107 50592 75100 64372933
Upper respiratory tract inflammation 15.62 11.18 17 50682 3765 64444268
Rectal tenesmus 15.57 11.18 10 50689 1063 64446970
Irritable bowel syndrome 15.53 11.18 5 50694 37364 64410669
Enterococcal sepsis 15.49 11.18 14 50685 2480 64445553
Product dose omission issue 15.32 11.18 90 50609 194657 64253376
Suicide attempt 15.30 11.18 20 50679 70987 64377046
Haemophagocytic lymphohistiocytosis 15.25 11.18 39 50660 17570 64430463
Fixed eruption 15.17 11.18 13 50686 2146 64445887
Cystic fibrosis hepatic disease 15.13 11.18 4 50695 39 64447994
Sweat test abnormal 15.13 11.18 4 50695 39 64447994
Feeling abnormal 15.13 11.18 54 50645 133548 64314485
Suicidal ideation 15.12 11.18 18 50681 66524 64381509
Gait disturbance 14.94 11.18 77 50622 172078 64275955
Premature delivery 14.90 11.18 40 50659 18549 64429484
Prothrombin level decreased 14.84 11.18 11 50688 1475 64446558
Transfusion 14.71 11.18 39 50660 17955 64430078
Cardiac failure 14.70 11.18 164 50535 132209 64315824
Kidney fibrosis 14.70 11.18 15 50684 3086 64444947
Hyperglycaemia 14.66 11.18 90 50609 60878 64387155
Localised infection 14.51 11.18 3 50696 30158 64417875
Beta 2 microglobulin urine increased 14.33 11.18 5 50694 131 64447902
Cardiac failure high output 14.33 11.18 6 50693 261 64447772
Neutropenia 14.23 11.18 266 50433 239358 64208675
Paraesthesia 14.17 11.18 56 50643 134466 64313567
Stress 14.15 11.18 16 50683 60518 64387515
Capillary leak syndrome 13.93 11.18 15 50684 3282 64444751
Allergic sinusitis 13.85 11.18 7 50692 471 64447562
Bacterial infection 13.70 11.18 47 50652 24903 64423130
Influenza like illness 13.69 11.18 17 50682 61685 64386348
Blood albumin decreased 13.65 11.18 42 50657 21031 64427002
Escherichia sepsis 13.61 11.18 22 50677 7143 64440890
Eye pain 13.56 11.18 4 50695 31621 64416412
Poor sucking reflex 13.49 11.18 4 50695 61 64447972
Heart rate decreased 13.49 11.18 14 50685 55053 64392980
Laryngomalacia 13.44 11.18 3 50696 13 64448020
Hepatic mass 13.34 11.18 12 50687 2112 64445921
Shock haemorrhagic 13.33 11.18 36 50663 16755 64431278
Red blood cell sedimentation rate increased 13.30 11.18 4 50695 31231 64416802
Stem cell transplant 13.26 11.18 15 50684 3466 64444567
Depression 13.22 11.18 87 50612 183204 64264829
Wound 13.19 11.18 25 50674 76452 64371581
Myelosuppression 13.18 11.18 45 50654 23785 64424248
Hypoaldosteronism 13.09 11.18 6 50693 325 64447708
Bile duct necrosis 13.08 11.18 3 50696 15 64448018
Therapy interrupted 13.04 11.18 40 50659 19996 64428037
Hyperplasia 12.92 11.18 9 50690 1095 64446938
Gastric antral vascular ectasia 12.90 11.18 8 50691 800 64447233
Back pain 12.89 11.18 130 50569 250041 64197992
Gastric varices haemorrhage 12.89 11.18 6 50693 337 64447696
Inappropriate schedule of product administration 12.79 11.18 34 50665 92252 64355781
Cardiac disorder 12.78 11.18 15 50684 55801 64392232
Liver injury 12.78 11.18 52 50647 29880 64418153
Hypoaesthesia 12.77 11.18 61 50638 139047 64308986
Acute myocardial infarction 12.73 11.18 22 50677 69696 64378337
Blister 12.67 11.18 28 50671 80939 64367094
Pneumonia fungal 12.63 11.18 24 50675 8853 64439180
Cholecystitis 12.59 11.18 39 50660 19597 64428436
Liver function test increased 12.59 11.18 53 50646 30917 64417116
Hypothyroidism 12.57 11.18 64 50635 40393 64407640
Complications of transplanted liver 12.56 11.18 6 50693 357 64447676
Total bile acids increased 12.53 11.18 4 50695 79 64447954
Dysarthria 12.53 11.18 17 50682 59389 64388644
Osteoarthritis 12.49 11.18 19 50680 63317 64384716
Necrotising gastritis 12.48 11.18 4 50695 80 64447953
Aspartate aminotransferase abnormal 12.48 11.18 10 50689 1504 64446529
Product quality issue 12.36 11.18 4 50695 29795 64418238
Klebsiella bacteraemia 12.35 11.18 12 50687 2328 64445705
Diabetes mellitus 12.31 11.18 92 50607 66382 64381651
Cytomegalovirus duodenitis 12.30 11.18 4 50695 84 64447949
Transient ischaemic attack 12.29 11.18 10 50689 44172 64403861
Asterixis 12.25 11.18 12 50687 2351 64445682
Proctitis haemorrhagic 12.23 11.18 3 50696 21 64448012
Gastrointestinal perforation 12.19 11.18 18 50681 5406 64442627
Hypokalaemia 12.19 11.18 148 50551 121755 64326278
Hyperamylasaemia 12.19 11.18 8 50691 883 64447150
Urticaria 12.16 11.18 67 50632 147250 64300783
Oedema 12.15 11.18 118 50581 91817 64356216
Cardiac failure congestive 12.14 11.18 57 50642 130523 64317510
Blood albumin abnormal 12.06 11.18 7 50692 621 64447412
Acute lymphocytic leukaemia 12.05 11.18 16 50683 4355 64443678
Oedema due to hepatic disease 11.99 11.18 3 50696 23 64448010
Injection site swelling 11.95 11.18 9 50690 41344 64406689
Medication error 11.91 11.18 13 50686 49953 64398080
Tumour lysis syndrome 11.90 11.18 38 50661 19402 64428631
Thalamus haemorrhage 11.89 11.18 10 50689 1609 64446424
Injury 11.83 11.18 16 50683 55976 64392057
Multiple sclerosis relapse 11.83 11.18 9 50690 41126 64406907
Iron deficiency anaemia 11.81 11.18 41 50658 21848 64426185
Asthma 11.80 11.18 37 50662 95188 64352845
Jaundice cholestatic 11.79 11.18 23 50676 8647 64439386
Haemosiderosis 11.79 11.18 6 50693 410 64447623
Emotional distress 11.55 11.18 7 50692 36031 64412002
Cardiac tamponade 11.53 11.18 22 50677 8142 64439891
Hypersplenism 11.51 11.18 6 50693 431 64447602
Hepatitis C RNA positive 11.50 11.18 5 50694 239 64447794
Enteritis infectious 11.45 11.18 13 50686 3015 64445018
Lethargy 11.44 11.18 25 50674 72569 64375464
Swelling face 11.43 11.18 18 50681 59148 64388885
Haemophilic arthropathy 11.42 11.18 4 50695 106 64447927
Dilatation intrahepatic duct acquired 11.41 11.18 7 50692 687 64447346
Thrombosis 11.41 11.18 24 50675 70618 64377415
Discharge 11.38 11.18 8 50691 988 64447045
Bacterial disease carrier 11.36 11.18 8 50691 991 64447042
Putamen haemorrhage 11.33 11.18 6 50693 445 64447588
Palpitations 11.32 11.18 43 50656 104445 64343588
Lip pruritus 11.31 11.18 7 50692 698 64447335
Human herpesvirus 6 infection 11.27 11.18 16 50683 4638 64443395
Cheilitis 11.26 11.18 16 50683 4640 64443393
Encephalopathy 11.23 11.18 82 50617 58737 64389296

FDA Adverse Event Reporting System (Pediatric)

None

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
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite
MeSH PA D002756 Cholagogues and Choleretics
MeSH PA D005765 Gastrointestinal Agents
FDA EPC N0000175802 Bile Acid

Drug Use | Suggest Off label Use Form| |View source of the data|

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




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 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
Phospholipase A2 Enzyme Kd 5 CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme WOMBAT-PK
Ectonucleotide pyrophosphatase/phosphodiesterase family member 2 Enzyme IC50 4.99 CHEMBL
CDGSH iron-sulfur domain-containing protein 1 Unclassified Ki 5.95 CHEMBL
G-protein coupled bile acid receptor 1 GPCR EC50 5.62 CHEMBL
M1-family alanyl aminopeptidase Enzyme IC50 5.59 CHEMBL

External reference:

IDSource
4019318 VUID
N0000147507 NUI
D00734 KEGG_DRUG
4019318 VANDF
C0042105 UMLSCUI
CHEBI:9907 CHEBI
CHEMBL1551 ChEMBL_ID
DB01586 DRUGBANK_ID
CHEMBL272427 ChEMBL_ID
31401 PUBCHEM_CID
7104 IUPHAR_LIGAND_ID
4920 INN_ID
724L30Y2QR UNII
11065 RXNORM
31954 MMSL
5659 MMSL
d01005 MMSL
001212 NDDF
108669000 SNOMEDCT_US
41143004 SNOMEDCT_US
D014580 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 25 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-3005 TABLET 500 mg ORAL NDA authorized generic 25 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-3159 CAPSULE 300 mg ORAL NDA authorized generic 18 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 0904-7168 CAPSULE 300 mg ORAL ANDA 17 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 24658-999 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 50268-797 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