ursodiol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 38 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK 13
kinase-selectivity-class EIF2AK3,GRK2 2
pfas-class PFAS structural alert (1 = True, 0 = False) 0

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 369.34 11.69 247 43517 46041 90538642
Blood bilirubin increased 304.30 11.69 214 43550 43256 90541427
Ascites 297.52 11.69 219 43545 47521 90537162
Hepatic failure 265.17 11.69 190 43574 39538 90545145
Aplastic anaemia 249.95 11.69 124 43640 13145 90571538
Aspartate aminotransferase increased 233.79 11.69 268 43496 102669 90482014
Hepatic encephalopathy 231.04 11.69 119 43645 13653 90571030
Venoocclusive liver disease 229.23 11.69 92 43672 5901 90578782
Alanine aminotransferase increased 197.65 11.69 264 43500 118074 90466609
Platelet count decreased 196.52 11.69 284 43480 136685 90447998
Blood alkaline phosphatase increased 193.92 11.69 171 43593 47908 90536775
Blood alkaline phosphatase abnormal 188.90 11.69 55 43709 1313 90583370
Infective pulmonary exacerbation of cystic fibrosis 184.58 11.69 93 43671 10186 90574497
Jaundice 177.81 11.69 138 43626 32379 90552304
Arthropathy 161.97 11.69 3 43761 366239 90218444
Cholestasis 160.33 11.69 136 43628 36163 90548520
Pruritus 154.47 11.69 592 43172 540933 90043750
Hepatocellular carcinoma 154.02 11.69 54 43710 2374 90582309
Febrile neutropenia 148.79 11.69 271 43493 158078 90426605
Graft versus host disease 147.16 11.69 74 43690 8070 90576613
Joint swelling 144.66 11.69 33 43731 503267 90081416
Glossodynia 140.81 11.69 3 43761 321776 90262907
Cholangitis 134.91 11.69 67 43697 7115 90577568
Pain 132.27 11.69 173 43591 996168 89588515
Mucosal inflammation 125.66 11.69 147 43617 57478 90527205
Disseminated intravascular coagulation 123.42 11.69 94 43670 21444 90563239
Systemic lupus erythematosus 123.22 11.69 15 43749 361881 90222802
Pulmonary malformation 122.32 11.69 30 43734 360 90584323
Contraindicated product administered 112.16 11.69 12 43752 320127 90264556
Drug intolerance 110.72 11.69 39 43725 447552 90137131
Hepatic fibrosis 106.20 11.69 48 43716 4127 90580556
Cholangitis sclerosing 105.85 11.69 40 43724 2181 90582502
Swelling 101.12 11.69 38 43726 419020 90165663
Drug hypersensitivity 100.78 11.69 49 43715 463560 90121123
Sepsis 100.45 11.69 249 43515 179565 90405118
Pericarditis 100.29 11.69 8 43756 270143 90314540
Neutrophil count decreased 99.13 11.69 146 43618 71386 90513297
Anaemia 98.96 11.69 384 43380 352418 90232265
Renal impairment 98.43 11.69 180 43584 105241 90479442
Portal hypertension 97.72 11.69 47 43717 4654 90580029
Interstitial lung disease 96.02 11.69 149 43615 76256 90508427
Varices oesophageal 94.71 11.69 43 43721 3736 90580947
Hyperbilirubinaemia 93.75 11.69 67 43697 13869 90570814
Treatment failure 93.31 11.69 17 43747 303911 90280772
Multiple organ dysfunction syndrome 92.57 11.69 138 43626 68198 90516485
Cholestasis of pregnancy 92.15 11.69 33 43731 1544 90583139
Psoriatic arthropathy 89.92 11.69 5 43759 228330 90356353
Primary biliary cholangitis 88.85 11.69 31 43733 1343 90583340
Cytomegalovirus infection 88.52 11.69 85 43679 26517 90558166
Gamma-glutamyltransferase increased 88.08 11.69 100 43664 37852 90546831
Hepatic cirrhosis 87.50 11.69 129 43635 63124 90521559
Impaired healing 86.75 11.69 7 43757 234192 90350491
Rheumatoid arthritis 85.61 11.69 34 43730 362580 90222103
Acute graft versus host disease 85.27 11.69 45 43719 5423 90579260
Thrombotic microangiopathy 84.28 11.69 66 43698 15677 90569006
Liver disorder 83.11 11.69 182 43582 121087 90463596
Therapeutic product effect decreased 80.05 11.69 18 43746 277553 90307130
Alopecia 79.79 11.69 73 43691 494998 90089685
Wound 79.10 11.69 24 43740 302956 90281727
Lung cyst 78.63 11.69 22 43742 453 90584230
Respiratory tract malformation 77.79 11.69 18 43746 165 90584518
Hypersensitivity 76.94 11.69 64 43700 454613 90130070
Pyrexia 76.56 11.69 563 43201 659922 89924761
Blister 74.62 11.69 16 43748 254982 90329701
Discomfort 72.94 11.69 21 43743 274314 90310369
Lower respiratory tract infection 72.79 11.69 16 43748 250643 90334040
Wheezing 71.61 11.69 14 43750 238066 90346617
Oesophageal varices haemorrhage 71.57 11.69 27 43737 1465 90583218
Fibromyalgia 71.53 11.69 8 43756 206261 90378422
Helicobacter infection 71.12 11.69 12 43752 226838 90357845
Autoimmune hepatitis 70.17 11.69 50 43714 10301 90574382
Hepatic cancer 70.02 11.69 38 43726 4843 90579840
Aspartate aminotransferase abnormal 69.11 11.69 31 43733 2618 90582065
Mobility decreased 68.89 11.69 18 43746 250716 90333967
Type 2 diabetes mellitus 67.73 11.69 9 43755 203235 90381448
Sinusitis 67.60 11.69 41 43723 343047 90241636
Irritable bowel syndrome 67.23 11.69 10 43754 207438 90377245
Premature delivery 66.98 11.69 88 43676 38674 90546009
Pre-eclampsia 65.02 11.69 49 43715 10999 90573684
Musculoskeletal stiffness 64.90 11.69 31 43733 296501 90288182
Infusion related reaction 64.15 11.69 64 43700 416716 90167967
Pleural effusion 63.46 11.69 156 43608 111835 90472848
Pancytopenia 63.42 11.69 163 43601 120100 90464583
Abdominal discomfort 62.97 11.69 83 43681 477245 90107438
CFTR gene mutation 62.38 11.69 16 43748 233 90584450
Neutropenia 62.32 11.69 244 43520 224660 90360023
Splenomegaly 60.31 11.69 50 43714 12874 90571809
Cystic fibrosis 60.23 11.69 32 43732 3909 90580774
Transfusion 54.66 11.69 54 43710 17434 90567249
Liver transplant rejection 54.12 11.69 23 43741 1705 90582978
Gamma-glutamyltransferase abnormal 54.06 11.69 17 43747 530 90584153
Septic shock 53.93 11.69 123 43641 84037 90500646
Exposure via breast milk 53.81 11.69 25 43739 2290 90582393
Cardiac failure 53.24 11.69 144 43620 109352 90475331
Premature baby 53.04 11.69 63 43701 25014 90559669
Hepatomegaly 52.91 11.69 47 43717 13279 90571404
Injury 52.64 11.69 15 43749 197334 90387349
Vanishing bile duct syndrome 52.25 11.69 21 43743 1351 90583332
Cytomegalovirus viraemia 52.24 11.69 37 43727 7549 90577134
Blood cholesterol increased 51.58 11.69 18 43746 207994 90376689
Foetal exposure during pregnancy 51.47 11.69 82 43682 42893 90541790
Ill-defined disorder 51.30 11.69 13 43751 184878 90399805
Total bile acids increased 50.83 11.69 12 43752 121 90584562
Bile duct stone 50.79 11.69 29 43735 4078 90580605
Arthralgia 50.71 11.69 199 43565 778323 89806360
Chronic graft versus host disease 50.58 11.69 29 43735 4110 90580573
Cytomegalovirus urinary tract infection 50.16 11.69 11 43753 77 90584606
Therapy cessation 50.05 11.69 74 43690 36287 90548396
Hypoalbuminaemia 49.53 11.69 49 43715 15848 90568835
C-reactive protein abnormal 49.51 11.69 3 43761 127426 90457257
Bursitis 48.55 11.69 4 43760 131650 90453033
Drug-induced liver injury 48.21 11.69 123 43641 90195 90494488
Blood lactate dehydrogenase increased 48.13 11.69 61 43703 25871 90558812
Portal hypertensive gastropathy 46.81 11.69 18 43746 1029 90583654
Osteoarthritis 46.73 11.69 18 43746 195712 90388971
Venoocclusive disease 46.39 11.69 23 43741 2432 90582251
Pain in extremity 44.85 11.69 94 43670 450435 90134248
Nasopharyngitis 44.82 11.69 80 43684 407024 90177659
Adenoviral hepatitis 44.48 11.69 14 43750 438 90584245
Acute graft versus host disease in skin 44.33 11.69 28 43736 4728 90579955
Completed suicide 42.62 11.69 9 43755 145049 90439634
Decreased appetite 42.36 11.69 319 43445 376221 90208462
Lip pruritus 42.26 11.69 18 43746 1342 90583341
Migraine 41.49 11.69 20 43744 190372 90394311
White blood cell count decreased 41.27 11.69 175 43589 166934 90417749
Poor sucking reflex 40.55 11.69 13 43751 432 90584251
Lactation disorder 40.29 11.69 13 43751 441 90584242
Thrombocytopenia 40.04 11.69 203 43561 208522 90376161
Vascular device infection 39.40 11.69 38 43726 11914 90572769
Hypoaesthesia 39.03 11.69 57 43707 314153 90270530
Aspergillus infection 38.71 11.69 36 43728 10787 90573896
Tonsillar haemorrhage 38.12 11.69 11 43753 254 90584429
Sciatica 37.60 11.69 3 43761 101379 90483304
Maternal exposure during breast feeding 37.52 11.69 28 43736 6192 90578491
Serum ferritin increased 37.48 11.69 30 43734 7351 90577332
Joint range of motion decreased 36.74 11.69 10 43754 135633 90449050
Hepatic necrosis 36.66 11.69 28 43736 6410 90578273
Hyperammonaemia 36.52 11.69 28 43736 6447 90578236
Peripheral swelling 36.42 11.69 92 43672 413014 90171669
Cholangitis acute 36.37 11.69 13 43751 605 90584078
Liver transplant 35.93 11.69 19 43745 2298 90582385
Cystitis haemorrhagic 35.92 11.69 26 43738 5487 90579196
Cytokine release syndrome 35.75 11.69 55 43709 27918 90556765
Hepatitis cholestatic 35.60 11.69 31 43733 8530 90576153
Pancreatitis relapsing 35.57 11.69 16 43748 1360 90583323
Off label use 35.27 11.69 736 43028 1101516 89483167
Wound infection 34.76 11.69 5 43759 106397 90478286
Gastrointestinal disorder 34.46 11.69 44 43720 256643 90328040
Palmar-plantar erythrodysaesthesia syndrome 34.28 11.69 54 43710 27969 90556714
Iron deficiency anaemia 33.78 11.69 49 43715 23613 90561070
Ammonia increased 33.60 11.69 24 43740 4962 90579721
Cerebral haemorrhage 33.53 11.69 60 43704 34462 90550221
Bilirubin conjugated increased 33.17 11.69 20 43744 3110 90581573
Contusion 32.76 11.69 44 43720 251172 90333511
Biliary tract disorder 31.90 11.69 13 43751 867 90583816
Product prescribing error 31.36 11.69 54 43710 30091 90554592
Hepatitis fulminant 31.31 11.69 21 43743 3924 90580759
Muscle spasms 30.97 11.69 46 43718 251837 90332846
Prescribed overdose 30.94 11.69 5 43759 97620 90487063
Pneumonia cytomegaloviral 30.72 11.69 19 43745 3092 90581591
Coagulation test abnormal 30.66 11.69 13 43751 958 90583725
Cytomegalovirus test positive 30.64 11.69 20 43744 3571 90581112
Adenovirus infection 30.58 11.69 22 43742 4600 90580083
Hypoproteinaemia 30.54 11.69 19 43745 3123 90581560
Gallbladder enlargement 30.51 11.69 13 43751 970 90583713
Acute lymphocytic leukaemia recurrent 30.43 11.69 18 43746 2703 90581980
Drug ineffective 30.24 11.69 479 43285 1383819 89200864
Hypercholesterolaemia 30.18 11.69 6 43758 100886 90483797
Pancreatitis acute 30.15 11.69 55 43709 32060 90552623
Normal newborn 29.95 11.69 46 43718 23316 90561367
Candida test positive 29.81 11.69 13 43751 1026 90583657
Hyperuricaemia 29.30 11.69 25 43739 6694 90577989
Acute kidney injury 29.29 11.69 259 43505 320128 90264555
Graft versus host disease in gastrointestinal tract 29.29 11.69 21 43743 4367 90580316
Allergic sinusitis 29.06 11.69 16 43748 2097 90582586
Bile duct stenosis 29.06 11.69 15 43749 1727 90582956
Diarrhoea 28.98 11.69 624 43140 938566 89646117
Hepatic pain 28.20 11.69 19 43745 3576 90581107
Gait inability 28.12 11.69 18 43746 146438 90438245
Cytomegalovirus infection reactivation 28.00 11.69 26 43738 7774 90576909
Venous haemorrhage 27.99 11.69 9 43755 302 90584381
Hyponatraemia 27.82 11.69 133 43631 133405 90451278
Night sweats 27.33 11.69 14 43750 128752 90455931
Intentional overdose 27.20 11.69 6 43758 93828 90490855
Abdominal pain 26.99 11.69 301 43463 395420 90189263
Renal failure 26.95 11.69 130 43634 130877 90453806
Faeces soft 26.89 11.69 25 43739 7486 90577197
Haemorrhage subcutaneous 26.77 11.69 18 43746 3378 90581305
Injection site reaction 26.46 11.69 6 43758 92074 90492609
Ocular icterus 26.46 11.69 19 43745 3961 90580722
Obesity 26.37 11.69 9 43755 105498 90479185
Hip arthroplasty 26.29 11.69 3 43761 76205 90508478
Product administered to patient of inappropriate age 25.97 11.69 20 43744 4633 90580050
Staphylococcal sepsis 25.73 11.69 27 43737 9356 90575327
Cholecystitis acute 25.68 11.69 27 43737 9377 90575306
Blood creatine phosphokinase increased 25.52 11.69 53 43711 33970 90550713
Peripheral venous disease 25.08 11.69 5 43759 83916 90500767
Paraesthesia 25.07 11.69 52 43712 250274 90334409
Urticaria 25.02 11.69 73 43691 312661 90272022
Enterocolitis 24.94 11.69 28 43736 10462 90574221
Hypothyroidism 24.94 11.69 69 43695 53058 90531625
Myocarditis 24.87 11.69 32 43732 13774 90570909
Knee arthroplasty 24.76 11.69 5 43759 83177 90501506
Intestinal anastomosis 24.72 11.69 11 43753 911 90583772
Melaena 24.70 11.69 53 43711 34744 90549939
Hepatitis C 24.56 11.69 21 43743 5639 90579044
Musculoskeletal pain 24.41 11.69 28 43736 171223 90413460
Liver sarcoidosis 24.40 11.69 5 43759 24 90584659
Premature labour 24.09 11.69 31 43733 13345 90571338
Term birth 24.08 11.69 7 43757 166 90584517
Spider naevus 23.85 11.69 7 43757 172 90584511
Alagille syndrome 23.77 11.69 4 43760 4 90584679
Bilirubin conjugated abnormal 23.74 11.69 6 43758 82 90584601
Fatigue 23.60 11.69 404 43360 1153619 89431064
Blood creatinine increased 23.35 11.69 104 43660 101282 90483401
Alanine aminotransferase abnormal 23.27 11.69 20 43744 5406 90579277
Loss of personal independence in daily activities 23.17 11.69 19 43745 136086 90448597
Injection site pain 23.07 11.69 30 43734 173669 90411014
Gestational diabetes 23.06 11.69 27 43737 10555 90574128
Bacterial sepsis 22.76 11.69 19 43745 4936 90579747
Cardiac tamponade 22.63 11.69 20 43744 5612 90579071
Joint stiffness 22.60 11.69 5 43759 78037 90506646
Respiratory failure 22.57 11.69 115 43649 118303 90466380
Rhabdomyolysis 22.53 11.69 65 43699 51191 90533492
Toxic epidermal necrolysis 22.47 11.69 49 43715 32479 90552204
Biliary tract infection 22.41 11.69 10 43754 834 90583849
Pulmonary fibrosis 22.36 11.69 12 43752 107491 90477192
Hepatic enzyme increased 22.28 11.69 94 43670 360642 90224041
Product use issue 22.26 11.69 83 43681 329836 90254847
Gait disturbance 22.18 11.69 59 43705 260437 90324246
Gastrointestinal stoma output increased 22.09 11.69 9 43755 600 90584083
Low birth weight baby 22.05 11.69 25 43739 9442 90575241
Haemophagocytic lymphohistiocytosis 22.05 11.69 32 43732 15427 90569256
Blood bilirubin abnormal 21.98 11.69 13 43751 1951 90582732
Lower limb fracture 21.68 11.69 7 43757 85006 90499677
Liver abscess 21.67 11.69 16 43748 3480 90581203
Caesarean section 21.63 11.69 35 43729 18542 90566141
Enterococcal sepsis 21.58 11.69 12 43752 1604 90583079
Cholelithiasis 21.57 11.69 65 43699 52441 90532242
Pneumonia necrotising 21.56 11.69 9 43755 638 90584045
Drug ineffective for unapproved indication 21.51 11.69 76 43688 66568 90518115
Memory impairment 21.46 11.69 39 43725 197205 90387478
Bronchopulmonary aspergillosis 21.45 11.69 27 43737 11371 90573312
Chronic hepatic failure 21.40 11.69 9 43755 650 90584033
Hypokalaemia 21.37 11.69 122 43642 130994 90453689
Coma hepatic 21.31 11.69 9 43755 657 90584026
Dry mouth 21.30 11.69 35 43729 184024 90400659
Oesophageal achalasia 21.28 11.69 9 43755 659 90584024
Altered state of consciousness 21.21 11.69 47 43717 31485 90553198
Chest pain 21.19 11.69 81 43683 319564 90265119
Intraventricular haemorrhage neonatal 20.99 11.69 7 43757 264 90584419
Road traffic accident 20.98 11.69 13 43751 107613 90477070
Intentional product use issue 20.93 11.69 46 43718 216846 90367837
Cholangitis infective 20.81 11.69 8 43756 457 90584226
Immature respiratory system 20.78 11.69 5 43759 55 90584628
Upper respiratory tract inflammation 20.67 11.69 14 43750 2658 90582025
Pneumonia fungal 20.66 11.69 21 43743 7010 90577673
Faeces discoloured 20.64 11.69 37 43727 21283 90563400
Histoplasmosis 20.60 11.69 13 43751 2191 90582492
Engraftment syndrome 20.57 11.69 9 43755 716 90583967
Cytopenia 20.48 11.69 33 43731 17416 90567267
Sopor 20.40 11.69 40 43724 24604 90560079
Granulicatella infection 20.34 11.69 6 43758 150 90584533
Gastrointestinal polyp 20.23 11.69 6 43758 153 90584530
Autoimmune disorder 20.15 11.69 6 43758 76738 90507945
Arthritis 20.13 11.69 31 43733 167284 90417399
Confusional state 20.12 11.69 107 43657 386098 90198585
Shock haemorrhagic 19.92 11.69 27 43737 12218 90572465
Asthma 19.75 11.69 56 43708 242104 90342579
Inflammation 19.71 11.69 35 43729 178557 90406126
Therapy interrupted 19.62 11.69 61 43703 50047 90534636
Spinal compression fracture 19.61 11.69 30 43734 15148 90569535
Acute respiratory distress syndrome 19.57 11.69 43 43721 28643 90556040
Bacteraemia 19.45 11.69 37 43727 22263 90562420
Product quality issue 19.42 11.69 7 43757 79318 90505365
Intracranial pressure increased 19.40 11.69 20 43744 6791 90577892
Major depression 19.25 11.69 24 43740 10011 90574672
Hepatorenal syndrome 18.94 11.69 12 43752 2036 90582647
Exposure during pregnancy 18.90 11.69 187 43577 238223 90346460
Gastrointestinal haemorrhage 18.87 11.69 90 43674 90158 90494525
Therapeutic product effect incomplete 18.81 11.69 41 43723 193855 90390828
Hypophosphataemia 18.69 11.69 29 43735 14825 90569858
Constipation 18.52 11.69 212 43552 280183 90304500
Weight increased 18.48 11.69 122 43642 417805 90166878
Renal tubular disorder 18.37 11.69 14 43750 3193 90581490
Sleep disorder 18.29 11.69 43 43721 197987 90386696
Forced expiratory volume decreased 18.27 11.69 18 43746 5790 90578893
Pneumothorax 18.21 11.69 33 43731 19134 90565549
Transaminases increased 18.15 11.69 49 43715 37143 90547540
Hepatitis B 18.06 11.69 16 43748 4503 90580180
Haematuria 18.04 11.69 47 43717 34890 90549793
Device related infection 17.99 11.69 39 43725 25747 90558936
Mucosal disorder 17.90 11.69 13 43751 2758 90581925
Foetor hepaticus 17.83 11.69 3 43761 3 90584680
Anion gap normal 17.83 11.69 3 43761 3 90584680
Water pollution 17.83 11.69 3 43761 3 90584680
Laparotomy 17.72 11.69 7 43757 430 90584253
Hyperhidrosis 17.63 11.69 24 43740 136281 90448402
Foetal exposure timing unspecified 17.54 11.69 7 43757 442 90584241
Mycobacterium abscessus infection 17.20 11.69 9 43755 1066 90583617
Epstein-Barr virus infection 17.12 11.69 23 43741 10321 90574362
Amylase increased 17.03 11.69 19 43745 7053 90577630
Viral haemorrhagic cystitis 17.02 11.69 10 43754 1483 90583200
Adverse event 16.94 11.69 19 43745 117399 90467284
Lymphocyte stimulation test positive 16.93 11.69 7 43757 484 90584199
Lung disorder 16.88 11.69 29 43735 149854 90434829
Pulmonary haemorrhage 16.73 11.69 20 43744 7993 90576690
Cystic fibrosis lung 16.66 11.69 5 43759 133 90584550
Congenital cystic lung 16.55 11.69 4 43760 45 90584638
Enterocolitis bacterial 16.53 11.69 6 43758 292 90584391
Hyperglycaemia 16.34 11.69 58 43706 50912 90533771
Acute graft versus host disease in intestine 16.32 11.69 11 43753 2072 90582611
Urine uric acid increased 16.31 11.69 4 43760 48 90584635
Pneumonia bacterial 16.13 11.69 25 43739 12765 90571918
Blood albumin decreased 16.06 11.69 29 43735 16774 90567909
Gastrointestinal infection 16.04 11.69 23 43741 10967 90573716
Dyspepsia 16.03 11.69 46 43718 198114 90386569
Hepatic mass 15.88 11.69 11 43753 2166 90582517
Polymyositis 15.87 11.69 11 43753 2168 90582515
Culture stool positive 15.86 11.69 6 43758 328 90584355
Neck pain 15.84 11.69 19 43745 113944 90470739
Liver carcinoma ruptured 15.81 11.69 4 43760 55 90584628
Parenteral nutrition associated liver disease 15.75 11.69 3 43761 9 90584674
Bile duct necrosis 15.75 11.69 3 43761 9 90584674
Pyelonephritis 15.74 11.69 33 43731 21283 90563400
Capillary leak syndrome 15.68 11.69 12 43752 2755 90581928
Fixed eruption 15.66 11.69 10 43754 1720 90582963
Overdose 15.58 11.69 33 43731 157676 90427007
Erythema multiforme 15.54 11.69 24 43740 12222 90572461
Cystic fibrosis respiratory infection suppression 15.50 11.69 6 43758 349 90584334
Medication error 15.45 11.69 11 43753 84641 90500042
Psoriasis 15.38 11.69 30 43734 147724 90436959
Pulmonary arterial hypertension 15.38 11.69 37 43727 26150 90558533
Pneumonia 15.37 11.69 410 43354 637649 89947034
Infection 15.36 11.69 107 43657 361987 90222696
Type 1 diabetes mellitus 15.30 11.69 15 43749 4797 90579886
Hepatic vein occlusion 15.24 11.69 4 43760 64 90584619
Graft versus host disease in liver 15.23 11.69 8 43756 955 90583728
Hepatitis 15.12 11.69 71 43693 70668 90514015
Cardiac failure chronic 15.04 11.69 16 43748 5630 90579053
Biliary cirrhosis 15.02 11.69 4 43760 68 90584615
Renal glycosuria 14.89 11.69 3 43761 13 90584670
Proteinuria 14.87 11.69 34 43730 23257 90561426
Necrotising gastritis 14.80 11.69 4 43760 72 90584611
Pneumonia staphylococcal 14.77 11.69 13 43751 3628 90581055
Hepatitis acute 14.75 11.69 22 43742 10865 90573818
Maternal exposure during pregnancy 14.72 11.69 250 43514 359813 90224870
Drug eruption 14.70 11.69 44 43720 35363 90549320
Aspergillus test positive 14.67 11.69 6 43758 404 90584279
Stevens-Johnson syndrome 14.64 11.69 39 43725 29337 90555346
Pericardial effusion 14.57 11.69 45 43719 36788 90547895
Hepatitis toxic 14.51 11.69 13 43751 3712 90580971
Faeces pale 14.51 11.69 10 43754 1953 90582730
Acute hepatic failure 14.47 11.69 33 43731 22528 90562155
Transplantation complication 14.41 11.69 5 43759 213 90584470
Bicytopenia 14.38 11.69 13 43751 3758 90580925
Tumour lysis syndrome 14.35 11.69 22 43742 11130 90573553
Pelvic venous thrombosis 14.34 11.69 10 43754 1991 90582692
Dialysis hypotension 14.32 11.69 5 43759 217 90584466
Pulmonary function test decreased 14.27 11.69 14 43750 4480 90580203
Hallucination, tactile 14.23 11.69 6 43758 436 90584247
Haemolysis 14.20 11.69 19 43745 8491 90576192
Gastric varices 14.19 11.69 5 43759 223 90584460
Post-traumatic stress disorder 14.18 11.69 17 43747 6811 90577872
Amnesia 14.14 11.69 19 43745 108486 90476197
Sedation 14.12 11.69 3 43761 48168 90536515
Malnutrition 14.02 11.69 29 43735 18529 90566154
Liver function test abnormal 13.92 11.69 55 43709 50790 90533893
Urinary retention 13.91 11.69 45 43719 37699 90546984
Blood albumin abnormal 13.90 11.69 8 43756 1141 90583542
Gallbladder oedema 13.80 11.69 5 43759 242 90584441
Blood urea increased 13.78 11.69 39 43725 30374 90554309
Allergic reaction to excipient 13.77 11.69 7 43757 781 90583902
Blood pressure decreased 13.76 11.69 72 43692 74823 90509860
Steatohepatitis 13.54 11.69 7 43757 809 90583874
Electrocardiogram QRS complex abnormal 13.53 11.69 5 43759 256 90584427
Back injury 13.47 11.69 3 43761 46619 90538064
Transposition of the great vessels 13.31 11.69 5 43759 268 90584415
Laryngitis 13.26 11.69 4 43760 50749 90533934
Psychotic symptom 13.26 11.69 10 43754 2246 90582437
Distal intestinal obstruction syndrome 13.26 11.69 6 43758 517 90584166
Gastrointestinal mucosal disorder 13.26 11.69 7 43757 844 90583839
Proctalgia 13.22 11.69 18 43746 8180 90576503
Pneumocystis jirovecii pneumonia 13.19 11.69 31 43733 21585 90563098
Atrial septal defect 13.16 11.69 18 43746 8216 90576467
Chronic obstructive pulmonary disease 12.95 11.69 10 43754 73819 90510864
Immune-mediated hepatic disorder 12.94 11.69 9 43755 1783 90582900
Condition aggravated 12.93 11.69 206 43558 595339 89989344
Primary adrenal insufficiency 12.87 11.69 5 43759 294 90584389
Liver injury 12.78 11.69 41 43723 170526 90414157
Hepatosplenomegaly 12.72 11.69 11 43753 2998 90581685
Hepatic enzyme abnormal 12.66 11.69 17 43747 7625 90577058
Coeliac disease 12.63 11.69 3 43761 44607 90540076
Oesophageal variceal ligation 12.55 11.69 3 43761 32 90584651
Aminoaciduria 12.53 11.69 4 43760 131 90584552
Syndactyly 12.52 11.69 6 43758 589 90584094
Abscess rupture 12.46 11.69 5 43759 320 90584363
Neonatal respiratory distress syndrome 12.43 11.69 11 43753 3090 90581593
Generalised oedema 12.37 11.69 28 43736 19025 90565658
Portal vein thrombosis 12.32 11.69 11 43753 3127 90581556
Stenotrophomonas infection 12.25 11.69 10 43754 2519 90582164
Flank pain 12.20 11.69 28 43736 19194 90565489
Sinus node dysfunction 12.11 11.69 14 43750 5398 90579285
Upper gastrointestinal haemorrhage 11.95 11.69 31 43733 22945 90561738
Acute myeloid leukaemia 11.94 11.69 29 43735 20611 90564072
Inappropriate antidiuretic hormone secretion 11.93 11.69 28 43736 19477 90565206
Hospitalisation 11.91 11.69 104 43660 127996 90456687
Hepatic haemorrhage 11.88 11.69 6 43758 660 90584023
Bile duct cancer 11.87 11.69 6 43758 661 90584022
Haemoglobin decreased 11.85 11.69 125 43639 161831 90422852
Hyperpyrexia 11.82 11.69 13 43751 4748 90579935
Premature rupture of membranes 11.81 11.69 14 43750 5544 90579139
Epstein-Barr virus associated lymphoproliferative disorder 11.79 11.69 10 43754 2657 90582026
Engraft failure 11.75 11.69 5 43759 372 90584311

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 362.23 11.86 332 38907 51235 42530861
Venoocclusive liver disease 268.37 11.86 148 39091 10154 42571942
Hepatic encephalopathy 235.05 11.86 161 39078 16281 42565815
Hepatic failure 234.33 11.86 228 39011 37872 42544224
Blood bilirubin increased 209.25 11.86 225 39014 42027 42540069
Aplastic anaemia 197.98 11.86 130 39109 12254 42569842
Hepatocellular carcinoma 184.45 11.86 107 39132 8087 42574009
Cholangitis 179.79 11.86 116 39123 10611 42571485
Infective pulmonary exacerbation of cystic fibrosis 170.45 11.86 100 39139 7718 42574378
Hepatic cancer 165.49 11.86 101 39138 8379 42573717
Ascites 165.25 11.86 231 39008 56447 42525649
Liver disorder 156.96 11.86 188 39051 39456 42542640
Venoocclusive disease 123.76 11.86 64 39175 3851 42578245
Pyrexia 122.36 11.86 697 38542 393345 42188751
Aspartate aminotransferase increased 113.94 11.86 232 39007 76931 42505165
Palmar-plantar erythrodysaesthesia syndrome 113.24 11.86 116 39123 20466 42561630
Interstitial lung disease 110.09 11.86 231 39008 78231 42503865
Acute graft versus host disease 106.99 11.86 76 39163 8139 42573957
Platelet count decreased 106.04 11.86 324 38915 138257 42443839
Jaundice 105.30 11.86 144 39095 34445 42547651
Mucosal inflammation 95.95 11.86 167 39072 49207 42532889
Alanine aminotransferase increased 93.75 11.86 233 39006 88173 42493923
Decreased appetite 87.69 11.86 381 38858 192756 42389340
Renal impairment 76.26 11.86 249 38990 109979 42472117
Gamma-glutamyltransferase increased 75.32 11.86 119 39120 32378 42549718
Drug-induced liver injury 71.17 11.86 127 39112 38146 42543950
Drug ineffective 64.22 11.86 331 38908 629866 41952230
Completed suicide 64.11 11.86 7 39232 96458 42485638
Drug abuse 63.89 11.86 10 39229 104761 42477335
Febrile neutropenia 63.70 11.86 338 38901 185365 42396731
Hepatorenal syndrome 63.50 11.86 37 39202 2817 42579279
Vanishing bile duct syndrome 63.24 11.86 32 39207 1839 42580257
Oesophageal varices haemorrhage 62.89 11.86 40 39199 3567 42578529
Dyspnoea 62.88 11.86 204 39035 442417 42139679
Blood alkaline phosphatase increased 61.85 11.86 111 39128 33486 42548610
Toxicity to various agents 60.73 11.86 73 39166 229063 42353033
Philadelphia positive chronic myeloid leukaemia 59.87 11.86 16 39223 137 42581959
Cholangitis sclerosing 59.85 11.86 31 39208 1871 42580225
Haemosiderosis 59.28 11.86 19 39220 322 42581774
Disseminated intravascular coagulation 59.12 11.86 92 39147 24702 42557394
Graft versus host disease in skin 58.32 11.86 44 39195 5168 42576928
Bile duct stone 58.12 11.86 35 39204 2832 42579264
Graft versus host disease 55.61 11.86 64 39175 12861 42569235
Cholangitis acute 54.56 11.86 25 39214 1152 42580944
Acute graft versus host disease in skin 54.38 11.86 49 39190 7375 42574721
Death 54.02 11.86 237 39002 470948 42111148
Hypoalbuminaemia 53.66 11.86 69 39170 15541 42566555
Myocardial infarction 51.30 11.86 25 39214 123984 42458112
Hyperbilirubinaemia 51.21 11.86 78 39161 20557 42561539
Cystitis haemorrhagic 51.00 11.86 47 39192 7282 42574814
Product dose omission issue 50.28 11.86 41 39198 154324 42427772
Cholangiocarcinoma 49.43 11.86 26 39213 1620 42580476
Fatigue 49.38 11.86 220 39019 435421 42146675
Cytomegalovirus infection 48.66 11.86 98 39141 32208 42549888
Organic brain syndrome 47.08 11.86 16 39223 328 42581768
Hepatic cirrhosis 46.82 11.86 73 39166 19629 42562467
Liver transplant rejection 46.65 11.86 29 39210 2484 42579612
Iron overload 42.58 11.86 23 39216 1512 42580584
Anxiety 39.21 11.86 31 39208 118529 42463567
Anaemia 39.13 11.86 412 38827 279866 42302230
Fall 39.11 11.86 100 39139 234420 42347676
Urge incontinence 39.07 11.86 16 39223 559 42581537
Bile duct stenosis 39.07 11.86 21 39218 1367 42580729
Stomatitis 37.77 11.86 117 39122 50212 42531884
Liver transplant 37.61 11.86 26 39213 2665 42579431
Hepatitis C 36.74 11.86 46 39193 10087 42572009
Hyperhidrosis 36.29 11.86 19 39220 90493 42491603
Engraftment syndrome 36.27 11.86 20 39219 1370 42580726
Varicella virus test positive 35.92 11.86 12 39227 233 42581863
Cholelithiasis 35.37 11.86 71 39168 23275 42558821
Biliary cirrhosis 34.79 11.86 11 39228 178 42581918
White blood cell count decreased 34.47 11.86 196 39043 110200 42471896
Joint swelling 34.31 11.86 10 39229 68012 42514084
Aplasia 33.58 11.86 31 39208 4812 42577284
Intentional overdose 33.51 11.86 4 39235 51452 42530644
Intentional product misuse 33.31 11.86 8 39231 61892 42520204
Chronic graft versus host disease 33.20 11.86 34 39205 5991 42576105
Cerebrovascular accident 32.63 11.86 25 39214 97135 42484961
Neutrophil count decreased 32.52 11.86 130 39109 63285 42518811
Dizziness 32.49 11.86 119 39120 249135 42332961
Retinitis viral 32.14 11.86 10 39229 153 42581943
Peripheral swelling 31.91 11.86 22 39217 90248 42491848
Mantle cell lymphoma stage IV 31.73 11.86 8 39231 53 42582043
Bladder hypertrophy 31.44 11.86 15 39224 758 42581338
Acute on chronic liver failure 30.94 11.86 9 39230 108 42581988
Septic shock 30.77 11.86 166 39073 91506 42490590
Cerebral infarction 30.75 11.86 80 39159 31089 42551007
Tonic posturing 30.70 11.86 7 39232 28 42582068
Chronic obstructive pulmonary disease 30.54 11.86 10 39229 63104 42518992
Mucosal disorder 30.37 11.86 21 39218 2153 42579943
Cystic fibrosis related diabetes 30.23 11.86 10 39229 188 42581908
Cytomegalovirus viraemia 29.76 11.86 42 39197 10335 42571761
Glomerulosclerosis 29.69 11.86 15 39224 859 42581237
Jaundice cholestatic 29.60 11.86 30 39209 5223 42576873
Metastases to skin 29.30 11.86 13 39226 555 42581541
Eosinophilic colitis 29.25 11.86 11 39228 305 42581791
Premature baby 28.81 11.86 65 39174 23088 42559008
Amylase increased 28.41 11.86 33 39206 6696 42575400
Enterocolitis 28.20 11.86 40 39199 9889 42572207
Memory impairment 28.01 11.86 6 39233 50216 42531880
Hypotension 27.97 11.86 132 39107 257499 42324597
Coronary artery disease 26.91 11.86 8 39231 53712 42528384
Hyperuricaemia 26.81 11.86 38 39201 9386 42572710
Liver carcinoma ruptured 26.77 11.86 10 39229 272 42581824
Musculoskeletal stiffness 26.49 11.86 10 39229 57755 42524341
Acute lymphocytic leukaemia recurrent 26.32 11.86 24 39215 3667 42578429
Overdose 26.31 11.86 35 39204 105229 42476867
Toxic epidermal necrolysis 25.72 11.86 68 39171 26682 42555414
Portal vein thrombosis 25.67 11.86 26 39213 4523 42577573
Liver abscess 25.51 11.86 27 39212 4943 42577153
Cytomegalovirus test positive 24.95 11.86 25 39214 4294 42577802
Varicella zoster virus infection 24.85 11.86 20 39219 2581 42579515
Biliary tract infection 24.79 11.86 13 39226 805 42581291
Varices oesophageal 24.72 11.86 25 39214 4340 42577756
Enterococcal sepsis 24.53 11.86 18 39221 2026 42580070
Hyperammonaemia 24.30 11.86 33 39206 7833 42574263
Device related bacteraemia 24.08 11.86 12 39227 667 42581429
Pruritus allergic 23.98 11.86 10 39229 366 42581730
Arthralgia 23.55 11.86 103 39136 205135 42376961
Graft versus host disease in liver 23.29 11.86 16 39223 1623 42580473
Stress 23.23 11.86 6 39233 44206 42537890
Pain in extremity 22.99 11.86 67 39172 150537 42431559
Vascular device infection 22.57 11.86 28 39211 6082 42576014
Thrombotic microangiopathy 22.44 11.86 45 39194 14737 42567359
Scaphocephaly 22.38 11.86 6 39233 52 42582044
Complications of transplanted liver 22.18 11.86 9 39230 307 42581789
Cardiac disorder 21.57 11.86 9 39230 48923 42533173
Viral haemorrhagic cystitis 21.52 11.86 16 39223 1838 42580258
Parenteral nutrition 21.47 11.86 11 39228 649 42581447
Psoriasis 21.33 11.86 9 39230 48595 42533501
Wheezing 21.22 11.86 12 39227 54769 42527327
Adjustment disorder 21.22 11.86 14 39225 1328 42580768
Human herpesvirus 6 infection 21.17 11.86 18 39221 2507 42579589
Gallbladder polyp 21.08 11.86 10 39229 499 42581597
Altered state of consciousness 21.01 11.86 67 39172 29192 42552904
Asthma 20.96 11.86 16 39223 62298 42519798
Paraesthesia 20.95 11.86 22 39217 73437 42508659
Hepatitis toxic 20.91 11.86 18 39221 2549 42579547
Drug intolerance 20.86 11.86 26 39213 80398 42501698
Dilatation intrahepatic duct acquired 20.86 11.86 6 39233 69 42582027
Hemivertebra 20.76 11.86 7 39232 140 42581956
Acute graft versus host disease in liver 20.74 11.86 16 39223 1942 42580154
Heart rate increased 20.16 11.86 12 39227 53243 42528853
Drug hypersensitivity 20.15 11.86 38 39201 99351 42482745
Capillary leak syndrome 20.09 11.86 18 39221 2689 42579407
Axonal neuropathy 19.81 11.86 13 39226 1222 42580874
Headache 19.81 11.86 134 39105 239235 42342861
Multiple organ dysfunction syndrome 19.80 11.86 155 39084 96880 42485216
Graft versus host disease in gastrointestinal tract 19.69 11.86 24 39215 5119 42576977
Portal hypertension 19.41 11.86 23 39216 4764 42577332
Pain 19.31 11.86 139 39100 244709 42337387
Somnolence 19.27 11.86 66 39173 141039 42441057
Cholecystitis acute 19.22 11.86 29 39210 7577 42574519
Pulmonary embolism 19.15 11.86 52 39187 119560 42462536
Blood urea increased 19.08 11.86 70 39169 32723 42549373
Hepatic pain 19.00 11.86 14 39225 1586 42580510
Haemobilia 18.91 11.86 9 39230 452 42581644
Cytokine release syndrome 18.74 11.86 86 39153 44441 42537655
Feeling abnormal 18.69 11.86 22 39217 69764 42512332
Primary mediastinal large B-cell lymphoma stage IV 18.69 11.86 4 39235 11 42582085
Hypoaldosteronism 18.66 11.86 8 39231 314 42581782
Rheumatoid arthritis 18.40 11.86 8 39231 42432 42539664
Bacterial disease carrier 18.20 11.86 10 39229 680 42581416
Cholestasis 18.14 11.86 69 39170 32810 42549286
Transaminases increased 18.14 11.86 69 39170 32816 42549280
Neurosensory hypoacusis 17.96 11.86 4 39235 14 42582082
Cystic fibrosis 17.95 11.86 15 39224 2040 42580056
Peroneal nerve palsy 17.93 11.86 19 39220 3483 42578613
Hyperplasia 17.92 11.86 10 39229 701 42581395
Prothrombin level decreased 17.86 11.86 12 39227 1174 42580922
Acute graft versus host disease in intestine 17.73 11.86 20 39219 3931 42578165
Neonatal respiratory distress 17.57 11.86 11 39228 954 42581142
Pleural effusion 17.56 11.86 151 39088 97015 42485081
Swelling 17.33 11.86 15 39224 54870 42527226
Cataract subcapsular 17.06 11.86 9 39230 564 42581532
Oesophagitis 16.99 11.86 41 39198 15206 42566890
Asthenia 16.94 11.86 171 39068 280622 42301474
Drug eruption 16.71 11.86 53 39186 23022 42559074
Suicide attempt 16.60 11.86 11 39228 46089 42536007
Hypertonia neonatal 16.53 11.86 9 39230 601 42581495
Sweat test abnormal 16.50 11.86 4 39235 22 42582074
Cystic fibrosis lung 16.42 11.86 5 39234 71 42582025
Sedation 16.27 11.86 4 39235 30471 42551625
Tinea capitis 16.20 11.86 4 39235 24 42582072
Kidney fibrosis 16.17 11.86 16 39223 2706 42579390
Thrombosis 15.90 11.86 24 39215 68487 42513609
Pancreatic enzymes increased 15.89 11.86 10 39229 875 42581221
Adenovirus infection 15.86 11.86 25 39214 6784 42575312
Biliary tract disorder 15.77 11.86 11 39228 1143 42580953
Initial insomnia 15.75 11.86 19 39220 4011 42578085
Pneumocystis jirovecii pneumonia 15.71 11.86 55 39184 25126 42556970
Blood albumin decreased 15.67 11.86 40 39199 15362 42566734
Blood lactate dehydrogenase increased 15.45 11.86 56 39183 26025 42556071
Cardiac failure congestive 15.43 11.86 35 39204 85567 42496529
Taste disorder 15.40 11.86 31 39208 10176 42571920
Porphyria non-acute 15.39 11.86 8 39231 486 42581610
Immune-mediated hepatic disorder 15.35 11.86 15 39224 2499 42579597
Organising pneumonia 15.30 11.86 26 39213 7506 42574590
Pulmonary fibrosis 15.26 11.86 3 39236 26678 42555418
Pouchitis 15.25 11.86 10 39229 939 42581157
Folliculitis 15.21 11.86 22 39217 5536 42576560
Pneumonia aspiration 15.01 11.86 88 39151 49990 42532106
Oesophageal atresia 14.88 11.86 8 39231 521 42581575
Gallbladder enlargement 14.82 11.86 11 39228 1260 42580836
Medication error 14.77 11.86 6 39233 33148 42548948
Hepatic enzyme increased 14.74 11.86 82 39157 45702 42536394
Drug interaction 14.73 11.86 166 39073 266833 42315263
Erythema multiforme 14.70 11.86 30 39209 9947 42572149
Benign hepatic neoplasm 14.68 11.86 3 39236 6 42582090
Injection site pain 14.66 11.86 19 39220 57779 42524317
Toxoplasmosis 14.60 11.86 12 39227 1595 42580501
Stem cell transplant 14.58 11.86 15 39224 2657 42579439
Necrotising retinitis 14.51 11.86 10 39229 1020 42581076
Antimitochondrial antibody positive 14.50 11.86 4 39235 39 42582057
Enteritis infectious 14.44 11.86 12 39227 1619 42580477
Suicidal ideation 14.21 11.86 14 39225 48147 42533949
Sleep disorder 14.17 11.86 14 39225 48081 42534015
Non-small cell lung cancer 14.07 11.86 20 39219 4954 42577142
Pancytopenia 14.05 11.86 168 39071 117575 42464521
Platelet transfusion 14.05 11.86 12 39227 1682 42580414
Cytomegalovirus enterocolitis 13.99 11.86 11 39228 1372 42580724
Full blood count abnormal 13.99 11.86 5 39234 29871 42552225
Biliary obstruction 13.91 11.86 16 39223 3213 42578883
Psoriatic arthropathy 13.88 11.86 3 39236 24964 42557132
Biliary dilatation 13.87 11.86 11 39228 1390 42580706
Pseudomonas infection 13.83 11.86 39 39200 15884 42566212
Chest pain 13.68 11.86 74 39165 139456 42442640
Sinusitis 13.67 11.86 14 39225 47278 42534818
Liver function test increased 13.64 11.86 45 39194 19953 42562143
Palpitations 13.62 11.86 16 39223 50781 42531315
Rectal tenesmus 13.53 11.86 10 39229 1138 42580958
Autoimmune hepatitis 13.53 11.86 21 39218 5624 42576472
Unresponsive to stimuli 13.48 11.86 6 39233 31397 42550699
Hepatic infarction 13.35 11.86 6 39233 264 42581832
Lower respiratory tract infection 13.33 11.86 11 39228 41195 42540901
Vision blurred 13.26 11.86 18 39221 53681 42528415
Therapeutic product effect decreased 13.23 11.86 10 39229 39140 42542956
Haematemesis 13.21 11.86 59 39180 30140 42551956
Dry skin 13.20 11.86 15 39224 48323 42533773
Oedema due to hepatic disease 13.16 11.86 3 39236 12 42582084
Acute lymphocytic leukaemia 13.12 11.86 16 39223 3415 42578681
Wrong technique in product usage process 13.04 11.86 12 39227 42623 42539473
Metastases to lung 13.03 11.86 31 39208 11393 42570703
Inappropriate schedule of product administration 12.99 11.86 45 39194 95857 42486239
Colitis ulcerative 12.88 11.86 53 39186 26122 42555974
Melaena 12.88 11.86 70 39169 38676 42543420
Splenic embolism 12.77 11.86 6 39233 293 42581803
Vitamin D deficiency 12.76 11.86 25 39214 8048 42574048
Impulse-control disorder 12.74 11.86 11 39228 1564 42580532
Serotonin syndrome 12.67 11.86 4 39235 25841 42556255
Retinitis 12.61 11.86 7 39232 486 42581610
Muscle spasms 12.60 11.86 39 39200 86005 42496091
Tremor neonatal 12.54 11.86 7 39232 491 42581605
Hallucination 12.54 11.86 21 39218 57486 42524610
Hyponatraemic encephalopathy 12.47 11.86 4 39235 68 42582028
Cholecystitis 12.46 11.86 33 39206 12955 42569141
Hypozincaemia 12.45 11.86 3 39236 16 42582080
Hepatitis C RNA positive 12.39 11.86 5 39234 168 42581928
Tumour haemorrhage 12.37 11.86 16 39223 3622 42578474
Lethargy 12.32 11.86 15 39224 46875 42535221
Hepatic cancer recurrent 12.31 11.86 6 39233 318 42581778
Brain stem haemorrhage 12.29 11.86 9 39230 1010 42581086
Portal vein occlusion 12.25 11.86 4 39235 72 42582024
Renal ischaemia 12.18 11.86 11 39228 1659 42580437
Cytomegalovirus duodenitis 12.15 11.86 4 39235 74 42582022
Diarrhoea 12.12 11.86 529 38710 460320 42121776
Adverse drug reaction 12.10 11.86 10 39229 37424 42544672
Insulin autoimmune syndrome 12.10 11.86 7 39232 526 42581570
Stenotrophomonas test positive 12.07 11.86 6 39233 332 42581764
Nightmare 12.03 11.86 4 39235 25008 42557088
Therapeutic product effect incomplete 11.99 11.86 30 39209 70909 42511187
Blepharospasm 11.98 11.86 10 39229 1358 42580738
Escherichia sepsis 11.89 11.86 20 39219 5727 42576369

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 612.49 11.01 492 72461 88803 110427543
Venoocclusive liver disease 603.27 11.01 262 72691 14945 110501401
Blood bilirubin increased 469.36 11.01 394 72559 75578 110440768
Hepatic failure 463.32 11.01 375 72578 68364 110447982
Aplastic anaemia 453.08 11.01 250 72703 24058 110492288
Hepatic encephalopathy 449.52 11.01 262 72691 27994 110488352
Ascites 409.03 11.01 398 72555 92410 110423936
Venoocclusive disease 394.65 11.01 151 72802 6199 110510147
Platelet count decreased 307.79 11.01 548 72405 229895 110286451
Cholangitis 293.44 11.01 164 72789 16171 110500175
Hepatocellular carcinoma 289.92 11.01 138 72815 9742 110506604
Aspartate aminotransferase increased 287.46 11.01 435 72518 159501 110356845
Infective pulmonary exacerbation of cystic fibrosis 280.97 11.01 154 72799 14617 110501729
Alanine aminotransferase increased 236.31 11.01 430 72523 183343 110333003
Mucosal inflammation 234.69 11.01 303 72650 95838 110420508
Jaundice 229.55 11.01 237 72716 58999 110457347
Hepatic cancer 205.82 11.01 114 72839 11042 110505304
Blood alkaline phosphatase increased 194.53 11.01 237 72716 70698 110445648
Pyrexia 179.22 11.01 1107 71846 897158 109619188
Interstitial lung disease 176.49 11.01 324 72629 139010 110377336
Joint swelling 175.04 11.01 39 72914 442806 110073540
Febrile neutropenia 171.09 11.01 528 72425 316239 110200107
Renal impairment 169.36 11.01 380 72573 188065 110328281
Liver disorder 167.99 11.01 321 72632 141922 110374424
Acute graft versus host disease 152.64 11.01 99 72854 12782 110503564
Anaemia 145.38 11.01 729 72224 546357 109969989
Gamma-glutamyltransferase increased 144.55 11.01 190 72763 61119 110455227
Disseminated intravascular coagulation 143.62 11.01 156 72797 41130 110475216
Pain 143.50 11.01 257 72696 954698 109561648
Graft versus host disease 142.53 11.01 110 72843 18696 110497650
Blood alkaline phosphatase abnormal 138.51 11.01 46 72907 1241 110515105
Drug intolerance 136.21 11.01 49 72904 406463 110109883
Hyperbilirubinaemia 135.88 11.01 132 72821 30539 110485807
Palmar-plantar erythrodysaesthesia syndrome 128.92 11.01 147 72806 40878 110475468
Glossodynia 128.19 11.01 4 72949 222000 110294346
Cholestasis 122.25 11.01 180 72773 64338 110452008
Cholangitis sclerosing 120.49 11.01 55 72898 3527 110512819
Vanishing bile duct syndrome 120.47 11.01 53 72900 3115 110513231
Decreased appetite 118.60 11.01 623 72330 475223 110041123
Oesophageal varices haemorrhage 118.00 11.01 60 72893 4885 110511461
Psoriatic arthropathy 115.61 11.01 3 72950 196758 110319588
Contraindicated product administered 115.50 11.01 14 72939 248253 110268093
Systemic lupus erythematosus 114.34 11.01 16 72937 254322 110262024
Neutrophil count decreased 113.24 11.01 248 72705 120693 110395653
Swelling 113.09 11.01 45 72908 350996 110165350
Pericarditis 110.68 11.01 9 72944 219105 110297241
Drug hypersensitivity 110.35 11.01 83 72870 454007 110062339
Completed suicide 109.54 11.01 15 72938 242366 110273980
Cytomegalovirus infection 109.13 11.01 156 72797 54288 110462058
Wheezing 105.91 11.01 20 72933 255210 110261136
Duodenal ulcer perforation 103.32 11.01 3 72950 177697 110338649
Hepatic cirrhosis 102.15 11.01 170 72783 67456 110448890
Musculoskeletal stiffness 100.25 11.01 30 72923 279792 110236554
Fibromyalgia 98.95 11.01 3 72950 170906 110345440
Rheumatoid arthritis 98.83 11.01 37 72916 299576 110216770
Drug-induced liver injury 97.77 11.01 233 72720 119834 110396512
Varices oesophageal 96.83 11.01 60 72893 7155 110509191
Sinusitis 95.60 11.01 38 72915 296650 110219696
Mobility decreased 93.55 11.01 21 72932 237401 110278945
Therapeutic product effect decreased 93.52 11.01 23 72930 244293 110272053
Multiple organ dysfunction syndrome 93.31 11.01 265 72688 151445 110364901
Hypoalbuminaemia 93.04 11.01 105 72848 28869 110487477
Lower respiratory tract infection 92.84 11.01 23 72930 243083 110273263
Impaired healing 91.72 11.01 11 72942 196706 110319640
Bile duct stone 91.32 11.01 55 72898 6234 110510112
Pulmonary malformation 91.20 11.01 23 72930 222 110516124
Hepatorenal syndrome 90.39 11.01 49 72904 4548 110511798
Portal hypertension 89.34 11.01 61 72892 8576 110507770
Cystitis haemorrhagic 87.29 11.01 69 72884 12140 110504206
Arthralgia 85.91 11.01 248 72705 779384 109736962
Irritable bowel syndrome 82.22 11.01 7 72946 164208 110352138
Cholestasis of pregnancy 81.90 11.01 31 72922 1234 110515112
Septic shock 80.70 11.01 258 72695 157270 110359076
Pruritus 78.99 11.01 654 72299 580906 109935440
Primary biliary cholangitis 78.02 11.01 31 72922 1408 110514938
Hypersensitivity 77.94 11.01 91 72862 403907 110112439
Wound 75.56 11.01 30 72923 234407 110281939
Pancytopenia 75.54 11.01 306 72647 209307 110307039
Blister 73.44 11.01 29 72924 227347 110288999
C-reactive protein abnormal 72.55 11.01 3 72950 129692 110386654
Sepsis 72.32 11.01 415 72538 326931 110189415
Liver transplant rejection 72.17 11.01 40 72913 3878 110512468
Haemosiderosis 71.44 11.01 23 72930 561 110515785
Acute graft versus host disease in skin 71.05 11.01 58 72895 10682 110505664
Hepatitis C 71.03 11.01 62 72891 12511 110503835
Helicobacter infection 69.83 11.01 17 72936 181860 110334486
Cholangitis acute 69.51 11.01 31 72922 1882 110514464
Alopecia 69.45 11.01 83 72870 364670 110151676
Pleural effusion 69.33 11.01 266 72687 177443 110338903
Pain in extremity 68.64 11.01 136 72817 486982 110029364
White blood cell count decreased 67.45 11.01 315 72638 229075 110287271
Hepatic fibrosis 67.35 11.01 50 72903 8016 110508330
Thrombotic microangiopathy 66.63 11.01 89 72864 29060 110487286
Liver transplant 66.29 11.01 40 72913 4549 110511797
Bile duct stenosis 65.40 11.01 33 72920 2643 110513703
Injury 65.32 11.01 18 72935 177247 110339099
Peripheral swelling 64.84 11.01 104 72849 403930 110112416
Chronic graft versus host disease 64.52 11.01 52 72901 9405 110506941
Fatigue 64.07 11.01 505 72448 1215453 109300893
Bursitis 63.79 11.01 6 72947 129912 110386434
Discomfort 63.62 11.01 31 72922 214676 110301670
Toxicity to various agents 62.81 11.01 140 72813 480415 110035931
Autoimmune hepatitis 62.38 11.01 62 72891 14742 110501604
Blood cholesterol increased 60.61 11.01 23 72930 184762 110331584
Cystic fibrosis 60.11 11.01 38 72915 4693 110511653
Iron overload 59.93 11.01 29 72924 2122 110514224
Migraine 58.62 11.01 20 72933 171632 110344714
Infusion related reaction 58.48 11.01 101 72852 381061 110135285
Nasopharyngitis 58.25 11.01 107 72846 394254 110122092
Lung cyst 57.94 11.01 19 72934 492 110515854
CFTR gene mutation 57.43 11.01 16 72937 233 110516113
Cytomegalovirus viraemia 56.39 11.01 64 72889 17700 110498646
Abdominal discomfort 56.29 11.01 109 72844 393749 110122597
Philadelphia positive chronic myeloid leukaemia 56.14 11.01 15 72938 185 110516161
Intentional overdose 55.77 11.01 10 72943 132491 110383855
Acute lymphocytic leukaemia recurrent 55.46 11.01 39 72914 5748 110510598
Dyspnoea 55.38 11.01 466 72487 1106406 109409940
Hyperammonaemia 55.09 11.01 56 72897 13676 110502670
Vascular device infection 55 11.01 61 72892 16451 110499895
Splenomegaly 54.77 11.01 74 72879 24424 110491922
Hyperuricaemia 54.22 11.01 57 72896 14474 110501872
Treatment failure 53.92 11.01 62 72891 277172 110239174
Graft versus host disease in skin 53.39 11.01 44 72909 8210 110508136
Aspartate aminotransferase abnormal 53.30 11.01 31 72922 3294 110513052
Osteoarthritis 53.15 11.01 27 72926 182596 110333750
Memory impairment 53.15 11.01 32 72921 196912 110319434
Folliculitis 53.12 11.01 22 72931 167631 110348715
Type 2 diabetes mellitus 51.89 11.01 26 72927 177206 110339140
Joint range of motion decreased 51.70 11.01 9 72944 121823 110394523
Toxic epidermal necrolysis 51.57 11.01 115 72838 56612 110459734
Enterococcal sepsis 50.78 11.01 30 72923 3282 110513064
Engraftment syndrome 50.69 11.01 25 72928 1907 110514439
Drug ineffective 49.73 11.01 706 72247 1519834 108996512
Cholangiocarcinoma 49.19 11.01 28 72925 2857 110513489
Sciatica 48.94 11.01 3 72950 92396 110423950
Respiratory tract malformation 48.84 11.01 12 72941 103 110516243
Biliary cirrhosis 48.80 11.01 14 72939 228 110516118
Blood lactate dehydrogenase increased 48.58 11.01 97 72856 44237 110472109
Muscle spasms 48.08 11.01 68 72885 278089 110238257
Graft versus host disease in liver 47.70 11.01 26 72927 2439 110513907
Ill-defined disorder 47.46 11.01 22 72931 156831 110359515
Cytokine release syndrome 47.36 11.01 127 72826 70179 110446167
Gamma-glutamyltransferase abnormal 46.90 11.01 19 72934 908 110515438
Poor sucking reflex 46.76 11.01 12 72941 125 110516221
Enterocolitis 46.63 11.01 60 72893 18889 110497457
Hypoaesthesia 46.62 11.01 85 72868 314138 110202208
Paraesthesia 46.42 11.01 69 72884 276452 110239894
Premature delivery 46.24 11.01 77 72876 30555 110485791
Renal failure 45.98 11.01 281 72672 226293 110290053
Transfusion 45.29 11.01 69 72884 25403 110490943
Exposure via breast milk 45.00 11.01 19 72934 1009 110515337
Urticaria 44.89 11.01 89 72864 318768 110197578
Biliary tract infection 44.31 11.01 22 72931 1702 110514644
Hepatomegaly 43.85 11.01 62 72891 21352 110494994
Cytomegalovirus urinary tract infection 43.73 11.01 11 72942 105 110516241
Cholecystitis acute 43.68 11.01 53 72900 15729 110500617
Drug abuse 43.59 11.01 32 72921 177379 110338967
Wound infection 43.49 11.01 6 72947 96459 110419887
Asthma 43.45 11.01 61 72892 250230 110266116
Liver abscess 43.39 11.01 38 72915 7701 110508645
Cholelithiasis 43.15 11.01 115 72838 63307 110453039
Anxiety 43.06 11.01 103 72850 344975 110171371
Portal hypertensive gastropathy 42.20 11.01 22 72931 1886 110514460
Off label use 42.19 11.01 1290 71663 1498895 109017451
Altered state of consciousness 41.78 11.01 107 72846 57519 110458827
Lip dry 41.16 11.01 8 72945 100075 110416271
Gallbladder enlargement 40.60 11.01 22 72931 2040 110514306
Neutropenia 40.40 11.01 401 72552 374219 110142127
Thrombocytopenia 40.35 11.01 379 72574 348506 110167840
Musculoskeletal pain 40.02 11.01 37 72916 182986 110333360
Amylase increased 39.56 11.01 45 72908 12474 110503872
Headache 39.46 11.01 382 72571 881995 109634351
Cerebral infarction 39.40 11.01 98 72855 51740 110464606
Adenovirus infection 39.03 11.01 42 72911 10952 110505394
Hepatic pain 39.00 11.01 29 72924 4661 110511685
Graft versus host disease in gastrointestinal tract 38.60 11.01 38 72915 8930 110507416
Peripheral venous disease 38.47 11.01 5 72948 84112 110432234
Cytomegalovirus test positive 38.35 11.01 34 72919 7002 110509344
Transaminases increased 38.24 11.01 110 72843 63280 110453066
Capillary leak syndrome 37.82 11.01 29 72924 4879 110511467
Lactation disorder 37.62 11.01 12 72941 284 110516062
Diarrhoea 37.54 11.01 1000 71953 1138505 109377841
Contusion 37.47 11.01 60 72893 233301 110283045
Biliary tract disorder 37.40 11.01 20 72933 1806 110514540
Lip pruritus 37.36 11.01 18 72935 1304 110515042
Hepatitis toxic 37.13 11.01 31 72922 5890 110510456
Product quality issue 36.83 11.01 4 72949 77295 110439051
Intentional product misuse 36.69 11.01 21 72932 132883 110383463
Injection site pain 36.56 11.01 38 72915 177884 110338462
Liver carcinoma ruptured 36.33 11.01 12 72941 318 110516028
Portal vein thrombosis 36.29 11.01 33 72920 7025 110509321
Ammonia increased 35.59 11.01 35 72918 8215 110508131
Dry mouth 35.43 11.01 48 72905 199900 110316446
Hyperhidrosis 35.21 11.01 43 72910 187255 110329091
Chronic obstructive pulmonary disease 35.10 11.01 14 72939 109144 110407202
Hepatitis cholestatic 34.70 11.01 50 72903 17516 110498830
Erythema multiforme 34.51 11.01 55 72898 21042 110495304
Dizziness 34.34 11.01 295 72658 697898 109818448
Gait inability 34.28 11.01 24 72929 136352 110379994
Hypothyroidism 34.26 11.01 116 72837 72783 110443563
Blood creatine phosphokinase increased 34.10 11.01 116 72837 72961 110443385
Parenteral nutrition 34.04 11.01 15 72938 885 110515461
Varicella virus test positive 34.01 11.01 12 72941 390 110515956
Overdose 33.99 11.01 64 72889 233730 110282616
Prescribed overdose 33.98 11.01 8 72945 87573 110428773
Sleep disorder 33.89 11.01 49 72904 198595 110317751
Mantle cell lymphoma stage IV 33.87 11.01 8 72945 57 110516289
Gastrointestinal disorder 33.65 11.01 68 72885 241884 110274462
Psoriasis 33.43 11.01 26 72927 139967 110376379
Lower limb fracture 33.24 11.01 5 72948 75343 110441003
Neck pain 33.22 11.01 20 72933 123110 110393236
Medication error 33.10 11.01 14 72939 105352 110410994
Pulmonary fibrosis 32.96 11.01 13 72940 102029 110414317
Injection site reaction 32.89 11.01 9 72944 89061 110427285
Viral haemorrhagic cystitis 32.79 11.01 23 72930 3376 110512970
Lung disorder 32.12 11.01 43 72910 180004 110336342
Knee arthroplasty 31.88 11.01 3 72950 64945 110451401
Night sweats 31.84 11.01 25 72928 133958 110382388
Intentional product use issue 31.71 11.01 73 72880 247833 110268513
Obesity 31.16 11.01 18 72935 113333 110403013
Inflammation 30.72 11.01 50 72903 193188 110323158
Ocular icterus 30.53 11.01 28 72925 6025 110510321
Melaena 30.22 11.01 107 72846 68650 110447696
Therapeutic product effect incomplete 30.19 11.01 64 72889 223741 110292605
Respiratory failure 30.12 11.01 244 72709 215088 110301258
Blood urea increased 29.95 11.01 92 72861 54865 110461481
Cardiac failure 29.80 11.01 219 72734 187407 110328939
Hyperglycaemia 29.65 11.01 123 72830 84967 110431379
Pneumocystis jirovecii pneumonia 29.59 11.01 78 72875 42657 110473689
Aplasia 29.58 11.01 31 72922 7842 110508504
Gastrointestinal infection 29.34 11.01 41 72912 13964 110502382
Adenoviral hepatitis 29.27 11.01 14 72939 998 110515348
Pancreatitis relapsing 29.21 11.01 16 72937 1516 110514830
Blood bilirubin abnormal 29.00 11.01 17 72936 1833 110514513
Pre-eclampsia 28.89 11.01 32 72921 8618 110507728
Incorrect route of product administration 28.84 11.01 4 72949 64057 110452289
Loss of personal independence in daily activities 28.67 11.01 34 72919 149986 110366360
Acute graft versus host disease in intestine 28.28 11.01 26 72927 5613 110510733
Maternal exposure during breast feeding 28.27 11.01 23 72930 4215 110512131
Oesophagitis 28.13 11.01 60 72893 28655 110487691
Cystic fibrosis related diabetes 28.02 11.01 9 72944 218 110516128
Acute respiratory distress syndrome 28.01 11.01 88 72865 53110 110463236
Arthritis 27.94 11.01 42 72911 167544 110348802
Acute kidney injury 27.70 11.01 580 72373 634850 109881496
Pancreatitis acute 27.53 11.01 95 72858 60179 110456167
Mucosal disorder 27.44 11.01 23 72930 4394 110511952
Cytopenia 27.31 11.01 61 72892 30055 110486291
Immune-mediated hepatic disorder 27.29 11.01 23 72930 4427 110511919
Foetal exposure timing unspecified 27.27 11.01 7 72946 73 110516273
Hypercholesterolaemia 27.07 11.01 13 72940 90824 110425522
Chest pain 27.02 11.01 142 72811 376233 110140113
Allergic sinusitis 26.96 11.01 16 72937 1765 110514581
Hepatic necrosis 26.94 11.01 33 72920 9889 110506457
Platelet transfusion 26.86 11.01 19 72934 2827 110513519
Shock haemorrhagic 26.77 11.01 57 72896 27190 110489156
Device related bacteraemia 26.69 11.01 14 72939 1216 110515130
Spider naevus 26.63 11.01 8 72945 154 110516192
Iron deficiency anaemia 26.49 11.01 62 72891 31497 110484849
Organic brain syndrome 26.20 11.01 11 72942 576 110515770
Oesophageal achalasia 26.16 11.01 13 72940 1008 110515338
Cystic fibrosis lung 25.93 11.01 8 72945 169 110516177
Sedation 25.80 11.01 7 72946 69676 110446670
Acute on chronic liver failure 25.78 11.01 10 72943 426 110515920
Drug eruption 25.76 11.01 86 72867 53573 110462773
Road traffic accident 25.57 11.01 20 72933 107378 110408968
Coma hepatic 25.50 11.01 13 72940 1064 110515282
Pneumonia cytomegaloviral 25.45 11.01 27 72926 6927 110509419
Retinitis viral 25.28 11.01 10 72943 449 110515897
Eosinophilic colitis 25.24 11.01 11 72942 632 110515714
Nail disorder 25.20 11.01 4 72949 57931 110458415
Cerebrovascular accident 25.16 11.01 51 72902 181233 110335113
Cerebral haemorrhage 25.11 11.01 97 72856 64871 110451475
Haemorrhage subcutaneous 24.83 11.01 24 72929 5515 110510831
Biliary obstruction 24.76 11.01 24 72929 5534 110510812
Aspergillus infection 24.49 11.01 53 72900 25563 110490783
Depression 24.33 11.01 117 72836 317218 110199128
Bilirubin conjugated increased 24.27 11.01 25 72928 6199 110510147
Complications of transplanted liver 24.22 11.01 10 72943 502 110515844
Myocardial infarction 24.21 11.01 57 72896 192026 110324320
Hepatitis fulminant 24.10 11.01 29 72924 8531 110507815
Gestational diabetes 24.10 11.01 27 72926 7362 110508984
Adverse event 23.78 11.01 22 72931 108787 110407559
Venous haemorrhage 23.55 11.01 9 72944 368 110515978
Hypokalaemia 23.52 11.01 203 72750 182245 110334101
Chronic hepatic failure 23.47 11.01 13 72940 1258 110515088
Glomerulosclerosis 23.42 11.01 13 72940 1264 110515082
Stress 23.38 11.01 21 72932 105327 110411019
Fall 23.38 11.01 270 72683 603212 109913134
Coagulation test abnormal 23.36 11.01 14 72939 1572 110514774
Psychotic disorder 23.36 11.01 3 72950 50934 110465412
Haemolysis 23.19 11.01 39 72914 15600 110500746
Bacteraemia 23.13 11.01 71 72882 42319 110474027
Blood albumin decreased 22.86 11.01 54 72899 27598 110488748
Accidental exposure to product 22.80 11.01 3 72950 50005 110466341
Candida test positive 22.70 11.01 13 72940 1342 110515004
Joint stiffness 22.67 11.01 8 72945 67235 110449111
Staphylococcal sepsis 22.59 11.01 41 72912 17413 110498933
Pneumonia bacterial 22.49 11.01 52 72901 26209 110490137
Suicide attempt 22.48 11.01 21 72932 103373 110412973
Cholangitis infective 22.44 11.01 11 72942 828 110515518
Jaundice cholestatic 22.42 11.01 37 72916 14571 110501775
Serum ferritin increased 22.35 11.01 33 72920 11814 110504532
Spinal compression fracture 22.29 11.01 42 72911 18350 110497996
Faeces soft 22.28 11.01 32 72921 11178 110505168
Bronchopulmonary aspergillosis 22.21 11.01 56 72897 29807 110486539
Urge incontinence 22.17 11.01 13 72940 1402 110514944
Haemobilia 21.88 11.01 10 72943 643 110515703
Tonsillar haemorrhage 21.85 11.01 8 72945 290 110516056
Sleep disorder due to a general medical condition 21.78 11.01 4 72949 52108 110464238
Upper respiratory tract inflammation 21.62 11.01 20 72933 4351 110511995
Inappropriate schedule of product administration 21.46 11.01 66 72887 203571 110312775
Type 1 diabetes mellitus 21.25 11.01 28 72925 9019 110507327
Malnutrition 21.18 11.01 52 72901 27227 110489119
Bilirubin conjugated abnormal 20.93 11.01 7 72946 193 110516153
Drug level decreased 20.82 11.01 41 72912 18507 110497839
Cholecystitis 20.81 11.01 50 72903 25832 110490514
Weight increased 20.73 11.01 177 72776 419467 110096879
Gastrointestinal haemorrhage 20.73 11.01 183 72770 165335 110351011
Biliary dilatation 20.73 11.01 18 72935 3607 110512739
Gallbladder polyp 20.63 11.01 12 72941 1275 110515071
Drug dependence 20.56 11.01 4 72949 50016 110466330
Device related infection 20.47 11.01 65 72888 39454 110476892
Sweat test abnormal 20.34 11.01 5 72948 43 110516303
Coronary artery disease 20.26 11.01 11 72942 71679 110444667
Antimitochondrial antibody positive 20.25 11.01 6 72947 110 110516236
Autoimmune disorder 20.09 11.01 9 72944 65474 110450872
Dyspepsia 20.05 11.01 62 72891 190903 110325443
Primary mediastinal large B-cell lymphoma stage IV 20.02 11.01 4 72949 11 110516335
Cytomegalovirus infection reactivation 19.95 11.01 40 72913 18293 110498053
Bile duct cancer 19.82 11.01 11 72942 1069 110515277
Pancreatic enzymes increased 19.78 11.01 13 72940 1716 110514630
Abdominal pain 19.72 11.01 460 72493 512529 110003817
Pneumonia fungal 19.53 11.01 35 72918 14719 110501627
Gastroenteritis 19.35 11.01 63 72890 38737 110477609
Renal disorder 19.22 11.01 74 72879 49405 110466941
Unresponsive to stimuli 19.21 11.01 9 72944 63781 110452565
Blood pressure fluctuation 19.02 11.01 13 72940 74811 110441535
Burning sensation 19.01 11.01 11 72942 69201 110447145
Confusional state 18.80 11.01 208 72745 468472 110047874
Coeliac disease 18.74 11.01 3 72950 43184 110473162
Metastases to skin 18.63 11.01 14 72939 2285 110514061
Pneumonia aspiration 18.57 11.01 104 72849 81129 110435217
Tumour haemorrhage 18.55 11.01 20 72933 5225 110511121
Intestinal anastomosis 18.42 11.01 10 72943 931 110515415
Pseudomonas test positive 18.34 11.01 14 72939 2340 110514006
Acute graft versus host disease in liver 18.31 11.01 14 72939 2345 110514001
Gait disturbance 18.30 11.01 108 72845 278100 110238246
Thalamus haemorrhage 18.27 11.01 13 72940 1951 110514395
Vision blurred 18.15 11.01 36 72917 128986 110387360
Stevens-Johnson syndrome 18.10 11.01 70 72883 46831 110469515
Haematemesis 17.96 11.01 82 72871 59026 110457320
Granulicatella infection 17.92 11.01 6 72947 166 110516180
Organising pneumonia 17.86 11.01 33 72920 14210 110502136
Hepatic mass 17.81 11.01 15 72938 2883 110513463
Condition aggravated 17.75 11.01 360 72593 734476 109781870
Foot deformity 17.71 11.01 5 72948 48475 110467871
Immune-mediated hepatitis 17.70 11.01 22 72931 6689 110509657
Pulmonary function test decreased 17.53 11.01 25 72928 8675 110507671
Porphyria non-acute 17.52 11.01 9 72944 748 110515598
Swollen tongue 17.44 11.01 9 72944 60353 110455993
Proteinuria 17.34 11.01 62 72891 39956 110476390
Palpitations 17.21 11.01 51 72902 159161 110357185
Forced expiratory volume decreased 17.12 11.01 31 72922 13145 110503201
Pericardial effusion 17.11 11.01 79 72874 57138 110459208
Sputum increased 17.04 11.01 20 72933 5731 110510615
Cheilitis 17.01 11.01 21 72932 6344 110510002
Acute lymphocytic leukaemia 17.00 11.01 20 72933 5745 110510601
Hepatitis acute 17.00 11.01 38 72915 18728 110497618
Red blood cell sedimentation rate increased 16.91 11.01 16 72937 78286 110438060
Water pollution 16.90 11.01 3 72950 3 110516343
Foetor hepaticus 16.90 11.01 3 72950 3 110516343
Prothrombin level decreased 16.89 11.01 12 72941 1798 110514548
Bladder hypertrophy 16.76 11.01 10 72943 1114 110515232
Gastrointestinal polyp 16.72 11.01 6 72947 205 110516141
Hypoproteinaemia 16.51 11.01 20 72933 5925 110510421
Major depression 16.43 11.01 27 72926 10594 110505752
Generalised oedema 16.36 11.01 51 72902 30653 110485693
Axonal neuropathy 16.35 11.01 13 72940 2305 110514041
Diabetes mellitus 16.35 11.01 117 72836 99264 110417082
Puncture site erythema 16.32 11.01 4 72949 34 110516312
Non-small cell lung cancer 16.28 11.01 23 72930 7912 110508434
Klebsiella bacteraemia 16.24 11.01 18 72935 4851 110511495
Primary adrenal insufficiency 16.15 11.01 8 72945 616 110515730
Encephalopathy 16.09 11.01 100 72853 80955 110435391
Malignant neoplasm progression 16.04 11.01 181 72772 174386 110341960
Nasal congestion 16.02 11.01 25 72928 98257 110418089
Pneumonia 16.00 11.01 719 72234 875995 109640351
Hepatitis 15.98 11.01 108 72845 89946 110426400
Influenza like illness 15.88 11.01 21 72932 88391 110427955
Hypophosphataemia 15.76 11.01 53 72900 33129 110483217
Immunosuppressant drug level increased 15.76 11.01 28 72925 11696 110504650
Cataract subcapsular 15.70 11.01 10 72943 1251 110515095
Hepatosplenomegaly 15.62 11.01 21 72932 6898 110509448
Rhabdomyolysis 15.53 11.01 134 72819 120267 110396079
Swelling face 15.52 11.01 23 72930 92298 110424048
Tinea capitis 15.47 11.01 4 72949 43 110516303
Bacterial sepsis 15.46 11.01 26 72927 10400 110505946
Varicella zoster virus infection 15.41 11.01 20 72933 6348 110509998
Subdural haematoma 15.39 11.01 56 72897 36398 110479948
Transaminases abnormal 15.28 11.01 9 72944 979 110515367
Suicidal ideation 15.21 11.01 24 72929 93913 110422433
Therapy cessation 14.97 11.01 64 72889 44793 110471553
Human herpesvirus 6 infection 14.89 11.01 20 72933 6561 110509785
Epstein-Barr virus infection 14.85 11.01 36 72917 18702 110497644
Joint injury 14.84 11.01 4 72949 39990 110476356
Cardiac failure acute 14.73 11.01 42 72911 24036 110492310
Lymphocyte stimulation test positive 14.73 11.01 9 72944 1047 110515299
Gastric varices haemorrhage 14.70 11.01 7 72946 494 110515852
Hepatobiliary disease 14.68 11.01 9 72944 1053 110515293
Polymyositis 14.65 11.01 15 72938 3693 110512653
Haemophagocytic lymphohistiocytosis 14.63 11.01 50 72903 31509 110484837
Hyponatraemia 14.62 11.01 213 72740 217440 110298906
Product administered to patient of inappropriate age 14.61 11.01 22 72931 8014 110508332
Escherichia bacteraemia 14.61 11.01 25 72928 10139 110506207
Heart rate decreased 14.52 11.01 20 72933 82736 110433610
Rectal tenesmus 14.51 11.01 12 72941 2250 110514096
Bacterial disease carrier 14.48 11.01 12 72941 2257 110514089
Escherichia sepsis 14.42 11.01 25 72928 10247 110506099
Gastrointestinal perforation 14.40 11.01 21 72932 7435 110508911
Cystic fibrosis hepatic disease 14.37 11.01 4 72949 58 110516288
Beta 2 microglobulin urine increased 14.37 11.01 5 72948 156 110516190
Aortic dissection 14.36 11.01 17 72936 4916 110511430
Cystitis viral 14.29 11.01 10 72943 1463 110514883
Hypomagnesaemia 14.27 11.01 78 72875 60292 110456054
Putamen haemorrhage 14.14 11.01 7 72946 538 110515808
Stem cell transplant 14.14 11.01 16 72937 4411 110511935
Laparotomy 14.13 11.01 7 72946 539 110515807
Serotonin syndrome 14.10 11.01 11 72942 59142 110457204
Enteritis infectious 14.08 11.01 15 72938 3867 110512479
Hyperplasia 14.01 11.01 10 72943 1508 110514838
Parenteral nutrition associated liver disease 13.96 11.01 3 72950 13 110516333
Cardiac tamponade 13.93 11.01 26 72927 11281 110505065
Blood albumin abnormal 13.90 11.01 8 72945 833 110515513
Anorectal varices 13.84 11.01 4 72949 67 110516279
Cardiac disorder 13.82 11.01 18 72935 76262 110440084
Gastric antral vascular ectasia 13.69 11.01 9 72944 1188 110515158
Blood pressure systolic increased 13.63 11.01 21 72932 82970 110433376
Histoplasmosis 13.63 11.01 13 72940 2940 110513406
Back pain 13.57 11.01 168 72785 370828 110145518
Necrotising retinitis 13.56 11.01 10 72943 1586 110514760
Hyperamylasaemia 13.53 11.01 9 72944 1212 110515134
Therapeutic response decreased 13.51 11.01 27 72926 96472 110419874
Pyelonephritis 13.51 11.01 42 72911 25208 110491138
Dialysis hypotension 13.31 11.01 5 72948 195 110516151
Acute myeloid leukaemia 13.20 11.01 55 72898 38055 110478291
Hypozincaemia 13.17 11.01 4 72949 80 110516266
Anal erosion 13.17 11.01 4 72949 80 110516266
Necrotising gastritis 13.08 11.01 4 72949 82 110516264
Pruritus allergic 13.07 11.01 10 72943 1678 110514668
Bile duct necrosis 12.99 11.01 4 72949 84 110516262
Vitamin D deficiency 12.98 11.01 34 72919 18518 110497828
Mycobacterium abscessus infection 12.97 11.01 10 72943 1696 110514650
Total bile acids increased 12.95 11.01 4 72949 85 110516261
Injection site bruising 12.91 11.01 9 72944 51254 110465092
Asterixis 12.89 11.01 13 72940 3145 110513201
Foetal exposure during pregnancy 12.88 11.01 20 72933 7485 110508861
Hypoaldosteronism 12.79 11.01 7 72946 662 110515684
Transient ischaemic attack 12.76 11.01 14 72939 63968 110452378
Hypertriglyceridaemia 12.76 11.01 31 72922 16123 110500223
Impulse-control disorder 12.76 11.01 11 72942 2183 110514163
Tumour lysis syndrome 12.74 11.01 47 72906 30754 110485592
Stenotrophomonas test positive 12.72 11.01 6 72947 415 110515931
Metastases to peritoneum 12.62 11.01 17 72936 5593 110510753
Pneumonia necrotising 12.62 11.01 10 72943 1765 110514581
Gastrointestinal stoma output increased 12.59 11.01 8 72945 996 110515350
Kidney fibrosis 12.56 11.01 15 72938 4377 110511969
Laryngomalacia 12.51 11.01 3 72950 23 110516323
Oedema due to hepatic disease 12.51 11.01 3 72950 23 110516323
Gastroenteritis adenovirus 12.48 11.01 6 72947 433 110515913
Distal intestinal obstruction syndrome 12.44 11.01 8 72945 1017 110515329
BK virus infection 12.40 11.01 27 72926 13079 110503267
Autoimmune neutropenia 12.39 11.01 7 72946 704 110515642
Cytomegalovirus enterocolitis 12.39 11.01 11 72942 2270 110514076
Haemolytic anaemia 12.32 11.01 36 72917 20884 110495462
Onychomycosis 12.29 11.01 5 72948 38526 110477820
Refractoriness to platelet transfusion 12.26 11.01 5 72948 243 110516103
Hepatic cytolysis 12.26 11.01 70 72883 54983 110461363
Hepatic enzyme increased 12.24 11.01 144 72809 320748 110195598
Acute myeloid leukaemia recurrent 12.22 11.01 16 72937 5123 110511223
Renal ischaemia 12.22 11.01 11 72942 2312 110514034
Restrictive cardiomyopathy 12.19 11.01 8 72945 1053 110515293
Hepatitis C RNA positive 12.19 11.01 5 72948 247 110516099
Liver sarcoidosis 12.18 11.01 3 72950 26 110516320
Acute hepatic failure 12.15 11.01 52 72901 36416 110479930
Insulin autoimmune syndrome 12.11 11.01 7 72946 735 110515611
Blepharospasm 12.09 11.01 11 72942 54840 110461506
Ileus paralytic 12.05 11.01 25 72928 11712 110504634
Immune-mediated enterocolitis 12.02 11.01 23 72930 10162 110506184
Live birth 11.98 11.01 17 72936 69467 110446879
Gastrointestinal mucosal exfoliation 11.98 11.01 5 72948 258 110516088
Infection in an immunocompromised host 11.90 11.01 10 72943 1917 110514429
Cystic fibrosis respiratory infection suppression 11.86 11.01 6 72947 483 110515863
Visual impairment 11.85 11.01 47 72906 134381 110381965
Injection site swelling 11.81 11.01 14 72939 61776 110454570
Wrong technique in product usage process 11.75 11.01 25 72928 87323 110429023
Metapneumovirus infection 11.74 11.01 11 72942 2433 110513913
Myocarditis 11.72 11.01 45 72908 30010 110486336
Laryngopharyngitis 11.71 11.01 4 72949 118 110516228
Papilloedema 11.69 11.01 19 72934 7390 110508956
Heart rate increased 11.62 11.01 52 72901 143782 110372564
Pneumonia staphylococcal 11.54 11.01 17 72936 6074 110510272
Agranulocytosis 11.52 11.01 75 72878 61685 110454661
Antithrombin III decreased 11.51 11.01 6 72947 514 110515832
Fixed eruption 11.37 11.01 14 72939 4218 110512128
Hypocalcaemia 11.36 11.01 78 72875 65288 110451058
Ulcerative duodenitis 11.30 11.01 3 72950 36 110516310
Dilatation intrahepatic duct acquired 11.29 11.01 7 72946 836 110515510
Laryngitis 11.28 11.01 7 72946 42404 110473942
Adverse drug reaction 11.27 11.01 34 72919 105525 110410821
Peritonitis 11.25 11.01 47 72906 32560 110483786
Bone marrow failure 11.25 11.01 71 72882 57777 110458569
Blood creatinine increased 11.13 11.01 176 72777 182713 110333633
Hypotension 11.08 11.01 262 72691 523587 109992759
Posterior reversible encephalopathy syndrome 11.06 11.01 48 72905 33813 110482533

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
MeSH PA D002756 Cholagogues and Choleretics
MeSH PA D005765 Gastrointestinal Agents
FDA EPC N0000175802 Bile Acid
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:75771 mouse metabolite
CHEBI has role CHEBI:77746 human metabolite
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

A05AA Bile acids and derivatives 4 drugs
chenodiolcholic acidobeticholic acidtaurursodiol

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




🐶 Veterinary Drug Use

None

🐶 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 IC50 4.17 CHEMBL CHEMBL
Phospholipase A2 Enzyme Kd 5 CHEMBL
G-protein coupled bile acid receptor 1 GPCR EC50 5.62 CHEMBL
Ectonucleotide pyrophosphatase/phosphodiesterase family member 2 Enzyme IC50 4.99 CHEMBL
Sodium/bile acid cotransporter Transporter INHIBITOR IC50 5.44 IUPHAR
CDGSH iron-sulfur domain-containing protein 1 Membrane other Ki 5.95 CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme WOMBAT-PK
Sodium/bile acid cotransporter Transporter INHIBITOR IC50 5.44 IUPHAR
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
CHEMBL272427 ChEMBL_ID
DB01586 DRUGBANK_ID
31401 PUBCHEM_CID
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
7104 IUPHAR_LIGAND_ID
724L30Y2QR INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0527-1326 CAPSULE 300 mg ORAL ANDA 19 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-3159 CAPSULE 300 mg ORAL NDA authorized generic 20 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 13 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6890 TABLET, FILM COATED 250 mg ORAL ANDA 24 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6890 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 24658-999 CAPSULE 300 mg ORAL ANDA 12 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 42291-923 CAPSULE 300 mg ORAL NDA authorized generic 18 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 42291-931 TABLET, FILM COATED 500 mg ORAL ANDA 24 sections
Ursodiol Human Prescription Drug Label 1 42385-946 CAPSULE 300 mg ORAL ANDA 18 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 42806-503 CAPSULE 300 mg ORAL ANDA 13 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 50268-864 CAPSULE 300 mg ORAL ANDA 17 sections
URSODIOL HUMAN PRESCRIPTION DRUG LABEL 1 51407-754 CAPSULE 300 mg ORAL ANDA 18 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 55154-2633 TABLET, FILM COATED 250 mg ORAL ANDA 24 sections
Urso 250 HUMAN PRESCRIPTION DRUG LABEL 1 58914-785 TABLET, FILM COATED 250 mg ORAL NDA 26 sections
Urso Forte HUMAN PRESCRIPTION DRUG LABEL 1 58914-790 TABLET, FILM COATED 500 mg ORAL NDA 26 sections
Ursodiol Human Prescription Drug Label 1 59651-421 CAPSULE 300 mg ORAL ANDA 18 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 60687-100 CAPSULE 300 mg ORAL ANDA 20 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 60687-527 TABLET 250 mg ORAL ANDA 25 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 62135-430 CAPSULE 300 mg ORAL ANDA 12 sections