ursodiol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 2797 | 128-13-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.75 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 31, 1987 | FDA | ACTAVIS LABS UT INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatic function abnormal | 334.39 | 11.99 | 224 | 34533 | 36918 | 63417347 |
| Ascites | 224.89 | 11.99 | 183 | 34574 | 40545 | 63413720 |
| Blood bilirubin increased | 222.38 | 11.99 | 175 | 34582 | 36965 | 63417300 |
| Hepatic failure | 207.02 | 11.99 | 165 | 34592 | 35491 | 63418774 |
| Hepatic encephalopathy | 204.50 | 11.99 | 107 | 34650 | 11175 | 63443090 |
| Aspartate aminotransferase increased | 165.90 | 11.99 | 225 | 34532 | 90052 | 63364213 |
| Pruritus | 158.96 | 11.99 | 496 | 34261 | 360957 | 63093308 |
| Platelet count decreased | 157.78 | 11.99 | 251 | 34506 | 115871 | 63338394 |
| Infective pulmonary exacerbation of cystic fibrosis | 152.35 | 11.99 | 81 | 34676 | 8736 | 63445529 |
| Hepatic cirrhosis | 136.20 | 11.99 | 111 | 34646 | 24623 | 63429642 |
| Liver disorder | 135.69 | 11.99 | 157 | 34600 | 53530 | 63400735 |
| Hepatocellular carcinoma | 133.95 | 11.99 | 49 | 34708 | 2145 | 63452120 |
| Venoocclusive liver disease | 126.84 | 11.99 | 59 | 34698 | 4776 | 63449489 |
| Jaundice | 125.91 | 11.99 | 114 | 34643 | 29137 | 63425128 |
| Alanine aminotransferase increased | 125.66 | 11.99 | 213 | 34544 | 103557 | 63350708 |
| Graft versus host disease | 125.01 | 11.99 | 65 | 34692 | 6698 | 63447567 |
| Pain | 124.17 | 11.99 | 134 | 34623 | 740494 | 62713771 |
| Blood alkaline phosphatase increased | 115.93 | 11.99 | 130 | 34627 | 42837 | 63411428 |
| Arthropathy | 114.49 | 11.99 | 3 | 34754 | 234789 | 63219476 |
| Pulmonary malformation | 111.03 | 11.99 | 27 | 34730 | 272 | 63453993 |
| Febrile neutropenia | 110.29 | 11.99 | 217 | 34540 | 118232 | 63336033 |
| Cholangitis | 101.50 | 11.99 | 53 | 34704 | 5508 | 63448757 |
| Disseminated intravascular coagulation | 99.66 | 11.99 | 83 | 34674 | 18968 | 63435297 |
| Cholestasis | 96.94 | 11.99 | 99 | 34658 | 29335 | 63424930 |
| Aplastic anaemia | 96.49 | 11.99 | 62 | 34695 | 9507 | 63444758 |
| Joint swelling | 96.05 | 11.99 | 30 | 34727 | 327636 | 63126629 |
| Drug intolerance | 94.61 | 11.99 | 26 | 34731 | 308635 | 63145630 |
| Contraindicated product administered | 89.72 | 11.99 | 8 | 34749 | 217640 | 63236625 |
| Drug ineffective | 89.63 | 11.99 | 285 | 34472 | 1044480 | 62409785 |
| Interstitial lung disease | 85.62 | 11.99 | 135 | 34622 | 61773 | 63392492 |
| Cholestasis of pregnancy | 84.71 | 11.99 | 30 | 34727 | 1195 | 63453070 |
| Primary biliary cholangitis | 81.53 | 11.99 | 29 | 34728 | 1170 | 63453095 |
| Cytomegalovirus infection | 81.14 | 11.99 | 77 | 34680 | 20875 | 63433390 |
| Rheumatoid arthritis | 78.47 | 11.99 | 21 | 34736 | 253798 | 63200467 |
| Lung cyst | 78.19 | 11.99 | 21 | 34736 | 323 | 63453942 |
| Systemic lupus erythematosus | 77.77 | 11.99 | 11 | 34746 | 208907 | 63245358 |
| Thrombotic microangiopathy | 76.98 | 11.99 | 56 | 34701 | 10505 | 63443760 |
| Drug hypersensitivity | 75.39 | 11.99 | 38 | 34719 | 310649 | 63143616 |
| Respiratory tract malformation | 74.59 | 11.99 | 18 | 34739 | 175 | 63454090 |
| Cholangitis sclerosing | 69.21 | 11.99 | 28 | 34729 | 1613 | 63452652 |
| Acute graft versus host disease | 69.02 | 11.99 | 38 | 34719 | 4390 | 63449875 |
| Treatment failure | 68.46 | 11.99 | 13 | 34744 | 199030 | 63255235 |
| Neutrophil count decreased | 67.19 | 11.99 | 115 | 34642 | 56291 | 63397974 |
| Renal impairment | 67.15 | 11.99 | 149 | 34608 | 88206 | 63366059 |
| Hyperbilirubinaemia | 67.00 | 11.99 | 53 | 34704 | 11261 | 63443004 |
| Swelling | 66.32 | 11.99 | 34 | 34723 | 275344 | 63178921 |
| Sepsis | 65.99 | 11.99 | 209 | 34548 | 152914 | 63301351 |
| Hepatic cancer | 65.83 | 11.99 | 37 | 34720 | 4450 | 63449815 |
| Portal hypertension | 65.73 | 11.99 | 35 | 34722 | 3784 | 63450481 |
| Oesophageal varices haemorrhage | 62.37 | 11.99 | 24 | 34733 | 1210 | 63453055 |
| Autoimmune hepatitis | 61.74 | 11.99 | 45 | 34712 | 8465 | 63445800 |
| Pyrexia | 60.89 | 11.99 | 453 | 34304 | 470025 | 62984240 |
| Varices oesophageal | 60.32 | 11.99 | 31 | 34726 | 3117 | 63451148 |
| Drug-induced liver injury | 60.21 | 11.99 | 91 | 34666 | 40131 | 63414134 |
| Therapeutic product effect decreased | 59.66 | 11.99 | 16 | 34741 | 193171 | 63261094 |
| Alopecia | 56.40 | 11.99 | 61 | 34696 | 337475 | 63116790 |
| Hypersensitivity | 55.77 | 11.99 | 47 | 34710 | 292638 | 63161627 |
| Blood alkaline phosphatase abnormal | 55.46 | 11.99 | 18 | 34739 | 547 | 63453718 |
| Anaemia | 55.42 | 11.99 | 311 | 34446 | 293119 | 63161146 |
| Gamma-glutamyltransferase increased | 53.81 | 11.99 | 79 | 34678 | 33952 | 63420313 |
| Pericarditis | 53.76 | 11.99 | 5 | 34752 | 131574 | 63322691 |
| Decreased appetite | 53.45 | 11.99 | 275 | 34482 | 250777 | 63203488 |
| Abdominal discomfort | 52.49 | 11.99 | 59 | 34698 | 320826 | 63133439 |
| Completed suicide | 51.19 | 11.99 | 9 | 34748 | 145664 | 63308601 |
| Multiple organ dysfunction syndrome | 50.40 | 11.99 | 102 | 34655 | 56650 | 63397615 |
| Chronic graft versus host disease | 49.40 | 11.99 | 27 | 34730 | 3075 | 63451190 |
| Total bile acids increased | 48.47 | 11.99 | 12 | 34745 | 131 | 63454134 |
| Cytomegalovirus viraemia | 48.23 | 11.99 | 33 | 34724 | 5616 | 63448649 |
| Pancytopenia | 48.02 | 11.99 | 139 | 34618 | 96794 | 63357471 |
| Hepatic fibrosis | 47.91 | 11.99 | 28 | 34729 | 3624 | 63450641 |
| Discomfort | 47.79 | 11.99 | 16 | 34741 | 167358 | 63286907 |
| Arthralgia | 46.10 | 11.99 | 159 | 34598 | 569551 | 62884714 |
| Bile duct stone | 45.26 | 11.99 | 27 | 34730 | 3629 | 63450636 |
| Cystic fibrosis | 45.18 | 11.99 | 26 | 34731 | 3270 | 63450995 |
| Splenomegaly | 45.11 | 11.99 | 42 | 34715 | 11115 | 63443150 |
| Hypoalbuminaemia | 44.97 | 11.99 | 43 | 34714 | 11762 | 63442503 |
| Exposure via breast milk | 44.52 | 11.99 | 22 | 34735 | 2035 | 63452230 |
| Vanishing bile duct syndrome | 43.40 | 11.99 | 16 | 34741 | 716 | 63453549 |
| Hepatomegaly | 42.84 | 11.99 | 42 | 34715 | 11847 | 63442418 |
| Portal hypertensive gastropathy | 42.17 | 11.99 | 16 | 34741 | 776 | 63453489 |
| Maternal exposure during breast feeding | 41.58 | 11.99 | 27 | 34730 | 4214 | 63450051 |
| Acute graft versus host disease in skin | 41.46 | 11.99 | 25 | 34732 | 3427 | 63450838 |
| Cardiac failure | 41.46 | 11.99 | 125 | 34632 | 89017 | 63365248 |
| Pleural effusion | 40.83 | 11.99 | 128 | 34629 | 93082 | 63361183 |
| Lower respiratory tract infection | 40.75 | 11.99 | 11 | 34746 | 132296 | 63321969 |
| Infusion related reaction | 40.29 | 11.99 | 45 | 34712 | 245476 | 63208789 |
| Pre-eclampsia | 40.08 | 11.99 | 36 | 34721 | 9097 | 63445168 |
| Cytomegalovirus urinary tract infection | 40.04 | 11.99 | 9 | 34748 | 62 | 63454203 |
| CFTR gene mutation | 39.84 | 11.99 | 10 | 34747 | 116 | 63454149 |
| Poor sucking reflex | 39.20 | 11.99 | 12 | 34745 | 300 | 63453965 |
| Liver transplant rejection | 39.16 | 11.99 | 18 | 34739 | 1417 | 63452848 |
| Sinusitis | 38.90 | 11.99 | 40 | 34717 | 226613 | 63227652 |
| Pain in extremity | 38.62 | 11.99 | 77 | 34680 | 331409 | 63122856 |
| Premature baby | 38.51 | 11.99 | 52 | 34705 | 20683 | 63433582 |
| Wound | 38.03 | 11.99 | 21 | 34736 | 163242 | 63291023 |
| Mucosal inflammation | 37.75 | 11.99 | 81 | 34676 | 46847 | 63407418 |
| Cystitis haemorrhagic | 37.38 | 11.99 | 25 | 34732 | 4098 | 63450167 |
| Tonsillar haemorrhage | 36.92 | 11.99 | 11 | 34746 | 250 | 63454015 |
| Lactation disorder | 36.56 | 11.99 | 12 | 34745 | 378 | 63453887 |
| Hyperammonaemia | 36.45 | 11.99 | 27 | 34730 | 5205 | 63449060 |
| Musculoskeletal stiffness | 35.94 | 11.99 | 29 | 34728 | 184589 | 63269676 |
| Premature delivery | 35.08 | 11.99 | 61 | 34696 | 30220 | 63424045 |
| Impaired healing | 34.60 | 11.99 | 7 | 34750 | 102535 | 63351730 |
| Palmar-plantar erythrodysaesthesia syndrome | 34.34 | 11.99 | 52 | 34705 | 22963 | 63431302 |
| Psoriatic arthropathy | 33.61 | 11.99 | 5 | 34752 | 91515 | 63362750 |
| White blood cell count decreased | 33.57 | 11.99 | 158 | 34599 | 138946 | 63315319 |
| Neutropenia | 33.32 | 11.99 | 186 | 34571 | 174819 | 63279446 |
| Hypoproteinaemia | 33.09 | 11.99 | 18 | 34739 | 2031 | 63452234 |
| Venoocclusive disease | 33.01 | 11.99 | 18 | 34739 | 2040 | 63452225 |
| Adenoviral hepatitis | 32.28 | 11.99 | 11 | 34746 | 390 | 63453875 |
| Septic shock | 31.51 | 11.99 | 94 | 34663 | 66535 | 63387730 |
| Foetal exposure during pregnancy | 31.46 | 11.99 | 60 | 34697 | 31902 | 63422363 |
| Blister | 31.25 | 11.99 | 16 | 34741 | 129798 | 63324467 |
| Fatigue | 31.06 | 11.99 | 324 | 34433 | 887704 | 62566561 |
| Intestinal anastomosis | 30.73 | 11.99 | 11 | 34746 | 452 | 63453813 |
| Serum ferritin increased | 30.40 | 11.99 | 26 | 34731 | 6156 | 63448109 |
| Blood lactate dehydrogenase increased | 30.01 | 11.99 | 49 | 34708 | 23067 | 63431198 |
| Cytokine release syndrome | 29.85 | 11.99 | 38 | 34719 | 14276 | 63439989 |
| Transfusion | 29.55 | 11.99 | 39 | 34718 | 15178 | 63439087 |
| Hyperuricaemia | 29.34 | 11.99 | 24 | 34733 | 5346 | 63448919 |
| Pneumonia cytomegaloviral | 29.11 | 11.99 | 17 | 34740 | 2197 | 63452068 |
| Hepatitis fulminant | 29.02 | 11.99 | 20 | 34737 | 3444 | 63450821 |
| Liver transplant | 28.57 | 11.99 | 17 | 34740 | 2274 | 63451991 |
| Coagulation test abnormal | 28.20 | 11.99 | 12 | 34745 | 786 | 63453479 |
| Hepatic necrosis | 28.14 | 11.99 | 24 | 34733 | 5663 | 63448602 |
| Hepatitis cholestatic | 28.01 | 11.99 | 26 | 34731 | 6852 | 63447413 |
| Venous haemorrhage | 27.29 | 11.99 | 9 | 34748 | 288 | 63453977 |
| Candida test positive | 26.86 | 11.99 | 12 | 34745 | 884 | 63453381 |
| Haemorrhage subcutaneous | 26.84 | 11.99 | 18 | 34739 | 2965 | 63451300 |
| Product prescribing error | 26.68 | 11.99 | 50 | 34707 | 26239 | 63428026 |
| Cytomegalovirus test positive | 26.65 | 11.99 | 18 | 34739 | 3000 | 63451265 |
| Loss of personal independence in daily activities | 26.56 | 11.99 | 10 | 34747 | 97280 | 63356985 |
| Ammonia increased | 25.84 | 11.99 | 21 | 34736 | 4635 | 63449630 |
| Cholangitis acute | 25.73 | 11.99 | 10 | 34747 | 518 | 63453747 |
| Product administered to patient of inappropriate age | 25.35 | 11.99 | 18 | 34739 | 3250 | 63451015 |
| Intentional overdose | 25.14 | 11.99 | 5 | 34752 | 74147 | 63380118 |
| Mobility decreased | 24.89 | 11.99 | 18 | 34739 | 121141 | 63333124 |
| Helicobacter infection | 24.57 | 11.99 | 10 | 34747 | 92775 | 63361490 |
| Aspergillus infection | 24.45 | 11.99 | 26 | 34731 | 8067 | 63446198 |
| Bacterial sepsis | 24.42 | 11.99 | 19 | 34738 | 3939 | 63450326 |
| Iron deficiency anaemia | 24.14 | 11.99 | 41 | 34716 | 19928 | 63434337 |
| Nasopharyngitis | 24.02 | 11.99 | 66 | 34691 | 254191 | 63200074 |
| Adenovirus infection | 23.92 | 11.99 | 18 | 34739 | 3553 | 63450712 |
| Acute lymphocytic leukaemia recurrent | 23.61 | 11.99 | 15 | 34742 | 2254 | 63452011 |
| Spider naevus | 23.46 | 11.99 | 7 | 34750 | 160 | 63454105 |
| Injection site pain | 23.30 | 11.99 | 22 | 34735 | 129778 | 63324487 |
| Irritable bowel syndrome | 23.30 | 11.99 | 8 | 34749 | 82404 | 63371861 |
| Alagille syndrome | 23.27 | 11.99 | 4 | 34753 | 4 | 63454261 |
| Lip pruritus | 23.12 | 11.99 | 11 | 34746 | 936 | 63453329 |
| Bronchopulmonary aspergillosis | 23.06 | 11.99 | 26 | 34731 | 8609 | 63445656 |
| Wheezing | 22.68 | 11.99 | 12 | 34745 | 95583 | 63358682 |
| Fibromyalgia | 22.40 | 11.99 | 8 | 34749 | 80412 | 63373853 |
| Peripheral swelling | 22.27 | 11.99 | 73 | 34684 | 265869 | 63188396 |
| Faeces soft | 22.19 | 11.99 | 21 | 34736 | 5671 | 63448594 |
| Hyponatraemia | 21.99 | 11.99 | 120 | 34637 | 111780 | 63342485 |
| Haemophagocytic lymphohistiocytosis | 21.82 | 11.99 | 28 | 34729 | 10599 | 63443666 |
| Cholangitis infective | 21.70 | 11.99 | 8 | 34749 | 358 | 63453907 |
| Liver carcinoma ruptured | 21.65 | 11.99 | 4 | 34753 | 8 | 63454257 |
| Enterococcal sepsis | 21.64 | 11.99 | 12 | 34745 | 1406 | 63452859 |
| Hepatitis C | 21.60 | 11.99 | 20 | 34737 | 5254 | 63449011 |
| Enterocolitis | 21.56 | 11.99 | 24 | 34733 | 7834 | 63446431 |
| Ocular icterus | 21.37 | 11.99 | 17 | 34740 | 3639 | 63450626 |
| Osteoarthritis | 21.15 | 11.99 | 13 | 34744 | 95330 | 63358935 |
| Staphylococcal sepsis | 20.90 | 11.99 | 24 | 34733 | 8104 | 63446161 |
| Therapy cessation | 20.51 | 11.99 | 49 | 34708 | 30408 | 63423857 |
| Pancreatitis relapsing | 20.49 | 11.99 | 10 | 34747 | 900 | 63453365 |
| Gastrointestinal disorder | 20.49 | 11.99 | 25 | 34732 | 131214 | 63323051 |
| Histoplasmosis | 20.44 | 11.99 | 13 | 34744 | 1958 | 63452307 |
| Pregnancy | 20.37 | 11.99 | 55 | 34702 | 36781 | 63417484 |
| Cerebral haemorrhage | 20.22 | 11.99 | 49 | 34708 | 30680 | 63423585 |
| Coma hepatic | 19.88 | 11.99 | 9 | 34748 | 684 | 63453581 |
| Premature labour | 19.72 | 11.99 | 29 | 34728 | 12475 | 63441790 |
| Spinal compression fracture | 19.53 | 11.99 | 31 | 34726 | 14252 | 63440013 |
| Therapy interrupted | 19.52 | 11.99 | 50 | 34707 | 32405 | 63421860 |
| Blood creatine phosphokinase increased | 19.47 | 11.99 | 48 | 34709 | 30382 | 63423883 |
| Cardiac tamponade | 19.35 | 11.99 | 18 | 34739 | 4757 | 63449508 |
| Myocarditis | 19.34 | 11.99 | 26 | 34731 | 10299 | 63443966 |
| Migraine | 19.16 | 11.99 | 17 | 34740 | 103329 | 63350936 |
| Engraftment syndrome | 19.15 | 11.99 | 8 | 34749 | 500 | 63453765 |
| Hepatic vein occlusion | 18.99 | 11.99 | 5 | 34752 | 71 | 63454194 |
| Off label use | 18.97 | 11.99 | 493 | 34264 | 673969 | 62780296 |
| Overdose | 18.95 | 11.99 | 21 | 34736 | 115057 | 63339208 |
| Cholelithiasis | 18.93 | 11.99 | 60 | 34697 | 43865 | 63410400 |
| Graft versus host disease in gastrointestinal tract | 18.80 | 11.99 | 15 | 34742 | 3226 | 63451039 |
| Abdominal pain | 18.73 | 11.99 | 244 | 34513 | 293212 | 63161053 |
| Hepatitis B | 18.68 | 11.99 | 16 | 34741 | 3796 | 63450469 |
| Hepatitis | 18.68 | 11.99 | 56 | 34701 | 39732 | 63414533 |
| Gestational diabetes | 18.64 | 11.99 | 23 | 34734 | 8373 | 63445892 |
| Hospitalisation | 18.62 | 11.99 | 94 | 34663 | 84987 | 63369278 |
| Altered state of consciousness | 18.53 | 11.99 | 42 | 34715 | 25188 | 63429077 |
| Allergic sinusitis | 18.52 | 11.99 | 10 | 34747 | 1112 | 63453153 |
| Ill-defined disorder | 18.34 | 11.99 | 11 | 34746 | 81744 | 63372521 |
| Laparotomy | 18.11 | 11.99 | 7 | 34750 | 357 | 63453908 |
| Rhabdomyolysis | 18.00 | 11.99 | 59 | 34698 | 43892 | 63410373 |
| Epstein-Barr virus infection | 17.78 | 11.99 | 22 | 34735 | 8028 | 63446237 |
| Gait disturbance | 17.70 | 11.99 | 47 | 34710 | 183131 | 63271134 |
| Haematuria | 17.62 | 11.99 | 45 | 34712 | 29112 | 63425153 |
| Muscle spasms | 17.53 | 11.99 | 37 | 34720 | 156113 | 63298152 |
| Upper respiratory tract inflammation | 17.53 | 11.99 | 13 | 34744 | 2510 | 63451755 |
| Bile duct stenosis | 17.46 | 11.99 | 10 | 34747 | 1246 | 63453019 |
| Foetor hepaticus | 17.46 | 11.99 | 3 | 34754 | 3 | 63454262 |
| Hypoaesthesia | 17.21 | 11.99 | 42 | 34715 | 168351 | 63285914 |
| Product use issue | 16.80 | 11.99 | 63 | 34694 | 220457 | 63233808 |
| Type 2 diabetes mellitus | 16.72 | 11.99 | 7 | 34750 | 63861 | 63390404 |
| Blood bilirubin abnormal | 16.69 | 11.99 | 9 | 34748 | 998 | 63453267 |
| Biliary tract infection | 16.67 | 11.99 | 8 | 34749 | 694 | 63453571 |
| Low birth weight baby | 16.59 | 11.99 | 20 | 34737 | 7109 | 63447156 |
| Cystic fibrosis lung | 16.57 | 11.99 | 5 | 34752 | 119 | 63454146 |
| Enterocolitis bacterial | 16.50 | 11.99 | 6 | 34751 | 258 | 63454007 |
| Foetal exposure timing unspecified | 16.37 | 11.99 | 6 | 34751 | 264 | 63454001 |
| Anion gap normal | 16.24 | 11.99 | 3 | 34754 | 6 | 63454259 |
| Chronic obstructive pulmonary disease | 16.20 | 11.99 | 7 | 34750 | 62679 | 63391586 |
| Congenital cystic lung | 16.05 | 11.99 | 4 | 34753 | 45 | 63454220 |
| Injection site reaction | 16.00 | 11.99 | 6 | 34751 | 58518 | 63395747 |
| Pulmonary arterial hypertension | 15.94 | 11.99 | 37 | 34720 | 22540 | 63431725 |
| Stomatitis | 15.87 | 11.99 | 130 | 34627 | 138595 | 63315670 |
| Cystic fibrosis respiratory infection suppression | 15.74 | 11.99 | 6 | 34751 | 295 | 63453970 |
| Lymphocyte stimulation test positive | 15.72 | 11.99 | 7 | 34750 | 512 | 63453753 |
| Contusion | 15.66 | 11.99 | 37 | 34720 | 150007 | 63304258 |
| Blood cholesterol increased | 15.66 | 11.99 | 17 | 34740 | 94015 | 63360250 |
| Cardiac failure high output | 15.66 | 11.99 | 6 | 34751 | 299 | 63453966 |
| Normal newborn | 15.61 | 11.99 | 21 | 34736 | 8320 | 63445945 |
| Hallucination, tactile | 15.58 | 11.99 | 6 | 34751 | 303 | 63453962 |
| Transplantation complication | 15.56 | 11.99 | 5 | 34752 | 147 | 63454118 |
| Pneumonia fungal | 15.56 | 11.99 | 17 | 34740 | 5438 | 63448827 |
| Fixed eruption | 15.47 | 11.99 | 9 | 34748 | 1155 | 63453110 |
| Blood albumin abnormal | 15.46 | 11.99 | 7 | 34750 | 532 | 63453733 |
| Psychotic symptom | 15.45 | 11.99 | 10 | 34747 | 1551 | 63452714 |
| Biliary tract disorder | 15.43 | 11.99 | 8 | 34749 | 819 | 63453446 |
| Bicytopenia | 15.40 | 11.99 | 12 | 34745 | 2493 | 63451772 |
| Parenteral nutrition associated liver disease | 15.38 | 11.99 | 3 | 34754 | 9 | 63454256 |
| Bile duct necrosis | 15.38 | 11.99 | 3 | 34754 | 9 | 63454256 |
| Diarrhoea | 15.21 | 11.99 | 505 | 34252 | 714861 | 62739404 |
| Erythema multiforme | 15.20 | 11.99 | 23 | 34734 | 10146 | 63444119 |
| Arthritis | 15.19 | 11.99 | 25 | 34732 | 115896 | 63338369 |
| Amylase increased | 15.09 | 11.99 | 18 | 34739 | 6327 | 63447938 |
| Viral haemorrhagic cystitis | 15.06 | 11.99 | 8 | 34749 | 861 | 63453404 |
| Acute respiratory distress syndrome | 14.93 | 11.99 | 37 | 34720 | 23497 | 63430768 |
| Eczema | 14.74 | 11.99 | 45 | 34712 | 32246 | 63422019 |
| Intraventricular haemorrhage neonatal | 14.71 | 11.99 | 5 | 34752 | 176 | 63454089 |
| Mucosal disorder | 14.68 | 11.99 | 11 | 34746 | 2158 | 63452107 |
| Hypothyroidism | 14.65 | 11.99 | 54 | 34703 | 42578 | 63411687 |
| Vascular device infection | 14.60 | 11.99 | 19 | 34738 | 7293 | 63446972 |
| Faeces pale | 14.59 | 11.99 | 10 | 34747 | 1707 | 63452558 |
| Melaena | 14.50 | 11.99 | 43 | 34714 | 30322 | 63423943 |
| Tumour lysis syndrome | 14.39 | 11.99 | 21 | 34736 | 8969 | 63445296 |
| Pelvic venous thrombosis | 14.39 | 11.99 | 10 | 34747 | 1745 | 63452520 |
| Hyperhidrosis | 14.37 | 11.99 | 23 | 34734 | 107813 | 63346452 |
| Necrotising gastritis | 14.31 | 11.99 | 4 | 34753 | 72 | 63454193 |
| Cytomegalovirus infection reactivation | 14.28 | 11.99 | 14 | 34743 | 3949 | 63450316 |
| Hepatic mass | 14.16 | 11.99 | 10 | 34747 | 1790 | 63452475 |
| Bilirubin conjugated increased | 14.10 | 11.99 | 12 | 34745 | 2822 | 63451443 |
| Biliary cirrhosis | 14.05 | 11.99 | 4 | 34753 | 77 | 63454188 |
| Hypokalaemia | 13.94 | 11.99 | 101 | 34656 | 103703 | 63350562 |
| Chest pain | 13.79 | 11.99 | 66 | 34691 | 215893 | 63238372 |
| Epstein-Barr virus associated lymphoproliferative disorder | 13.70 | 11.99 | 10 | 34747 | 1884 | 63452381 |
| Injury | 13.63 | 11.99 | 12 | 34745 | 73235 | 63381030 |
| Renal glycosuria | 13.57 | 11.99 | 3 | 34754 | 19 | 63454246 |
| Hepatic pain | 13.32 | 11.99 | 12 | 34745 | 3044 | 63451221 |
| Transposition of the great vessels | 13.31 | 11.99 | 5 | 34752 | 236 | 63454029 |
| Syndactyly | 13.19 | 11.99 | 6 | 34751 | 461 | 63453804 |
| Gallbladder enlargement | 13.19 | 11.99 | 7 | 34750 | 752 | 63453513 |
| Toxic epidermal necrolysis | 13.18 | 11.99 | 37 | 34720 | 25297 | 63428968 |
| Child-Pugh-Turcotte score increased | 13.07 | 11.99 | 3 | 34754 | 23 | 63454242 |
| Aspartate aminotransferase abnormal | 13.05 | 11.99 | 8 | 34749 | 1130 | 63453135 |
| Gastrointestinal mucosal disorder | 13.01 | 11.99 | 7 | 34750 | 773 | 63453492 |
| Pneumothorax | 12.99 | 11.99 | 28 | 34729 | 16233 | 63438032 |
| Granulicatella infection | 12.99 | 11.99 | 4 | 34753 | 102 | 63454163 |
| Liver sarcoidosis | 12.95 | 11.99 | 3 | 34754 | 24 | 63454241 |
| Cytopenia | 12.95 | 11.99 | 23 | 34734 | 11578 | 63442687 |
| Colectomy | 12.90 | 11.99 | 11 | 34746 | 2595 | 63451670 |
| Antithrombin III decreased | 12.85 | 11.99 | 5 | 34752 | 260 | 63454005 |
| Renal failure | 12.78 | 11.99 | 109 | 34648 | 117543 | 63336722 |
| Dyspnoea | 12.67 | 11.99 | 271 | 34486 | 661042 | 62793223 |
| Pneumonia | 12.55 | 11.99 | 333 | 34424 | 456434 | 62997831 |
| Gastrointestinal infection | 12.49 | 11.99 | 20 | 34737 | 9261 | 63445004 |
| Blood albumin decreased | 12.46 | 11.99 | 26 | 34731 | 14740 | 63439525 |
| Abscess rupture | 12.34 | 11.99 | 5 | 34752 | 289 | 63453976 |
| Culture stool positive | 12.21 | 11.99 | 5 | 34752 | 297 | 63453968 |
| Drug abuse | 12.20 | 11.99 | 13 | 34744 | 72505 | 63381760 |
| Aminoaciduria | 12.19 | 11.99 | 4 | 34753 | 126 | 63454139 |
| Therapeutic product effect incomplete | 12.14 | 11.99 | 32 | 34725 | 125024 | 63329241 |
| Acute graft versus host disease in intestine | 12.12 | 11.99 | 9 | 34748 | 1740 | 63452525 |
| Pulmonary haemorrhage neonatal | 12.10 | 11.99 | 3 | 34754 | 33 | 63454232 |
| Liver abscess | 12.03 | 11.99 | 11 | 34746 | 2843 | 63451422 |
| Urine uric acid increased | 12.01 | 11.99 | 3 | 34754 | 34 | 63454231 |
| Oedema | 11.99 | 11.99 | 93 | 34664 | 97529 | 63356736 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatic function abnormal | 348.24 | 11.96 | 304 | 31867 | 44059 | 34880701 |
| Hepatic encephalopathy | 249.27 | 11.96 | 160 | 32011 | 14525 | 34910235 |
| Hepatic failure | 205.68 | 11.96 | 203 | 31968 | 34328 | 34890432 |
| Venoocclusive liver disease | 190.01 | 11.96 | 108 | 32063 | 7858 | 34916902 |
| Blood bilirubin increased | 182.87 | 11.96 | 200 | 31971 | 38096 | 34886664 |
| Infective pulmonary exacerbation of cystic fibrosis | 180.74 | 11.96 | 99 | 32072 | 6702 | 34918058 |
| Hepatic cancer | 162.67 | 11.96 | 99 | 32072 | 8176 | 34916584 |
| Hepatocellular carcinoma | 158.39 | 11.96 | 94 | 32077 | 7415 | 34917345 |
| Cholangitis | 153.20 | 11.96 | 97 | 32074 | 8592 | 34916168 |
| Ascites | 152.87 | 11.96 | 201 | 31970 | 46370 | 34878390 |
| Liver disorder | 146.63 | 11.96 | 166 | 32005 | 32831 | 34891929 |
| Pyrexia | 119.20 | 11.96 | 612 | 31559 | 332401 | 34592359 |
| Palmar-plantar erythrodysaesthesia syndrome | 117.55 | 11.96 | 108 | 32063 | 16687 | 34908073 |
| Aspartate aminotransferase increased | 111.31 | 11.96 | 213 | 31958 | 67570 | 34857190 |
| Interstitial lung disease | 104.56 | 11.96 | 203 | 31968 | 65079 | 34859681 |
| Platelet count decreased | 92.73 | 11.96 | 281 | 31890 | 119436 | 34805324 |
| Acute graft versus host disease | 91.33 | 11.96 | 63 | 32108 | 6440 | 34918320 |
| Aplastic anaemia | 85.11 | 11.96 | 71 | 32100 | 9645 | 34915115 |
| Jaundice | 82.76 | 11.96 | 123 | 32048 | 31759 | 34893001 |
| Decreased appetite | 81.69 | 11.96 | 336 | 31835 | 166056 | 34758704 |
| Alanine aminotransferase increased | 81.60 | 11.96 | 209 | 31962 | 80606 | 34844154 |
| Venoocclusive disease | 71.41 | 11.96 | 40 | 32131 | 2827 | 34921933 |
| Completed suicide | 68.18 | 11.96 | 6 | 32165 | 98162 | 34826598 |
| Renal impairment | 67.71 | 11.96 | 216 | 31955 | 94297 | 34830463 |
| Drug abuse | 63.84 | 11.96 | 8 | 32163 | 99088 | 34825672 |
| Graft versus host disease | 62.61 | 11.96 | 62 | 32109 | 10507 | 34914253 |
| Cholangitis sclerosing | 62.19 | 11.96 | 29 | 32142 | 1392 | 34923368 |
| Gamma-glutamyltransferase increased | 60.93 | 11.96 | 102 | 32069 | 29129 | 34895631 |
| Oesophageal varices haemorrhage | 60.18 | 11.96 | 37 | 32134 | 3109 | 34921651 |
| Graft versus host disease in skin | 59.82 | 11.96 | 40 | 32131 | 3885 | 34920875 |
| Toxicity to various agents | 58.41 | 11.96 | 59 | 32112 | 200303 | 34724457 |
| Disseminated intravascular coagulation | 57.80 | 11.96 | 85 | 32086 | 21731 | 34903029 |
| Myocardial infarction | 55.52 | 11.96 | 21 | 32150 | 121064 | 34803696 |
| Cystitis haemorrhagic | 54.99 | 11.96 | 44 | 32127 | 5635 | 34919125 |
| Dyspnoea | 53.94 | 11.96 | 173 | 31998 | 376609 | 34548151 |
| Death | 52.74 | 11.96 | 189 | 31982 | 397860 | 34526900 |
| Philadelphia positive chronic myeloid leukaemia | 52.48 | 11.96 | 14 | 32157 | 119 | 34924641 |
| Acute graft versus host disease in skin | 51.87 | 11.96 | 41 | 32130 | 5160 | 34919600 |
| Drug ineffective | 49.24 | 11.96 | 235 | 31936 | 456516 | 34468244 |
| Febrile neutropenia | 48.28 | 11.96 | 251 | 31920 | 136598 | 34788162 |
| Drug-induced liver injury | 47.75 | 11.96 | 91 | 32080 | 28741 | 34896019 |
| Hepatorenal syndrome | 47.58 | 11.96 | 30 | 32141 | 2636 | 34922124 |
| Hypoalbuminaemia | 46.96 | 11.96 | 57 | 32114 | 12117 | 34912643 |
| Blood alkaline phosphatase increased | 46.31 | 11.96 | 94 | 32077 | 31081 | 34893679 |
| Product dose omission issue | 43.92 | 11.96 | 28 | 32143 | 119683 | 34805077 |
| Fatigue | 43.92 | 11.96 | 184 | 31987 | 370469 | 34554291 |
| Cytomegalovirus infection | 43.91 | 11.96 | 83 | 32088 | 26052 | 34898708 |
| Bile duct stone | 43.50 | 11.96 | 28 | 32143 | 2549 | 34922211 |
| Organic brain syndrome | 42.39 | 11.96 | 14 | 32157 | 262 | 34924498 |
| Cholangitis acute | 41.60 | 11.96 | 19 | 32152 | 869 | 34923891 |
| Stomatitis | 40.86 | 11.96 | 108 | 32063 | 42406 | 34882354 |
| Cholangiocarcinoma | 39.64 | 11.96 | 21 | 32150 | 1328 | 34923432 |
| Vanishing bile duct syndrome | 39.13 | 11.96 | 19 | 32152 | 999 | 34923761 |
| Liver transplant rejection | 38.20 | 11.96 | 24 | 32147 | 2095 | 34922665 |
| White blood cell count decreased | 37.84 | 11.96 | 181 | 31990 | 95264 | 34829496 |
| Haemosiderosis | 37.10 | 11.96 | 13 | 32158 | 293 | 34924467 |
| Hepatitis C | 36.26 | 11.96 | 45 | 32126 | 9785 | 34914975 |
| Cytomegalovirus viraemia | 35.76 | 11.96 | 39 | 32132 | 7391 | 34917369 |
| Biliary cirrhosis | 35.51 | 11.96 | 10 | 32161 | 106 | 34924654 |
| Fall | 34.99 | 11.96 | 85 | 32086 | 202800 | 34721960 |
| Engraftment syndrome | 33.55 | 11.96 | 17 | 32154 | 980 | 34923780 |
| Aplasia | 33.06 | 11.96 | 30 | 32141 | 4558 | 34920202 |
| Mucosal inflammation | 33.01 | 11.96 | 94 | 32077 | 38528 | 34886232 |
| Urge incontinence | 32.99 | 11.96 | 14 | 32157 | 536 | 34924224 |
| Hepatic cirrhosis | 32.90 | 11.96 | 58 | 32113 | 17256 | 34907504 |
| Hyperbilirubinaemia | 32.75 | 11.96 | 57 | 32114 | 16786 | 34907974 |
| Cystic fibrosis related diabetes | 30.85 | 11.96 | 10 | 32161 | 176 | 34924584 |
| Anxiety | 30.41 | 11.96 | 28 | 32143 | 99400 | 34825360 |
| Glomerulosclerosis | 30.38 | 11.96 | 15 | 32156 | 818 | 34923942 |
| Bladder hypertrophy | 30.24 | 11.96 | 14 | 32157 | 661 | 34924099 |
| Hyperhidrosis | 30.17 | 11.96 | 16 | 32155 | 75676 | 34849084 |
| Amylase increased | 29.90 | 11.96 | 32 | 32139 | 5936 | 34918824 |
| Anaemia | 29.85 | 11.96 | 337 | 31834 | 232998 | 34691762 |
| Joint swelling | 29.84 | 11.96 | 9 | 32162 | 59881 | 34864879 |
| Liver transplant | 29.71 | 11.96 | 22 | 32149 | 2512 | 34922248 |
| Cerebrovascular accident | 29.53 | 11.96 | 21 | 32150 | 84790 | 34839970 |
| Intentional overdose | 29.43 | 11.96 | 3 | 32168 | 43671 | 34881089 |
| Dizziness | 29.34 | 11.96 | 103 | 32068 | 218418 | 34706342 |
| Cerebral infarction | 28.70 | 11.96 | 72 | 32099 | 27383 | 34897377 |
| Eosinophilic colitis | 28.47 | 11.96 | 10 | 32161 | 227 | 34924533 |
| Hyperuricaemia | 28.36 | 11.96 | 36 | 32135 | 8007 | 34916753 |
| Neutrophil count decreased | 28.04 | 11.96 | 107 | 32064 | 50997 | 34873763 |
| Retinitis viral | 27.97 | 11.96 | 8 | 32163 | 90 | 34924670 |
| Peripheral swelling | 27.93 | 11.96 | 18 | 32153 | 76523 | 34848237 |
| Bile duct stenosis | 27.75 | 11.96 | 16 | 32155 | 1195 | 34923565 |
| Mucosal disorder | 27.29 | 11.96 | 18 | 32153 | 1708 | 34923052 |
| Cytokine release syndrome | 27.13 | 11.96 | 63 | 32108 | 22814 | 34901946 |
| Liver carcinoma ruptured | 26.60 | 11.96 | 9 | 32162 | 182 | 34924578 |
| Iron overload | 26.32 | 11.96 | 16 | 32155 | 1317 | 34923443 |
| Hypotension | 25.58 | 11.96 | 111 | 32060 | 221538 | 34703222 |
| Cytomegalovirus test positive | 25.27 | 11.96 | 24 | 32147 | 3862 | 34920898 |
| Altered state of consciousness | 24.94 | 11.96 | 61 | 32110 | 22832 | 34901928 |
| Hyperammonaemia | 24.86 | 11.96 | 30 | 32141 | 6337 | 34918423 |
| Cholelithiasis | 24.82 | 11.96 | 58 | 32113 | 21090 | 34903670 |
| Chronic graft versus host disease | 24.69 | 11.96 | 25 | 32146 | 4348 | 34920412 |
| Intentional product misuse | 24.32 | 11.96 | 6 | 32165 | 45605 | 34879155 |
| Graft versus host disease in liver | 24.30 | 11.96 | 15 | 32156 | 1269 | 34923491 |
| Acute graft versus host disease in liver | 23.96 | 11.96 | 16 | 32155 | 1550 | 34923210 |
| Thrombotic microangiopathy | 23.36 | 11.96 | 38 | 32133 | 10592 | 34914168 |
| Device related bacteraemia | 22.78 | 11.96 | 10 | 32161 | 416 | 34924344 |
| Coronary artery disease | 22.76 | 11.96 | 8 | 32163 | 48297 | 34876463 |
| Memory impairment | 22.52 | 11.96 | 6 | 32165 | 43312 | 34881448 |
| Metastases to skin | 22.22 | 11.96 | 10 | 32161 | 442 | 34924318 |
| Acute graft versus host disease in intestine | 22.09 | 11.96 | 19 | 32152 | 2689 | 34922071 |
| Dilatation intrahepatic duct acquired | 21.71 | 11.96 | 6 | 32165 | 59 | 34924701 |
| Chronic obstructive pulmonary disease | 21.55 | 11.96 | 9 | 32162 | 48909 | 34875851 |
| Mantle cell lymphoma stage IV | 21.53 | 11.96 | 6 | 32165 | 61 | 34924699 |
| Liver abscess | 21.51 | 11.96 | 22 | 32149 | 3873 | 34920887 |
| Arthralgia | 20.94 | 11.96 | 83 | 32088 | 169958 | 34754802 |
| Oesophagitis | 20.90 | 11.96 | 41 | 32130 | 13220 | 34911540 |
| Enterocolitis | 20.86 | 11.96 | 31 | 32140 | 7995 | 34916765 |
| Cystic fibrosis | 20.81 | 11.96 | 15 | 32156 | 1643 | 34923117 |
| Graft versus host disease in gastrointestinal tract | 20.70 | 11.96 | 21 | 32150 | 3662 | 34921098 |
| Pleural effusion | 20.56 | 11.96 | 137 | 32034 | 81409 | 34843351 |
| Cardiac disorder | 20.56 | 11.96 | 7 | 32164 | 43119 | 34881641 |
| Viral haemorrhagic cystitis | 20.36 | 11.96 | 13 | 32158 | 1167 | 34923593 |
| Pain in extremity | 20.24 | 11.96 | 55 | 32116 | 126458 | 34798302 |
| Hemivertebra | 20.22 | 11.96 | 7 | 32164 | 152 | 34924608 |
| Portal vein thrombosis | 20.20 | 11.96 | 21 | 32150 | 3767 | 34920993 |
| Acute lymphocytic leukaemia recurrent | 20.18 | 11.96 | 19 | 32152 | 3025 | 34921735 |
| Overdose | 20.09 | 11.96 | 33 | 32138 | 91026 | 34833734 |
| Haemobilia | 20.05 | 11.96 | 9 | 32162 | 395 | 34924365 |
| Asthenia | 19.93 | 11.96 | 138 | 32033 | 245113 | 34679647 |
| Musculoskeletal stiffness | 19.91 | 11.96 | 9 | 32162 | 46671 | 34878089 |
| Kidney fibrosis | 18.93 | 11.96 | 16 | 32155 | 2212 | 34922548 |
| Axonal neuropathy | 18.92 | 11.96 | 12 | 32159 | 1065 | 34923695 |
| Hypoaldosteronism | 18.72 | 11.96 | 7 | 32164 | 191 | 34924569 |
| Biliary tract infection | 18.69 | 11.96 | 10 | 32161 | 645 | 34924115 |
| Varices oesophageal | 18.57 | 11.96 | 20 | 32151 | 3735 | 34921025 |
| Cardiac failure congestive | 18.53 | 11.96 | 30 | 32141 | 83240 | 34841520 |
| Pouchitis | 18.19 | 11.96 | 10 | 32161 | 681 | 34924079 |
| Heart rate increased | 18.16 | 11.96 | 10 | 32161 | 46333 | 34878427 |
| Blood urea increased | 17.84 | 11.96 | 65 | 32106 | 30299 | 34894461 |
| Hepatic pain | 17.79 | 11.96 | 13 | 32158 | 1455 | 34923305 |
| Erythema multiforme | 17.77 | 11.96 | 30 | 32141 | 8619 | 34916141 |
| Jaundice cholestatic | 17.77 | 11.96 | 22 | 32149 | 4772 | 34919988 |
| Sweat test abnormal | 17.17 | 11.96 | 4 | 32167 | 18 | 34924742 |
| Gallbladder polyp | 17.04 | 11.96 | 8 | 32163 | 390 | 34924370 |
| Rheumatoid arthritis | 16.90 | 11.96 | 7 | 32164 | 38231 | 34886529 |
| Blood albumin decreased | 16.78 | 11.96 | 38 | 32133 | 13534 | 34911226 |
| Headache | 16.74 | 11.96 | 112 | 32059 | 200523 | 34724237 |
| Hyperplasia | 16.62 | 11.96 | 9 | 32162 | 595 | 34924165 |
| Pruritus allergic | 16.59 | 11.96 | 7 | 32164 | 264 | 34924496 |
| Vision blurred | 16.50 | 11.96 | 11 | 32160 | 45952 | 34878808 |
| Paraesthesia | 16.37 | 11.96 | 21 | 32150 | 64151 | 34860609 |
| Adenovirus infection | 16.16 | 11.96 | 22 | 32149 | 5235 | 34919525 |
| Multiple organ dysfunction syndrome | 16.03 | 11.96 | 123 | 32048 | 76443 | 34848317 |
| Prothrombin level decreased | 16.01 | 11.96 | 11 | 32160 | 1117 | 34923643 |
| Pancreatic enzymes increased | 15.97 | 11.96 | 9 | 32162 | 643 | 34924117 |
| Blood lactate dehydrogenase increased | 15.93 | 11.96 | 52 | 32119 | 22938 | 34901822 |
| Injection site pain | 15.90 | 11.96 | 8 | 32163 | 38997 | 34885763 |
| Pain | 15.73 | 11.96 | 117 | 32054 | 204558 | 34720202 |
| Porphyria non-acute | 15.47 | 11.96 | 8 | 32163 | 481 | 34924279 |
| Folliculitis | 15.41 | 11.96 | 20 | 32151 | 4546 | 34920214 |
| Adjustment disorder | 15.38 | 11.96 | 11 | 32160 | 1190 | 34923570 |
| Drug hypersensitivity | 15.26 | 11.96 | 32 | 32139 | 80497 | 34844263 |
| Oesophageal atresia | 15.11 | 11.96 | 8 | 32163 | 505 | 34924255 |
| C-reactive protein increased | 14.93 | 11.96 | 93 | 32078 | 54005 | 34870755 |
| Metastases to lung | 14.91 | 11.96 | 29 | 32142 | 9291 | 34915469 |
| Discharge | 14.89 | 11.96 | 7 | 32164 | 342 | 34924418 |
| Feeling abnormal | 14.82 | 11.96 | 22 | 32149 | 63213 | 34861547 |
| Septic shock | 14.81 | 11.96 | 115 | 32056 | 71719 | 34853041 |
| Capillary leak syndrome | 14.79 | 11.96 | 14 | 32157 | 2244 | 34922516 |
| Wheezing | 14.74 | 11.96 | 10 | 32161 | 41392 | 34883368 |
| Drug eruption | 14.69 | 11.96 | 46 | 32125 | 19852 | 34904908 |
| Benign hepatic neoplasm | 14.69 | 11.96 | 3 | 32168 | 6 | 34924754 |
| Drug intolerance | 14.67 | 11.96 | 20 | 32151 | 59550 | 34865210 |
| Antimitochondrial antibody positive | 14.50 | 11.96 | 4 | 32167 | 39 | 34924721 |
| Psoriasis | 14.32 | 11.96 | 9 | 32162 | 38803 | 34885957 |
| Chest pain | 14.28 | 11.96 | 64 | 32107 | 126698 | 34798062 |
| Enterococcal sepsis | 14.19 | 11.96 | 12 | 32159 | 1660 | 34923100 |
| Toxic epidermal necrolysis | 14.15 | 11.96 | 48 | 32123 | 21598 | 34903162 |
| Hypozincaemia | 14.09 | 11.96 | 3 | 32168 | 8 | 34924752 |
| Suicidal ideation | 14.05 | 11.96 | 10 | 32161 | 40378 | 34884382 |
| Liver function test increased | 13.98 | 11.96 | 37 | 32134 | 14528 | 34910232 |
| Complications of transplanted liver | 13.96 | 11.96 | 6 | 32165 | 237 | 34924523 |
| Cataract subcapsular | 13.89 | 11.96 | 7 | 32164 | 399 | 34924361 |
| Primary mediastinal large B-cell lymphoma stage IV | 13.83 | 11.96 | 3 | 32168 | 9 | 34924751 |
| Transaminases increased | 13.76 | 11.96 | 55 | 32116 | 26768 | 34897992 |
| Syncope | 13.71 | 11.96 | 41 | 32130 | 91410 | 34833350 |
| Stem cell transplant | 13.51 | 11.96 | 13 | 32158 | 2126 | 34922634 |
| Pneumonia aspiration | 13.47 | 11.96 | 75 | 32096 | 41828 | 34882932 |
| Escherichia sepsis | 13.44 | 11.96 | 19 | 32152 | 4685 | 34920075 |
| Varicella zoster virus infection | 13.39 | 11.96 | 12 | 32159 | 1794 | 34922966 |
| Cholecystitis | 13.30 | 11.96 | 30 | 32141 | 10658 | 34914102 |
| Premature baby | 13.24 | 11.96 | 44 | 32127 | 19589 | 34905171 |
| Proctitis haemorrhagic | 13.16 | 11.96 | 3 | 32168 | 12 | 34924748 |
| Peroneal nerve palsy | 13.11 | 11.96 | 15 | 32156 | 2996 | 34921764 |
| Hyponatraemic encephalopathy | 12.99 | 11.96 | 4 | 32167 | 59 | 34924701 |
| Tumour embolism | 12.99 | 11.96 | 4 | 32167 | 59 | 34924701 |
| Colitis ulcerative | 12.95 | 11.96 | 39 | 32132 | 16481 | 34908279 |
| Cystic fibrosis lung | 12.93 | 11.96 | 4 | 32167 | 60 | 34924700 |
| Pulmonary embolism | 12.91 | 11.96 | 41 | 32130 | 89705 | 34835055 |
| Therapeutic product effect decreased | 12.90 | 11.96 | 8 | 32163 | 34735 | 34890025 |
| Pulmonary alveolar haemorrhage | 12.79 | 11.96 | 24 | 32147 | 7488 | 34917272 |
| Cytomegalovirus duodenitis | 12.75 | 11.96 | 4 | 32167 | 63 | 34924697 |
| Stress | 12.71 | 11.96 | 6 | 32165 | 30341 | 34894419 |
| Engraft failure | 12.69 | 11.96 | 7 | 32164 | 480 | 34924280 |
| Initial insomnia | 12.66 | 11.96 | 15 | 32156 | 3109 | 34921651 |
| Ileus paralytic | 12.59 | 11.96 | 21 | 32150 | 5976 | 34918784 |
| Portal vein occlusion | 12.52 | 11.96 | 4 | 32167 | 67 | 34924693 |
| Taste disorder | 12.36 | 11.96 | 23 | 32148 | 7132 | 34917628 |
| Bacterial disease carrier | 12.34 | 11.96 | 7 | 32164 | 507 | 34924253 |
| Hepatic cancer recurrent | 12.33 | 11.96 | 6 | 32165 | 317 | 34924443 |
| Toxoplasmosis | 12.32 | 11.96 | 10 | 32161 | 1306 | 34923454 |
| Oedema due to hepatic disease | 12.30 | 11.96 | 3 | 32168 | 17 | 34924743 |
| Hepatitis C RNA positive | 12.26 | 11.96 | 5 | 32166 | 173 | 34924587 |
| Enteritis infectious | 12.20 | 11.96 | 10 | 32161 | 1324 | 34923436 |
| Antithrombin III decreased | 12.14 | 11.96 | 6 | 32165 | 328 | 34924432 |
| Hepatic atrophy | 12.12 | 11.96 | 5 | 32166 | 178 | 34924582 |
| Vascular device infection | 12.10 | 11.96 | 17 | 32154 | 4168 | 34920592 |
| Suicide attempt | 11.97 | 11.96 | 11 | 32160 | 39105 | 34885655 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatic function abnormal | 549.96 | 10.59 | 443 | 57661 | 72664 | 79613620 |
| Hepatic encephalopathy | 431.35 | 10.59 | 250 | 57854 | 23916 | 79662368 |
| Venoocclusive liver disease | 398.20 | 10.59 | 187 | 57917 | 11584 | 79674700 |
| Hepatic failure | 373.74 | 10.59 | 329 | 57775 | 60883 | 79625401 |
| Blood bilirubin increased | 351.45 | 10.59 | 329 | 57775 | 65903 | 79620381 |
| Ascites | 340.25 | 10.59 | 343 | 57761 | 75219 | 79611065 |
| Infective pulmonary exacerbation of cystic fibrosis | 259.07 | 10.59 | 144 | 57960 | 12707 | 79673577 |
| Platelet count decreased | 241.90 | 10.59 | 475 | 57629 | 194189 | 79492095 |
| Hepatocellular carcinoma | 235.23 | 10.59 | 120 | 57984 | 8901 | 79677383 |
| Liver disorder | 232.20 | 10.59 | 275 | 57829 | 72142 | 79614142 |
| Cholangitis | 222.19 | 10.59 | 130 | 57974 | 12646 | 79673638 |
| Aspartate aminotransferase increased | 211.98 | 10.59 | 370 | 57734 | 138271 | 79548013 |
| Hepatic cancer | 196.03 | 10.59 | 112 | 57992 | 10417 | 79675867 |
| Aplastic anaemia | 177.45 | 10.59 | 128 | 57976 | 17777 | 79668507 |
| Jaundice | 165.07 | 10.59 | 199 | 57905 | 53150 | 79633134 |
| Alanine aminotransferase increased | 154.69 | 10.59 | 356 | 57748 | 162214 | 79524070 |
| Interstitial lung disease | 152.29 | 10.59 | 285 | 57819 | 112315 | 79573969 |
| Pyrexia | 145.96 | 10.59 | 918 | 57186 | 677791 | 79008493 |
| Venoocclusive disease | 131.47 | 10.59 | 65 | 58039 | 4508 | 79681776 |
| Completed suicide | 129.63 | 10.59 | 14 | 58090 | 245753 | 79440531 |
| Decreased appetite | 128.73 | 10.59 | 542 | 57562 | 341876 | 79344408 |
| Graft versus host disease | 127.81 | 10.59 | 98 | 58006 | 14928 | 79671356 |
| Hepatic cirrhosis | 127.76 | 10.59 | 142 | 57962 | 34764 | 79651520 |
| Palmar-plantar erythrodysaesthesia syndrome | 126.83 | 10.59 | 138 | 57966 | 32996 | 79653288 |
| Disseminated intravascular coagulation | 122.99 | 10.59 | 141 | 57963 | 35701 | 79650583 |
| Pain | 120.67 | 10.59 | 205 | 57899 | 703597 | 78982687 |
| Renal impairment | 117.81 | 10.59 | 315 | 57789 | 157468 | 79528816 |
| Blood alkaline phosphatase increased | 113.34 | 10.59 | 182 | 57922 | 63482 | 79622802 |
| Joint swelling | 112.82 | 10.59 | 35 | 58069 | 288611 | 79397673 |
| Drug intolerance | 110.71 | 10.59 | 28 | 58076 | 264091 | 79422193 |
| Febrile neutropenia | 109.01 | 10.59 | 393 | 57711 | 230606 | 79455678 |
| Acute graft versus host disease | 106.07 | 10.59 | 75 | 58029 | 10092 | 79676192 |
| Oesophageal varices haemorrhage | 100.80 | 10.59 | 53 | 58051 | 4183 | 79682101 |
| Cytomegalovirus infection | 94.48 | 10.59 | 135 | 57969 | 42509 | 79643775 |
| Drug-induced liver injury | 92.67 | 10.59 | 170 | 57934 | 65947 | 79620337 |
| Gamma-glutamyltransferase increased | 91.47 | 10.59 | 152 | 57952 | 54528 | 79631756 |
| Cystitis haemorrhagic | 89.58 | 10.59 | 65 | 58039 | 9107 | 79677177 |
| Cholangitis sclerosing | 89.49 | 10.59 | 42 | 58062 | 2595 | 79683689 |
| Toxicity to various agents | 86.61 | 10.59 | 108 | 57996 | 421432 | 79264852 |
| Pruritus | 86.50 | 10.59 | 537 | 57567 | 394111 | 79292173 |
| Rheumatoid arthritis | 85.62 | 10.59 | 23 | 58081 | 208447 | 79477837 |
| Hyperbilirubinaemia | 85.03 | 10.59 | 97 | 58007 | 24421 | 79661863 |
| Anaemia | 84.45 | 10.59 | 584 | 57520 | 444431 | 79241853 |
| Drug ineffective | 83.35 | 10.59 | 456 | 57648 | 1080457 | 78605827 |
| Contraindicated product administered | 82.97 | 10.59 | 9 | 58095 | 157529 | 79528755 |
| Pulmonary malformation | 80.35 | 10.59 | 21 | 58083 | 212 | 79686072 |
| Neutrophil count decreased | 75.63 | 10.59 | 193 | 57911 | 93766 | 79592518 |
| Vanishing bile duct syndrome | 75.15 | 10.59 | 33 | 58071 | 1745 | 79684539 |
| Cholestasis of pregnancy | 75.09 | 10.59 | 28 | 58076 | 965 | 79685319 |
| Bile duct stone | 74.51 | 10.59 | 48 | 58056 | 5541 | 79680743 |
| Hypoalbuminaemia | 73.42 | 10.59 | 84 | 58020 | 21213 | 79665071 |
| Drug hypersensitivity | 73.20 | 10.59 | 66 | 58038 | 298850 | 79387434 |
| Mucosal inflammation | 72.34 | 10.59 | 166 | 57938 | 75414 | 79610870 |
| Cholestasis | 71.78 | 10.59 | 133 | 57971 | 51976 | 79634308 |
| Arthralgia | 71.75 | 10.59 | 198 | 57906 | 571605 | 79114679 |
| Primary biliary cholangitis | 67.49 | 10.59 | 27 | 58077 | 1128 | 79685156 |
| Therapeutic product effect decreased | 65.56 | 10.59 | 19 | 58085 | 163844 | 79522440 |
| Hepatitis C | 64.65 | 10.59 | 60 | 58044 | 11865 | 79674419 |
| Glossodynia | 62.67 | 10.59 | 3 | 58101 | 103334 | 79582950 |
| Fatigue | 62.17 | 10.59 | 410 | 57694 | 929317 | 78756967 |
| Varices oesophageal | 62.04 | 10.59 | 44 | 58060 | 5947 | 79680337 |
| Drug abuse | 61.28 | 10.59 | 21 | 58083 | 162670 | 79523614 |
| Acute graft versus host disease in skin | 60.89 | 10.59 | 48 | 58056 | 7610 | 79678674 |
| White blood cell count decreased | 60.75 | 10.59 | 285 | 57819 | 188003 | 79498281 |
| Swelling | 60.40 | 10.59 | 42 | 58062 | 216669 | 79469615 |
| Lung cyst | 59.87 | 10.59 | 18 | 58086 | 313 | 79685971 |
| Pain in extremity | 59.74 | 10.59 | 109 | 57995 | 364429 | 79321855 |
| Thrombotic microangiopathy | 58.74 | 10.59 | 73 | 58031 | 20096 | 79666188 |
| Hepatorenal syndrome | 57.90 | 10.59 | 37 | 58067 | 4212 | 79682072 |
| Autoimmune hepatitis | 55.75 | 10.59 | 55 | 58049 | 11728 | 79674556 |
| Musculoskeletal stiffness | 55.65 | 10.59 | 29 | 58075 | 174979 | 79511305 |
| Cytomegalovirus viraemia | 55.45 | 10.59 | 57 | 58047 | 12764 | 79673520 |
| Multiple organ dysfunction syndrome | 55.30 | 10.59 | 203 | 57901 | 120043 | 79566241 |
| Pericarditis | 54.76 | 10.59 | 6 | 58098 | 104230 | 79582054 |
| Dyspnoea | 54.73 | 10.59 | 383 | 57721 | 856642 | 78829642 |
| Sinusitis | 54.33 | 10.59 | 38 | 58066 | 195463 | 79490821 |
| Pancytopenia | 53.54 | 10.59 | 251 | 57853 | 165494 | 79520790 |
| Pleural effusion | 52.17 | 10.59 | 227 | 57877 | 145035 | 79541249 |
| Hyperuricaemia | 52.01 | 10.59 | 53 | 58051 | 11746 | 79674538 |
| Liver transplant rejection | 51.12 | 10.59 | 31 | 58073 | 3217 | 79683067 |
| Intentional overdose | 51.11 | 10.59 | 8 | 58096 | 105952 | 79580332 |
| Hypersensitivity | 50.91 | 10.59 | 70 | 58034 | 262169 | 79424115 |
| Systemic lupus erythematosus | 50.42 | 10.59 | 13 | 58091 | 121136 | 79565148 |
| Lower respiratory tract infection | 49.85 | 10.59 | 16 | 58088 | 129204 | 79557080 |
| Hyperammonaemia | 49.21 | 10.59 | 50 | 58054 | 11043 | 79675241 |
| Chronic graft versus host disease | 48.61 | 10.59 | 40 | 58064 | 6741 | 79679543 |
| Cystic fibrosis | 48.48 | 10.59 | 32 | 58072 | 3848 | 79682436 |
| Graft versus host disease in skin | 48.15 | 10.59 | 38 | 58066 | 6035 | 79680249 |
| Cytokine release syndrome | 47.23 | 10.59 | 90 | 58014 | 35908 | 79650376 |
| Liver transplant | 47.00 | 10.59 | 33 | 58071 | 4390 | 79681894 |
| Portal hypertension | 46.96 | 10.59 | 40 | 58064 | 7068 | 79679216 |
| Philadelphia positive chronic myeloid leukaemia | 46.96 | 10.59 | 13 | 58091 | 166 | 79686118 |
| Respiratory tract malformation | 46.86 | 10.59 | 12 | 58092 | 111 | 79686173 |
| Biliary cirrhosis | 46.67 | 10.59 | 13 | 58091 | 170 | 79686114 |
| Acute lymphocytic leukaemia recurrent | 45.04 | 10.59 | 33 | 58071 | 4691 | 79681593 |
| Psoriatic arthropathy | 45.03 | 10.59 | 3 | 58101 | 77996 | 79608288 |
| Cholangitis acute | 44.70 | 10.59 | 22 | 58082 | 1510 | 79684774 |
| Myocardial infarction | 44.63 | 10.59 | 41 | 58063 | 184088 | 79502196 |
| Mobility decreased | 43.92 | 10.59 | 17 | 58087 | 122158 | 79564126 |
| Engraftment syndrome | 43.41 | 10.59 | 21 | 58083 | 1388 | 79684896 |
| Sepsis | 42.68 | 10.59 | 339 | 57765 | 269089 | 79417195 |
| Peripheral swelling | 42.05 | 10.59 | 83 | 58021 | 269534 | 79416750 |
| Bile duct stenosis | 41.75 | 10.59 | 23 | 58081 | 1993 | 79684291 |
| Altered state of consciousness | 41.64 | 10.59 | 96 | 58008 | 43726 | 79642558 |
| Poor sucking reflex | 40.99 | 10.59 | 11 | 58093 | 124 | 79686160 |
| Discomfort | 39.66 | 10.59 | 21 | 58083 | 125596 | 79560688 |
| Wheezing | 39.10 | 10.59 | 18 | 58086 | 116646 | 79569638 |
| Septic shock | 38.21 | 10.59 | 184 | 57920 | 122617 | 79563667 |
| Splenomegaly | 37.83 | 10.59 | 60 | 58044 | 20694 | 79665590 |
| Impaired healing | 37.26 | 10.59 | 9 | 58095 | 87646 | 79598638 |
| Duodenal ulcer perforation | 36.93 | 10.59 | 3 | 58101 | 66208 | 79620076 |
| Liver carcinoma ruptured | 36.76 | 10.59 | 11 | 58093 | 188 | 79686096 |
| Haemosiderosis | 36.73 | 10.59 | 14 | 58090 | 513 | 79685771 |
| Amylase increased | 36.60 | 10.59 | 43 | 58061 | 11166 | 79675118 |
| Injection site pain | 36.38 | 10.59 | 25 | 58079 | 129813 | 79556471 |
| Anxiety | 35.81 | 10.59 | 80 | 58024 | 248432 | 79437852 |
| Fibromyalgia | 35.65 | 10.59 | 3 | 58101 | 64337 | 79621947 |
| Stomatitis | 35.43 | 10.59 | 205 | 57899 | 146552 | 79539732 |
| Alopecia | 35.40 | 10.59 | 72 | 58032 | 231283 | 79455001 |
| Iron overload | 35.15 | 10.59 | 20 | 58084 | 1844 | 79684440 |
| Abdominal discomfort | 35.09 | 10.59 | 82 | 58022 | 250645 | 79435639 |
| Erythema multiforme | 34.93 | 10.59 | 53 | 58051 | 17598 | 79668686 |
| Overdose | 34.91 | 10.59 | 50 | 58054 | 184156 | 79502128 |
| Cytomegalovirus urinary tract infection | 34.88 | 10.59 | 9 | 58095 | 86 | 79686198 |
| Nasopharyngitis | 34.76 | 10.59 | 84 | 58020 | 253797 | 79432487 |
| Portal hypertensive gastropathy | 34.52 | 10.59 | 18 | 58086 | 1396 | 79684888 |
| Lactation disorder | 34.47 | 10.59 | 11 | 58093 | 235 | 79686049 |
| Cytomegalovirus test positive | 34.34 | 10.59 | 31 | 58073 | 5916 | 79680368 |
| Exposure via breast milk | 34.22 | 10.59 | 16 | 58088 | 980 | 79685304 |
| Enterocolitis | 33.70 | 10.59 | 47 | 58057 | 14465 | 79671819 |
| Hepatomegaly | 33.63 | 10.59 | 54 | 58050 | 18820 | 79667464 |
| Headache | 33.42 | 10.59 | 310 | 57794 | 653462 | 79032822 |
| CFTR gene mutation | 33.25 | 10.59 | 9 | 58095 | 105 | 79686179 |
| Cholelithiasis | 33.23 | 10.59 | 99 | 58005 | 52565 | 79633719 |
| Blood alkaline phosphatase abnormal | 32.90 | 10.59 | 15 | 58089 | 867 | 79685417 |
| Enterococcal sepsis | 32.90 | 10.59 | 22 | 58082 | 2704 | 79683580 |
| Treatment failure | 32.58 | 10.59 | 46 | 58058 | 170440 | 79515844 |
| Maternal exposure during breast feeding | 32.47 | 10.59 | 22 | 58082 | 2763 | 79683521 |
| Cholangiocarcinoma | 32.12 | 10.59 | 21 | 58083 | 2485 | 79683799 |
| Blood lactate dehydrogenase increased | 32.06 | 10.59 | 81 | 58023 | 39089 | 79647195 |
| Adenovirus infection | 32.00 | 10.59 | 35 | 58069 | 8412 | 79677872 |
| Biliary tract infection | 31.99 | 10.59 | 17 | 58087 | 1371 | 79684913 |
| Cystic fibrosis related diabetes | 31.23 | 10.59 | 10 | 58094 | 216 | 79686068 |
| Oesophagitis | 30.97 | 10.59 | 60 | 58044 | 24229 | 79662055 |
| Hyperhidrosis | 30.85 | 10.59 | 39 | 58065 | 151453 | 79534831 |
| Chronic obstructive pulmonary disease | 30.51 | 10.59 | 12 | 58092 | 85407 | 79600877 |
| Infusion related reaction | 30.09 | 10.59 | 78 | 58026 | 230159 | 79456125 |
| Irritable bowel syndrome | 29.34 | 10.59 | 5 | 58099 | 62236 | 79624048 |
| Cerebral infarction | 28.95 | 10.59 | 86 | 58018 | 45590 | 79640694 |
| Dizziness | 28.92 | 10.59 | 245 | 57859 | 526196 | 79160088 |
| Graft versus host disease in gastrointestinal tract | 28.84 | 10.59 | 29 | 58075 | 6327 | 79679957 |
| Fall | 28.58 | 10.59 | 223 | 57881 | 487406 | 79198878 |
| Intentional product misuse | 28.47 | 10.59 | 17 | 58087 | 95148 | 79591136 |
| Viral haemorrhagic cystitis | 28.21 | 10.59 | 18 | 58086 | 2043 | 79684241 |
| Liver abscess | 28.16 | 10.59 | 28 | 58076 | 6026 | 79680258 |
| Hepatitis cholestatic | 27.99 | 10.59 | 42 | 58062 | 13810 | 79672474 |
| Acute graft versus host disease in intestine | 27.23 | 10.59 | 23 | 58081 | 4018 | 79682266 |
| Wound | 26.83 | 10.59 | 27 | 58077 | 116152 | 79570132 |
| Coma hepatic | 26.69 | 10.59 | 14 | 58090 | 1099 | 79685185 |
| Retinitis viral | 26.61 | 10.59 | 8 | 58096 | 139 | 79686145 |
| Toxic epidermal necrolysis | 26.44 | 10.59 | 82 | 58022 | 44499 | 79641785 |
| Device related bacteraemia | 26.38 | 10.59 | 12 | 58092 | 690 | 79685594 |
| Blister | 26.21 | 10.59 | 29 | 58075 | 119447 | 79566837 |
| Ammonia increased | 26.12 | 10.59 | 30 | 58074 | 7605 | 79678679 |
| Cerebrovascular accident | 25.79 | 10.59 | 46 | 58058 | 155246 | 79531038 |
| Hepatic fibrosis | 25.57 | 10.59 | 29 | 58075 | 7251 | 79679033 |
| Aplasia | 25.54 | 10.59 | 30 | 58074 | 7790 | 79678494 |
| Hypothyroidism | 25.39 | 10.59 | 90 | 58014 | 52302 | 79633982 |
| Portal vein thrombosis | 25.37 | 10.59 | 26 | 58078 | 5801 | 79680483 |
| Transaminases increased | 25.17 | 10.59 | 89 | 58015 | 51654 | 79634630 |
| Gastrointestinal infection | 24.96 | 10.59 | 36 | 58068 | 11425 | 79674859 |
| Ocular icterus | 24.78 | 10.59 | 25 | 58079 | 5475 | 79680809 |
| Migraine | 24.30 | 10.59 | 17 | 58087 | 87476 | 79598808 |
| Blood creatine phosphokinase increased | 24.26 | 10.59 | 104 | 58000 | 65986 | 79620298 |
| Premature delivery | 24.07 | 10.59 | 53 | 58051 | 23414 | 79662870 |
| Hepatitis fulminant | 23.95 | 10.59 | 28 | 58076 | 7234 | 79679050 |
| Blood urea increased | 23.80 | 10.59 | 84 | 58020 | 48706 | 79637578 |
| Glomerulosclerosis | 23.78 | 10.59 | 13 | 58091 | 1109 | 79685175 |
| Muscle spasms | 23.76 | 10.59 | 58 | 58046 | 174672 | 79511612 |
| Gallbladder enlargement | 23.71 | 10.59 | 15 | 58089 | 1678 | 79684606 |
| Eosinophilic colitis | 23.61 | 10.59 | 10 | 58094 | 484 | 79685800 |
| Intestinal anastomosis | 23.52 | 10.59 | 11 | 58093 | 674 | 79685610 |
| Loss of personal independence in daily activities | 23.50 | 10.59 | 24 | 58080 | 102556 | 79583728 |
| Foetal exposure timing unspecified | 23.48 | 10.59 | 6 | 58098 | 55 | 79686229 |
| Venous haemorrhage | 23.23 | 10.59 | 9 | 58095 | 345 | 79685939 |
| Graft versus host disease in liver | 23.22 | 10.59 | 15 | 58089 | 1739 | 79684545 |
| Hepatic pain | 23.07 | 10.59 | 21 | 58083 | 4051 | 79682233 |
| Pre-eclampsia | 22.97 | 10.59 | 27 | 58077 | 7014 | 79679270 |
| Haemobilia | 22.96 | 10.59 | 10 | 58094 | 518 | 79685766 |
| Vision blurred | 22.90 | 10.59 | 26 | 58078 | 105872 | 79580412 |
| Sedation | 22.71 | 10.59 | 5 | 58099 | 51890 | 79634394 |
| Bronchopulmonary aspergillosis | 22.47 | 10.59 | 50 | 58054 | 22244 | 79664040 |
| Mantle cell lymphoma stage IV | 22.41 | 10.59 | 6 | 58098 | 67 | 79686217 |
| Chest pain | 22.19 | 10.59 | 118 | 57986 | 282186 | 79404098 |
| Coronary artery disease | 22.09 | 10.59 | 10 | 58094 | 65464 | 79620820 |
| Cystic fibrosis lung | 22.09 | 10.59 | 7 | 58097 | 146 | 79686138 |
| Paraesthesia | 22.08 | 10.59 | 61 | 58043 | 176262 | 79510022 |
| Cytopenia | 22.01 | 10.59 | 47 | 58057 | 20336 | 79665948 |
| Vascular device infection | 21.97 | 10.59 | 32 | 58072 | 10244 | 79676040 |
| Cholecystitis acute | 21.96 | 10.59 | 37 | 58067 | 13414 | 79672870 |
| Haemorrhage subcutaneous | 21.92 | 10.59 | 22 | 58082 | 4787 | 79681497 |
| Spider naevus | 21.87 | 10.59 | 7 | 58097 | 151 | 79686133 |
| Osteoarthritis | 21.67 | 10.59 | 19 | 58085 | 87290 | 79598994 |
| Coagulation test abnormal | 21.59 | 10.59 | 13 | 58091 | 1332 | 79684952 |
| Mucosal disorder | 21.58 | 10.59 | 19 | 58085 | 3509 | 79682775 |
| Blood pressure fluctuation | 21.52 | 10.59 | 11 | 58093 | 67134 | 79619150 |
| Pneumonia cytomegaloviral | 21.32 | 10.59 | 22 | 58082 | 4947 | 79681337 |
| Candida test positive | 21.22 | 10.59 | 12 | 58092 | 1094 | 79685190 |
| Tonsillar haemorrhage | 21.07 | 10.59 | 8 | 58096 | 290 | 79685994 |
| Iron deficiency anaemia | 20.91 | 10.59 | 53 | 58051 | 25619 | 79660665 |
| Faeces soft | 20.90 | 10.59 | 28 | 58076 | 8295 | 79677989 |
| Forced expiratory volume decreased | 20.72 | 10.59 | 27 | 58077 | 7787 | 79678497 |
| Spinal compression fracture | 20.54 | 10.59 | 41 | 58063 | 16917 | 79669367 |
| Contusion | 20.53 | 10.59 | 49 | 58055 | 148727 | 79537557 |
| Organic brain syndrome | 20.51 | 10.59 | 9 | 58095 | 475 | 79685809 |
| Memory impairment | 20.50 | 10.59 | 31 | 58073 | 111703 | 79574581 |
| Adenoviral hepatitis | 20.37 | 10.59 | 11 | 58093 | 916 | 79685368 |
| Product dose omission issue | 20.28 | 10.59 | 102 | 58002 | 247435 | 79438849 |
| Psychotic disorder | 20.25 | 10.59 | 3 | 58101 | 41399 | 79644885 |
| Neutropenia | 20.22 | 10.59 | 308 | 57796 | 287402 | 79398882 |
| Stress | 20.16 | 10.59 | 17 | 58087 | 79595 | 79606689 |
| Inappropriate schedule of product administration | 20.08 | 10.59 | 42 | 58062 | 133586 | 79552698 |
| Drug dependence | 19.83 | 10.59 | 3 | 58101 | 40766 | 79645518 |
| Burning sensation | 19.71 | 10.59 | 9 | 58095 | 58623 | 79627661 |
| Diarrhoea | 19.71 | 10.59 | 806 | 57298 | 879683 | 78806601 |
| Blood albumin decreased | 19.70 | 10.59 | 50 | 58054 | 24193 | 79662091 |
| Hypoaesthesia | 19.63 | 10.59 | 66 | 58038 | 179286 | 79506998 |
| Antimitochondrial antibody positive | 19.56 | 10.59 | 6 | 58098 | 112 | 79686172 |
| Acute graft versus host disease in liver | 19.55 | 10.59 | 14 | 58090 | 1921 | 79684363 |
| Medication error | 19.51 | 10.59 | 13 | 58091 | 68629 | 79617655 |
| Neck pain | 19.22 | 10.59 | 16 | 58088 | 75401 | 79610883 |
| Injury | 19.07 | 10.59 | 17 | 58087 | 77479 | 79608805 |
| Injection site reaction | 19.07 | 10.59 | 8 | 58096 | 54777 | 79631507 |
| Heart rate increased | 18.94 | 10.59 | 37 | 58067 | 120687 | 79565597 |
| Pancreatic enzymes increased | 18.88 | 10.59 | 12 | 58092 | 1353 | 79684931 |
| Cardiac failure | 18.86 | 10.59 | 184 | 57920 | 154658 | 79531626 |
| Biliary obstruction | 18.81 | 10.59 | 20 | 58084 | 4654 | 79681630 |
| Hyperglycaemia | 18.79 | 10.59 | 101 | 58003 | 70234 | 79616050 |
| Gestational diabetes | 18.68 | 10.59 | 23 | 58081 | 6270 | 79680014 |
| Renal failure | 18.57 | 10.59 | 226 | 57878 | 200742 | 79485542 |
| Urge incontinence | 18.54 | 10.59 | 11 | 58093 | 1097 | 79685187 |
| Transfusion | 18.39 | 10.59 | 45 | 58059 | 21285 | 79664999 |
| Psoriasis | 18.30 | 10.59 | 23 | 58081 | 89564 | 79596720 |
| Asthma | 18.24 | 10.59 | 45 | 58059 | 135050 | 79551234 |
| Aspergillus infection | 18.23 | 10.59 | 42 | 58062 | 19119 | 79667165 |
| Blood bilirubin abnormal | 18.10 | 10.59 | 12 | 58092 | 1453 | 79684831 |
| Unresponsive to stimuli | 18.09 | 10.59 | 9 | 58095 | 55779 | 79630505 |
| Capillary leak syndrome | 17.98 | 10.59 | 18 | 58086 | 3907 | 79682377 |
| Bladder hypertrophy | 17.86 | 10.59 | 9 | 58095 | 650 | 79685634 |
| Lip pruritus | 17.78 | 10.59 | 10 | 58094 | 902 | 79685382 |
| Localised infection | 17.75 | 10.59 | 3 | 58101 | 37572 | 79648712 |
| Cholangitis infective | 17.63 | 10.59 | 9 | 58095 | 668 | 79685616 |
| Drug eruption | 17.58 | 10.59 | 71 | 58033 | 43864 | 79642420 |
| Upper respiratory tract inflammation | 17.56 | 10.59 | 18 | 58086 | 4017 | 79682267 |
| Hepatic necrosis | 17.55 | 10.59 | 27 | 58077 | 9073 | 79677211 |
| Hypoproteinaemia | 17.52 | 10.59 | 18 | 58086 | 4028 | 79682256 |
| Helicobacter infection | 17.51 | 10.59 | 15 | 58089 | 69689 | 79616595 |
| Arthritis | 17.35 | 10.59 | 36 | 58068 | 114844 | 79571440 |
| Serum ferritin increased | 17.30 | 10.59 | 28 | 58076 | 9819 | 79676465 |
| Bile duct necrosis | 17.28 | 10.59 | 4 | 58100 | 23 | 79686261 |
| Sputum increased | 17.27 | 10.59 | 19 | 58085 | 4594 | 79681690 |
| Suicide attempt | 17.25 | 10.59 | 21 | 58083 | 82911 | 79603373 |
| Feeling abnormal | 17.14 | 10.59 | 59 | 58045 | 159140 | 79527144 |
| Urticaria | 17.13 | 10.59 | 73 | 58031 | 185128 | 79501156 |
| Biliary dilatation | 17.03 | 10.59 | 15 | 58089 | 2771 | 79683513 |
| Gallbladder polyp | 17.01 | 10.59 | 10 | 58094 | 980 | 79685304 |
| Shock haemorrhagic | 16.96 | 10.59 | 42 | 58062 | 20018 | 79666266 |
| Hospitalisation | 16.81 | 10.59 | 122 | 57982 | 94114 | 79592170 |
| Porphyria non-acute | 16.77 | 10.59 | 9 | 58095 | 740 | 79685544 |
| Bacterial sepsis | 16.77 | 10.59 | 25 | 58079 | 8173 | 79678111 |
| Biliary tract disorder | 16.72 | 10.59 | 12 | 58092 | 1652 | 79684632 |
| Bile duct cancer | 16.70 | 10.59 | 10 | 58094 | 1014 | 79685270 |
| Heart rate decreased | 16.62 | 10.59 | 16 | 58088 | 70300 | 79615984 |
| Hepatic mass | 16.62 | 10.59 | 14 | 58090 | 2437 | 79683847 |
| Foetor hepaticus | 16.60 | 10.59 | 3 | 58101 | 3 | 79686281 |
| Blood cholesterol increased | 16.58 | 10.59 | 22 | 58082 | 83698 | 79602586 |
| Back pain | 16.47 | 10.59 | 142 | 57962 | 304038 | 79382246 |
| Hypotension | 16.44 | 10.59 | 224 | 57880 | 440093 | 79246191 |
| Therapeutic product effect incomplete | 16.28 | 10.59 | 51 | 58053 | 141594 | 79544690 |
| Hepatitis | 16.25 | 10.59 | 82 | 58022 | 55645 | 79630639 |
| Cholecystitis | 16.20 | 10.59 | 44 | 58060 | 22168 | 79664116 |
| Influenza like illness | 16.17 | 10.59 | 17 | 58087 | 71690 | 79614594 |
| Wrong technique in product usage process | 16.12 | 10.59 | 18 | 58086 | 73857 | 79612427 |
| Product administered to patient of inappropriate age | 16.01 | 10.59 | 20 | 58084 | 5533 | 79680751 |
| Thalamus haemorrhage | 15.99 | 10.59 | 12 | 58092 | 1770 | 79684514 |
| Staphylococcal sepsis | 15.95 | 10.59 | 34 | 58070 | 14692 | 79671592 |
| Injection site bruising | 15.94 | 10.59 | 5 | 58099 | 40997 | 79645287 |
| Palpitations | 15.70 | 10.59 | 44 | 58060 | 126566 | 79559718 |
| Transaminases abnormal | 15.59 | 10.59 | 9 | 58095 | 853 | 79685431 |
| Hepatitis toxic | 15.58 | 10.59 | 19 | 58085 | 5128 | 79681156 |
| Allergic sinusitis | 15.54 | 10.59 | 9 | 58095 | 858 | 79685426 |
| Cystic fibrosis hepatic disease | 15.43 | 10.59 | 4 | 58100 | 39 | 79686245 |
| Sweat test abnormal | 15.43 | 10.59 | 4 | 58100 | 39 | 79686245 |
| Malignant neoplasm progression | 15.31 | 10.59 | 159 | 57945 | 135831 | 79550453 |
| Epstein-Barr virus infection | 15.29 | 10.59 | 33 | 58071 | 14383 | 79671901 |
| Complications of transplanted liver | 15.25 | 10.59 | 7 | 58097 | 411 | 79685873 |
| Suicidal ideation | 15.18 | 10.59 | 20 | 58084 | 76320 | 79609964 |
| Acute respiratory distress syndrome | 15.15 | 10.59 | 68 | 58036 | 43999 | 79642285 |
| Laparotomy | 15.01 | 10.59 | 7 | 58097 | 426 | 79685858 |
| Histoplasmosis | 14.99 | 10.59 | 13 | 58091 | 2352 | 79683932 |
| Balance disorder | 14.91 | 10.59 | 31 | 58073 | 98826 | 79587458 |
| Gastric varices haemorrhage | 14.85 | 10.59 | 7 | 58097 | 437 | 79685847 |
| Gastric antral vascular ectasia | 14.71 | 10.59 | 9 | 58095 | 949 | 79685335 |
| Depression | 14.69 | 10.59 | 95 | 58009 | 216695 | 79469589 |
| Escherichia sepsis | 14.69 | 10.59 | 24 | 58080 | 8484 | 79677800 |
| Pneumonia fungal | 14.67 | 10.59 | 28 | 58076 | 11182 | 79675102 |
| Stevens-Johnson syndrome | 14.65 | 10.59 | 62 | 58042 | 39104 | 79647180 |
| Anal erosion | 14.60 | 10.59 | 4 | 58100 | 49 | 79686235 |
| Prothrombin level decreased | 14.59 | 10.59 | 11 | 58093 | 1633 | 79684651 |
| Gait disturbance | 14.54 | 10.59 | 90 | 58014 | 207416 | 79478868 |
| Jaundice cholestatic | 14.54 | 10.59 | 28 | 58076 | 11256 | 79675028 |
| Primary mediastinal large B-cell lymphoma stage IV | 14.52 | 10.59 | 3 | 58101 | 9 | 79686275 |
| Axonal neuropathy | 14.48 | 10.59 | 12 | 58092 | 2042 | 79684242 |
| Myelosuppression | 14.47 | 10.59 | 63 | 58041 | 40233 | 79646051 |
| Beta 2 microglobulin urine increased | 14.39 | 10.59 | 5 | 58099 | 140 | 79686144 |
| Pancreatitis relapsing | 14.39 | 10.59 | 9 | 58095 | 987 | 79685297 |
| Nasal congestion | 14.27 | 10.59 | 21 | 58083 | 76531 | 79609753 |
| Cerebral haemorrhage | 14.19 | 10.59 | 81 | 58023 | 57592 | 79628692 |
| Hypokalaemia | 14.19 | 10.59 | 164 | 57940 | 143876 | 79542408 |
| Joint stiffness | 14.15 | 10.59 | 6 | 58098 | 40824 | 79645460 |
| Klebsiella bacteraemia | 14.15 | 10.59 | 14 | 58090 | 2996 | 79683288 |
| Antithrombin III decreased | 14.05 | 10.59 | 7 | 58097 | 493 | 79685791 |
| Incorrect route of product administration | 14.05 | 10.59 | 4 | 58100 | 34925 | 79651359 |
| Metastases to skin | 14.04 | 10.59 | 11 | 58093 | 1728 | 79684556 |
| Kidney fibrosis | 14.01 | 10.59 | 15 | 58089 | 3520 | 79682764 |
| Blood pressure systolic increased | 13.89 | 10.59 | 17 | 58087 | 66969 | 79619315 |
| Musculoskeletal pain | 13.89 | 10.59 | 34 | 58070 | 102320 | 79583964 |
| Putamen haemorrhage | 13.83 | 10.59 | 7 | 58097 | 510 | 79685774 |
| Swelling face | 13.81 | 10.59 | 19 | 58085 | 71193 | 79615091 |
| Accidental exposure to product | 13.74 | 10.59 | 3 | 58101 | 31319 | 79654965 |
| Parenteral nutrition associated liver disease | 13.66 | 10.59 | 3 | 58101 | 13 | 79686271 |
| Encephalopathy | 13.64 | 10.59 | 90 | 58014 | 67307 | 79618977 |
| Cardiac failure high output | 13.54 | 10.59 | 6 | 58098 | 324 | 79685960 |
| Death | 13.54 | 10.59 | 312 | 57792 | 566202 | 79120082 |
| Product quality issue | 13.45 | 10.59 | 4 | 58100 | 33936 | 79652348 |
| Stem cell transplant | 13.43 | 10.59 | 15 | 58089 | 3689 | 79682595 |
| Lymphocyte stimulation test positive | 13.33 | 10.59 | 9 | 58095 | 1124 | 79685160 |
| Cardiac disorder | 13.31 | 10.59 | 17 | 58087 | 65740 | 79620544 |
| Pneumonia aspiration | 13.30 | 10.59 | 89 | 58015 | 66878 | 79619406 |
| Haemolysis | 13.21 | 10.59 | 29 | 58075 | 12783 | 79673501 |
| Laryngomalacia | 13.15 | 10.59 | 3 | 58101 | 16 | 79686268 |
| Bacteraemia | 13.10 | 10.59 | 53 | 58051 | 32771 | 79653513 |
| Metastases to peritoneum | 13.01 | 10.59 | 16 | 58088 | 4356 | 79681928 |
| Sciatica | 13.01 | 10.59 | 4 | 58100 | 33218 | 79653066 |
| Gastrointestinal perforation | 12.96 | 10.59 | 19 | 58085 | 6118 | 79680166 |
| Acute lymphocytic leukaemia | 12.91 | 10.59 | 17 | 58087 | 4952 | 79681332 |
| Bursitis | 12.86 | 10.59 | 5 | 58099 | 35839 | 79650445 |
| Pneumonia bacterial | 12.82 | 10.59 | 37 | 58067 | 19294 | 79666990 |
| Necrotising gastritis | 12.78 | 10.59 | 4 | 58100 | 80 | 79686204 |
| Hypoaldosteronism | 12.64 | 10.59 | 6 | 58098 | 380 | 79685904 |
| Generalised oedema | 12.59 | 10.59 | 42 | 58062 | 23667 | 79662617 |
| Proteinuria | 12.59 | 10.59 | 52 | 58052 | 32450 | 79653834 |
| Pneumocystis jirovecii pneumonia | 12.58 | 10.59 | 52 | 58052 | 32456 | 79653828 |
| Hyperplasia | 12.57 | 10.59 | 9 | 58095 | 1234 | 79685050 |
| Eczema | 12.57 | 10.59 | 61 | 58043 | 40757 | 79645527 |
| Enterocolitis viral | 12.54 | 10.59 | 6 | 58098 | 387 | 79685897 |
| Fixed eruption | 12.53 | 10.59 | 13 | 58091 | 2941 | 79683343 |
| Respiratory failure | 12.44 | 10.59 | 193 | 57911 | 180718 | 79505566 |
| Tumour lysis syndrome | 12.36 | 10.59 | 42 | 58062 | 23897 | 79662387 |
| Ill-defined disorder | 12.35 | 10.59 | 18 | 58086 | 65857 | 79620427 |
| Cardiac failure acute | 12.34 | 10.59 | 36 | 58068 | 18893 | 79667391 |
| Cytomegalovirus duodenitis | 12.30 | 10.59 | 4 | 58100 | 91 | 79686193 |
| Eye pain | 12.28 | 10.59 | 6 | 58098 | 37572 | 79648712 |
| Portal venous gas | 12.27 | 10.59 | 6 | 58098 | 406 | 79685878 |
| Intentional product use issue | 12.27 | 10.59 | 63 | 58041 | 152049 | 79534235 |
| Rectal tenesmus | 12.26 | 10.59 | 10 | 58094 | 1665 | 79684619 |
| Pneumonia | 12.22 | 10.59 | 593 | 57511 | 659653 | 79026631 |
| Total bile acids increased | 12.22 | 10.59 | 4 | 58100 | 93 | 79686191 |
| Cataract subcapsular | 12.19 | 10.59 | 8 | 58096 | 953 | 79685331 |
| Swollen tongue | 12.18 | 10.59 | 8 | 58096 | 42562 | 79643722 |
| Thrombosis | 12.16 | 10.59 | 27 | 58077 | 84073 | 79602211 |
| Ovarian failure | 12.07 | 10.59 | 7 | 58097 | 669 | 79685615 |
| Diabetes mellitus | 12.04 | 10.59 | 98 | 58006 | 78292 | 79607992 |
| Escherichia bacteraemia | 12.00 | 10.59 | 19 | 58085 | 6543 | 79679741 |
| Condition aggravated | 11.96 | 10.59 | 276 | 57828 | 500848 | 79185436 |
| Oedema due to hepatic disease | 11.89 | 10.59 | 3 | 58101 | 26 | 79686258 |
| Haemophagocytic lymphohistiocytosis | 11.88 | 10.59 | 39 | 58065 | 21798 | 79664486 |
| Joint injury | 11.87 | 10.59 | 4 | 58100 | 31331 | 79654953 |
| Cystic fibrosis respiratory infection suppression | 11.85 | 10.59 | 6 | 58098 | 438 | 79685846 |
| Restrictive cardiomyopathy | 11.84 | 10.59 | 8 | 58096 | 1000 | 79685284 |
| Blood albumin abnormal | 11.81 | 10.59 | 7 | 58097 | 697 | 79685587 |
| Chronic hepatic failure | 11.76 | 10.59 | 8 | 58096 | 1011 | 79685273 |
| Hypoxia | 11.76 | 10.59 | 121 | 57983 | 103122 | 79583162 |
| Aspartate aminotransferase abnormal | 11.74 | 10.59 | 10 | 58094 | 1766 | 79684518 |
| Haemolytic anaemia | 11.72 | 10.59 | 34 | 58070 | 17786 | 79668498 |
| Pulmonary fibrosis | 11.69 | 10.59 | 9 | 58095 | 44103 | 79642181 |
| Hepatitis C RNA positive | 11.69 | 10.59 | 5 | 58099 | 248 | 79686036 |
| Asterixis | 11.64 | 10.59 | 12 | 58092 | 2695 | 79683589 |
| Melaena | 11.54 | 10.59 | 80 | 58024 | 60810 | 79625474 |
| BK virus infection | 11.53 | 10.59 | 22 | 58082 | 8782 | 79677502 |
| Granulicatella infection | 11.51 | 10.59 | 4 | 58100 | 112 | 79686172 |
| Dilatation intrahepatic duct acquired | 11.50 | 10.59 | 7 | 58097 | 731 | 79685553 |
| Bilirubin conjugated increased | 11.48 | 10.59 | 17 | 58087 | 5522 | 79680762 |
| Gastric varices | 11.48 | 10.59 | 7 | 58097 | 734 | 79685550 |
| Rotavirus infection | 11.47 | 10.59 | 7 | 58097 | 735 | 79685549 |
| Ileus paralytic | 11.34 | 10.59 | 23 | 58081 | 9597 | 79676687 |
| Proctitis haemorrhagic | 11.33 | 10.59 | 3 | 58101 | 32 | 79686252 |
| Transient ischaemic attack | 11.32 | 10.59 | 13 | 58091 | 52682 | 79633602 |
| Bacterial infection | 11.30 | 10.59 | 49 | 58055 | 31231 | 79655053 |
| Off label use | 11.27 | 10.59 | 786 | 57318 | 906429 | 78779855 |
| Type 1 diabetes mellitus | 11.25 | 10.59 | 19 | 58085 | 6900 | 79679384 |
| Hypophosphataemia | 11.23 | 10.59 | 36 | 58068 | 19877 | 79666407 |
| Enteritis infectious | 11.22 | 10.59 | 13 | 58091 | 3325 | 79682959 |
| Platelet transfusion | 11.21 | 10.59 | 11 | 58093 | 2331 | 79683953 |
| Pulmonary function test decreased | 11.15 | 10.59 | 20 | 58084 | 7617 | 79678667 |
| Hepatobiliary disease | 11.13 | 10.59 | 7 | 58097 | 775 | 79685509 |
| Device related infection | 11.10 | 10.59 | 52 | 58052 | 34242 | 79652042 |
| Prescribed overdose | 11.00 | 10.59 | 7 | 58097 | 37876 | 79648408 |
| Serotonin syndrome | 10.93 | 10.59 | 10 | 58094 | 45017 | 79641267 |
| Renal disorder | 10.93 | 10.59 | 60 | 58044 | 42045 | 79644239 |
| Hyperamylasaemia | 10.91 | 10.59 | 8 | 58096 | 1139 | 79685145 |
| Pseudarthrosis | 10.90 | 10.59 | 5 | 58099 | 293 | 79685991 |
| Bone marrow failure | 10.80 | 10.59 | 69 | 58035 | 51038 | 79635246 |
| Asthenia | 10.80 | 10.59 | 287 | 57817 | 511402 | 79174882 |
| Gastroenteritis eosinophilic | 10.79 | 10.59 | 5 | 58099 | 300 | 79685984 |
| Emotional distress | 10.79 | 10.59 | 8 | 58096 | 39961 | 79646323 |
| Gastrointestinal disorder | 10.79 | 10.59 | 49 | 58055 | 122156 | 79564128 |
| Pulmonary alveolar haemorrhage | 10.77 | 10.59 | 25 | 58079 | 11432 | 79674852 |
| Pericardial effusion | 10.77 | 10.59 | 64 | 58040 | 46173 | 79640111 |
| Abdominal cavity drainage | 10.75 | 10.59 | 7 | 58097 | 823 | 79685461 |
| Cardiac tamponade | 10.73 | 10.59 | 22 | 58082 | 9254 | 79677030 |
| Thrombocytopenia | 10.72 | 10.59 | 261 | 57843 | 264998 | 79421286 |
| Haemophilic arthropathy | 10.62 | 10.59 | 4 | 58100 | 142 | 79686142 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.92 | acidic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Bile acid receptor | Nuclear hormone receptor | AGONIST | 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 | Unclassified | 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:
| ID | Source |
|---|---|
| 4019318 | VUID |
| N0000147507 | NUI |
| D00734 | KEGG_DRUG |
| 4019318 | VANDF |
| C0042105 | UMLSCUI |
| CHEBI:9907 | CHEBI |
| CHEMBL1551 | ChEMBL_ID |
| DB01586 | DRUGBANK_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 |
| CHEMBL272427 | ChEMBL_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 | 0527-1326 | CAPSULE | 300 mg | ORAL | ANDA | 19 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 | 0591-2998 | 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 | 0591-3005 | TABLET | 500 mg | ORAL | NDA authorized generic | 25 sections |
| Ursodiol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-3159 | CAPSULE | 300 mg | ORAL | NDA authorized generic | 20 sections |
| Ursodiol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-3159 | CAPSULE | 300 mg | ORAL | NDA authorized generic | 20 sections |
| Ursodiol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-3159 | CAPSULE | 300 mg | ORAL | NDA authorized generic | 20 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 | 42291-923 | CAPSULE | 300 mg | ORAL | NDA authorized generic | 18 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 | 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 | 50268-797 | CAPSULE | 300 mg | ORAL | ANDA | 17 sections |
| Ursodiol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51079-383 | CAPSULE | 300 mg | ORAL | ANDA | 18 sections |