All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

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:

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

FDA Adverse Event Reporting System (Male)

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

FDA Adverse Event Reporting System (Geriatric)

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

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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	Q96RI1	NR1H4_HUMAN	AGONIST				CHEMBL	CHEMBL
Phospholipase A2	Enzyme	P04054	PA21B_HUMAN		Kd	5		CHEMBL
Aldo-keto reductase family 1 member C2	Enzyme	P52895	AK1C2_HUMAN					WOMBAT-PK
Ectonucleotide pyrophosphatase/phosphodiesterase family member 2	Enzyme	Q13822	ENPP2_HUMAN		IC50	4.99		CHEMBL
CDGSH iron-sulfur domain-containing protein 1	Unclassified	Q9NZ45	CISD1_HUMAN		Ki	5.95		CHEMBL
G-protein coupled bile acid receptor 1	GPCR	Q8TDU6	GPBAR_HUMAN		EC50	5.62		CHEMBL
M1-family alanyl aminopeptidase	Enzyme		Q8IEK1_PLAF7		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
CHEMBL272427	ChEMBL_ID
31401	PUBCHEM_CID
7104	IUPHAR_LIGAND_ID
4920	INN_ID
724L30Y2QR	UNII
11065	RXNORM
31954	MMSL
5659	MMSL
d01005	MMSL
001212	NDDF
108669000	SNOMEDCT_US
41143004	SNOMEDCT_US
D014580	MESH_DESCRIPTOR_UI

Pharmaceutical products:

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	0591-2998	TABLET	250 mg	ORAL	NDA authorized generic	25 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3005	TABLET	500 mg	ORAL	NDA authorized generic	25 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3159	CAPSULE	300 mg	ORAL	NDA authorized generic	18 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3159	CAPSULE	300 mg	ORAL	NDA authorized generic	18 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0615-1374	CAPSULE	300 mg	ORAL	NDA	17 sections
Ursodiol 200 mg	HUMAN PRESCRIPTION DRUG LABEL	1	0722-7143	CAPSULE	200 mg	ORAL	ANDA	19 sections
Ursodiol 400 mg	HUMAN PRESCRIPTION DRUG LABEL	1	0722-7144	CAPSULE	400 mg	ORAL	ANDA	19 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6221	CAPSULE	300 mg	ORAL	ANDA	12 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6890	TABLET, FILM COATED	250 mg	ORAL	ANDA	24 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7168	CAPSULE	300 mg	ORAL	ANDA	17 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	10135-543	CAPSULE	300 mg	ORAL	ANDA	18 sections
URSODIOL	HUMAN PRESCRIPTION DRUG LABEL	1	16590-349	CAPSULE	300 mg	ORAL	NDA	17 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	24658-780	CAPSULE	300 mg	ORAL	ANDA	12 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	24658-999	CAPSULE	300 mg	ORAL	ANDA	12 sections
Ursodiol	Human Prescription Drug Label	1	42385-946	CAPSULE	300 mg	ORAL	ANDA	17 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	42806-503	CAPSULE	300 mg	ORAL	ANDA	12 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	49884-412	TABLET, FILM COATED	250 mg	ORAL	ANDA	24 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	49884-413	TABLET, FILM COATED	500 mg	ORAL	ANDA	24 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	50268-797	CAPSULE	300 mg	ORAL	ANDA	17 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	51079-383	CAPSULE	300 mg	ORAL	ANDA	18 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	51224-151	CAPSULE	300 mg	ORAL	ANDA	19 sections
BAMBOO SALT Eunganggo Jook Yeom Toothpaste	HUMAN OTC DRUG LABEL	7	53208-459	PASTE	0.02 g	DENTAL	OTC monograph not final	4 sections
BAMBOO SALT Eunganggo Jook Yeom	HUMAN OTC DRUG LABEL	7	53208-505	PASTE	0.02 g	DENTAL	OTC monograph not final	8 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5033	CAPSULE	300 mg	ORAL	NDA AUTHORIZED GENERIC	17 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	55154-3355	CAPSULE	300 mg	ORAL	ANDA	12 sections
Urso 250	HUMAN PRESCRIPTION DRUG LABEL	1	58914-785	TABLET, FILM COATED	250 mg	ORAL	NDA	25 sections
Urso Forte	HUMAN PRESCRIPTION DRUG LABEL	1	58914-790	TABLET, FILM COATED	500 mg	ORAL	NDA	25 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	60429-662	CAPSULE	300 mg	ORAL	ANDA	18 sections