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

Stem definition	Drug id	CAS RN
	882	20830-75-5

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: digoxin cardiogoxin digoxine

A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666) Molecular weight: 780.95 Formula: C41H64O14 CLOGP: 1.42 LIPINSKI: 3 HAC: 14 HDO: 6 TPSA: 203.06 ALOGS: -3.79 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.25	mg	O
0.25	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.99 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	60 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.00 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	70 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	4.10 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.70 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.70 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	38 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Oct. 24, 1975	FDA	EUROHLTH INTL SARL

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
Cardioactive drug level increased	1174.10	10.42	329	78019	1730	46605984
Bradycardia	900.43	10.42	804	77544	65494	46542220
International normalised ratio increased	794.85	10.42	646	77702	46237	46561477
Atrial fibrillation	729.10	10.42	883	77465	102707	46505007
Cardiac failure congestive	559.05	10.42	728	77620	91022	46516692
Toxicity to various agents	470.26	10.42	1072	77276	210694	46397020
Drug interaction	458.58	10.42	1035	77313	202059	46405655
Cardiac failure	384.12	10.42	566	77782	79382	46528332
Drug ineffective	307.45	10.42	415	77933	677423	45930291
Hyperkalaemia	265.32	10.42	374	77974	50335	46557379
Rheumatoid arthritis	239.35	10.42	55	78293	240160	46367554
Acute kidney injury	231.81	10.42	894	77454	234961	46372753
Pulmonary hypertension	194.98	10.42	270	78078	35723	46571991
Bradyarrhythmia	183.22	10.42	82	78266	1924	46605790
Right ventricular failure	177.30	10.42	174	78174	15919	46591795
Product complaint	162.41	10.42	146	78202	11955	46595759
Torsade de pointes	157.93	10.42	144	78204	12010	46595704
Off label use	156.30	10.42	248	78100	379593	46228121
Renal failure	153.49	10.42	479	77869	113115	46494599
Drug hypersensitivity	152.64	10.42	112	78236	243713	46364001
Dyspnoea	146.74	10.42	1412	76936	514136	46093578
Melaena	143.95	10.42	204	78144	27568	46580146
Arthralgia	140.76	10.42	248	78100	364355	46243359
Pain	134.75	10.42	385	77963	476563	46131151
Ventricular tachycardia	134.52	10.42	154	78194	16813	46590901
Pulmonary arterial hypertension	130.77	10.42	188	78160	25740	46581974
Gastrointestinal haemorrhage	127.21	10.42	350	77998	77023	46530691
Cardioactive drug level above therapeutic	114.28	10.42	30	78318	117	46607597
Atrioventricular block	111.34	10.42	92	78256	6719	46600995
Rash	107.11	10.42	279	78069	356233	46251481
Hypotension	105.76	10.42	710	77638	231879	46375835
Arrhythmia	100.89	10.42	197	78151	34644	46573070
Treatment failure	97.31	10.42	19	78329	93068	46514646
Completed suicide	95.21	10.42	64	78284	145856	46461858
Upper gastrointestinal haemorrhage	94.28	10.42	128	78220	16610	46591104
Subdural haematoma	93.10	10.42	112	78236	12885	46594829
Joint swelling	90.65	10.42	87	78261	165986	46441728
Atrioventricular block first degree	87.70	10.42	77	78271	6109	46601605
Injection site pain	86.05	10.42	36	78312	107116	46500598
Nodal rhythm	84.13	10.42	46	78302	1679	46606035
Atrioventricular block complete	83.13	10.42	82	78266	7545	46600169
Syncope	82.79	10.42	372	77976	104431	46503283
Synovitis	79.53	10.42	6	78342	61069	46546645
Drug intolerance	79.12	10.42	78	78270	146971	46460743
Fluid overload	79.05	10.42	154	78194	27031	46580683
Injection site erythema	78.19	10.42	15	78333	74412	46533302
International normalised ratio abnormal	75.88	10.42	53	78295	3006	46604708
Alopecia	75.54	10.42	97	78251	162317	46445397
Drug abuse	75.24	10.42	9	78339	63399	46544315
Lower gastrointestinal haemorrhage	74.81	10.42	76	78272	7244	46600470
Cardioactive drug level decreased	74.63	10.42	20	78328	86	46607628
Therapeutic product effect decreased	74.39	10.42	23	78325	82578	46525136
Oedema peripheral	73.37	10.42	489	77859	159217	46448497
Musculoskeletal stiffness	70.88	10.42	38	78310	97955	46509759
International normalised ratio decreased	67.59	10.42	58	78290	4462	46603252
Nodal arrhythmia	67.56	10.42	36	78312	1247	46606467
Atrial flutter	67.44	10.42	80	78268	9068	46598646
Myocardial infarction	67.38	10.42	333	78015	97195	46510519
Cardiac arrest	67.02	10.42	315	78033	90084	46517630
Drug level increased	65.64	10.42	114	78234	18327	46589387
Psoriasis	65.40	10.42	25	78323	78579	46529135
Cerebral haemorrhage	64.15	10.42	145	78203	28226	46579488
Fluid retention	64.06	10.42	210	78138	50836	46556878
Contraindicated product administered	63.95	10.42	27	78321	79920	46527794
Infusion related reaction	63.86	10.42	46	78302	101162	46506552
Confusional state	63.16	10.42	472	77876	159420	46448294
Pruritus	62.22	10.42	204	78144	242148	46365566
Febrile neutropenia	61.03	10.42	42	78306	94585	46513129
Sinus bradycardia	60.97	10.42	94	78254	13688	46594026
Asthenia	60.63	10.42	792	77556	310283	46297431
Cerebrovascular accident	60.13	10.42	331	78017	100708	46507006
Presyncope	59.83	10.42	129	78219	24325	46583389
Sinusitis	59.81	10.42	78	78270	129690	46478024
Haemorrhage intracranial	59.42	10.42	89	78259	12635	46595079
Injection site reaction	58.77	10.42	6	78342	47843	46559871
Paraesthesia	57.90	10.42	67	78281	117370	46490344
Atrioventricular block second degree	57.32	10.42	49	78299	3750	46603964
Systemic lupus erythematosus	57.18	10.42	19	78329	65161	46542553
Tachyarrhythmia	56.53	10.42	53	78295	4579	46603135
Ventricular fibrillation	55.97	10.42	82	78266	11414	46596300
Therapeutic product effect incomplete	55.51	10.42	31	78317	78122	46529592
Rectal haemorrhage	55.02	10.42	165	78183	38090	46569624
Prothrombin time prolonged	54.98	10.42	74	78274	9522	46598192
Anaemia	54.83	10.42	663	77685	255116	46352598
Orthopnoea	54.61	10.42	58	78290	5822	46601892
Hypoxia	54.41	10.42	201	78147	51637	46556077
Electrocardiogram ST segment depression	53.94	10.42	41	78307	2652	46605062
Ischaemic stroke	53.90	10.42	99	78249	16623	46591091
Dehydration	51.61	10.42	450	77898	159090	46448624
Injection site pruritus	51.47	10.42	4	78344	39739	46567975
Neutropenia	51.03	10.42	102	78246	143102	46464612
Cardiomegaly	50.78	10.42	99	78249	17383	46590331
Nasopharyngitis	50.45	10.42	115	78233	153883	46453831
Sinus node dysfunction	50.29	10.42	48	78300	4241	46603473
Haematoma	50.18	10.42	142	78206	31730	46575984
Blood creatinine increased	49.33	10.42	256	78092	76147	46531567
Suicidal ideation	48.48	10.42	17	78331	56365	46551349
Blood urea increased	48.06	10.42	121	78227	25231	46582483
Hypersensitivity	47.84	10.42	114	78234	150207	46457507
Abdominal wall haematoma	47.26	10.42	39	78309	2842	46604872
Injection site swelling	47.16	10.42	6	78342	40321	46567393
Multiple sclerosis relapse	45.29	10.42	8	78340	42117	46565597
Overdose	44.25	10.42	308	78040	101671	46506043
Ventricular extrasystoles	44.17	10.42	72	78276	10991	46596723
Heart rate decreased	43.90	10.42	135	78213	31588	46576126
Renal injury	43.51	10.42	66	78282	9475	46598239
Ventricular arrhythmia	43.40	10.42	40	78308	3381	46604333
Hyponatraemia	43.35	10.42	305	78043	101027	46506687
Hand deformity	43.34	10.42	4	78344	34570	46573144
Blood potassium increased	43.23	10.42	91	78257	16876	46590838
Arthropathy	43.19	10.42	47	78301	84653	46523061
Dyspnoea exertional	43.10	10.42	183	78165	50106	46557608
Dizziness	43.06	10.42	806	77542	339608	46268106
Activated partial thromboplastin time prolonged	42.36	10.42	55	78293	6834	46600880
Leukopenia	41.89	10.42	32	78316	68311	46539403
Atrial tachycardia	41.85	10.42	32	78316	2088	46605626
Stomatitis	41.83	10.42	32	78316	68265	46539449
Tricuspid valve incompetence	41.45	10.42	79	78269	13638	46594076
Fibromyalgia	41.28	10.42	6	78342	36457	46571257
Urticaria	41.12	10.42	85	78263	117807	46489907
Drug therapeutic incompatibility	40.37	10.42	11	78337	51	46607663
Electrocardiogram QT prolonged	40.35	10.42	182	78166	51143	46556571
Oedema	40.07	10.42	220	78128	66851	46540863
Hypoglycaemia	39.25	10.42	188	78160	54161	46553553
White blood cell count decreased	39.07	10.42	81	78267	112150	46495564
Cardiac failure chronic	38.61	10.42	38	78310	3486	46604228
Electrocardiogram abnormal	38.54	10.42	53	78295	6959	46600755
Decreased appetite	38.29	10.42	495	77853	193341	46414373
Arthritis	38.22	10.42	44	78304	77272	46530442
Neuropathy peripheral	37.55	10.42	59	78289	90834	46516880
Cardiogenic shock	37.33	10.42	84	78264	16300	46591414
Asthma	37.27	10.42	60	78288	91482	46516232
Supraventricular tachycardia	37.15	10.42	74	78274	13196	46594518
Bundle branch block right	36.94	10.42	43	78305	4776	46602938
Coagulopathy	36.86	10.42	90	78258	18409	46589305
Mitral valve incompetence	36.80	10.42	91	78257	18761	46588953
Migraine	36.66	10.42	38	78310	69988	46537726
Electrocardiogram QT shortened	36.31	10.42	12	78336	118	46607596
Intentional product use issue	35.96	10.42	22	78326	52758	46554956
Pleural effusion	35.66	10.42	250	78098	82702	46525012
Glossodynia	35.45	10.42	15	78333	44358	46563356
Product use issue	34.93	10.42	66	78282	94578	46513136
Psoriatic arthropathy	34.84	10.42	9	78339	36370	46571344
Headache	34.57	10.42	580	77768	477772	46129942
Heart rate irregular	34.47	10.42	88	78260	18503	46589211
Depression	34.11	10.42	158	78190	169946	46437768
Embolic stroke	33.98	10.42	36	78312	3603	46604111
Insomnia	33.78	10.42	152	78196	164772	46442942
Xanthopsia	33.58	10.42	12	78336	152	46607562
Cardioactive drug level below therapeutic	33.42	10.42	7	78341	6	46607708
Medication error	33.39	10.42	121	78227	30790	46576924
Atrioventricular dissociation	33.38	10.42	13	78335	212	46607502
Hypocoagulable state	32.86	10.42	21	78327	1026	46606688
Cardiac failure acute	32.83	10.42	53	78295	8025	46599689
Hypoaesthesia	32.61	10.42	97	78251	118772	46488942
Epistaxis	32.61	10.42	202	78146	64103	46543611
Back pain	32.32	10.42	213	78135	209826	46397888
Electrocardiogram ST segment abnormal	31.57	10.42	20	78328	962	46606752
Sleep disorder	31.20	10.42	20	78328	46775	46560939
Pulmonary arterial pressure increased	31.18	10.42	33	78315	3299	46604415
Neutrophil count decreased	31.15	10.42	17	78331	43409	46564305
Chest pain	31.00	10.42	441	77907	175883	46431831
Transfusion	30.33	10.42	68	78280	13163	46594551
Ejection fraction decreased	30.29	10.42	82	78266	17855	46589859
Pulmonary oedema	30.09	10.42	167	78181	50938	46556776
Herpes zoster	30.03	10.42	42	78306	67830	46539884
Intentional self-injury	29.75	10.42	3	78345	24163	46583551
Palpitations	29.38	10.42	266	78082	94993	46512721
Fall	29.32	10.42	741	77607	328356	46279358
Cor pulmonale	29.19	10.42	25	78323	1918	46605796
Bundle branch block left	28.80	10.42	44	78304	6355	46601359
Respiratory failure	28.35	10.42	263	78085	94553	46513161
Renal impairment	27.89	10.42	217	78131	74155	46533559
Left ventricular failure	27.85	10.42	38	78310	4952	46602762
Shock haemorrhagic	27.72	10.42	51	78297	8573	46599141
Death	27.71	10.42	748	77600	334800	46272914
Intentional product misuse	27.70	10.42	23	78325	47105	46560609
Wound	27.58	10.42	19	78329	42783	46564931
Pyrexia	27.46	10.42	416	77932	348386	46259328
Infection	27.42	10.42	123	78225	133469	46474245
Muscle spasms	27.33	10.42	110	78238	123003	46484711
Cardiomyopathy	26.67	10.42	73	78275	16000	46591714
Coagulation time prolonged	26.31	10.42	20	78328	1294	46606420
Oropharyngeal pain	26.25	10.42	53	78295	74115	46533599
Drug monitoring procedure not performed	26.17	10.42	13	78335	388	46607326
Pain in extremity	26.05	10.42	293	78055	258387	46349327
Cardiac disorder	25.61	10.42	143	78205	43715	46563999
Brain natriuretic peptide increased	25.34	10.42	35	78313	4615	46603099
Multiple organ dysfunction syndrome	25.32	10.42	161	78187	51549	46556165
Product dose omission issue	24.86	10.42	173	78175	168347	46439367
Hypochromic anaemia	24.75	10.42	20	78328	1415	46606299
Fatigue	24.59	10.42	807	77541	607890	45999824
Urine output decreased	24.29	10.42	56	78292	11041	46596673
Intentional overdose	24.21	10.42	45	78303	64899	46542815
Malignant neoplasm progression	24.19	10.42	45	78303	64881	46542833
Musculoskeletal pain	24.07	10.42	51	78297	70077	46537637
Rheumatoid factor positive	24.03	10.42	3	78345	20458	46587256
Chromatopsia	23.54	10.42	13	78335	484	46607230
Cardiac pacemaker insertion	23.47	10.42	30	78318	3669	46604045
Erythrodermic psoriasis	23.45	10.42	16	78332	873	46606841
Hyperthyroidism	23.36	10.42	57	78291	11654	46596060
Myocardial ischaemia	23.28	10.42	60	78288	12689	46595025
Drug level above therapeutic	23.13	10.42	29	78319	3480	46604234
Hepatic enzyme increased	22.96	10.42	66	78282	81721	46525993
Tremor	22.82	10.42	108	78240	115531	46492183
Extrasystoles	22.65	10.42	34	78314	4835	46602879
Mitral valve stenosis	22.33	10.42	17	78331	1102	46606612
Pulse absent	22.20	10.42	34	78314	4922	46602792
Loss of consciousness	22.01	10.42	278	78070	107960	46499754
Disorientation	21.97	10.42	121	78227	36797	46570917
Acute respiratory failure	21.91	10.42	102	78246	29036	46578678
Wrong technique in product usage process	21.84	10.42	36	78312	54386	46553328
Catheter management	21.53	10.42	25	78323	2770	46604944
Stupor	21.48	10.42	28	78320	3492	46604222
Toxic epidermal necrolysis	21.40	10.42	84	78264	22194	46585520
Osteoporosis	21.29	10.42	22	78326	40586	46567128
Accidental overdose	21.21	10.42	78	78270	19988	46587726
Product use in unapproved indication	21.09	10.42	79	78269	90194	46517520
Creatinine renal clearance decreased	21.09	10.42	40	78308	6880	46600834
Coronary artery disease	21.02	10.42	112	78236	33640	46574074
Mobility decreased	20.85	10.42	44	78304	60550	46547164
Congestive hepatopathy	20.65	10.42	23	78325	2435	46605279
Oxygen consumption increased	20.60	10.42	28	78320	3635	46604079
Haemoglobin decreased	20.49	10.42	317	78031	128632	46479082
Anxiety	20.37	10.42	201	78147	181756	46425958
Joint stiffness	20.35	10.42	10	78338	27098	46580616
Retroperitoneal haemorrhage	20.33	10.42	24	78324	2706	46605008
Unevaluable event	20.32	10.42	140	78208	46035	46561679
Haematemesis	20.32	10.42	99	78249	28707	46579007
Hypertension	20.31	10.42	221	78127	196135	46411579
Splenic injury	20.31	10.42	9	78339	206	46607508
Swelling	20.29	10.42	124	78224	124387	46483327
Alveolitis	20.23	10.42	23	78325	2490	46605224
Subarachnoid haemorrhage	19.86	10.42	52	78296	11101	46596613
Dilatation ventricular	19.84	10.42	23	78325	2544	46605170
Therapeutic response decreased	19.79	10.42	26	78322	43119	46564595
Aortic valve calcification	19.76	10.42	11	78337	416	46607298
Suicide attempt	19.76	10.42	39	78309	54997	46552717
Occult blood positive	19.64	10.42	27	78321	3543	46604171
Central nervous system injury	19.52	10.42	8	78340	150	46607564
Prothrombin time shortened	19.33	10.42	19	78329	1740	46605974
Neuralgia	19.16	10.42	6	78342	21377	46586337
Metabolic acidosis	19.14	10.42	121	78227	38659	46569055
Potentiating drug interaction	19.12	10.42	28	78320	3895	46603819
Oliguria	18.95	10.42	44	78304	8715	46598999
Drug dependence	18.91	10.42	5	78343	19896	46587818
Pyroglutamic acidosis	18.78	10.42	9	78339	248	46607466
Chills	18.76	10.42	90	78258	95942	46511772
Anaphylactic reaction	18.75	10.42	38	78310	53074	46554640
Haematuria	18.73	10.42	92	78256	26766	46580948
Pulmonary congestion	18.66	10.42	61	78287	14738	46592976
Maternal exposure during pregnancy	18.39	10.42	99	78249	102450	46505264
Lymphocyte count decreased	18.38	10.42	10	78338	25579	46582135
Fear	18.05	10.42	64	78284	16108	46591606
Inappropriate schedule of product administration	17.86	10.42	53	78295	64960	46542754
Blood pressure decreased	17.81	10.42	160	78188	56999	46550715
Dilatation atrial	17.81	10.42	20	78328	2137	46605577
Packed red blood cell transfusion	17.76	10.42	20	78328	2143	46605571
Electrocardiogram PR prolongation	17.72	10.42	12	78336	647	46607067
Hypochromasia	17.69	10.42	9	78339	283	46607431
Hypovolaemia	17.50	10.42	46	78302	9842	46597872
Knee arthroplasty	17.36	10.42	9	78339	23656	46584058
Cardiac murmur	17.16	10.42	50	78298	11354	46596360
Conduction disorder	17.07	10.42	16	78332	1382	46606332
Subcutaneous haematoma	17.05	10.42	17	78331	1584	46606130
Exposure during pregnancy	16.99	10.42	109	78239	108103	46499611
Abdominal discomfort	16.91	10.42	167	78181	150998	46456716
Left atrial dilatation	16.88	10.42	18	78330	1815	46605899
Lethargy	16.86	10.42	145	78203	51026	46556688
Device related infection	16.82	10.42	75	78273	20966	46586748
Haemorrhage	16.79	10.42	153	78195	54716	46552998
Osteoarthritis	16.72	10.42	51	78297	61974	46545740
Brain stem haemorrhage	16.71	10.42	12	78336	711	46607003
Supraventricular extrasystoles	16.65	10.42	27	78321	4102	46603612
Anticoagulation drug level above therapeutic	16.64	10.42	15	78333	1232	46606482
Serotonin syndrome	16.63	10.42	10	78338	24210	46583504
Deep vein thrombosis	16.63	10.42	73	78275	79700	46528014
Fungal infection	16.63	10.42	15	78333	29505	46578209
Transplant evaluation	16.48	10.42	14	78334	1062	46606652
Electrocardiogram repolarisation abnormality	16.45	10.42	15	78333	1250	46606464
Rheumatic heart disease	16.30	10.42	4	78344	11	46607703
Cerebral infarction	16.27	10.42	80	78268	23286	46584428
Pericarditis	16.26	10.42	10	78338	23917	46583797
Cardiopulmonary bypass	16.18	10.42	3	78345	0	46607714
Pneumocystis jirovecii pneumonia	16.16	10.42	3	78345	15245	46592469
Lung transplant	16.11	10.42	22	78326	2870	46604844
Sopor	16.09	10.42	71	78277	19757	46587957
Constipation	16.04	10.42	201	78147	173896	46433818
Electrocardiogram QRS complex prolonged	15.99	10.42	31	78317	5418	46602296
Irritability	15.96	10.42	15	78333	28931	46578783
Rhythm idioventricular	15.81	10.42	7	78341	160	46607554
Neoplasm progression	15.71	10.42	13	78335	26670	46581044
Seizure	15.47	10.42	132	78216	122922	46484792
Left ventricular dysfunction	15.47	10.42	45	78303	10210	46597504
Ventricular hypertrophy	15.47	10.42	25	78323	3789	46603925
Transient ischaemic attack	15.46	10.42	106	78242	34797	46572917
Loss of personal independence in daily activities	15.43	10.42	47	78301	57136	46550578
Depressed mood	15.36	10.42	20	78328	33299	46574415
Hypoglycaemic seizure	15.30	10.42	10	78338	508	46607206
Haemoptysis	15.03	10.42	85	78263	26104	46581610
Ventricular dysfunction	14.96	10.42	21	78327	2811	46604903
Dialysis	14.89	10.42	44	78304	10072	46597642
Cytomegalovirus infection	14.71	10.42	6	78342	18138	46589576
Multiple sclerosis	14.69	10.42	12	78336	24779	46582935
Right ventricular systolic pressure increased	14.69	10.42	10	78338	544	46607170
Obesity	14.63	10.42	3	78345	14203	46593511
Ecchymosis	14.62	10.42	45	78303	10531	46597183
Electrocardiogram R on T phenomenon	14.43	10.42	4	78344	20	46607694
Foot deformity	14.42	10.42	4	78344	15421	46592293
Panic attack	14.41	10.42	8	78340	20234	46587480
No adverse event	14.34	10.42	22	78326	34209	46573505
Choroidal haemorrhage	14.31	10.42	5	78343	59	46607655
Iron deficiency anaemia	14.26	10.42	62	78286	17144	46590570
Oxygen saturation decreased	14.21	10.42	178	78170	68986	46538728
Colitis ulcerative	14.15	10.42	6	78342	17726	46589988
Mitral valve disease	14.13	10.42	18	78330	2194	46605520
Basal ganglia haemorrhage	13.93	10.42	10	78338	592	46607122
Labelled drug-drug interaction medication error	13.90	10.42	40	78308	9021	46598693
Pregnancy	13.89	10.42	15	78333	27122	46580592
Injection site mass	13.87	10.42	4	78344	15036	46592678
Pain in jaw	13.85	10.42	111	78237	38261	46569453
Blood cholesterol increased	13.81	10.42	29	78319	39984	46567730
Bone pain	13.78	10.42	37	78311	46853	46560861
Electrocardiogram change	13.77	10.42	10	78338	603	46607111
Cardioversion	13.71	10.42	13	78335	1139	46606575
Blood culture positive	13.65	10.42	26	78322	4486	46603228
Cyanosis	13.58	10.42	58	78290	15913	46591801
Osteonecrosis of jaw	13.57	10.42	23	78325	34379	46573335
Blood bilirubin increased	13.51	10.42	101	78247	34083	46573631
Abdominal tenderness	13.48	10.42	34	78314	7094	46600620
Exercise tolerance decreased	13.39	10.42	26	78322	4551	46603163
Coronary arterial stent insertion	13.38	10.42	20	78328	2833	46604881
Blood loss anaemia	13.34	10.42	38	78310	8519	46599195
Palmar-plantar erythrodysaesthesia syndrome	13.28	10.42	9	78339	20442	46587272
Ischaemic cardiomyopathy	13.26	10.42	19	78329	2591	46605123
Diabetic ketoacidosis	13.25	10.42	7	78341	18203	46589511
Intervertebral disc protrusion	13.22	10.42	9	78339	20396	46587318
Hip arthroplasty	13.12	10.42	7	78341	18105	46589609
Prerenal failure	13.04	10.42	14	78334	1423	46606291
Atrial thrombosis	12.98	10.42	14	78334	1430	46606284
Right ventricular hypertrophy	12.91	10.42	10	78338	665	46607049
Walking distance test abnormal	12.91	10.42	9	78339	509	46607205
Faeces discoloured	12.79	10.42	59	78289	16728	46590986
Depressed level of consciousness	12.75	10.42	129	78219	47440	46560274
Hypomagnesaemia	12.69	10.42	72	78276	22138	46585576
Calcium deficiency	12.64	10.42	11	78337	862	46606852
Acne	12.62	10.42	9	78339	19910	46587804
Ear infection	12.60	10.42	12	78336	23001	46584713
Delirium	12.53	10.42	106	78242	37122	46570592
Blood pressure increased	12.52	10.42	144	78204	126522	46481192
Anhedonia	12.49	10.42	42	78306	10293	46597421
Red blood cell sedimentation rate increased	12.46	10.42	12	78336	22877	46584837
Pharyngitis	12.44	10.42	7	78341	17576	46590138
Rales	12.41	10.42	40	78308	9591	46598123
Hypersensitivity vasculitis	12.37	10.42	24	78324	4197	46603517
Blood pressure fluctuation	12.34	10.42	20	78328	30428	46577286
Orthostatic hypotension	12.21	10.42	77	78271	24581	46583133
Chronic obstructive pulmonary disease	12.13	10.42	149	78199	57484	46550230
Catheter site erythema	12.11	10.42	23	78325	3960	46603754
Drug withdrawal syndrome	12.06	10.42	17	78331	27367	46580347
Erythema	12.02	10.42	168	78180	142652	46465062
Hypoglycaemic coma	12.01	10.42	18	78330	2556	46605158
Thromboembolectomy	11.95	10.42	4	78344	41	46607673
Catheter site rash	11.94	10.42	10	78338	744	46606970
Anisocytosis	11.91	10.42	9	78339	577	46607137
Paracentesis	11.89	10.42	11	78337	934	46606780
Therapeutic response increased	11.89	10.42	7	78341	295	46607419
Cataract	11.78	10.42	38	78310	45377	46562337
Aortic stenosis	11.74	10.42	24	78324	4358	46603356
Haemodialysis	11.63	10.42	38	78310	9179	46598535
Injection site rash	11.62	10.42	6	78342	15807	46591907
Venous pressure jugular increased	11.61	10.42	8	78340	444	46607270
Peripheral swelling	11.57	10.42	191	78157	157880	46449834
Impaired healing	11.56	10.42	28	78320	36715	46570999
Diabetic metabolic decompensation	11.56	10.42	12	78336	1173	46606541
Cardiorenal syndrome	11.46	10.42	9	78339	611	46607103
Dizziness postural	11.42	10.42	30	78318	6416	46601298
Concomitant disease progression	11.37	10.42	16	78332	2146	46605568
Respiratory distress	11.34	10.42	92	78256	31824	46575890
Dry eye	11.31	10.42	21	78327	30301	46577413
Mucosal inflammation	11.27	10.42	31	78317	38945	46568769
Anger	11.22	10.42	3	78345	11849	46595865
Blood pressure immeasurable	11.21	10.42	12	78336	1215	46606499
Breast cancer	11.18	10.42	39	78309	45479	46562235
Paralysis	11.04	10.42	36	78312	8685	46599029
Foot fracture	10.97	10.42	10	78338	19572	46588142
Catheter site pruritus	10.94	10.42	15	78333	1964	46605750
Polyneuropathy	10.92	10.42	3	78345	11641	46596073
Cardiac valve disease	10.89	10.42	22	78326	3962	46603752
Haematocrit decreased	10.85	10.42	98	78250	34959	46572755
Adams-Stokes syndrome	10.83	10.42	4	78344	56	46607658
Microcytic anaemia	10.82	10.42	19	78329	3079	46604635
C-reactive protein increased	10.81	10.42	56	78292	58534	46549180
Aortic valve incompetence	10.80	10.42	28	78320	5942	46601772
Acute myocardial infarction	10.79	10.42	91	78257	31833	46575881
Ventricular failure	10.72	10.42	7	78341	355	46607359
Azotaemia	10.69	10.42	23	78325	4328	46603386
Lactic acidosis	10.60	10.42	95	78253	33814	46573900
Hyperchloraemia	10.58	10.42	9	78339	684	46607030
Heart sounds abnormal	10.57	10.42	9	78339	685	46607029
Nephrolithiasis	10.55	10.42	25	78323	33026	46574688
Prothrombin level increased	10.54	10.42	6	78342	237	46607477
Cough	10.52	10.42	300	78048	229949	46377765
Cerebellar haematoma	10.51	10.42	7	78341	367	46607347
Hepatic steatosis	10.51	10.42	15	78333	24027	46583687
Upper respiratory tract infection	10.50	10.42	63	78285	63493	46544221
Blood alkaline phosphatase increased	10.42	10.42	107	78241	39502	46568212

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
Cardioactive drug level increased	770.38	10.84	241	67167	1398	29883672
Bradycardia	649.68	10.84	768	66640	64758	29820312
Cardiac failure congestive	576.59	10.84	823	66585	83584	29801486
Atrial fibrillation	535.63	10.84	909	66499	107215	29777855
International normalised ratio increased	524.07	10.84	590	66818	47149	29837921
Ventricular tachycardia	243.11	10.84	284	67124	23578	29861492
Cardiac failure	226.67	10.84	547	66861	82871	29802199
Hyperkalaemia	180.45	10.84	434	66974	65576	29819494
Product complaint	157.03	10.84	119	67289	5687	29879383
Toxicity to various agents	156.98	10.84	800	66608	176383	29708687
Drug abuse	155.03	10.84	7	67401	82065	29803005
Off label use	146.58	10.84	209	67199	249081	29635989
Gastrointestinal haemorrhage	122.90	10.84	440	66968	83006	29802064
Drug ineffective	121.46	10.84	379	67029	340008	29545062
Drug interaction	116.00	10.84	807	66601	198761	29686309
Venous pressure jugular increased	113.48	10.84	47	67361	664	29884406
Cardiac murmur	89.78	10.84	93	67315	6741	29878329
Hypotension	88.59	10.84	761	66647	199804	29685266
Acute kidney injury	87.21	10.84	970	66438	272872	29612198
Right ventricular failure	84.06	10.84	97	67311	7939	29877131
Dyspnoea	82.99	10.84	1127	66281	332168	29552902
Cardioactive drug level above therapeutic	82.51	10.84	21	67387	47	29885023
Atrial flutter	78.35	10.84	126	67282	14155	29870915
Melaena	77.74	10.84	203	67205	32234	29852836
Myocardial infarction	73.98	10.84	510	66898	125115	29759955
Ischaemic cardiomyopathy	70.94	10.84	79	67329	6218	29878852
Febrile neutropenia	69.13	10.84	83	67325	106610	29778460
Nodal rhythm	66.75	10.84	41	67367	1382	29883688
Neutropenia	66.59	10.84	117	67291	128423	29756647
Ventricular fibrillation	66.48	10.84	121	67287	15017	29870053
Bradyarrhythmia	66.44	10.84	46	67362	1906	29883164
Cardiac arrest	65.09	10.84	394	67014	92456	29792614
Arrhythmia	65.09	10.84	193	67215	32976	29852094
Dizziness	64.92	10.84	697	66711	194212	29690858
Cardioactive drug level decreased	61.81	10.84	17	67391	57	29885013
Pulmonary hypertension	59.44	10.84	132	67276	18904	29866166
Ventricular extrasystoles	58.57	10.84	98	67310	11376	29873694
Product dose omission issue	55.49	10.84	75	67333	91556	29793514
Product use in unapproved indication	52.48	10.84	53	67355	73640	29811430
Tricuspid valve incompetence	51.34	10.84	79	67329	8544	29876526
Cardiomegaly	50.34	10.84	105	67303	14404	29870666
Prothrombin time prolonged	49.55	10.84	81	67327	9222	29875848
Atrioventricular block	49.51	10.84	71	67337	7211	29877859
Rheumatoid arthritis	48.65	10.84	16	67392	41181	29843889
Xanthopsia	47.98	10.84	17	67391	152	29884918
Pyrexia	47.57	10.84	429	66979	294060	29591010
International normalised ratio decreased	47.32	10.84	55	67353	4535	29880535
Atrioventricular block complete	46.77	10.84	75	67333	8402	29876668
Mitral valve incompetence	45.01	10.84	95	67313	13139	29871931
Rash	44.89	10.84	251	67157	191638	29693432
Left ventricular dysfunction	44.05	10.84	74	67334	8617	29876453
Heart rate irregular	44.03	10.84	90	67318	12169	29872901
Cardiogenic shock	44.00	10.84	109	67299	16752	29868318
Subdural haematoma	43.68	10.84	117	67291	18855	29866215
Drug hypersensitivity	43.62	10.84	54	67354	68465	29816605
Arthralgia	43.53	10.84	158	67250	135633	29749437
Torsade de pointes	42.98	10.84	66	67342	7124	29877946
Coronary artery disease	42.79	10.84	223	67185	49489	29835581
Renal failure	42.76	10.84	461	66947	128505	29756565
Completed suicide	41.82	10.84	102	67306	99390	29785680
Cardiomyopathy	41.76	10.84	100	67308	15043	29870027
Cardiac failure chronic	41.09	10.84	58	67350	5805	29879265
Confusional state	41.07	10.84	474	66934	134360	29750710
Cerebrovascular accident	40.59	10.84	324	67084	83153	29801917
Headache	39.17	10.84	245	67163	182061	29703009
Intentional product use issue	38.29	10.84	17	67391	36423	29848647
Pruritus	38.23	10.84	137	67271	118067	29767003
Heart rate decreased	38.21	10.84	119	67289	20875	29864195
Atrioventricular block first degree	37.99	10.84	55	67353	5633	29879437
Sinus node dysfunction	37.88	10.84	45	67363	3798	29881272
Left ventricular failure	37.41	10.84	51	67357	4940	29880130
Asthenia	37.33	10.84	702	66706	220588	29664482
Syncope	36.73	10.84	321	67087	84582	29800488
Pulmonary arterial hypertension	36.67	10.84	71	67337	9230	29875840
Haematuria	36.45	10.84	198	67210	44636	29840434
Nodal arrhythmia	35.94	10.84	23	67385	834	29884236
Ventricular arrhythmia	35.50	10.84	46	67362	4242	29880828
Supraventricular tachycardia	34.08	10.84	73	67335	10199	29874871
Blood urea increased	33.66	10.84	150	67258	31231	29853839
Intentional product misuse	33.65	10.84	18	67390	34649	29850421
Psoriasis	33.29	10.84	28	67380	42478	29842592
Atrial tachycardia	33.18	10.84	32	67376	2127	29882943
Leukopenia	32.94	10.84	47	67361	56112	29828958
White blood cell count decreased	32.26	10.84	90	67318	83857	29801213
Injection site pain	32.06	10.84	14	67394	30296	29854774
Nasopharyngitis	31.87	10.84	52	67356	58797	29826273
Blood lactic acid	31.72	10.84	16	67392	364	29884706
Chronic obstructive pulmonary disease	31.18	10.84	194	67214	45932	29839138
Neuropathy peripheral	30.60	10.84	71	67337	70404	29814666
Coagulopathy	30.21	10.84	101	67307	18386	29866684
Dissociation	30.07	10.84	23	67385	1114	29883956
Cardiac disorder	29.65	10.84	172	67236	39721	29845349
Ejection fraction decreased	29.47	10.84	88	67320	15087	29869983
Ischaemic stroke	29.38	10.84	92	67316	16183	29868887
Intentional overdose	29.33	10.84	30	67378	41451	29843619
Oedema peripheral	29.11	10.84	365	67043	105467	29779603
Jugular vein distension	29.07	10.84	17	67391	523	29884547
Electrocardiogram ST segment depression	28.98	10.84	31	67377	2331	29882739
Orthostatic hypotension	28.31	10.84	118	67290	23861	29861209
Aortic stenosis	28.30	10.84	40	67368	4008	29881062
Cytomegalovirus infection	28.29	10.84	9	67399	23665	29861405
Cardiorenal syndrome	28.28	10.84	19	67389	749	29884321
Conduction disorder	28.27	10.84	28	67380	1923	29883147
Blood creatinine increased	28.13	10.84	322	67086	91053	29794017
Suicidal ideation	28.02	10.84	24	67384	36090	29848980
Depression	27.80	10.84	107	67301	90330	29794740
Neutrophil count decreased	27.49	10.84	33	67375	42421	29842649
Drug dependence	27.47	10.84	7	67401	21288	29863782
Stomatitis	27.46	10.84	26	67382	37253	29847817
Haematoma	26.83	10.84	116	67292	23837	29861233
Congestive cardiomyopathy	26.63	10.84	51	67357	6576	29878494
Mucosal inflammation	26.56	10.84	18	67390	30476	29854594
Blood potassium increased	25.98	10.84	88	67320	16125	29868945
Bundle branch block left	25.96	10.84	44	67364	5160	29879910
Cardioactive drug level below therapeutic	25.49	10.84	5	67403	0	29885070
International normalised ratio abnormal	24.88	10.84	33	67375	3113	29881957
Pleural effusion	24.62	10.84	265	67143	73801	29811269
Product use issue	24.60	10.84	41	67367	45975	29839095
Oedema	24.33	10.84	173	67235	42820	29842250
Fall	24.08	10.84	557	66851	181315	29703755
Dyspnoea exertional	23.93	10.84	149	67259	35281	29849789
Myasthenic syndrome	23.93	10.84	13	67395	346	29884724
Peripheral embolism	23.80	10.84	18	67390	857	29884213
Therapeutic product effect incomplete	23.32	10.84	25	67383	33809	29851261
Diabetic ketoacidosis	23.20	10.84	4	67404	15982	29869088
Anuria	23.12	10.84	63	67345	10253	29874817
Dilatation atrial	22.87	10.84	26	67382	2093	29882977
Faeces discoloured	22.61	10.84	76	67332	13870	29871200
Malignant neoplasm progression	22.55	10.84	85	67323	72202	29812868
Epistaxis	22.21	10.84	199	67209	52782	29832288
Hypersensitivity	22.21	10.84	56	67352	53972	29831098
Polymerase chain reaction	22.15	10.84	8	67400	76	29884994
Drug reaction with eosinophilia and systemic symptoms	22.02	10.84	19	67389	28469	29856601
Upper gastrointestinal haemorrhage	21.92	10.84	103	67305	21925	29863145
Cardiac output decreased	21.67	10.84	17	67391	855	29884215
Brain natriuretic peptide increased	21.31	10.84	35	67373	4000	29881070
Benign gastrointestinal neoplasm	21.24	10.84	9	67399	135	29884935
Lethargy	21.20	10.84	157	67251	39362	29845708
Cardiac death	21.17	10.84	18	67390	1015	29884055
Dilatation ventricular	21.02	10.84	28	67380	2652	29882418
Orthopnoea	20.84	10.84	37	67371	4503	29880567
Concomitant disease progression	20.81	10.84	27	67381	2493	29882577
Psoriatic arthropathy	20.68	10.84	5	67403	15756	29869314
Intentional self-injury	20.51	10.84	3	67405	13529	29871541
Renal impairment	20.49	10.84	284	67124	83900	29801170
Back pain	20.41	10.84	141	67267	102455	29782615
Lip discolouration	20.38	10.84	9	67399	150	29884920
Oesophageal achalasia	20.37	10.84	11	67397	289	29884781
Blood pressure increased	20.28	10.84	88	67320	71840	29813230
Drug resistance	20.21	10.84	10	67398	20123	29864947
Pain	20.00	10.84	271	67137	172370	29712700
Activated partial thromboplastin time prolonged	19.78	10.84	50	67358	7778	29877292
Drug withdrawal syndrome	19.64	10.84	10	67398	19799	29865271
Pancytopenia	19.43	10.84	112	67296	84940	29800130
Fluid retention	19.37	10.84	109	67299	24889	29860181
Haemorrhage intracranial	19.36	10.84	76	67332	14956	29870114
Lymphadenopathy	19.16	10.84	16	67392	24360	29860710
Infusion related reaction	19.14	10.84	39	67369	40525	29844545
Muscle spasms	19.10	10.84	78	67330	64760	29820310
Palpitations	18.94	10.84	135	67273	33438	29851632
Creatinine renal clearance decreased	18.69	10.84	30	67378	3363	29881707
Treatment failure	18.44	10.84	31	67377	34648	29850422
Ventricular dysfunction	18.28	10.84	31	67377	3636	29881434
Irritability	18.27	10.84	15	67393	23035	29862035
Electrocardiogram repolarisation abnormality	18.23	10.84	14	67394	682	29884388
Colitis ulcerative	18.13	10.84	5	67403	14429	29870641
Acute myocardial infarction	17.86	10.84	190	67218	52749	29832321
Enzyme induction	17.74	10.84	6	67402	46	29885024
Hepatitis C	17.70	10.84	4	67404	13201	29871869
Hyperthyroidism	17.70	10.84	49	67359	8049	29877021
Ventricular hypertrophy	17.69	10.84	36	67372	4851	29880219
Burning feet syndrome	17.64	10.84	7	67401	88	29884982
Atrioventricular block second degree	17.62	10.84	28	67380	3112	29881958
Coronary artery bypass	17.48	10.84	37	67371	5125	29879945
Haemorrhage	17.27	10.84	169	67239	45910	29839160
Insomnia	17.25	10.84	131	67277	93205	29791865
Chromatopsia	17.11	10.84	9	67399	224	29884846
Transient ischaemic attack	17.03	10.84	106	67302	25094	29859976
Tachycardia foetal	16.72	10.84	10	67398	321	29884749
Diverticulum intestinal haemorrhagic	16.60	10.84	22	67386	2073	29882997
Cardiac failure acute	16.57	10.84	52	67356	9157	29875913
Drug intolerance	16.34	10.84	50	67358	45241	29839829
Pulmonary arterial pressure increased	16.29	10.84	16	67392	1088	29883982
Hepatocellular injury	16.27	10.84	20	67388	25451	29859619
Brain natriuretic peptide	16.12	10.84	5	67403	28	29885042
Joint swelling	16.11	10.84	53	67355	46893	29838177
Embolic stroke	15.96	10.84	29	67379	3593	29881477
Anaphylactic reaction	15.83	10.84	24	67384	27958	29857112
Sinusitis	15.78	10.84	32	67376	33313	29851757
Injury	15.69	10.84	93	67315	21638	29863432
Eosinophilia	15.69	10.84	16	67392	22144	29862926
Hyponatraemia	15.66	10.84	225	67183	66977	29818093
Influenza	15.59	10.84	48	67360	43350	29841720
Peripheral coldness	15.56	10.84	41	67367	6542	29878528
Drug-induced liver injury	15.48	10.84	15	67393	21259	29863811
Aortic valve stenosis	15.29	10.84	19	67389	1680	29883390
Subdural haemorrhage	15.28	10.84	25	67383	2847	29882223
Normochromic normocytic anaemia	15.28	10.84	30	67378	3940	29881130
Mitral valve sclerosis	15.22	10.84	7	67401	129	29884941
Presyncope	15.19	10.84	74	67334	15982	29869088
Congestive hepatopathy	15.10	10.84	20	67388	1884	29883186
Pneumocystis jirovecii pneumonia	15.05	10.84	10	67398	17110	29867960
COVID-19	14.98	10.84	11	67397	17867	29867203
Abnormal loss of weight	14.96	10.84	29	67379	3773	29881297
Polypectomy	14.89	10.84	11	67397	505	29884565
Cerebral haematoma	14.88	10.84	32	67376	4482	29880588
Sleep disorder	14.83	10.84	20	67388	24459	29860611
Anhedonia	14.82	10.84	47	67361	8322	29876748
Urticaria	14.67	10.84	68	67340	54538	29830532
Arthropathy	14.64	10.84	15	67393	20712	29864358
Tricuspid valve sclerosis	14.60	10.84	5	67403	40	29885030
Haematemesis	14.56	10.84	105	67303	26098	29858972
Right atrial dilatation	14.53	10.84	9	67399	308	29884762
Gastric mucosal lesion	14.34	10.84	11	67397	535	29884535
Cyanosis	14.30	10.84	59	67349	11876	29873194
Cerebral infarction	14.27	10.84	105	67303	26268	29858802
Constipation	14.26	10.84	174	67234	112732	29772338
Somnolence	14.25	10.84	144	67264	96619	29788451
Palmar-plantar erythrodysaesthesia syndrome	14.02	10.84	8	67400	14862	29870208
Tracheal injury	13.99	10.84	4	67404	16	29885054
Withdrawal syndrome	13.94	10.84	4	67404	11246	29873824
Aspergillus infection	13.88	10.84	3	67405	10211	29874859
Haemothorax	13.88	10.84	27	67381	3522	29881548
Dyspnoea paroxysmal nocturnal	13.79	10.84	15	67393	1150	29883920
Atrial thrombosis	13.76	10.84	19	67389	1862	29883208
Graft versus host disease	13.76	10.84	3	67405	10147	29874923
Electrocardiogram QRS complex prolonged	13.73	10.84	30	67378	4247	29880823
N-terminal prohormone brain natriuretic peptide increased	13.66	10.84	16	67392	1330	29883740
Suicide attempt	13.60	10.84	40	67368	36657	29848413
Inappropriate schedule of product administration	13.53	10.84	45	67363	39683	29845387
Colitis	13.41	10.84	31	67377	30789	29854281
Electrocardiogram abnormal	13.22	10.84	36	67372	5856	29879214
Chills	13.14	10.84	102	67306	72236	29812834
Electrocardiogram ST-T change	13.11	10.84	11	67397	609	29884461
Synovitis	13.04	10.84	3	67405	9780	29875290
Rectal haemorrhage	13.02	10.84	128	67280	34811	29850259
Dystonia	12.93	10.84	3	67405	9724	29875346
Tremor	12.89	10.84	108	67300	75255	29809815
Generalised tonic-clonic seizure	12.86	10.84	15	67393	19536	29865534
Infection	12.85	10.84	113	67295	77961	29807109
Haematocrit decreased	12.70	10.84	115	67293	30584	29854486
Angina unstable	12.57	10.84	58	67350	12252	29872818
Osteonecrosis of jaw	12.56	10.84	14	67394	18604	29866466
Oliguria	12.47	10.84	41	67367	7398	29877672
Neuralgia	12.47	10.84	4	67404	10462	29874608
Rash maculo-papular	12.37	10.84	24	67384	25394	29859676
Hypovolaemia	12.31	10.84	45	67363	8560	29876510
Limited symptom panic attack	12.18	10.84	5	67403	69	29885001
Tumour lysis syndrome	12.05	10.84	7	67401	12878	29872192
Cerebral haemorrhage	12.02	10.84	120	67288	32767	29852303
Morning glory syndrome	12.01	10.84	3	67405	6	29885064
Musculoskeletal pain	12.00	10.84	33	67375	30907	29854163
Blood pressure fluctuation	11.98	10.84	13	67395	17490	29867580
Transplant rejection	11.92	10.84	3	67405	9203	29875867
Mania	11.82	10.84	3	67405	9151	29875919
Cardioversion	11.76	10.84	12	67396	854	29884216
Drug level increased	11.65	10.84	76	67332	18278	29866792
Urine leukocyte esterase positive	11.63	10.84	8	67400	328	29884742
Herpes zoster	11.57	10.84	32	67376	29911	29855159
Bundle branch block	11.50	10.84	12	67396	877	29884193
Electrocardiogram ST segment abnormal	11.49	10.84	10	67398	582	29884488
Wrong patient received product	11.31	10.84	17	67391	1800	29883270
Encephalopathy	11.30	10.84	36	67372	32169	29852901
Seizure	11.23	10.84	155	67253	98320	29786750
Pulmonary embolism	11.20	10.84	117	67291	78018	29807052
Lymphopenia	11.15	10.84	8	67400	13155	29871915
Erythema	11.09	10.84	116	67292	77335	29807735
Emotional distress	11.08	10.84	67	67341	15698	29869372
Medication error	11.06	10.84	83	67325	20889	29864181
Pain in extremity	11.02	10.84	178	67230	110043	29775027
Posterior reversible encephalopathy syndrome	10.97	10.84	3	67405	8704	29876366
Aortic valve incompetence	10.97	10.84	30	67378	4893	29880177
Tinnitus	10.96	10.84	12	67396	16076	29868994
Haemodynamic test abnormal	10.89	10.84	4	67404	40	29885030

Pharmacologic Action:

Source	Code	Description
ATC	C01AA05	CARDIOVASCULAR SYSTEM CARDIAC THERAPY CARDIAC GLYCOSIDES Digitalis glycosides
FDA CS	M0003451	Cardiac Glycosides
FDA EPC	N0000175568	Cardiac Glycoside
CHEBI has role	CHEBI:38070	antiarrhythmic agent
CHEBI has role	CHEBI:38147	cardiotonic drugs
CHEBI has role	CHEBI:53000	epitope function
CHEBI has role	CHEBI:63510	na(+)/k(+)-pump inhibitors
MeSH PA	D000889	Anti-Arrhythmia Agents
MeSH PA	D002316	Cardiotonic Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D020011	Protective Agents

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Poisoning by digitalis glycoside	indication	12876009
Chronic heart failure	indication	48447003
Atrial fibrillation	indication	49436004	DOID:0060224
Senile cardiac amyloidosis	contraindication	16573007
Myocardial infarction	contraindication	22298006	DOID:5844
Sick sinus syndrome	contraindication	36083008	DOID:13884
Myxedema	contraindication	43153006	DOID:11634
Hypokalemia	contraindication	43339004
Sinus bradycardia	contraindication	49710005
Myocarditis	contraindication	50920009	DOID:820
Acute nephropathy	contraindication	58574008
Hypercalcemia	contraindication	66931009	DOID:12678
Ventricular fibrillation	contraindication	71908006
Wolff-Parkinson-White pattern	contraindication	74390002	DOID:384
Cor pulmonale	contraindication	83291003	DOID:8515
Constrictive pericarditis	contraindication	85598007	DOID:11481
Kidney disease	contraindication	90708001	DOID:557
Hypomagnesemia	contraindication	190855004
Atrioventricular block	contraindication	233917008	DOID:0050820
Idiopathic hypertrophic subaortic stenosis	contraindication	360465008
Restrictive cardiomyopathy	contraindication	415295002	DOID:397

Acid dissociation constants calculated using MoKa v3.0.0

None

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
Sodium/potassium-transporting ATPase	Transporter	P05023 P05026 P13637 P14415 P50993 P54709 P54710 Q13733	AT1A1_HUMAN AT1A2_HUMAN AT1A3_HUMAN AT1A4_HUMAN AT1B1_HUMAN AT1B2_HUMAN AT1B3_HUMAN ATNG_HUMAN	INHIBITOR	IC50	6.40		CHEMBL	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	4.14		WOMBAT-PK
Signal transducer and activator of transcription 3	Transcription factor	P40763	STAT3_HUMAN		IC50	5.73		CHEMBL
Nuclear receptor ROR-gamma	Nuclear hormone receptor	P51449	RORG_HUMAN		IC50	5.70		CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-1	Transporter		AT1A1_CANFA		IC50	6.30		CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-2	Ion channel		AT1A2_PIG		IC50	5.78		DRUG MATRIX
Nuclear receptor ROR-gamma	Unclassified		RORG_MOUSE		IC50	5.70		CHEMBL

External reference:

ID	Source
4018047	VUID
N0000146388	NUI
D00298	KEGG_DRUG
4018047	VANDF
C2825111	UMLSCUI
CHEBI:4551	CHEBI
DGX	PDB_CHEM_ID
CHEMBL1751	ChEMBL_ID
DB00390	DRUGBANK_ID
D004077	MESH_DESCRIPTOR_UI
3062	PUBCHEM_CID
4726	IUPHAR_LIGAND_ID
389	INN_ID
73K4184T59	UNII
3407	RXNORM
1413	MMSL
4597	MMSL
d00210	MMSL
000593	NDDF
387461009	SNOMEDCT_US
796001	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0057	SOLUTION	0.05 mg	ORAL	NDA	27 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9811	TABLET	125 ug	ORAL	ANDA	26 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9822	TABLET	250 ug	ORAL	ANDA	26 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-1240	TABLET	125 ug	ORAL	ANDA	26 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-1241	TABLET	250 ug	ORAL	ANDA	26 sections
DIGITEK	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6155	TABLET	0.13 mg	ORAL	ANDA	26 sections
DIGITEK	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6156	TABLET	0.25 mg	ORAL	ANDA	26 sections
DIGOX	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1324	TABLET	125 ug	ORAL	ANDA	22 sections
DIGOX	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1325	TABLET	250 ug	ORAL	ANDA	22 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-0547	TABLET	0.13 mg	ORAL	ANDA	12 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7729	TABLET	125 ug	ORAL	ANDA	22 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7730	TABLET	250 ug	ORAL	ANDA	22 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8202	TABLET	125 ug	ORAL	ANDA	27 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0641-1410	INJECTION	0.25 mg	INTRAMUSCULAR	ANDA	26 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6184	INJECTION	0.25 mg	INTRAMUSCULAR	ANDA	26 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3059	INJECTION, SOLUTION	250 ug	INTRAMUSCULAR	ANDA	26 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0904-5921	TABLET	125 ug	ORAL	ANDA	26 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	0904-5922	TABLET	250 ug	ORAL	ANDA	26 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	16714-590	TABLET	125 ug	ORAL	ANDA	25 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	16714-591	TABLET	250 ug	ORAL	ANDA	25 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	17856-0057	SOLUTION	0.05 mg	ORAL	NDA	25 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	21695-678	TABLET	0.13 mg	ORAL	ANDA	17 sections
LANOXIN	HUMAN PRESCRIPTION DRUG LABEL	1	24987-262	INJECTION, SOLUTION	100 ug	INTRAMUSCULAR	NDA	24 sections
DIGITEK	HUMAN PRESCRIPTION DRUG LABEL	1	42292-002	TABLET	0.25 mg	ORAL	ANDA	26 sections
DIGITEK	HUMAN PRESCRIPTION DRUG LABEL	1	42292-003	TABLET	0.13 mg	ORAL	ANDA	26 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4432	TABLET	125 ug	ORAL	ANDA	28 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5276	TABLET	125 ug	ORAL	ANDA	22 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5311	TABLET	250 ug	ORAL	ANDA	22 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	50436-0324	TABLET	125 ug	ORAL	ANDA	22 sections
Digoxin	HUMAN PRESCRIPTION DRUG LABEL	1	50564-544	TABLET	125 ug	ORAL	ANDA	22 sections