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

eplerenone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
mineralocorticoid receptor (MR, MCR, aldosterone receptor) antagonists	1032	107724-20-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: eplerenone (+)-Eplerenone epoxymexrenone	A spironolactone derivative and selective ALDOSTERONE RECEPTOR antagonist that is used in the management of HYPERTENSION and CONGESTIVE HEART FAILURE, post-MYOCARDIAL INFARCTION. Molecular weight: 414.50 Formula: C24H30O6 CLOGP: 0.47 LIPINSKI: 0 HAC: 6 HDO: 0 TPSA: 82.20 ALOGS: -4.66 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
50	mg	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)	3 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.72 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	69 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Sept. 27, 2002	FDA	GD SEARLE LLC

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
Cardiac failure	206.27	21.36	119	5843	89023	63394037
Hyperkalaemia	162.77	21.36	86	5876	54117	63428943
Acute kidney injury	157.49	21.36	156	5806	263259	63219801
Cardiac failure chronic	103.22	21.36	31	5931	4387	63478673
Subclavian vein thrombosis	79.46	21.36	21	5941	1869	63481191
Drug interaction	75.67	21.36	100	5862	229031	63254029
Atrial fibrillation	72.96	21.36	71	5891	116565	63366495
Hypotension	69.33	21.36	105	5857	272499	63210561
Cardiomyopathy	52.97	21.36	28	5934	17556	63465504
Hyponatraemia	51.78	21.36	58	5904	111842	63371218
Therapeutic drug monitoring analysis not performed	47.32	21.36	13	5949	1339	63481721
Cardiac failure acute	46.21	21.36	21	5941	9502	63473558
Wound haemorrhage	43.40	21.36	14	5948	2502	63480558
Hypomagnesaemia	42.62	21.36	29	5933	28708	63454352
Hydrothorax	42.28	21.36	11	5951	920	63482140
Femoral neck fracture	42.00	21.36	19	5943	8504	63474556
Bradycardia	40.98	21.36	42	5920	73185	63409875
Embolism venous	40.29	21.36	14	5948	3140	63479920
Oedema peripheral	39.82	21.36	67	5895	189444	63293616
Hypophosphataemia	39.61	21.36	20	5942	11406	63471654
Hypocalcaemia	37.78	21.36	28	5934	31685	63451375
Vascular stent thrombosis	37.01	21.36	10	5952	967	63482093
Degenerative aortic valve disease	36.25	21.36	7	5955	148	63482912
Dyspnoea	35.60	21.36	139	5823	661174	62821886
Cardiac ventricular disorder	35.17	21.36	7	5955	174	63482886
Hypovolaemia	35.01	21.36	18	5944	10655	63472405
Tachypnoea	34.40	21.36	21	5941	17281	63465779
Renal impairment	32.89	21.36	41	5921	88314	63394746
Exercise tolerance decreased	32.74	21.36	14	5948	5483	63477577
Angina pectoris	32.38	21.36	25	5937	30053	63453007
Glomerular filtration rate decreased	31.12	21.36	18	5944	13423	63469637
Therapeutic drug monitoring analysis incorrectly performed	30.69	21.36	7	5955	337	63482723
Ejection fraction decreased	29.51	21.36	21	5941	22311	63460749
Subclavian artery thrombosis	29.29	21.36	6	5956	173	63482887
Glomerular filtration rate increased	28.51	21.36	8	5954	890	63482170
Left ventricular dilatation	28.07	21.36	7	5955	494	63482566
Orthopnoea	27.85	21.36	13	5949	6248	63476812
Pulmonary arterial pressure increased	27.67	21.36	11	5951	3584	63479476
Left ventricular dysfunction	27.61	21.36	16	5946	11972	63471088
Coronary artery occlusion	27.41	21.36	14	5948	8177	63474883
Ventricular tachycardia	26.89	21.36	19	5943	19960	63463100
N-terminal prohormone brain natriuretic peptide increased	25.34	21.36	9	5953	2152	63480908
Stenosis	24.71	21.36	8	5954	1446	63481614
Vascular purpura	24.58	21.36	8	5954	1470	63481590
Hypokalaemia	23.52	21.36	38	5924	103766	63379294
Arrhythmia	23.39	21.36	23	5939	38117	63444943
Electrocardiogram Q wave abnormal	23.39	21.36	5	5957	178	63482882
Fall	23.10	21.36	85	5877	392249	63090811
Subdural haematoma	22.53	21.36	15	5947	14313	63468747
Congestive cardiomyopathy	21.95	21.36	11	5951	6171	63476889

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
Cardiac failure	643.22	15.57	519	23594	90729	34842089
Cardiac failure chronic	380.34	15.57	158	23955	7721	34925097
Rales	257.43	15.57	129	23984	9754	34923064
Ventricular tachycardia	256.93	15.57	183	23930	26396	34906422
Acute kidney injury	232.87	15.57	591	23522	304397	34628421
Ejection fraction decreased	218.34	15.57	146	23967	19008	34913810
Oedema peripheral	213.62	15.57	332	23781	119480	34813338
N-terminal prohormone brain natriuretic peptide increased	203.74	15.57	75	24038	2640	34930178
Hypotension	182.94	15.57	443	23670	221206	34711612
Mitral valve incompetence	182.66	15.57	119	23994	14824	34917994
Hyperkalaemia	181.17	15.57	231	23882	69158	34863660
Dyspnoea	156.73	15.57	591	23522	376191	34556627
Glomerular filtration rate decreased	153.00	15.57	101	24012	12860	34919958
Dyspnoea at rest	123.89	15.57	58	24055	3770	34929048
Exercise tolerance decreased	118.37	15.57	62	24051	5136	34927682
Ventricular enlargement	108.63	15.57	33	24080	631	34932187
Tricuspid valve incompetence	107.82	15.57	73	24040	9687	34923131
Dyspnoea exertional	101.84	15.57	137	23976	43142	34889676
Ventricular arrhythmia	101.03	15.57	57	24056	5471	34927347
Computerised tomogram coronary artery abnormal	98.02	15.57	24	24089	193	34932625
Atrial enlargement	91.43	15.57	29	24084	643	34932175
Renal impairment	90.89	15.57	201	23912	94312	34838506
Congestive cardiomyopathy	89.77	15.57	59	24054	7451	34925367
Cardiac failure acute	88.97	15.57	67	24046	10503	34922315
Soft tissue mass	87.10	15.57	31	24082	988	34931830
Oesophageal perforation	85.83	15.57	32	24081	1167	34931651
Multimorbidity	85.64	15.57	30	24083	912	34931906
Atrial fibrillation	80.39	15.57	225	23888	122168	34810650
Ischaemic cardiomyopathy	75.89	15.57	50	24063	6339	34926479
Low cardiac output syndrome	69.53	15.57	23	24090	585	34932233
Febrile neutropenia	69.35	15.57	7	24106	136842	34795976
Blood pressure decreased	67.93	15.57	125	23988	51390	34881428
Liver palpable	67.34	15.57	19	24094	277	34932541
General physical health deterioration	66.50	15.57	217	23896	128052	34804766
Death	65.44	15.57	109	24004	397940	34534878
Blood potassium increased	65.02	15.57	68	24045	16427	34916391
Bradycardia	64.29	15.57	153	23960	75265	34857553
Superinfection	62.98	15.57	32	24081	2487	34930331
Arrhythmia	57.78	15.57	95	24018	35713	34897105
Electrocardiogram abnormal	55.29	15.57	48	24065	9199	34923619
Labelled drug-drug interaction medication error	54.31	15.57	59	24054	14880	34917938
Drug interaction	54.07	15.57	302	23811	225644	34707174
Left atrial enlargement	53.46	15.57	21	24092	884	34931934
Hepatic vein dilatation	53.27	15.57	15	24098	217	34932601
Transplant failure	52.69	15.57	32	24081	3521	34929297
Electrolyte imbalance	52.53	15.57	57	24056	14355	34918463
Type V hyperlipidaemia	52.27	15.57	20	24093	784	34932034
Myocardial ischaemia	51.84	15.57	62	24051	17346	34915472
Hyperuricaemia	50.63	15.57	43	24070	8000	34924818
Cardiomyopathy	50.27	15.57	60	24053	16748	34916070
Cardiac amyloidosis	50.12	15.57	22	24091	1229	34931589
Blood thyroid stimulating hormone increased	49.81	15.57	33	24080	4222	34928596
Right ventricular dysfunction	48.15	15.57	21	24092	1155	34931663
Immunosuppressant drug level increased	47.91	15.57	37	24076	6018	34926800
Cardiogenic shock	47.57	15.57	74	24039	26544	34906274
Gynaecomastia	47.51	15.57	46	24067	10134	34922684
Syncope	46.70	15.57	154	23959	91297	34841521
Ventricular extrasystoles	46.42	15.57	49	24064	11959	34920859
Inferior vena cava dilatation	46.18	15.57	18	24095	742	34932076
Cardiomegaly	45.99	15.57	55	24058	15383	34917435
Venous pressure jugular increased	45.26	15.57	18	24095	783	34932035
Jugular vein distension	44.85	15.57	17	24096	649	34932169
Product prescribing error	44.16	15.57	66	24047	22861	34909957
Respiratory tract haemorrhage	43.45	15.57	20	24093	1250	34931568
Concomitant disease aggravated	43.29	15.57	34	24079	5667	34927151
Seizure	42.62	15.57	10	24103	104847	34827971
Coronary artery stenosis	42.17	15.57	42	24071	9574	34923244
Orthopnoea	42.17	15.57	32	24081	5071	34927747
Ventricular hypokinesia	41.92	15.57	33	24080	5519	34927299
Breath sounds abnormal	41.71	15.57	36	24077	6845	34925973
Blood creatinine increased	41.60	15.57	152	23961	94824	34837994
Left ventricular dysfunction	40.77	15.57	42	24071	9965	34922853
Hyperthyroidism	40.64	15.57	43	24070	10523	34922295
Inflammatory marker increased	40.38	15.57	31	24082	4997	34927821
Lung consolidation	39.98	15.57	33	24080	5903	34926915
White blood cell count decreased	39.00	15.57	9	24104	95436	34837382
Blood pressure systolic decreased	38.90	15.57	29	24084	4474	34928344
Atrial flutter	37.66	15.57	50	24063	15524	34917294
Dizziness	37.25	15.57	268	23845	218253	34714565
Asthma-chronic obstructive pulmonary disease overlap syndrome	37.06	15.57	18	24095	1269	34931549
Left ventricular enlargement	36.99	15.57	15	24098	687	34932131
Off label use	36.74	15.57	157	23956	419367	34513451
Malignant neoplasm progression	36.58	15.57	8	24105	88038	34844780
Waist circumference increased	36.51	15.57	16	24097	890	34931928
Platelet distribution width increased	36.22	15.57	10	24103	134	34932684
Neutropenia	36.09	15.57	33	24080	156745	34776073
Bundle branch block left	35.67	15.57	31	24082	5948	34926870
Bronchial hyperreactivity	35.00	15.57	19	24094	1690	34931128
Palpitations	34.99	15.57	82	24031	39904	34892914
Pulmonary arterial pressure increased	34.36	15.57	17	24096	1248	34931570
Oesophageal carcinoma	34.26	15.57	37	24076	9267	34923551
Drug ineffective	34.12	15.57	181	23932	456570	34476248
Glomerular filtration rate abnormal	34.00	15.57	15	24098	848	34931970
Mitral valve thickening	33.73	15.57	12	24101	382	34932436
Glomerular filtration rate	33.66	15.57	9	24104	106	34932712
Contraindicated product administered	33.31	15.57	56	24057	21425	34911393
Atrial tachycardia	32.67	15.57	24	24089	3621	34929197
N-terminal prohormone brain natriuretic peptide abnormal	32.54	15.57	10	24103	199	34932619
Left ventricular dilatation	32.39	15.57	14	24099	753	34932065
Aortic valve incompetence	32.01	15.57	29	24084	5875	34926943
Ventricular dyskinesia	30.90	15.57	10	24103	237	34932581
Venous pressure jugular decreased	30.66	15.57	7	24106	40	34932778
Sinus bradycardia	30.40	15.57	41	24072	12922	34919896
Cardiac ventricular thrombosis	29.77	15.57	15	24098	1145	34931673
Stenosis	29.13	15.57	16	24097	1457	34931361
Chronic kidney disease	28.21	15.57	77	24036	41133	34891685
Cardiac failure congestive	28.19	15.57	123	23990	83147	34849671
Atrial thrombosis	27.94	15.57	18	24095	2196	34930622
Pulmonary oedema	27.87	15.57	84	24029	47445	34885373
Pyonephrosis	27.79	15.57	7	24106	64	34932754
Arthralgia	27.41	15.57	47	24066	169994	34762824
Pleural effusion	27.26	15.57	120	23993	81426	34851392
Micturition frequency decreased	27.18	15.57	10	24103	351	34932467
Hypotonia	26.78	15.57	30	24083	7823	34924995
Pyrexia	26.49	15.57	129	23984	332884	34599934
Rash	26.46	15.57	73	24040	222679	34710139
Conduction disorder	26.25	15.57	17	24096	2093	34930725
Mitral valve calcification	25.91	15.57	11	24102	566	34932252
Pulmonary congestion	25.61	15.57	39	24074	13726	34919092
Leukopenia	25.52	15.57	6	24107	62850	34869968
Pulmonary function test abnormal	25.25	15.57	18	24095	2592	34930226
Blood pressure inadequately controlled	25.06	15.57	18	24095	2622	34930196
Neutrophil count decreased	24.88	15.57	3	24110	51101	34881717
Thrombocytopenia	24.44	15.57	44	24069	156203	34776615
Arterial intramural haematoma	23.90	15.57	6	24107	54	34932764
Pericardial fibrosis	23.86	15.57	7	24106	118	34932700
Infusion related reaction	23.77	15.57	4	24109	53053	34879765
Neuropathy peripheral	23.71	15.57	14	24099	83249	34849569
Infection	23.57	15.57	17	24096	90898	34841920
Deep vein thrombosis	23.22	15.57	8	24105	65240	34867578
Heart rate irregular	22.91	15.57	40	24073	15767	34917051
Circulatory collapse	22.77	15.57	47	24066	20991	34911827
Heart valve stenosis	21.76	15.57	6	24107	80	34932738
Pain in extremity	21.28	15.57	34	24079	126479	34806339
Right ventricular failure	20.93	15.57	28	24085	8756	34924062
Ascites	20.75	15.57	75	24038	46496	34886322
Pancytopenia	20.75	15.57	21	24092	95136	34837682
Non-compaction cardiomyopathy	20.55	15.57	5	24108	39	34932779
Blood lactic acid	20.34	15.57	8	24105	338	34932480
Gastric dilatation	20.33	15.57	10	24103	725	34932093
Ureteric haemorrhage	19.98	15.57	6	24107	110	34932708
Brain natriuretic peptide increased	19.95	15.57	22	24091	5637	34927181
Depression	19.43	15.57	23	24090	97075	34835743
Coma	19.27	15.57	4	24109	45674	34887144
Hypokinesia	19.19	15.57	27	24086	8853	34923965
Haemoglobin increased	18.99	15.57	17	24096	3392	34929426
Dyspnoea paroxysmal nocturnal	18.45	15.57	12	24101	1487	34931331
Back pain	18.41	15.57	35	24078	121754	34811064
Renal failure	18.23	15.57	153	23960	130404	34802414
Hypertrophy	18.12	15.57	8	24105	453	34932365
Dehydration	17.98	15.57	152	23961	129817	34803001
Ventricular fibrillation	17.86	15.57	45	24068	22909	34909909
Hypersensitivity	17.75	15.57	10	24103	61025	34871793
Adrenocortical insufficiency acute	17.74	15.57	12	24101	1588	34931230
Hypoglycaemia	17.19	15.57	79	24034	54561	34878257
Angina pectoris	17.05	15.57	54	24059	31309	34901509
Varicose vein	17.00	15.57	11	24102	1352	34931466
Weight increased	16.90	15.57	116	23997	92917	34839901
Glycosylated haemoglobin increased	16.79	15.57	29	24084	11331	34921487
Lower respiratory tract infection	16.77	15.57	54	24059	31583	34901235
Brain natriuretic peptide abnormal	16.44	15.57	7	24106	363	34932455
Scrotal oedema	16.31	15.57	12	24101	1814	34931004
Crepitations	15.97	15.57	15	24098	3181	34929637
Sudden cardiac death	15.92	15.57	16	24097	3685	34929133
Renal atrophy	15.86	15.57	10	24103	1175	34931643
Cardiac dysfunction	15.75	15.57	13	24100	2325	34930493
Haemodynamic test abnormal	15.74	15.57	4	24109	38	34932780
Cardiac resynchronisation therapy	15.74	15.57	4	24109	38	34932780
Intentional product use issue	15.74	15.57	11	24102	59805	34873013
Cardiac murmur	15.72	15.57	23	24090	7814	34925004
Hypervolaemia	15.71	15.57	39	24074	19670	34913148

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
Cardiac failure	889.80	16.54	593	27086	154249	79562460
Cardiac failure chronic	519.66	16.54	181	27498	10954	79705755
Acute kidney injury	466.83	16.54	723	26956	518681	79198028
Hyperkalaemia	349.65	16.54	301	27378	114097	79602612
Ventricular tachycardia	302.98	16.54	186	27493	41749	79674960
Hypotension	265.86	16.54	515	27164	439802	79276907
Rales	261.04	16.54	131	27548	19870	79696839
Oedema peripheral	252.22	16.54	370	27309	251918	79464791
Ejection fraction decreased	236.14	16.54	148	27531	34429	79682280
N-terminal prohormone brain natriuretic peptide increased	209.17	16.54	74	27605	4681	79712028
Glomerular filtration rate decreased	204.05	16.54	116	27563	22586	79694123
Mitral valve incompetence	186.86	16.54	119	27560	28446	79688263
Dyspnoea	179.85	16.54	677	27002	856348	78860361
Atrial fibrillation	178.74	16.54	277	27402	197609	79519100
Cardiac failure acute	149.64	16.54	89	27590	18840	79697869
Renal impairment	139.79	16.54	219	27460	157564	79559145
Drug interaction	139.49	16.54	386	27293	414797	79301912
Exercise tolerance decreased	138.04	16.54	66	27613	9005	79707704
Dyspnoea at rest	123.03	16.54	57	27622	7245	79709464
Ventricular enlargement	123.02	16.54	32	27647	700	79716009
Bradycardia	119.83	16.54	188	27491	135369	79581340
Computerised tomogram coronary artery abnormal	114.31	16.54	24	27655	194	79716515
Tricuspid valve incompetence	113.91	16.54	76	27603	19636	79697073
Atrial enlargement	111.80	16.54	32	27647	1011	79715698
Congestive cardiomyopathy	110.72	16.54	62	27617	11718	79704991
Ventricular arrhythmia	109.76	16.54	56	27623	8784	79707925
Cardiomyopathy	107.10	16.54	85	27594	28689	79688020
Dyspnoea exertional	98.98	16.54	136	27543	86937	79629772
Soft tissue mass	96.65	16.54	30	27649	1258	79715451
Ischaemic cardiomyopathy	96.27	16.54	49	27630	7646	79709063
Oesophageal perforation	94.82	16.54	31	27648	1540	79715169
Multimorbidity	89.30	16.54	29	27650	1410	79715299
Labelled drug-drug interaction medication error	78.76	16.54	70	27609	27580	79689129
Coronary artery stenosis	76.66	16.54	50	27629	12434	79704275
Liver palpable	76.54	16.54	19	27660	342	79716367
Blood pressure decreased	75.73	16.54	129	27550	99337	79617372
Low cardiac output syndrome	72.81	16.54	23	27656	1022	79715687
Cardiogenic shock	72.70	16.54	81	27598	41833	79674876
Completed suicide	72.39	16.54	3	27676	245764	79470945
Left ventricular dysfunction	71.63	16.54	57	27622	19304	79697405
Blood potassium increased	71.49	16.54	68	27611	29207	79687502
Blood creatinine increased	70.55	16.54	162	27517	154895	79561814
Arrhythmia	68.55	16.54	95	27584	61177	79655532
Orthopnoea	68.43	16.54	43	27636	10030	79706679
Cardiomegaly	67.77	16.54	63	27616	26289	79690420
General physical health deterioration	67.06	16.54	229	27450	275009	79441700
Hyperuricaemia	64.60	16.54	44	27635	11755	79704954
Syncope	64.20	16.54	171	27508	179278	79537431
Infusion related reaction	64.04	16.54	4	27675	230233	79486476
Myocardial ischaemia	63.69	16.54	60	27619	25459	79691250
Left ventricular dilatation	63.53	16.54	21	27658	1080	79715629
Hepatic vein dilatation	62.50	16.54	15	27664	233	79716476
Immunosuppressant drug level increased	62.50	16.54	39	27640	8988	79707721
Arthralgia	62.37	16.54	64	27615	571739	79144970
Transplant failure	62.30	16.54	31	27648	4610	79712099
Product prescribing error	61.78	16.54	77	27602	44736	79671973
Superinfection	60.69	16.54	31	27648	4871	79711838
Type V hyperlipidaemia	60.61	16.54	20	27659	1023	79715686
Rheumatoid arthritis	59.90	16.54	3	27676	208467	79508242
Electrocardiogram abnormal	59.21	16.54	48	27631	16689	79700020
Left atrial enlargement	57.81	16.54	20	27659	1183	79715526
Electrolyte imbalance	57.59	16.54	62	27617	30819	79685890
Stenosis	57.29	16.54	24	27655	2398	79714311
Pain	57.17	16.54	98	27581	703704	79013005
Respiratory tract haemorrhage	56.71	16.54	22	27657	1801	79714908
Ventricular hypokinesia	56.57	16.54	37	27642	9242	79707467
Ventricular extrasystoles	56.34	16.54	50	27629	19654	79697055
Inferior vena cava dilatation	55.87	16.54	18	27661	853	79715856
Pulmonary arterial pressure increased	54.07	16.54	28	27651	4527	79712182
Febrile neutropenia	53.84	16.54	8	27671	230991	79485718
Gynaecomastia	52.71	16.54	33	27646	7648	79709061
Renal failure	51.37	16.54	170	27509	200798	79515911
Left ventricular enlargement	50.24	16.54	16	27663	730	79715979
Cardiac failure congestive	50.20	16.54	135	27544	142267	79574442
Joint swelling	49.72	16.54	19	27660	288627	79428082
Oesophageal carcinoma	48.37	16.54	36	27643	11048	79705661
Venous pressure jugular increased	48.28	16.54	18	27661	1322	79715387
Blood thyroid stimulating hormone increased	47.98	16.54	34	27645	9674	79707035
Alopecia	47.52	16.54	11	27668	231344	79485365
Angina pectoris	47.40	16.54	73	27606	51659	79665050
Arthropathy	46.61	16.54	4	27675	177107	79539602
N-terminal prohormone brain natriuretic peptide abnormal	46.11	16.54	12	27667	263	79716446
Lung consolidation	45.76	16.54	32	27647	8915	79707794
Hypersensitivity	45.60	16.54	17	27662	262222	79454487
Rash	45.59	16.54	82	27597	578276	79138433
Concomitant disease aggravated	44.97	16.54	37	27642	13130	79703579
Atrial flutter	44.93	16.54	46	27633	21579	79695130
Atrial thrombosis	44.92	16.54	23	27656	3633	79713076
Hyperthyroidism	43.91	16.54	46	27633	22163	79694546
Pulmonary oedema	43.23	16.54	95	27584	88159	79628550
Platelet distribution width increased	42.97	16.54	10	27669	135	79716574
Chronic kidney disease	42.88	16.54	80	27599	66074	79650635
Pleural effusion	42.72	16.54	129	27550	145133	79571576
Right ventricular dysfunction	42.62	16.54	20	27659	2615	79714094
Breath sounds abnormal	40.69	16.54	38	27641	15946	79700763
Bronchial hyperreactivity	39.90	16.54	20	27659	3020	79713689
Blood pressure systolic decreased	39.67	16.54	32	27647	11044	79705665
Jugular vein distension	39.64	16.54	16	27663	1454	79715255
Drug abuse	39.40	16.54	5	27674	162686	79554023
Inflammatory marker increased	38.40	16.54	31	27648	10709	79706000
Hyponatraemia	38.14	16.54	142	27537	177706	79539003
Drug hypersensitivity	37.89	16.54	29	27650	298887	79417822
Glomerular filtration rate abnormal	37.88	16.54	16	27663	1632	79715077
Headache	37.52	16.54	110	27569	653662	79063047
Waist circumference increased	37.50	16.54	16	27663	1673	79715036
Sinusitis	36.90	16.54	11	27668	195490	79521219
Glomerular filtration rate	36.85	16.54	9	27670	151	79716558
Mitral valve thickening	36.53	16.54	11	27668	416	79716293
Coronary artery occlusion	36.30	16.54	35	27644	15280	79701429
Asthma-chronic obstructive pulmonary disease overlap syndrome	35.95	16.54	19	27660	3202	79713507
Pain in extremity	35.13	16.54	45	27634	364493	79352216
Dizziness	34.78	16.54	306	27373	526135	79190574
Brain natriuretic peptide increased	34.63	16.54	27	27652	8873	79707836
Drug ineffective	34.02	16.54	228	27451	1080685	78636024
Cardiac ventricular disorder	33.79	16.54	10	27669	356	79716353
Cardiac ventricular thrombosis	33.52	16.54	15	27664	1758	79714951
Pulmonary congestion	33.31	16.54	44	27635	27056	79689653
Treatment failure	33.27	16.54	9	27670	170477	79546232
Hepatic enzyme increased	33.17	16.54	11	27668	182599	79534110
Aortic valve incompetence	33.01	16.54	27	27652	9503	79707206
Ventricular dyskinesia	32.72	16.54	10	27669	398	79716311
Infection	32.52	16.54	22	27657	241690	79475019
Dehydration	32.52	16.54	171	27508	248016	79468693
Hypovolaemia	32.07	16.54	35	27644	17656	79699053
Seizure	31.56	16.54	13	27666	188821	79527888
Pulmonary function test abnormal	31.48	16.54	19	27660	4125	79712584
Melaena	31.48	16.54	67	27612	60823	79655886
Back pain	30.93	16.54	36	27643	304144	79412565
Venous pressure jugular decreased	30.84	16.54	7	27672	84	79716625
Bundle branch block left	30.52	16.54	28	27651	11485	79705224
Off label use	30.22	16.54	188	27491	907027	78809682
Gout	30.14	16.54	40	27639	24709	79692000
Ascites	30.07	16.54	75	27604	75487	79641222
Pyonephrosis	29.91	16.54	7	27672	97	79716612
White blood cell count decreased	29.83	16.54	14	27665	188274	79528435
Subclavian vein thrombosis	28.87	16.54	15	27664	2442	79714267
Abdominal discomfort	27.34	16.54	28	27651	250699	79466010
Drug intolerance	27.13	16.54	31	27648	264088	79452621
Conduction disorder	26.99	16.54	16	27663	3363	79713346
Pericardial fibrosis	26.62	16.54	7	27672	160	79716549
Mitral valve calcification	26.38	16.54	12	27667	1461	79715248
Stomatitis	26.37	16.54	9	27670	146748	79569961
Therapeutic drug monitoring analysis not performed	26.19	16.54	13	27666	1923	79714786
Cardiovascular insufficiency	26.15	16.54	15	27664	2966	79713743
Urticaria	26.07	16.54	16	27663	185185	79531524
Hypomagnesaemia	25.86	16.54	53	27626	46858	79669851
Arterial intramural haematoma	25.78	16.54	6	27673	81	79716628
Heart rate irregular	25.66	16.54	43	27636	32636	79684073
Degenerative aortic valve disease	25.65	16.54	7	27672	185	79716524
Scrotal oedema	25.54	16.54	12	27667	1573	79715136
Neutropenia	25.22	16.54	38	27641	287672	79429037
Hypoglycaemia	25.09	16.54	85	27594	101509	79615200
Ventricular fibrillation	25.06	16.54	42	27637	31884	79684825
Circulatory collapse	24.96	16.54	46	27633	37622	79679087
Micturition frequency decreased	24.52	16.54	10	27669	933	79715776
Subdural haematoma	24.20	16.54	41	27638	31393	79685316
Non-compaction cardiomyopathy	23.97	16.54	5	27674	39	79716670
Rash scarlatiniform	23.90	16.54	7	27672	240	79716469
Cardiac amyloidosis	23.84	16.54	12	27667	1828	79714881
Nasopharyngitis	23.76	16.54	32	27647	253849	79462860
Tachypnoea	23.61	16.54	41	27638	32022	79684687
Musculoskeletal stiffness	23.44	16.54	16	27663	174992	79541717
Blood lactic acid	23.42	16.54	8	27671	455	79716254
Hydrothorax	23.31	16.54	11	27668	1457	79715252
Injection site pain	23.26	16.54	8	27671	129830	79586879
Right ventricular failure	22.71	16.54	34	27645	23463	79693246
Hypotonia	22.53	16.54	25	27654	12845	79703864
Coma	22.28	16.54	4	27675	100645	79616064
Sinus bradycardia	22.24	16.54	35	27644	25212	79691497
Abdominal pain upper	22.20	16.54	27	27652	223792	79492917
Left ventricular hypertrophy	21.80	16.54	23	27656	11168	79705541
Dyspnoea paroxysmal nocturnal	21.68	16.54	12	27667	2216	79714493
Wound haemorrhage	21.55	16.54	15	27664	4146	79712563
Heart valve stenosis	21.52	16.54	6	27673	172	79716537
Hypocalcaemia	21.40	16.54	51	27628	49873	79666836
Haematochezia	21.35	16.54	73	27606	87572	79629137
Acute myocardial infarction	21.31	16.54	67	27612	76969	79639740
Gastrointestinal haemorrhage	20.88	16.54	104	27575	147615	79569094
Gastric dilatation	20.72	16.54	10	27669	1392	79715317
Vascular stent thrombosis	20.70	16.54	14	27665	3696	79713013
Acute pulmonary oedema	20.49	16.54	25	27654	14205	79702504
Hypokinesia	20.48	16.54	29	27650	19031	79697678
Osteoarthritis	20.38	16.54	3	27676	87306	79629403
Malignant neoplasm progression	20.20	16.54	11	27668	135979	79580730
Palpitations	19.96	16.54	92	27587	126518	79590191
Benign prostatic hyperplasia	19.37	16.54	22	27657	11590	79705119
Deep vein thrombosis	19.13	16.54	9	27670	120910	79595799
Hypertrophy	19.07	16.54	8	27671	802	79715907
Glomerular filtration rate increased	19.00	16.54	9	27670	1202	79715507
Dyspepsia	18.95	16.54	7	27672	108680	79608029
Intentional product use issue	18.95	16.54	15	27664	152097	79564612
Aortic bruit	18.69	16.54	6	27673	281	79716428
Haemoptysis	18.63	16.54	52	27627	55947	79660762
Anaemia	18.62	16.54	236	27443	444779	79271930
Peripheral artery haematoma	18.55	16.54	5	27674	126	79716583
Femoral neck fracture	18.53	16.54	20	27659	9964	79706745
Sudden cardiac death	18.51	16.54	15	27664	5210	79711499
Haemoglobin increased	18.41	16.54	16	27663	6116	79710593
Neutrophil count decreased	18.25	16.54	5	27674	93954	79622755
Atrial tachycardia	18.23	16.54	17	27662	7116	79709593
Renal atrophy	18.23	16.54	10	27669	1815	79714894
Adrenocortical insufficiency acute	18.22	16.54	12	27667	3031	79713678
Pyrexia	18	16.54	150	27529	678559	79038150
Blood cyanide increased	17.94	16.54	4	27675	44	79716665
Hypervolaemia	17.64	16.54	43	27636	42647	79674062
Epistaxis	17.55	16.54	81	27598	111434	79605275
Injection site erythema	17.55	16.54	3	27676	78194	79638515
Neuropathy peripheral	17.52	16.54	14	27665	141291	79575418
Pemphigoid	17.50	16.54	24	27655	15291	79701418
Limited symptom panic attack	17.47	16.54	4	27675	50	79716659
Activated partial thromboplastin time prolonged	17.33	16.54	23	27656	14205	79702504
Cardiac dysfunction	17.12	16.54	13	27666	4111	79712598
Eosinophilia	16.99	16.54	44	27635	45301	79671408
Suicidal ideation	16.97	16.54	3	27676	76337	79640372
Peripheral coldness	16.72	16.54	24	27655	15946	79700763
Hypokalaemia	16.67	16.54	96	27583	143944	79572765
Supraventricular extrasystoles	16.62	16.54	16	27663	6971	79709738
Therapeutic drug monitoring analysis incorrectly performed	16.62	16.54	7	27672	709	79716000

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C03DA04	CARDIOVASCULAR SYSTEM DIURETICS ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS Aldosterone antagonists
FDA MoA	N0000011310	Aldosterone Antagonists
FDA EPC	N0000175557	Aldosterone Antagonist
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D004232	Diuretics
MeSH PA	D006727	Hormone Antagonists
MeSH PA	D000451	Mineralocorticoid Receptor Antagonists
MeSH PA	D045283	Natriuretic Agents
CHEBI has role	CHEBI:35674	antihypertensive drugs

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

Disease	Relation	SNOMED_ID	DOID
Hypertensive disorder	indication	38341003	DOID:10763
Chronic Heart Failure Following Myocardial Infarction	indication
Hyperkalemia	contraindication	14140009
Diabetic renal disease	contraindication	127013003
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN	ANTAGONIST	IC50	7		WOMBAT-PK	CHEMBL
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN		IC50	4.74		CHEMBL
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN		IC50	4.77		CHEMBL
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN		Ki	4.70		CHEMBL
Mineralocorticoid receptor	Transcription factor		MCR_RAT		IC50	7.40		CHEMBL

External reference:

ID	Source
4021363	VUID
N0000148782	NUI
D01115	KEGG_DRUG
4021363	VANDF
C0961485	UMLSCUI
CHEBI:31547	CHEBI
YNU	PDB_CHEM_ID
CHEMBL1095097	ChEMBL_ID
D000077545	MESH_DESCRIPTOR_UI
DB00700	DRUGBANK_ID
C058465	MESH_SUPPLEMENTAL_RECORD_UI
443872	PUBCHEM_CID
2876	IUPHAR_LIGAND_ID
7596	INN_ID
6995V82D0B	UNII
298869	RXNORM
147386	MMSL
16969	MMSL
d04815	MMSL
009774	NDDF
398699008	SNOMEDCT_US
407010008	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Inspra	HUMAN PRESCRIPTION DRUG LABEL	1	0025-1710	TABLET, FILM COATED	25 mg	ORAL	NDA	27 sections
Inspra	HUMAN PRESCRIPTION DRUG LABEL	1	0025-1710	TABLET, FILM COATED	25 mg	ORAL	NDA	27 sections
Inspra	HUMAN PRESCRIPTION DRUG LABEL	1	0025-1720	TABLET, FILM COATED	50 mg	ORAL	NDA	27 sections
Inspra	HUMAN PRESCRIPTION DRUG LABEL	1	0025-1720	TABLET, FILM COATED	50 mg	ORAL	NDA	27 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	0185-5368	TABLET	25 mg	ORAL	ANDA	25 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	0185-5368	TABLET	25 mg	ORAL	ANDA	25 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	0185-5369	TABLET	50 mg	ORAL	ANDA	25 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	0185-5369	TABLET	50 mg	ORAL	ANDA	25 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1030	TABLET, FILM COATED	25 mg	ORAL	ANDA	27 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1030	TABLET, FILM COATED	25 mg	ORAL	ANDA	27 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1031	TABLET, FILM COATED	50 mg	ORAL	ANDA	27 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1031	TABLET, FILM COATED	50 mg	ORAL	ANDA	27 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	16729-293	TABLET, FILM COATED	25 mg	ORAL	ANDA	26 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	16729-294	TABLET, FILM COATED	50 mg	ORAL	ANDA	26 sections
Inspra	HUMAN PRESCRIPTION DRUG LABEL	1	21695-797	TABLET	25 mg	ORAL	NDA	27 sections
EPLERENONE	HUMAN PRESCRIPTION DRUG LABEL	1	31722-049	TABLET, FILM COATED	25 mg	ORAL	ANDA	23 sections
EPLERENONE	HUMAN PRESCRIPTION DRUG LABEL	1	31722-050	TABLET, FILM COATED	50 mg	ORAL	ANDA	23 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	42254-011	TABLET	50 mg	ORAL	ANDA	23 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	42291-454	TABLET, COATED	25 mg	ORAL	ANDA	29 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	42291-454	TABLET, COATED	25 mg	ORAL	ANDA	29 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	42291-455	TABLET, COATED	50 mg	ORAL	ANDA	29 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	42291-455	TABLET, COATED	50 mg	ORAL	ANDA	29 sections
EPLERENONE	HUMAN PRESCRIPTION DRUG LABEL	1	51991-877	TABLET, FILM COATED	25 mg	ORAL	ANDA	27 sections
EPLERENONE	HUMAN PRESCRIPTION DRUG LABEL	1	51991-878	TABLET, FILM COATED	50 mg	ORAL	ANDA	27 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6065	TABLET	25 mg	ORAL	ANDA	23 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	59762-1710	TABLET, FILM COATED	25 mg	ORAL	NDA AUTHORIZED GENERIC	27 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	59762-1710	TABLET, FILM COATED	25 mg	ORAL	NDA AUTHORIZED GENERIC	27 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	59762-1720	TABLET, FILM COATED	50 mg	ORAL	NDA AUTHORIZED GENERIC	27 sections
Eplerenone	HUMAN PRESCRIPTION DRUG LABEL	1	59762-1720	TABLET, FILM COATED	50 mg	ORAL	NDA AUTHORIZED GENERIC	27 sections
EPLERENONE	HUMAN PRESCRIPTION DRUG LABEL	1	60687-451	TABLET, FILM COATED	25 mg	ORAL	ANDA	27 sections