Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Finerenone
Drug ID BADD_D02557
Description Finerenone, or BAY 94-8862, is a mineralocorticoid receptor antagonist indicated to reduce the risk of sustained decline in glomerular filtration rate, end stage kidney disease, cardiovascular death, heart attacks, and hospitalization due to heart failure in adults with chronic kidney disease associated with type II diabetes mellitus.[A236519,L34739] Patients with kidney disease, would originally be given [spironolactone] or [eplerenone] to antagonize the mineraclocorticoid receptor.[A236544] Spironolactone has low selectivity and affinity for the receptor; it dissociates quickly and can also have effects at the androgen, progesterone, and glucocorticoid receptors.[A236544] Eplerenone is more selective and has longer lasting effects.[A236544] More selective nonsteroidal mineralocorticoid antagonists such as [apararenone], [esaxerenone], and finerenone were later developed.[A236544] So far, finerenone is the only nonsteroidal mineralocorticoid receptor antagonist to be FDA approved.[A236544,L34739] Finerenone was granted FDA approval on 9 July 2021.[L34739]
Indications and Usage Finerenone is indicated to reduce the risk of sustained decline in glomerular filtration rate, end stage kidney disease, cardiovascular death, heart attacks, and hospitalization due to heart failure in adults with chronic kidney disease associated with type II diabetes mellitus.[L34739]
Marketing Status approved; investigational
ATC Code C03DA05
DrugBank ID DB16165
KEGG ID D10633
MeSH ID C576501
PubChem ID 60150535
TTD Drug ID D0NV5O
NDC Product Code 50419-541; 12527-0640; 50419-540; 12527-0541; 50683-0540
UNII DE2O63YV8R
Synonyms finerenone | kerendia | BAY 94-8862
Chemical Information
Molecular Formula C21H22N4O3
CAS Registry Number 1050477-31-0
SMILES CCOC1=NC=C(C2=C1C(C(=C(N2)C)C(=O)N)C3=C(C=C(C=C3)C#N)OC)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.000523%Not Available
Back pain15.03.04.0050.000593%
Death08.04.01.0010.000436%
Dehydration14.05.05.0010.000058%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.001216%
Dyspepsia07.01.02.0010.000198%
Dyspnoea02.11.05.003; 22.02.01.0040.000494%
Feeling abnormal08.01.09.0140.000395%Not Available
Feeling jittery08.01.09.0160.000198%Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.000128%
Hyperkalaemia14.05.03.0010.001192%
Hypoglycaemia05.06.03.001; 14.06.03.0010.000227%
Hypokalaemia14.05.03.0020.000058%
Hyponatraemia14.05.04.0020.000680%
Hypotension24.06.03.0020.000611%
Joint swelling15.01.02.0040.000198%Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.000198%
Loss of consciousness17.02.04.0040.000058%Not Available
Muscle spasms15.05.03.0040.000326%
Myalgia15.05.02.0010.000425%
Myocardial infarction24.04.04.009; 02.02.02.0070.000087%
Nausea07.01.07.0010.001343%
Palpitations02.11.04.0120.000297%
Rash23.03.13.0010.001285%Not Available
Renal failure20.01.03.0050.000174%Not Available
Renal pain20.02.03.0030.000198%Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.000128%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.000198%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.11.04.0150.000058%
Urticaria23.04.02.001; 10.01.06.0010.000326%
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