Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vericiguat
Drug ID BADD_D02605
Description Vericiguat is a direct stimulator of soluble guanylate cyclase (sGC) used in the management of systolic heart failure to reduce mortality and hospitalizations.[L31153] A key component of the NO-sGC-cGMP signaling pathway that helps to regulate the cardiovascular system, sGC enzymes are intracellular enzymes found in vascular smooth muscle cells (amongst other cell types) that catalyze the synthesis of cyclic guanosine monophosphate (cGMP) in response to activation by nitric oxide (NO).[A227458,A227488] Cyclic GMP acts as a second messenger, activating a number of downstream signaling cascades that elicit a broad variety of effects, and these diverse cellular effects have implicated deficiencies in its production (primarily due to insufficient NO bioavailability) in the pathogenesis of various cardiovascular diseases.[A227458] As a direct stimulator of sGC, vericiguat mitigates the need for a functional NO-sGC-cGMP axis and thereby helps to prevent the myocardial and vascular dysfunction associated with decreased sGC activity in heart failure.[L31178] Vericiguat was approved by the FDA in January 2021 - developed by Merck under the brand name Verquvo - for use in certain patients with systolic heart failure.[L31178] Although not the first sGC stimulator to be granted FDA approval ([riociguat] was approved in 2013 for use in pulmonary hypertension),[L3955] vericiguat is unique amongst its peers in that modifications to its structure have dramatically decreased its susceptibility to oxidative metabolism,[A227458] resulting in a relatively long half-life and allowing for once-daily dosing.
Indications and Usage Vericiguat is indicated in adults with symptomatic, chronic heart failure and an ejection fraction of <45% to reduce the risk of cardiovascular death and heart failure-related hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics.[L31153]
Marketing Status approved; investigational
ATC Code C01DX22
DrugBank ID DB15456
KEGG ID D11051
MeSH ID C000603960
PubChem ID 54674461
TTD Drug ID D06ZEO
NDC Product Code 12527-5029; 0006-5029; 0006-5028; 12527-5030; 12527-5028; 0006-5030
UNII LV66ADM269
Synonyms vericiguat | verquvo | BAY 1021189
Chemical Information
Molecular Formula C19H16F2N8O2
CAS Registry Number 1350653-20-1
SMILES COC(=O)NC1=C(N=C(N=C1N)C2=NN(C3=C2C=C(C=N3)F)CC4=CC=CC=C4F)N
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 discomfort07.01.06.0010.000288%Not Available
Abdominal pain upper07.01.05.0030.000575%
Alopecia23.02.02.0010.000288%
Anaemia01.03.02.0010.001235%
Asthenia08.01.01.0010.000516%Not Available
Cardiac failure02.05.01.0010.000211%
Cerebrovascular accident24.03.05.001; 17.08.01.0070.000085%
Death08.04.01.0010.001269%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.002343%
Dyspepsia07.01.02.0010.000288%
Dyspnoea02.11.05.003; 22.02.01.0040.000617%
Fatigue08.01.01.0020.001091%
Feeling abnormal08.01.09.0140.000431%Not Available
Hypotension24.06.03.0020.003459%
Malaise08.01.01.0030.000863%
Muscular weakness17.05.03.005; 15.05.06.0010.000186%
Myalgia15.05.02.0010.000288%
Myocardial infarction24.04.04.009; 02.02.02.0070.000085%
Oedema14.05.06.010; 08.01.07.0060.000186%Not Available
Oedema peripheral02.05.04.007; 14.05.06.011; 08.01.07.0070.000330%
Palpitations02.11.04.0120.000431%
Rash23.03.13.0010.000761%Not Available
Swelling face23.04.01.018; 10.01.05.018; 08.01.03.1000.000288%Not Available
Tremor17.01.06.0020.000288%
Ventricular tachycardia02.03.04.0100.000085%
Peripheral swelling08.01.03.053; 02.05.04.0150.000288%Not Available
Adverse event08.06.01.0100.000567%Not Available
Ill-defined disorder08.01.03.0490.000457%Not Available
Drug intolerance08.06.01.0130.000288%Not Available
Illness08.01.03.0910.000169%Not Available
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