Vericiguat side effects: what 966 FDA adverse event reports show

Vericiguat · Verquvo · 10 reaction terms · 320 drug–reaction co-reports · data 2026-09-14

Drug class

Soluble Guanylate Cyclase Stimulator

FDA label (Established Pharmacologic Class)

Brand names

Verquvo

openFDA label

Who reports

966 reports · 50% serious · 148 with death outcome · 34% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VERQUVO ® is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% .

FDA label, Indications and Usage

What it is

VERQUVO tablets contains vericiguat, a soluble guanylate cyclase stimulator.

FDA label, Description section

Boxed warning

EMBRYO-FETAL TOXICITY Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 9 strongest signals

Labeled — boxed warning 3Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 2

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Cardiac failure (heart failure)	72	19.5 15.6–24.3ROR 21.0 · χ² 1,247 / p 2e-273	19.4 EB05 15.9 · IC025 +3.7 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 22.4	no trial data cached
Inability to afford medication	7	15.5 7.4–32.4ROR 15.6 · χ² 81 / p 1e-19	12.6 EB05 5.2 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Mitral valve incompetence	8	15.4 7.7–30.6ROR 15.5 · χ² 93 / p 2e-22	13.0 EB05 5.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 17.7	no trial data cached
Ejection fraction decreased	11	15.3 8.5–27.6ROR 15.5 · χ² 134 / p 3e-31	13.9 EB05 7.3 · IC025 +2.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 15.9	no trial data cached
Blood pressure decreased	40	13.1 9.7–17.7ROR 13.6 · χ² 436 / p 4e-97	12.8 EB05 9.6 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 11.0	no trial data cached
Hypotension (low blood pressure)	111	12.0 10.1–14.3ROR 13.5 · χ² 1,122 / p 2e-246	11.9 EB05 10.1 · IC025 +3.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.4	no trial data cached
Product prescribing issue	11	11.7 6.5–21.1ROR 11.9 · χ² 98 / p 3e-23	9.9 EB05 5.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 32.2	no trial data cached
Product availability issue	7	6.8 3.2–14.2ROR 6.8 · χ² 29 / p 4e-8	4.9 EB05 2.6 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 2.3	no trial data cached
No adverse event	49	6.0 4.6–7.9ROR 6.3 · χ² 201 / p 7e-46	5.7 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	71% consumer	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hypotension (low blood pressure)	111	12.0 10.1–14.3ROR 13.5 · χ² 1,122 / p 2e-246	11.9 EB05 10.1 · IC025 +3.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.4	no trial data cached
Cardiac failure (heart failure)	72	19.5 15.6–24.3ROR 21.0 · χ² 1,247 / p 2e-273	19.4 EB05 15.9 · IC025 +3.7 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 22.4	no trial data cached
No adverse event	49	6.0 4.6–7.9ROR 6.3 · χ² 201 / p 7e-46	5.7 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	71% consumer	no trial data cached
Blood pressure decreased	40	13.1 9.7–17.7ROR 13.6 · χ² 436 / p 4e-97	12.8 EB05 9.6 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 11.0	no trial data cached
Product prescribing issue	11	11.7 6.5–21.1ROR 11.9 · χ² 98 / p 3e-23	9.9 EB05 5.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 32.2	no trial data cached
Ejection fraction decreased	11	15.3 8.5–27.6ROR 15.5 · χ² 134 / p 3e-31	13.9 EB05 7.3 · IC025 +2.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 15.9	no trial data cached
Mitral valve incompetence	8	15.4 7.7–30.6ROR 15.5 · χ² 93 / p 2e-22	13.0 EB05 5.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 17.7	no trial data cached
Product availability issue	7	6.8 3.2–14.2ROR 6.8 · χ² 29 / p 4e-8	4.9 EB05 2.6 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 2.3	no trial data cached
Inability to afford medication	7	15.5 7.4–32.4ROR 15.6 · χ² 81 / p 1e-19	12.6 EB05 5.2 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hospice care	4	8.8 3.3–23.5ROR 8.9 · χ² 20 / p 3e-6	5.2 EB05 2.1 · IC025 +0.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Vericiguat?

In FDA FAERS, the most frequently co-reported reaction terms for Vericiguat are hypotension, cardiac failure, blood pressure decreased, ejection fraction decreased, mitral valve incompetence, inability to afford medication. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Vericiguat have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: EMBRYO-FETAL TOXICITY Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment.

Do FAERS signals prove that Vericiguat causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 17056d73-1b1b-4bf2-9c07-b7a9367f0d6d, effective 20260121; matched on openfda.generic_name.exact:"VERICIGUAT")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 10 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.