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vericiguat

Sold as Verquvo. First FDA approval 01/19/2021: 5 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

D

Score breakdown (59/100)

Safety ×35%
C
Evidence ×25%
F
Regulatory ×15%
B
Money & lawsuits ×15%
C
Options ×10%
F

Safety: 68

Evidence: 34

Regulatory history: 81

Money & lawsuits: 70

Options: 40

FDA boxed warning

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 not administer VERQUVO to a pregnant female because it may cause fetal harm [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Do not administer VERQUVO to a pregnant female because it may cause fetal harm. ( 4 , 5.1 , 8.1 ) 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. ( 2.2 , 5.1 , 8.3 )

What the FDA label says

Approved uses

® 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% [see Clinical Studies (14) ] . VERQUVO is a soluble guanylate cyclase (sGC) stimulator, 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%. ( 1 )

Contraindications

is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators [see Drug Interactions (7.1) ] . VERQUVO is contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. ( 4 , 7.1 ) Pregnancy ( 4 )

Warnings and precautions

5.1 Embryo-Fetal Toxicity Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose [see Dosage and Administration (2.2) and Use in Specific Populations (8.1 , 8.3) ].

Adverse reactions (label)

Most common adverse reactions reported in ≥5% are hypotension and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. VERQUVO was evaluated in VICTORIA, which included 2,519 patients treated with VERQUVO (up to 10 mg once daily). The mean duration of VERQUVO exposure was 1 year, and the maximum duration was 2.6 years [see Clinical Studies (14) ] . Table 1 lists adverse drug reactions occurring more commonly with VERQUVO than placebo and in ≥5% of patients treated with VERQUVO in VICTORIA. Table 1: Adverse Drug Reactions Occurring with VERQUVO in VICTORIA Adverse Drug Reaction VERQUVO % N = 2,519 Placebo % N = 2,515 Hypotension 16 15 Anemia 10 7 VELOCITY The safety and tolerability of VERQUVO 5 mg once daily as a starting dose was evaluated in VELOCITY, a single-arm, open-label, 2-week study ...

Recent major label changes

Dosage and Administration ( 2.1 ) 01/2026

Source: FDA SPL label for VERQUVO (Merck Sharp & Dohme LLC), effective 20260121. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

961reports that mention this drug
958of those blame this drug, not another one the person was taking
50%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
15.4%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Hypotension · 111Death · 95Cardiac Failure · 70Dizziness · 68Product Dose Omission Issue · 54No Adverse Event · 49Blood Pressure Decreased · 40Anaemia · 38Fatigue · 37Malaise · 34Dyspnoea · 33Nausea · 31Asthenia · 29Diarrhoea · 29Product Use Issue · 28

Reports per year

202120222023202420252026
11421821317718158

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

0recall actions on file
1 / 0brand / generic applications
2label changes since 2021
NoREMS program

Evidence base

37randomized trials (PubMed)
13systematic reviews
51registered trials
30%of completed trials posted results
0%terminated or withdrawn
61%industry-funded

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $1,685,874 in payments to US physicians and hospitals tied to this drug across 40,813 transactions (Verquvo $1,685,874).

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

11,127Medicare Part D patients (2024)
49,590prescriptions filled
$1,002average cost per fill
$50Mtotal Medicare spend

Same-class alternatives

No same-class alternatives found in RxClass.

Questions to ask your prescriber

  1. This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
  2. The most-reported problems in FDA's adverse event data are hypotension, death, cardiac failure, dizziness. How would we recognize and handle those?
  3. There is no generic. Is there an older generic in the same class that works as well for my situation?
  4. The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
  5. What result are we expecting, by when, and what is the plan if it does not happen?
  6. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)