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verapamil

Sold as Calan, Isoptin, Verelan. Class: Phenylalkylamine derivatives. First FDA approval 08/12/1981: 45 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.

A

Score breakdown (89/100)

Safety ×35%
A
Evidence ×25%
D
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
A

Safety: 100

Evidence: 61

Regulatory history: 98

Money & lawsuits: 100

Options: 90

Independent reviews and post-approval warnings

WHO Essential Medicine

Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.

What the FDA label says

Approved uses

Verapamil Hydrochloride Extended-release Capsules (PM) for oral use is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it ...

Contraindications

Verapamil is contraindicated in: Severe left ventricular dysfunction [ see Warnings and Precautions (5.1) ]. Hypotension (less than 90 mm Hg systolic pressure) or cardiogenic shock. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker). Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) [ see Warnings and Precautions (5.4) ]. Severe left ventricular dysfunction (4) Hypotension (<90 mmHg systolic pressure) or cardiogenic shock (4) Sick sinus syndrome (except in patients with pacemaker) (4) 2nd- or 3rd-degree AV block (except in patients with pacemaker) (4) Atrial flutter or atrial fibrillation and an accessory bypass tract

Warnings and precautions

Congestive heart failure or pulmonary edema may develop ( 5.1 ) Hypotension/dizziness may occur ( 5.2 ) Elevated transaminases have occurred; monitor liver function ( 5.3 ) Ventricular fibrillation has occurred in patients with atrial flutter or atrial fibrillation and an accessory bypass tract ( 5.4 ) Reduce dose or discontinue therapy if marked first-degree AV block or progression to second- or third-degree AV block occurs ( 5.5 ) Sinus bradycardia, pulmonary edema, severe hypotension, second-degree AV block, sinus arrest, and death occurred in patients with hypertrophic cardiomyopathy ( 5.6 ) 5.1 Heart Failure Verapamil has a negative inotropic effect which, in most patients, is compensated by its afterload reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance. In previous clinical experience with 4,954 patients primarily with immediate-release verapamil, 87 (1.8%) developed congestive heart failure or pulmonary edema. Avoid verapamil in patients with severe left ventricular dysfunction (e.g., ejection fraction less than 30% or moderate to severe symptoms of cardiac failure) and in patients with any degree of ventricula...

Adverse reactions (label)

Most common adverse reactions (incidence ≥ 3% and more common than in patients treated with placebo) are headache, infection, constipation, flu syndrome, peripheral edema, dizziness, pharyngitis, and sinusitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-877-495-6856 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose. See Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4 , 5.5 ) for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinua...

Source: FDA SPL label for Verapamil Hydrochloride (Wilshire Pharmaceuticals, Inc.), effective 20241127. 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.

30,221reports that mention this drug
29,970of those blame this drug, not another one the person was taking
73%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
14.3%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Drug Ineffective · 2,005Dyspnoea · 1,803Fatigue · 1,739Nausea · 1,666Headache · 1,503Off Label Use · 1,494Dizziness · 1,426Diarrhoea · 1,406Completed Suicide · 1,261Hypotension · 1,236Toxicity To Various Agents · 1,214Drug Interaction · 1,188Malaise · 1,152Fall · 1,139Asthenia · 1,063

Reports per year

20192020202120222023202420252026
3,3502,9702,2291,9761,8461,7311,501712

2,376 reports blaming this drug for every million Medicare prescriptions filled, which is 0.9× the typical drug on this site. (3,841 reports in 2024–2026, against 1,616,837 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

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

3recall actions on file
9 / 62brand / generic applications
1label changes since 2021
NoREMS program
DateClassFirmReason
07/2024Class IIIZydus Pharmaceuticals (USA) IncCross contamination with other products.
07/2024Class IIIZydus Pharmaceuticals (USA) IncCross contamination with other products.
03/2021Class IICardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.

Evidence base

624randomized trials (PubMed)
27systematic reviews
176registered trials
26%of completed trials posted results
11%terminated or withdrawn
32%industry-funded

Independent Cochrane reviews

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 $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.

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

413,685Medicare Part D patients (2024)
1,616,837prescriptions filled
$52average cost per fill
$85Mtotal Medicare spend
ProductFills$/fill
Verapamil ER1,065,275$30
Verapamil SR266,884$115
Verapamil HCl232,510$12
Verapamil ER PM51,938$373
Verelan PM230$480

Same-class alternatives

etripamilgallopamil

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, nausea. How would we recognize and handle those?
  2. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
  3. Why this one over etripamil, gallopamil? What would make you pick one of those instead?
  4. What result are we expecting, by when, and what is the plan if it does not happen?
  5. 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.)