Prescription medication · Neprilysin Inhibitor / ARB Combination

sacubitril/valsartan

Also sold as Entresto. Entresto is used to treat heart failure in adults and children aged one year and older.

Data updated 2026-05-15

72,301
FDA reports
5
InteractionsFew interactions
$11.00
Brand price (NADAC)

What the data shows

sacubitril/valsartan (Entresto) is a prescription Neprilysin Inhibitor / ARB Combination, with 72,301 FDA adverse-event reports on file, with 5 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

sacubitril/valsartan (Entresto) is a prescription Neprilysin Inhibitor / ARB Combination. Entresto is used to treat heart failure in adults and children aged one year and older.

Entresto is a medicine that combines two drugs to help adults and children with heart failure. It helps to lower the risk of heart problems and hospital visits.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Brand Price

$11.00/unit

Generic Available

No

NOVARTIS PHARMS CORP

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

Entresto is used to treat heart failure in adults and children aged one year and older.

Common side effects

Low blood pressure, High potassium levels in the blood, Cough

Key warnings

Entresto can harm an unborn baby, even causing death.

The sections below are summarized in plain English from sacubitril/valsartan's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Entresto works by blocking a substance in your body that can worsen heart failure. It also relaxes your blood vessels, which helps your heart pump blood more easily. This combination helps to improve how well your heart works.

Side Effects (from patient reports)

Based on 72,301 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for sacubitril/valsartan, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

Entresto can harm an unborn baby, even causing death. If you are pregnant or become pregnant, stop taking Entresto right away and tell your doctor.

Known Drug Interactions

major aliskiren

7 DRUG INTERACTIONS Avoid concomitant use with aliskiren in patients with estimated glomerular filtration rate (eGFR) less than 60. The concomitant use of ENTRESTO with aliskiren is contraindicated in patients with diabetes [see Contraindications (4)] . Avoid use with aliskiren in patients with renal impairment (eGFR less than 60 mL/min/1.73 m 2 ).

Mechanism: Both drugs target the same blood pressure system, which can cause the kidneys to stop working correctly or lead to high potassium levels. This risk is much higher for people with diabetes or existing kidney disease.

major valsartan

( 7.4 ) 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications (4)] . Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan. The concomitant use of ENTRESTO with aliskiren is contraindicated in patients with diabetes [see Contraindications (4)] .

Mechanism: Entresto already contains the drug valsartan as one of its ingredients. Taking both together would result in a double dose of the same medicine, which increases the risk of side effects.

moderate lithium

( 7.3 ) Lithium: Increased risk of lithium toxicity. 7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with ENTRESTO.

Mechanism: This medication can prevent your body from clearing lithium properly, causing it to build up to unsafe levels. This can lead to lithium poisoning, which is a serious medical condition.

minor spironolactone

7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions (5.5)] .

Mechanism: Both of these medications cause the kidneys to keep potassium in the body instead of flushing it out. Taking them together can cause potassium to build up to unsafe levels in your blood.

minor amiloride

7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions (5.5)] .

Mechanism: These drugs both prevent the body from getting rid of potassium through the urine. This can lead to a dangerous buildup of potassium in your bloodstream.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I take Entresto with my ACE inhibitor?
No, you should not take Entresto with an ACE inhibitor. Make sure you have not taken an ACE inhibitor for at least 36 hours before starting Entresto.
What should I do if I experience swelling of my face, lips, or tongue?
Stop taking Entresto immediately and seek medical help right away. This could be a sign of angioedema.
Can I take Entresto if I have diabetes and am taking aliskiren?
No, you should not take Entresto if you have diabetes and are taking aliskiren.
Will Entresto affect my kidney function?
Entresto can affect kidney function, especially if you have kidney problems already. Your doctor will monitor your kidney function while you are taking this medicine.
Can Entresto cause low blood pressure?
Yes, Entresto can lower your blood pressure. If you feel dizzy or lightheaded, tell your doctor.
Can I use salt substitutes with Entresto?
Salt substitutes that contain potassium can raise your potassium levels too high. Talk to your doctor before using them.
What if I am already taking an ARB?
You should not take Entresto with another ARB medicine.
How often will my doctor adjust my dose?
Your doctor may adjust your dose every 2 to 4 weeks, depending on how well you tolerate the medicine.
What are the inactive ingredients in Entresto?
The tablets contain inactive ingredients like cellulose, silicon dioxide, and magnesium stearate. The film coating contains hypromellose, iron oxide, polyethylene glycol, talc, and titanium dioxide.
What do the tablet debossments mean?
The tablets are marked with “NVR” and other codes to identify the tablet strength.
What are the common side effects of sacubitril/valsartan?
The registry lists Low blood pressure, High potassium levels in the blood, Cough, Dizziness, Kidney problems among the most-reported FAERS reaction terms for sacubitril/valsartan. The compiled record contains 72,301 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does sacubitril/valsartan interact with other medications?
The registry has 5 documented interaction rows for sacubitril/valsartan. Notable source-record pairings include aliskiren, valsartan, lithium. These rows are not a complete medication review.
What drug class is sacubitril/valsartan?
sacubitril/valsartan belongs to the Neprilysin Inhibitor / ARB Combination drug class. It requires a prescription (Rx). Entresto is used to treat heart failure in adults and children aged one year and older.
What pregnancy or breastfeeding source fields are listed for sacubitril/valsartan?
The FDA label for sacubitril/valsartan contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Related Medications in Neprilysin Inhibitor / ARB Combination

Other drugs grouped near sacubitril/valsartan - same-class peers and common alternatives.

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What the FDA Data Shows for sacubitril/valsartan

The FDA label for sacubitril/valsartan (sold under brand names such as Entresto) classifies it as a prescription-only medication in the Neprilysin Inhibitor / ARB Combination class. Entresto is used to treat heart failure in adults and children aged one year and older. Official labeling lists 5 commonly reported side effects, including Low blood pressure, High potassium levels in the blood, Cough.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 72,301 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: October 29, 2025

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page