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sacubitril/valsartan

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Brand names: Entresto

Neprilysin Inhibitor / ARB Combination Rx

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.

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 →

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.

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.

How to Take It

For adults, the usual starting dose is 49 mg/51 mg twice a day. Your doctor may increase this dose every 2 to 4 weeks to a target dose of 97 mg/103 mg twice a day, as you can handle it. For children, your doctor will determine the correct dose based on weight, using tablets or oral pellets. Take your dose twice a day, and your doctor may adjust it every 2 weeks.

Pregnancy & Breastfeeding

Entresto can cause serious harm or death to an unborn baby. Do not take this medicine if you are pregnant. Breastfeeding is not recommended while taking Entresto.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store Entresto at room temperature, away from moisture.

Side Effects (from patient reports)

Based on 75,821 FDA adverse event reports.

Low blood pressure
11,457
Death
9,093
Shortness of breath
8,895
Feeling dizzy
8,621
Feeling tired
8,606
Cough
7,820
Incorrect use of the medicine
7,289
Weight loss
5,172
Heart failure
4,449
Feeling unwell
4,419

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

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.

What to do: Avoid taking these medications together if you have diabetes or kidney problems. Your healthcare provider will need to monitor your kidney function closely or change your prescription.

( 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.

What to do: Avoid taking these two medications at the same time. Your doctor will likely stop your separate valsartan pill before you start taking Entresto.

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.

What to do: Your doctor should frequently test your blood to make sure your lithium levels stay in a safe range.

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.

What to do: Your doctor should check your blood potassium levels regularly. Avoid using potassium supplements or salt substitutes that contain potassium unless your doctor tells you otherwise.

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.

What to do: Monitor your potassium levels closely with blood tests as directed by your healthcare provider. Tell your doctor if you use any salt substitutes or potassium-containing supplements.

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 most commonly reported side effects of sacubitril/valsartan include Low blood pressure, High potassium levels in the blood, Cough, Dizziness, Kidney problems. Based on 75,821 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does sacubitril/valsartan interact with other medications?
Yes, sacubitril/valsartan has 5 known drug interactions. Notable interactions include aliskiren, valsartan, lithium. Always inform your doctor about all medications you are taking.
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.
Is sacubitril/valsartan safe during pregnancy?
Entresto can cause serious harm or death to an unborn baby. Do not take this medicine if you are pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 75,821 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: October 29, 2025

All federal data sources used on this page