sacubitril/valsartan
Brand names: Entresto
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.
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.
( 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?
What should I do if I experience swelling of my face, lips, or tongue?
Can I take Entresto if I have diabetes and am taking aliskiren?
Will Entresto affect my kidney function?
Can Entresto cause low blood pressure?
Can I use salt substitutes with Entresto?
What if I am already taking an ARB?
How often will my doctor adjust my dose?
What are the inactive ingredients in Entresto?
What do the tablet debossments mean?
What are the common side effects of sacubitril/valsartan?
Does sacubitril/valsartan interact with other medications?
What drug class is sacubitril/valsartan?
Is sacubitril/valsartan safe during pregnancy?
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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
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages