Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.


Last reviewed on RxList: 2/25/2021
Entresto Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Entresto?

Entresto (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

What Are Side Effects of Entresto?

Common side effects of Entresto include:

Dosage for Entresto

The recommended starting dose of Entresto is 49/51 mg twice-daily. Double the dose of Entresto after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice-daily, as tolerated by the patient.

What Drugs, Substances, or Supplements Interact with Entresto?

Entresto may interact with:

  • angiotensin-converting-enzyme (ACE) inhibitors,
  • other angiotensin receptor blockers (ARBs),
  • potassium-sparing diuretics,
  • nonsteroidal anti-inflammatory drugs (NSAIDs), or
  • lithium

Tell your doctor all medications and supplements you use.

Entresto During Pregnancy and Breastfeeding

Entresto is not recommended for use during pregnancy. It may harm a fetus. Entresto is not recommended for use while breastfeeding.

Additional Information

Our Entresto (sacubitril and valsartan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


In the U.S., 1 in every 4 deaths is caused by heart disease. See Answer
Entresto Professional Information

3 pharmacies near 20147 have coupons for Entresto (Brand Names:Entresto for 24-26MG)

CVS Pharmacy
CVS Pharmacy

Est. Regular Price


with free coupon

View Coupon

Est. Regular Price


with free coupon

View Coupon
Walmart Pharmacy
Walmart Pharmacy

Est. Regular Price


with free coupon

View Coupon


Clinically significant adverse reactions that appear in other sections of the labeling include:

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.

Adult Heart Failure

In the PARADIGM-HF trial, subjects were required to complete sequential enalapril and ENTRESTO run-in periods of (median) 15 and 29 days, respectively, prior to entering the randomized double-blind period comparing ENTRESTO and enalapril. During the enalapril run-in period, 1,102 patients (10.5%) were permanently discontinued from the study, 5.6% because of an adverse event, most commonly renal dysfunction (1.7%), hyperkalemia (1.7%) and hypotension (1.4%). During the ENTRESTO run-in period, an additional 10.4% of patients permanently discontinued treatment, 5.9% because of an adverse event, most commonly renal dysfunction (1.8%), hypotension (1.7%) and hyperkalemia (1.3%). Because of this run-in design, the adverse reaction rates described below are lower than expected in practice.

In the double-blind period, safety was evaluated in 4,203 patients treated with ENTRESTO and 4,229 treated with enalapril. In PARADIGM-HF, patients randomized to ENTRESTO received treatment for up to 4.3 years, with a median duration of exposure of 24 months; 3,271 patients were treated for more than one year. Discontinuation of therapy because of an adverse event during the double-blind period occurred in 450 (10.7%) of ENTRESTO treated patients and 516 (12.2%) of patients receiving enalapril.

Adverse reactions occurring at an incidence of ≥ 5% in patients who were treated with ENTRESTO in the double-blind period are shown in Table 2.

Table 2: Adverse Reactions Reported in ≥ 5% of Patients Treated with ENTRESTO in the Double-Blind Period

(n = 4,203)
(n = 4,229)
Hypotension 18 12
Hyperkalemia 12 14
Cough 9 13
Dizziness 6 5
Renal failure/acute renal failure 5 5

In the PARADIGM-HF trial, the incidence of angioedema was 0.1% in both the enalapril and ENTRESTO run-in periods. In the double-blind period, the incidence of angioedema was higher in patients treated with ENTRESTO than enalapril (0.5% and 0.2%, respectively). The incidence of angioedema in Black patients was 2.4% with ENTRESTO and 0.5% with enalapril [see WARNINGS AND PRECAUTIONS].

Orthostasis was reported in 2.1% of patients treated with ENTRESTO compared to 1.1% of patients treated with enalapril during the double-blind period of PARADIGM-HF. Falls were reported in 1.9% of patients treated with ENTRESTO compared to 1.3% of patients treated with enalapril.

Pediatric Heart Failure

The adverse reactions observed in pediatric patients 1 to <18 years old who received treatment with ENTRESTO were consistent with those observed in adult patients.

Laboratory Abnormalities

Hemoglobin and Hematocrit

Decreases in hemoglobin/hematocrit of > 20% were observed in approximately 5% of both ENTRESTO-and enalapriltreated patients in the double-blind period in PARADIGM-HF.

Serum Creatinine

Increases in serum creatinine of > 50% were observed in 1.4% of patients in the enalapril run-in period and 2.2% of patients in the ENTRESTO run-in period. During the double-blind period, approximately 16% of both ENTRESTO-and enalapril-treated patients had increases in serum creatinine of > 50%.

Serum Potassium

Potassium concentrations > 5.5 mEq/L were observed in approximately 4% of patients in both the enalapril and ENTRESTO run-in periods. During the double-blind period, approximately 16% of both ENTRESTO-and enalapriltreated patients had potassium concentrations > 5.5 mEq/L.

Postmarketing Experience

The following additional adverse reactions have been reported in postmarketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity including rash, pruritus, and anaphylactic reaction

Read the entire FDA prescribing information for Entresto (Sacubitril and Valsartan Film-coated Tablets for Oral Administration)


Heart Disease: Symptoms, Signs, and Causes See Slideshow
Related Resources for Entresto

Related Drugs

© Entresto Patient Information is supplied by Cerner Multum, Inc. and Entresto Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors