Entrestosacubitril + valsartan
According to the FDA label: ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
114,605 adverse event reports submitted to the FDA (2013–2026)
Top Reported Adverse Events
The most frequently reported events in association with Entresto in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Hypotension 11,502 reports
Death 9,125 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Dyspnoea 8,943 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Dizziness 8,665 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Fatigue 8,657 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Cough 7,844 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Wrong Technique in Product Usage Process 7,305 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Weight Decreased 5,191 reports
Cardiac Failure 4,476 reports
A condition where the heart cannot pump blood as well as it should, often called heart failure.
Full definition in the glossary →Malaise 4,443 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Asthenia 3,784 reports
Physical weakness or lack of strength.
Full definition in the glossary →Weight Increased 3,503 reports
- Blood Pressure Decreased 3,155 reports
Product Dose Omission Issue 2,831 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Myocardial Infarction 2,770 reports
The medical term for a heart attack.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 67,974 |
| Female | 38,086 |
| Unknown | 14 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 237 |
| 18-34 | 573 |
| 35-49 | 2,802 |
| 50-64 | 10,774 |
| 65-74 | 10,501 |
| 75+ | 12,972 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Entresto. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 56,124 |
| Other Serious | 34,020 |
| Hospitalization | 20,631 |
| Death | 14,085 |
| Life-Threatening | 2,352 |
| Disability | 1,073 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Entresto. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 971 |
| 2016 | 6,442 |
| 2017 | 7,877 |
| 2018 | 12,218 |
| 2019 | 12,941 |
| 2020 | 12,382 |
| 2021 | 16,985 |
| 2022 | 19,264 |
| 2023 | 16,687 |
| 2024 | 4,595 |
| 2025 | 3,580 |
| 2026 (partial) | 659 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Entresto
In FDA adverse event reports that mention Entresto, these medications appeared most often in the same report.
- Furosemide (10,406 reports)
- Carvedilol (8,112 reports)
- Spironolactone (7,708 reports)
- Aspirin (4,975 reports)
- Bisoprolol (4,239 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026