Sacubitril
Active ingredient
Sold as Neparvis · ENTRESTO
- Drug class
- -
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 24
- FDA reports (12 mo)
- 2,572
Overview
Plain-language summary, compiled from the cited regulatory records
Sacubitril is a neprilysin inhibitor [1]. It is approved for use in combination with valsartan, an angiotensin II receptor blocker, under the brand name ENTRESTO [1]. This combination is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure [1]. The benefits are most apparent in patients who have a left ventricular ejection fraction below normal [1]. It is also indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction [1].
In the past 12 months, there have been 2572 adverse event reports associated with sacubitril [2]. The most frequently reported adverse reactions include hypotension, fatigue, diarrhea, off-label use, and dizziness [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 9 | April 2, 2026 |
| GB United Kingdom | MHRA | 7 | May 8, 2026 |
| US United States | FDA | 6 | April 1, 2026 |
| EU European Union | EMA | 2 | January 13, 2026 |
CACanada· Health Canada
9 products
Uses
AND CLINICAL USE ...................................................................................... 2 CONTRAINDICATIONS ........................................................................................................... 3 WARNINGS AND PRECAUTIONS ..........................................................................................
3 ADVERSE REACTIONS ............................................................................................................ 7 DRUG INTERACTIONS ..........................................................................................................
14 DOSAGE AND ADMINISTRATION ...................................................................................... 18 OVERDOSAGE ........................................................................................................................
20 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 21 STORAGE AND STABILITY .................................................................................................. 24 DOSAGE FORMS, COMPOSITION AND PACKAGING .....................................................
GBUnited Kingdom· MHRA
7 products
Uses
1).
How to take
USUnited States· FDA
6 products
Uses
1 INDICATIONS AND USAGE Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and sacubitril and valsartan tablets are 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. 1 ) • for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
Sacubitril and valsartan reduces NT-proBNP and is expected to improve cardiovascular outcomes. 1 Adult Heart Failure Sacubitril and valsartan tablets are 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. 1 )] . 2 Pediatric Heart Failure Sacubitril and valsartan tablets are indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
EUEuropean Union· EMA
2 products
Uses
1). 1).
How to take
Drug interactions
Known interactions involving Sacubitril. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02564432 · revised January 28, 2026
- [2]MHRA (UK) · PL045691900 · revised May 8, 2026
- [3]FDA DailyMed · 064a7c51-de30-47… · revised April 1, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/004062 · revised January 13, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.