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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

SACUBITRIL\VALSARTAN: 111,200 Adverse Event Reports & Safety Profile

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111,200
Total FAERS Reports
15,665 (14.1%)
Deaths Reported
18,923
Hospitalizations
111,200
As Primary/Secondary Suspect
2,109
Life-Threatening
901
Disabilities

First Report: 1988 · Latest Report: 20250920

What Are the Most Common SACUBITRIL\VALSARTAN Side Effects?

#1 Most Reported
Hypotension
11,718 reports (10.5%)
#2 Most Reported
Death
9,605 reports (8.6%)
#3 Most Reported
Dyspnoea
8,952 reports (8.1%)

All SACUBITRIL\VALSARTAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hypotension 11,718 10.5% 450 2,781
Death 9,605 8.6% 9,603 461
Dyspnoea 8,952 8.1% 536 3,020
Dizziness 8,548 7.7% 144 1,413
Fatigue 8,172 7.4% 187 1,368
Wrong technique in product usage process 8,022 7.2% 806 1,098
Cough 7,743 7.0% 152 1,134
Weight decreased 5,030 4.5% 91 819
Cardiac failure 4,504 4.1% 1,164 2,175
Malaise 4,299 3.9% 155 859
Asthenia 3,667 3.3% 173 973
Weight increased 3,485 3.1% 59 657
Blood pressure decreased 3,168 2.9% 144 751
Myocardial infarction 3,120 2.8% 1,043 831
Inappropriate schedule of product administration 2,870 2.6% 239 566
Feeling abnormal 2,595 2.3% 40 410
Ejection fraction decreased 2,551 2.3% 121 670
Product dose omission issue 2,548 2.3% 30 318
Fall 2,504 2.3% 205 1,004
Hypertension 2,494 2.2% 89 508

Who Reports SACUBITRIL\VALSARTAN Side Effects? Age & Gender Data

Gender: 35.6% female, 64.4% male. Average age: 67.0 years. Most reports from: US. View detailed demographics →

Is SACUBITRIL\VALSARTAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 4 0 0
2001 3 0 0
2002 7 0 3
2003 4 0 0
2005 7 1 5
2006 9 0 0
2007 5 0 1
2008 5 3 1
2009 10 1 5
2010 9 3 6
2011 20 1 11
2012 13 1 6
2013 14 2 8
2014 27 3 14
2015 533 51 137
2016 2,400 416 818
2017 3,260 742 1,261
2018 2,943 889 1,061
2019 3,337 945 1,043
2020 4,933 1,105 1,303
2021 5,586 1,086 1,343
2022 4,830 717 1,094
2023 3,300 388 880
2024 1,175 77 514
2025 495 53 177

View full timeline →

What Is SACUBITRIL\VALSARTAN Used For?

IndicationReports
Product used for unknown indication 69,693
Cardiac failure 24,514
Cardiac failure chronic 5,882
Cardiac failure congestive 4,229
Hypertension 2,401
Cardiac disorder 907
Left ventricular failure 752
Cardiomyopathy 527
Ejection fraction decreased 342
Congestive cardiomyopathy 286

SACUBITRIL\VALSARTAN vs Alternatives: Which Is Safer?

SACUBITRIL\VALSARTAN vs SAFINAMIDE SACUBITRIL\VALSARTAN vs SAIZEN SACUBITRIL\VALSARTAN vs SALICYLATE SACUBITRIL\VALSARTAN vs SALICYLIC ACID SACUBITRIL\VALSARTAN vs SALMETEROL SACUBITRIL\VALSARTAN vs SAMSCA SACUBITRIL\VALSARTAN vs SANDOSTATIN LAR SACUBITRIL\VALSARTAN vs SANDOZ FENTANYL SYSTEM SACUBITRIL\VALSARTAN vs SAPROPTERIN SACUBITRIL\VALSARTAN vs SAQUINAVIR

Official FDA Label for SACUBITRIL\VALSARTAN

Official prescribing information from the FDA-approved drug label.