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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is SACUBITRIL\VALSARTAN Used For?
| Indication | Reports |
|---|---|
| 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.