82/100 · Critical
Manufactured by Novartis Pharmaceuticals Corporation
High Safety Concerns with Sacubitril and Valsartan, Particularly for Older Adults
209,561 FDA adverse event reports analyzed
Last updated: 2026-05-12
SACUBITRIL AND VALSARTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. Based on analysis of 209,561 FDA adverse event reports, SACUBITRIL AND VALSARTAN has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for SACUBITRIL AND VALSARTAN include HYPOTENSION, DEATH, DYSPNOEA, DIZZINESS, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SACUBITRIL AND VALSARTAN.
Sacubitril And Valsartan has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 209,561 adverse event reports for this medication, which is primarily manufactured by Novartis Pharmaceuticals Corporation.
The most commonly reported adverse events include Hypotension, Death, Dyspnoea. Of classified reports, 50.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common adverse reactions include hypotension, dyspnea, and dizziness, indicating cardiovascular side effects.
Serious adverse events such as death and cardiac failure are frequent, highlighting significant risks. Weight changes and renal impairment are also notable, suggesting potential metabolic and renal side effects.
Patients taking Sacubitril And Valsartan should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other blood pressure medications and diuretics are possible, and patients should be monitored for electrolyte imbalances and renal function. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sacubitril And Valsartan received a safety concern score of 82/100 (high concern). This is based on a 50.8% serious event ratio across 113,854 classified reports. The score accounts for 209,561 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 67,577, Female: 37,829, Unknown: 14. The most frequently reported age groups are age 70 (1,249 reports), age 75 (1,126 reports), age 73 (1,098 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 113,854 classified reports for SACUBITRIL AND VALSARTAN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Interactions with other blood pressure medications and diuretics are possible, and patients should be monitored for electrolyte imbalances and renal function.
If you are taking Sacubitril And Valsartan, here are important things to know. The most commonly reported side effects include hypotension, death, dyspnoea, dizziness, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor blood pressure closely, especially in elderly patients. Regularly check renal function and electrolyte levels. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of this drug, and patients should report any adverse events to their healthcare provider.
The FDA has received approximately 209,561 adverse event reports associated with Sacubitril And Valsartan. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Sacubitril And Valsartan include Hypotension, Death, Dyspnoea, Dizziness, Fatigue. By volume, the top reported reactions are: Hypotension (11,457 reports), Death (9,093 reports), Dyspnoea (8,895 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sacubitril And Valsartan.
Out of 113,854 classified reports, 57,890 (50.8%) were classified as serious and 55,964 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Sacubitril And Valsartan break down by patient sex as follows: Male: 67,577, Female: 37,829, Unknown: 14. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Sacubitril And Valsartan adverse events are: age 70: 1,249 reports, age 75: 1,126 reports, age 73: 1,098 reports, age 80: 1,084 reports, age 72: 1,069 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Sacubitril And Valsartan adverse event reports is Novartis Pharmaceuticals Corporation. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Sacubitril And Valsartan include: Cough, Wrong Technique In Product Usage Process, Weight Decreased, Cardiac Failure, Malaise. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Sacubitril And Valsartan to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Sacubitril And Valsartan has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The most common adverse reactions include hypotension, dyspnea, and dizziness, indicating cardiovascular side effects.
Key safety signals identified in Sacubitril And Valsartan's adverse event data include: High frequency of serious adverse events (50.8%). Cardiovascular issues like hypotension and cardiac failure are prevalent. Renal impairment and increased blood creatinine are common. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other blood pressure medications and diuretics are possible, and patients should be monitored for electrolyte imbalances and renal function. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sacubitril And Valsartan.
Monitor blood pressure closely, especially in elderly patients. Regularly check renal function and electrolyte levels.
Sacubitril And Valsartan has 209,561 adverse event reports on file with the FDA. Serious adverse events such as death and cardiac failure are frequent, highlighting significant risks. The volume of reports for Sacubitril And Valsartan reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of this drug, and patients should report any adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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