From the FDA Drug Label
Sacubitril and Valsartan Tablets may cause serious side effects including: • Serious allergic reactions causing swelling of your face, lips, tongue, and throat (angioedema) that may cause trouble breathing and death. • Low blood pressure (hypotension). • Kidney problems • Increased amount of potassium in your blood (hyperkalemia). The most common side effects of Sacubitril and Valsartan Tablets also include cough and dizziness
The risks of Entresto (sacubitril/valsartan) include:
- Serious allergic reactions: angioedema, which can cause trouble breathing and death
- Low blood pressure (hypotension): common during treatment, especially when taking diuretics
- Kidney problems: common and can be serious, leading to kidney failure
- Increased potassium levels (hyperkalemia): common during treatment
- Cough and dizziness: common side effects Additionally, the drug can cause:
- Orthostasis (reported in 2.1% of patients)
- Falls (reported in 1.9% of patients)
- Renal failure/acute renal failure (reported in 5% of patients)
- Decreases in hemoglobin/hematocrit (reported in approximately 5% of patients)
- Increases in serum creatinine (reported in approximately 16% of patients)
- Increases in serum potassium (reported in approximately 16% of patients) 1 1
From the Research
Entresto (sacubitril/valsartan) carries several important risks that patients should be aware of, including angioedema, hypotension, kidney function decline, hyperkalemia, and potential harm to the developing fetus during pregnancy. The most serious risk is angioedema, which can cause life-threatening swelling of the face, lips, tongue, and throat 2. Hypotension (low blood pressure) is common, potentially causing dizziness, lightheadedness, or fainting, especially when starting treatment or increasing the dose 3. Kidney function may decline, particularly in patients with pre-existing kidney problems or those taking other medications affecting kidney function 4. Hyperkalemia (high potassium levels) can occur, especially in patients with kidney impairment or those taking potassium supplements or potassium-sparing medications. Entresto should never be taken during pregnancy as it can harm or cause death to the developing fetus, particularly in the second and third trimesters.
Some key points to consider when prescribing Entresto include:
- Monitoring blood pressure, kidney function, and potassium levels regularly while taking this medication 4
- Being aware of the potential for angioedema and hypotension, especially in patients with a history of these conditions 2, 3
- Avoiding use in patients with pregnancy or planned pregnancy due to potential harm to the fetus
- Considering alternative treatments for patients with kidney impairment or those taking medications that affect kidney function 4
It's essential to weigh the benefits and risks of Entresto (sacubitril/valsartan) for each patient, considering their individual medical history and current health status. According to the most recent study 5, sacubitril/valsartan treatment demonstrated significantly lower 5-year mortality rates and greater LVEF improvement in HFrEF patients with coexisting ESRD compared with candesartan or valsartan, suggesting that sacubitril/valsartan is a beneficial treatment option for this patient population. However, the risk of hypotension should be carefully considered, especially in patients with higher LVEF 3.