What are the side effects of Entresto (sacubitril/valsartan)?

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Last updated: February 10, 2025 • View editorial policy

From the Guidelines

Entresto (sacubitril/valsartan) is associated with several side effects, including hypotension, angioedema, and hyperkalemia.

Common Side Effects

  • Hypotension: Entresto can cause a decrease in blood pressure, which can lead to dizziness, lightheadedness, and fainting 1.
  • Angioedema: Entresto can cause swelling of the face, lips, tongue, and throat, which can be life-threatening 2, 3.
  • Hyperkalemia: Entresto can cause an increase in potassium levels, which can lead to muscle weakness, fatigue, and heart arrhythmias 3, 4.

Less Common Side Effects

  • Renal impairment: Entresto can cause a decline in renal function, especially in patients with pre-existing renal disease 2, 1.
  • Hepatic impairment: Entresto can cause an increase in liver enzymes, especially in patients with pre-existing liver disease 2, 1.

Special Considerations

  • Pregnancy and lactation: Entresto is contraindicated in pregnancy and lactation due to the potential risk of harm to the fetus or baby 2.
  • Concomitant medications: Entresto should not be used with certain medications, such as ACE inhibitors, aliskiren, and ARBs, due to the increased risk of adverse effects 2, 1. It is essential to monitor patients taking Entresto for these side effects and adjust the dose or discontinue the medication as needed 1, 3, 4.

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 side effects of Entresto (sacubitril/valsartan) include:

  • Serious allergic reactions (angioedema)
  • Low blood pressure (hypotension)
  • Kidney problems
  • Increased blood potassium levels (hyperkalemia)
  • Cough
  • Dizziness 5

From the Research

Side Effects of Entresto (Sacubitril/Valsartan)

The side effects of Entresto (sacubitril/valsartan) include:

  • Hypotension: a common side effect, with studies showing a higher risk of hypotension compared to other treatments such as valsartan 6, 7, 8
  • Angioedema: a possible side effect, although the incidence is low 6, 8
  • Impaired renal function: a possible side effect, particularly in patients with pre-existing renal impairment 6
  • Elevation in serum potassium levels: a possible side effect, although some studies have shown no increased risk of hyperkalemia 6, 7
  • Other side effects may include worsening renal function, although some studies have shown no increased risk of this side effect 7, 9

Special Considerations

Entresto (sacubitril/valsartan) should not be used in certain patient populations, including:

  • Pregnant or breastfeeding women 6
  • Patients with severe hepatic impairment (Child-Pugh C) 6
  • Patients with diabetes who are taking aliskiren 6

References

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.