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Sacubitril / valsartan Side Effects

For the Consumer

Applies to sacubitril / valsartan: oral tablet

Along with its needed effects, sacubitril / valsartan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sacubitril / valsartan:

More common
  • Abdominal or stomach pain
  • blurred vision
  • confusion
  • difficult breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • irregular heartbeat
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • sweating
  • unusual tiredness or weakness
  • weakness or heaviness of the legs
Less common
  • Bloody urine
  • decreased frequency or amount of urine
  • increased thirst
  • loss of appetite
  • lower back or side pain
  • swelling of the face, fingers, or lower legs
  • weight gain
Rare
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects of sacubitril / valsartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Cough
  • dizziness

For Healthcare Professionals

Applies to sacubitril / valsartan: oral tablet

General

The most common adverse reactions were hypotension, hyperkalemia, cough, dizziness, and renal failure.[Ref]

Cardiovascular

Very common (10% or more): Hypotension (18%)
Common (1% to 10%): Orthostasis[Ref]

Metabolic

Very common (10% or more): Potassium greater than 5.5 mEq/L (16%), hyperkalemia (12%)[Ref]

Renal

Very common (10% or more): Serum creatinine increased greater than 50% (16%)
Common (1% to 10%): Renal failure/acute renal failure[Ref]

Respiratory

Common (1% to 10%): Cough[Ref]

Nervous system

Common (1% to 10%): Dizziness[Ref]

Dermatologic

Uncommon (0.1% to 1%): Angioedema[Ref]

The incidence of angioedema was 2.4% in Black patients.[Ref]

Hematologic

Common (1% to 10%): Hemoglobin/hematocrit decreased greater than 20%[Ref]

Other

Common (1% to 10%): Falls[Ref]

References

1. "Product Information. Entresto (sacubitril-valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.

Some side effects of sacubitril / valsartan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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