Sacubitril and valsartan are blood pressure medicines. Valsartan is an angiotensin II receptor blocker (sometimes called an ARB).

Sacubitril and valsartan is a combination medicine that is used in adults with chronic heart failure. This medicine helps lower the risk of needing to be hospitalized when symptoms get worse, and helps lower the risk of death from heart failure.

Sacubitril and valsartan is also used to treat heart failure in children who are at least 1 year old.

Sacubitril and valsartan is usually given together with other heart medications.

Sacubitril and valsartan may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to sacubitril or valsartan (Diovan), or if you have ever had a severe allergic reaction to a blood pressure medication such as:

• an ACE inhibitor--benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril (Lotensin, Vasotec, Prinivil, Accupril, Mavik, and others); or
• an ARB--azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan (Atacand, Avapro, Benicar, Diovan, Edarbi, Micardis, Teveten, and others).

You should not take sacubitril and valsartan within 36 hours before or after you have taken any ACE inhibitor medication.

If you have diabetes, do not use sacubitril and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking sacubitril and valsartan with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• liver disease;
• hereditary angioedema; or
• if you are on a low-salt-diet.

Do not use if you are pregnant, and tell your doctor right away if you become pregnant. Sacubitril and valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Use Sacubitril And Valsartan (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Also call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• extreme tiredness;
• high potassium--slow heart rate, weak pulse, muscle weakness, tingly feeling; or
• kidney problems--little or no urination, rapid weight gain, painful or difficult urination, swelling in your hands, feet, or ankles.

Common side effects may include:

• kidney problems;
• high potassium;
• dizziness, feeling light-headed; or
• cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.