What is the most important information I should know about ENTRESTO?

ENTRESTO can harm or cause death to your unborn baby. Talk to your doctor about other ways to treat heart failure if you plan to become pregnant. Tell your doctor right away if you become pregnant during treatment with ENTRESTO.

Do not take ENTRESTO if you:

are allergic to any of the ingredients in ENTRESTO
have had an allergic reaction including swelling of your face, lips, tongue, throat (angioedema), or trouble breathing while taking a type of medicine called an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)
take an ACE inhibitor medicine. Do not take ENTRESTO for at least 36 hours before or after you take an ACE inhibitor medicine. Talk with your doctor or pharmacist before taking ENTRESTO if you are not sure if you take an ACE inhibitor medicine
have diabetes and take a medicine that contains aliskiren

Before taking ENTRESTO tell your doctor about all of your medical conditions, including if you:

have a history of hereditary angioedema
have kidney or liver problems
have diabetes
are pregnant or plan to become pregnant; are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with ENTRESTO

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take potassium supplements or a salt substitute; nonsteroidal anti-inflammatory drugs (NSAIDs); lithium; or other medicines for high blood pressure or heart problems such as an ACE inhibitor, ARB, or aliskiren.

What are the possible side effects of ENTRESTO?

ENTRESTO may cause serious side effects including:

swelling of your face, lips, tongue, and throat (angioedema) that may cause trouble breathing and death. Get emergency medical help right away if you have symptoms of angioedema or trouble breathing. Do not take ENTRESTO again if you have had angioedema while taking ENTRESTO
people who are Black or who have had angioedema and take ENTRESTO may have a higher risk of having angioedema
low blood pressure (hypotension), which is common, and your risk of low blood pressure is greater if you also take water pills (diuretics). Call your doctor if you become dizzy or lightheaded, or you develop extreme tiredness (fatigue)
kidney problems, which are common, and can be serious and can lead to kidney failure
increased amount of potassium in your blood (hyperkalemia), which is common

The most common side effects also include cough and dizziness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

This information is not comprehensive. Please see full Prescribing Information, including Boxed WARNING, and Patient Prescribing Information.