Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Entresto. If you are concerned about side effects, discuss the risks and benefits of Entresto with your doctor.

The following side effects have been reported by at least 1% of people taking Entresto. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• dizziness
• itchiness
• nausea
• rash
• spinning sensation
• tiredness
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• low blood pressure when rising from a sitting or lying position
• signs of kidney problems (e.g., decreased urination, nausea, vomiting, swelling of the feet and ankles)
• signs of low blood pressure such as dizziness, lightheadedness, or fainting
• signs of too much potassium in the body (e.g., irregular heartbeat, muscle weakness, generally feeling unwell)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction, including angioedema (swelling of face or throat, Hives, difficulty breathing)
• sudden loss of consciousness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Entresto.

24 mg/26 mg 
Each violet-white, ovaloid, biconvex, film-coated tablet, with bevelled edges, unscored, debossed with "NVR" on one side and "LZ" on the other, contains 24.3 mg of sacubitril and 25.7 mg of valsartan. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc; film-coating: hypromellose, iron oxide red (E 172), iron oxide black (E 172), Macrogol 4000, talc, and titanium dioxide (E 171).

49 mg/51 mg 
Each pale yellow, ovaloid, biconvex, film-coated tablet, with bevelled edges, unscored, debossed with "NVR" on one side and "L1" on the other, contains 48.6 mg of sacubitril and 51.4 mg of valsartan. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose and talc; film-coating: hypromellose, iron oxide red (E 172), iron oxide yellow (E 172), Macrogol 4000, talc, and titanium dioxide (E 171).

97 mg/103 mg
Each light pink, ovaloid, biconvex, film-coated tablet, with bevelled edges, unscored, debossed with "NVR" on one side and "L11" on the other, contains 97.2 mg of sacubitril and 102.8 mg of valsartan. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose and talc; film-coating: hypromellose, iron oxide red (E 172), iron oxide black (E 172), Macrogol 4000, talc, and titanium dioxide (E 171).

Do not take Entresto if you:

• are allergic to sacubitril, valsartan, or any ingredients of the medication
• are experiencing or have recently experienced dizziness or lightheadedness caused by Low Blood Pressure
• are taking any medication containing an angiotensin-converting enzyme inhibitor (ACEI)
• have had angioedema (swelling of the face and throat) after taking an ACE inhibitor or angiotensin II receptor blocker (ARB)
• have Diabetes and are taking the medication Aliskiren
• have moderate-to-severe Kidney Disease and are taking the medication aliskiren
• have a history of hereditary angioedema or angioedema that appears to occur without a cause
• are or may become pregnant

There may be an interaction between sacubitril - valsartan and any of the following:

• Aldesleukin
• aliskiren
• alpha-agonists (e.g., Clonidine, methyldopa)
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• amifostine
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Ramipril)
• other angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• anti-psychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apomorphine
• barbiturates (e.g., Phenobarbital)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Bortezomib
• brimonidine
• Bromocriptine
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Cyclosporine
• dexmethylphenidate
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Duloxetine
• drospirenone
• Eltrombopag
• Eplerenone
• Guanfacine
• Gemfibrozil
• Heparin
• Hepatitis C antivirals (e.g., dasabuvir, ombitasvir, paritaprevir)
• herbs that affect blood pressure (e.g., cayenne, ginger, ephedra, ginseng (American) licorice, black cohosh, goldenseal)
• Hydralazine
• iron sucrose
• levodopa
• lithium
• low-molecular-weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• Methylphenidate
• Minoxidil
• Morphine
• nitrates (e.g., Nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• Obinutuzumab
• Pentoxifylline
• phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• potassium supplements
• Pramipexole
• quinine
• Rasagiline
• Ropinirole
• Rotigotine
• salt substitutes that contain potassium
• Selegiline
• sodium phosphates
• Tacrolimus
• Teriflunomide
• thalidomide
• tolcapone
• Tolvaptan
• tretinoin
• Trimethoprim
• Warfarin
• Yohimbine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Entresto. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Entresto.

Angioedema: Angioedema is a condition where the deeper layers of the skin around the eyes and lips swell. It can be life-threatening if the swelling is severe enough to cause the throat or tongue to swell and block the airways. The risk of developing angioedema with Entresto increases if it is taken with other ARBs (angiotensin receptor blockers) or any medications in the family of angiotensin-converting enzyme inhibitors (ACEIs).

This condition has been associated with ARBs such as valsartan and may occur with Entresto. If you have experienced angioedema in the past with ACEIs or ARBs, discuss with your doctor how Entresto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entresto, and whether any special monitoring is needed.

Low blood pressure: Sacubitril - valsartan may cause a lowering of blood pressure when rising from a sitting or lying position, or a racing heart rate, especially during the first few weeks of treatment. If you feel dizzy or lightheaded or feel your pulse is racing, and this feeling does not go away after a few minutes, call your doctor. Because Entresto can cause dizziness or lightheadedness, do not get up too quickly after you have been sitting or lying for prolonged periods. If you have heart disease (e.g., heart failure, Heart Attack) or are taking medications that lower blood pressure, discuss with your doctor how Entresto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entresto, and whether any special monitoring is needed.

Kidney problems: Valsartan can cause changes to kidney function that may result in decreased kidney function, kidney failure, or possibly death. Certain people have experienced changes in kidney function (e.g., people with narrowed blood vessels in their kidneys, or those with severe Congestive Heart Failure).

The use of aliskiren with Entresto may further increase risk of kidney problems for people already at risk for this problem. If you have reduced kidney function, renal artery stenosis (narrowing of blood vessels in the kidneys), or congestive heart failure, discuss with your doctor how Entresto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entresto, and whether any special monitoring is needed. If you have reduced kidney function, you may require lower doses of Entresto.

Entresto should not be taken by people with severely decreased kidney function.

Liver problems:  Liver disease or reduced liver function may cause Entresto to build up in the body, causing side effects. People with reduced liver function may need a lower-than-normal dose of valsartan; therefore, it may be necessary to use the components of the combination product separately. If you have reduced liver function or liver disease, discuss with your doctor how Entresto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entresto, and whether any special monitoring is needed. Entresto is not recommended for people with severe liver impairment.

Entresto may also cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Potassium levels: Increases in blood levels of potassium occur for some people who take sacubitril - valsartan. Potassium levels should be monitored by your doctor. If you experience unexplained nausea, fatigue, muscle weakness, or tingling sensations, contact your doctor.

If you have diabetes, severely reduced kidney function, or a high potassium intake in your diet, discuss with your doctor how Entresto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entresto, and whether any special monitoring is needed.

Pregnancy: Valsartan may cause severe harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking Entresto, stop taking it immediately and call your doctor. It is important to use effective birth control while taking Entresto and for 1 week after the last dose.

Breast-feeding: It is not known if sacubitril - valsartan passes into breast milk. If you are a breast-feeding mother and are taking Entresto, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Entresto have not been established for children.