Edarbi

Edarbi is a prescription medication used to treat high blood pressure. Edarbi belongs to a group of drugs called angiotensin II receptor blockers (ARBs) which block a natural substance that narrows blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.

This medication comes in tablet form and is taken once daily, with or without food.

Diarrhea is the most common side effect.

Edarbi is a prescription medication used to treat high blood pressure in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Takeda Pharmaceuticals America, Inc.

Edarbi may cause side effects, including:

• Harm or death to your unborn fetus if taken in the second or third trimester. See "FDA Warning" and "Pregnancy" sections.
• Low blood pressure (hypotension) and dizziness is most likely to happen if you also:
  • take water pills (diuretics)
  • are on a low-salt diet
  • take other medicines that affect your blood pressure
  • get sick with vomiting or diarrhea
  • do not drink enough fluids

If you feel faint or dizzy, lie down and call your doctor right away.

The most common side effect in clinical trials was diarrhea, occurring in 2 percent of the people taking Edarbi. Other reported side effects included:

• nausea
• weakness
• fatigue 
• muscle spasms
• dizziness
• dizziness when standing from a lying position
• cough

These are not all the possible side effects with Edarbi. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aliskiren (Tekturna, in Amturnide, Tekamlo, Tekturna HCT)
• aspirin
• other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• selective COX-2 inhibitors such as celecoxib (Celebrex)
• diuretics ('water pills') such as amiloride, spironolactone, and triamterene
• other medications to treat high blood pressure or heart problems
• potassium supplements

This is not a complete list of Edarbi drug interactions. Ask your doctor or pharmacist for more information.

Contact your doctor right away if you become pregnant while taking Edarbi. See "Pregnancy" and "FDA Warning" sections for more information.

Edarbi can cause very low blood pressure leading to dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more commonly seen at the beginning of therapy in people who take diuretics, or in people on dialysis. Diarrhea, vomiting, not drinking enough fluids, and sweating can cause a decrease in blood pressure and can lead to lightheadedness and fainting. Tell your doctor if you have any of these problems during your treatment. 

• Avoid getting up too fast from a sitting or lying position.
• Get up slowly and prevent falls by steadying yourself.
• Do not drive or operate heavy machinery until you know how Edarbi affects you.
• Limit alcoholic beverages.

Your doctor may monitor your kidney function if you are elderly, have kidney disease, have severe congestive heart failure (CHF) or if you are taking nonsteroidal anti-inflammatory drugs, as Edarbi may cause a decrease in kidney function.

Do not use potassium supplements or salt substitutes while you are receiving Edarbi, unless your doctor instructs you to.

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Edarbi there are no specific foods that you must exclude from your diet when receiving Edarbi.

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

• are allergic to any ingredient in Edarbi, or any other allergies you have to medications, foods, or dyes
• have diabetes and you are taking aliskiren (Tekturna, in Amturnide, Tekamlo, Tekturna HCT)
• have heart or kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Edarbi can cause harm or death to your unborn baby.

• Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
• If you become pregnant while taking Edarbi, tell your doctor right away. Your doctor may switch you to a different medicine to treat your high blood pressure.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Edarbi is excreted in human breast milk or if it will harm your nursing baby. 

You and your doctor should decide if you will take Edarbi or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Edarbi.

• Take Edarbi exactly as your doctor tells you to.
• Your doctor will tell you how much Edarbi to take and when to take it.
• Your doctor may prescribe other medicines for you to take along with Edarbi to treat your high blood pressure.
• Edarbi comes in tablet form and is usually taken once daily, at around the same time each day.
• Edarbi can be taken with or without food.
• If you miss a dose, take it later in the same day. Do not take more than 1 dose of Edarbi in a day.

The recommended Edarbi dose in adults is 80 mg taken by mouth, once daily.

If you take too much Edarbi call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Edarbi is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Edarbi at room temperature between 59°F to 86°F (15°C to 30°C).
• Store Edarbi in the original container that you received from your pharmacist or doctor. Do not put Edarbi into a different container.
• Keep Edarbi in a tightly closed container, and keep Edarbi out of the light.
• Keep Edarbi and all medicines out of the reach of children.

WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue Edarbi as soon as possible.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.