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About EDARBI

What is high blood pressure (hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too great.

High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. EDARBI can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure may lower your chance of having a stroke or heart attack, but they don’t work alone. It should be part of a complete treatment plan.

What is EDARBI?

EDARBI is a prescription medicine called an angiotensin II receptor blocker (ARB) used to treat high blood pressure (hypertension) in adults. Your doctor may prescribe other medicines for you to take along with EDARBI to treat your high blood pressure.

Your doctor knows how important management of your high blood pressure is. That’s why you were prescribed EDARBI.

In addition to medicine, lifestyle changes are also important to help lower blood pressure. By taking small steps, you can make healthy changes in the way you live. iPlan is designed to help you make these changes and work toward lowering blood pressure.

EDARBI was superior to DIOVAN and BENICAR in head-to-head clinical studies.

EDARBI lowered blood pressure more than two of the most commonly prescribed brands of ARB blood pressure medicine called DIOVAN® (valsartan) and BENICAR® (olmesartan medoxomil). As part of a clinical study where systolic blood pressure was measured over 24 hours, EDARBI (80 mg) lowered blood pressure by 15.3 mmHg and DIOVAN (320 mg) lowered blood pressure by 11.3 mmHg. In a second study, EDARBI (80 mg) lowered blood pressure by 13.2 mmHg and BENICAR (40 mg) lowered blood pressure by 11.2 mmHg.

EDARBI works with you and your treatment plan.

Whether you are taking EDARBI alone or in combination with other high blood pressure medicines, it has been shown to be effective in clinical studies. EDARBI should be taken once per day, with or without food.

EDARBI is well-tolerated.

In clinical studies, treatment with EDARBI was well-tolerated. Adverse reactions were similar to that of placebo and were generally mild. The most common side effect was diarrhea. To learn more, please see the EDARBI accompanying Product Information.

Call your doctor for medical advice if you have any of the above side effects or any other side effects that concern you while using EDARBI. 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.

How does EDARBI work?

EDARBI is a prescription medicine called an angiotensin II receptor blocker (ARB) used to treat high blood pressure in adults. EDARBI blocks the action of angiotensin II in the arteries, and can help relax your blood vessels so your blood pressure is lower.

What can you expect when taking EDARBI?

You may not feel any different when you start to take EDARBI. If your doctor wants you to check your blood pressure at home, do not stop taking EDARBI if your blood pressure numbers have gone down.

Important Safety Information

WARNING: EDARBI and EDARBYCLOR can cause harm or death to your unborn baby. If you become pregnant while taking EDARBI or EDARBYCLOR, tell your doctor right away. If you plan to become pregnant, talk to your doctor about other treatments to lower blood pressure.

  • Before taking EDARBI or EDARBYCLOR, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. It is not known if EDARBYCLOR passes into breast milk. You and your doctor should decide if you will take EDARBI or EDARBYCLOR and breastfeed. You should not do both.
  • Do not take EDARBYCLOR if you make less urine because of kidney problems (anuria).
  • Tell your doctor about all your medical conditions, including if you have heart problems or stroke, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with EDARBYCLOR.
  • Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium, a medicine used to treat some types of depression; or digoxin.
  • EDARBI and EDARBYCLOR may cause serious side-effects including low blood pressure (hypotension) which may cause you to feel faint and dizzy. Vomiting and diarrhea, a low salt diet or not drinking enough fluid can also lead to low blood pressure.
  • If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint) have someone call your doctor or get medical help. Stop taking EDARBYCLOR.
  • If you have fluid and body salt (electrolytes) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy/weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, and constipation.
  • People who have increased levels of uric acid in the blood may develop gout. If you already have gout tell your doctor about worsening of your gout symptoms.
  • In clinical studies, the most common side effect seen with EDARBI was diarrhea.
  • In clinical studies, the side effects seen with EDARBYCLOR included dizziness and tiredness.

For further information please talk to your healthcare professional and see accompanying Product Information for EDARBI and EDARBYCLOR.

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.

Use of EDARBI and EDARBYCLOR

EDARBI and EDARBYCLOR are prescription medicines used to treat high blood pressure (hypertension). Your doctor may prescribe other medicines for you to take along with EDARBI or EDARBYCLOR to treat your high blood pressure. EDARBYCLOR is used when one medicine is not enough or as the first medicine if your doctor decides you are likely to need more than one medicine. Medicines that lower your blood pressure may lower your chances of having a stroke or heart attack, but they don’t work alone. It should be part of a complete treatment plan.