ious problems in the fetus and infant including low blood pressure, poor development of skull bones, kidney failure, and death. These consequences do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. Discuss other treatment options with female patients planning to become pregnant. Women using Edarbi who become pregnant should notify their physicians as soon as possible [see FDA-Approved Patient Labeling (17.2)].
Patient Information Edarbi (eh-DAR-bee) (azilsartan medoxomil)Tablets
Read this Patient Information leaflet before you start taking Edarbi and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is the most important information I should know about Edarbi?
Taking Edarbi during your second and third trimester can cause harm and even death to your unborn baby. If you think that you are pregnant, stop taking Edarbi and tell your doctor right away. If you plan to become pregnant, talk to your doctor about other ways to lower your blood pressure.
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.
It is not known if Edarbi is safe and effective in children under 18 years of age.
What should I tell my doctor before taking Edarbi?
Before you take Edarbi, tell your doctor if you:
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:
Ask your doctor if you are not sure if you are taking a medicine listed above.
Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.
How should I take Edarbi?
What are the possible side effects of Edarbi?
Edarbi may cause side effects, including:
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.
How do I store Edarbi?
Keep Edarbi and all medicines out of the reach of children.
General information about Edarbi.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not give Edarbi to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Edarbi. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Edarbi that is written for health professionals.
For more information, go to www.edarbi.com or call 1-877-825-3327.
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 tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your bloo