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U.S. Department of Health and Human Services

Safety

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Edarbi (azilsartan medoxomil) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   

 

April 2014

Summary View

6 ADVERSE REACTIONS   

6.3 Postmarketing Experience

The following adverse reactions have been identified during the postmarketing use of EDARBI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Nausea
  • Muscle spasms
  • Rash
  • Pruritus
  • Angioedema

 

December 2011

Summary View

BOXED WARNING

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.

WARNINGS AND PRECAUTIONS (revised)

*Fetal toxicity

  • Use of drugs that act on the rennin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death… 

USE IN SPECIFIC POPULATIONS (revised)

Pregnancy
  • Pregnancy Category D 

PATIENT COUNSELING INFORMATION (revised)

General Information
  • Pregnancy: Tell female patients of childbearing potential about the consequences of exposure to Edarbi during pregnancy… 

PATIENT PACKAGE INSERT (revised)

What is the most important information I should know about Edarbi?
  • 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.