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U.S. Department of Health and Human Services

Safety

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Cozaar (losartan potassium) 25 mg, 50 mg, and 100 mg Tablets

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

 

 

March 2013

Summary View

PATIENT INFORMATION/Who should not take COZAAR?

  • Do not take COZAAR if you have diabetes and are taking a medicine called aliskiren to reduce blood pressure

 

November 2011

Summary View

PRECAUTIONS

  • Dual blockade of the renin-angiotensin-aldosterone system: Dual blockade of the renin-angiotensin-aldosterone system is associated with increased risk of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure). Closely monitor blood pressure, renal function and electrolytes in patients.

PATIENT PACKAGE INSERT

What should I tell my doctor before taking?

Especially tell your doctor if you are taking:

  • other medicines to reduce blood pressure

 

June 2009

Summary View

 

ADVERSE REACTIONS

Post Marketing Experience
  • General Disorders and Administration Site Conditions: Malaise

 

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