Label Changes for:

Cozaar (losartan) Tablets

November 2011

Changes have been made to the PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.

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

 

November 2011

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

 

ADVERSE REACTIONS

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

 

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