Label Changes for:
Cozaar (losartan potassium) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
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
- 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
Post Marketing Experience
- General Disorders and Administration Site Conditions: Malaise