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Label Changes for:

Hyzaar (losartan potassium hydrochlorothiazide) 50-12.5 mg, 100-12.5 mg, and 100-25 mg Tablets

June 2009

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009


Losartan Potassium
  • General disorders and administration site conditions: Malaise
Hydrochlorothiazide/Post-Marketing Experience
  • Hemic: Thrombocytopenia (reworded)