Label Changes for:

Ziac (bisoprolol fumarate and hydrochlorothiazide) tablets

December 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) – December 2009

ADVERSE REACTIONS 

Hydrochlorothiazide
  • Skin -Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis.
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