• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Zestoretic (lisinopril and hydrochlorothiazide) tablets

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

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

 

November 2013

Summary View

CONTRAINDICATIONS

  • Do not co-administer aliskiren with ZESTORETIC in patients with diabetes

ADVERSE REACTIONS

Nervous System/Psychiatric

  • hallucinations

 

 

May 2009 

Summary View

 

ADVERSE REACTIONS

Nervous System/Psychiatric
  • …and mood alterations (including depressive symptoms)