Label Changes for:

Zestril (Lisinopril) Tablets

November 2013

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

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

CONTRAINDICATIONS

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

ADVERSE REACTIONS

Nervous System/Psychiatric
  • hallucinations

 

 

May 2009

 

ADVERSE REACTIONS

Nervous System/Psychiatric

  • …and mood alterations (including depressive symptoms)

 

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