Label Changes for:

Zestril (lisinopril) tablets

June 2014

Changes have been made to the WARNINGS, PRECAUTIONS 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.

 

June 2014

Content, Editorial and organizational changes were made throughout the label to comply with structured product labeling (SPL) formatIncluding content to the following safety sections

WARNINGS AND PRECAUTIONS
--Fetal Toxicity
Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

ADVERSE REACTIONS...

DRUG INTERACTIONS...

 

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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