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U.S. Department of Health and Human Services

Safety

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Lotensin (benazepril hydrochloride) Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

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.


Summary View

Sections Modified

PRECAUTIONS

  • Drug Interactions
    • Lithium
    • Anti-diabetics
  • Carcinogenesis, Mutagenesis, Impairment of Fertility

ADVERSE REACTIONS

  • Other
    • Frequent Urination
    • The following adverse events of unknown frequency have been reported during post-marketing use of benazepril: small bowel angioedema, anaphylactoid reactions, hyperkalemia, agranulocytosis, and neutropenia.

 

Label approved 05/29/2008 is not available on Drugs@FDA

For current prescribing information, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682.