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U.S. Department of Health and Human Services


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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


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


  • 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.