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


  • Print
  • Share
  • E-mail

Monopril HCT (fosinopril/hydrochlorothiazide) 20/12.5mg and 10/12.5mg Tablets February 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2009


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. Read about the new physician labeling format.

Summary View

Sections Modified


  • Drug Interaction
    • Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and
      hypotension) have been reported rarely in patients on therapy with injectable gold (sodium
      aurothiomalate) and concomitant ACE inhibitor therapy including MONOPRIL/ MONOPRIL HCT.

The latest label (approved 02/09/2009) is not available on this site