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

Safety

  • Print
  • Share
  • E-mail

Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension) June 2008


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

  • General
    • A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.
    • Drug Interactions
      • ...reduced efficacy of combined oral estrogen/progesterone contraceptives.

ADVERSE REACTIONS

  • Infections and Infestations
    • Mucocutaneous Candidiasis
  • Gastrointestinal
    • Black Hairy Tongue
  • Hypersensitivity Reactions
    • Anaphylaxis (See WARNINGS)