Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail
-

Bactrim (Sulfamethoxazole and Trimethoprim) Tablet and Bactrim DS (Sulfamethoxazole and Trimethoprim) Double-Strength Tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

WARNINGS

  • Hypersensitivity and Other Fatal Reactions***
  • Thrombocytopenia***
  • Streptococcal Infections and Rheumatic Fever***
  • Clostridium difficile associated diarrhe***
  • Adjunctive treatment with Leucovorin for Pneumocystis jiroveci pneumonia:
    • Treatment failure and excess mortality were observed when trimethoprim-sulfamethoxazole was used concomitantly with leucovorin for the treatment of HIV positive patients with Pneumocystis jiroveci pneumonia in a randomized placebo controlled trial. Co-administration of trimethoprimsulfamethoxazole and leucovorin during treatment of Pneumocystis jiroveci pneumonia should be avoided.

PRECAUTIONS

  • Development of drug resistant bacteria***
  • Folate deficiency***
  • Hemolysis***
  • Hemolysis***
  • Hypoglycemia***
  • Phenylalanine metabolism***
  • Porphyria and Hypothyroidism

 

-
-