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U.S. Department of Health and Human Services

Safety

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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)

 

July 2013

Summary View

WARNINGS

Embryofetal Toxicity
  • Severe and symptomatic hyponatremia can occur in patients receiving BACTRIM, particularly for the treatment of P. jiroveci pneumonia. Evaluation for hyponatremia and appropriate correction is necessary in symptomatic patients to prevent life-threatening complicationsome epidemiologic studies suggest that exposure to sulfamethoxazole/trimethoprim during pregnancy may be associated with an increased risk of congenital malformations, particularly neural tube defects, cardiovascular malformations, urinary tract defects, oral clefts, and club foot.
  • If sulfamethoxazole/trimethoprim is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential hazards to the fetus.

PRECAUTIONS

Electrolyte Abnormalities
  • Severe and symptomatic hyponatremia can occur in patients receiving BACTRIM, particularly for the treatment of P. jiroveci pneumonia. Evaluation for hyponatremia and appropriate correction is necessary in symptomatic patients to prevent life-threatening complications

ADVERSE REACTIONS

Metabolic and Nutritional: hyponatremia

Postmarketing Experience

  • QT prolongation resulting in ventricular tachycardia and torsade de pointes
     

 

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