What is the frequency of adverse reactions to Bactrim (sulfamethoxazole and trimethoprim)?

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Frequency of Adverse Reactions to Bactrim

Adverse reactions to Bactrim (trimethoprim-sulfamethoxazole) occur in approximately 6-8% of patients in the general population, with the most common being mild gastrointestinal disturbances and skin reactions. 1

Common Adverse Reactions (Most Frequent)

  • Gastrointestinal disturbances are the most common adverse reactions, including nausea, vomiting, and anorexia 2
  • Allergic skin reactions such as rash and urticaria occur frequently 2
  • Gastrointestinal intolerance and skin eruptions are the most prevalent adverse reactions overall 3

Serious but Rare Adverse Reactions

While most adverse reactions are mild, serious toxicity is a rare event 4. When severe reactions do occur, they typically manifest as:

  • Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) 2
  • Hematologic toxicity including thrombocytopenia, leukopenia, agranulocytosis, and aplastic anemia 2, 4
  • Fulminant hepatic necrosis 2
  • Anaphylaxis and circulatory shock 2

Special Population Considerations

AIDS Patients - Dramatically Higher Risk

The incidence of adverse reactions is greatly increased in AIDS patients compared to non-AIDS patients, particularly when treating Pneumocystis carinii pneumonia 5:

  • Rash, fever, leukopenia, and elevated liver enzymes occur at substantially higher rates 5
  • Hyperkalemia appears to be increased in AIDS patients receiving Bactrim 5
  • Adverse effects are generally less severe when used for prophylaxis rather than active treatment 5

Timing of Adverse Reactions

  • Most untoward reactions develop within two weeks of onset of therapy 3
  • The incidence compares favorably with standard agents used for the same indications 3

Risk Factors for Increased Toxicity

Patients at higher risk for adverse reactions include those with 5:

  • Impaired renal or hepatic function
  • Possible folate deficiency (elderly, chronic alcoholics, patients on anticonvulsants, malabsorption syndrome, malnutrition)
  • Severe allergies or bronchial asthma
  • Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis)
  • Renal dysfunction, liver disease, or malnutrition (higher risk of hypoglycemia)

Clinical Pitfall

Rare severe allergic reactions, particularly Stevens-Johnson syndrome, make Bactrim a potentially undesirable therapy when alternative treatments exist 6. This is especially relevant when considering off-label uses where other effective options are available.

References

Research

Drug therapy reviews: trimethoprim-sulfamethoxazole.

American journal of hospital pharmacy, 1979

Research

Adverse reactions to trimethoprim-sulfamethoxazole.

Reviews of infectious diseases, 1982

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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