Adverse Reactions:
The adverse effects encountered most often with trimethoprim were rash and pruritus.
Dermatologic:
Rash, pruritus, and phototoxic skin eruptions. At the recommended dosage regimens of 100 mg b.i.d. or 200 mg q.d., each for 10 days, the incidence of rash is 2.9% to 6.7%. In clinical studies which employed high doses of PROLOPRIM, an elevated incidence of rash was noted. These rashes were maculopapular, morbilliform, pruritic, and generally mild to moderate, appearing 7 to 14 days after the initiation of therapy.
Hypersensitivity:
Rare reports of exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell Syndrome), and anaphylaxis have been received.
Gastrointestinal:
Epigastric distress, nausea, vomiting, and glossitis. Elevation of serum transaminase and bilirubin has been noted, but the significance of this finding is unknown. Cholestatic jaundice has been rarely reported.
Hematologic:
Thrombocytopenia, leukopenia, neutropenia, megaloblastic anemia, and methemoglobinemia.
Metabolic:
Hyperkalemia, hyponatremia.
Neurologic:
Aseptic meningitis has been rarely reported.
Miscellaneous:
Fever, and increases in BUN and serum creatinine levels.
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