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Fansidar Side Effects, and Drug Interactions - Sulfadoxine and Pyrimethamine
SIDE EFFECTS
For completeness, all major reactions to sulfonamides and to pyrimethamine are included below, even though they may not have been reported with Fansidar (see WARNINGS and PRECAUTIONS: Information for the Patient).
Hematological Changes
Agranulocytosis, aplastic anemia, megaloblastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia, methemoglobinemia, and eosinophilia.
Skin and Miscellaneous Sites Allergic Reactions
Erythema multiforme, Stevens-Johnson syndrome, generalized skin eruptions, toxic epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, slight hair loss, Lyell’s syndrome, and allergic pericarditis.
Gastrointestinal Reactions
Glossitis, stomatitis, nausea, emesis, abdominal pains, hepatitis, hepatocellular necrosis, diarrhea, pancreatitis, feeling of fullness, and transient rise of liver enzymes.
Central Nervous System Reactions
Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo, insomnia, apathy, fatigue, muscle weakness, nervousness, and polyneuritis.
Respiratory Reactions
Pulmonary infiltrates resembling eosinophilic or allergic alveolitis.
Genitourinary
Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, and crystalluria.
Miscellaneous Reactions
Drug fever, chills, periarteritis nodosa and LE phenomenon have occurred.
The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has produced thyroid malignancies in the species.
There have been reports which may indicate an increase in incidence and severity of adverse reactions when chloroquine is used with Fansidar as compared to the use of Fansidar alone. Fansidar is compatible with quinine and with antibiotics. However, antifolic drugs such as sulfonamides, trimethoprim, or trimethoprim-sulfamethoxazole combinations should not be used while the patient is receiving Fansidar for antimalarial prophylaxis. Fansidar has not been reported to interfere with antidiabetic agents. If signs of folic acid deficiency develop, Fansidar should be discontinued. When recovery of depressed platelets or white blood cell counts in patients with drug-induced folic acid deficiency is too slow, folinic acid (leucovorin) may be administered in doses of 5-15 mg intramuscularly daily for 3 days or longer.
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