GANTRISIN SIDE EFFECTS

SIDE EFFECTS

The listing that follows includes adverse reactions both that have been reported with Gantrisin (acetyl sulfisoxazole pediatric suspension) and some which have not been reported with this specific drug; however, the pharmacologic similarities among the sulfonamides require that each of the reactions be considered with the administration of Gantrisin (acetyl sulfisoxazole pediatric suspension) .

Allergic/Dermatologic: Anaphylaxis, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis, exfoliative dermatitis, angioedema, arteritis and vasculitis, allergic myocarditis, serum sickness, rash, urticaria, pruritus, photosensitivity, and conjunctival and scleral injection, generalized allergic reactions and generalized skin eruptions. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

Cardiovascular: Tachycardia, palpitations, syncope, cyanosis.

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and thiazides) and oral hypoglycemia agents. Cross-sensitivity may exist with these agents. Development of goiter, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

Gastrointestinal: Hepatitis, hepatocellular necrosis, jaundice, pseudomembranous colitis, nausea, emesis, anorexia, abdominal pain, diarrhea, gastrointestinal hemorrhage, melena, flatulence, glossitis, stomatitis, salivary gland enlargement, pancreatitis.

Onset of pseudomembranous colitis symptoms may occur during or after treatment with sulfisoxazole.

Sulfisoxazole has been reported to cause increased elevations of liver-associated enzymes in patients with hepatitis.

Genitourinary: Crystalluria, hematuria, BUN and creatinine elevations, nephritis and toxic nephrosis with oliguria and anuria. Acute renal failure and urinary retention have also been reported. The frequency of renal complications, commonly associated with some sulfonamides, is lower in patients receiving the more soluble sulfonamides such as sulfisoxazole.

Hematologic: Leukopenia, agranulocytosis, aplastic anemia, thrombocytopenia, purpura, hemolyticanemia, anemia, eosinophilia, clotting disorders including hypoprothrombinemia, and hypofibrinogenemia, sulfhemoglobinemia, methemoglobinemia.

Musculoskeletal: Arthralgia, myalgia.

Neurologic: Headache, dizziness, peripheral neuritis, paresthesia, convulsions, tinnitus, vertigo, ataxia, intracranial hypertension.

Psychiatric: Psychosis, hallucination, disorientation, depression, anxiety, apathy.

Respiratory: Cough, shortness of breath, pulmonary infiltrates.

Vascular: Angioedema, arteritis, vasculitis.

Miscellaneous:Edema (including periorbital), pyrexia, drowsiness, weakness, fatigue, lassitude, rigors, flushing, hearing loss, insomnia, pneumonitis, chills.