Gantrisin Pediatric Side Effects
Generic Name: sulfisoxazole
Note: This document contains side effect information about sulfisoxazole. Some of the dosage forms listed on this page may not apply to the brand name Gantrisin Pediatric.
Applies to sulfisoxazole: compounding powder, oral suspension, oral tablet
In general, although not every side effect listed in the side effects section may have been reported with the use of sulfisoxazole (the active ingredient contained in Gantrisin Pediatric) they have all been reported with the use of one or more sulfonamide compounds.
Sulfisoxazole was generally well tolerated. Less than 0.1% of patients experienced serious side effects from sulfisoxazole.[Ref]
Hypersensitivity side effects have included anaphylaxis, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis, angioedema, arteritis and vasculitis, serum sickness, conjunctival and scleral injection, generalized allergic reactions, and allergic myocarditis.[Ref]
Hematologic side effects have included agranulocytosis, leukopenia, thrombocytopenia, aplastic anemia, purpura, hemolytic anemia, eosinophilia, clotting disorders including hypoprothrombinemia, hypofibrinogenemia, sulfhemoglobinemia, and methemoglobinemia.[Ref]
Hepatic side effects have included hepatitis, hepatocellular necrosis, and jaundice. Elevated liver-associated enzymes have been reported in patients with hepatitis. Rare cases of hepatic necrosis have been associated with some sulfonamides.[Ref]
Renal side effects have included elevated BUN and creatinine, acute renal failure, nephritis, and nephrosis with oliguria and anuria. The frequency of renal complications is lower with the more soluble sulfonamides, such as sulfisoxazole (the active ingredient contained in Gantrisin Pediatric) [Ref]
Gastrointestinal side effects have included pseudomembranous colitis, nausea, emesis, anorexia, abdominal pain, diarrhea, gastrointestinal hemorrhage, melena, flatulence, glossitis, stomatitis, enlarged salivary gland, and pancreatitis.
Pseudomembranous colitis has occurred during or after sulfisoxazole therapy.
Nervous system side effects have included headache, dizziness, peripheral neuritis, paresthesia, convulsions, drowsiness, hearing loss, insomnia, tinnitus, vertigo, ataxia, and intracranial hypertension.[Ref]
Other side effects have included edema (including periorbital), pyrexia, weakness, fatigue, lassitude, rigors, flushing, and chills.
Respiratory side effects have included cough, shortness of breath, pulmonary infiltrates, and pneumonitis.
Musculoskeletal side effects have included arthralgia and myalgia.
1. "Multum Information Services, Inc. Expert Review Panel"
2. Kounis GN, Kouni SA, Chiladakis JA, Kounis NG "Comment: Mesalamine-Associated Hypersensitivity Myocarditis in Ulcerative Colitis and the Kounis Syndrome (February)." Ann Pharmacother 43 (2009): 393-4
3. Flach A, Peterson J, Mathias T "Photosensitivity to topically applied sulfisoxazole ointment." Arch Ophthalmol 100 (1982): 1286-7
4. Roujeau JC, Kelly JP, Naldi L, et al. "Medication use and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis." N Engl J Med 333 (1995): 1600-7
5. Flach A "Photosensitivity to sulfisoxazole ointment." Arch Ophthalmol 99 (1981): 609-10
6. "Product Information. Gantrisin (sulfisoxazole)." Roche Laboratories, Nutley, NJ.
7. Boyer W, Lake C "Interaction of phenelzine and sulfisoxazole." Am J Psychiatry 140 (1983): 264-5
More about Gantrisin Pediatric (sulfisoxazole)
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Some side effects may not be reported. You may report them to the FDA.