Home FDA labels 4418402d-8008-00cf-e054-00144ff8d46c FDA label 4418402d-8008-00cf-e054-00144ff8d46c openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
SPL set ID acbd120b-c517-4acd-9fe9-04d8ae7465dc
SPL ID 4418402d-8008-00cf-e054-00144ff8d46c
Version 3
Effective date 2016-12-20
Source export date 2026-09-28
Source partition 2
Source file https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:16:40 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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warnings WARNINGS Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, anaphylaxis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitizations may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue use of this drug. Caution is advised for patients receiving concomitant high-dose aspirin and DIAMOX, as anorexia, tachypnea, lethargy, metabolic acidosis, coma, and death have been reported.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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adverse reactions ADVERSE REACTIONS Headache, malaise, fatigue, fever, pain at injection site, flushing, growth retardation in children, flaccid paralysis, anaphylaxis. Gastrointestinal disturbances such as nausea, vomiting, diarrhea. Blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, thrombocytopenic purpura, melena. Abnormal liver function, cholestatic jaundice, hepatic insufficiency, fulminant hepatic necrosis. Metabolic acidosis, electrolyte imbalance, including hypokalemia, hyponatremia, osteomalacia with long-term phenytoin therapy, loss of appetite, taste alteration, hyper/hypoglycemia. Drowsiness, paresthesia (including numbness and tingling of extremities and face), depression, excitement, ataxia, confusion, convulsions, dizziness. Allergic skin reactions including urticaria, photosensitivity, Stevens- Johnson syndrome, toxic epidermal necrolysis. Hearing disturbances, tinnitus, transient myopia. Crystalluria, increased risk of nephrolithiasis with long-term therapy, hematuria, glycosuria, renal failure, polyuria.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.