Home FDA labels 37ffbc23-adf5-052b-e054-00144ff88e88 FDA label 37ffbc23-adf5-052b-e054-00144ff88e88 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 d478769c-1137-44a8-a3eb-301ad053c3e7
SPL ID 37ffbc23-adf5-052b-e054-00144ff88e88
Version 3
Effective date 2016-07-19
Source export date 2026-08-17
Source partition 10
Source file https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-17/02a497ed455224db2b03c6e57c80c30915819e1b465153908a5d9e68e3a47b21/drug-label-0010-of-0014.json.zip
Source manifest SHA-256 ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run 20260818T065550Z
Imported at 2026-08-18 08:07:57 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 WARNINGS The sulfonamides should not be used for the treatment of group A betahemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis. Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias. The presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders. The frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.
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adverse reactions ADVERSE REACTIONS Blood Dyscrasias Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia and methemoglobinemia. Allergic Reactions Erythema multiforme (Stevens-Johnson syndrome), generalized skin eruptions, epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, drug fever and chills. Gastrointestinal Reactions Nausea, emesis, abdominal pains, hepatitis, diarrhea, anorexia, pancreatitis and stomatitis. C.N.S. Reactions Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo and insomnia. Renal Crystalluria, stone formation, toxic nephrosis with oliguria and anuria; periarteritis nodosa and lupus erythematosus phenomenon have been noted. Miscellaneous Reactions The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Goiter production, diuresis, and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents.