FDA label 542806e4-8a0e-4376-89fe-004e69e75292

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
9d5e2c9e-9a70-45e2-a497-4ec1c51d5f51
SPL ID
542806e4-8a0e-4376-89fe-004e69e75292
Version
4
Effective date
2017-01-14
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:31

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sulfacetamide sodium topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Reports of irritation and hypersensitivity to sulfacetamide sodium are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sulfacetamide sodium, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome has been reported (see WARNINGS ).

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.