FDA label a0bc3cb4-d400-477d-9bf9-730b429c491f

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
9b095c9e-3a49-49b0-af66-8b010170f798
SPL ID
a0bc3cb4-d400-477d-9bf9-730b429c491f
Version
2
Effective date
2012-03-26
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:42:11

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Severe adverse reactions have been reported with the use of fluorescein sodium injection. These are cardiac arrest, acute myocardial infarction, basilar artery ischemia, severe shock and other signs and symptoms of hypersensitivity. convulsions. syncope. thrombophlebitis at the injection site, and transient dyspnea. See PRECAUTIONS.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

adverse reactions

ADVERSE REACTIONS The following adverse reactions have been reported after use of fluorescein sodium injection: cardiac arrest, acute myocardial infarction, basilar artery ischemia, thrombophlebitis at the injection site, severe shock, and other signs and symptoms of hypersensitivity, convulsions, syncope, pyrexia, transient dyspnea, angioneurotic edema, moderate to marked nausea and headache, gastrointestinal distress, slight dizziness, urticaria and pruritus. Rare cases of death have been reported. The most common reaction is nausea, reported to occur in 1-15% of all patients. Extravasation of the solution at the injection site causes intense pain at the site and dull, aching pain in the injection arm, These symptoms are self-limiting, These reactions generally are noted soon after injection and may occur irrespective of previous exposure to the dye. Localized eczematous dermatitis is reported rarely to have occurred one day after injection. To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc. at (631) 722-5988 • 9am -5pm EST Monday -Friday.

Reported adverse events (FAERS/openFDA)#

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