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
- 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
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | a0bc3cb4-d400-477d-9bf9-730b429c491f | id | |
| spl set id | 9b095c9e-3a49-49b0-af66-8b010170f798 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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
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.