FDA approved Fluorescite (fluorescein sodium) for Retinal and Iris AngiographyFDA approved Fluorescite injection for eye imaging tests.

FDA From the archive Source published March 28, 2006 Summary added June 13, 2026 DOI ↗ Editorial oversight: Dr. Lars van Dijk, PhD · Surgical, Procedural & Diagnostic

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Key Takeaway

Consider screening patients for allergy history before fluorescein angiography due to risk of anaphylaxis.

The FDA has approved Fluorescite Injection 10% (fluorescein sodium) for use in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. This approval provides clinicians with a standard diagnostic tool for evaluating retinal and iris blood flow. The drug is administered intravenously, with a typical adult dose of 500 mg. For children, dosing is calculated at 7.7 mg per kg of actual body weight, up to a maximum of 500 mg. Fluorescein angiography is a key procedure for detecting vascular abnormalities such as diabetic retinopathy, macular degeneration, and retinal vein occlusion. The approval is based on the drug's established role in ophthalmic imaging, though specific clinical trial data are not included in the label. Clinicians should be aware of the risk of hypersensitivity reactions, including rare cases of anaphylaxis, and should screen patients for prior allergic history before administration.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Fluorescein sodium is a diagnostic dye that, when injected intravenously, produces fluorescence upon excitation with blue light. This allows visualization of retinal and choroidal vasculature during angiography or angioscopy.

Indication & Patient Population

Fluorescite Injection 10% is indicated for diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature in adult and pediatric patients.

Dosing & Administration

Adult dose: 500 mg (5 mL of 10% solution) via intravenous administration. Pediatric dose: 7.7 mg per kg of actual body weight (or 35 mg per 10 pounds) up to a maximum of 500 mg IV. Administer rapidly (1 mL per second recommended) into the antecubital vein after ensuring no extravasation. Flush IV cannulas before and after injection. Do not mix or dilute with other solutions. Reduction to 2 mL may be appropriate when using a highly sensitive imaging system (e.g., scanning laser ophthalmoscope).

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Contraindicated in patients with known hypersensitivity to fluorescein sodium or any product ingredients. Rare cases of death due to anaphylaxis have been reported. Serious intolerance reactions are unpredictable but more frequent in patients with prior adverse reaction (other than nausea/vomiting) or history of allergy (food/drug urticaria, asthma, eczema, allergic rhinitis). Detailed questioning for allergy history is recommended before angiography.

Place in Therapy

Fluorescite is a standard diagnostic agent for fluorescein angiography, essential for evaluating retinal and iris vasculature in conditions such as diabetic retinopathy, age-related macular degeneration, and retinal vascular occlusions. It is a first-line imaging tool in ophthalmology.

The FDA has approved Fluorescite Injection 10% (fluorescein sodium) for use in diagnostic eye imaging tests. These tests, called fluorescein angiography or angioscopy, help doctors see blood flow in the retina and iris. The drug is given through a vein and is used to detect conditions such as diabetic retinopathy, macular degeneration, and retinal vein occlusion.

Fluorescite is for adults and children. The typical adult dose is 500 mg. For children, the dose is based on weight, up to a maximum of 500 mg. This approval is based on the drug's established role in eye imaging, not on new clinical trials.

This approval means that doctors have a standard, FDA-approved option for these important eye tests. It does not mean the drug is new or that it treats eye diseases directly. It is a diagnostic tool that helps doctors make better decisions about your eye health.

One important caveat: Fluorescite can cause allergic reactions, including rare but serious ones. Before you receive this drug, your doctor should ask about any allergies you have had in the past. If you have a history of allergies, especially to fluorescein, talk to your doctor about your risks and alternatives.

What this means for you:

Fluorescite is an FDA-approved dye for eye imaging tests; tell your doctor about any allergies before use.

Study Details

Study typeFda approval

PublishedMar 2006

View Original Abstract ↓

1 INDICATIONS AND USAGE FLUORESCITE ® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. FLUORESCITE ® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. (1)

FDA approved Fluorescite (fluorescein sodium) for Retinal and Iris AngiographyFDA approved Fluorescite injection for eye imaging tests.

Study Details

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FDA approved Fluorescite (fluorescein sodium) for Retinal and Iris AngiographyFDA approved Fluorescite injection for eye imaging tests.

Study Details

Systematic review of extensive macular atrophy with pseudodrusen reports visual acuity decline and atrophy progression

Eye disease linked to vision loss and thicker eye layers in study

Clinical research that matters. Delivered to your inbox.

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