Fluorescein: uses, dosing, side effects & brands

Fluorescein is a diagnostic dye sold in the U.S. under 4 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Diagnostic Dye
Available as: Injectable
Sold as: 4 products — Funduscein-25, Ak-Fluor 10% and Ak-Fluor 25%, and others
Prescription?: Prescription only
Generic available?: Not in our catalog

How fluorescein is dosed

From the FDA label for Ak-Fluor 10% (application NDA022186). Other fluorescein products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

The normal adult dose of AK-FLUOR ® 10% is 5 mL (500 mg) via intravenous administration. ( 2.1 ) For children, the dose should be calculated on the basis of 35 mg for each 4.54 kg of body weight. (7.7 mg/kg body weight) ( 2.1 ) Do not mix or dilute with other solutions or drugs. ( 2.2 ) 2.1 Dosing Adult Dose The recommended dosage of AK-FLUOR ® 10% (100 mg/mL) is 500 mg via intravenous administration. Pediatric Dose For children, the dose is 7.7 mg/kg (actual body weight) up to a maximum of 500 mg, via intravenous infusion calculated on the basis of 35 mg for each 4.54 kg of body weight. 2.2 Preparation for Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not mix or dilute with other solutions or drugs. Discard unused portion. 2.3 Administration Inject the dose (over 5-10 seconds is normally recommended) into the antecubital vein, after taking precautions to avoid extravasation. A syringe, filled with AK-FLUOR ® , may be attached to transparent tubing and a 23 gauge butterfly needle for injection. Insert the needle and draw the patient's blood to the hub of the syringe so that a small air bubble separates the patient's blood in the tubing from the fluorescein. With the room lights on, slowly inject the blood back into the vein while watching the skin over the needle tip. If the needle has…

Fluorescein side effects

The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Long Grove Pharmaceuticals, LLC at 1-855-642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 ) 6.1 Skin and urine discoloration The most common reaction is discoloration of the skin and urine. Skin will attain a temporary yellowish discoloration. Urine attains a bright yellow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours. 6.2 Gastrointestinal Reaction The next most common adverse reaction is nausea. Vomiting, and gastrointestinal distress have also occurred. A strong taste may develop after injection. 6.3 Hypersensitivity Reactions Symptoms and signs of hypersensitivity have occurred. Generalized hives and itching, bronchospasm and anaphylaxis have been reported. [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.1 ) ] 6.4 Cardiopulmonary Reactions Syncope and hypotension may occur. Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely. [see Warnings and Precautions ( 5.1 ) ] 6.5 Neurologic Reactions Headache may occur. Convulsions may rarely occur following injection. 6.6 Thrombophlebitis Thrombophlebitis at the injection site has been reported. Extravasation of the solution at the…

Who shouldn’t take fluorescein

Hypersensitivity to any component of this product. ( 4.1 ) 4.1 Hypersensitivity AK-FLUOR is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )].

Every fluorescein product we track (4)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Fluorescein products
#	Drug	Rating	Type	Form	Generic?	Pharmacy pays
1	Funduscein-25	70/100	Prescription	Injectable	No data	—	View →
2	Ak-Fluor 10%	Not yet rated	Prescription	Injectable	No data	—	View →
3	Ak-Fluor 25%	Not yet rated	Prescription	Injectable	No data	—	View →
4	Fluorescite	Not yet rated	Prescription	Injectable	No data	—	View →

Combination products containing fluorescein

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

Altafluor Benox

Fluorescein recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long fluorescein keeps

No fluorescein label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does fluorescein expire? The in-use limits and storage rules from its labels

Fluorescein and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Because absorption from the eye is limited, fluorescein would not be expected to cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Full LactMed record for fluorescein: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about fluorescein

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 360 reports naming fluorescein, and the FDA flagged 94% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

pruritus52 reports
nausea40 reports
dizziness33 reports
rash33 reports
anaphylactic shock32 reports
vomiting29 reports
loss of consciousness24 reports
hyperhidrosis22 reports

Read these as a signal, not a rate. A report does not mean fluorescein caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved August 25, 2026.

Related calculators

How long it stays in your system →

Frequently asked questions

What is fluorescein?

AK-FLUOR (fluorescein injection) contains fluorescein sodium, a diagnostic aid, in a sterile solution for use intravenously. It is a dark reddish orange clear solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg.

What kind of drug is fluorescein?

The FDA classifies fluorescein as a diagnostic dye. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take fluorescein with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run fluorescein against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is fluorescein sold under?

We track 4 fluorescein-containing products in the U.S.: Funduscein-25, Ak-Fluor 10%, Ak-Fluor 25% and Fluorescite. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does fluorescein come in?

Across the brands we track, fluorescein is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic fluorescein?

We do not currently list a generic-labelled fluorescein product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Has fluorescein been recalled?

The FDA's Enforcement database lists 4 recall records whose product description mentions fluorescein. The most recent: BioGlo Fluorescein Sodium Ophthalmic Strips USP (Dec 31, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Cite this page

APA: pharmaranks. (2026, July 24). Fluorescein: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/fluorescein
MLA: “Fluorescein: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/fluorescein.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for fluorescein on DailyMed (NIH) ↗.