pharmacopeia
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/api/v1/drug/fluorescein

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Dyes; Imaging Contrast Activity.

Indications

Sourced from openFDA
  • For testing tear film stability by determining the fluorescein break-up time (FBUT).

Contraindications

Sourced from openFDA
  • Hypersensitivity to components or mercury-containing compounds.contraindicated

Dosage & administration

Sourced from openFDA

DIRECTIONS FOR USE Procedure for measuring Fluorescein Break-up Time (FBUT) with Amcon Dry Eye Test Strips. 1. Apply one or two drops of non-preserved saline to the impregnated paper tip. Excess fluid will automatically fall off. Shaking is neither required nor desirable. 2. Ask the patient to look down and in. 3. Gently touch the strip to the superior temporal bulbar conjunctiva for one or two seconds. 4. Ask the patient to blink three times and open eyes naturally. 5. Conduct the FBUT measurements immediately. 6. Perform two consecutive measurements. If not consistent, conduct a third and average the results. 7. Repeat steps 1 through 6 using a new strip for the second eye FBUT values of less than 10 seconds are considered abnormal. Values less than 5 seconds are indicative of dry eye disorder. Values of 5 to 9 seconds are borderline dry eye. NOTE: The contents may not be sterile if the individual strip package has been damaged or previously opened. This product is intended for external use only. Keep out of reach of children. Store below 30°C.

Approval history

Sourced from openFDA
  • Mar 28, 2006NDANDA021980Alcon Labs Inc
  • Aug 8, 2008NDANDA022186Long Grove Pharms
  • Dec 14, 2017NDANDA208582Altaire Pharms Inc
  • Mar 9, 2020NDANDA211039Bausch Lomb Ireland
  • Sep 25, 2023ANDAANDA215709Nexus
  • Apr 30, 2026ANDAANDA220046Bpi Labs
  • Jun 1, 2026ANDAANDA218651Zydus Lifesciences

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
905 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea11012%
  2. 2Pruritus10311%
  3. 3Anaphylactic Shock879.6%
  4. 4Rash849.3%
  5. 5Dizziness788.6%
  6. 6Vomiting748.2%
  7. 7Dyspnoea728.0%
  8. 8Loss Of Consciousness606.6%
  9. 9Urticaria546.0%
  10. 10Chest Discomfort535.9%
  11. 11Visual Acuity Reduced525.7%
  12. 12Hyperhidrosis414.5%
  13. 13Syncope414.5%
  14. 14Anaphylactic Reaction374.1%
  15. 15Blood Pressure Decreased364.0%

Literature

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Recent PubMed references pinned to Fluorescein as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 290 ClinicalTrials.gov registrations naming Fluorescein as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Fluorescein work?
Mechanism-of-action classes: Dyes; Imaging Contrast Activity.
What is Fluorescein used for?
According to FDA labeling, Fluorescein carries indications including: For testing tear film stability by determining the fluorescein break-up time (FBUT).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Fluorescein?
Fluorescein is classified as Colouring agents, Diagnostic Dye, Dyes, Imaging Contrast Activity.
What are the brand names for Fluorescein?
Fluorescein is marketed under brand names including Altafluor, Flucaine, Fluoracaine.
What are the contraindications for Fluorescein?
Fluorescein labeling lists contraindications including: Hypersensitivity to components or mercury-containing compounds.. Always consult the full prescribing information and a clinician.
Note. Data for fluorescein is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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