Fluorescein
Colouring Agents
Sold as FLUORESCITE
- Drug class
- Colouring Agents
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 7
- FDA reports (12 mo)
- 65
Overview
Plain-language summary, compiled from the cited regulatory records
Fluorescein is a diagnostic agent classified as a Colouring Agent [1]. It is approved for use in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature [1]. This agent is available in different concentrations, including 10% (100 mg/mL) and 25% (250 mg/mL) injections [1].
In the past 12 months, there have been 65 adverse event reports associated with fluorescein [2]. Common adverse reactions reported include pruritus, rash, vomiting, dizziness, and dyspnoea [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 5 | March 6, 2026 |
| US United States | FDA | 1 | October 25, 2023 |
| CA Canada | Health Canada | 1 | December 16, 2025 |
GBUnited Kingdom· MHRA
5 products
Uses
Fluorescein angiography of the ocular fundus. This medicinal product is for diagnostic use only.
How to take
USUnited States· FDA
1 product
Uses
1. INDICATIONS & USAGE Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. Fluorescein Injection, USP is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
( 1 )
How to take
CACanada· Health Canada
1 product
1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Brands in Canada (1)
Drug interactions
Known interactions involving Fluorescein. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL439560002 · revised March 6, 2026
- [2]FDA DailyMed · 0a2a65b1-dc88-44… · revised October 25, 2023 [PDF]
- [3]Health Canada (DPD) · 00505005 · revised December 16, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.