Fluorescein
Ak-fluor, Altafluor Benox, Fluorescein, Fluorescite (fluorescein) is a small molecule pharmaceutical. Fluorescein was first approved as Funduscein-25 on 1982-01-01.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Ak-fluor, Fluorescein, Fluorescite (discontinued: Ak-fluor, Funduscein)
CombinationsAltafluor benox, Fluorescein benoxinate
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluorescein sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FLUORESCITE | Alcon Research | N-021980 RX | 2006-03-28 | 1 products, RLD, RS |
| AK-FLUOR 10% | Long Grove Pharmaceuticals | N-022186 RX | 2008-08-08 | 1 products, RLD, RS |
Show 2 discontinued
Benoxinate hydrochloride
+
Fluorescein sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ALTAFLUOR BENOX | Altaire Pharmaceuticals | N-208582 RX | 2017-12-14 | 1 products, RLD, RS |
| FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE | Bausch Health Companies | N-211039 RX | 2020-03-09 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ak-fluor | New Drug Application | 2024-12-06 |
| altafluor | New Drug Application | 2017-12-30 |
| bioglo | unapproved drug other | 2024-01-01 |
| c20h10na2o5 fluorescein sodium ophthalmic strips | unapproved drug other | 2025-06-01 |
| dry eye test | unapproved drug other | 2019-12-23 |
| fluorecein sodium and proparacaine hydrochloride | unapproved drug other | 2014-07-17 |
| fluorescein | ANDA | 2023-10-25 |
| fluorescein sodium and benoxinate hydrochloride | New Drug Application | 2025-05-12 |
| fluorescein sodium and proparacaine hydrochloride | unapproved drug other | 2022-10-28 |
| fluorescite | New Drug Application | 2023-12-14 |
Show 2 more
Indications
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Agency Specific
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HCPCS
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Clinical
Clinical Trials
242 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinal diseases | D012164 | — | H35.9 | 3 | 3 | 1 | 3 | 13 | 22 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 4 | 2 | 1 | 2 | 12 | 20 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | 4 | 4 | 1 | 12 | 20 |
| Dry eye syndromes | D015352 | — | H04.12 | — | 3 | — | 1 | 16 | 20 |
| Macular edema | D008269 | — | — | 2 | 3 | 3 | 3 | 6 | 16 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | 2 | — | 1 | 12 | 15 |
| Edema | D004487 | — | R60.9 | 2 | 3 | 2 | 2 | 5 | 13 |
| Syndrome | D013577 | — | — | — | — | — | 1 | 6 | 7 |
| Central serous chorioretinopathy | D056833 | — | H35.71 | — | 1 | 1 | 1 | 4 | 6 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | 2 | 3 | 6 |
Show 12 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | 1 | — | 3 | — | 6 | 10 |
| Choroidal neovascularization | D020256 | — | — | 1 | 3 | 4 | — | 1 | 8 |
| Pathologic neovascularization | D009389 | — | — | 1 | 3 | 4 | — | 1 | 8 |
| Myopia | D009216 | EFO_0003927 | H52.1 | 1 | 1 | 1 | — | 1 | 4 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | — | 1 | — | 3 | 4 |
| Telangiectasis | D013684 | — | — | 2 | — | 1 | — | — | 3 |
| Wet macular degeneration | D057135 | EFO_0004683 | — | — | 1 | 1 | — | 2 | 3 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | 2 | 2 | — | 1 | 3 |
| Vision disorders | D014786 | — | H53.11 | — | — | 1 | — | 1 | 2 |
| Low vision | D015354 | — | — | — | — | 1 | — | 1 | 2 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 3 | 1 | — | — | 6 | 9 |
| Melanoma | D008545 | — | — | 1 | 3 | — | — | 2 | 5 |
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | — | — | 3 | 5 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 3 | 1 | — | — | 1 | 4 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | 1 | — | — | 1 | 3 |
| Uveitis | D014605 | EFO_1001231 | H20.9 | — | 1 | — | — | 2 | 3 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 2 | — | — | 1 | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 2 | — | — | 1 | 3 |
| Fibrosis | D005355 | — | — | 2 | 1 | — | — | 1 | 3 |
| Pterygium | D011625 | — | H11.0 | — | 1 | — | — | 1 | 2 |
Show 23 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | 3 | 4 |
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | 3 | 4 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | 2 | 3 |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | 1 | — | — | — | 2 | 3 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | 1 | 2 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 1 | — | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | — | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | — | — | 1 |
| Orthostatic hypotension | D007024 | — | I95.1 | 1 | — | — | — | — | 1 |
Show 14 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eye diseases | D005128 | EFO_0003966 | H44 | — | — | — | — | 7 | 7 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 6 | 6 |
| Recurrence | D012008 | — | — | — | — | — | — | 4 | 4 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 4 | 4 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | — | — | — | 4 | 4 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | — | — | — | 4 | 4 |
| Rectal neoplasms | D012004 | — | — | — | — | — | — | 3 | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 3 | 3 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 3 | 3 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | — | 3 | 3 |
Show 114 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fluorescein |
| INN | _ |
| Description | Fluorescein (lactone form) is a xanthene dye that is highly fluorescent, detectable even when present in minute quantities. Used forensically to detect traces of blood, in analytical chemistry as an indicator in silver nitrate titrations and in microscopy. It has a role as a radioopaque medium and a fluorescent dye. It is a xanthene dye, a gamma-lactone, a polyphenol, an oxaspiro compound, a member of 2-benzofurans and an organic heteropentacyclic compound. It is functionally related to a fluorescein (acid form). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1C=CC2C(=C1)Oc1cc(O)ccc1C21OC(=O)c2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 2321-07-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297067 |
| ChEBI ID | — |
| PubChem CID | 16850 |
| DrugBank | DB00693 |
| UNII ID | TPY09G7XIR (ChemIDplus, GSRS) |
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Fluorescein
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Trends
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Safety
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Adverse Events
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1,028 adverse events reported
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