Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fluorescein
Drug ID BADD_D00926
Description A phthalic indicator dye that appears yellow-green in normal tear film and bright green in a more alkaline medium, such as the aqueous humor, and is used therapeutically as a diagnostic aid in corneal injuries and corneal trauma. It has been approved by FDA for use in externally applied drugs and cosmetics. (From Merck Index, 12th ed; American Medical Association Drug Evaluations; 1995, p2275)
Indications and Usage For diagnostic imaging. Primarily indicated in diagnostic fluorescein angiography or angioscopy of the fundus and of the iris vasculature.
Marketing Status approved
ATC Code S01JA01
DrugBank ID DB00693
KEGG ID D01261
MeSH ID D019793
PubChem ID 16850
TTD Drug ID D06TJJ
NDC Product Code 45633-100; 11712-375; 51662-1533
UNII TPY09G7XIR
Synonyms Fluorescein | Optifluor Diba | Fluorescein Dipotassium Salt | Dipotassium Salt, Fluorescein | C.I. 45350 | D & C Yellow No. 7 | D&C Yellow No. 7 | D and C Yellow No. 7 | Fluorescein Monosodium Salt | Monosodium Salt, Fluorescein | Fluorescein Sodium | Sodium, Fluorescein | D & C Yellow No. 8 | Sodium Fluorescein | Fluorescein, Sodium | D and C Yellow No. 8 | D&C Yellow No. 8 | Fluorescite | Colircusi Fluoresceina | Fluoresceina, Colircusi | Diofluor | Fluorets | Minims Fluoresceine | Fluoresceine, Minims | Fluorescéine sodique Faure | Ful-Glo | Ful Glo | Funduscein | Minims Fluorescein Sodium | Fluorescein Sodium, Minims | Minims Stains | Disodium Fluorescein | Fluorescein, Disodium | Fluorescein Disodium Salt | Disodium Salt, Fluorescein | Uranine | Fluor-I-Strip A.T. | Fluor I Strip A.T.
Chemical Information
Molecular Formula C20H12O5
CAS Registry Number 2321-07-5
SMILES C1=CC=C2C(=C1)C(=O)OC23C4=C(C=C(C=C4)O)OC5=C3C=CC(=C5)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.0030.000591%
Lip swelling10.01.05.005; 23.04.01.007; 07.05.04.0050.000107%Not Available
Loss of consciousness17.02.04.0040.000591%Not Available
Macular degeneration06.09.03.001--Not Available
Macular oedema06.04.06.005--Not Available
Malaise08.01.01.0030.000398%
Menopausal symptoms21.02.02.002--Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.000107%
Mydriasis17.02.11.003; 06.05.03.0040.000107%Not Available
Myocardial ischaemia24.04.04.010; 02.02.02.0080.000107%Not Available
Nasal congestion22.04.04.001--
Nasal oedema22.04.03.012--Not Available
Nausea07.01.07.0010.002869%
Neoplasm16.16.02.001--Not Available
Nervous system disorder17.02.10.001--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Pain08.01.08.004--
Pallor24.03.04.001; 23.03.03.031; 08.01.03.0320.000376%Not Available
Palpitations02.11.04.0120.000537%
Papule23.03.03.0380.000161%Not Available
Paraesthesia23.03.03.094; 17.02.06.0050.000290%
Peripheral vascular disorder24.03.01.003--Not Available
Pruritus23.03.12.0010.001709%
Pulmonary oedema22.01.03.003; 02.05.02.0030.000161%
Pyrexia08.05.02.0030.000376%
Rash23.03.13.0010.001601%Not Available
Rash erythematous23.03.13.0290.000269%Not Available
Rash papular23.03.13.0170.000107%Not Available
Rash pruritic23.03.13.0300.000505%Not Available
Renal failure20.01.03.0050.000161%Not Available
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