{"id":"fluorescein","rwe":[{"pmid":"41906915","year":"2026","title":"Copper sulfide nanoparticles coated with Fe-EGCG networks for targeted MR imaging and chemo/photothermal/chemodynamic synergetic therapy of tumors.","finding":"","journal":"Biomaterials science","studyType":"Clinical Study"},{"pmid":"41906288","year":"2026","title":"Exosomes of Porphyromonas gingivalis-Infected Macrophages Impair the Endothelial Barrier and Angiogenesis In Vitro.","finding":"","journal":"Oral diseases","studyType":"Clinical Study"},{"pmid":"41901820","year":"2026","title":"Polyelectrolyte Microcapsule Stability: Non-Monotonic Layer-Dependent Desorption Kinetics of Poly(allylamine hydrochloride).","finding":"","journal":"Polymers","studyType":"Clinical Study"},{"pmid":"41900998","year":"2026","title":"Potential Protective Effects of Naloxone in Traumatic Brain Injury Through JAK2/STAT3 Signaling Modulation.","finding":"","journal":"Life (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41900785","year":"2026","title":"Synthesis and Characterisation of Bioactive Fluorescent FITC-Insulin Glulisine Conjugates for Potential Use in Insulin Delivery.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"}],"_fda":{"id":"7490418c-b489-4b90-bc3d-33ed71231e2d","set_id":"04866053-f973-471e-b3bc-241fb76303a2","openfda":{"unii":["93X55PE38X"],"route":["OPHTHALMIC"],"spl_id":["7490418c-b489-4b90-bc3d-33ed71231e2d"],"brand_name":["Dry Eye Test"],"spl_set_id":["04866053-f973-471e-b3bc-241fb76303a2"],"package_ndc":["51801-008-15"],"product_ndc":["51801-008"],"generic_name":["FLUORESCEIN SODIUM"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["FLUORESCEIN SODIUM"],"manufacturer_name":["Nomax Inc."],"is_original_packager":[true]},"version":"3","how_supplied":["HOW SUPPLIED Carton of 50 pouches of two strips each."],"effective_time":"20191223","contraindications":["CONTRAINDICATIONS Hypersensitivity to components or mercury-containing compounds."],"instructions_for_use":["Grasp free tab ends of overwrap and slowly pull apart. Peel the overwrap back until the entire strip is exposed. 2. Gently lift the exposed strip off of the overwrap without damaging the impregnated tip."],"indications_and_usage":["INDICATIONS For testing tear film stability by determining the fluorescein break-up time (FBUT)."],"spl_unclassified_section":["Dry Eye Test Fluorescein Sodium Ophthalmic Strips U.S.P. diagnostic agent is for professional use only Each strip is impregnated with 0.12 mg of fluorescein sodium USP.","Nomax, Inc. • St. Louis, MO 63123 USA Rev. 12/13 MSN 015-153"],"dosage_and_administration":["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."],"spl_product_data_elements":["Dry Eye Test Fluorescein Sodium Fluorescein Sodium FLUORESCEIN paper is white and tip is orange with tapered end"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 Sterile Strips (50 Pouches of 2 Strips Each) DET box"]},"tags":[{"label":"Diagnostic Dye","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Cytochrome P450 2C19","category":"target"},{"label":"CYP2C19","category":"gene"},{"label":"PRMT1","category":"gene"},{"label":"S01JA01","category":"atc"},{"label":"Ophthalmic","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Solution","category":"form"},{"label":"Solution/ Drops","category":"form"},{"label":"Strip","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Active","category":"status"},{"label":"Fluorescein staining of eye","category":"indication"},{"label":"Novartis","category":"company"},{"label":"Approved 2020s","category":"decade"},{"label":"Coloring Agents","category":"pharmacology"},{"label":"Contrast Media","category":"pharmacology"},{"label":"Diagnostic Uses of Chemicals","category":"pharmacology"},{"label":"Fluorescent Dyes","category":"pharmacology"},{"label":"Indicators and Reagents","category":"pharmacology"},{"label":"Luminescent Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":301.351,"date":"","count":76,"signal":"Anaphylactic shock","source":"DrugCentral FAERS","actionTaken":"Reported 76 times (LLR=301)"},{"llr":96.024,"date":"","count":40,"signal":"Anaphylactic reaction","source":"DrugCentral FAERS","actionTaken":"Reported 40 times (LLR=96)"},{"llr":60.643,"date":"","count":34,"signal":"Chest discomfort","source":"DrugCentral FAERS","actionTaken":"Reported 34 times (LLR=61)"},{"llr":59.753,"date":"","count":11,"signal":"Haemangioma congenital","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=60)"},{"llr":57.162,"date":"","count":37,"signal":"Urticaria","source":"DrugCentral FAERS","actionTaken":"Reported 37 times (LLR=57)"},{"llr":53.458,"date":"","count":49,"signal":"Pruritus","source":"DrugCentral FAERS","actionTaken":"Reported 49 times (LLR=53)"},{"llr":52.556,"date":"","count":7,"signal":"Histamine level increased","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=53)"},{"llr":51.699,"date":"","count":17,"signal":"Cold sweat","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=52)"}],"commonSideEffects":[{"effect":"Skin discoloration","drugRate":"","severity":"common","organSystem":""},{"effect":"Urine discoloration","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Gastrointestinal distress","drugRate":"","severity":"common","organSystem":""},{"effect":"Strong taste","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""}],"specialPopulations":{"Pregnancy":"Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to pregnant woman. Fluorescein sodium should be given to pregnant woman only if clearly needed.","Geriatric use":"No overall differences in safety or effectiveness have been observed between elderly and other adult patients.","Paediatric use":"Pediatric patients have been included in clinical studies. No overall differences in safety or effectiveness have been observed between pediatric and adult patients."},"seriousAdverseEvents":[{"effect":"Anaphylaxis","drugRate":"","severity":"serious"},{"effect":"Bronchospasm","drugRate":"","severity":"serious"},{"effect":"Generalized hives and itching","drugRate":"","severity":"serious"},{"effect":"Syncope","drugRate":"","severity":"serious"},{"effect":"Hypotension","drugRate":"","severity":"serious"},{"effect":"Cardiac arrest","drugRate":"","severity":"serious"},{"effect":"Basilar artery ischemia","drugRate":"","severity":"serious"},{"effect":"Severe shock","drugRate":"","severity":"serious"},{"effect":"Death","drugRate":"","severity":"serious"},{"effect":"Convulsions","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Novartis","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FLUORESCEIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:42:37.020173+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T05:42:55.304328+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:42:43.552010+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLUORESCEIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:42:44.229143+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:42:34.936490+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:42:34.936561+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL177756/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:42:44.700423+00:00"}},"allNames":"fluorescite","offLabel":[],"synonyms":["fluorescein","fluorescein acid","resorcinolphthalein","yellow fluorescein","fluorescein sodium"],"timeline":[{"date":"2006-03-28","type":"positive","source":"FDA Orange Book","milestone":"Fluorescite approved — EQ 500MG BASE/5ML (EQ 100MG BASE/ML)"},{"date":"2008-08-08","type":"positive","source":"FDA Orange Book","milestone":"Ak-Fluor 10% approved — EQ 500MG BASE/5ML (EQ 100MG BASE/ML)"},{"date":"2020-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BAUSCH to Novartis"},{"date":"2020-03-09","type":"positive","source":"DrugCentral","milestone":"FDA approval (Bausch)"},{"date":"2023-09-25","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Fluorescein, marketed as Fluorescite by Novartis, is a well-established drug used for fluorescein staining of the eye, with a key composition patent expiring in 2028. Its primary competitive advantage lies in its mechanism of action, which involves binding to Cytochrome P450 2C19 to effectively visualize the eye's structures during staining. The primary risk is competition from same-class drugs like rose bengal, whose patent status is unknown, potentially impacting market share.","approvals":[{"date":"2020-03-09","orphan":false,"company":"BAUSCH","regulator":"FDA"}],"brandName":"Fluorescite","ecosystem":[{"indication":"Fluorescein staining of eye","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Cytochrome P450 2C19","novelty":"Follow-on","targets":[{"gene":"CYP2C19","source":"DrugCentral","target":"Cytochrome P450 2C19","protein":"Cytochrome P450 2C19"},{"gene":"PRMT1","source":"DrugCentral","target":"Protein arginine N-methyltransferase 1","protein":"Protein arginine N-methyltransferase 1"}],"moaClass":"Dyes","modality":"Small Molecule","drugClass":"Diagnostic Dye","explanation":"","oneSentence":"","technicalDetail":"Fluorescein binds to the active site of Cytochrome P450 2C19, a member of the cytochrome P450 enzyme family, which is involved in the metabolism of various substances. This binding causes the enzyme to fluoresce, allowing for visualization of the eye's structures during staining."},"commercial":{"launchDate":"2020","_launchSource":"DrugCentral (FDA 2020-03-09, BAUSCH)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1207","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=FLUORESCEIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLUORESCEIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T11:32:00.522742","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T05:42:55.304891+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"rose bengal","drugSlug":"rose-bengal","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"fluorescein","indications":{"approved":[{"name":"Fluorescein staining of eye","source":"DrugCentral","snomedId":414273009,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned, but generally considered safe for use in adults and children. However, use in children should be done with caution and under the guidance of a healthcare professional."}],"offLabel":[{"name":"Administration of Corneal Anesthesia","source":"DrugCentral","drugName":"FLUORESCEIN"},{"name":"Local Anesthesia for Ophthalmologic Procedure","source":"DrugCentral","drugName":"FLUORESCEIN","evidenceCount":28,"evidenceLevel":"moderate"}],"pipeline":[]},"currentOwner":"Novartis","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"rose-bengal","brandName":"rose bengal","genericName":"rose bengal","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07352930","phase":"NA","title":"A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Guangdong Provincial People's Hospital","startDate":"2026-04-01","conditions":["Breast-Conserving Surgery"],"enrollment":172,"completionDate":"2027-03-31"},{"nctId":"NCT07224529","phase":"PHASE4","title":"Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction","status":"NOT_YET_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2026-04-01","conditions":["Meibomian Gland Dysfunction (MGD)"],"enrollment":48,"completionDate":"2027-02-01"},{"nctId":"NCT07463677","phase":"PHASE2","title":"Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2026-03-15","conditions":["Lung Cancer (NSCLC)"],"enrollment":55,"completionDate":"2029-03-31"},{"nctId":"NCT07298356","phase":"NA","title":"Automated Applanation Tonometry - Updated","status":"RECRUITING","sponsor":"Duke University","startDate":"2026-03-02","conditions":["Glaucoma","Glaucoma, Suspect"],"enrollment":200,"completionDate":"2026-12-29"},{"nctId":"NCT06416371","phase":"","title":"Retinal Vessel Leakage in Cerebral Small Vessel Disease","status":"RECRUITING","sponsor":"University of Edinburgh","startDate":"2025-01-13","conditions":["Cerebral Small Vessel Diseases","Lacunar Stroke","Vascular Dementia"],"enrollment":40,"completionDate":"2029-02-15"},{"nctId":"NCT06414590","phase":"PHASE2","title":"Neoadjuvant Tebentafusp for Uveal Melanoma","status":"RECRUITING","sponsor":"Thomas Jefferson University","startDate":"2025-09-05","conditions":["Locally Advanced Unresectable Uveal Melanoma"],"enrollment":19,"completionDate":"2032-03"},{"nctId":"NCT05615740","phase":"NA","title":"Prevention of Onset and Transition to an Advanced Form of Diabetic Retinopathy in Children","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Hospital Ostrava","startDate":"2022-05-02","conditions":["Diabetic Retinopathy"],"enrollment":187,"completionDate":"2026-12"},{"nctId":"NCT07233954","phase":"","title":"Intraoperative Use of I.V. 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