{"id":"riboflavin","rwe":[{"pmid":"41906339","year":"2026","title":"Oral riboflavin supplementation and sunlight exposure: A possible novel and accessible approach to stabilize progressive keratoconus.","finding":"","journal":"European journal of ophthalmology","studyType":"Clinical Study"},{"pmid":"41901235","year":"2026","title":"Biosynthesis, Regulation, and Biotechnological Production Strategies of Riboflavin (Vitamin B(2)) and Its Derivatives: A Review.","finding":"","journal":"Pharmaceuticals (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41895370","year":"2026","title":"Biochemical pathways linking adiposity, diet, and endometrial carcinogenesis.","finding":"","journal":"Biochimie","studyType":"Clinical Study"},{"pmid":"41893670","year":"2026","title":"Integrated Transcriptomics Reveals a SHEV ORF3-Mediated circRNA Network That Disrupts Riboflavin Metabolism and Activates the ko05212 Pathway.","finding":"","journal":"Veterinary sciences","studyType":"Clinical Study"},{"pmid":"41893350","year":"2026","title":"Dietary Citrus Peel Supplementation Enhances Hepatic Energy Metabolism, Muscle 9-HODE Generation and Isoleucine Catabolism in Beef Cattle.","finding":"","journal":"Metabolites","studyType":"Clinical Study"}],"_fda":{"id":"d9913eda-a019-4227-9dd3-9e8358dec165","set_id":"06508e37-5ae6-4a17-bf60-b3828c6082a7","openfda":{"nui":["N0000193618","M0001797"],"upc":["0105420121004"],"unii":["PQ6CK8PD0R","6SO6U10H04","568ET80C3D","8406EY2OQA","935E97BOY8","25X51I8RD4","68Y4CF58BV","TLM2976OFR","8K0I04919X","K72I3DEX9B"],"route":["ORAL"],"spl_id":["d9913eda-a019-4227-9dd3-9e8358dec165"],"brand_name":["Dialyvite with Zinc"],"spl_set_id":["06508e37-5ae6-4a17-bf60-b3828c6082a7"],"package_ndc":["10542-012-10","10542-012-02"],"product_ndc":["10542-012"],"generic_name":["ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Ascorbic Acid [CS]"],"substance_name":["ASCORBIC ACID","BIOTIN","CALCIUM PANTOTHENATE","COBALAMIN","FOLIC ACID","NIACINAMIDE","PYRIDOXINE HYDROCHLORIDE","RIBOFLAVIN","THIAMINE MONONITRATE","ZINC CITRATE"],"pharm_class_epc":["Vitamin C [EPC]"],"manufacturer_name":["Hillestad Pharmaceuticals USA"],"is_original_packager":[true]},"version":"5","description":["DESCRIPTION Dialyvite with Zinc is a prescription folic acid supplement with zinc and additional nutrients for kidney dialysis patients. Dialyvite with Zinc is a small, round, yellow, clear-coated tablet, with debossed \"H\" on one side. Each tablet contains: Folic Acid.....1 mg Vitamin C (Ascorbic Acid).....100 mg Thiamine (Thiamine Mononitrate).....1.5 mg Riboflavin.....1.7 mg Niacinamide.....20 mg Vitamin B6 (Pyridoxine HCl).....10 mg Vitamin B12 (Methylcobalamin).....6 mcg Biotin.....300 mcg Pantothenic Acid (Calcium Pantothenate).....10 mg Zinc (Zinc Citrate).....50 mg Inactive ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Starch, Calcium Stearate."],"precautions":["PRECAUTIONS Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress. Keep out of reach of children."],"effective_time":"20260127","adverse_reactions":["ADVERSE REACTIONS Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with known hypersensitivity to any of the ingredients."],"indications_and_usage":["INDICATIONS AND USAGE Dialyvite with Zinc is a prescription folic acid supplement with Zinc and additional nutrients indicated for use in improving the nutritional status of renal dialysis patients."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Take one tablet per day or as directed by your physician, orally."],"spl_product_data_elements":["Dialyvite with Zinc Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc Ascorbic Acid Ascorbic Acid Thiamine Mononitrate Thiamine Ion Thiamine Riboflavin Riboflavin Niacinamide Niacinamide Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid Cobalamin Cobalamin Biotin Biotin Calcium Pantothenate Pantothenic Acid Zinc Citrate Zinc Cation Microcrystalline Cellulose Croscarmellose Sodium Glyceryl Monostearate Shellac Starch, Corn Calcium Stearate H"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 10542-012-10 Dialyvite with Zinc Multivitamin Supplement for Dialysis Patients 100 Tablets Dialyvite with Zinc PDP"]},"tags":[{"label":"riboflavin (vit B2)","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Flavin reductase (NADPH)","category":"target"},{"label":"BLVRB","category":"gene"},{"label":"RFK","category":"gene"},{"label":"A11HA04","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Mineral Deficiency Prevention","category":"indication"},{"label":"Mineral deficiency","category":"indication"},{"label":"Vitamin Deficiency Prevention","category":"indication"},{"label":"Vitamin deficiency","category":"indication"},{"label":"Glaukos","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Dermatologic Agents","category":"pharmacology"},{"label":"Micronutrients","category":"pharmacology"},{"label":"Photosensitizing Agents","category":"pharmacology"},{"label":"Radiation-Sensitizing Agents","category":"pharmacology"},{"label":"Vitamin B Complex","category":"pharmacology"},{"label":"Vitamins","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"3296 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"2241 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"2214 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"2049 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"1786 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1633 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"1630 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"1510 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"1431 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"1371 reports"}],"commonSideEffects":[{"effect":"Pemphigus","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Systemic lupus erythematosus","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Glossodynia","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Hand deformity","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Arthropathy","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Rheumatoid arthritis","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Alopecia","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Abdominal discomfort","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Wound","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Maternal exposure during pregnancy","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Toxicity to various agents","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Completed suicide","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Synovitis","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Joint swelling","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Contraindicated product administered","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3}],"contraindications":["Acute Thromboembolic Stroke","Agoraphobia","Alcoholism","Atrophic gastritis","Blood coagulation disorder","Cardiovascular event risk","Chronic heart failure","Conduction disorder of the heart","Coronary artery bypass graft","Disease of liver","Gastrectomy","Gastrointestinal hemorrhage","Gastrointestinal perforation","Gastrointestinal ulcer","Hemophilia","Hepatic failure","Hypertensive disorder","Hypokalemia","Impaired renal function disorder","Insomnia","Kidney disease","Leber's optic atrophy","Low blood pressure","Myocardial infarction","Myocardial infarction in recovery phase"],"specialPopulations":{"Pregnancy":"Methaver is not intended for use as prenatal/postnatal multivitamin for lactating and non-lactating mother. This product contains vitamins in active form. Talk with your medical practitioner before using if pregnant or lactating.","Paediatric use":"Not for pediatric use."}},"trials":[],"aliases":[],"company":"Glaukos","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=RIBOFLAVIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:38:12.559551+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:38:19.040610+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:38:11.194358+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=RIBOFLAVIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:38:19.681365+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:38:10.014435+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:38:10.014497+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:38:10.014511+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:38:21.240784+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1534/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:38:20.193142+00:00"}},"allNames":"infuvite pediatric","offLabel":[],"synonyms":["riboflavine","beflavine","lactoflavin","lactoflavine","Vitamin B2","riboflavin (vit B2)","riboflavin"],"timeline":[{"date":"1953-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from HOSPIRA to Glaukos"},{"date":"1953-02-20","type":"positive","source":"DrugCentral","milestone":"FDA approval (Hospira)"},{"date":"2025-10-17","type":"positive","source":"FDA Orange Book","milestone":"Epioxa Hd/Epioxa Kit approved — EQ 0.239% BASE/ML;EQ 0.177% BASE/ML"}],"aiSummary":"Infuvite Pediatric (Riboflavin) is a small molecule drug developed by HOSPIRA and currently owned by Glaukos. It targets the enzyme flavin reductase (NADPH) and belongs to the drug class of riboflavin (vitamin B2). Infuvite Pediatric is FDA-approved for the prevention of mineral and vitamin deficiencies, with an approval date of 1953. The drug is off-patent, meaning it is no longer protected by active patents. As a result, there are currently no generic manufacturers of the drug.","approvals":[{"date":"1953-02-20","orphan":false,"company":"HOSPIRA","regulator":"FDA"}],"brandName":"Infuvite Pediatric","ecosystem":[{"indication":"Mineral Deficiency Prevention","otherDrugs":[{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"},{"name":"folic acid","slug":"folic-acid","company":"Lederle"},{"name":"retinol","slug":"retinol","company":"Hospira"},{"name":"thiamine","slug":"thiamine","company":"Hospira"}],"globalPrevalence":null},{"indication":"Mineral deficiency","otherDrugs":[{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"},{"name":"folic acid","slug":"folic-acid","company":"Lederle"},{"name":"retinol","slug":"retinol","company":"Hospira"},{"name":"thiamine","slug":"thiamine","company":"Hospira"}],"globalPrevalence":null},{"indication":"Vitamin Deficiency Prevention","otherDrugs":[{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"ergocalciferol","slug":"ergocalciferol","company":"Sanofi Aventis Us"},{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"},{"name":"folic acid","slug":"folic-acid","company":"Lederle"}],"globalPrevalence":null},{"indication":"Vitamin deficiency","otherDrugs":[{"name":"colecalciferol","slug":"colecalciferol","company":"Sandoz"},{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"ergocalciferol","slug":"ergocalciferol","company":"Sanofi Aventis Us"},{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"}],"globalPrevalence":null}],"mechanism":{"target":"Flavin reductase (NADPH)","novelty":"Follow-on","targets":[{"gene":"BLVRB","source":"DrugCentral","target":"Flavin reductase (NADPH)","protein":"Flavin reductase (NADPH)"},{"gene":"RFK","source":"DrugCentral","target":"Riboflavin kinase","protein":"Riboflavin kinase"}],"modality":"Small Molecule","drugClass":"Vitamin C [EPC]","explanation":"","oneSentence":"","technicalDetail":"Infuvite Pediatric acts as a cofactor for flavin reductase, facilitating the reduction of NADP+ to NADPH, which is essential for various cellular processes, including fatty acid synthesis and antioxidant defense mechanisms."},"commercial":{"launchDate":"1953","_launchSource":"DrugCentral (FDA 1953-02-20, HOSPIRA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2834","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=RIBOFLAVIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=RIBOFLAVIN","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":"2026-03-30T15:32:17.173766","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:38:24.500991+00:00","fieldsConflicting":16,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"nicotinamide","drugSlug":"nicotinamide","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"pyridoxine","drugSlug":"pyridoxine","fdaApproval":"1993-12-29","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"Vitamin E","drugSlug":"vitamin-e","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"biotin","drugSlug":"biotin","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"pyridoxal 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supplementation as determined by licensed medical practitioner"},{"name":"Vitamin Deficiency Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"patients in need of dietary supplementation as determined by licensed medical practitioner"},{"name":"Vitamin deficiency","source":"DrugCentral","snomedId":85670002,"regulator":"FDA","eligibility":"patients in need of dietary supplementation as determined by licensed medical practitioner"}],"offLabel":[{"name":"Glutaric aciduria, type 1","source":"DrugCentral","drugName":"RIBOFLAVIN","evidenceCount":14,"evidenceLevel":"moderate"},{"name":"Glutaric aciduria, type 2","source":"DrugCentral","drugName":"RIBOFLAVIN","evidenceCount":130,"evidenceLevel":"strong"},{"name":"Migraine Prevention","source":"DrugCentral","drugName":"RIBOFLAVIN","evidenceCount":103,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Glaukos","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"nicotinamide","brandName":"nicotinamide","genericName":"nicotinamide","approvalYear":"1953","relationship":"same-class"},{"drugId":"pyridoxine","brandName":"pyridoxine","genericName":"pyridoxine","approvalYear":"1993","relationship":"same-class"},{"drugId":"vitamin-e","brandName":"Vitamin E","genericName":"Vitamin E","approvalYear":"1953","relationship":"same-class"},{"drugId":"biotin","brandName":"biotin","genericName":"biotin","approvalYear":"1953","relationship":"same-class"},{"drugId":"pyridoxal-phosphate","brandName":"pyridoxal phosphate","genericName":"pyridoxal 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