{"id":"griseofulvin-ultramicrosize","rwe":[],"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Skin rashes","drugRate":"","severity":"common","organSystem":""},{"effect":"Urticaria","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Epigastric distress","drugRate":"","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"","severity":"common","organSystem":""},{"effect":"Mental confusion","drugRate":"","severity":"common","organSystem":""},{"effect":"Impairment of performance of routine activities","drugRate":"","severity":"common","organSystem":""},{"effect":"Oral thrush","drugRate":"","severity":"common","organSystem":""},{"effect":"Paresthesia of the hands and feet","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Alcoholism","Granulocytopenic disorder","Hepatic failure","Liver function tests abnormal","Lupus erythematosus and erythema multiforme-like syndrome","Porphyria","Pregnancy, function","Systemic lupus erythematosus"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Erythema multiforme-like drug reactions","drugRate":"","severity":"serious"},{"effect":"Angioneurotic edema","drugRate":"","severity":"serious"},{"effect":"Severe skin adverse events","drugRate":"","severity":"serious"},{"effect":"Severe hepatic adverse events","drugRate":"","severity":"serious"},{"effect":"Proteinuria","drugRate":"","severity":"serious"},{"effect":"Leukopenia","drugRate":"","severity":"serious"},{"effect":"Granulocytopenia","drugRate":"","severity":"serious"}]},"status":"approved","trials":[],"aliases":[],"company":"CHARTWELL RX","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=GRISEOFULVIN, ULTRAMICROSIZE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:52:29.640866+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:52:34.614610+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GRISEOFULVIN, ULTRAMICROSIZE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:52:34.961986+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Tubulin inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:52:36.008118+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL562/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:52:35.674549+00:00"}},"allNames":"fulvicin p/g 330","offLabel":[],"timeline":[],"brandName":"FULVICIN P/G 330","ecosystem":[],"mechanism":{"target":"Lanosterol 14-alpha demethylase, Solute carrier family 22 member 1, Tubulin","novelty":"","modality":"Small Molecule","drugClass":"","explanation":"","oneSentence":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:52:37.287979+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://www.fda.gov/drugs","name":"FDA Drugs@FDA","fields":["phase","status","brandName","company"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"GRISEOFULVIN, ULTRAMICROSIZE","indications":{"approved":[{"name":"Onychomycosis due to dermatophyte","diseaseId":"onychomycosis-due-to-dermatophyte","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea barbae","diseaseId":"tinea-barbae","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea capitis","diseaseId":"tinea-capitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea corporis","diseaseId":"tinea-corporis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea cruris","diseaseId":"tinea-cruris","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea pedis","diseaseId":"tinea-pedis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"currentOwner":"CHARTWELL RX","labelChanges":[],"relatedDrugs":[],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"ORAL","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL562"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":2,"therapeuticAreas":["Dermatology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"companyName":"CHARTWELL RX","companyId":"chartwell-rx","modality":"Small Molecule","firstApprovalDate":"","aiSummary":"FULVICIN P/G 330 is a small molecule inhibitor that targets tubulin. It is classified as a tubulin inhibitor, which is a type of drug that works by interfering with the function of tubulin, a protein involved in cell division.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1982-04-06T00:00:00.000Z","mah":"CHARTWELL RX","brand_name_local":"FULVICIN P/G 165","application_number":"ANDA061996"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2012-10-22T00:00:00.000Z","mah":"SIGMAPHARM LABS LLC","brand_name_local":"GRISEOFULVIN,ULTRAMICROSIZE","application_number":"ANDA202545"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2014-01-09T00:00:00.000Z","mah":"MOUNTAIN","brand_name_local":"GRISEOFULVIN, ULTRAMICROSIZE","application_number":"ANDA204371"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2018-12-26T00:00:00.000Z","mah":"SANDOZ","brand_name_local":"GRISEOFULVIN, ULTRAMICROSIZE","application_number":"ANDA202805"},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:52:37.287979+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":false,"score":2}}