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reports"},{"date":"","signal":"CEREBELLAR STROKE","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"5 reports"}],"commonSideEffects":[{"effect":"Peripheral swelling","drugRate":"17.5%","severity":"common","organSystem":""},{"effect":"Arthralgia","drugRate":"17.3%","severity":"common","organSystem":""},{"effect":"Hypothyroidism","drugRate":"16%","severity":"common","organSystem":""},{"effect":"Elevated HbA1c","drugRate":"14%","severity":"common","organSystem":""},{"effect":"Eosinophilia","drugRate":"12%","severity":"common","organSystem":""},{"effect":"Hematoma","drugRate":"9%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Hypertriglyceridemia","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Leg pain","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Injection site 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puberty","drugRate":"","severity":"serious"},{"effect":"Aggravation of preexisting scoliosis","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Shionogi","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BENZYL ALCOHOL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:27:50.526191+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:27:56.365474+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BENZYL ALCOHOL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:27:56.789929+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label 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(EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:27:57.883507+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M017","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:27:49.172479+00:00"}},"allNames":"ulesfia","offLabel":[],"synonyms":["benzyl alcohol","benzenemethanol","phenylmethanol","phenylcarbinol","hydroxytoluene"],"timeline":[{"date":"2009-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SHIONOGI INC to Shionogi Inc"},{"date":"2009-04-09","type":"positive","source":"DrugCentral","milestone":"FDA approval (Shionogi Inc)"}],"aiSummary":"Ulesfia (BENZYL ALCOHOL) is a small molecule pediculicide developed by Shionogi Inc, currently owned by the same company. It was FDA approved in 2009 for the treatment of itching of the skin and skin irritation. Ulesfia is off-patent, with no active Orange Book patents. As a pediculicide, it targets and kills lice and their eggs. It is commercially available, but there are no generic manufacturers.","brandName":"Ulesfia","ecosystem":[{"indication":"Itching of skin","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Skin irritation","otherDrugs":[{"name":"allantoin","slug":"allantoin","company":""},{"name":"aluminum acetate","slug":"aluminum-acetate","company":"Bayer Pharms"},{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"benzethonium","slug":"benzethonium","company":""}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"Pediculicide [EPC]","explanation":"","oneSentence":"","technicalDetail":"Benzyl alcohol, the active ingredient in Ulesfia, is a small molecule that acts as a pediculicide by disrupting the cellular membrane of lice and their eggs, ultimately leading to their death."},"commercial":{"launchDate":"2009","_launchSource":"DrugCentral (FDA 2009-04-09, SHIONOGI INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/334","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BENZYL%20ALCOHOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BENZYL ALCOHOL","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 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skin","source":"DrugCentral","snomedId":418363000,"regulator":"FDA","eligibility":"Adults and children 2 years and older"},{"name":"Skin irritation","source":"DrugCentral","snomedId":367466007,"regulator":"FDA","eligibility":"Adults and children 2 years and older"}],"offLabel":[],"pipeline":[]},"currentOwner":"Shionogi Inc","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"benzyl-benzoate","brandName":"benzyl benzoate","genericName":"benzyl 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