{"id":"baraclude","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Headache","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"1.5%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"0.25%","severity":"common","organSystem":""},{"effect":"Somnolence","drugRate":"0.25%","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"0.25%","severity":"common","organSystem":""}],"contraindications":["Drug Resistance to Anti-retroviral Therapy","Impaired renal function disorder","Lactic acidosis","Liver function tests abnormal","Steatosis of liver"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"ALT >5 × ULN","drugRate":"11.5%","severity":"serious"},{"effect":"Lipase ≥2.1 × ULN","drugRate":"7%","severity":"serious"},{"effect":"Hematuria","drugRate":"8.5%","severity":"serious"},{"effect":"Glycosuria","drugRate":"4.25%","severity":"serious"},{"effect":"Hyperglycemia (fasting >250 mg/dL)","drugRate":"2%","severity":"serious"},{"effect":"Total bilirubin >2.5 × ULN","drugRate":"2.25%","severity":"serious"},{"effect":"ALT >10 × ULN and >2 × baseline","drugRate":"3.75%","severity":"serious"},{"effect":"Albumin <2.5 g/dL","drugRate":"0.5%","severity":"serious"},{"effect":"Confirmed creatinine increase ≥0.5 mg/dL","drugRate":"1.25%","severity":"serious"},{"effect":"Platelets <50,000/mm3","drugRate":"0.25%","severity":"serious"}]},"trials":[],"_chembl":null,"aliases":["entecavir"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Baraclude","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:44:09.705784+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T02:44:23.871543+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:44:15.169851+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Baraclude","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:44:15.595968+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: DNA polymerase/reverse transcriptase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:44:16.646250+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5314362/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:44:16.299597+00:00"}},"offLabel":[],"timeline":[],"_dailymed":{"setId":"046e61c9-9298-4b2e-b76e-b26b81fecd20","title":"BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.]"},"aiSummary":"Baraclude, marketed by Bristol-Myers Squibb, is a treatment for chronic type B viral hepatitis with a well-established presence in the market. The drug's key strength lies in its mechanism of action, which effectively targets the virus, and it benefits from a key composition patent that remains in effect until 2028. The primary risk to Baraclude is the eventual patent expiry in 2028, which could lead to increased competition from generic alternatives.","ecosystem":[],"mechanism":{"target":"Capsid protein, Protein P, Protein P"},"_scrapedAt":"2026-03-27T23:30:38.650Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:44:23.871623+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Chronic type B viral hepatitis","diseaseId":"chronic-type-b-viral-hepatitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Lamivudine-Refractory Chronic Hepatitis 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