FDA label
What is entecavir used for?
The FDA-approved uses of entecavir, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease”
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Entecavir, tablet, film coated
Indications and Usage, quoted from the label by Yaopharma Co., Ltd. (ANDA212201). Cross-references to other label sections are left out.
Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease
Source: DailyMed label, set id 73dea2a4-a596-477f-b66d-5a80dd019837, version 13, effective July 7, 2026. NDC 50771-013, one of 13 listings for this product.
Questions
What is entecavir used for?
The FDA label says: “Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease”
What drug class is entecavir?
FDA lists entecavir in the Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.