Entecavir Anhydrous: Side Effects, Uses & Monitoring
Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or
- Data source
- FDA labeling via NIH DailyMed (label 5a1cbf7e…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. The following points should be considered when initiating therapy with entecavir tablets: In adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and lamivudine-resistant subjects with HBeAg-positive and HBeAg-negative HBV infection and compensated liver disease and a more limited number of subjects with decompensated liver disease [see Clinical Studies (14.1) ] . Pediatric use information is approved for Bristol-Myers Squibb Company’s Baraclude ® (entecavir) tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that information.
Conditions associated with Entecavir Anhydrous in labeling
Frequently Asked Questions
What is Entecavir Anhydrous used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Entecavir Anhydrous?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Entecavir Anhydrous require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Entecavir Anhydrous.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.