Entecavir
Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
Sold as BARACLUDE
- Drug class
- Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 46
- FDA reports (12 mo)
- 574
Overview
Entecavir is an active pharmaceutical ingredient in the Nucleoside and Nucleotide Reverse Transcriptase Inhibitors group (J05AF). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 28 | May 15, 2026 |
| CA Canada | Health Canada | 11 | March 22, 2025 |
| US United States | FDA | 4 | January 9, 2025 |
| EU European Union | EMA | 3 | May 7, 2026 |
GBUnited Kingdom· MHRA
28 products
Uses
1) in adults with: • compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. 4) For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection.
1. Entecavir is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to < 18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
1.
CACanada· Health Canada
11 products
Uses
3 CONTRAINDICATIONS .............................................................................................................. 8 DRUG INTERACTIONS..........................................................................................................
25 CLINICAL TRIALS ................................................................................................................. 30 TOXICOLOGY .........................................................................................................................
35 REFERENCES .......................................................................................................................... 48 SIDE EFFECTS AND WHAT TO DO ABOUT THEM ..........................................................
5 mg lactose monohydrate For a complete listing, see Dosage Forms, Composition and Packaging section INDICATIONS AND CLINICAL USE JAMP ENTECAVIR (entecavir) is 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.
USUnited States· FDA
4 products
Uses
1 INDICATIONS AND USAGE Entecavir tablets are 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.
Entecavir tablets are a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
( 1 )
How to take
EUEuropean Union· EMA
3 products
Uses
1) in adults with: • compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. 4) For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection.
1. 3 Entecavir Viatris is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
1.
Drug interactions
Known interactions involving Entecavir. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL494450005 · revised September 12, 2025
- [2]Health Canada (DPD) · 02467232 · revised March 22, 2025
- [3]FDA DailyMed · 007a6ad8-4d23-45… · revised November 24, 2019 [PDF]
- [4]European Medicines Agency · EMEA/H/C/004377 · revised May 7, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.