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Entecavir

Baraclude · ATC code J05AF10

Also known as: Entekavir · Brand names: Baraclude, Entecavir Ratiopharm, Entecavir Al, Entecavir Amarox, Entecavir Aristo, Entecavir Axiromed, Entecavir Basics, Entecavir Beta, Entecavir Cipla, Entecavir Hec Pharm, Entecavir Heumann, Entecavir Hexal, Entecavir Puren, Entecavir Zentiva, Aviravir …

Key facts
Active substance
Entecavir
Drug class
Direct acting antiviral
ATC code
J05AF10
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Baraclude 0.5 mg film-coated tablets / Baraclude 1 mg film-coated tablets · Baraclude 0.05 mg/ml oral solution
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Information as of
2026-10-28

Key facts

Entecavir is a nucleoside analogue active against hepatitis B virus. It is used to treat chronic hepatitis B in adults and in children from 2 years of age.

What it is used for

  • Chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and active viral replication, persistently elevated ALT and histological inflammation and/or fibrosis (Baraclude film-coated tablets and oral solution).
  • Adults with decompensated liver disease.
  • Nucleoside-naive paediatric patients from 2 to < 18 years with compensated liver disease and active viral replication.

Dosing

  • Adults, compensated, nucleoside-naive: 0.5 mg once daily, with or without food.
  • Adults, lamivudine-refractory or with decompensated liver disease: 1 mg once daily on an empty stomach (more than 2 hours before and more than 2 hours after a meal).
  • Children weighing at least 32.6 kg: one 0.5 mg tablet or 10 ml (0.5 mg) of oral solution daily; below 32.6 kg the oral solution (0.05 mg/ml) is dosed by weight - see the full text.
  • Renal impairment (creatinine clearance < 50 ml/min, including haemodialysis/CAPD): reduce the daily dose using the oral solution or extend the dosing interval - see the table in the full text.
  • Duration: in HBeAg-positive adults at least until 12 months after HBe seroconversion; stopping is not recommended in decompensated liver disease or cirrhosis.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.

Important warnings

  • Exacerbations of hepatitis during therapy and after discontinuation, including severe or fatal ones; monitor liver tests and HBV DNA regularly after stopping.
  • Decompensated liver disease: higher rate of serious hepatic events, lactic acidosis and hepatorenal syndrome; monitor closely.
  • Lactic acidosis and severe hepatomegaly with steatosis are possible with nucleoside analogues.
  • Do not use in HIV/HBV co-infection without concomitant HAART (risk of HIV resistance).
  • Lamivudine-refractory patients have a higher risk of resistance; monitor virological response closely in renal impairment.

Side effects

  • Most common (compensated liver disease): headache (9%), fatigue (6%), dizziness (4%) and nausea (3%).
  • Exacerbations of hepatitis during and after discontinuation of therapy. See the full text for more.

Interactions

  • Entecavir is mainly eliminated by the kidney; medicines that reduce renal function or compete for tubular secretion may increase levels - monitor for adverse reactions.
  • No pharmacokinetic interactions with lamivudine, adefovir or tenofovir; CYP450 interactions are unlikely.

Pregnancy and breastfeeding

  • Women of childbearing potential should use effective contraception; use in pregnancy only if clearly necessary. Interventions to prevent neonatal HBV acquisition are needed.
  • Breast-feeding: see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Entecavir RatiopharmTeva B.V · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Entecavir AlAliud Pharma Gmbh · 1 register entry
  • Entecavir AmaroxAmarox Pharma Gmbh · 1 register entry
  • Entecavir AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Entecavir AxiromedMedical Valley Invest Ab · 1 register entry
  • Entecavir BasicsBasics Gmbh · 1 register entry
  • Entecavir BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Entecavir CiplaCipla Europe Nv · 1 register entry
  • Entecavir Hec PharmHec Pharm Gmbh · 1 register entry
  • Entecavir HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Entecavir HexalHexal Ag · 1 register entry
  • Entecavir PurenPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Entecavir RatiopharmRatiopharm Gmbh · 1 register entry
Show all 13 brand names
  • Entecavir ZentivaZentiva Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • AviravirHUMANİS SAĞLIK A.Ş. · 2 register entries
  • BaracludeBRISTOL-MYERS SQUIBB İLAÇLARI INC. İSTANBUL ŞUBESİ · 2 register entries
  • BaravirDROGSAN İLAÇLARI SAN. VE TİC. A.Ş. · 2 register entries
  • EntefilWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • EperiaCOSTA SAĞLIK SPOR HİZMETLERİ TİC. LTD. ŞTİ. · 2 register entries
  • FortevirİLKO İLAÇ SAN.VE TİC. A.Ş. · 2 register entries
  • HednavirATABAY KİMYA SAN. VE TİC. A.Ş. · 2 register entries
  • HepagardSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
  • Hepatovir-BDEVA HOLDİNG A.Ş. · 3 register entries
  • OvametBİLİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • QuantavirABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • ViratitFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
Show all 14 brand names
  • VirenteNOBEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • ZenticavirSANOFİ İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 22 more European countries
Bulgaria
Ентекавир Pharmascience International Ltd, Ентекавир Зентива
Cyprus
Entevirem
Czechia
Entecavir Fmk, Entecavir Sandoz, Entecavir Sanexcel, Entecavir Zentiva K.S
Denmark
Edevira, Entecavir Medical Valley, Entecavir Pharmathen, Entecavir Stada, Entecavir Teva
Finland
Entecavir Stada
France
Entecavir Arrow, Entecavir Biogaran, Entecavir Cristers, Entecavir Eg, Entecavir Evolugen, Entecavir Pharmathen, Entecavir Sandoz, Entecavir Teva, Entecavir Zentiva K.S., Entecavir Zydus
Greece
Edevira, Entecavir Sandoz, Entecavir Vocate, Istergan
Hungary
Entecavir Pharmascience International Ltd, Entecavir Sanexcel, Entecavir Teva, Entecavir Zentiva, Entekavir Onkogen
Iceland
Baraclude, Entecavir Accord, Entecavir Viatris
Italy
Entecavir Aurobindo, Entecavir Doc, Entecavir Kabi, Entecavir Sandoz, Entecavir Sun, Entecavir Teva
Liechtenstein
Baraclude, Entecavir Accord, Entecavir Viatris
Lithuania
Entecavir Sandoz
Malta
Entecavir Dr. Reddy's, Entecavir Normon
Netherlands
Entecavir Amarox, Entecavir Aurobindo, Entecavir Glenmark, Entecavir Medicopharm, Entecavir Polpharma, Entecavir Sandoz, Entecavir Teva, Entecavir Vocate, Entecavir Zentiva
Norway
Baraclude, Entecavir Accord, Entecavir Medical Valley, Entecavir Sandoz, Entecavir Teva, Entecavir Viatris
Poland
Entecavir Aurovitas, Entecavir Polpharma, Entecavir Ranbaxy, Entecavir Zentiva, Entekavir Adamed
Portugal
Entecavir Farmoz, Entecavir Generis, Entecavir Kabi
Romania
Entecavir Labormed, Entecavir Sandoz, Entecavir Sanexcel, Entecavir Sanience, Entecavir Terapia, Entecavir Teva
Slovakia
Entecavir Fmk
Slovenia
Entekavir Sandoz, Entekavir Stada
Spain
Entecavir Aurovitas, Entecavir Dr. Reddys, Entecavir Kabi, Entecavir Kern Pharma, Entecavir Normon, Entecavir Sandoz, Entecavir Sun, Entecavir Tarbis, Entecavir Teva
Sweden
Entecavir Amarox, Entecavir Medical Valley, Entecavir Sandoz, Entecavir Stada

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Baraclude – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/baraclude-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC J05AF.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.