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Entecavir

Entecavir is an antiviral medication used to treat chronic hepatitis B virus (HBV) infection in adults and, with certain formulations, in children as young as 2 years old.

Brand name Baraclude
Drug classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 17 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026 🚨Recall on record · 2
Entecavir at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Entecavir (Baraclude) is a once-daily antiviral for chronic hepatitis B that blocks the virus from copying itself; it is a preferred first choice, on the market since about 2005 and available as a generic. Most people tolerate it very well, noticing at most a headache, some tiredness or mild nausea. Its boxed warning is plain that stopping can trigger a severe, even dangerous hepatitis B flare, so never stop on your own, and expect liver tests for months afterward. The same warning covers HIV (taken without full HIV treatment, entecavir can make HIV resistant to key medicines) and a rare buildup of lactic acid in the blood.

Clinical pearls

  • Take it on an empty stomach, at least two hours after eating and two hours before your next meal.
  • Your kidney function guides the dose, so expect periodic kidney blood tests, especially if you are an older adult.
  • It skips the liver enzyme pathway behind many interactions, but flag any new medicine that is hard on the kidneys.
  • Entecavir usually controls hepatitis B rather than curing it, so most people take it long term; order refills before you run out.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Entecavir carries three serious warnings required by the FDA:

1. Severe hepatitis B flare-up after stopping: If you stop entecavir, your hepatitis B can come back much worse than before — sometimes dangerously so. Your liver must be watched closely for several months after you stop the drug. Never stop without your doctor's guidance.

2. HIV resistance risk in co-infected patients: If you have both HIV and hepatitis B but are NOT being treated for your HIV, using entecavir alone can cause the HIV virus to develop resistance to important HIV medicines. Entecavir is not recommended in this situation — you must also be on effective HIV treatment (HAART).

3. Lactic acidosis and severe liver enlargement: This class of antiviral drugs, including entecavir, has been linked to a rare but life-threatening buildup of lactic acid in the blood and dangerous liver swelling with fat accumulation. Fatal cases have been reported. Symptoms include unusual muscle pain, weakness, trouble breathing, stomach pain, nausea, vomiting, or feeling cold. Seek medical help immediately if these occur.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Oral solution
Earliest FDA record2005
Companies listing it with the FDA16
FDA label last updatedNov 6, 2019
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Entecavir, written from its FDA label.

What Entecavir is used for

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Entecavir is an antiviral drug used to treat chronic hepatitis B virus (HBV) infection — a long-lasting infection that can cause ongoing liver damage. It is prescribed when the virus is actively reproducing and there are signs of liver inflammation (raised liver enzymes) or tissue damage.

  • Baraclude (oral solution and tablet): treats chronic hepatitis B in adults and children 2 years of age and older with active viral replication and liver disease evidence
  • Entecavir tablets (generic, film-coated): treats chronic hepatitis B in adults with active viral replication and liver disease evidence; pediatric approval is specific to Baraclude
  • Used in both patients who are new to hepatitis B treatment and those who have developed resistance to the antiviral lamivudine
  • Used in patients with compensated liver disease (liver still functioning) and in adults with decompensated liver disease (liver struggling to function)

How Entecavir works

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Entecavir belongs to a class of drugs called nucleoside analogue reverse transcriptase inhibitors. Inside your cells, it is converted into an active form that mimics one of the building blocks the hepatitis B virus needs to copy its genetic material. By competing with that natural building block, entecavir blocks three separate steps the virus uses to replicate — effectively stopping it from making new copies of itself and reducing the amount of virus in your body.

Entecavir does not interact with the liver's main drug-processing enzyme system (CYP450), which means it is unlikely to interfere with many other medications through that pathway. It is mainly cleared by the kidneys, so kidney function is an important factor in how well the drug is managed in your body.

Entecavir dosage

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Entecavir is taken by mouth once daily. Both the tablet and oral solution must be taken on an empty stomach — at least 2 hours after eating and at least 2 hours before the next meal, because food reduces how much drug your body absorbs.

  • Tablets and oral solution are both taken once daily
  • Always take on an empty stomach — food noticeably reduces absorption
  • In children, the dose is based on body weight; the oral solution is typically used for children weighing up to 30 kg
  • If you have kidney disease, your doctor may adjust the dose or how often you take it — follow their guidance exactly

Do not stop taking entecavir without talking to your doctor first. Stopping suddenly can cause a serious flare-up of hepatitis B.

Dosing details from the FDA-approved label

From the Entecavir prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Nucleoside-inhibitor-treatment-naïve adults and adolescents 16 years of age and older with compensated liver disease (chronic hepatitis B virus infection)
    • 0.5 mg once daily
    • Administer on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal)
  • Adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L
    • 1 mg once daily
    • Administer on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal)
  • Adults with decompensated liver disease
    • 1 mg once daily
    • Administer on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal)
  • Pediatric patients 2 years of age or older and weighing at least 10 kg, treatment-naïve
    • Oral solution once daily by body weight: 10 to 11 kg 3 mL
    • Greater than 11 to 14 kg 4 mL
    • Greater than 14 to 17 kg 5 mL
    • Greater than 17 to 20 kg 6 mL
    • Greater than 20 to 23 kg 7 mL
    • Greater than 23 to 26 kg 8 mL
    • Greater than 26 to 30 kg 9 mL
    • Greater than 30 kg 10 mL (0.5 mg) of oral solution or one 0.5 mg tablet once daily
    • Oral solution should be used for body weight up to 30 kg
  • Pediatric patients 2 years of age or older and weighing at least 10 kg, lamivudine-experienced
    • Oral solution once daily by body weight: 10 to 11 kg 6 mL
    • Greater than 11 to 14 kg 8 mL
    • Greater than 14 to 17 kg 10 mL
    • Greater than 17 to 20 kg 12 mL
    • Greater than 20 to 23 kg 14 mL
    • Greater than 23 to 26 kg 16 mL
    • Greater than 26 to 30 kg 18 mL
    • Greater than 30 kg 20 mL (1 mg) of oral solution or one 1 mg tablet once daily
    • Oral solution should be used for body weight up to 30 kg
  • Adults with renal impairment, usual dose (0.5 mg)
    • Creatinine clearance 50 or greater: 0.5 mg once daily
    • 30 to less than 50: 0.25 mg once daily OR 0.5 mg every 48 hours
    • 10 to less than 30: 0.15 mg once daily OR 0.5 mg every 72 hours
    • Less than 10, hemodialysis or CAPD: 0.05 mg once daily OR 0.5 mg every 7 days
    • For doses less than 0.5 mg, oral solution is recommended; on a hemodialysis day, administer after the hemodialysis session; once-daily regimens are preferred
  • Adults with renal impairment, lamivudine-refractory or decompensated liver disease (1 mg)
    • Creatinine clearance 50 or greater: 1 mg once daily
    • 30 to less than 50: 0.5 mg once daily OR 1 mg every 48 hours
    • 10 to less than 30: 0.3 mg once daily OR 1 mg every 72 hours
    • Less than 10, hemodialysis or CAPD: 0.1 mg once daily OR 1 mg every 7 days
    • For doses less than 0.5 mg, oral solution is recommended; on a hemodialysis day, administer after the hemodialysis session; once-daily regimens are preferred
  • Patients with hepatic impairment
    • No dosage adjustment is necessary
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 2.1 Timing of Administration 2.4 Renal Impairment 2.2 Recommended Dosage in Adults 2.5 Hepatic Impairment 2.3 Recommended Dosage in Pediatric Patients 2.6 Duration of Therapy ● Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily. (2.2) ● Nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric patients at least 2 years of age and weighing at least 10 kg: dosing is based on weight. (2.3) ● Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (greater than or equal to 16 years old): 1 mg once daily. (2.2) ● Decompensated liver disease (adults): 1 mg once daily. (2.2) ● Renal impairment: Dosage adjustment is recommended if creatinine clearance is less than 50 mL/min. (2.4) ● Entecavir tablets should be administered on an empty stomach. (2.1) 2.1 Timing of Administration Entecavir tablets should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). 2.2 Recommended Dosage in Adults Compensated Liver Disease The recommended dose of entecavir tablets for chronic hepatitis B virus infection in nucleoside-inhibitor-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily. The recommended dose of entecavir tablets in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily. Decompensated Liver Disease The recommended dose of entecavir tablets for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily. 2.3 Recommended Dosage in Pediatric Patients Table 1 describes the recommended dose of entecavir for pediatric patients 2 years of age or older and weighing at least 10 kg. The oral solution should be used for patients with body weight up to 30 kg.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Entecavir side effects

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Most people tolerate entecavir well. The most commonly reported side effects include:

Common side effects

  • Headache
  • Fatigue (feeling tired)
  • Dizziness
  • Nausea
  • Diarrhea

When to get medical help

  • Call your doctor immediately if you stop taking entecavir — hepatitis B can flare up severely after stopping, and liver function must be monitored for several months
  • Seek emergency care for symptoms of lactic acidosis: unusual muscle pain, trouble breathing, stomach pain, nausea/vomiting, feeling cold, dizziness, or fast/irregular heartbeat
  • Tell your doctor right away if you develop signs of liver problems: yellowing of skin or eyes, dark urine, severe tiredness, or stomach pain
  • If you have HIV and are not on full HIV treatment, do not use entecavir — contact your doctor before starting

Serious reactions to watch for include symptoms of lactic acidosis (muscle pain, trouble breathing, stomach pain, nausea, vomiting, weakness, or feeling very cold) and signs of a hepatitis B flare after stopping the drug (jaundice, dark urine, severe stomach pain, extreme tiredness). Seek medical attention immediately if these occur.

Entecavir warnings and precautions

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  • Hepatitis B flare after stopping: Stopping entecavir can trigger a severe, sometimes life-threatening worsening of hepatitis B. Your liver function must be monitored for at least several months after discontinuing — never stop without your doctor's knowledge.
  • HIV co-infection risk: If you have HIV that is not being treated, using entecavir alone for hepatitis B can cause the HIV virus to become resistant to important HIV medications. Entecavir should only be used in HIV/HBV co-infected patients who are also on full HIV treatment (HAART). HIV testing should be offered to all patients before starting entecavir.
  • Lactic acidosis and severe liver enlargement: Rare but potentially fatal lactic acidosis (dangerous acid buildup in the blood) and severe liver enlargement with fat accumulation have occurred with this drug class. Women, people with obesity, and those on long-term therapy may be at higher risk. Stop the drug and contact your doctor immediately if symptoms develop.
  • Kidney function: Entecavir is cleared mainly by the kidneys. Reduced kidney function — including in older adults — increases drug exposure and may require dose adjustments.

Entecavir interactions

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Entecavir has a relatively low risk of drug interactions through liver enzyme pathways, but kidney-related interactions are important to know about:

  • Drugs that reduce kidney function or compete for kidney elimination: These may raise entecavir blood levels or the levels of the other drug — tell your doctor about all medications you take
  • Lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate: No significant interactions were found in studies, but these are also renally eliminated antivirals that your doctor will monitor
  • CYP450-metabolized drugs: Entecavir does not use the CYP450 liver enzyme system, so interactions through this common pathway are unlikely

Interactions listed in the FDA-approved label

From the Entecavir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Drugs that reduce renal function or compete for active tubular secretion: Coadministration may increase serum concentrations of either entecavir or the coadministered drug, since entecavir is primarily eliminated by the kidneys. Patients should be monitored closely for adverse events when coadministered with other renally eliminated drugs or drugs known to affect renal function.
  • Lamivudine: Coadministration did not result in significant drug interactions.
  • Adefovir dipivoxil: Coadministration did not result in significant drug interactions.
  • Tenofovir disoproxil fumarate: Coadministration did not result in significant drug interactions.
  • Agents metabolized by, inhibiting, or inducing the CYP450 system: Entecavir is not a substrate, inhibitor, or inducer of the CYP450 enzyme system, and pharmacokinetics are unlikely to be affected by such agents or of known CYP substrates by entecavir.
Read the label’s full interactions text

7 DRUG INTERACTIONS Since entecavir is primarily eliminated by the kidneys [see Clinical Pharmacology (12.3) ] , coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions. The effects of coadministration of BARACLUDE with other drugs that are renally eliminated or are known to affect renal function have not been evaluated, and patients should be monitored closely for adverse events when BARACLUDE is coadministered with such drugs.

Drug Interactions The metabolism of entecavir was evaluated in in vitro and in vivo studies. Entecavir is not a substrate, inhibitor, or inducer of the cytochrome P450 (CYP450) enzyme system. At concentrations up to approximately 10,000-fold higher than those obtained in humans, entecavir inhibited none of the major human CYP450 enzymes 1A2, 2C9, 2C19, 2D6, 3A4, 2B6, and 2E1. At concentrations up to approximately 340-fold higher than those observed in humans, entecavir did not induce the human CYP450 enzymes 1A2, 2C9, 2C19, 3A4, 3A5, and 2B6. The pharmacokinetics of entecavir are unlikely to be affected by coadministration with agents that are either metabolized by, inhibit, or induce the CYP450 system. Likewise, the pharmacokinetics of known CYP substrates are unlikely to be affected by coadministration of entecavir. The steady-state pharmacokinetics of entecavir and coadministered drug were not altered in interaction studies of entecavir with lamivudine, adefovir dipivoxil, and tenofovir disoproxil fumarate [see Drug Interactions (7) ].

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿17 supplements and herbs with documented Entecavir interactions, ranked by severity Check Entecavir against a supplement or herb →

Before taking Entecavir

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  • HIV infection: If you have HIV and it is not being treated, entecavir is not recommended — it could cause HIV drug resistance. HIV testing should be offered before starting.
  • Kidney disease: Entecavir is mainly eliminated by the kidneys; dose adjustment is required if kidney function is significantly reduced, including patients on dialysis.
  • Older adults: Elderly patients are more likely to have reduced kidney function, which affects how the body handles entecavir — kidney function should be monitored.
  • Pregnancy: There is not enough data yet to fully assess the risk to a developing baby. A pregnancy registry (the Antiretroviral Pregnancy Registry) is available — ask your doctor about enrolling.
  • Breastfeeding: It is unknown whether entecavir passes into human breast milk. Discuss the benefits and risks with your doctor before breastfeeding while on this medication.
  • Children under 2 years: Safety and efficacy have not been established in this age group — entecavir should not be used.
  • Lamivudine-experienced patients: Those with a history of hepatitis B on lamivudine or known lamivudine/telbivudine resistance require a higher dose — be sure your doctor knows your full treatment history.
  • Liver transplant recipients: Only limited safety and efficacy data are available; discuss this with your transplant team.

Entecavir overdose

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There is limited experience with entecavir overdose. In studies, healthy volunteers who took high single doses or elevated daily doses for up to 14 days did not experience unexpected side effects. If an overdose occurs, the patient should be monitored for signs of toxicity and given supportive care as needed. Hemodialysis removes only a small fraction of the drug from the body.

How your body processes Entecavir

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After you take entecavir by mouth, it is absorbed quickly, with peak blood levels reached within about 30 to 90 minutes. Taking it with food — even a light meal — significantly delays and reduces absorption, which is why it must be taken on an empty stomach. The drug distributes widely throughout body tissues and is only about 13% bound to proteins in the blood.

Entecavir is not broken down by the liver's CYP450 enzyme system; only minor amounts are converted into inactive compounds. It is eliminated almost entirely by the kidneys — about 62–73% is excreted unchanged in the urine. The drug has a long terminal half-life of roughly 128 to 149 hours, but its effective working half-life with once-daily dosing is about 24 hours, leading to steady blood levels after 6 to 10 days of daily use. Because the kidneys do the heavy lifting for elimination, reduced kidney function leads to higher drug exposure and may require dose adjustment.

How to store Entecavir

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Entecavir Tablets should be stored in a tightly closed container at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) . Store entecavir tablets in a tightly closed container to protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

17

Supplements & herbs that interact with Entecavir

17 supplements and herbal products have documented interactions with Entecavir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
ACTIVATED CHARCOAL Major COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate SLIPPERY ELM Moderate TRAGACANTH Moderate +9 more
Every supplement checked against Entecavir — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Entecavir against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Entecavir: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Entecavir — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is entecavir treating — is it curing my hepatitis B?

▾
Entecavir keeps the hepatitis B virus under control by stopping it from copying itself, which protects your liver from ongoing damage. It's not a cure — it doesn't permanently clear the virus from your body in most people — but it can lower the virus to undetectable levels and significantly reduce the risk of serious liver complications over time. Many people take it long-term as part of managing chronic hepatitis B.

Does it matter when I take it — can I take it with breakfast?

▾
Yes, timing really does matter here. You need to take entecavir on an empty stomach — at least 2 hours after eating and at least 2 hours before your next meal. Studies showed that food, even a light meal, noticeably reduces how much of the drug your body absorbs. Taking it at the same time each day (like first thing in the morning or at bedtime) can help you build the habit.

What should I do if I want to stop taking entecavir?

▾
Please don't stop without talking to your doctor first — this is one of the most important things to know about this medication. When people stop entecavir suddenly, hepatitis B can flare up severely, sometimes causing serious liver damage. Your doctor will want to monitor your liver function closely for at least several months after stopping. If you're having side effects or concerns, call your doctor — there may be a safe plan that works for you.

I also have HIV. Is entecavir safe for me to take?

▾
This is really important to discuss with your doctor before starting. If your HIV is not being actively treated, entecavir is not recommended for you — there's evidence that using it for hepatitis B alone in someone with untreated HIV can cause the HIV virus to become resistant to key HIV medications, which could limit your future treatment options. If you are on full HIV treatment (called HAART), that's a different situation and your doctor can guide you. HIV testing is recommended for everyone before starting entecavir.

What side effects should I actually watch out for?

▾
For most people, entecavir is well-tolerated. The most common things reported are headache, fatigue, dizziness, and nausea — usually mild. The more serious thing to watch for is a rare condition called lactic acidosis — symptoms include unusual muscle pain, trouble breathing, stomach pain, nausea, vomiting, or feeling unusually cold or weak. That needs medical attention right away. Also, if you ever stop the drug, watch for signs of a hepatitis B flare like yellowing skin or eyes, very dark urine, or severe stomach pain.

I'm pregnant — is it safe to take entecavir?

▾
There isn't enough data yet from human pregnancies to say definitively how much risk there is, though animal studies at very high doses showed some concerns. The key thing is to not make any changes on your own — hepatitis B during pregnancy can be serious too, so your doctor will weigh the benefits and risks for your specific situation. There is a pregnancy registry called the Antiretroviral Pregnancy Registry that tracks outcomes in women who take this drug while pregnant — your doctor can enroll you, which helps build the research for everyone.

Is Entecavir available over the counter?

▾
No. Entecavir is a prescription medicine: every Entecavir product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Entecavir first available?

▾
The earliest FDA record we hold for Entecavir is from 2005: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Entecavir was first used.

Who makes Entecavir?

▾
16 companies currently list Entecavir products in the FDA's NDC Directory, including Epic Pharma, Llc, E.R. Squibb & Sons, L.L.C., Amneal Pharmaceuticals LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Entecavir on HelloPharmacist

📊Entecavir supplement interactions17 checked — ranked by severity 🌿Drug & Supplement CheckerEntecavir vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Entecavir NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Entecavir Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Entecavir forms and strengths (how it comes)

Entecavir is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Entecavir inactive ingredients by manufacturer.

Tablet

By mouth
Brands Baraclude
How this form is used
What it may be used for
  • Baraclude tablets are used to treat chronic hepatitis B virus infection in adults and children 2 years of age and older with evidence of active viral replication and liver inflammation or damage
  • Entecavir tablets are indicated to treat chronic hepatitis B virus infection in adults with evidence of active viral replication and liver inflammation or damage
  • Baraclude tablets may be used in children over 30 kg as an alternative to the oral solution, based on weight-based dosing guidance
Important instructions
  • Baraclude tablets and Entecavir tablets should both be taken on an empty stomach — at least 2 hours after a meal and 2 hours before the next meal
  • Both Baraclude and Entecavir tablets are taken once daily by mouth; follow your prescriber's dosing instructions
  • Entecavir tablets: if you have kidney disease, your doctor may adjust the dose or frequency — do not change your regimen without guidance
Available strengths 2 strengths
0.5 mg 1 mg
68 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Baraclude
How this form is used
What it may be used for
  • Baraclude oral solution is used to treat chronic hepatitis B virus infection in adults and children 2 years of age and older with evidence of active viral replication and liver inflammation or damage
  • Baraclude oral solution is the recommended form for pediatric patients weighing up to 30 kg, with dosing based on body weight
Important instructions
  • Baraclude oral solution should be taken on an empty stomach — at least 2 hours after a meal and 2 hours before the next meal
  • Baraclude oral solution is taken once daily; the dose for children is determined by body weight — follow your prescriber's instructions exactly
  • Baraclude oral solution can be used for adult patients who require doses smaller than the lowest available tablet strength
Available strengths 1 strength
0.05 mg/mL
4 FDA-listed product records ⓘ

Entecavir on the U.S. market: products, makers and brands

How Entecavir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

16 companies list 31 Entecavir product records with the FDA, mostly as tablet, oral solution; the earliest marketing or approval year on record is 2005. Brand names on the directory include Baraclude; the rest are generics.

2
Dose forms ⓘ
16
Labelers (makers, repackagers, distributors)
2
Brand names
31
FDA-listed product records ⓘ
2005
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (11) · Granule (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Epic Pharma, Llc13%
E.R. Squibb & Sons, L.L.C.10%
Amneal Pharmaceuticals LLC6%
Aurobindo Pharma Limited6%
Camber Pharmaceuticals, Inc.6%
Cameron Pharmaceuticals6%
Other makers52%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Entecavir is used (Medicaid data)

A general measure of how commonly Entecavir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Entecavir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

54,796
Medicaid prescriptions filled (Q1–Q4 2025)
$4.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Entecavir prescribed? Of the 1,601 medications we measure, Entecavir ranks #620 by Medicaid prescriptions — more than 61% of them.

Where Entecavir ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #620 of 1,601
#615 Metolazone 56,621 Rx #616 Ivermectin 55,437 Rx #617 Abatacept Injection 55,268 Rx #618 Fluticasone Topical 55,053 Rx #619 Darunavir, Cobicistat,... 54,928 Rx #620 Entecavir 54,796 Rx #621 Ivacaftor 53,353 Rx #622 Tadalafil 53,237 Rx #623 Cefepime Injection 52,968 Rx #624 Sulindac 52,720 Rx #625 Leucovorin Injection 52,618 Rx

Utilization by Entecavir product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.5 mg oral tablet is the most-dispensed Entecavir product — about 82% of these Medicaid prescriptions.

entecavir 0.5 MG Oral Tablet Most dispensed

45,118 Medicaid prescriptions (Q1–Q4 2025) 82% of Entecavir prescriptions shown $3.6M gross reimbursement (before rebates) ≈ $80 per prescription (gross)

Summed across the 8 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485434

entecavir 1 MG Oral Tablet

9,522 Medicaid prescriptions (Q1–Q4 2025) 17% of Entecavir prescriptions shown $584,654 gross reimbursement (before rebates) ≈ $61 per prescription (gross)

Summed across the 5 of 37 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485436

entecavir 0.05 MG/ML Oral Solution

156 Medicaid prescriptions (Q1–Q4 2025) <1% of Entecavir prescriptions shown $177,716 gross reimbursement (before rebates) ≈ $1,139 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485536

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Entecavir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 14 of 84 listed Entecavir NDCs with Medicaid activity.

Compare Entecavir products

A representative set of FDA-listed product records for Entecavir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 31 of 31 products — FDA National Drug Code Directory. See every product, package size and price: browse all 31 Entecavir NDCs →

Entecavir recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Entecavir recalls since July 2021, covering 4 product listings. Both are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Sep 24, 2025 · Zydus Pharmaceuticals (USA) Inc
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
  • Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-9… Lots: Lot#: E409309, Exp 12/31/2026 FDA record D-0002-2026 →
  • Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382… Lots: Lot#: E409308, Exp 12/31/2026 FDA record D-0001-2026 →
Ongoing Class II Sep 4, 2025 · Zydus Pharmaceuticals (USA) Inc
Failed Impurity/Degradation Specifications
  • Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. Lots: Lot E309377, Exp 11/30/2025 FDA record D-0657-2025 →
  • Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-… Lots: Lot E309376; Exp 11/30/2025 FDA record D-0656-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Entecavir RxCUI 306266 2 dose forms · 3 strengths
  1. Dose form (SCDF) Oral Solution RxCUI 485535 In current FDA listings
    Clinical drug / strength (SCD) 0.05 MG/ML RxCUI 485536
  2. Dose form (SCDF) Oral Tablet RxCUI 485433 In current FDA listings
    Clinical drug / strength (SCD) 0.5 MG RxCUI 485434 1 MG RxCUI 485436

Look up RxCUI 306266 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Entecavir costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 0.5 mg $44.19 per tablet NDC details & price history
Tablet · Oral 0.5 mg $0.219 per tablet NDC details & price history
Tablet · Oral 1 mg $0.368 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Entecavir brand names

Entecavir is sold under one brand name in the FDA directory — Baraclude. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Baraclude

Who makes Entecavir: manufacturers and labelers

16 companies list Entecavir products with the FDA. By number of product records, the largest are Epic Pharma, Llc, E.R. Squibb & Sons, L.L.C., Amneal Pharmaceuticals LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Epic Pharma, Llc 4 E.R. Squibb & Sons, L.L.C. 3 Amneal Pharmaceuticals LLC 2 Aurobindo Pharma Limited 2 Camber Pharmaceuticals, Inc. 2 Cameron Pharmaceuticals 2 Cipla USA Inc. 2 NorthStar RxLLC 2 Solco Healthcare LLC 2 Yaopharma Co., Ltd. 2 Zydus Lifesciences Limited 2 Zydus Pharmaceuticals USA Inc. 2 American Health Packaging 1 AvKARE 1 Carlsbad Technology, Inc. 1 Golden State Medical Supply, Inc. 1

Entecavir drug class (RxNorm)

Entecavir belongs to the Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor class.

Pharmacologic class Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Drug family (ATC) Nucleoside and nucleotide reverse transcriptase inhibitors
How it works Nucleoside Reverse Transcriptase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Entecavir page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 6, 2019
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Entecavir.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Entecavir after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
17
Finished products in the current FDA directory
31
Companies listing them (makers, repackagers, distributors)
16
FDA labeler codes behind them ⓘ
16
Linked representative label ⓘ
E.R. Squibb & Sons, L.L.C.
Linked label effective
Nov 6, 2019
Composite sections available
22
Linked SPL Set ID
046e61c9-9298-4b2e-b76e-b26b81fecd20
Linked SPL Document ID
275a2584-65d6-40f8-8aac-49eb54479f6d
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. E.R. Squibb & Sons, L.L.C. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →