Baraclude (Entecavir) – Oral

What Is Baraclude?

Baraclude (entecavir) is an antiviral medication that works against the hepatitis B virus (HBV) in adults and children (must be at least 2 years old and weigh 22 pounds and above).

Baraclude is not a cure for HBV but only limits the ability of HBV to multiply and infect new liver cells. It may also improve the condition of your liver. 

Baraclude available as 0.5 milligram (mg) white and 1 mg pink tablets and a 0.05 milligrams per milliliter (mg/mL) oral solution (colorless to pale yellow).

Drug Facts

Generic Name: Entecavir

Brand Name(s): Baraclude

Administration Route(s): Oral

Drug Availability: Prescription

Therapeutic Classification: Antiviral

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Entecavir

Dosage Form(s): Tablet, solution

Baraclude (Entecavir) Drug Information - Illustration by Dennis Madamba

Verywell / Dennis Madamba

What Is Baraclude Used For?

The Food and Drug Administration (FDA) approved Baraclude to treat long-term (chronic) hepatitis B virus infection in those aged 2 years or older.

How to Take Baraclude

Use this medicine exactly as directed by your healthcare provider. Follow all the directions on your medicine label and package.

When taking Baraclude, follow these instructions:

  • Take once daily on an empty stomach, at least two hours after a meal and two hours before the next meal.
  • If taking the liquid formulation, measure carefully, using the dosing spoon (not a kitchen spoon). Call your healthcare provider for further instructions if you lose the dosing spoon.

Ask your healthcare provider if you do not understand how to take your medications.

Storage

Store all formulations of Baraclude in a tightly closed container at room temperature of 68 degrees to 77 degrees Fahrenheit. Keep away from light and out of the reach of children and pets. When traveling, transport entecavir in your carry-on or your checked baggage with its original label.

How Long Does It Take Baraclude to Work?

Baraclude enters the bloodstream in about 30 minutes to an hour and starts working. It is removed from the body in about four weeks. Taking entecavir with food can delay how quickly it is absorbed into the body.

What Are the Side Effects of Baraclude?

This is not a complete list of side effects, and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist, doctor, or other medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects of Baraclude include:

  • Headache
  • Fatigue
  • Dizziness
  • Nausea

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 immediately if you think you or someone else is having a medical emergency. Serious side effects can include:

Lactic Acidosis

This is a serious medical emergency caused by a buildup of acid in the blood. It can lead to death. Call your healthcare provider or get emergency medical help if you have:

  • Unusual muscle pain
  • Trouble breathing
  • Stomach pain
  • Dizziness
  • Feeling cold
  • Very weak or tired
  • Fast or irregular heartbeats

Severe Hepatomegaly With Steatosis

This condition causes liver enlargement (hepatomegaly) and fat in the liver (steatosis). It is a serious medical emergency that can cause death. Call your healthcare provider or get emergency medical help if you have:

  • Yellowing of the skin or the white part of your eyes (jaundice
  • Dark urine 
  • Light-colored stool
  • Appetite loss
  • Nausea
  • Stomach pain or swelling

Long-Term Side Effects

Your HBV infection may become active or worsen after you stop using entecavir. This usually happens within six months after stopping the drug. Do not stop it without talking to your healthcare provider. Your liver should be monitored closely for several months after stopping.

Report Side Effects

Baraclude may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Baraclude Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (solution or tablets):
    • For chronic hepatitis B infection:
      • Adults and children 16 years of age and older—0.5 to 1 milligram (mg) or 10 to 20 milliliters (mL) once per day.
      • Children 2 years of age and older weighing more than 30 kilograms (kg)—0.5 to 1 milligram (mg) or 10 to 20 milliliters (mL) once per day.
      • Children 2 years of age and older weighing 10 to 30 kg—dose is determined by body weight, usually between 3 to 20 milliliters (mL) once a day.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Modifications

It is not known if Baraclude will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. If you take this medicine while you are pregnant, your name may be listed on a pregnancy registry to track the effects of entecavir on the health of you and your baby.

It is not known if Baraclude can pass into your breast milk or affect milk production. You and your healthcare provider should decide whether you should take Baraclude or breastfeed.

Missed Dose

Do not change your dose or stop taking Baraclude without talking to your healthcare provider. If you miss a dose, take it as soon as you remember and then resume your next dose at its regular time. If it is almost time for your next dose, skip the missed dose. Do not try to double up your dose. Get your prescription refilled before you run out of medicine completely. Missing doses can make your hepatitis B resistant and harder to treat.

Overdose: What Happens If I Take Too Much Baraclude?

According to the FDA, limited experiences of Baraclude overdoses have been reported. In the event you take too much Baraclude, you may be monitored for potential toxicity and receive standard supportive treatment, if necessary.

What Happens If I Overdose on Baraclude?

If you think you or someone else may have overdosed on Baraclude, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses, has a seizure, has trouble breathing, or can’t wake up after taking too much Baraclude, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking this medicine.

If you have or get HIV (human immunodeficiency virus) infection, be sure to discuss your treatment with your doctor. If you are taking this medicine to treat chronic hepatitis B and are not taking medicines for your HIV at the same time, some HIV treatments that you take in the future may be less likely to work. Your doctor may need you to get an HIV test before you start taking this medicine and anytime after that when there is a chance you were exposed to HIV. This medicine will not help your HIV infection.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child feel tired, weak, dizzy, or nauseated, if you vomit or have stomach pain, dark urine, light-colored stools, unusual muscle pains, trouble with breathing, or if your skin or eyes turn yellow.

Liver disease may become worse if treatment with entecavir is stopped. Do not stop taking entecavir unless your doctor tells you to stop.

Treatment with entecavir has not been shown to decrease the chance of giving hepatitis B virus infection to other people through sexual contact or blood contamination.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are the Reasons I Shouldn’t Take Baraclude?

Avoid Baraclude if you are allergic to it or any of its ingredients or if you also have HIV (human immunodeficiency virus) that is not being treated.

Before taking Baraclude, you may need to get tested for HIV. Baraclude works against HIV and HBV. If you have both HIV and HBV, the medication you take must treat both viruses adequately. Taking the wrong medicine can cause HIV infection to become harder to treat.

Tell your healthcare provider about all the medicines you have used for hepatitis B in the past. Baraclude may not be a suitable option if you have used certain other treatments for HBV.

What Other Medications Interact With Baraclude?

Watch out for certain medications when taking Baraclude as they can affect how this drug works in the body.

Some medications may increase levels of Baraclude in the body by decreasing elimination of the drug through the kidneys. This heightens the risk of side effects. These medications include:

  • Angiotensin receptor blockers (ARBs): Examples include Edarbi (azilsartan), Atacand (candesartan), and Micardis (telmisartan)
  • ACE (angiotensin-converting enzyme) inhibitors: Examples include Lotensin (benazepril), Capoten (captopril), Monopril (fosinopril)
  • Diuretics: Examples include Bumex (bumetanide), Diuril (chlorothiazide), and Lozol (indapamide)
  • Cyclosporine
  • Dolobid (diflunisal)
  • Magnesium citrate
  • Aredia (pamidronate) and (Zometa) zoledronic acid
  • Poly-Rx (polymyxin B)
  • Astagraf XL, Envarsus XR, Prograf (tacrolimus): As entecavir treats the hepatitis B virus, liver function may improve, which can also alter levels of tacrolimus in the body.
  • Zonegran (zonisamide)
  • Neptazane (methazolamide)

Other medications that can increase side effects when used with Baraclude include:

  • Tikosyn (dofetilide): Do not take in combination with Baraclude, which can raise dofetilide levels, causing serious heart problems.
  • Antivirals: Combining the drugs may increase levels of both drugs by decreasing elimination through the kidneys; examples include Cytovene (ganciclovir) and Valcyte (valganciclovir).
  • Visken (pindolol): Combining the drugs may increase pindolol levels and affect blood pressure

If you take sodium phosphate (bowel preparation for colonoscopy), take it at least an hour apart from taking your Baraclude dose. Taking both medications near the same time can decrease the absorption of Baraclude.

This is not a comprehensive list of all medications that may affect how Baraclude works. Tell your healthcare provider about all your current medicines and supplements.

What Medications Are Similar?

Medications similar to Baraclude include:

  • Epivir-HBV (lamivudine)
  • Hepsera (adefovir dipivoxil)
  • Vemlidy (tenofovir alafenamide) 

Epivir-HBV (Lamivudine)

Lamivudine is an antiviral medicine that prevents HBV from multiplying in your body. It works by inhibiting the replication of HBV, just like entecavir. You can take it with or without food, unlike Baraclude, which must be taken on an empty stomach.

There are two brands of this medication available: Epivir and Epivir-HBV. Epivir contains a higher dose of lamivudine than Epivir-HBV. Epivir is for treating HIV, while Epivir-HBV is for treating hepatitis B. Each time you get a refill of this medication, ensure you received the correct product to treat your condition.

Epivir-HBV may be a better option for you if you are breastfeeding. However, try to avoid breastfeeding if your nipples are cracked or bleeding.

Hepsera (Adefovir Dipivoxil)

Hepsera is an antiviral medicine that treats chronic hepatitis B in adults and children at least 12 years old. It is less versatile than Baraclude, which can be used in patients as young as 2 years old.

It works by inhibiting the replication of HBV, just like entecavir. It can be taken with or without food, unlike Baraclude, which has to be taken on an empty stomach. Hepsera can harm your kidneys, especially if you already have kidney problems or take certain medicines.

Vemlidy (Tenofovir Alafenamide)

Vemlidy is used to treat chronic hepatitis B and HIV in adults and children at least 2 years old (weighing 22 pounds). It works by inhibiting the replication of HBV, just like entecavir. It is taken with food, unlike Baraclude, which requires an empty stomach.

Unlike Baraclude, there is no dosage adjustment necessary for those with kidney disease. This might be a better option for you if you have kidney problems. Drinking alcohol while on this medication may increase your risk of liver damage.

Frequently Asked Questions

  • What should I avoid while taking Baraclude?

    Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share needles, razors, or toothbrushes. Talk with your healthcare provider about safe ways to prevent hepatitis B transmission during sex.

  • What should I do before I start taking Baraclude?

    You should get an HIV test before taking Baraclude and at any time after if there is a possibility of HIV exposure. If your HIV is left untreated while taking Baraclude, the virus may become resistant to certain medications and become harder to treat.

  • How do I stop taking Baraclude?

    Do not change your dose or stop taking Baraclude without talking to your healthcare provider. Your hepatitis B infection may get worse if you stop taking Baraclude. This worsening usually happens within six months of stopping it. Your provider should monitor your health and do regular blood tests to check your liver after you stop treatment.

How Can I Stay Healthy While Taking Baraclude?

Baraclude does not stop you from spreading HBV to others through sex, sharing needles, or exposure to blood. Do not share items that may have bodily fluids on them, like toothbrushes or razor blades. Talk with your healthcare provider about sexual practices that can protect your partner. An HBV vaccine is available to protect those at risk from becoming infected.

Baraclude dosing is based on weight, especially in children and teenagers. A child’s dose may change if they gain or lose weight. Let their provider know of any weight changes.

Take Baraclude regularly to ensure it works properly. Missing doses can make your hepatitis B resistant and harder to treat. If you have trouble remembering to take your medicine, consider setting reminders on your cell phone. Call your provider if your hepatitis symptoms worsen or do not improve.

Do not stop taking Baraclude without talking to your provider. HBV may get worse after you stop treatment. You may need frequent liver tests for several months after.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your doctor before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

Was this page helpful?
4 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Baraclude Label.

  2. Food and Drug Administration. Epivir HBV label.

  3. Food and Drug Administration. Hepsera label.

  4. Food and Drug Administration. Vemlidy label.