Prescription medicine
Entecavir Brand names: Baraclude
Entecavir (Baraclude) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.219 per entecavir 0.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the entecavir FDA label on DailyMed (effective November 6, 2019, E.R. Squibb & Sons, L.L.C.); the NDA 21797 record on Drugs@FDA; every entecavir label on DailyMed.
Highlights of the record
FDA label of November 6, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV,.
and LACTIC ACIDOSIS AND HEPATOMEGALY Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ]. Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) [see Warnings and Precautions (5.2) ]. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals [see Warnings and Precautions (5.3) ]. […]
Used for
From the label: indications and usageBARACLUDE ® (entecavir) is 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.
Forms and strengths
- 0.5 mg
- 1 mg
- 0.05 mg/ml
Film-coated tablet; tablet; solution.
On the market
- Earliest approval on file
- March 29, 2005 Baraclude, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first August 26, 2014; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 15 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.219 per tablet Entecavir 0.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest September 24, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 11,608 through July 30, 2026
What is entecavir used for?
From the label: indications and usageBARACLUDE ® (entecavir) is 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. BARACLUDE is 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.
Conditions named in the indications of entecavir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (BARACLUDE), E.R. Squibb & Sons, L.L.C., effective November 6, 2019 (SPL set 046e61c9-9298-4b2e-b76e-b26b81fecd20), via openFDA; the full label on DailyMed
What does the patient leaflet for entecavir say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about BARACLUDE?Your hepatitis B virus (HBV) infection may get worse if you stop taking BARACLUDE. This usually happens within 6 months after stopping BARACLUDE. • Take BARACLUDE exactly as prescribed. • Do not run out of BARACLUDE. • Do not stop BARACLUDE without talking to your healthcare provider. • Your healthcare provider should monitor your health and do regular blood tests to check your liver if you stop taking BARACLUDE. 2. If you have or get HIV that is not being treated with medicines while taking BARACLUDE, the HIV virus may develop resistance to certain HIV medicines and become harder to treat. You should get an HIV test before you start taking BARACLUDE and anytime after that when there is a chance you were exposed to HIV. BARACLUDE can cause serious side effects including: 3. Lactic acidosis (buildup of acid in the blood). Some people who have taken BARACLUDE or medicines like BARACLUDE (a nucleoside analogue) have developed a serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death. Lactic acidosis must be treated in the hospital. Reports of lactic acidosis with BARACLUDE generally involved patients who were seriously ill due to their liver disease or other medical condition. Call your healthcare provider right away if you get any of the following signs or symptoms of lactic acidosis: • You feel very weak or tired. • You have unusual (not normal) muscle pain. • You have trouble breathing. • You have stomach pain with nausea and vomiting. • You feel cold, especially in your arms and legs. • You feel dizzy or light-headed. • You have a fast or irregular heartbeat. 4. Serious liver problems. […]
From the patient leaflet: How should I store BARACLUDE?Store BARACLUDE Tablets or Oral Solution at room temperature, between 68°F and 77°F (20°C and 25°C). • Keep BARACLUDE Tablets in a tightly closed container. • Store BARACLUDE Tablets or BARACLUDE Oral Solution in the original carton, and keep the carton out of the light. • Safely throw away BARACLUDE that is out of date or no longer needed. Dispose of unused medicines through community take-back disposal programs when available or place BARACLUDE in an unrecognizable closed container in the household trash. Keep BARACLUDE and all medicines out of the reach of children.
Source: FDA drug label (BARACLUDE), E.R. Squibb & Sons, L.L.C., effective November 6, 2019 (SPL set 046e61c9-9298-4b2e-b76e-b26b81fecd20), via openFDA; the full label on DailyMed
Is there a generic for entecavir (Baraclude)?
The FDA approved the first generic entecavir on August 26, 2014. 18 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists entecavir from 15 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2005 earliest approval on file
- 2014 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for entecavir (Baraclude)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.219 per Entecavir 0.5 mg tablet, down 17% from $0.264 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Entecavir 0.5 mg tablet (generic)
- Baraclude 0.5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Entecavir 0.5 mg tablet | Generic | $0.219 per tablet | $6.56 | -17% |
| Entecavir 1 mg tablet | Generic | $0.368 per tablet | $11.05 | -14% |
| Baraclude 0.5 mg tablet | Brand | $44.19 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,325.60 | +0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has entecavir been recalled?
The FDA's Enforcement Report lists 6 recalls naming entecavir since 2013: 0 Class I (the most serious), 6 Class II, 0 Class III; 4 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of entecavir and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 24, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity |
| September 4, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Impurity/Degradation Specifications |
| July 20, 2017 | Class II | Hetero USA Inc | Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC 59148000613 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the entecavir label say about other medicines?
The entecavir label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name entecavir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Adefovir dipivoxil | drug interactions | Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions. |
| Lamivudine | drug interactions | Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions. |
| Tenofovir disoproxil | drug interactions | Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions. |
Source: FDA drug label (BARACLUDE), E.R. Squibb & Sons, L.L.C., effective November 6, 2019 (SPL set 046e61c9-9298-4b2e-b76e-b26b81fecd20), via openFDA; the full label on DailyMed
What do FAERS reports show for entecavir?
The FDA Adverse Event Reporting System holds 11,608 reports that list entecavir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,880 are coded as a death and 4,431 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as entecavir?
4 other medicines are given the same way (oral) and in the same FDA class as entecavir or labeled mainly for the same use (hepatitis b), the same class first. Hepatitis B lists all 7 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lamivudine | Hepatitis B | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Tenofovir disoproxil | Hepatitis B | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Adefovir dipivoxil | Hepatitis B | 2 labelers | $21.73 per tablet 10 mg tablet | No current entry |
| Tenofovir alafenamide | Hepatitis B | none listed | $51.98 per tablet 25 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to entecavir
- 4 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Entecavir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other