Baraclude Side Effects
Generic Name: entecavir
Note: This document contains side effect information about entecavir. Some of the dosage forms listed on this page may not apply to the brand name Baraclude.
More frequent side effects include: glycosuria, hematuria, increased serum aspartate aminotransferase, and increased serum lipase. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to entecavir: oral solution, oral tablet
Oral route (Tablet; Solution)
Severe acute exacerbations of hepatitis B have been reported upon discontinuation of anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months in patients who discontinue therapy and reinitiation of anti-hepatitis B therapy may be warranted. Entecavir is not recommended in HIV/HBV co-infected patients not treated with highly active antiretroviral therapy because there is potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors.
Side effects requiring immediate medical attention
Along with its needed effects, entecavir (the active ingredient contained in Baraclude) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking entecavir:
Incidence not known
- Abdominal or stomach discomfort
- decreased appetite
- difficulty with swallowing
- fast heartbeat
- fast, shallow breathing
- general feeling of discomfort
- hives, itching, or rash
- muscle pain or cramping
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- right upper abdominal or stomach pain and fullness
- tightness in the chest
- unusual tiredness or weakness
Side effects not requiring immediate medical attention
Some side effects of entecavir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Trouble sleeping
- Unusual drowsiness
Incidence not known
- Hair loss
- thinning of the hair
For Healthcare Professionals
Applies to entecavir: oral solution, oral tablet
The most common side effects reported in patients with chronic hepatitis B virus (HBV) infection and compensated liver disease during clinical trials have included headache, fatigue, dizziness, and nausea. One percent of patients discontinued therapy due to side effects or laboratory abnormalities (compared to 4% of lamivudine-treated patients).
The most common side effects reported in patients with chronic HBV infection and evidence of hepatic decompensation (n=102) through Week 48 of a study have included peripheral edema, ascites, pyrexia, hepatic encephalopathy, and upper respiratory infection. The cumulative death rate was 23% with entecavir (the active ingredient contained in Baraclude) during the first 48 weeks of therapy (compared to 33% with adefovir). The majority of deaths were due to liver-related causes such as hepatic failure, hepatic encephalopathy, hepatorenal syndrome, and upper gastrointestinal hemorrhage. Through Week 48, up to 7% of patients discontinued this drug due to a side effect.[Ref]
Elevated ALT (greater than 10 times ULN and greater than 2 times baseline: up to 2%; greater than 5 times ULN: up to 12%; greater than 3 times baseline: up to 5%; greater than 2 times baseline [with total bilirubin greater than 2 times ULN and greater than 2 times baseline]: up to 1%) and total bilirubin (greater than 2.5 times ULN; up to 3%) have been reported.
Posttreatment exacerbations of hepatitis or ALT flare, as defined by ALT greater than 10 times ULN and greater than 2 times baseline, have been reported in patients who discontinued therapy at or after 52 weeks after achieving a defined treatment response (nucleoside-naive hepatitis B e antigen [HBeAg]-positive: 2%; nucleoside-naive HBeAg-negative: 8%; lamivudine-refractory: 12%). The median time to exacerbation was 23 to 24 weeks. The rate may be higher in patients who discontinue this drug without regard to treatment response.
Hepatic encephalopathy and deaths due to liver-related causes (such as hepatic failure, hepatic encephalopathy, hepatorenal syndrome, and upper gastrointestinal hemorrhage) were reported in patients with hepatic decompensation.[Ref]
Very common (10% or more): Elevated ALT (up to 12%), posttreatment exacerbation of hepatitis/ALT flare (up to 12%), deaths due to liver-related causes (e.g., hepatic failure, hepatic encephalopathy, hepatorenal syndrome, upper gastrointestinal hemorrhage; 11%), hepatic encephalopathy (10%)
Common (1% to 10%): On-treatment exacerbation of hepatitis/ALT flares
Frequency not reported: Elevated AST, lactic acidosis and severe hepatomegaly with steatosis (including fatal cases), severe acute exacerbations of hepatitis B (after discontinuation of therapy)
Postmarketing reports: Increased transaminases[Ref]
Very common (10% or more): Decreased albumin (up to 30%), decreased platelets (up to 20%)
Decreased albumin (less than 2.5 g/dL) and platelets (less than 50,000/mm3) were reported in 30% and 20% of patients with hepatic decompensation, respectively.
Neutropenia was very common in pediatric patients.[Ref]
Very common (10% or more): Elevated lipase (up to 18%)
Elevated lipase (greater than 3 times baseline: up to 18%; at least 2.1 times upper limit of normal [ULN]: 7%) and amylase (greater than 3 times baseline: 2%) have been reported.[Ref]
Peripheral edema, ascites, and pyrexia were reported in patients with hepatic decompensation.[Ref]
Very common (10% or more): Peripheral edema (16%), ascites (15%), pyrexia/fever (14%)
Common (1% to 10%): Fatigue
Hepatocellular carcinoma was reported in patients with hepatic decompensation.
Malignant neoplasms, occurring at a rate of 8.4 per 1000 patient-years, have been reported.[Ref]
Very common (10% or more): Hepatocellular carcinoma (up to 12%)
Frequency not reported: Malignant neoplasms[Ref]
Confirmed creatinine increase of at least 0.5 mg/dL was reported in up to 2% of patients with compensated liver disease. Confirmed increase in serum creatinine of 0.5 mg/dL (11%) and renal failure were reported in patients with hepatic decompensation.[Ref]
Very common (10% or more): Increased serum creatinine (up to 11%)
Uncommon (0.1% to 1%): Renal failure[Ref]
Upper respiratory infection was reported in patients with hepatic decompensation.[Ref]
Very common (10% or more): Upper respiratory infection (10%)
Frequency not reported: Cough, nasopharyngitis, rhinitis[Ref]
Common (1% to 10%): Elevated fasting hyperglycemia, decreased blood bicarbonate
Frequency not reported: Elevated alkaline phosphatase
Postmarketing reports: Lactic acidosis[Ref]
Elevated fasting hyperglycemia (greater than 250 mg/dL) was reported in up to 3% of patients.
Decreased blood bicarbonate was reported in patients with hepatic decompensation.
Lactic acidosis was often associated with hepatic decompensation, other serious medical conditions, or drug exposures.[Ref]
Common (1% to 10%): Hematuria, glycosuria
Grade 3 to 4 hematuria (9%) and glycosuria (4%) were reported.[Ref]
Common (1% to 10%): Headache, dizziness, somnolence[Ref]
Postmarketing reports: Anaphylactoid reaction[Ref]
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2. Cerner Multum, Inc. "Australian Product Information." O 0
3. Rivkina A, Rybalov S "Chronic hepatitis B: current and future treatment options." Pharmacotherapy 22 (2002): 721-37
4. Robinson DM, Scott LJ, Plosker GL "Entecavir: a review of its use in chronic hepatitis B." Drugs 66 (2006): 1605-22
5. de Man RA, Wolters LM, Nevens F, et al. "Safety and efficacy of oral entecavir given for 28 days in patients with chronic hepatitis B virus infection." Hepatology 34 (2001): 578-82
6. "Product Information. Baraclude (entecavir)." Bristol-Myers Squibb, Princeton, NJ.
7. Sims KA, Woodland AM "Entecavir: a new nucleoside analog for the treatment of chronic hepatitis B infection." Pharmacotherapy 26 (2006): 1745-57
8. Chang TT, Gish RG, Hadziyannis SJ, et al. "A dose-ranging study of the efficacy and tolerability of entecavir in Lamivudine-refractory chronic hepatitis B patients." Gastroenterology 129 (2005): 1198-209
9. Chang TT, Gish RG, de Man R, et al. "A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B." N Engl J Med 354 (2006): 1001-10
10. Gish RG "Clinical trial results of new therapies for HBV: implications for treatment guidelines." Semin Liver Dis 25 Suppl 1 (2005): 29-39
11. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
12. Yan JH, Bifano M, Olsen S, et al. "Entecavir pharmacokinetics, safety, and tolerability after multiple ascending doses in healthy subjects." J Clin Pharmacol 46 (2006): 1250-8
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
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