Baraclude Side Effects
Generic Name: entecavir
Note: This page contains information about the side effects of entecavir. Some of the dosage forms included on this document may not apply to the brand name Baraclude.
Not all side effects for Baraclude may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to entecavir: oral solution, oral tablet
In addition to its needed effects, some unwanted effects may be caused by entecavir (the active ingredient contained in Baraclude). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when 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
Some of the side effects that can occur with entecavir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:Less common
- Acid or sour stomach
- stomach discomfort, upset, or pain
- Trouble sleeping
- Unusual drowsiness
- 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]
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]
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 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]
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.[Ref]
Very common (10% or more): Decreased albumin (up to 30%), decreased platelets (up to 20%)[Ref]
Very common (10% or more): Elevated lipase (up to 18%)
Common (1% to 10%): Diarrhea, dyspepsia, nausea, vomiting, elevated amylase
Frequency not reported: Abdominal pain (unspecified), upper abdominal pain, upper gastrointestinal hemorrhage[Ref]
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]
Very common (10% or more): Peripheral edema (16%), ascites (15%), pyrexia/fever (14%)
Common (1% to 10%): Fatigue
Frequency not reported: Accidental injury, influenza[Ref]
Peripheral edema, ascites, and pyrexia were reported in patients with hepatic decompensation.[Ref]
Very common (10% or more): Hepatocellular carcinoma (up to 12%)
Frequency not reported: Malignant neoplasms[Ref]
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]
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]
Very common (10% or more): Upper respiratory infection (10%)
Frequency not reported: Cough, nasopharyngitis, rhinitis[Ref]
Upper respiratory infection was reported in patients with hepatic decompensation.[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
Frequency not reported: Dysuria[Ref]
Grade 3 to 4 hematuria (9%) and glycosuria (4%) were reported.[Ref]
Common (1% to 10%): Headache, dizziness, somnolence[Ref]
Common (1% to 10%): Insomnia[Ref]
Postmarketing reports: Anaphylactoid reaction[Ref]
Frequency not reported: Erythema, photosensitivity with lethargy
Postmarketing reports: Rash, alopecia[Ref]
Frequency not reported: Arthralgia, myalgia, back pain[Ref]
1. Lai CL, Shouval D, Lok AS, et al. "Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B." N Engl J Med 354 (2006): 1011-20
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. 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
4. Robinson DM, Scott LJ, Plosker GL "Entecavir: a review of its use in chronic hepatitis B." Drugs 66 (2006): 1605-22
5. Rivkina A, Rybalov S "Chronic hepatitis B: current and future treatment options." Pharmacotherapy 22 (2002): 721-37
6. 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
7. 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
8. "Product Information. Baraclude (entecavir)." Bristol-Myers Squibb, Princeton, NJ.
9. Sims KA, Woodland AM "Entecavir: a new nucleoside analog for the treatment of chronic hepatitis B infection." Pharmacotherapy 26 (2006): 1745-57
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
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