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Entecavir Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 10, 2024.

Applies to entecavir: oral solution, oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet; solution)

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 for at least several months after discontinuation.

Initiation of anti-hepatitis B therapy may be warranted.

Entecavir is not recommended in patients co-infected with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) who are not also receiving highly active antiretroviral therapy (HAART) because of the 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.

Common side effects of entecavir

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:

Less common

  • acid or sour stomach
  • belching
  • headache
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain

Rare

  • trouble sleeping
  • unusual drowsiness

Incidence not known

Serious side effects of entecavir

Along with its needed effects, entecavir 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
  • cough
  • decreased appetite
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • general feeling of discomfort
  • hives, itching, or rash
  • muscle pain or cramping
  • nausea
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • right upper abdominal or stomach pain and fullness
  • sleepiness
  • tightness in the chest
  • unusual tiredness or weakness

For healthcare professionals

Applies to entecavir: oral solution, oral tablet.

General

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 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]

Hepatic

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]

Hematologic

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]

Gastrointestinal

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]

Other

Peripheral edema, ascites, and pyrexia were reported in patients with hepatic decompensation.[Ref]

Oncologic

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]

Renal

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]

Respiratory

Upper respiratory infection was reported in patients with hepatic decompensation.[Ref]

Metabolic

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]

Genitourinary

Grade 3 to 4 hematuria (9%) and glycosuria (4%) were reported.[Ref]

Nervous system

Psychiatric

Hypersensitivity

Dermatologic

Musculoskeletal

References

1. Rivkina A, Rybalov S (2002) "Chronic hepatitis B: current and future treatment options." Pharmacotherapy, 22, p. 721-37

2. (2005) "Product Information. Baraclude (entecavir)." Bristol-Myers Squibb

3. de Man RA, Wolters LM, Nevens F, et al. (2001) "Safety and efficacy of oral entecavir given for 28 days in patients with chronic hepatitis B virus infection." Hepatology, 34, p. 578-82

4. Chang TT, Gish RG, Hadziyannis SJ, et al. (2005) "A dose-ranging study of the efficacy and tolerability of entecavir in Lamivudine-refractory chronic hepatitis B patients." Gastroenterology, 129, p. 1198-209

5. Lai CL, Shouval D, Lok AS, et al. (2006) "Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B." N Engl J Med, 354, p. 1011-20

6. Chang TT, Gish RG, de Man R, et al. (2006) "A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B." N Engl J Med, 354, p. 1001-10

7. Robinson DM, Scott LJ, Plosker GL (2006) "Entecavir: a review of its use in chronic hepatitis B." Drugs, 66, p. 1605-22

8. Sims KA, Woodland AM (2006) "Entecavir: a new nucleoside analog for the treatment of chronic hepatitis B infection." Pharmacotherapy, 26, p. 1745-57

9. Cerner Multum, Inc. "Australian Product Information."

10. Cerner Multum, Inc. "UK Summary of Product Characteristics."

11. Gish RG (2005) "Clinical trial results of new therapies for HBV: implications for treatment guidelines." Semin Liver Dis, 25 Suppl 1, p. 29-39

12. Yan JH, Bifano M, Olsen S, et al. (2006) "Entecavir pharmacokinetics, safety, and tolerability after multiple ascending doses in healthy subjects." J Clin Pharmacol, 46, p. 1250-8

Further information

Entecavir side effects can vary depending on the individual. 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.