Epivir-HBV Side Effects
Generic name: lamivudine
Medically reviewed by Drugs.com. Last updated on Jun 27, 2022.
Note: This document contains side effect information about lamivudine. Some of the dosage forms listed on this page may not apply to the brand name Epivir-HBV.
For the Consumer
Applies to lamivudine: oral solution, oral tablet
Oral route (Tablet; Solution)
Epivir®Exacerbations of Hepatitis B, and Different Formulations of LamivudineExacerbations of Hepatitis BSevere acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.Important Differences Among Lamivudine-Containing ProductsEpivir® tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than Epivir-HBV® tablets and oral solution (used to treat chronic hepatitis B virus infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1.
Oral route (Tablet; Solution)
Epivir-HBV®Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including lamivudine). 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.Lamivudine is not approved for the treatment of HIV-1 infection because the lamivudine dosage in this formulation is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B-infected patients with unrecognized or untreated HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine and periodically during treatment.
Side effects requiring immediate medical attention
Along with its needed effects, lamivudine (the active ingredient contained in Epivir-HBV) 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 lamivudine:
Incidence not known
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- dark urine
- decreased appetite
- difficulty with swallowing
- dry mouth
- fast heartbeat
- fast, shallow breathing
- flushed, dry skin
- fruit-like breath odor
- general feeling of discomfort
- general tiredness and weakness
- increased hunger
- increased thirst
- increased urination
- light-colored stools
- loss of appetite
- muscle cramps, pain, stiffness, or spasms
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- right upper abdominal or stomach pain and fullness
- skin rash, hives, or itching
- stomach discomfort
- tightness in the chest
- troubled breathing with exertion
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- yellow eyes or skin
Side effects not requiring immediate medical attention
Some side effects of lamivudine 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:
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- general feeling of discomfort or illness
- joint pain
- sensation of pins and needles
- sore throat
- stabbing pain
- stomach discomfort, upset, or pain
- stuffy or runny nose
- trouble sleeping
- weight loss
Incidence not known
- Hair loss or thinning of the hair
- pale skin
- weight gain around your neck, upper back, breast, face, or waist
For Healthcare Professionals
Applies to lamivudine: oral solution, oral tablet
The most common side effects reported with this drug have included headache, nausea, malaise, fatigue, nasal signs and symptoms, respiratory tract infections, throat and tonsil discomfort, abdominal discomfort and pain, vomiting, diarrhea, and cough. During clinical studies in HIV-1-infected patients, this drug was used with zidovudine (with or without other antiretroviral agents). Patients with hepatitis B virus (HBV) infection received lamivudine (the active ingredient contained in Epivir-HBV) monotherapy.[Ref]
Increased serum lipase (at least 2.5 times the upper limit of normal [2.5 x ULN]) and amylase (greater than 2 x ULN) have been reported in 10% and up to 4.2% of patients, respectively. Amylase increases greater than 3 x ULN have also been reported.
Very common (10% or more): Nausea (up to 42%), diarrhea (up to 18%), vomiting (up to 15%), nausea and vomiting (up to 13%), abdominal discomfort and pain (up to 11.3%)
Common (1% to 10%): Abdominal pain, increased serum lipase, dyspeptic symptoms, abdominal cramps, taste disorders, abdominal discomfort, dyspepsia, increased amylase, upper abdominal pain, fungal gastrointestinal (GI) infection, GI discomfort and pain, gaseous symptoms
Uncommon (0.1% to 1%): Pancreatitis
Rare (0.01% to 0.1%): Abnormal pancreatic enzymes
Frequency not reported: Oral ulcerations, lesions
Very common (10% or more): Headache (up to 35.1%), dizziness (up to 35%), neuropathy (12.4%)
Common (1% to 10%): Hypnagogic effects, peripheral paresthesia
Uncommon (0.1% to 1%): Paresthesia, hypoesthesia
Very rare (less than 0.01%): Peripheral neuropathy
Postmarketing reports: Peripheral neuropathy, paresthesia[Ref]
Very common (10% or more): Fatigue (up to 29%); malaise and fatigue (up to 27%); ear, nose, and throat infections (up to 25%)
Common (1% to 10%): Fever/chills; fever; malaise; viral ear, nose, and throat infection; viral infection
Postmarketing reports: Weakness
-Frequency not reported: Increased weight, increased blood lipid levels
Combination antiretroviral therapy:
-Frequency not reported: Fat loss, fat gain[Ref]
Very common (10% or more): Posttreatment ALT elevations (up to 27%), ALT elevations
Uncommon (0.1% to 1%): Elevated bilirubin, transient elevations in liver enzymes (AST, ALT)
Rare (0.01% to 0.1%): Hepatitis
Frequency not reported: Severe hepatomegaly with steatosis, hepatic decompensation, exacerbations of hepatitis/recurrent hepatitis
Postmarketing reports: Hepatic steatosis, posttreatment exacerbation of hepatitis B[Ref]
In HBV patients monitored for up to 16 weeks after discontinuing therapy, posttreatment ALT elevations occurred more often in those who had taken the HBV-specific product than subjects who had taken placebo.
Elevated AST (greater than 5 x ULN), ALT (greater than 5 x ULN), and bilirubin (greater than 2.5 x ULN) have been reported in up to 4%, up to 3.8%, and up to 0.8% of patients, respectively. ALT increases greater than 3 x ULN have also been reported.
Exacerbations of hepatitis (primarily detected by serum ALT elevations) have been reported during HBV therapy and after drug discontinuation. Most events were self-limited; however, fatalities were reported in some cases.
Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.
Hepatic decompensation (some fatal) has been reported in patients coinfected with HIV-1 and hepatitis C receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.
Severe acute exacerbations of hepatitis B (including fatalities) have been reported in HBV-infected patients (including those coinfected with HIV-1) who have discontinued this drug. The causal relationship to stopping therapy was unknown.[Ref]
Very common (10% or more): Rash (up to 23%)
Rare (0.01% to 0.1%): Angioedema
Frequency not reported: Paronychia, periungual pyogenic granulomata
Very common (10% or more): Nasal signs and symptoms (20%), cough (up to 18%), viral respiratory infections (up to 15%), sore throat (13%), throat and tonsil discomfort and pain (up to 11.6%)
Common (1% to 10%): Bronchitis, sinus disorders, sinusitis, throat signs and symptoms, upper respiratory inflammation, breathing disorders
Frequency not reported: Respiratory tract infections, throat and tonsil discomfort
Postmarketing reports: Abnormal breath sounds/wheezing[Ref]
Decreased absolute neutrophil count (less than 750/mm3), platelets (less than 50,000/mm3), and hemoglobin (less than 8 g/dL) have been reported in up to 15%, up to 4%, and up to 2.9% of patients, respectively.
Very common (10% or more): Decreased absolute neutrophil count (up to 15%)
Common (1% to 10%): Lymphatic signs and symptoms, neutropenia, decreased white cells, anemia, decreased platelets, decreased hemoglobin
Uncommon (0.1% to 1%): Thrombocytopenia
Very rare (less than 0.01%): Pure red cell aplasia
Elevated CPK (at least 7 x baseline) has been reported in 9% of patients.[Ref]
Very common (10% or more): Musculoskeletal pain (up to 13.5%)
Common (1% to 10%): Elevated creatine phosphokinase (CPK), myalgia, arthralgia, muscle disorders, cramps
Rare (0.01% to 0.1%): Rhabdomyolysis
Frequency not reported: Osteonecrosis
Postmarketing reports: Muscle weakness, elevated CPK, rhabdomyolysis, muscle disorders (including myalgia, cramps)[Ref]
Very common (10% or more): Anorexia (up to 12%)
Common (1% to 10%): Anorexia and/or decreased appetite, hypertriglyceridemia, hyperamylasemia, abnormal enzyme levels
Uncommon (0.1% to 1%): Eating problems, disorders of thirst/fluid intake
Very rare (less than 0.01%): Lactic acidosis
Postmarketing reports: Hyperglycemia, redistribution/accumulation of body fat, hyperlactatemia, lactic acidosis
-Frequency not reported: Increased glucose levels[Ref]
Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.[Ref]
Frequency not reported: Anaphylactoid reaction
Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)[Ref]
Frequency not reported: Fanconi syndrome (at least 1 case)[Ref]
Frequently asked questions
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More about Epivir-HBV (lamivudine)
- Drug interactions
- Dosage information
- During pregnancy or Breastfeeding
- Reviews (1)
- Drug images
- Pricing & coupons
- Generic availability
- En español
- Drug class: nucleoside reverse transcriptase inhibitors (NRTIs)
Related treatment guides
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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.