The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Lactic acidosis and severe hepatomegaly with steatosis [see WARNINGS AND PRECAUTIONS].
- Exacerbation of hepatitis B after discontinuation of treatment [see WARNINGS AND PRECAUTIONS].
- Risk of emergence of resistant HIV-1 infection [see WARNINGS AND PRECAUTIONS].
- Risk of emergence of resistant HBV infection [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Clinical Trials of Adults With Chronic Hepatitis B Virus Infection
Clinical adverse reactions (regardless of investigator's causality assessment) reported in greater or equal to 10% of subjects who received EPIVIR-HBV and reported at a rate greater than placebo are listed in Table 2.
Table 2: Clinical Adverse Reactionsa Reported in ≥ 10%
of Subjects who Received EPIVIRHBV for 52 to 68 Weeks and at an Incidence
Greater than Placebo (Trials 1-3)
(n = 332)
(n = 200)
|Ear, Nose, and Throat|
|Ear, nose, and throat infections||25%||21%|
|a Includes adverse events regardless of severity and causality assessment.|
Specified laboratory abnormalities reported in subjects who received EPIVIR-HBV and reported at a rate greater than in subjects who received placebo are listed in Table 3.
Table 3: Frequencies of Specified Laboratory
Abnormalities Reported During Treatment at a Greater Frequency in Subjects
Treated with EPIVIR-HBV Than With Placebo (Trials 1-3)a
|Test (Abnormal Level)||Subjects With Abnormality/Subjects With Observations|
|Serum Lipase ≥ 2.5 x ULNb||10%||7%|
|CPK ≥ 7 x baseline||9%||5%|
|Platelets < 50,000/mm³||4%||3%|
|a Includes subjects treated for 52 to 68 weeks.
bIncludes observations during and after treatment in the 2 placebo-controlled trials that collected this information.
ULN = Upper limit of normal.
In subjects followed for up to 16 weeks after discontinuation of treatment, posttreatment ALT elevations were observed more frequently in subjects who had received EPIVIR-HBV than in subjects who had received placebo. A comparison of ALT elevations between Weeks 52 and 68 in subjects who discontinued EPIVIR-HBV at Week 52 and subjects in the same trials who received placebo throughout the treatment course is shown in Table 4.
Table 4: Posttreatment ALT Elevations With
No-Active-Treatment Follow-up (Trials 1 and 3)
|Abnormal Value||Subjects With ALT Elevation/ Subjects With Observationsa|
|ALT ≥ 2 x baseline value||27%||19%|
|ALT ≥ 3 x baseline valuec||21%||8%|
|ALT ≥ 2 x baseline value and absolute ALT > 500 IU/L||15%||7%|
|ALT ≥ 2 x baseline value; and bilirubin > 2 x ULN and ≥ 2 x baseline value||0.7%||0.9%|
|a Each subject may be represented in one or
b During treatment phase.
c Comparable to a Grade 3 toxicity in accordance with modified WHO criteria.
ULN = Upper limit of normal.
Adverse Reactions in Clinical Trials of Pediatric Subjects With Chronic Hepatitis B Virus Infection
Most commonly observed adverse reactions in the pediatric trials were similar to those in adult trials. Posttreatment transaminase elevations were observed in some subjects followed after cessation of EPIVIR-HBV.
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been reported during postmarketing use of EPIVIR-HBV. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to lamivudine.
Blood and Lympatic System Disorders: Thrombocytopenia.
Endocrine and Metabolic: Hyperglycemia.
Musculoskeletal: Cramps, rhabdomyolysis.
Respiratory: Abnormal breath sounds/wheezing.
Read the Epivir-HBV (lamivudine tablets and oral solution) Side Effects Center for a complete guide to possible side effects
Lamivudine is predominantly eliminated in the urine by active organic cationic secretion. The possibility of interactions with other drugs administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system (e.g., trimethoprim). No data are available regarding interactions with other drugs that have renal clearance mechanisms similar to that of lamivudine.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/6/2014
Additional Epivir-HBV Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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