Epivir Side Effects

Please note - some side effects for Epivir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Epivir - for the Consumer

Epivir

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Epivir:

Cough; diarrhea; dizziness; general body discomfort; headache; loss of appetite; mild mouth pain or swelling; muscle or joint pain; nausea; runny/stuffy nose; stomach pain or cramps; tiredness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling sensation; dark urine; ear pain or discharge; fever, chills, or sore throat; mental or mood changes; pale stools; persistent loss of appetite; severe or persistent muscle pain, ache, or tenderness; severe or persistent nausea, vomiting, or diarrhea; severe or persistent stomach pain or tenderness; swollen lymph nodes; symptoms of lactic acidosis (eg, fast or difficult breathing; fast, slow, or irregular heartbeat; severe or persistent weakness or tiredness; unusual drowsiness, dizziness, or lightheadedness; unusual feeling of cold in the arms or legs; wheezing); yellowing of the skin or eyes.

Epivir-HBV

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Epivir-HBV:

Changes in body fat; chills; coughing; decreased appetite; diarrhea; difficulty sleeping; dizziness; ear, nose, and throat infection; general body discomfort; headache; indigestion; joint pain; muscle pain; nausea; sinus drainage; sore throat; stomach discomfort; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression (mental or mood changes); enlarged stomach; increased heart rate; numbness or tingling in the arms or legs; persistent sore throat, chills, or fever; severe muscle or joint pain; stomach tenderness or pain; unusual bleeding or bruising; unusual weakness or exhaustion; vomiting; yellowing of the skin or eyes.

Epivir-HBV Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Epivir-HBV Solution:

Changes in body fat; chills; coughing; decreased appetite; diarrhea; difficulty sleeping; dizziness; ear, nose, and throat infection; general body discomfort; headache; indigestion; joint pain; muscle pain; nausea; sinus drainage; sore throat; stomach discomfort; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression (mental or mood changes); enlarged stomach; increased heart rate; numbness or tingling in the arms or legs; persistent sore throat, chills, or fever; severe muscle or joint pain; stomach tenderness or pain; unusual bleeding or bruising; unusual weakness or exhaustion; vomiting; yellowing of the skin or eyes.

Epivir Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Epivir Solution:

Cough; diarrhea; dizziness; general body discomfort; headache; loss of appetite; mild mouth pain or swelling; muscle or joint pain; nausea; runny/stuffy nose; stomach pain or cramps; tiredness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling sensation; dark urine; ear pain or discharge; fever, chills, or sore throat; mental or mood changes; pale stools; persistent loss of appetite; severe or persistent muscle pain, ache, or tenderness; severe or persistent nausea, vomiting, or diarrhea; severe or persistent stomach pain or tenderness; swollen lymph nodes; symptoms of lactic acidosis (eg, fast or difficult breathing; fast, slow, or irregular heartbeat; severe or persistent weakness or tiredness; unusual drowsiness, dizziness, or lightheadedness; unusual feeling of cold in the arms or legs; wheezing); yellowing of the skin or eyes.

Epivir Side Effects - for the Professional

Epivir

• The most common reported adverse reactions (incidence ≥15%) in adults were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. (6.1)
• The most common reported adverse reactions (incidence ≥15%) in pediatric patients were fever and cough. (6.1)

  To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

General

General side effects have included headache, malaise, weakness, fatigue, fever, and chills. The adverse effects of lamivudine are sometimes difficult to distinguish from the symptomatology observed during the clinical course of AIDS, as well as from the possible adverse effects of other drugs used in the treatment of HIV infection. Many of the side effects associated with nucleoside reverse transcriptase inhibitor therapy (myopathy, pancreatitis, liver failure, lactic acidosis, etc.) are attributable to their direct toxic effect on mitochondria which causes decreased mitochondrial energy generating capacity.

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, vomiting, anorexia, dyspepsia, abdominal pain and cramps. Oral ulcerations and lesions have also been observed. Pancreatitis has been rarely reported in adults (less than 0.5%), but may be more common in pediatric patients (up to 15% in 2 limited studies).

Nervous system

Nervous system side effects have included dizziness, sleep disorders (primarily insomnia), and depression. Peripheral neuropathy has been reported but occurs much less frequently than with other nucleoside reverse transcriptase inhibitors. Post approval side effects have included paresthesia.

Hepatic

Hepatic side effects have included elevations in hepatic enzymes and bilirubin and rare cases of hepatic decompensation. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of lamivudine and other nucleoside analogs alone or in combination with other antiretroviral agents.

Posttreatment exacerbations of hepatitis have occurred after discontinuation of lamivudine. Although most events appear to have been self-limited, fatalities have been reported. The casual relationship to stopping lamivudine treatment is unknown. Patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.

Hematologic

Hematologic side effects have included bone marrow toxicity. However, at normally recommended dosages bone marrow toxicity is uncommon. High dosages (up to 20 mg/kg/day) may be associated with decreased neutrophil counts. However, absolute neutropenia, anemia, and thrombocytopenia occur rarely when lamivudine is given alone. Moreover, the addition of lamivudine to zidovudine does not significantly increase the frequency or severity of hematologic toxicity associated with zidovudine. The overall incidences reported for neutropenia, anemia, and thrombocytopenia are 7.2%, 2.9%, and 0.4%, respectively, when lamivudine is given concurrently with zidovudine. Post marketing adverse effects have included lymphadenopathy, pure red cell aplasia, and splenomegaly.

Dermatologic

Dermatologic side effects have included skin rash and pruritus. Hair loss has been attributed to lamivudine in a few patients. Paronychia and periungual pyogenic granulomata have also been reported.

Endocrine

Endocrine side effects have included hyperglycemia.

Hypersensitivity

Hypersensitivity side effects have included angioedema, urticaria, and anaphylactoid reaction have been infrequently reported in association with lamivudine therapy.

Musculoskeletal

Musculoskeletal side effects have included muscle pain, myalgia, rhabdomyolysis, and arthralgia with or without concomitant zidovudine.

Respiratory

Respiratory side effects have included nasal symptoms (20%) and cough (20%) in patients treated with lamivudine and zidovudine simultaneously. Abnormal breath sounds and wheezing have also been reported with lamivudine.

Other

Although progressive subcutaneous fat wasting has been attributed to the use of protease inhibitors, nucleoside reverse transcriptase inhibitors may have an independent contribution. This syndrome has been observed in patients naive to protease inhibitors, however, not to the same degree as in patients on a combination regimen that includes a protease inhibitor.

Other

Other side effects have included the redistribution and accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance. The mechanism and long term consequences of these events are currently unknown. A causal relationship has not been established.

Ocular

Ocular side effects have included eye redness.

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