Epivir Side Effects
Generic name: lamivudine
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.
Some side effects of Epivir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to lamivudine: oral solution, oral tablet
Along with its needed effects, lamivudine (the active ingredient contained in Epivir) 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:More common—especially in children
- Abdominal or stomach pain (severe)
- feeling of fullness
- sensation or pins and needles
- skin rash
- stabbing pain
- tingling, burning, numbness, or pain in the hands, arms, feet, or legs
- unsteadiness or awkwardness
- Abdominal discomfort
- decreased appetite
- fast, shallow breathing
- feeling of fullness
- fever, chills, or sore throat
- general feeling of discomfort
- muscle pain or cramping
- shortness of breath
- unusual tiredness or weakness
- dark urine
- difficulty swallowing
- fast heartbeat
- hives or welts
- light-colored stools
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of skin
- tightness in chest
- upper right abdominal pain
- yellow eyes and skin
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:More common
- Canker sores
- difficulty in moving
- ear discharge
- ear swelling
- feeling sad or empty
- general feeling of discomfort or illness
- loss of appetite
- loss of interest or pleasure
- nasal discharge or congestion
- pain in joints
- sores, ulcers, or white spots on lips or tongue or inside the mouth
- stomach pain or cramps
- swollen and painful spots on neck, armpit, or groin
- swollen joints
- trouble concentrating
- trouble sleeping
- unusually warm skin
- weight loss
- Acid or sour stomach
- stomach discomfort or upset
For Healthcare Professionals
Applies to lamivudine: oral solution, oral tablet
The most common side effects reported with lamivudine (the active ingredient contained in Epivir) have included headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhea, and cough. During clinical studies, HIV-1-infected patients received lamivudine plus zidovudine. Patients with hepatitis B received lamivudine monotherapy.
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-1 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.
Nervous system side effects have included headache (up to 35%), neuropathy (12%), insomnia and other sleep disorders (11%), and dizziness (10%). Peripheral neuropathy and paresthesia have been reported during postmarketing experience.
Gastrointestinal side effects have included nausea (33%), diarrhea (up to 18%), abdominal discomfort and pain (16%), nausea and vomiting (up to 15%), anorexia and/or decreased appetite (10%), abdominal pain (9%), abdominal cramps (6%), and dyspepsia (5%). Oral ulcerations and lesions have been observed. Pancreatitis has been rarely reported in adults (less than 0.5%), but may be more common in pediatric patients (up to 18% in 2 limited studies). Pancreatitis and stomatitis have been reported during postmarketing experience.
Hepatic side effects have included elevated ALT (greater than 3 times ULN: 11%; greater than 5 times ULN: up to 3.8%), AST (greater than 5 times ULN; up to 4%), and bilirubin (greater than 2.5 times ULN; up to 0.8%). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of lamivudine (the active ingredient contained in Epivir) and other nucleoside analogs alone or in combination with other antiretroviral agents. Severe acute exacerbations of hepatitis B, including fatalities, have been reported in patients with HBV (including those coinfected with HIV-1) who have discontinued lamivudine. The causal relationship to stopping lamivudine treatment is unknown. 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. Lactic acidosis and hepatic steatosis and posttreatment exacerbation of hepatitis B have been reported during postmarketing experience.
Other side effects have included malaise and fatigue (up to 27%); ear, nose, and throat infections (25%); sore throat (13%); and fever or chills (up to 10%). Weakness has been reported during postmarketing experience.
Respiratory side effects have included nasal signs and symptoms (20%) and cough (18%). Abnormal breath sounds/wheezing have been reported during postmarketing experience.
Hematologic side effects have included decreased absolute neutrophil count (less than 750/mm3; up to 15%), platelets (less than 50,000/mm3; up to 4%), and hemoglobin (less than 8 g/dL; up to 2.9%). Anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, and splenomegaly have been reported during postmarketing experience.
Musculoskeletal side effects have included myalgia (up to 14%), musculoskeletal pain (12%), increased creatine phosphokinase (greater than or equal to 7 times baseline; 9%), and arthralgia (up to 7%). Muscle weakness, elevated creatine phosphokinase, and rhabdomyolysis have been reported during postmarketing experience.
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.
Metabolic side effects have included increased serum lipase (greater than or equal to 2.5 times ULN; 10%) and amylase (greater than 2 times ULN: up to 4.2%; greater than 3 times ULN: less than 1%). Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral agents; however, a causal relationship has not been established. Progressive subcutaneous fat wasting has been reported. Hyperglycemia and redistribution/accumulation of body fat have been reported during postmarketing experience.
Dermatologic side effects have included skin rashes (up to 9%). Paronychia and periungual pyogenic granulomata have been reported. Alopecia, rash, and pruritus have been reported during postmarketing experience.
Psychiatric side effects have included depressive disorders (9%).
Hypersensitivity side effects have infrequently included angioedema and anaphylactoid reaction. Anaphylaxis and urticaria have been reported during postmarketing experience.
Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.
Renal side effects have included at least one case of Fanconi syndrome.
Ocular side effects have included eye redness.
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