Abacavir and lamivudine Side Effects

Please note - some side effects for Abacavir and lamivudine 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 by Body System

Hypersensitivity

Hypersensitivity reactions associated with abacavir therapy have been serious and sometimes fatal. Frequently observed signs and symptoms include, fever, skin rash (maculopapular, urticarial, or variable appearance), nausea, vomiting, diarrhea, abdominal pain, pharyngitis, malaise, fatigue, achiness, dyspnea, and cough. Abacavir should be permanently discontinued as soon as a hypersensitivity reaction is suspected. Severe or fatal hypersensitivity reactions can also occur within hours after restarting abacavir in patients who have no identified history or unrecognized symptoms of this reaction. Other symptoms of abacavir hypersensitivity have included lethargy, myolysis, edema, abnormal chest X-ray (infiltrates), paresthesia, anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, lymphadenopathy, mucous membrane lesions (conjunctivitis and stomatitis), elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia.

Stevens-Johnson syndrome and toxic epidermal necrolysis have also been reported with abacavir (alone or in combination with other drugs). Lamivudine has been associated with angioedema, urticaria, and anaphylactoid reactions.

Abacavir hypersensitivity is a clinical syndrome affecting multiple organs in two or more of the following groups:
(1) fever
(2) rash
(3) gastrointestinal
(4) constitutional
(5) respiratory

A strong predictor of hypersensitivity reaction may be the presence of human leukocyte antigen subtype B*5701 (HLA-B*5701). Analyzing past studies, patients testing positive for HLA-B*5701 had a greater risk (about 70%) of developing hypersensitivity reactions with abacavir, while patients without HLA-B*5701 had a low risk (less than 1%). Prospective screening for HLA-B*5701 may decrease the incidence of abacavir hypersensitivity reactions.

Hepatic

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

Gastrointestinal

Gastrointestinal side effects have included nausea (5%), diarrhea (5%), and abdominal pain/gastritis (4%) with abacavir/lamivudine/efavirenz therapy. Stomatitis and pancreatitis have also been reported with abacavir and/or lamivudine. 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) receiving lamivudine.

Dermatologic

Dermatologic side effects associated with abacavir have included rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Sweet's syndrome. Lamivudine has been associated with rash, pruritus, and alopecia.

Hematologic

Hematologic side effects have included aplastic anemia, anemia (pure red cell aplasia and severe progressive anemias), lymphadenopathy, neutropenia, splenomegaly, and thrombocytopenia with abacavir and/or lamivudine. Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen.

Metabolic

Metabolic side effects have included elevations of blood glucose, triglycerides, bilirubin, amylase, and lipase. In addition, redistribution and/or accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance has been observed in patients taking antiretroviral agents. A causal relationship has not been established. The mechanism and long-term effects of these complications have not been determined.

Nervous system

Nervous system side effects have included insomnia (7%), headache/migraine (7%), and dizziness/vertigo (6%) with abacavir/lamivudine/efavirenz combination therapy. Peripheral neuropathy, paresthesia, and seizures have been reported with abacavir and/or lamivudine.

Endocrine

Endocrine side effects associated with lamivudine have included hyperglycemia.

Other

Other side effects have included fatigue/malaise (6%), pyrexia (5%) with abacavir/lamivudine/efavirenz therapy. Weakness has also been reported with abacavir and/or lamivudine.

Musculoskeletal

Musculoskeletal side effects have included muscle weakness, CPK elevations, and rhabdomyolysis with abacavir and/or lamivudine.

Respiratory

Respiratory side effects have included abnormal breath sounds and wheezing with lamivudine.

Psychiatric

Psychiatric side effects have included depression (7%), abnormal dreams (4%), and anxiety (3%) with abacavir/lamivudine/efavirenz therapy.

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