Ziagen Side Effects

Generic name: abacavir

Please note - some side effects for Ziagen 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 Ziagen - for the consumer

Ziagen

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 Ziagen:

Headache; lack of energy; mild nausea; tiredness; trouble sleeping; unusual dreams; 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 of the skin; change in the amount of urine produced; chest pain or discomfort, numbness of an arm or leg, or sudden vision changes; ear pain; eye pain, redness, or swelling; fainting; fever or chills; general feeling of being unwell; mental or mood changes (eg, depression); mouth sores; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea, vomiting, or diarrhea; shortness of breath, cough, or sore throat; stomach pain; swollen lymph nodes; symptoms of lactic acidosis (eg, fast breathing; muscle pain; unusual cold feeling in the arms or legs; sluggishness; unusual drowsiness, dizziness, or lightheadedness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, severe or persistent tiredness); unusual achiness or swelling.

Ziagen 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 Ziagen Solution:

Headache; lack of energy; mild nausea; tiredness; trouble sleeping; unusual dreams; 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 of the skin; change in the amount of urine produced; chest pain or discomfort, numbness of an arm or leg, or sudden vision changes; ear pain; eye pain, redness, or swelling; fainting; fever or chills; general feeling of being unwell; mental or mood changes (eg, depression); mouth sores; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea, vomiting, or diarrhea; shortness of breath, cough, or sore throat; stomach pain; swollen lymph nodes; symptoms of lactic acidosis (eg, fast breathing; muscle pain; unusual cold feeling in the arms or legs; sluggishness; unusual drowsiness, dizziness, or lightheadedness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, severe or persistent tiredness); unusual achiness or swelling.

By body system

General side effects

Patients receiving once-daily abacavir had a significantly higher incidence of severe hypersensitivity reactions and severe diarrhea than patients on the twice-daily regimen.

Hypersensitivity side effects

Fatal hypersensitivity reactions have been associated with abacavir therapy. Frequently observed signs and symptoms include, but are not limited to, fever, skin rash, fatigue, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, dyspnea, and cough. There has been at least one report of abacavir hypersensitivity reaction presenting as acute fibrinous and organizing pneumonia. 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. Abacavir should not be coadministered with any other abacavir containing product.

Abacavir should not be restarted following a hypersensitivity reaction because more severe symptoms will occur within hours and may include life-threatening hypotension and death. It should be permanently discontinued if hypersensitivity can not be ruled out, even when other diagnoses are possible, to minimize the risk of a life-threatening hypersensitivity reaction.

In one case report a 57-year-old HIV positive male presented to medical attention with a 2-day history of fever, malaise, and diarrhea related to initiation of abacavir. Six days prior to the onset of symptoms the patient's antiretroviral therapy was switched from efavirenz and lamivudine-zidovudine to zidovudine, abacavir, and lopinavir-ritonavir after a drop in his CD4 cell count. The patient developed acute dyspnea and severe hypoxemia, hemoptysis, and diffuse bilateral pulmonary infiltrates within 72 hours of admission and abacavir was discontinued due to suspicion of a hypersensitivity reaction. Three days following discontinuation of abacavir the patient's status improved and chest films showed resolution of infiltrates.

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 side effects

Hepatic side effects such as lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretroviral agents. Liver function test abnormalities were seen in clinical trials when abacavir was administered with lamivudine and zidovudine.

The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration. Elevations of ALT and AST (greater than 5 times ULN) have been associated with abacavir in combination with lamivudine and efavirenz.

Gastrointestinal side effects

Gastrointestinal side effects such as nausea (47%), nausea and vomiting (16%), diarrhea (12%), and loss of appetite/anorexia (11%) were seen in clinical trials when abacavir was administered with lamivudine and zidovudine. Pancreatitis was observed in the expanded access program.

Nervous system side effects

Nervous system side effects have included headache (7% to 13%), insomnia, and other sleep disorders (10%) in clinical trials when abacavir was administered with other antiretrovirals.

Hematologic side effects

Hematologic side effects have included anemia (Hgb less than 6.9 g/dL), neutropenia (ANC less than 750/mm3), thrombocytopenia (platelets less than 50,000/mm3), and leukopenia (WBC less than 1500/mm3) when abacavir was administered with lamivudine and zidovudine. The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration. Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen. Rarely, eosinophilia has been reported.

Metabolic side effects

Metabolic side effects have included mild elevations of blood glucose, hypertriglyceridemia (greater than 5 times ULN), hyperamylasemia (greater than 2 times ULN), and elevated CPK (greater than 4 times ULN). 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 reported.

Other side effects

In one case report, a 31-year-old HIV-infected male patient switched to abacavir and experienced a disulfiram-like reaction with nausea, facial flushing, and tachycardia following alcohol consumption. When the patient was rechallenged with a shot of vodka, the same reaction occurred.

In another case, a 27-year-old HIV-infected male patient switched to abacavir and noticed reduced alcohol tolerance. The patient reported that he felt as if he had ingested 1.5 bottles of wine following 3 glasses, with loss of memory until the next morning and vomiting. The patient was able to tolerate small quantities of alcohol or alcohol consumed with food.

Other side effects associated with abacavir in combination with other antiretrovirals have included malaise and fatigue (12%), fever/chills (6%), nonspecific pain (less than 1%), and asthenia. Reduced alcohol tolerance and disulfiram-like reaction have also been reported.

Respiratory side effects

Respiratory side effects have included bronchitis (4%), ear/nose/throat infections (5%), viral respiratory infections (5%) when abacavir was administered in combination with other antiretrovirals. Tachypnea, cough, and pharyngitis have also been reported. Pneumonia has been reported in pediatric patients (4%).

Dermatologic side effects

Dermatologic side effects have included rash, which may be a sign of hypersensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Sweet's syndrome.

Renal side effects

Renal side effects have included renal signs and symptoms (not specified) in less than 1% of patients. Acute renal failure and interstitial nephritis have been reported.

Psychiatric side effects

Psychiatric side effects have included dreams/sleep disorders, depressive disorders, anxiety, mania, and lethargy when abacavir was administered in combination with other antiretrovirals.

Musculoskeletal side effects

Musculoskeletal side effects have included musculoskeletal pain.

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