Ziagen Side Effects

Generic name: abacavir

Medically reviewed by Drugs.com. Last updated on Aug 14, 2024.

Note: This document provides detailed information about Ziagen Side Effects associated with abacavir. Some dosage forms listed on this page may not apply specifically to the brand name Ziagen.

Applies to abacavir: oral solution, oral tablet.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are also using other medicines containing abacavir (the active ingredient contained in Ziagen) (eg, Epzicom®, Triumeq®, Trizivir®).

This medicine may cause severe allergic reactions in some patients. These reactions usually occur within 6 weeks after the medicine is started but may occur at any time. If untreated, it can lead to severe low blood pressure and even death. Check with your doctor immediately if you or your child notice sudden fever, skin rash, diarrhea, nausea, stomach pain, vomiting, or a feeling of unusual tiredness or illness, cough, trouble breathing, or sore throat.

When you begin taking this medicine, you or your child will be given a warning card which describes symptoms of severe allergic reactions that may be caused by abacavir. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.

Do not stop using this medicine unless your doctor tells you to do so. If you stop using this medicine for any reason, do not start taking it again without talking first to your doctor.

If you must stop using abacavir because of an allergic reaction, you should never use the medicine again. Return the unused medicine to your doctor or pharmacist. A worse reaction, possibly even death, can occur if you use the medicine again. Tell your doctor right away if you or your child have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have more than one of these symptoms: stomach discomfort or cramping, dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

When you start taking HIV medicines, your immune system may get stronger. If you or your child have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. Tell your doctor right away if you or your child notice any changes in health.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area, or a loss of fat from the legs, arms, and face.

This medicine may increase your risk of having a heart attack. This is more likely to occur if you smoke or already have heart disease, high blood pressure, or high cholesterol or fats in the blood. Call your doctor right away if you have chest pain or discomfort, nausea, pain or discomfort in the arms, jaw, back or neck, trouble breathing, sweating, or vomiting. These could be symptoms of a heart attack.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, such as using latex condoms, even if your partner also has HIV. Do not share needles, toothbrushes, and razor blades with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Ziagen

Some side effects of abacavir 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:

Serious side effects of Ziagen

Along with its needed effects, abacavir 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 abacavir:

For healthcare professionals

Applies to abacavir: oral solution, oral tablet.

General adverse events

In 1 study, patients receiving the once-daily regimen had a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea than patients on the twice-daily regimen.

Many of the side effects listed occurred commonly in patients with abacavir (the active ingredient contained in Ziagen) hypersensitivity (e.g., nausea, vomiting, diarrhea, fever, lethargy, rash).^[Ref]

Hypersensitivity

• Common (1% to 10%): Drug hypersensitivity, hypersensitivity reaction (including fever, rash [maculopapular, urticarial], nausea, vomiting, malaise, diarrhea, headache, fatigue, myalgia, achiness, abdominal pain, pharyngitis, dyspnea, cough, lethargy, myolysis, edema, elevated liver function tests, mucous membrane lesions [conjunctivitis, mouth ulceration], sore throat, adult respiratory distress syndrome, respiratory failure, lymphadenopathy, hypotension, anaphylaxis, paresthesia, lymphopenia, hepatitis, liver failure, arthralgia, elevated creatine phosphokinase, elevated creatinine, renal failure, erythema multiforme, abnormal chest x-ray findings [mainly localized infiltrates], death)
• Frequency not reported: Serious and sometimes fatal hypersensitivity reactions, abacavir hypersensitivity reaction presenting as acute fibrinous and organizing pneumonia^[Ref]

Serious and sometimes fatal hypersensitivity reactions have been reported with this drug. Such reactions have included multi-organ failure and anaphylaxis and usually occurred within the first 6 weeks of therapy (median onset: 9 to 11 days); however, abacavir (the active ingredient contained in Ziagen) hypersensitivity reactions have occurred any time during therapy.

Patients with the human leukocyte antigen subtype B*5701 (HLA-B*5701) allele are at higher risk of hypersensitivity reactions to this drug; however, such reactions have occurred in patients without the HLA-B*5701 allele. Abacavir hypersensitivity was reported in about 8% of patients in 9 clinical trials with abacavir-containing products where patients were not screened for the HLA-B*5701 allele; incidence of suspected abacavir hypersensitivity reactions was 1% in clinical trials where HLA-B*5701 carriers were excluded.

Abacavir hypersensitivity reactions have been characterized by at least 2 of the following key signs/symptoms: (1) fever; (2) rash; (3) gastrointestinal symptoms (including nausea, vomiting, diarrhea, abdominal pain); (4) constitutional symptoms (including generalized malaise, fatigue, achiness); (5) respiratory symptoms (including dyspnea, cough, pharyngitis). Almost all reactions have included fever and/or rash (usually maculopapular or urticarial); however, reactions also reported without fever or rash. Signs/symptoms reported in at least 10% of patients with hypersensitivity reaction have included rash, nausea, vomiting, malaise, diarrhea, headache, fatigue/lethargy, abdominal pain, dyspnea, cough, fever, elevated liver function tests, and myalgia. Other signs/symptoms of hypersensitivity have included mouth ulceration, sore throat, adult respiratory distress syndrome, respiratory failure, edema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis, paresthesia, lymphopenia, hepatitis, liver failure, myolysis, arthralgia, elevated creatine phosphokinase, elevated creatinine, renal failure, abnormal chest x-ray findings (mainly infiltrates, which were localized), and death.

Symptoms of abacavir hypersensitivity reaction worsened with continued therapy and generally resolved when this drug was discontinued. Restarting this drug after a hypersensitivity reaction has resulted in more severe symptoms within hours and included life-threatening hypotension and death. Rarely, life-threatening reactions have occurred within hours after restarting this drug in patients who stopped it for reasons other than symptoms of hypersensitivity (or who stopped it with only 1 key symptom of hypersensitivity).

In 1 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 this drug. 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 this drug was discontinued due to suspicion of a hypersensitivity reaction. Three days after drug discontinuation, the patient's status improved and chest films showed resolution of infiltrates.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 47%), nausea and vomiting (up to 38%), diarrhea (up to 16%)
• Common (1% to 10%): Abdominal pain/gastritis/gastrointestinal signs and symptoms, vomiting, abdominal discomfort and pain, abnormal amylase
• Rare (0.01% to 0.1%): Pancreatitis^[Ref]

Pancreatitis was observed in the expanded access program.^[Ref]

Other

• Very common (10% or more): Malaise and fatigue (up to 34%), temperature regulation disturbance (up to 19%)
• Common (1% to 10%): Fever/pyrexia, lethargy, fatigue, fatigue/malaise, fever and/or chills
• Uncommon (0.1% to 1%): Non-site-specific pain
• Frequency not reported: Asthenia, reduced alcohol tolerance, disulfiram-like reaction^[Ref]

In 1 case report, a 31-year-old HIV-infected male patient switched to this drug and experienced a disulfiram-like reaction with nausea, facial flushing, and tachycardia after 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 this drug and noticed reduced alcohol tolerance. The patient reported that he felt as if he had ingested 1.5 bottles of wine after 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.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 31%)
• Common (1% to 10%): Headaches/migraine, dizziness, neuropathy^[Ref]

Respiratory

• Very common (10% or more): Cough (up to 24%), ear/nose/throat infections (up to 19%), nasal signs/symptoms (up to 11%)
• Common (1% to 10%): Viral respiratory infections (including viral ear, nose, and throat infection), bronchitis
• Frequency not reported: Tachypnea, pharyngitis^[Ref]

Musculoskeletal

• Very common (10% or more): Elevated creatine phosphokinase (up to 12%)
• Common (1% to 10%): Musculoskeletal pain

Combination antiretroviral therapy:

• Frequency not reported: Osteonecrosis^[Ref]

Elevated creatine phosphokinase (greater than 4 times the upper limit of normal [4 x ULN]) has been reported in up to 8% of patients.^[Ref]

Dermatologic

• Very common (10% or more): Skin rashes (maculopapular, urticarial, or variable appearance; up to 11%)
• Common (1% to 10%): Rash (without systemic symptoms)
• Frequency not reported: Sweet's syndrome
• Very rare (less than 0.01%): Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme^[Ref]

Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported during postmarketing experience in patients using this drug primarily in combination with agents known to be associated with SJS and TEN, respectively.

Cases of erythema multiforme, SJS, or TEN have been reported very rarely when abacavir hypersensitivity could not be ruled out.^[Ref]

Metabolic

• Very common (10% or more): Feeding problems (up to 11%)
• Common (1% to 10%): Hypertriglyceridemia, hyperamylasemia, anorexia, abnormal triglycerides, hyperlactatemia
• Uncommon (0.1% to 1%): Hyperglycemia, abnormal alkaline phosphatase, abnormal glucose, abnormal sodium
• Rare (0.01% to 0.1%): Lactic acidosis
• Frequency not reported: Mild elevations of blood glucose, hypoglycemia, loss of appetite
• Postmarketing reports: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")

Combination antiretroviral therapy:

• Frequency not reported: Metabolic abnormalities (e.g., hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, hyperlactatemia)^[Ref]

Hypertriglyceridemia (greater than 750 mg/dL), hyperamylasemia (greater than 2 x ULN), and hyperglycemia (greater than 13.9 mmol/L) have been reported in up to 6%, up to 4%, and less than 1% of patients, respectively.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.^[Ref]

Psychiatric

• Very common (10% or more): Dreams/sleep disorders (10%)
• Common (1% to 10%): Depression, anxiety, sleep disorders, insomnia, abnormal dreams
• Frequency not reported: Mania, worsening of preexisting depression, lethargy^[Ref]

Hepatic

• Common (1% to 10%): Elevated ALT, elevated AST
• Uncommon (0.1% to 1%): Abnormal bilirubin
• Frequency not reported: Increased GGT, severe hepatomegaly with steatosis
• Postmarketing reports: Hepatic steatosis^[Ref]

Elevated ALT (greater than 5 x ULN) and AST (greater than 5 x ULN) have been reported in 6% and up to 6% of patients, respectively.

The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration.

Increased GGT was observed in the expanded access program.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.^[Ref]

Hematologic

• Common (1% to 10%): Neutropenia, thrombocytopenia, decreased white cells, abnormal absolute neutrophils
• Uncommon (0.1% to 1%): Anemia, leukopenia, abnormal hemoglobin, abnormal platelets, abnormal WBC
• Rare (less than 0.1%): Eosinophilia
• Frequency not reported: Agranulocytosis, increased platelet reactivity^[Ref]

Neutropenia (absolute neutrophil count less than 750/mm3), thrombocytopenia (platelets less than 50,000/mm3), anemia (hemoglobin 6.9 g/dL or less), and leukopenia (WBC 1500/mm3 or less) have been reported in up to 5%, 1%, less than 1%, and less than 1% of patients, respectively.

The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration.

Agranulocytosis has been reported after the addition of this drug to a multi-drug regimen.^[Ref]

Renal

• Uncommon (0.1% to 1%): Renal signs/symptoms, abnormal creatinine
• Frequency not reported: Acute renal failure, interstitial nephritis^[Ref]

Immunologic

• Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Cardiovascular

• Frequency not reported: Endothelial dysfunction, peripheral arterial disease, coronary bypass surgery, ischemic stroke, deep venous thrombosis, angina, transient ischemic attack
• Postmarketing reports: Myocardial infarction (MI)^[Ref]

An observational study investigating the rate of MI in patients on combination antiretroviral therapy showed an increased risk of MI with the use of this drug within the previous 6 months. A sponsor-conducted pooled analysis of clinical trials showed no excess risk of MI in abacavir-treated patients as compared with control subjects. Overall, available data from the observational cohort and from clinical trials were inconclusive.^[Ref]

See also:

Further information

Ziagen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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