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Abacavir Side Effects

Some side effects of abacavir 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 abacavir: oral solution, oral tablet

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:

Less common
  • Abdominal or stomach pain
  • cough
  • diarrhea
  • difficult or labored breathing
  • fever
  • headache
  • joint or muscle pain
  • nausea
  • numbness or tingling of the hands, feet, or face
  • redness and soreness of the eyes
  • shortness of breath
  • skin rash
  • sore throat
  • sores in the mouth
  • swelling of the feet or lower legs
  • unusual feeling of discomfort or illness
  • unusual tiredness
  • vomiting
Rare
  • Abdominal or stomach swelling
  • decreased appetite
  • fast, shallow breathing
  • sleepiness
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • chest pain or discomfort
  • chills
  • dark urine
  • itching
  • light-colored stools
  • pain or discomfort in the arms, jaw, back, or neck
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • sores, ulcers, or white spots in the mouth or on the lips
  • sweating
  • unusual weakness
  • upper right abdominal or stomach pain
  • yellow eyes and skin

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:

More common
  • Headache
Less common
  • Trouble with sleeping
Incidence not known
  • Breast enlargement
  • buffalo hump
  • central obesity
  • facial wasting
  • gaining weight around your neck, upper back, breast, face, or waist
  • peripheral wasting

For Healthcare Professionals

Applies to abacavir: oral solution, oral tablet

General

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

Common (1% to 10%): Drug hypersensitivity (Grades 2 to 4; 9%), hypersensitivity reaction (Grades 2 to 4; 8%)
Rare (less than 0.1%): Abacavir hypersensitivity reaction presenting as acute fibrinous and organizing pneumonia (at least 1 case)
Frequency not reported: Serious and sometimes fatal hypersensitivity reactions (including fever, skin rash [maculopapular, urticarial, or variable appearance], malaise, fatigue, achiness, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, dyspnea, cough, lethargy, myolysis, edema, abnormal chest X-ray [infiltrates], paresthesia, anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions [conjunctivitis and stomatitis], elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, lymphopenia)

Serious and sometimes fatal hypersensitivity reactions have been reported. Frequently observed signs and symptoms have included, but were not limited to, fever, skin rash (maculopapular, urticarial, or variable appearance), malaise, fatigue, achiness, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, dyspnea, and cough. 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, death, lymphadenopathy, mucous membrane lesions (conjunctivitis and stomatitis), elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia.

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.

Abacavir hypersensitivity is a clinical syndrome affecting multiple organs generally characterized by a sign or symptom in two or more of the following groups:
(1) Fever
(2) Rash
(3) Gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain)
(4) Constitutional (including generalized malaise, fatigue, or achiness)
(5) Respiratory (including dyspnea, cough, or pharyngitis)

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 the HLA-B*5701 allele had a greater risk (61% to about 70%) of developing hypersensitivity reactions with abacavir, while patients without the HLA-B*5701 allele had a low risk (less than 1% to 4%); therefore, screening for the HLA-B*5701 allele is recommended prior to starting abacavir treatment. Therapy with an abacavir-containing regimen is not recommended for HLA-B*5701-positive patients and should be considered only with close medical supervision under exceptional conditions where potential benefit outweighs the risk. Considerably less frequently, HLA-B*5701-negative patients may experience hypersensitivity reaction with abacavir.

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. It should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible, to minimize the risk of a life-threatening hypersensitivity reaction.

Hepatic

Common (1% to 10%): Elevated ALT (greater than 5 times ULN; 6%), elevated AST (greater than 5 times ULN; up to 6%)
Frequency not reported: Increased gamma-glutamyltransferase, severe hepatomegaly with steatosis
Postmarketing reports: Lactic acidosis, hepatic steatosis

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

Increased gamma-glutamyltransferase 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 alone or in combination with other antiretroviral agents.

Gastrointestinal

Pancreatitis was observed in the expanded access program.

Very common (10% or more): Nausea (at least moderate intensity: up to 19%), nausea and vomiting (at least moderate intensity: 10%)
Common (1% to 10%): Diarrhea (at least moderate intensity: 7%), abdominal pain/gastritis/gastrointestinal signs and symptoms (at least moderate intensity: 6%), vomiting (at least moderate intensity: 2%)
Frequency not reported: Loss of appetite/anorexia, pancreatitis

Nervous system

Very common (10% or more): Headache (at least moderate intensity: 13%)
Common (1% to 10%): Headaches/migraine (at least moderate intensity: 7%), dizziness (at least moderate intensity: 6%)
Frequency not reported: Insomnia, other sleep disorders

Other

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.

Very common (10% or more): Malaise and fatigue (at least moderate intensity: 12%)
Common (1% to 10%): Fatigue/malaise (at least moderate intensity: 7%), fever and/or chills (at least moderate intensity: 6%), ear/nose/throat infections (at least moderate intensity: 5%)
Uncommon (0.1% to 1%): Non-site-specific pain (at least moderate intensity: less than 1%)
Frequency not reported: Asthenia, reduced alcohol tolerance, disulfiram-like reaction

Psychiatric

Very common (10% or more): Dreams/sleep disorders (at least moderate intensity: 10%)
Common (1% to 10%): Depressive disorders (at least moderate intensity: 6%), anxiety (at least moderate intensity: 5%)
Frequency not reported: Mania, worsening of preexisting depression, lethargy

Dermatologic

Common (1% to 10%): Rashes (at least moderate intensity: 6%), skin rashes (at least moderate intensity: 5%)
Frequency not reported: Sweet's syndrome
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme

Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Due to overlap of clinical signs and symptoms between abacavir hypersensitivity and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be permanently discontinued in such cases.

Metabolic

Common (1% to 10%): Elevated creatine phosphokinase (greater than 4 times ULN; up to 8%), hypertriglyceridemia (greater than 750 mg/dL; up to 6%), hyperamylasemia (greater than 2 times ULN; up to 4%)
Uncommon (0.1% to 1%): Hyperglycemia (greater than 13.9 mmol/L; less than 1%)
Rare (less than 0.1%): Hypoglycemia (at least 1 case)
Frequency not reported: Mild elevations of blood glucose
Postmarketing reports: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")

Hematologic

Common (1% to 10%): Neutropenia (ANC less than 750/mm3; up to 5%), thrombocytopenia (platelets less than 50,000/mm3; 1%)
Uncommon (0.1% to 1%): Anemia (Hgb 6.9 g/dL or less; less than 1%), leukopenia (WBC 1500/mm3 or less; less than 1%)
Rare (less than 0.1%): Eosinophilia
Frequency not reported: Agranulocytosis, increased platelet reactivity

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.

Musculoskeletal

Common (1% to 10%): Musculoskeletal pain (at least moderate intensity: up to 6%)

Immunologic

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

Respiratory

Common (1% to 10%): Viral respiratory infections (at least moderate intensity: 5%), bronchitis (at least moderate intensity: 4%)
Frequency not reported: Tachypnea, cough, pharyngitis

Cardiovascular

Rare (less than 0.1%): Peripheral arterial disease (at least 2 cases), coronary bypass surgery (at least 1 case), ischemic stroke (at least 1 case), deep venous thrombosis (at least 1 case), angina (at least 1 case), transient ischemic attack (at least 1 case)
Frequency not reported: Endothelial dysfunction
Postmarketing reports: Myocardial infarction

A study investigating the frequency of myocardial infarction (MI) in patients taking combination antiretroviral treatment showed an increased risk of MI with the use of abacavir within the previous 6 months; however, these results are not conclusive. The manufacturer reviewed its own clinical study databases and although the results of the analysis are inconclusive, they did not show an excess risk of MI. A meta-analysis conducted by the FDA showed no statistically significant difference in MI events between patients who received abacavir and those who did not.

Renal

Uncommon (0.1% to 1%): Renal signs/symptoms (at least moderate intensity: less than 1%)
Frequency not reported: Acute renal failure, interstitial nephritis

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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