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Trizivir Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Trizivir (abacavir sulfate, lamivudine, and zidovudine) is a type of antiviral medication called a reverse transcriptase inhibitor used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Trizivir is not a cure for HIV or AIDS. Common side effects of Trizivir include headache, tiredness, weakness, nausea, vomiting, loss of appetite, diarrhea, dizziness, trouble sleeping, joint pain, depression, nervousness, cold symptoms (stuffy nose, sneezing, sinus pain), or changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Trizivir in Detail - Patient Information: Side Effects
Stop using Trizivir and call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:
- Group 1 - fever;
- Group 2 - rash;
- Group 3 - nausea, vomiting, diarrhea, stomach pain;
- Group 4 - general ill feeling, extreme tiredness, body aches;
- Group 5 - shortness of breath, cough, sore throat.
Once you have had an allergic reaction to this medication, you must never use it again. If you stop taking Trizivir for any reason, talk to your doctor before you start taking it again.
Trizivir may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.
Trizivir can cause other serious side effects that may not be signs of an allergic reaction. Call your doctor at once if you have:
- the first sign of any skin rash, no matter how mild;
- signs of a new infection such as flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores;
- severe pain in your upper stomach spreading to your back;
- pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
- itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);
- diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
- swelling in your neck or throat (goiter);
- problems with walking, breathing, speech, swallowing, or eye movement;
- severe lower back pain, loss of bladder or bowel control; or
- chest pain or heavy feeling, pain spreading to the arm or shoulder.
Less serious side effects may include:
- headache, joint pain, depression, nervousness;
- cold symptoms such as stuffy nose, sneezing, sinus pain;
- mild nausea or diarrhea; or
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk);
Read the entire detailed patient monograph for Trizivir (Abacavir Sulfate, Lamivudine, and Zidovudine)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Trizivir Overview - Patient Information: Side Effects
Headache, tiredness, weakness, nausea, vomiting, loss of appetite, diarrhea, dizziness, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), easy bruising/bleeding, skin/nail color changes.
Get medical help right away if you have any very serious side effects, including: signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever).
Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Trizivir (Abacavir Sulfate, Lamivudine, and Zidovudine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Trizivir FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in other sections of the labeling:
- Serious and sometimes fatal hypersensitivity reactions [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Hematologic toxicity, including neutropenia and anemia [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Symptomatic myopathy [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Lactic acidosis and severe hepatomegaly with steatosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Exacerbations of hepatitis B [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see WARNINGS AND PRECAUTIONS].
- Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see WARNINGS AND PRECAUTIONS].
- Immune reconstitution syndrome [see WARNINGS AND PRECAUTIONS].
- Fat redistribution [see WARNINGS AND PRECAUTIONS].
- Myocardial infarction [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Serious and Fatal Abacavir-associated Hypersensitivity Reactions
In clinical trials, serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of TRIZIVIR [see BOXED WARNING, WARNINGS AND PRECAUTIONS]. These reactions have been characterized by 2 or more of the following signs or symptoms: (1) fever; (2) rash; (3) gastrointestinal symptoms (including nausea, vomiting, diarrhea, or abdominal pain); (4) constitutional symptoms (including generalized malaise, fatigue, or achiness); (5) respiratory symptoms (including dyspnea, cough, or pharyngitis). Almost all abacavir hypersensitivity reactions include fever and/or rash as part of the syndrome.
Other signs and symptoms have included lethargy, headache, myalgia, edema, arthralgia, and paresthesia. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, myolysis, and death have occurred in association with these hypersensitivity reactions. Physical findings have included lymphadenopathy, mucous membrane lesions (conjunctivitis and mouth ulcerations), and maculopapular or urticarial rash (although some patients had other types of rashes and others did not have a rash). There were reports of erythema multiforme. Laboratory abnormalities included elevated liver chemistries, elevated creatine phosphokinase, elevated creatinine, and lymphopenia, and abnormal chest x-ray findings (predominantly infiltrates, which were localized).
Additional Adverse Reactions with Use of TRIZIVIR
Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a frequency greater than or equal to 5% during therapy with abacavir 300 mg twice daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily compared with indinavir 800 mg 3 times daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily from CNA3005 are listed in Table 1.
Table 1: Treatment-Emergent (All Causality) Adverse
Reactions of at Least Moderate Intensity (Grades 2-4, Greater than or Equal to
5% Frequency) in Therapy-naive Adults (CNA3005) through 48 Weeks of Treatment
|Adverse Reaction||ZIAGEN plus Lamivudine/ Zidovudine
(n = 262)
|Indinavir plus Lamivudine/ Zidovudine
(n = 264)
|Malaise and fatigue||12%||12%|
|Nausea and vomiting||10%||10%|
|Fever and/or chills||6%||3%|
|Viral respiratory infections||5%||5%|
|Renal signs/symptoms||< 1%||5%|
|Pain (non-site-specific)||< 1%||5%|
Five subjects receiving abacavir in CNA3005 experienced worsening of pre-existing depression compared to none in the indinavir arm. The background rates of pre-existing depression were similar in the 2 treatment arms.
Laboratory abnormalities in CNA3005 are listed in Table 2.
Table 2: Treatment-emergent Laboratory Abnormalities
(Grades 3/4) in CNA3005
|Laboratory Parameter||ZIAGEN plus Lamivudine/ Zidovudine
(n = 262)
|Indinavir plus Lamivudine/ Zidovudine
(n = 264)
|Elevated CPK ( > 4 x ULN)||18 (7%)||18 (7%)|
|ALT ( > 5.0 x ULN)||16 (6%)||16 (6%)|
|Neutropenia ( < 750/mm )||13 (5%)||13 (5%)|
|Hypertriglyceridemia ( > 750 mg/dL)||5 (2%)||3 (1%)|
|Hyperamylasemia ( > 2.0 x ULN)||5 (2%)||1 ( < 1%)|
|Hyperglycemia ( > 13.9 mmol/L)||2 ( < 1%)||2 ( < 1%)|
|Anemia (Hgb ≤ 6.9 g/dL)||0 (0%)||3 (1%)|
|ULN = Upper limit of normal.
n = Number of subjects assessed.
Other Adverse Events
In addition to adverse reactions in Tables 1 and 2, other adverse events observed in the expanded access program for abacavir were pancreatitis and increased GGT.
The following adverse reactions have been identified during postmarketing use. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular: Myocardial infarction.
Skin: 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. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases. There have also been reports of erythema multiforme with abacavir use [see Clinical Trials Experience].
Abacavir, Lamivudine, and/or Zidovudine
Body as a Whole: Redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].
Digestive: Stomatitis. Endocrine and Metabolic: Gynecomastia.
General: Vasculitis, weakness.
Hypersensitivity: Sensitization reactions (including anaphylaxis), urticaria. Musculoskeletal: Arthralgia, myalgia, muscle weakness, rhabdomyolysis. Nervous: Dizziness, paresthesia, peripheral neuropathy, seizures.
Read the entire FDA prescribing information for Trizivir (Abacavir Sulfate, Lamivudine, and Zidovudine)
Additional Trizivir Information
Trizivir - User Reviews
Trizivir User Reviews
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