In some patients, the abacavir in this product has caused a serious (sometimes fatal) allergic reaction. Your doctor may order a blood test to measure your risk before you start this medication or take it again. If the blood test shows you are at greater risk, your doctor should discuss the risks and benefits of abacavir and other treatment choices with you. Symptoms of an allergic reaction may include any of the following: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever, extreme tiredness, nausea, vomiting, diarrhea, stomach pain, muscle aches, sore throat, mouth sores, or cough. Seek immediate medical attention if you experience any of these symptoms. If you have stopped taking abacavir because of an allergic reaction, you must never take any form of abacavir again. Notify all of your doctors and pharmacists if you have stopped taking abacavir due to an allergic reaction. Read the warning card provided with this medication for more details.
The zidovudine in this product can decrease bone marrow function, which may lead to low numbers of red and white blood cells. A low number of red blood cells can lead to anemia. A low number of white blood cells can decrease your body's ability to fight serious, life-threatening infections. These serious side effects occur more frequently in people with advanced HIV disease (AIDS). Seek immediate medical attention if you develop any signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat) or signs of infection (such as fever, chills, cough, persistent sore throat). Your doctor will check your blood cell counts while you are taking this medication to decrease the risk of these side effects.
Zidovudine may also cause muscle problems. Seek immediate medical attention if you develop signs of muscle problems (such as wasting or decrease in muscle size, weight loss, muscle weakness/pain/tenderness).
Rarely, abacavir/lamivudine/zidovudine has caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis). Tell your doctor immediately if you develop symptoms of liver problems (such as persistent nausea, vomiting, stomach/abdominal pain, pale stools, dark urine, yellowing eyes/skin, unusual tiredness), or of lactic acidosis (such as stomach discomfort, nausea, vomiting, fast/difficult breathing, drowsiness, muscle pain, weakness, cold skin). These serious side effects may occur more often in women and obese patients.
If you have hepatitis B infection and HIV, you may have a serious worsening of hepatitis symptoms if you stop taking lamivudine. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop lamivudine. Tell your doctor immediately if you develop symptoms of worsening liver problems.
Before taking abacavir/lamivudine/zidovudine, tell your doctor or pharmacist if you are allergic to any of these drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as hepatitis B or C, cirrhosis), disease of the pancreas (pancreatitis), alcohol use, low red/white blood cell counts.
Abacavir may increase your risk of a heart attack. Discuss the risks and benefits of treatment with your doctor and ways to lower your risk of heart disease. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart disease, such as high blood pressure, diabetes, or high cholesterol levels.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages, because they can increase dizziness and increase the risk of liver problems and pancreatitis.
Children may be more sensitive to the side effects of this drug, especially pancreatitis.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Abacavir/lamivudine/zidovudine may be part of that treatment. Discuss the risks and benefits with your doctor.
It is not known if abacavir passes into breast milk. However, lamivudine and zidovudine pass into breast milk. Because breast milk can transmit HIV, do not breast-feed.
See also Warning and How to Use sections.
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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression, anxiety), signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever), easy bruising/bleeding, skin/nail color changes.
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.
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