What are Some Possible Side Effects of ATRIPLA?

ATRIPLA may cause serious side effects

• Are pregnant: Women should not become pregnant while taking ATRIPLA and for
  12 weeks after stopping ATRIPLA. Serious birth defects have been seen in children of women treated during pregnancy with one of the medicines in ATRIPLA. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control while on ATRIPLA and for 12 weeks after stopping ATRIPLA.
• Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV through their milk to the baby. Also, ATRIPLA may pass through breast milk and cause serious harm to the baby.
• Have liver problems, including hepatitis B or C virus infection.
• Have ever had seizures: Seizures have occurred in patients taking a component of ATRIPLA, usually in those with a history of seizures. If you have ever had seizures, or take medicine for seizures, your healthcare provider may want to switch you to another medicine or monitor you.
• Have ever had mental illness or use drugs or alcohol.

• Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients. Some patients have had thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness.
• Kidney problems (including decline or failure of kidney function). If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider should do regular blood tests. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness.
• Other serious liver problems. Some patients have experienced serious liver problems, including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
• Bone changes. Lab tests show changes in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV patients treated with tenofovir DF developed thinning of the bones (osteopenia) which could lead to fractures. Also, bone pain and softening of the bone (which may lead to fractures) may occur as a consequence of kidney problems. If you have had bone problems in the past, your healthcare provider may want to check your bones.

• Dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams.These side effects tend to go away after taking ATRIPLA^® (efavirenz
  600 mg/ emtricitabine 200 mg/tenofovir DF 300 mg) for a few weeks. These symptoms may be more severe with the use of alcohol and/or mood-altering (street) drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
• Rash is a common side effect that usually goes away without any change in treatment, but may be serious in a small number of patients.
• Other common side effects include: tiredness, upset stomach, vomiting, gas, and diarrhea.

• Changes in body fat have been seen in some people taking anti-HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), in the breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects are not known.
• Skin discoloration (small spots or freckles) may also happen.
• If you notice any symptoms of infection, contact your healthcare provider right away.
• Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness, and indigestion.