Atripla may cause peripheral neuropathy (damage to nerves - may cause pain, numbness, tingling, weakness, loss of muscle control, burning, loss of feeling, dizziness, vision problems, digestive tract problems, bloating, constipation, urinary incontinence, incomplete bladder emptying; symptoms may start in the hands or feet) in more than 5% of people.
This drug may also cause the following symptoms that are related to peripheral neuropathy:
• Lack of energy/fatigue in 9% of people
• Burning, prickling, tickling or tingling in more than 5% of people
• Liver failure
• Liver injury
• Low potassium levels
• Muscle destruction/damage
• Muscle weakness
• Nerve damage in more than 5% of people
• Numbness of the arms/legs
• Numbness or tingling in more than 5% of people
Medical Source Information
Words in italics indicate symptoms related to peripheral neuropathy.
Musculoskeletal side effects have included arthralgia and myalgia in at least 5% of patients receiving emtricitabine or tenofovir. Arthralgia, myalgia, and myopathy have been reported during postmarketing experience with efavirenz. Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, and myopathy have been reported during postmarketing experience with tenofovir.
Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur as a result of proximal renal tubulopathy.
Renal side effects have included new onset or worsening renal impairment with tenofovir. Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, acute tubular necrosis, nephrogenic diabetes insipidus, and interstitial nephritis (including acute cases) have been reported during postmarketing experience with tenofovir.
Rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.
Nervous system side effects (Grades 2 to 4) have included dizziness (8%) and headache (6%). Selected side effects of moderate to severe intensity have included impaired concentration and somnolence in greater than or equal to 2% of efavirenz-treated patients. Nervous system symptoms of any grade and regardless of causality (53%) included dizziness (28.1%), insomnia (16.3%), impaired concentration (8.3%), somnolence (7%), abnormal dreams (6.2%), hallucinations (1.2%), amnesia, agitation, euphoria, depersonalization, confusion, abnormal thinking, and stupor during clinical trials of efavirenz in combination with other antiretroviral agents. These symptoms were mild in 33.3%, moderate in 17.4%, and severe in 2% of patients. Therapy was discontinued in 2.1% of patients due to these side effects. Paresthesia and peripheral neuropathy (including peripheral neuritis and neuropathy) have been reported in at least 5% of patients receiving emtricitabine or tenofovir. Abnormal coordination, ataxia, cerebellar coordination and balance disturbances, convulsions, hypoesthesia, paresthesia, neuropathy, tremor, and tinnitus have been reported during postmarketing experience with efavirenz.
The most common side effects (any severity; greater than or equal to 10%) reported during a clinical study of efavirenz, emtricitabine, and tenofovir included diarrhea, nausea, headache, fatigue, dizziness, depression, insomnia, abnormal dreams, and rash. The most significant side effects associated with efavirenz are nervous system symptoms, psychiatric symptoms, and rash.
Other side effects (Grades 2 to 4) have included fatigue (9%). Pain (moderate to severe intensity; 2% or greater) has been reported with efavirenz. Fever, pain, and back pain have been reported in at least 5% of patients receiving emtricitabine or tenofovir. Asthenia has been reported during postmarketing experience with efavirenz and tenofovir. Contraceptive failure (with an implantable hormonal contraceptive) has been reported during postmarketing experience with efavirenz.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Efavirenz, emtricitabine, and tenofovir 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. Call your doctor at once if you have any of these other serious side effects: signs of liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); urinating less than usual or not at all; fever, chills, body aches, flu symptoms; unusual thoughts or behavior, severe depression, extreme fear, thoughts of hurting yourself or others, hallucinations; severe blistering, peeling, and red skin rash; or seizure (convulsions). Less serious side effects may include: dizziness, drowsiness, anxiety, depressed mood; headache, tired feeling, ringing in your ears, vision problems; sleep problems (insomnia), confusion, strange dreams, forgetfulness; mild nausea, vomiting, diarrhea, loss of appetite, upset stomach; darkened skin on the palms of your hands or the soles of your feet; joint pain, back pain; numbness or tingly feeling; runny or stuffy nose, cough; or changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist). This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Hepatic side effects have included elevated AST (greater than 180 units/L in males and 170 units/L in females; 3%) and ALT (greater than 215 units/L in males and 170 units/L in females; 2%). Elevated bilirubin (greater than 2.5 times ULN) has been reported in up to 3% of patients treated with emtricitabine or tenofovir. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogs, including tenofovir, in combination with other antiretrovirals. Hepatic enzyme increase, hepatic failure, and hepatitis have been reported during postmarketing experience with efavirenz. Hepatic steatosis, hepatitis, and increased liver enzymes (primarily AST, ALT, and gamma glutamyl transferase) have been reported during postmarketing experience with tenofovir. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and hepatitis B after discontinuation of emtricitabine or tenofovir and were associated with liver failure and liver decompensation in some of the emtricitabine-treated patients.
Metabolic side effects have included hyperglycemia (greater than 250 mg/dL; up to 2%), altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL; up to 3%), and elevated fasting cholesterol (greater than 240 mg/dL; up to 22%), creatine kinase (greater than 990 units/L in males and 845 units/L in females; up to 9%), serum amylase (greater than 175 units/L; up to 8%), fasting triglycerides (greater than 750 mg/dL; 4%), and alkaline phosphatase (greater than 550 units/L; 1%). Elevated pancreatic amylase (greater than 2 times ULN; up to 3%) and serum lipase (greater than 2 times ULN; up to 3%) have been reported in up to 3% of patients treated with emtricitabine or tenofovir. Increased body weight has also been reported. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. Hypercholesterolemia and hypertriglyceridemia have been reported during postmarketing experience with efavirenz. Hypokalemia, lactic acidosis, and hypophosphatemia have been reported during postmarketing experience with tenofovir.
Hypokalemia and hypophosphatemia may occur as a result of proximal renal tubulopathy.
Side Effects to Watch
Watch closely for the following side effects and notify your physician immediately should any of these develop:
•Abnormal heart rate, fluttering in the chest, weakness, faintness, dizziness or loss of consciousness (signs of a serious condition called "torsade de pointe or QT prolongation" in which irregular heartbeats occur)
Lab and Diagnostic Tests
If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them):
•Monitor phosphorus, creatinine and liver function tests
•EKG - if abnormal heartbeats (rapid slow or irregular) develop
•creatinine clearance - check before starting treatment
•Monitor blood tests closely