Atripla Side Effects

Please note - some side effects for Atripla may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Atripla - for the Consumer

Atripla

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Atripla:

Back pain; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; drowsiness; gas or indigestion; headache; loss of appetite; mild stomach pain; muscle or joint aches; nausea; skin discoloration (small spots or freckles); stomach upset; strange dreams; stuffy or runny nose; tiredness; trouble concentrating; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; chest pain; confusion; decreased coordination; decreased urination; delusions; fever, chills, or persistent sore throat; hallucinations; lactic acidosis (eg, cold feeling, especially in the arms and legs; extreme weakness or tiredness; fast or irregular heartbeat; severe or persistent dizziness or lightheadedness; stomach pain with nausea or vomiting; trouble breathing; unusual muscle pain); liver problems (eg, dark urine; pale stools; yellowing of the skin or eyes); memory loss; mental, mood, or behavior changes (eg, abnormal thoughts, agitation, depression); numbness, burning, pain, or tingling of the hands, feet, or skin; red, swollen, blistered, or peeling skin; seizures; severe or persistent stomach pain; suicidal thoughts or actions.

Atripla Side Effects - for the Professional

Atripla

Most common adverse reactions (incidence ≥10%) observed in an active-controlled clinical study of efavirenz, emtricitabine, and tenofovir DF are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. (6)

 
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

General

The most common side effects associated with antiretrovirals have included headache, asthenia, pain, abdominal pain, back pain, chest pain, fatigue, tinnitus, and fever.

Hepatic

Hepatic side effects have rarely included lactic acidosis and severe hepatomegaly with steatosis, including fatal cases associated with the use of nucleoside analogs alone or in combination with other antiretrovirals.

Hepatic side effects have included increases in ALT (greater than 5 times ULN), AST (greater than 5 times ULN), GGT (greater than 5 times ULN), and amylase (greater than 2 times ULN), most often in patients with hepatitis B and/or C seropositivity. Pancreatitis has been reported, although causality was not determined. Hepatic failure and hepatitis have been reported during postmarketing experience with efavirenz.

Exacerbations of hepatitis B have been reported in patients coinfected with HIV and hepatitis B after discontinuation of tenofovir.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (9%), nausea (9%), and vomiting (2%).

Abdominal pain, dyspepsia, constipation, and malabsorption have been reported with use of these agents.

Psychiatric

Psychiatric side effects have included depression (9%), anxiety (5%), insomnia (5%), and abnormal dreams (4%). Other psychiatric side effects associated with efavirenz have included suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive behavior (0.4%), paranoid reactions (0.4%), and manic reactions (0.2%).

Aggressive reactions, delusions, emotional lability, mania neurosis, paranoia, psychosis, and suicide have been reported during postmarketing experience of efavirenz.

Dermatologic

Dermatologic side effects have included rash event (7%; including rash, exfoliative rash, generalized rash, macular rash, maculopapular rash, pruritic rash, and vesicular rash).

Other dermatologic side effects associated with efavirenz have included pruritus (up to 9%), nail disorders, skin discoloration, photoallergic dermatitis, leukocytoclastic vasculitis, blistering rash, moist desquamation and ulceration. Erythema multiforme and Stevens-Johnson syndrome have been reported in 0.1% of patients treated with 600 mg of efavirenz.

Rashes associated with efavirenz are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy and usually resolves within one month.

Grade 1 rash, consisting of erythema and/or pruritus, occurred in approximately 10% of all patients during efavirenz clinical trials. Grade 2 rash, defined as diffuse maculopapular rash and/or dry desquamation, occurred in 16.7% of adults and 24.5% of pediatric patients. Grade 3 rash, including vesiculation, moist desquamation and ulceration, occurred in less than 1% of adults but in 3.5% of children. Grade 4 rash, the most severe and which includes erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrosis requiring surgery and exfoliative dermatitis, occurred in 3.5% of children. The percentage of patients who discontinued treatment due to rash was 1.7% in adults and 8.8% in pediatric patients.

The median time to onset of rash in adults was 11 days. In most patients, the rash resolved within one month despite continued use of the drug. Patients who discontinue efavirenz therapy because of rash may be reinstated with the use of appropriate antihistamines and/or corticosteroids. The drug should be withdrawn if severe rash develops, such as that associated with blistering, desquamation, mucosal involvement, or fever.

There is limited experience with the use of efavirenz in patients who have previously discontinued other nonnucleoside reverse transcriptase inhibitors (NNRTIs) due to rash. In 19 such patients formerly on nevirapine, approximately half developed a mild to moderate rash, and two of them discontinued efavirenz because of the rash.

Nervous system

Nervous system side effects have included paresthesia, dizziness, and peripheral neuropathies.

Nervous system side effects as a whole were reported with the highest frequency (53%) during clinical trials of efavirenz in combination with other antiretroviral agents. Most were mild or moderate in severity, including dizziness (up to 10%), insomnia (up to 7%), headache (up to 6%), somnolence (up to 3%), and hypesthesia (up to 2%). These symptoms were classified as severe in 2% of patients and therapy was discontinued in 2.1% of patients due to these side effects. Amnesia, agitation, euphoria, depersonalization have also been reported. Abnormal coordination, ataxia, cerebellar coordination and balance disturbances, convulsions, hypoesthesia, paresthesia, neuropathies, and tremor have been reported during postmarketing experience.

Other

Redistribution and 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.

Metabolic

Metabolic side effects have included elevations in serum glucose, urine glucose, alkaline phosphatase, cholesterol, triglycerides, serum lipase, and hypophosphatemia. Increased body weight has also been reported.

Respiratory

Respiratory side effects have included sinusitis (8%), upper respiratory tract infections (8%), and nasopharyngitis (5%). Other side effects include dyspnea and cough.

Renal

Renal side effects associated with tenofovir have included renal insufficiency, renal failure, acute renal failure, Fanconi's syndrome, proximal tubulopathy, proteinuria, increased creatinine, acute tubular necrosis, nephrogenic diabetes insipidus, polyuria, and interstitial nephritis (including acute cases).

Hematologic

Hematologic side effects have included neutropenia. Increased hemoglobin has been reported.

Endocrine

Endocrine side effects associated with efavirenz have included gynecomastia.

Cardiovascular

Cardiovascular side effects associated with efavirenz have included flushing, palpitations, QT interval prolongation, and Torsade de Pointes.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, myalgia, myopathy, and elevated creatine kinase levels. Osteomalacia and myopathy (both associated with proximal renal tubulopathy) have been reported during postmarketing experience with tenofovir.

Ocular

Ocular side effects associated with efavirenz have included abnormal vision.

Genitourinary

Genitourinary side effects associated with tenofovir have included hematuria.

Other

False positive urine cannabinoid test results have been reported in association with efavirenz in uninfected volunteers who received efavirenz. False positive test results have only been observed with the CEDIA DAU Multilevel THC assay, which is used for screening, and have not been observed with other assays tested including tests used for confirmation of positive results.

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