"The National Institutes of Health has launched a clinical trial to assess the effects of aspirin and cholesterol-lowering drugs, or statins, on preventing cardiovascular disease in people with long-term HIV infections. This group, which includ"...
Emtriva Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Emtriva (emtricitabine) is an antiviral medication used to treat the human immunodeficiency virus (HIV) which causes the acquired immunodeficiency syndrome (AIDS). Emtriva is not a cure for HIV or AIDS. Common side effects of Emtriva include:
- upset stomach
- trouble sleeping
- darkening skin color on palms of hands and soles of feet
- strange dreams
- runny nose
- skin rash or changes in the shape or location of body fat (especially in the arms legs face neck breasts and trunk)
The adult dosage of Emtriva is one 200 mg capsule administered once daily orally, or 240 mg (24 mL) oral solution administered once daily orally. Pediatric dose is determined by the child's weight. Other drugs may affect Emtriva, making it less effective or making side effects more likely to occur. Tell your doctor all medications and supplements you use. During pregnancy, Emtriva should be used only when prescribed. HIV medicines are usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.
Our Emtriva (emtricitabine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
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.
Emtriva in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
This medication 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;
- feeling dizzy, light-headed, tired, or very weak;
- stomach pain, nausea with vomiting; or
- fast or uneven heart rate.
Stop using emtricitabine and call your doctor at once if you have a serious side effect such as:
- signs of a new infection such as fever, chills, sore throat, flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores;
- nausea, upper stomach pain, 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 (enlarged thyroid);
- weakness or prickly feeling in your fingers or toes;
- problems with walking, breathing, speech, swallowing, or eye movement; or
- severe lower back pain, loss of bladder or bowel control.
Less serious side effects may include:
- headache, dizziness;
- mild diarrhea, mild nausea, upset stomach;
- darkened patches of skin on your palms and/or soles;
- strange dreams;
- cough, runny nose;
- mild skin rash; or
- change in the shape or location of body fat (especially in the arms, legs, face, neck, breasts, and trunk).
Read the entire detailed patient monograph for Emtriva (Emtricitabine)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Emtriva Overview - Patient Information: Side Effects
Headache, nausea, diarrhea, trouble sleeping, or darkening skin color on palms of hands and soles of feet may occur. If any of these effects persist or worsen, notify 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).
Changes in body fat (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs) may occur while you are taking HIV medication. The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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 Emtriva (Emtricitabine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Emtriva FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in other sections of the labeling:
- Lactic acidosis/severe hepatomegaly with steatosis [See BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Severe acute exacerbations of Hepatitis B [See BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Immune reconstitution syndrome [See WARNINGS AND PRECAUTIONS].
Adverse Reactions from Clinical Trials Experience
Clinical Trials in Adult Subjects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (incidence greater than or equal to 10%, any severity) identified from any of the 3 large controlled clinical trials include headache, diarrhea nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis.
Studies 301A and 303- Treatment Emergent Adverse Reactions: The most common adverse reactions that occurred in subjects receiving EMTRIVA with other antiretroviral agents in clinical trials 301A and 303 were headache, diarrhea, nausea, and rash, which were generally of mild to moderate severity. Approximately 1% of subjects discontinued participation in the clinical trials due to these events. All adverse reactions were reported with similar frequency in EMTRIVA and control treatment groups with the exception of skin discoloration which was reported with higher frequency in the EMTRIVA treated group.
A summary of EMTRIVA treatment-emergent clinical adverse reactions in Studies 301A and 303 is provided in Table 2.
Table 2 : Selected Treatment-Emergent Adverse
Reactions (All Grades, Regardless of Causality) Reported in ≥ 3% of
EMTRIVA-Treated Subjects in Either Study 301A or 303 (0-48 Weeks)
|EMTRIVA + ZDV/d4T + NNRTI/PI
|Lamivudine + ZDV/d4T + NNRTI/PI
|EMTRIVA + didanosine + efavirenz
|Stavudine + didanosine + efavirenz
|Body as a Whole|
|Abnormal dreams||2%||< 1%||11%||19%|
|a Rash event includes rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, and allergic reaction.|
Studies 301A and 303- Laboratory Abnormalities: Laboratory abnormalities in these trials occurred with similar frequency in the EMTRIVA and comparator groups. A summary of Grades 3-4 laboratory abnormalities is provided in Table 3 below.
Table 3 : Treatment-Emergent Grades 3-4 Laboratory
Abnormalities Reported in ≥ 1% of EMTRIVA-Treated Subjects in
Either Study 301A or 303
|EMTRIVA + ZDV/d4T + NNRTI/PI
|Lamivudine + ZDV/d4T + NNRTI/PI
|EMTRIVA + Didanosine + Efavirenz
|Stavudine + Didanosine + Efavirenz
|Percentage with grade 3 or grade 4 laboratory abnormality||31%||28%||34%||38%|
|ALT ( > 5.0 x ULNa)||2%||1%||5%||6%|
|AST ( > 5.0 x ULN)||3%||< 1%||6%||9%|
|Bilirubin ( > 2.5 x ULN)||1%||2%||< 1%||< 1%|
|Creatine kinase ( > 4.0 x ULN)||11%||14%||12%||11%|
|Neutrophils ( < 750 mm³)||5%||3%||5%||7%|
|Pancreatic amylase ( > 2.0 x ULN)||2%||2%||< 1%||1%|
|Serum amylase ( > 2.0 x ULN)||2%||2%||5%||10%|
|Serum glucose < 40 or > 250 mg/dL)||3%||3%||2%||3%|
|Serum lipase ( > 2.0 x ULN)||< 1%||< 1%||1%||2%|
|Triglycerides ( > 750 mg/dL)||10%||8%||9%||6%|
|a ULN = Upper limit of normal|
Study 934- Treatment Emergent Adverse Reactions: In Study 934, 511 antiretroviralna´ve subjects received either VIREAD® + EMTRIVA administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254). Adverse reactions observed in this trial were generally consistent with those seen in previous trials in treatment-experienced or treatment-na´ve subjects (Table 4).
Table 4 : Selected Treatment-Emergent Adverse
Reactionsa (Grades 2-4) Reported in ≥ 5% in Any Treatment Group in
Study 934 (0-144 Weeks)
|TDFb + EMTRIVA + EFV
|AZT/3TC + EFV
|General Disorders and Administration Site Condition|
|Infections and Infestations|
|Upper respiratory tract infections||8%||5%|
|Nervous System Disorders|
|Skin and Subcutaneous Tissue Disorders|
|a Frequencies of adverse reactions are based
on all treatment-emergent adverse events, regardless of relationship to study
b From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of VIREAD + EMTRIVA with efavirenz.
c Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.
Study 934 - Laboratory Abnormalities: Significant laboratory abnormalities observed in this trial are shown in Table 5.
Table 5 : Significant Laboratory Abnormalities
Reported in ≥ 1% of Subjects in Any Treatment Group in Study 934
|TDFa + EMTRIVA + EFV
|AZT/3TC + EFV
|Any ≥ Grade 3 Laboratory Abnormality||30%||26%|
|Fasting Cholesterol ( > 240 mg/dL)||22%||24%|
|Creatine Kinase (M: > 990 U/L) (F: > 845 U/L)||9%||7%|
|Serum Amylase ( > 175 U/L)||8%||4%|
|Alkaline Phosphatase ( > 550 U/L)||1%||0%|
|AST (M: > 180 U/L) (F: > 170 U/L)||3%||3%|
|ALT (M: > 215 U/L) (F: > 170 U/L)||2%||3%|
|Hemoglobin ( < 8.0 mg/dL)||0%||4%|
|Hyperglycemia ( > 250 mg/dL)||2%||1%|
|Hematuria ( > 75 RBC/HPF)||3%||2%|
|Glycosuria (3+)||< 1%||1%|
|Neutrophils ( < 750/mm )||3%||5%|
|Fasting Triglycerides ( > 750 mg/dL)||4%||2%|
|a From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of VIREAD + EMTRIVA with efavirenz.|
Clinical Trials in Pediatric Subjects
Assessment of adverse reactions is based on data from Study 203, an open label, uncontrolled trial of 116 HIV-1-infected pediatric subjects who received emtricitabine through 48 weeks. The adverse reaction profile in pediatric subjects was generally comparable to that observed in clinical trials of EMTRIVA in adult subjects. Hyperpigmentation was more frequent in children. Additional adverse reactions identified from this trial include anemia.
Selected treatment-emergent adverse events, regardless of causality, reported in subjects during 48 weeks of treatment were the following: infection (44%), hyperpigmentation (32%), increased cough (28%), vomiting (23%), otitis media (23%), rash (21%), rhinitis (20%), diarrhea (20%), fever (18%), pneumonia (15%), gastroenteritis (11%), abdominal pain (10%), and anemia (7%). Treatment-emergent grades 3-4 laboratory abnormalities were experienced by 9% of pediatric subjects, including elevated amylase ( > 2.0 x ULN) (n=4), decreased neutrophils ( < 750/mm³) (n=3), elevated ALT ( > 5 x ULN) (n=2), elevated CPK ( > 4 x ULN) (n=2) and one subject each with elevated bilirubin ( > 3.0 x ULN), elevated GGT ( > 10 x ULN), elevated lipase ( > 2.5 x ULN), decreased hemoglobin ( < 7 g/dL), and decreased glucose ( < 40 mg/dL).
Read the entire FDA prescribing information for Emtriva (Emtricitabine)
Additional Emtriva Information
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