Emtriva

Last updated on RxList: 7/6/2021
Emtriva Side Effects Center

What Is Emtriva?

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.

What Are Side Effects of Emtriva?

Common side effects of Emtriva include:

  • headache
  • nausea
  • upset stomach
  • diarrhea
  • trouble sleeping
  • darkening skin color on palms of hands and soles of feet
  • dizziness
  • strange dreams
  • cough
  • runny nose
  • skin rash or changes in the shape or location of body fat (especially in the arms legs face neck breasts and trunk)
Tell your doctor if you have serious side effects of Emtriva including:
  • unexplained weight loss,
  • persistent muscle aches or weakness,
  • joint pain,
  • numbness or tingling of the hands/feet/arms/legs,
  • severe tiredness,
  • vision changes,
  • severe or 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), or
  • mental/mood changes (such as depression).

Dosage for Emtriva

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.

What Drugs, Substances, or Supplements Interact with Emtriva?

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.

Emtriva During Pregnancy or Breastfeeding

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.

Additional Information

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.

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Emtriva Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: 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 symptoms of liver problems: swelling around your midsection, upper stomach pain, nausea, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Emtricitabine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with emtricitabine. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
  • cold sores, sores on your genital or anal area;
  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

  • headache, dizziness, weakness;
  • indigestion, stomach pain, nausea, vomiting, diarrhea;
  • sleep problems, strange dreams;
  • rash, skin discoloration; 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.

Read the entire detailed patient monograph for Emtriva (Emtricitabine)

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Emtriva Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

  • Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see WARNINGS AND PRECAUTIONS].
  • Immune Reconstitution Syndrome [see WARNINGS AND PRECAUTIONS].
  • Lactic Acidosis/Severe Hepatomegaly with Steatosis [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

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.

Adverse Reactions From Clinical Trials Experience In Adults

More than 2,000 adult subjects with HIV-1 infection have been treated with EMTRIVA alone or in combination with other antiretroviral agents for periods of 10 days to 200 weeks in clinical trials. The most common adverse reactions (incidence greater than or equal to 10%, any severity) identified from any of the three large, controlled clinical trials include headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis.

In Trials 301A and 303, the most common adverse reactions that occurred in subjects receiving EMTRIVA with other antiretroviral agents were headache, diarrhea, nausea, and rash, which were generally mild to moderate. 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 except for skin discoloration, which was reported with higher frequency in the EMTRIVA-treated group.

Skin discoloration, manifested by hyperpigmentation on the palms or soles, was generally mild and asymptomatic. The mechanism and clinical significance are unknown.

A summary of EMTRIVA treatment-emergent clinical adverse reactions in Trials 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 Trial 301A or 303 (0-48 Weeks)

  303 301A
EMTRIVA + AZT/d4T + NNRTI/PI
(N=294)
3TC + AZT/d4T + NNRTI/PI
(N=146)
EMTRIVA + didanosine + EFV
(N=286)
d4T + didanosine + EFV
(N=285)
Body as a Whole
Asthenia 16% 10% 12% 17%
Headache 13% 6% 22% 25%
Abdominal pain 8% 11% 14% 17%
Digestive System
Diarrhea 23% 18% 23% 32%
Nausea 18% 12% 13% 23%
Vomiting 9% 7% 9% 12%
Dyspepsia 4% 5% 8% 12%
Musculoskeletal
Myalgia 4% 4% 6% 3%
Arthralgia 3% 4% 5% 6%
Nervous System
Insomnia 7% 3% 16% 21%
Depressive disorders 6% 10% 9% 13%
Paresthesia 5% 7% 6% 12%
Dizziness 4% 5% 25% 26%
Neuropathy/peripheral neuritis 4% 3% 4% 13%
Abnormal dreams 2% <1% 11% 19%
Respiratory
Rhinitis 18% 12% 12% 10%
Increased cough 14% 11% 14% 8%
Skin
Rash eventa 17% 14% 30% 33%
AZT=zidovudine; d4T=stavudine; NNRTI/PI=non-nucleoside reverse transcriptase inhibitor/protease inhibitor; 3TC=lamivudine; EFV=efavirenz.
a Rash event includes rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, and allergic reaction.

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.

Table 3 : Treatment-Emergent Grades 3-4 Laboratory Abnormalities Reported in ≥1% of EMTRIVA-Treated Subjects in Either Trial 301A or 303

  303 301A
EMTRIVA + AZT/d4T + NNRTI/PI
(N=294)
3TC + AZT/d4T + NNRTI/PI
(N=146)
EMTRIVA + Didanosine + EFV
(N=286)
d4T + Didanosine + EFV
(N=285)
Any ≥ Grade 3 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

In Trial 934, 511 antiretroviral-naive subjects received efavirenz (EFV) administered in combination with either EMTRIVA + tenofovir disoproxil fumarate (TDF) (N=257) or AZT/3TC (N=254) for 144 weeks. The most common adverse reactions (incidence greater than or equal to 10%, all grades) included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Table 4 provides the treatment-emergent adverse reactions (Grades 2-4) occurring in greater than or equal to 5% of subjects treated in any treatment group.

Table 4 : Selected Adverse Reactionsa (Grades 2-4) Reported in ≥5% in Any Treatment Group in Trial 934 (0-144 Weeks)

  EMTRIVA + TDF + EFVb
N=257
AZT/3TC + EFV
N=254
Fatigue 9% 8%
Depression 9% 7%
Nausea 9% 7%
Diarrhea 9% 5%
Dizziness 8% 7%
Upper respiratory tract infections 8% 5%
Sinusitis 8% 4%
Rash eventc 7% 9%
Headache 6% 5%
Insomnia 5% 7%
Nasopharyngitis 5% 3%
Vomiting 2% 5%
a Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug.
b From Weeks 96 to 144 of the trial, subjects received TRUVADA® with EFV in place of EMTRIVA + TDF with EFV.
c Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.

Laboratory Abnormalities

Laboratory abnormalities observed in Trial 934 were generally consistent with those seen in previous trials (Table 5).

Table 5 : Significant Laboratory Abnormalities Reported in ≥1% of Subjects in Any Treatment Group in Trial 934 (0-144 Weeks)

  EMTRIVA + TDF + EFVa
N=257
AZT/3TC + EFV
N=254
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/mm³) 3% 5%
Fasting Triglycerides (>750 mg/dL) 4% 2%
a From Weeks 96 to 144 of the trial, subjects received TRUVADA with EFV in place of EMTRIVA + TDF with EFV.

Adverse Reactions From Clinical Trials Experience In Pediatric Subjects

Assessment of adverse reactions in pediatric subjects is based on data from Trial 203, an open label, uncontrolled trial of 116 HIV-1 infected subjects who received FTC through 48 weeks. The adverse reaction profile in pediatric subjects was generally comparable to that observed in clinical trials of EMTRIVA in adult subjects [see ADVERSE REACTIONS]. 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 > ULN) (n=4), decreased neutrophils (<750/mm³) (n=3), elevated ALT (>5 > ULN) (n=2), elevated CPK (>4 > ULN) (n=2) and one subject each with elevated bilirubin (>3.0 > ULN), elevated GGT (>10 > ULN), elevated lipase (>2.5 > ULN), decreased hemoglobin (<7 g/dL), and decreased glucose (<40 mg/dL).

Read the entire FDA prescribing information for Emtriva (Emtricitabine)

© Emtriva Patient Information is supplied by Cerner Multum, Inc. and Emtriva Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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