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Emtriva

Generic Name: emtricitabine (em trye SYE ta been)
Brand Names: Emtriva
Emtriva is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Learn about side effects, interactions and indications.
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Drug Information:
Emtriva (emtricitabine) is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. Emtriva is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Emtriva is not a cure for HIV or AIDS. Do not take Emtriva if you also take other medicines that contain emtricitabine or lamivudine. Emtriva may cause a serious condition called Get emergency medical help if you have even mild symptoms 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. Learn more

Emtriva Side Effects

Emtriva Side Effects

Note: This document contains side effect information about emtricitabine. Some of the dosage forms listed on this page may not apply to the brand name Emtriva.

In Summary

More frequent side effects include: increased serum alanine aminotransferase, increased serum amylase, increased serum aspartate aminotransferase, and neutropenia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to emtricitabine: oral capsule, oral solution

Warning

Oral route (Capsule; Solution)

Emtricitabine is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Closely monitor hepatic function in patients co-infected with HBV and HIV-1 for several months after discontinuing emtricitabine because severe, acute exacerbations of hepatitis B have been reported. Initiation of anti-HBV therapy may be warranted.

Along with its needed effects, emtricitabine (the active ingredient contained in Emtriva) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking emtricitabine:

More common

  • Burning, crawling, itching, numbness, prickling, "pins and needles”, or tingling feelings
  • chest pain or tightness
  • cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Less common

  • Sensation of pins and needles
  • stabbing pain

Some side effects of emtricitabine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Abdominal or stomach pain
  • abnormal dreams
  • darkening or redness of the skin
  • depression
  • dizziness
  • earache
  • headache
  • heartburn or indigestion
  • itching skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash, hives, or welts on the skin
  • spots on your skin resembling a blister or pimple
  • vomiting

Less common

  • Joint pain or swelling
  • muscle stiffness
  • trouble sleeping
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet

For Healthcare Professionals

Applies to emtricitabine: oral capsule, oral solution

General

The most common side effects reported during clinical trials in adults were headache, diarrhea, elevated creatine kinase, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis. The most common side effects reported during clinical trials in children were anemia and skin discoloration/hyperpigmentation.

Dermatologic

Very common (10% or more): Rash event (included rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash, allergic reaction; up to 30%)

Common (1% to 10%): Vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discoloration (hyperpigmentation)

Postmarketing reports: Angioedema

Combination antiretroviral therapy:

-Frequency not reported: Lipodystrophy/redistribution of body fat

Grades 2 to 4 rash event and rash were reported in 7% and 5% of patients, respectively.

Skin discoloration (manifested by hyperpigmentation primarily on the palms and/or soles) was generally mild and asymptomatic. Clinical significance and mechanism are unknown; according to some authorities, skin discoloration was of little clinical significance.

Skin discoloration (hyperpigmentation) was very common in pediatric patients.

Nervous system

Grades 2 to 4 dizziness and headache were reported in 8% and 6% of patients, respectively.

Very common (10% or more): Dizziness (up to 25%), headache (up to 22%)

Common (1% to 10%): Paresthesia, neuropathy/peripheral neuritis

Frequency not reported: Somnolence

Gastrointestinal

Very common (10% or more): Diarrhea (up to 23%), nausea (up to 18%), abdominal pain (up to 14%)

Common (1% to 10%): Elevated amylase (including elevated pancreatic amylase), elevated serum lipase, vomiting, dyspepsia

Frequency not reported: Gastroenteritis

Grades 2 to 4 diarrhea, nausea, and vomiting were reported in 9%, 9%, and 2% of patients, respectively.

Elevated serum amylase (greater than 2 times the upper limit of normal [2 x ULN), pancreatic amylase (greater than 2 x ULN), and serum lipase (greater than 2 x ULN) have been reported in up to 5%, up to 2%, and up to 1% of patients, respectively. Elevated serum amylase (greater than 175 units/L) was reported in 8% of patients.

Gastroenteritis was only reported in pediatric patients.

Metabolic

Elevated fasting cholesterol (greater than 240 mg/dL) and fasting triglycerides (greater than 750 mg/dL) were reported in 22% and 4% of patients, respectively. Elevated triglycerides (greater than 750 mg/dL [greater than 8.47 mmol/L]) and increased/decreased serum glucose (less than 40 or greater than 250 mg/dL [less than 2.2 or greater than 13.9 mmol/L]) have been reported in up to 10% and up to 3% of patients, respectively. Elevated triglycerides (greater than 750 mg/dL) and hyperglycemia (greater than 250 mg/dL) were reported in 5% and 2% of patients, respectively.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Very common (10% or more): Elevated fasting cholesterol (22%)

Common (1% to 10%): Hypertriglyceridemia, hyperglycemia, elevated triglycerides, increased/decreased serum glucose, elevated fasting triglycerides

Frequency not reported: Lactic acidosis

Antiretroviral therapy:

-Frequency not reported: Increased blood lipid levels, increased glucose levels

Respiratory

Very common (10% or more): Rhinitis (up to 18%), increased cough (up to 14%)

Common (1% to 10%): Sinusitis, upper respiratory tract infections, nasopharyngitis

Frequency not reported: Pneumonia

Grades 2 to 4 sinusitis, upper respiratory tract infections, and nasopharyngitis were reported in 8%, 8%, and 5% of patients, respectively.

Pneumonia was only reported in pediatric patients.

Psychiatric

Grades 2 to 4 depression, insomnia, and abnormal dreams were reported in 9%, 5%, and 4% of patients, respectively.

Very common (10% or more): Insomnia (up to 16%), abnormal dreams (up to 11%)

Common (1% to 10%): Depressive disorders, depression

Other

Grades 2 to 4 fatigue was reported in 9% of patients.

Elevated alkaline phosphatase (greater than 550 units/L) was reported in 1% of patients.

Infection, otitis media, and fever were only reported in pediatric patients.

Very common (10% or more): Asthenia (up to 16%)

Common (1% to 10%): Pain, fatigue, elevated alkaline phosphatase

Frequency not reported: Infection, otitis media, fever

Antiretroviral therapy:

-Frequency not reported: Increased weight

Musculoskeletal

Very common (10% or more): Elevated creatine kinase (up to 12%)

Common (1% to 10%): Myalgia, arthralgia

Frequency not reported: Osteonecrosis

Elevated creatine kinase (greater than 4 x ULN) has been reported in up to 12% of patients. Elevated creatine kinase (greater than 990 units/L in males and 845 units/L in females) was reported in 9% of patients.

Hepatic

Elevated AST (greater than 5 x ULN), ALT (greater than 5 x ULN), and bilirubin (greater than 2.5 x ULN) have been reported in up to 6%, up to 5%, and up to 1% of patients, respectively. Elevated AST (greater than 180 units/L in males and 170 units/L in females) and ALT (greater than 215 units/L in males and 170 units/L in females) were reported in 3% and 2% of patients, respectively.

Elevated AST and ALT was reported more often in patients coinfected with HIV and hepatitis B virus (HBV) than in those only infected with HIV.

Severe acute exacerbations of hepatitis B (including fatalities) have been reported in patients coinfected with HIV-1 and HBV after discontinuation of this drug and were associated with liver failure and liver decompensation in some patients.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Elevated GGT was only reported in a pediatric patient.

Common (1% to 10%): Elevated serum AST, elevated serum ALT, hyperbilirubinemia

Uncommon (0.1% to 1%): Elevated bilirubin

Frequency not reported: Posttreatment exacerbation of hepatitis B, liver failure, liver decompensation, severe hepatomegaly with steatosis, elevated GGT

Hematologic

Decreased neutrophils (less than 750/mm3) have been reported in up to 5% of patients.

Anemia was common in pediatric patients. Decreased hemoglobin (less than 7 g/dL) was only reported in a pediatric patient.

Common (1% to 10%): Neutropenia, decreased neutrophils

Uncommon (0.1% to 1%): Anemia

Frequency not reported: Decreased hemoglobin

Genitourinary

Common (1% to 10%): Hematuria

Frequency not reported: Glycosuria

Hematuria (greater than 75 RBC/high power field) and glycosuria (3 plus) were reported in 3% and less than 1% of patients, respectively.

Hypersensitivity

Common (1% to 10%): Allergic reaction

Immunologic

Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Emtriva