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AIDSinfo Drug Database

AIDSinfo Drug Database

Drugs by class

FDA-approved

Investigational

Emtricitabine  Audio icon

Brand Name: Emtriva
Other Names: FTC
Drug Class: Nucleoside Reverse Transcriptase Inhibitors
Approved Use: Treatment of HIV Infection
Drug Images:
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Emtriva 200mg
Emtriva Bottle
Chemical Image:
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Emtricitabine
Emtricitabine
Molecular Weight: 247.249

WARNING:

Emtricitabine can cause serious, life-threatening side effects. These include lactic acidosis (buildup of lactic acid in the blood) and serious liver problems.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

  • Feeling very weak or tired.
  • Unusual (not normal) muscle pain.
  • Trouble breathing.
  • Stomach pain with nausea and vomiting.
  • Feeling cold, especially in the arms and legs.
  • Feeling dizzy or lightheaded.
  • Fast or irregular heartbeat.

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice).
  • Dark-colored urine.
  • Light-colored bowel movements.
  • Loss of appetite for several days or longer.
  • Nausea.
  • Pain in the lower stomach (abdominal) area.

Emtricitabine is not approved for the treatment of hepatitis B virus (HBV) infection. People infected with HBV who take emtricitabine and then stop taking it may get severe worsening of their HBV infections. For information about the “off-label” use of emtricitabine to treat HBV infection in people who are also receiving combination antiretroviral therapy (ART) for HIV infection, see the “What is emtricitabine?” section below. (“Off-label” use refers to use of a U.S. Food and Drug Administration [FDA]-approved medicine in a manner different from that described on the medicine label.)

While taking emtricitabine, it is important to keep all of your appointments with your health care provider.

What is emtricitabine?

Emtricitabine is a prescription medicine approved by FDA for the treatment of HIV infection in adults, children, and infants. Emtricitabine is always used in combination with other HIV medicines.

Emtricitabine belongs to a class (group) of HIV drugs called nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, NRTIs prevent HIV from multiplying and can reduce the amount of HIV in the body. 

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, including emtricitabine, don’t cut down on, skip, or stop taking them unless your health care provider tells you to.

Emtricitabine can also be used “off-label” to treat hepatitis B virus (HBV) infection, an opportunistic infection of HIV infection.

  • “Off-label” use refers to use of an FDA-approved medicine in a manner different from that described on the medicine label. Good medical practice and the best interests of a patient sometimes require that a medicine be used “off-label.”
  • An opportunistic infection is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as those infected with HIV—than in people with healthy immune systems.

The Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, prepared by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the HIV Medicine Association of the Infectious Diseases Society of America (IDSA-HIVMA), includes recommendations for the “off-label” use of emtricitabine to treat HBV infection in people who are also receiving combination ART for HIV infection. In addition to emtricitabine, the ART regimen should include another drug that is effective against both HBV and HIV. Emtricitabine should not be used to treat HBV in HIV-infected individuals who are not receiving ART.

What should I tell my health care provider before taking emtricitabine?

Before taking emtricitabine, tell your health care provider:

  • If you are allergic to emtricitabine or any other medicines.
  • If you have kidney problems.
  • If you have any liver problems, including HBV infection.
  • If you have any other medical conditions. 
  • If you are pregnant or plan to become pregnant. Whether emtricitabine can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking emtricitabine when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking emtricitabine.
  • If you are using hormone-based birth control (such as pills, injections, or implants). 
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Emtricitabine may affect the way other medicines or products work, and other medicines and products may affect how emtricitabine works. Taking emtricitabine together with certain medicines or products may cause serious side effects.

How should I take emtricitabine?

Emtricitabine comes in the following forms and strengths:

  • 200-mg capsules (brand name: Emtriva).
  • 10-mg/mL oral solution. An oral solution is a mixture of a medicine and a liquid that can be taken by mouth.

Take emtricitabine according to your health care provider’s instructions.

Take emtricitabine by mouth, with or without food.

Always take emtricitabine in combination with other HIV medicines.

If you take too much emtricitabine, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room. 

For more information on how to take emtricitabine, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

What should I do if I forget a dose?

If you miss a dose of emtricitabine, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take more than one dose of emtricitabine in a day. Do not take two doses at the same time to make up for a missed dose.

What side effects can emtricitabine cause?

Emtricitabine can cause serious, life-threatening side effects. These include lactic acidosis (buildup of lactic acid in the blood) and serious liver problems. (See the WARNING above.)

Other possible side effects of emtricitabine include:

  • Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection. Tell your health care provider if you start having new symptoms after starting your HIV medicine.
  • Changes in body fat (lipodystrophy).
  • Skin discoloration.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of emtricitabine. To learn more about possible side effects of emtricitabine, read the drug label or package insert or talk to your health care provider or pharmacist.

The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to emtricitabine.

You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at https://www.accessdata.fda.gov/scripts/medwatch/.

How should emtricitabine be stored?

  • Store emtricitabine capsules between 59°F and 86°F (15°C to 30°C).
  • Store emtricitabine oral solution in a refrigerator, between 36°F and 46°F (2°C to 8°C). Do not freeze the oral solution. Or store emtricitabine oral solution at room temperature for up to 3 months. After the 3 months, throw away any remaining solution in the bottle.
  • Do not use emtricitabine if the original seal over the bottle opening is broken or missing.
  • Throw away emtricitabine that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep emtricitabine and all medicines out of reach of children.

Where can I find more information about emtricitabine?

More information about emtricitabine is available:

Manufacturer Information

Gilead Sciences, Inc.
800-445-3235

The above Patient Version drug summary is based on the following FDA label(s): Capsule, solution.

Last Reviewed: March 16, 2015

Last Updated: March 16, 2015


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