Drug Notebook

FDA Alerts

  • Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals. (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)
  • Single entity or fixed-combination preparations containing emtricitabine not indicated for treatment of chronic hepatitis B virus (HBV) infection; safety and efficacy not established for treatment of HIV infection in patients coinfected with HBV.
  • Severe, acute exacerbations of HBV reported following discontinuance of emtricitabine. Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months after emtricitabine is discontinued in patients coinfected with HBV and HIV. If appropriate, initiation of treatment for HBV infection may be warranted.

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emtricitabine
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What is the most important information I should know about emtricitabine?

This medication may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Emtricitabine may also cause severe liver damage, which can be fatal. Call your doctor at once if you have any of these symptoms of liver problems: nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Treatment of HIV/AIDS almost always requires using many medicines together. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

What is emtricitabine?

Emtricitabine is an antiviral medication. It is in a category of HIV medicines called reverse transcriptase inhibitors. Emtricitabine works by preventing HIV cells from multiplying in the body.

Emtricitabine is used to treat the human immunodeficiency virus (HIV), which causes the acquired immunodeficiency syndrome (AIDS). Emtricitabine is not a cure for HIV or AIDS.

Emtricitabine may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking emtricitabine?

Do not use this medication if you are allergic to emtricitabine, or if you are also using: Before taking emtricitabine, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of the conditions listed above, you may not be able to use emtricitabine or you may require a dosage adjustment or special monitoring during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

You should not breast-feed while you are using emtricitabine. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.
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