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Emtricitabine (Emtriva): Uses, Side Effects and Dosage

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Prescription (Rx) Boxed warning
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200 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Emtricitabine

What is the most important information I should know about Emtricitabine capsules?

Emtricitabine can cause serious side effects, including:

  • Worsening of Hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before starting treatment with emtricitabine. If you have HBV infection and take emtricitabine, your HBV may get worse (flare-up) if you stop taking emtricitabine. A "flare-up" is when your HBV infection suddenly returns in a worse way than before.
  • Do not stop taking emtricitabine without first talking to your healthcare provider.
  • Do not run out of emtricitabine. Refill your prescription or talk to your healthcare provider before your emtricitabine is all gone.
  • If you stop taking emtricitabine, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medication to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking emtricitabine.

For more information about side effects, see the section "What are the possible side effects of emtricitabine?"

What are Emtricitabine capsules?

Emtricitabine is a prescription medicine used in combination with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Who should not take Emtricitabine capsules?

Do not take Emtricitabine capsules if you are allergic to emtricitabine or any of the ingredients in emtricitabine capsules. See the end of this leaflet for a complete list of ingredients in emtricitabine capusles.

What should I tell my healthcare provider before taking emtricitabine?

Before taking emtricitabine capsules, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems, including HBV infection
  • have kidney problems or receive kidney dialysis treatment
  • are pregnant or planning to become pregnant. It is not known if Emtricitabine can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with emtricitabine.
  • Pregnancy Registry : There is a pregnancy registry for women who take emtricitabine during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

  • are breastfeeding or plan to breastfeed. Emtricitabine can pass to your baby in your breast milk. Do not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Talk with your healthcare provider about the best way to feed your baby

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines may interact with emtricitabine. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with emtricitabine. Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take emtricitabine with other medicines.

How should I take Emtricitabine capsules?

  • Take Emtricitabine capsules exactly as your healthcare provider tells you to take it.
  • Dosing in adults: Take emtricitabine capsules by mouth 1 time each day.
  • Dosing in children: Take emtricitabine capsules by mouth 1 time each day. The child's healthcare provider will calculate the right dose of Emtricitabine capsule based on the child's weight.

  • Emtricitabine may be taken with or without food.

  • Do not miss a dose of emtricitabine. Missing a dose lowers the amount of medicine in your blood. Refill your emtricitabine prescription before you run out of medicine.
  • Do not change your dose or stop taking emtricitabine capsules without first talking with your healthcare provider. Stay under a healthcare provider's care when taking emtricitabine.
  • If you take too much Emtricitabine capsules, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of emtricitabine?

Emtricitabine may cause serious side effects, including:

  • See "What is the most important information I should know about emtricitabine capsules?"
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when an HIV-infected person starts taking antiretroviral medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting emtricitabine capsules.
  • Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you develop any of these symptoms:
  • weakness or being more tired than usual
  • being short of breath or fast breathing
  • cold or blue hands and feet
  • fast or abnormal heartbeat.
  • unusual muscle pain
  • stomach pain with nausea and vomiting
  • feel dizzy or lightheaded
  • Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Your healthcare provider may tell you to stop taking emtricitabine if you develop new or worse liver problems during treatment with emtricitabine. Tell your healthcare provider right away if you develop any of these symptoms:
  • fatigue
  • weakness
  • yellowing of your skin or the white part of your eyes (jaundice)
  • light-colored stools
  • nausea and vomiting
  • confusion
  • dark "tea-colored" urine
  • loss of appetite for several days or longer
  • stomach-area (abdominal) swelling and pain.

The most common side effects of emtricitabine include:

  • headache
  • diarrhea
  • nausea
  • tiredness
  • dizziness
  • depression
  • problems sleeping
  • abnormal dreams
  • rash
  • abdominal pain
  • weakness
  • cough
  • runny nose

Skin discoloration in children may also happen with emtricitabine.

These are not all the possible side effects of emtricitabine.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store Emtricitabine capsules?

  • Store Emtricitabine capsules between 59 °F and 86 °F (15°C to 30°C).
  • Keep emtricitabine capsules in the original container and keep the container tightly closed.
  • Do not use emtricitabine capsules if seal over bottle opening is broken or missing.

Keep emtricitabine capsules and all other medicines out of reach of children.

General information about the safe and effective use of emtricitabine:

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use emtricitabine for a condition for which it was not prescribed. Do not give emtricitabine to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about emtricitabine that is written for health professionals.

What are the ingredients of Emtricitabine capsules?

Active Ingredient: emtricitabine USP

Inactive Ingredients for Emtricitabine capsules: mannitol, hypromellose, and magnesium stearate. The capsules are printed with ink containing black iron oxide.

Disclaimer: Other brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Ltd.

Manufactured by:

Cipla Limited,

Verna-403722,

Goa, India

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ - 07059

Revised: 09/2023

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 091168 · View the label on DailyMed

Revision date stated in the text: September 2023

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Emtricitabine

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Active ingredient Emtricitabine 200 mg
Dosage form Capsule
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) CIPLA
FDA approval ANDA 091168Abbreviated New Drug Application (ANDA) – generic drug Approved July 2, 2018
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Emtriva with the same TE code
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
200 mg – 1000 in 1 bottle NDC 69097-642-15
200 mg – 30 in 1 bottle NDC 69097-642-02

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.