- Hepatitis B has gotten worse when this drug was stopped in some people with hepatitis B. Close follow-up for a few months is needed when therapy is stopped in people who have hepatitis B. Do not stop taking this drug without calling your doctor. Talk with your doctor.
- This drug is not approved to treat hepatitis B. Hepatitis B testing needs to be done before taking this drug. Talk with your doctor.
- It is used to treat HIV infection.
- If you have an allergy to efavirenz, emtricitabine, tenofovir, or any other part of this drug.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have had red, blistered, swollen, or peeling skin after taking efavirenz.
- If you have any of these health problems: Kidney disease or liver disease.
- If you weigh less than 88 pounds (40 kilograms). This drug is not for use in people who weigh less than 88 pounds (40 kilograms).
- If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this drug.
- If you are using another drug that has the same drug in it.
- If you are taking any drugs that can raise the chance of kidney problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
- If you are breast-feeding. Do not breast-feed while you take this drug.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
- Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- This drug interacts with many other drugs. The chance of this drug’s side effects may be raised or how well this drug works may be lowered. The chance of the other drugs’ side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take this drug with all of your other drugs (prescription or OTC, natural products, vitamins).
- Bone problems like bone pain, soft bones, and thin bones have happened with this drug. This may lead to broken bones. You may need to have a test to check your bones. Talk with your doctor.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
- Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
- Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take this drug. Tell your doctor right away if you have any new signs after you start this drug, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.
- This drug may rarely cause swollen liver and an acid health problem in the blood. This may be deadly in some cases. The chance may be higher in women, in overweight people, and in people who have taken drugs like this one for a long time. Talk with your doctor.
- A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
- Kidney problems like kidney failure have happened with this drug. Tell your doctor if you have ever had kidney problems.
- Liver problems have happened with this drug. Sometimes, this has been very bad and has led to the need for a liver transplant or death. Liver problems may happen in people with or without liver disease. Talk with the doctor.
- Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this drug.
- This drug may cause harm to the unborn baby if you take it while you are pregnant.
- Use birth control that you can trust to prevent pregnancy while taking this drug and for 3 months after care ends.
- If you get pregnant while taking this drug or within 3 months after your last dose, call your doctor right away.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
- Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
- Hallucinations (seeing or hearing things that are not there).
- Memory problems or loss.
- Feeling confused.
- Bone pain.
- Muscle pain or weakness.
- Pain in arms or legs.
- Change in body fat.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Upset stomach or throwing up.
- Change in color of skin.
- Feeling tired or weak.
- Signs of a common cold.
- This drug may cause you to have dizziness, sleepiness, trouble sleeping, trouble focusing, or dreams that are not normal. Most of the time, these effects go away after taking this drug for 2 to 4 weeks. It may help if you take this drug at bedtime. If you feel dizzy or sleepy, or you have trouble focusing, avoid driving and doing other tasks or actions that call for you to be alert. Call your doctor if these effects last, they bother you, or are very bad.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take on an empty stomach.
- Take with a full glass of water.
- Taking this drug at bedtime may help with some side effects.
- Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
- It is important that you do not miss or skip a dose of this drug during treatment.
- Take calcium and vitamin D as you were told by your doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Have your urine checked as you have been told by your doctor.
- This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
- This drug is not a cure for HIV. Stay under the care of your doctor.
- This drug does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
- If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting this drug. Talk with your doctor.
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- If you are not sure what to do if you miss a dose, call your doctor.
- Store in the original container at room temperature.
- Keep lid tightly closed.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
© 2019 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.