What are the most important things to know about tenofovir disoproxil fumarate?
Tenofovir disoproxil fumarate (tenofovir DF) can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), liver problems, and new or worsening kidney problems, including kidney failure.
Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:
- Weakness or tiredness
- Unusual muscle pain
- Shortness of breath or fast breathing
- Stomach pain with nausea or vomiting
- Cold or blue hands or feet
- Dizziness or lightheadedness
- Fast or abnormal heartbeat
- 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 or vomiting
- Pain, aching, or tenderness on the right side of your stomach/abdominal area
If you have hepatitis B virus infection (HBV) and take tenofovir DF, your HBV infection may get much worse (flare up) if you stop taking tenofovir DF. Do not stop taking tenofovir DF without first talking to your health care provider.
Contact your health care provider right away if you have any of the following symptoms that could be signs of a worsening kidney problem (called Fanconi Syndrome), which may be related to tenofovir-containing drugs:
- Bone pain that does not go away or gets worse
- Pain in your arms, hands, legs, or feet
- Broken bones
- Muscle pain or weakness
While taking tenofovir DF, it is important to keep all of your appointments with your health care provider.
What is tenofovir disoproxil fumarate?
Tenofovir DF (brand name: Viread) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 2 years of age and older who weigh at least 22 lb (10 kg). Tenofovir DF is always used in combination with other HIV medicines.
For more information on the use of tenofovir DF in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
HIV medicines cannot cure HIV/AIDS, but taking HIV medicines 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, do not cut down on, skip, or stop taking them unless your health care provider tells you to.
Tenofovir DF is also approved by FDA for the treatment of chronic hepatitis B virus infection (HBV) in adults and children 2 years of age and older who weigh at least 22 lb (10 kg). Tenofovir DF may be included as part of an antiretroviral therapy (ART) regimen to treat both HIV and HBV infection in people with HIV/HBV coinfection. In addition to tenofovir DF, the ART regimen should include another drug that is active against both HIV and HBV. For more information on the HBV-related use of tenofovir DF, please refer to the HBV section of the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV and the Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV.
What should I tell my health care provider before taking tenofovir disoproxil fumarate?
Before taking tenofovir DF, tell your health care provider:
- If you are allergic to tenofovir DF or any other medicines.
- If you have liver problems, including hepatitis B virus infection (HBV).
- If you have kidney problems or receive kidney dialysis treatment.
- If you have bone problems.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking tenofovir DF during pregnancy. For more information on the use of tenofovir DF during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
- If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
- If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Tenofovir DF may affect the way other medicines or products work, and other medicines or products may affect how tenofovir DF works. Taking tenofovir DF together with certain medicines or products may cause serious side effects.
How should I take tenofovir disoproxil fumarate?
Tenofovir DF comes in the following forms and strengths:
- 150-mg, 200-mg, 250-mg, and 300-mg tablets
- Oral powder (40 mg of tenofovir DF per 1 g of powder)
Take tenofovir DF according to your health care provider's instructions. Do not miss a dose of tenofovir DF, and do not change your dose or stop taking tenofovir DF without first talking with your health care provider.
Tenofovir DF tablets should be swallowed whole and can be taken with or without food.
People who are unable to swallow the tablets whole may take the oral powder. Use the provided dosing scoop to measure the oral powder. Mix the oral powder with soft foods that can be swallowed without chewing, such as applesauce, baby food, or yogurt. Do not mix the oral powder with liquid, as the powder may float to the top even after stirring. Take the dose of oral powder right after mixing it. Read the “Instructions for Use” that comes with tenofovir DF oral powder for information about the right way to prepare and take a dose.
Always take tenofovir DF in combination with other HIV medicines.
If you have taken too much tenofovir DF, 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 tenofovir DF, see the FDA drug label.
What should I do if I forget a dose?
If you miss a dose of tenofovir DF, 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 two doses at the same time to make up for a missed dose.
What side effects can tenofovir disoproxil fumarate cause?
Tenofovir DF may cause side effects. Some side effects of tenofovir DF can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.
Other possible side effects of tenofovir DF include:
- Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is 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.
- Bone problems, including bone pain, or softening or thinning of the bones (osteopenia), which may lead to fractures.
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 tenofovir DF. To learn more about possible side effects of tenofovir DF, read the drug label or package insert or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.
How should tenofovir disoproxil fumarate be stored?
- Store tenofovir DF tablets and oral powder at room temperature, 68°F to 77°F (20°C to 25°C).
- Keep tenofovir DF in the container that it came in and keep the container tightly closed.
- Do not use tenofovir DF if the original seal over the container opening is broken or missing.
- Throw away tenofovir DF that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep tenofovir DF and all medicines out of reach of children.
Where can I find more information about tenofovir disoproxil fumarate?
- For more information on the use of tenofovir DF in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
- Recommendations on the use of tenofovir DF in people with HIV and HBV, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV and the Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV.
- This Patient Version drug summary is based on the following FDA label(s): Powder, tablet (coated). The Patient Package Insert and Instructions For Use include information for people taking tenofovir DF.
- The American Hospital Formulary Service (AHFS) Patient Medication Information for tenofovir disoproxil fumarate available from MedlinePlus.
- Tenofovir DF-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)
- A list of FDA-approved HIV medicines, from HIVinfo.
Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056
Last Reviewed: April 12, 2023