Symtuza (darunavir/cobicistat/emtricitabine/tenofovir
alafenamide) is a brand-name oral tablet prescribed to treat HIV in adults and certain children. As with other drugs, Symtuza can cause side effects, such as diarrhea and skin rashes.

Symtuza is approved by the Food and Drug Administration (FDA) to treat HIV-1, the most common type of HIV. Doctors may prescribe the drug as a first-time treatment or to replace a different HIV-1 treatment in certain situations.

Symtuza can cause certain side effects. Some of them are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Symtuza in clinical trials:

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Symtuza use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Symtuza’s prescribing information.

Mild side effects that have been reported with Symtuza include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Symtuza and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Symtuza may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Symtuza’s prescribing information.

If you develop serious side effects while taking Symtuza, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

  • Liver problems such as hepatitis (liver inflammation). Symptoms can include:
  • Lactic acidosis (high lactic acid level in your blood). Symptoms can include:
  • High blood sugar level and diabetes. Symptoms can include:
    • urinating more than is typical
    • feeling much thirstier than is typical
  • Changes in body fat. Symptoms can include:
    • decrease in fat in your face, arms, and legs
    • increase in fat in your upper back, neck, and abdomen
    • breast enlargement
  • Kidney problems such as acute (sudden) kidney failure. Symptoms can include:
    • urinating less than is typical
    • swollen ankles or feet
    • itching
    • confusion
    • shortness of breath
  • Immune reconstitution syndrome (a condition caused by an overactive immune system, causing it to attack hidden infections or healthy tissues in your body). Symptoms may vary depending on the situation. Contact your doctor if you have any new symptoms during Symtuza treatment.
  • Severe skin reactions.*
  • Severe allergic reaction.*
  • Risk of worsening of hepatitis B.†

* For more information about this side effect, see “Side effect specifics” below.
† Symtuza has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see “Side effect specifics” below.

Symtuza may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

How do side effects of Symtuza compare with those seen with Tivicay or Biktarvy?

Symtuza and Biktarvy contain similar active drugs and can cause very similar side effects. Tivicay has a different active drug and fewer side effects than Symtuza.

Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide), Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), and Tivicay (dolutegravir) are all medications prescribed to treat HIV-1. (HIV-1 is the most common type of HIV.)

Symtuza and Biktarvy are both complete treatments for HIV-1. This means you don’t need to take other HIV drugs with them. In contrast, doctors must prescribe Tivicay with other HIV medications that may also cause side effects.

To learn more about how Symtuza compares with other HIV drugs, talk with your doctor. They can help determine the best treatment option for you.

Is Symtuza safe for older adults?

Yes, Symtuza is generally considered safe for older adults (ages 65 years and over). In clinical trials, side effects of Symtuza in older adults were similar to those reported in younger adults.

Older adults are more likely to have other conditions that may interact with Symtuza. These include liver and kidney problems. They’re also more likely to take other medications or have other health factors that can interact with Symtuza. But your doctor will check for these interactions before prescribing Symtuza. You can learn more about interactions with Symtuza in this article.

If you’re 65 years old or over, be sure to tell your doctor about your health history and any other medications you take. This will help your doctor determine whether Symtuza is safe for you.

Learn more about some of the side effects that Symtuza may cause. To find out how often side effects occurred in clinical trials, see the drug’s prescribing information.

Risk of worsening of hepatitis B

Symtuza has a boxed warning for the risk of worsening hepatitis B. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

If you have hepatitis B, stopping Symtuza could cause it to worsen suddenly. This could cause severe liver problems or even liver failure. For more information, see Symtuza’s label information. You can also talk with your doctor.

What you can do

Your doctor will likely perform a test for hepatitis B virus (HBV) before you start taking Symtuza.

If you have HBV, it’s especially important that you do not run out of Symtuza or stop taking it without your doctor’s approval. Skipping even just a few doses could make hepatitis B worsen.

Due to this risk, always refill your Symtuza prescription before you run out of medication. And do not stop taking the medication without talking with your doctor first. If you have HBV and your doctor recommends stopping Symtuza, they’ll likely monitor your liver for several months afterward. They may also prescribe medication to treat hepatitis B.

Note: Symtuza is prescribed to treat HIV-1 (a specific type of HIV) in certain situations. Skipping doses can also allow the HIV-1 in your body to develop resistance to Symtuza. This can make it harder to treat.

Skin reactions

You may have a skin reaction, such as a rash, while taking Symtuza. In clinical trials, skin reactions were commonly reported with Symtuza.

Most skin reactions with Symtuza are mild. They typically occur in the first 4 weeks of taking the medication and tend to get better with continued treatment. Examples of mild skin reactions include mild rash, itching, skin discoloration or darkening, dermatitis, and increased sensitivity to sunlight.

Symtuza can also cause severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. These reactions are rare but serious. They may require treatment in hospital and can even be life threatening.

Symptoms of severe skin reactions can include:

What you can do

If you have symptoms of a severe skin reaction with Symtuza, stop taking the medication and contact your doctor right away. You may need treatment in hospital. If your symptoms seem life threatening, call 911 or your local emergency number or go to the nearest emergency room right away.

If you have a mild skin reaction while taking Symtuza, call your doctor right away. Your doctor may want to assess your skin reaction before deciding whether you should continue taking Symtuza. They may also prescribe medication to help reduce the reaction, such as a corticosteroid cream.

If you have concerns or questions about skin reactions with Symtuza, talk with your doctor for more information.

Allergic reaction

As with most drugs, Symtuza can cause an allergic reaction in some people. This side effect was rare in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Symtuza. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Below is important information you should consider before taking Symtuza.

Boxed warning: Risk of worsening of hepatitis B

This drug has a boxed warning for the risk of worsening of hepatitis B. This is the most serious warning from the Food and Drug Administration (FDA). For details, see “Side effect specifics” above.

Other precautions

Be sure to talk with your doctor about your health history before you take Symtuza. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Liver or kidney problems. If you have a liver or kidney problem, Symtuza could make your condition worse. Your doctor will order tests to check your liver and kidneys before prescribing Symtuza and regularly throughout your treatment. But if you have a severe liver or kidney condition, your doctor will likely not prescribe the drug. Ask them what other HIV medications may be better options for you.

Diabetes. Symtuza may increase your blood sugar level. If you have diabetes, this could make your blood sugar harder to manage. Ask your doctor whether Symtuza is right for you. Your doctor may want to monitor your blood sugar more often while you’re taking Symtuza. If needed, they may adjust your dosage of diabetes medication.

Hemophilia. If you have hemophilia, taking Symtuza may increase your risk of bleeding. Talk with your doctor about whether this medication is the right treatment option for you.

Pregnancy. If you’re pregnant, your doctor will likely not prescribe Symtuza. This is because the drug can be less effective in pregnant people. Your doctor can advise you about other HIV medications that may be more effective.

Breastfeeding. If you have HIV, you should not breastfeed your child, even if you take HIV medication such as Symtuza. Breastfeeding can pass HIV to your child through breast milk. Talk with your doctor about other healthy ways to feed your child.

Alcohol consumption. Drinking alcohol with Symtuza may raise your risk of certain Symtuza side effects. These include nausea, headache, diarrhea, and liver problems. If you drink alcohol, ask your doctor whether you should limit or avoid alcohol while taking Symtuza.

Allergic reaction. If you’ve had an allergic reaction* to Symtuza or any of its ingredients in the past, your doctor will likely not prescribe the drug. Ask your doctor what other medications may be better options for you.

Sulfonamide allergy. If you’ve had an allergic reaction to sulfonamide (sulfa) drugs in the past, taking Symtuza may cause an allergic reaction.* Talk with your doctor right away if you have symptoms of an allergic reaction while taking Symtuza.

* For details about allergic reaction and Symtuza, see “Side effects specifics” above.

If you’d like to learn more about Symtuza, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Symtuza. For details about other aspects of Symtuza, refer to this article.
  • Cost. If you’d like to learn about Symtuza’s cost, see this article.
  • Dosage. For information about the dosage ofSymtuza, view this article.
  • Interactions. To find out about Symtuza’s interactions, see this article.
  • A look at HIV. For details about your condition, see our HIV and AIDS hub.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.