Dovato (dolutegravir/lamivudine) is a brand-name tablet that’s prescribed to treat HIV in certain adults. As with other drugs, Dovato can cause side effects, such as headache, nausea, and insomnia.
Dovato contains two active drugs: dolutegravir and lamivudine. Dolutegravir belongs to a drug class called integrase inhibitors. Lamivudine belongs to a class of drugs called nucleoside reverse transcriptase inhibitors. The drug isn’t available in a generic version.
Read on to learn about potential common, mild, and serious side effects of Dovato. For a general overview of the drug, including details about its uses, see this article.
Dovato can cause certain side effects, some of which 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 Dovato in clinical trials:
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Dovato use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Dovato’s prescribing information.
Mild side effects that have been reported with Dovato 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 Dovato and want to tell the FDA about it, visit MedWatch.
* For more information about this side effect, see “Side effect specifics” below.
Serious side effects of Dovato aren’t common, but they may occur. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Dovato’s prescribing information.
If you develop serious side effects while taking Dovato, 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. Symptoms can include:
- nausea or vomiting
- pain on the right side of your body
- loss of appetite
- Depression or suicidal thoughts. Symptoms can include:
- a feeling of hopelessness or sadness
- not participating in activities you used to enjoy
- difficulty sleeping or sleeping more often than usual
- weight loss or weight gain
- Lactic acidosis. Symptoms can include:
- weakness
- difficulty breathing
- increased or irregular heart rate
- muscle pain
- abdominal pain, nausea, or vomiting
- a cold feeling
- Immune reconstitution syndrome (a hypersensitivity reaction that can occur when starting HIV treatment). Symptoms can include:
- swollen lymph nodes
- Risk of worsening hepatitis B.*
- Risk of hepatitis B virus that’s resistant to certain drugs.*
- Severe allergic reaction.†
* Dovato has a
† An allergic reaction is possible after using Dovato. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the Side effect specifics section below.
Dovato 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 Dovato compare with those seen with Biktarvy?
Some of the side effects of these medications may be similar, while others may be different. Dovato and Biktarvy are prescribed to treat HIV. However, the drugs work in different ways to treat this condition.
For example, Dovato and Biktarvy can cause nausea, diarrhea, or headache. However, Biktarvy may cause kidney problems to occur. Dovato isn’t known to cause this side effect. However, Dovato may cause depression or suicidal thoughts to occur. Biktarvy isn’t known to cause these side effects.
If you have questions about side effects from Dovato or Biktarvy, talk with your doctor or pharmacist.
Can Dovato cause weight gain or weight loss?
It’s possible. In clinical trials, weight gain wasn’t reported as a side effect of Dovato. However, after the drug was approved, weight gain was reported in some people taking the medication. Because this side effect wasn’t seen in trials, it’s not known how often weight gain may occur from taking Dovato.
An HIV infection may cause you to lose weight. However, weight loss was not reported in clinical trials of Dovato. It’s possible that treatment with Dovato can help increase your strength and energy. This may help you gain weight if you’ve had weight loss due to your condition.
In addition, weight gain or weight loss can be due to other side effects of Dovato. For example, depression can increase your risk of weight gain or weight loss.
If you experience changes in your body weight during treatment with Dovato, talk with your doctor. They can help determine what may be causing your weight changes to occur and the best ways to manage them.
Learn more about some of the side effects that Dovato may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Dovato.
Risk of worsening hepatitis B
Tell your doctor whether you have a history of hepatitis B infection before starting treatment with Dovato. Dovato has a
It’s possible that stopping treatment with lamivudine, one of the active drugs in Dovato, may cause worsening of hepatitis B. This can only occur if you have a history of hepatitis B. So, your doctor will test your blood before starting treatment with Dovato to see whether you have hepatitis B.
Clinical trials haven’t been done in people with HIV and hepatitis B taking Dovato. It’s not known whether the drug may be safe or how many people may develop worsening symptoms when stopping treatment.
Symptoms of worsening hepatitis B may include:
- abdominal pain
- nausea or vomiting
- jaundice
- dark urine
What you can do
If you need to stop treatment with Dovato, be sure to talk with your doctor first. If you’re stopping treatment and you have hepatitis B, your doctor will monitor you for worsening of your hepatitis B. Be sure to tell your doctor whether you develop any symptoms of worsening hepatitis B while you’re taking Dovato or after stopping treatment.
In some cases, if you have hepatitis B infection, your doctor may recommend taking a different medication to manage your hepatitis B after stopping Dovato. This can help prevent your hepatitis B from worsening.
If you have concerns about the risk of worsening of hepatitis B from stopping treatment with Dovato, talk with your doctor. They can help determine the best treatment option for you.
Risk of hepatitis B virus that’s resistant to certain drugs
If you have hepatitis B and you take Dovato, this medication may increase your risk of developing hepatitis B that’s resistant to certain drugs. In fact, Dovato has a
It’s possible for your hepatitis B virus to mutate, or change, from taking Dovato. If your hepatitis B mutates, certain medications used to treat it may no longer work.
However, it’s not known how often Dovato may cause hepatitis B to become resistant to other drugs. This is because clinical trials didn’t include people with hepatitis B and HIV.
What you can do
Before you start taking Dovato, your doctor will test you for hepatitis B. If you have hepatitis B, your doctor may recommend that you take a different medication to treat your HIV. Talk with your doctor about the best treatment option for you.
Nausea
Taking Dovato may cause nausea. This was a common side effect reported in the drug’s clinical trials.
What you can do
If you experience nausea during your treatment with Dovato, talk with your doctor. In some cases, taking Dovato with food may decrease nausea that you experience.
If you have nausea that’s severe or bothersome to you from taking Dovato, talk with your doctor or pharmacist. They can help recommend the best ways to manage this side effect.
Headache
Taking Dovato may cause headache. This was a common side effect reported in the drug’s clinical trials.
What you can do
If you have headaches during your treatment with Dovato, tell your doctor or pharmacist. They can recommend ways to decrease headache from occurring. For example, they may recommend taking an over-the-counter medication, such as acetaminophen (Tylenol) to manage your headaches.
Allergic reaction
As with most drugs, Dovato can cause an allergic reaction in some people. It’s unknown whetherthis side effect occurred in clinical trials of the drug.
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 Dovato. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Suicide prevention
If you know someone at immediate risk of self-harm, suicide, or hurting another person:
- Ask the tough question: “Are you considering suicide?”
- Listen to the person without judgment.
- Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
- Stay with the person until professional help arrives.
- Try to remove any weapons, medications, or other potentially harmful objects.
If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.
Before starting treatment with Dovato, be sure to tell your doctor about any medical conditions that you have or any medications that you’re taking. They can help determine whetherDovato is safe for you.
Boxed warnings
This drug has
Other precautions
Be sure to talk with your doctor about your health history before you take Dovato. This drug may not be the right treatment 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 problems. If you have any liver problems, including hepatitis B or hepatitis C, tell your doctor before taking Dovato. This medication can cause liver problems to occur. And, if you already have a history of liver problems, taking Dovato may worsen your condition. Your doctor can help determine whether Dovato may be safe for you to take.
Allergic reaction. If you’ve had an allergic reaction to Dovato or any of its ingredients, your doctor will likely not prescribe Dovato. Ask your doctor what other medications may be better options for you.
Kidney problems. If you have kidney problems, tell your doctor before taking Dovato. This drug may not be safe for certain people with severe kidney problems, such as kidney failure. In some cases, your doctor may recommend a different treatment option for you.
Alcohol with Dovato
Dovato isn’t known to interact with alcohol. However, it’s possible for alcohol to worsen side effects from Dovato. For example, Dovato and alcohol may cause nausea, headache, or liver problems.
If you have questions about drinking alcohol while taking Dovato, talk with your doctor.
Pregnancy and breastfeeding while taking Dovato
Below is important information about taking Dovato while pregnant or breastfeeding.
Pregnancy
Dovato is not safe to take during pregnancy.
One of the active drugs in Dovato, dolutegravir, may harm a developing fetus. This drug may cause structural changes in the neural tube, which are differences in how the brain or spinal cord develops. Because of this risk, if you’re pregnant or planning to become pregnant, your doctor may recommend that you take a different medication to treat your HIV.
Because of the possible risks of taking Dovato during pregnancy, doctors usually recommend that people that can become pregnant take a pregnancy test before starting treatment. In addition, they’ll recommend using a form of contraception, such as condoms, while you’re taking Dovato.
If you’re pregnant or planning to become pregnant, talk with your doctor before taking Dovato. They can recommend other treatment options for you.
Dovato has a pregnancy registry. A pregnancy registry is a collection of data on people who have taken Dovato while pregnant. The registry collects information about how a drug affects pregnancy and whether the drug may increase the risk of harm to a fetus. To find out more information about the pregnancy registry, call 800-258-4263.
Breastfeeding
It is not recommended to breastfeed if you have HIV. This is because the HIV infection can pass from breast milk to a breastfed child.
In addition, the active drugs in Dovato (dolutegravir and lamivudine) are present in breast milk. It’s unknown what effects these drugs may have on a breastfed child.
If you have questions about breastfeeding during Dovato treatment, talk with your doctor.
You may experience side effects from taking Dovato. However, these side effects are usually mild.
If you’d like to learn more about Dovato, 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 Dovato. For details about other aspects of Dovato, refer to this article.
- Drug comparison. To learn how Dovato compares with Biktarvy, read 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.