Dovato (dolutegravir/lamivudine) is a prescription oral tablet used for HIV in certain situations. Dovato can cause side effects that range from mild to serious. Examples include headache and diarrhea.
Keep reading to learn about the common, mild, and serious side effects Dovato can cause. For a general overview of the drug, including details about what it’s used for, refer to this Dovato overview.
Some people may experience mild to serious side effects during their Dovato treatment. Examples of the drug’s commonly reported side effects include:
Mild side effects have been reported with Dovato. These include:
- diarrhea
- dizziness
- fatigue (low energy)
- anxiety
- feeling weak or unwell
- headache
- insomnia (trouble sleeping)
- nausea
- mild allergic reaction (see “Side effects explained” for details)
In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop taking Dovato unless your doctor recommends it.
Dovato may cause mild side effects other than those listed here. See the drug’s prescribing information for details.
While rare, serious side effects are possible with Dovato. Serious side effects reported in the drug’s studies include:
- liver problems, including liver damage
- lactic acidosis (too much acid in the body)
- depression or suicidal thoughts
- immune reconstitution syndrome
- boxed warning: risk of worsening hepatitis B and lamivudine-resistant hepatitis B virus (HBV)
- severe allergic reaction
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.
For more information about some of these side effects, see “Side effects explained.”
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Dovato, visit MedWatch.
Side effects in children
In studies, side effects in children 12 years and older were similar to side effects seen in adults.
Help is out there
If you or someone you know is in crisis and considering suicide or self-harm, please seek support:
- Call or text the 988 Suicide and Crisis Lifeline at 988 or chat at 988lifeline.org. Caring counselors are available to listen and provide free and confidential support 24/7.
- Text HOME to the Crisis Text Line at 741741 to connect with a volunteer crisis counselor for free and confidential support 24/7.
- Not in the United States? Find a helpline in your country with Befrienders Worldwide.
- Call 911 or your local emergency services number if you feel safe to do so.
If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.
If you’re not in the same household, stay on the phone with them until help arrives.
Get answers to some frequently asked questions about Dovato’s side effects.
How do side effects of Dovato compare with those of Biktarvy?
Dovato and Biktarvy are prescribed to treat HIV in adults in certain situations. Side effects of these two drugs are similar.
Common side effects of both drugs include diarrhea, headache, and nausea. And although it’s rare, both drugs can cause liver problems, including liver damage. But unlike Dovato, Biktarvy can also cause kidney problems or damage in rare cases.
Dovato and Biktarvy have a boxed warning for the risk of worsening hepatitis B. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
To learn more about how Dovato and Biktarvy compare, check out the “Dovato vs. Biktarvy” section of this Dovato overview. You can also talk with your doctor or pharmacist.
Can Dovato cause weight gain or weight loss?
It’s not known for certain, but weight changes may be possible with Dovato.
In studies, people taking Dovato didn’t report weight gain or loss as a side effect. But weight gain has happened in people taking lamivudine or dolutegravir (the active ingredients in Dovato) as part of an HIV treatment plan. It’s not known how much (if any) part these drugs (or other factors) played in causing weight gain in these cases.
Let your doctor know if you have concerns about your weight while taking Dovato. They can suggest ways to help you maintain a weight that’s healthy for you.
Learn more about some of the side effects Dovato may cause.
Risk of lamivudine-resistant HBV
Dovato has a boxed warning about the risk of hepatitis B virus (HBV) becoming resistant to certain drugs. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).
According to Dovato’s manufacturer, lamivudine (one of Dovato’s two active ingredients) can make an existing HBV infection harder to treat. It’s not known whether Dovato is safe or effective for people with HIV and HBV. The drug hasn’t been studied in people with both conditions.
What might help
Your doctor should test you for HBV before prescribing Dovato for you. If you have HBV, they’ll likely discuss treatment options with you. They may also suggest an HIV treatment besides Dovato.
Risk of worsening hepatitis B
Dovato has a boxed warning about the risk of worsening hepatitis B. People with HBV infection and HIV who stop taking lamivudine to treat HIV have experienced worsening hepatitis B, according to reports. (Lamivudine is one of the two active ingredients in Dovato.)
Symptoms of worsening HBV include:
- jaundice (yellowing of your skin or the whites of your eyes)
- nausea and vomiting
- abdominal pain
What might help
Your doctor should test you for HBV before prescribing Dovato. If you have HBV and are prescribed this drug, your doctor will closely monitor you for side effects if you need to stop taking Dovato. They may prescribe treatment for HBV if your condition shows signs of worsening after stopping this medication.
If you have HBV, do not stop taking Dovato without first speaking with your doctor. If you both agree you’ll stop treatment, your doctor will likely want to closely monitor your liver function for some time after you’ve stopped taking Dovato.
Immune reconstitution syndrome
According to studies, treatment with Dovato can cause immune reconstitution syndrome in rare cases. This is an overactive response by your immune system.
Symptoms of immune reconstitution syndrome can mimic those of an infection. They may also resemble symptoms of an autoimmune condition, including autoimmune hepatitis. Symptoms of immune reconstitution syndrome include:
Infection-like symptoms caused by immune reconstitution syndrome are more likely to occur when you first start taking Dovato. But the syndrome can occur at any time during treatment.
What might help
Contact your doctor right away if you develop symptoms of immune reconstitution syndrome while taking Dovato. They can review your symptoms and recommend the best treatment for them.
Depression or suicidal thoughts
Although rare, Dovato can cause depression or suicidal thoughts, according to the drug’s studies. These reactions mostly occurred in people with preexisting depression or other mental health conditions. But anyone taking Dovato is at risk of these side effects.
Symptoms of depression include:
- loss of interest in activities or hobbies you usually enjoy
- feelings of hopelessness or worthlessness
- concentration or memory difficulties
- thoughts of harming yourself
What might help
Immediately call your doctor if you notice symptoms of depression or suicidal thoughts. They can recommend the best treatment for your symptoms. This may include stopping Dovato and exploring other treatments for HIV.
In the United States, you can also get help by calling or texting the National Suicide Prevention Lifeline at 988.
Allergic reaction
Like most drugs, Dovato can cause an allergic reaction in some people. Allergic reactions to lamivudine and dolutegravir (the two active ingredients in Dovato) have been reported in rare cases.
Symptoms can be mild to serious and can include:
What might help
If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:
- an antihistamine you swallow, such as Benadryl (diphenhydramine)
- a product you apply to your skin, such as hydrocortisone cream
If your doctor confirms you’ve had a mild allergic reaction to Dovato, they’ll decide whether you should continue taking it.
If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.
If your doctor confirms you’ve had a serious allergic reaction to Dovato, they may have you switch to a different treatment.
There are important warnings to consider before starting Dovato.
Boxed warnings
Dovato has boxed warnings about the risk of worsening hepatitis B and lamivudine-resistant hepatitis B virus (HBV). Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA). To learn more, see the “Side effects explained” section.
Other warnings
Dovato may not be right for you if you have certain medical conditions. This is known as a drug-condition interaction. Other factors may also affect whether this drug is a good treatment option for you. Talk with your doctor about your health history before starting Dovato. Factors to consider include those described here.
Kidney problems. Depending on the severity of your kidney problem, Dovato may not be safe for you to take. Be sure to tell your doctor about any kidney condition you have, such as chronic kidney disease, before starting Dovato. Your doctor can determine whether this drug is safe for you, depending on how well your kidneys function.
Liver problems besides hepatitis. It’s not known whether it’s safe to take Dovato if you have a serious liver problem besides hepatitis, such as cirrhosis. Talk with your doctor to learn whether your liver is healthy enough for treatment with Dovato.
Taking the heart rhythm drug dofetilide. Doctors will usually avoid prescribing Dovato and the heart rhythm drug dofetilide together. Taking these medications together may increase the risk of serious, possibly life threatening, side effects that dofetilide can cause. Your doctor can review safer treatments with you instead.
Allergic reaction. If you’ve had an allergic reaction to Dovato or any of its ingredients, your doctor will likely not prescribe it for you. Ask them about other medications that might be better options.
Alcohol and Dovato
There’s no known direct interaction between Dovato and alcohol. However, alcohol and Dovato can cause some similar side effects, such as diarrhea, headache, and liver problems. Liver problems caused by Dovato or alcohol can be serious. Combining Dovato and alcohol can increase your risk of these side effects, including the risk that they’re severe.
If you drink alcohol, talk with your doctor about how much, if any, is safe to consume while taking Dovato.
Pregnancy and breastfeeding with Dovato
It’s not known whether it’s safe to take Dovato during pregnancy. More research is needed to determine whether the drug is safe to take while pregnant.
If you and your doctor agree that you’ll take Dovato while you’re pregnant, consider joining the Antiretroviral Pregnancy Registry. (Dovato is an antiretroviral drug, which means it treats HIV.) A pregnancy registry allows healthcare professionals to collect information about a drug’s safety when taken during pregnancy. You can learn more or sign up at the registry website or by calling 800-258-4263.
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Disclaimer: Healthline 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.