Dolutegravir Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 30, 2024.

Applies to dolutegravir: oral tablet, oral tablet for suspension.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You should not use this medicine together with dofetilide (Tikosyn®). Using these medicines together may cause serious or life-threatening side effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Do not use this medicine during the first part of your pregnancy unless your doctor tells you to. Use an effective form of birth control to keep from getting pregnant.

Serious skin and allergic reactions may occur while taking this medicine. Check with your doctor right away if you or your child have a severe rash or rash with fever, blistering or peeling skin, joint or muscle pain, sores in the mouth, swelling of the face, trouble breathing, unusual tiredness or weakness, or yellow eyes or skin.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notices any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, or Guillain-Barré syndrome) may also occur.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of dolutegravir

Along with its needed effects, dolutegravir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dolutegravir:

Other side effects of dolutegravir

Some side effects of dolutegravir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to dolutegravir: oral tablet, oral tablet dispersible.

General adverse events

The most common side effects were diarrhea, nausea, and headache. The most common side effects of moderate to severe intensity were insomnia, fatigue, and headache.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 18%), nausea (up to 13%), elevated lipase
• Common (1% to 10%): Abdominal pain, abdominal discomfort, flatulence, upper abdominal pain, vomiting^[Ref]

Grade 2 and grade 3 to 4 elevations in lipase were reported in up to 11% and up to 5% of therapy-naive patients, respectively. Elevated lipase was reported in 10% of therapy-experienced integrase strand transfer inhibitor (INSTI)-experienced patients.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 13%)
• Common (1% to 10%): Dizziness^[Ref]

Hepatic

• Common (1% to 10%): Elevated AST, elevated ALT, elevated total bilirubin
• Uncommon (0.1% to 1%): Hepatitis
• Rare (0.01% to 0.1%): Increased bilirubin (in combination with increased transaminases)
• Frequency not reported: Liver chemistry elevations consistent with immune reconstitution syndrome
• Postmarketing reports: Acute liver failure, hepatotoxicity^[Ref]

Grade 2 and grade 3 to 4 elevations in AST were reported in up to 5% and up to 3% of therapy-naive patients, respectively. Grade 2 and grade 3 to 4 elevations in ALT were reported in 4% and up to 2% of therapy-naive patients, respectively. Grade 2 and grade 3 to 4 elevations in total bilirubin were reported in up to 3% and less than 1% of therapy-naive patients, respectively. Elevated ALT and AST were reported in 9% and 8% of therapy-experienced INSTI-experienced patients, respectively.

The rates of AST and ALT abnormalities were higher patients coinfected with hepatitis B and/or C virus. ALT abnormalities (grade 2 to 4) in hepatitis B and/or C coinfected patients compared with HIV monoinfected patients were reported in 18% versus 3% with 50 mg once a day and 13% versus 8% with 50 mg twice a day.

Liver chemistry elevations consistent with immune reconstitution syndrome were reported in some patients with hepatitis B and/or C at the start of therapy, especially when antihepatitis therapy was stopped.

Acute liver failure has been reported in a regimen containing this drug; contribution of this drug was unclear.^[Ref]

Metabolic

• Common (1% to 10%): Hyperglycemia
• Frequency not reported: Fasted lipid values increased (including cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)

Antiretroviral therapy:

• Frequency not reported: Increased glucose levels^[Ref]

Grade 2 and grade 3 hyperglycemia were reported in up to 9% and up to 2% of therapy-naive patients, respectively. Hyperglycemia and elevated cholesterol were reported in 14% and 10% of therapy-experienced INSTI-experienced patients, respectively.^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, abnormal dreams, depression
• Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt
• Frequency not reported: Suicidal behavior, suicide completion
• Postmarketing reports: Anxiety^[Ref]

Suicidal ideation, attempt, behavior, or completion were observed primarily in patients with history of depression or other psychiatric illness.^[Ref]

Musculoskeletal

• Common (1% to 10%): Elevated creatine phosphokinase (CPK)
• Uncommon (0.1% to 1%): Arthralgia, myalgia
• Frequency not reported: Myositis^[Ref]

Grade 2 and grade 3 to 4 elevations in CPK were reported in up to 5% and up to 7% of therapy-naive patients, respectively. Elevated CPK was reported in 6% of therapy-experienced INSTI-experienced patients.

Arthralgia and myalgia have also been reported during postmarketing experience.^[Ref]

Hematologic

• Common (1% to 10%): Decreased total neutrophils, hematology laboratory abnormality
• Frequency not reported: Decreased neutrophil count, decreased hemoglobin^[Ref]

Grade 2 and grade 3 to 4 reductions in total neutrophils were reported in up to 4% and up to 3% of therapy-naive patients, respectively. Hematology laboratory abnormality (grade 3 to 4) was reported in 2% of therapy-experienced INSTI-experienced patients, with neutropenia (2%) reported most often.^[Ref]

Dermatologic

• Common (1% to 10%): Pruritus, rash (includes rash, generalized rash, macular rash, maculopapular rash, pruritic rash, drug eruption)^[Ref]

Renal

• Frequency not reported: Renal impairment, increased serum creatinine (due to inhibition of tubular secretion of creatinine), changes in median serum creatinine^[Ref]

Increased serum creatinine occurred due to inhibition of tubular secretion of creatinine without affecting renal glomerular function. Increased serum creatinine was reported within the first week of therapy and remained stable through 48 weeks; a mean change of 9.96 mcmol/L (range of -53 to 54.8 mcmol/L) was reported after 48 weeks of therapy in therapy-naive patients. Increased serum creatinine was reported within the first 4 weeks of therapy and remained stable through 96 weeks; a mean change of 0.15 mg/dL (range of -0.32 to 0.65 mg/dL) was reported after 96 weeks of therapy in therapy-naive patients.^[Ref]

Other

• Common (1% to 10%): Fatigue
• Frequency not reported: Decreased blood bicarbonate, increased blood potassium
• Postmarketing reports: Increased weight

Antiretroviral therapy:

• Frequency not reported: Increased weight, increased blood lipid levels^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury)^[Ref]

Immunologic

• Uncommon (0.1% to 1%): Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)
• Frequency not reported: Immune reconstitution inflammatory syndrome^[Ref]

See also:

Frequently asked questions

• What drugs are contained in HIV treatment Juluca?

Further information

Dolutegravir side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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