Dolutegravir can cause serious, life-threatening side effects. These include allergic reactions and liver problems.
Contact your health care provider right away if you develop a rash with any of the following symptoms:
Some people taking dolutegravir have had liver problems. People with a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking dolutegravir. Liver problems have also occurred in people taking dolutegravir who have no history of liver disease. Liver function tests may be done before and during treatment with dolutegravir.
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
Do not take dolutegravir if you take dofetilide. Taking dolutegravir and dofetilide can cause side effects that may be life threatening.
While taking dolutegravir, it is important to keep all of your appointments with your health care provider.
Dolutegravir is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 12 years of age and older and weighing at least 88 pounds (40 kilograms). Dolutegravir is always used in combination with other HIV medicines.
Dolutegravir belongs to a class (group) of HIV drugs called integrase inhibitors. Integrase inhibitors block an HIV enzyme called integrase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking integrase, integrase inhibitors prevent HIV from multiplying and can reduce the amount of HIV in the body.
HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.
Before taking dolutegravir, tell your health care provider:
Dolutegravir (brand name: Tivicay) comes in tablet form. Each tablet contains 50 mg dolutegravir.
Take dolutegravir according to your health care provider’s instructions.
Take dolutegravir by mouth, with or without food.
Always take dolutegravir in combination with other HIV medicines.
If you take too much dolutegravir, 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 dolutegravir, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
If you miss a dose of dolutegravir, take the missed dose as soon as you remember it. But if it is within 4 hours of 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.
Dolutegravir may cause side effects. Most side effects from dolutegravir are manageable, but a few can be serious. Serious side effects of dolutegravir include allergic reactions and liver problems. (See the WARNING above.)
Other possible side effects of dolutegravir include:
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 dolutegravir. To learn more about possible side effects of dolutegravir, read the drug label or package insert or talk to your health care provider or pharmacist.
The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to dolutegravir.
You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at https://www.accessdata.fda.gov/scripts/medwatch/.
More information about dolutegravir is available:
Last Reviewed: April 22, 2016