Dolutegravir: Side Effects, Uses & Monitoring
‑ TIVICAY and TIVICAY PD are indicated in combination with: other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑ 1) infection in adults (treatment-naïve or -experienced) and in pedia
- Data source
- FDA labeling via NIH DailyMed (label b00132b8…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
‑ TIVICAY and TIVICAY PD are indicated in combination with: other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑ 1) infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve)aged at least 4 weeks and weighing at least 3 kg [ see Microbiology ( 12.4 )]. TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated…
Conditions associated with Dolutegravir in labeling
Frequently Asked Questions
What is Dolutegravir used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Dolutegravir?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Dolutegravir require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Dolutegravir.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.