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dolutegravir

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Brand names: Tivicay

Integrase Strand Transfer Inhibitor Rx

TRIUMEQ is a drug that contains three medicines in one pill: dolutegravir, abacavir, and lamivudine. It is used to treat HIV-1 infection in adults and children.

Drug Pricing (NADAC)

Brand Price

$73.02/unit

Generic Available

No

VIIV HLTHCARE

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

TRIUMEQ treats HIV-1, the virus that causes AIDS.

Common side effects

Trouble sleeping (insomnia), Headache, Feeling tired

Key warnings

TRIUMEQ can cause serious allergic reactions.

How It Works

TRIUMEQ contains three drugs that each work differently to stop HIV from multiplying. Dolutegravir is an integrase strand transfer inhibitor (INSTI). Abacavir and lamivudine are nucleoside analogue reverse transcriptase inhibitors.

How to Take It

Take one TRIUMEQ tablet every day. You can take it with or without food. For children weighing 6 kg to less than 25 kg, use TRIUMEQ PD tablets for oral suspension as directed by your doctor. Do not substitute TRIUMEQ tablets and TRIUMEQ PD tablets for oral suspension on a milligram-per-milligram basis.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. There is a pregnancy registry to monitor outcomes in people who take TRIUMEQ during pregnancy. Talk to your doctor about the risks and benefits of taking TRIUMEQ during pregnancy.

Missed Dose

If you miss a dose of TRIUMEQ, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store TRIUMEQ tablets in the original bottle at room temperature (68°F to 77°F). Keep the bottle tightly closed and protect from moisture. Do not remove the desiccant.

Side Effects (from patient reports)

Based on 8,059 FDA adverse event reports.

Pain
1,425
Anxiety
1,051
Emotional Distress
1,048
Anhedonia
942
Chronic Kidney Disease
701
Fatigue
628
Exposure During Pregnancy
606
Headache
566
Off Label Use
553
Renal Failure
539

FDA Adverse Event Report Analysis

Detailed analysis of 8,756 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2010–2025.

Total Reports

8,756

Death-Related Reports

865

Hospitalization Reports

1,908

Top Indication

Hiv Infection

Gender Distribution

Female 2,600 (35%)
Male 4,713 (64%)

Age Distribution

0–17 224
18–44 1,839
45–64 2,345
65–74 467
75+ 92

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 PAIN 1,425
2 ANXIETY 1,051
3 EMOTIONAL DISTRESS 1,048
4 ANHEDONIA 942
5 CHRONIC KIDNEY DISEASE 701
6 FATIGUE 628
7 EXPOSURE DURING PREGNANCY 606
8 HEADACHE 566
9 OFF LABEL USE 553
10 RENAL FAILURE 539
11 RASH 487
12 FOETAL EXPOSURE DURING PREGNANCY 478
13 PYREXIA 445
14 HYPERTENSION 428
15 OSTEOPOROSIS 425

Reactions in Death Reports

DEATH 390
PAIN 149
FOETAL DEATH 141
FATIGUE 130
PYREXIA 130
THROMBOCYTOPENIA 126
HEPATIC ENZYME INCREASED 125
OFF LABEL USE 121
OVERDOSE 116
EXPOSURE DURING PREGNANCY 115

Reactions in Hospitalization Reports

PAIN 307
EMOTIONAL DISTRESS 276
ANXIETY 273
ANHEDONIA 244
CHRONIC KIDNEY DISEASE 220
RENAL FAILURE 213
ACUTE KIDNEY INJURY 190
HOSPITALISATION 155
FATIGUE 147
END STAGE RENAL DISEASE 121

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

TRIUMEQ can cause serious allergic reactions. If you have a gene called HLA-B*5701, you are more likely to have an allergic reaction. You should be tested for this gene before taking TRIUMEQ. Symptoms can include fever, rash, nausea, vomiting, diarrhea, or stomach pain. Some people can also experience liver problems or a heart attack.

Known Drug Interactions

Dolutegravir may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 (dofetilide, dalfampridine, and metformin) [see Contraindications ( 4 ), Drug Interactions ( 7.3 )] . Other Agents Antiarrhythmic: Dofetilide ↑Dofetilide Coadministration is contraindicated with TRIUMEQ and TRIUMEQ PD [see Contraindications ( 4 )] .

Mechanism: Dolutegravir blocks the proteins in the kidneys that normally help remove dofetilide from the body. This causes the levels of dofetilide in your blood to rise.

What to do: Do not take these two medications together. Your doctor will need to find an alternative treatment.

Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] .

Mechanism: Dolutegravir blocks the kidneys from removing metformin from the body. This can cause metformin levels to rise, which increases the risk of a serious condition called lactic acidosis.

What to do: Your doctor may need to adjust your dose or monitor you more closely for side effects.

Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] .

Mechanism: Dolutegravir blocks the kidneys from filtering metformin out of your blood, which makes metformin levels rise. Higher levels of metformin increase the risk of a serious health problem called lactic acidosis.

What to do: Your doctor may need to lower your metformin dose or check your blood levels more often.

Drugs that Reduce Metformin Clearance Clinical Impact: The risk of lactic acidosis may increase due to concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) which increase systemic exposure to metformin Intervention Consider the benefits and risks of concomitant use.

Mechanism: Dolutegravir blocks the kidneys from removing metformin from the body, which causes metformin levels to rise and increases the risk of side effects.

What to do: Your doctor should carefully consider the risks and benefits of using these two medications at the same time.

moderate linagliptin

Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] .

Mechanism: Dolutegravir prevents your kidneys from removing metformin from your body. This can cause the drug to build up and increase the risk of a serious condition called lactic acidosis.

What to do: Your doctor may need to adjust your dose or monitor you more closely. Tell your doctor if you feel very weak, dizzy, or have trouble breathing.

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Common Questions

Can I take TRIUMEQ if I am allergic to any of its ingredients?
No, you should not take TRIUMEQ if you are allergic to abacavir, dolutegravir, or lamivudine.
Can I take TRIUMEQ if I have liver problems?
You should not take TRIUMEQ if you have moderate or severe liver problems.
What should I do if I think I am having an allergic reaction to TRIUMEQ?
Stop taking TRIUMEQ immediately and seek medical attention.
Can TRIUMEQ cure HIV?
No, TRIUMEQ does not cure HIV, but it can help control the virus.
Will TRIUMEQ prevent me from spreading HIV to others?
TRIUMEQ can reduce your risk of spreading HIV, but it is still important to practice safe sex.
Can I take TRIUMEQ with other medications?
Some medications can interact with TRIUMEQ. Tell your doctor about all the medications you are taking.
How often should I see my doctor while taking TRIUMEQ?
You should see your doctor regularly to monitor your HIV and overall health.
What tests should I have before starting TRIUMEQ?
You should be tested for the HLA-B*5701 gene and hepatitis B virus (HBV) before starting TRIUMEQ.
Can I switch between TRIUMEQ tablets and TRIUMEQ PD tablets?
No, do not substitute TRIUMEQ tablets and TRIUMEQ PD tablets for oral suspension on a milligram-per-milligram basis.
What do I do if I cannot swallow the TRIUMEQ tablet?
Talk to your doctor about whether TRIUMEQ PD tablets for oral suspension are right for you.
What are the common side effects of dolutegravir?
The most commonly reported side effects of dolutegravir include Trouble sleeping (insomnia), Headache, Feeling tired. Based on 8,059 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does dolutegravir interact with other medications?
Yes, dolutegravir has 28 known drug interactions. Notable interactions include dofetilide, empagliflozin, empagliflozin/linagliptin. Always inform your doctor about all medications you are taking.
What drug class is dolutegravir?
dolutegravir belongs to the Integrase Strand Transfer Inhibitor drug class. It requires a prescription (Rx). TRIUMEQ treats HIV-1, the virus that causes AIDS.
Is dolutegravir safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. There is a pregnancy registry to monitor outcomes in people who take TRIUMEQ during pregnancy. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for dolutegravir

The FDA label for dolutegravir (sold under brand names such as Tivicay) classifies it as a prescription-only medication in the Integrase Strand Transfer Inhibitor class. TRIUMEQ treats HIV-1, the virus that causes AIDS. Official labeling lists 3 commonly reported side effects, including Trouble sleeping (insomnia), Headache, Feeling tired.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 8,059 voluntary reports. The database also lists 28 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: July 8, 2024

All federal data sources used on this page