Prescription medication · Integrase Strand Transfer Inhibitor
dolutegravir
Also sold as Tivicay. TRIUMEQ treats HIV-1, the virus that causes AIDS.
Data updated 2026-05-15
- 8,756
- FDA reportsLightly reported
- 28
- InteractionsSeveral interactions
- $73.02
- Brand price (NADAC)
What the data shows
dolutegravir (Tivicay) is a prescription Integrase Strand Transfer Inhibitor, reported less often than most tracked drugs (8,756 FDA reports), with 28 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
dolutegravir (Tivicay) is a prescription Integrase Strand Transfer Inhibitor. TRIUMEQ treats HIV-1, the virus that causes AIDS.
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.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from dolutegravir's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 8,756 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for dolutegravir, by number of reports
- Pain
Pain
1,425 reports
- Anxiety
Anxiety
1,051 reports
- Emotional Distress
Emotional Distress
1,048 reports
- Anhedonia
Anhedonia
942 reports
- Chronic Kidney Disease
Chronic Kidney Disease
701 reports
- Fatigue
Fatigue
628 reports
- Exposure During Pregnancy
Exposure During Pregnancy
606 reports
- Headache 566
Headache
566 reports
- Renal Failure 539
Renal Failure
539 reports
- Rash 487
Rash
487 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for dolutegravir each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where dolutegravir sits
dolutegravir has more FDA adverse-event reports than 36% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is dolutegravir; the line is the median (50th percentile).
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
Reports Mentioning Death
865
9.9% of reports — not proof of cause
Hospitalization Reports
1,908
Top Indication
Hiv Infection
Gender Distribution
Age Distribution
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 |
| 10 | RENAL FAILURE | 539 |
| 11 | RASH | 487 |
| 12 | FOETAL EXPOSURE DURING PREGNANCY | 478 |
| 13 | PYREXIA | 445 |
| 14 | HYPERTENSION | 428 |
| 15 | OSTEOPOROSIS | 425 |
| 17 | DEPRESSION | 406 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take TRIUMEQ if I am allergic to any of its ingredients?
Can I take TRIUMEQ if I have liver problems?
What should I do if I think I am having an allergic reaction to TRIUMEQ?
Can TRIUMEQ cure HIV?
Will TRIUMEQ prevent me from spreading HIV to others?
Can I take TRIUMEQ with other medications?
How often should I see my doctor while taking TRIUMEQ?
What tests should I have before starting TRIUMEQ?
Can I switch between TRIUMEQ tablets and TRIUMEQ PD tablets?
What do I do if I cannot swallow the TRIUMEQ tablet?
What are the common side effects of dolutegravir?
Does dolutegravir interact with other medications?
What drug class is dolutegravir?
What pregnancy or breastfeeding source fields are listed for dolutegravir?
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for dolutegravir: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 8,756.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.88%.
- letrozole Δ 0.01 pts · 59,013 reports · Aromatase Inhibitor 9.89%death share
- benralizumab Δ 0.01 pts · 17,680 reports · Anti-IL-5R Monoclonal Antibody 9.89%death share
- famciclovir Δ 0.02 pts · 2,678 reports · Antiviral (Nucleoside Analog) 9.90%death share
- doxycycline hyclate Δ 0.02 pts · 63,762 reports · Tetracycline Antibiotic (Antimalarial) 9.90%death share
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Narrow Therapeutic Index Drugs
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Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 8,756 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: July 8, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages