What the label lists and what reports show
Abacavir and dolutegravir and lamivudine side effects
Abacavir and dolutegravir and lamivudine's FDA label: “The most commonly reported adverse reactions of at least moderate intensity and incidence at least 2% (in those receiving TRIUMEQ) were insomnia, headache, and fatigue.” FAERS holds 6,307 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (807 reports).
- No generic listed
- Boxed warning
Check it at the source: the abacavir and dolutegravir and lamivudine FDA label on DailyMed (effective July 8, 2024, ViiV Healthcare Company); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TRIUMEQ or TRIUMEQ PD?TRIUMEQ or TRIUMEQ PD can cause serious side effects, including: • See “What is the most important information I should know about TRIUMEQ and TRIUMEQ PD?” • Liver problems. People with a history of hepatitis B or C virus may have an increased risk of developing new or worsening changes in certain liver function tests during treatment with TRIUMEQ or TRIUMEQ PD. Liver problems including liver failure have also happened with TRIUMEQ or TRIUMEQ PD in people without a history of liver disease or other risk factors. Liver failure resulting in liver transplant has also been reported with TRIUMEQ. Your healthcare provider may do blood tests to check your liver. Call your healthcare provider right away if you develop any of the signs or symptoms of liver problems listed below. […]
Source: FDA drug label, ViiV Healthcare Company, effective July 8, 2024 (SPL set 2997739a-aa91-42aa-a206-a70e2db7b84f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse reactions of at least moderate intensity and incidence at least 2% (in those receiving TRIUMEQ) were insomnia, headache, and fatigue.
Table 3. Treatment-Emergent Adverse Drug Reactions of at Least Moderate Intensity (Grades 2 to 4) and at Least 2% Frequency in Treatment-Naive Subjects in SINGLE (Week 144 Analysis)
| Adverse Reaction | TIVICAY + EPZICOM Once Daily (n = 414) | ATRIPLA Once Daily (n = 419) |
|---|---|---|
| Insomnia | 3% | 3% |
| Depression | 1% | 2% |
| Abnormal dreams | <1% | 2% |
| Dizziness | <1% | 5% |
| Headache | 2% | 2% |
| Nausea | <1% | 3% |
| Diarrhea | <1% | 2% |
| Fatigue | 2% | 2% |
| Rash a | <1% | 6% |
| Vertigo | 0 | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in other sections of the labeling: • Serious and sometimes fatal hypersensitivity reaction [see Boxed Warning, Warnings and Precautions ( 5.1 )]. • Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions ( 5.3 )]. • Hepatotoxicity [see Warnings and Precautions ( 5.3 )]. • Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions ( 5.4 )]. • Immune reconstitution syndrome [see Warnings and Precautions ( 5.6 )]. • Myocardial infarction [see Warnings and Precautions ( 5.8 )]. The most commonly reported adverse reactions of at least moderate intensity and incidence at least 2% (in those receiving TRIUMEQ) were insomnia, headache, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, ViiV Healthcare Company, effective July 8, 2024 (SPL set 2997739a-aa91-42aa-a206-a70e2db7b84f), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,307 reports list abacavir and dolutegravir and lamivudine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 325 are coded as a death and 1,185 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Abacavir and dolutegravir and lamivudine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions