What the label lists and what reports show
Dolutegravir and lamivudine side effects
Dolutegravir and lamivudine's FDA label: “The most common adverse reactions (all grades) observed in ≥2% (in those receiving DOVATO) were headache, nausea, diarrhea, insomnia, fatigue, and anxiety.” FAERS holds 3,529 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 anxiety (155 reports).
- No generic listed
- Boxed warning
Check it at the source: the dolutegravir and lamivudine FDA label on DailyMed (effective October 29, 2025, 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 DOVATO?DOVATO can cause serious side effects, including: • See “What is the most important information I should know about DOVATO?” • Allergic reactions. Call your healthcare provider right away if you develop a rash with DOVATO. Stop taking DOVATO and get medical help right away if you develop a rash with any of the following signs or symptoms: • fever • generally ill feeling • tiredness • muscle or joint aches • blisters or sores in mouth • blisters or peeling of the skin • redness or swelling of the eyes • swelling of the mouth, face, lips, or tongue • problems breathing • 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 tests during treatment with DOVATO. Liver problems, including liver failure, have also happened in people without a history of liver disease or other risk factors. […]
Source: FDA drug label, ViiV Healthcare Company, effective October 29, 2025 (SPL set 68e45422-43ed-4cfb-9356-fae88d14a53a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (all grades) observed in ≥2% (in those receiving DOVATO) were headache, nausea, diarrhea, insomnia, fatigue, and anxiety.
Table 2. Adverse Reactions (All Grades) Reported in ≥2% of Subjects in Any Treatment Group in Adults with No Antiretroviral Treatment History in GEMINI-1 and GEMINI-2 (Week 144 Pooled Analysis)
| Adverse Reaction | TIVICAY plus EPIVIR (n = 716) | TIVICAY plus TRUVADA (n = 717) |
|---|---|---|
| Headache | 3% | 4% |
| Nausea | 2% | 6% |
| Diarrhea | 2% | 3% |
| Insomnia | 2% | 3% |
| Fatigue a | 2% | 2% |
| Anxiety | 2% | 1% |
| Dizziness | 1% | 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: • Patients co-infected with HIV-1 and HBV [see Warnings and Precautions ( 5.1 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] • 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 )] The most common adverse reactions (all grades) observed in ≥2% (in those receiving DOVATO) were headache, nausea, diarrhea, insomnia, fatigue, and anxiety. ( 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 October 29, 2025 (SPL set 68e45422-43ed-4cfb-9356-fae88d14a53a), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,529 reports list dolutegravir and lamivudine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 118 are coded as a death and 415 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 17 reactions below, 7 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?
- 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