What the label lists and what reports show
Dolutegravir and rilpivirine side effects
Dolutegravir and rilpivirine's FDA label: “The most common adverse reactions (all grades) observed in at least 2% of subjects were diarrhea, headache, and nausea.” FAERS holds 1,742 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 (311 reports).
- No generic listed
Check it at the source: the dolutegravir and rilpivirine 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 JULUCA?JULUCA can cause serious side effects, including: • Severe skin rash and allergic reactions. Call your healthcare provider right away if you develop a rash with JULUCA . Stop taking JULUCA 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 who have certain liver function test changes may have an increased risk of developing new or worsening changes in certain liver tests during treatment with JULUCA. Liver problems, including liver failure, have also happened in people without history of liver disease or other risk factors. […]
Source: FDA drug label, ViiV Healthcare Company, effective October 29, 2025 (SPL set 806653d1-bf35-4924-b999-ad5d21821cc1), 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 at least 2% of subjects were diarrhea, headache, and nausea.
Table 3. Selected Laboratory Abnormalities (Grades 2 and 3 to 4; Week 48 Pooled Analyses) in SWORD-1 and SWORD-2 Trials
| Laboratory Parameter Preferred Term | Dolutegravir plus Rilpivirine (n = 513) | Current Antiretroviral Regimen (n = 511) |
|---|---|---|
| Grade 2 (>2.5-5.0 x ULN) | 2% | <1% |
| Grade 3 to 4 (>5.0 x ULN) | <1% | <1% |
| Grade 2 (>2.5-5.0 x ULN) | <1% | 2% |
| Grade 3 to 4 (>5.0 x ULN) | <1% | <1% |
| Grade 2 (1.6-2.5 x ULN) | 2% | 4% |
| Grade 3 to 4 (>2.5 x ULN) | 0 | 3% |
| Grade 2 (6.0-9.9 x ULN) | <1% | <1% |
| Grade 3 to 4 (≥10.0 x ULN) | 1% | 2% |
| Grade 2 (126-250 mg/dL) | 4% | 5% |
| Grade 3 to 4 (>250 mg/dL) | <1% | <1% |
| Grade 2 (>1.5-3.0 x ULN) | 5% | 5% |
| Grade 3 to 4 (>3.0 x ULN) | 2% | 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 described below and in other sections of the labeling: • Skin and hypersensitivity reactions [see Warnings and Precautions ( 5.1 )]. • Hepatotoxicity [see Warnings and Precautions ( 5.2 )]. • Depressive disorders [see Warnings and Precautions ( 5.3 )]. The most common adverse reactions (all grades) observed in at least 2% of subjects were diarrhea, headache, and nausea. ( 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 practice. The safety assessment of JULUCA is based on the pooled primary Week 48 analyses of data from 2 identical, international, multicenter, open-label trials, SWORD-1 and SWORD-2, including additional follow up through Week 148. …
Source: FDA drug label, ViiV Healthcare Company, effective October 29, 2025 (SPL set 806653d1-bf35-4924-b999-ad5d21821cc1), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,742 reports list dolutegravir and rilpivirine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 96 are coded as a death and 309 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, 5 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 rilpivirine: 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