Drug · FAERS side-effect profile with label screen
Dolutegravir and Rilpivirine side effects: what 1,742 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Dolutegravir Sodium And Rilpivirine Hydrochloride (Juluca)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,742 reports · 52% serious · 96 with death outcome · 29% female
openFDA FAERS counts, all years, deduplication not applied
Used for
JULUCA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on.
FDA label, Indications and Usage
What it is
JULUCA is a fixed-dose combination tablet containing dolutegravir (as dolutegravir sodium), an INSTI, and rilpivirine (as rilpivirine hydrochloride), an NNRTI.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 4Labeled (related wording) 8Reporting / coding artifact 6Lab value / disease marker 2Not in label — unassessed 20
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 24 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Anhedonia | 251 | 115.2 102.6–129.2ROR 134.4 · χ² 28,054 / p <1e-300 | 113.1 EB05 101.8 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 135.6 · 100% consumer | no trial data cached |
| Economic problem | 84 | 66.0 53.5–81.3ROR 69.3 · χ² 5,284 / p <1e-300 | 64.7 EB05 53.9 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 77.0 · 100% consumer | no trial data cached |
| Osteopenia | 69 | 54.7 43.4–68.9ROR 56.9 · χ² 3,569 / p <1e-300 | 53.7 EB05 43.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 65.6 | no trial data cached |
| End stage renal disease | 83 | 54.5 44.1–67.2ROR 57.2 · χ² 4,288 / p <1e-300 | 53.6 EB05 44.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 59.6 | no trial data cached |
| Decreased activity | 32 | 36.1 25.6–50.8ROR 36.7 · χ² 1,053 / p 2e-231 | 35.3 EB05 26.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 55.9 | no trial data cached |
| Quality of life decreased | 40 | 35.9 26.4–48.8ROR 36.8 · χ² 1,321 / p 2e-289 | 35.3 EB05 27.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 46.2 | no trial data cached |
| Chronic kidney disease | 203 | 32.0 28.1–36.4ROR 36.0 · χ² 6,064 / p <1e-300 | 31.8 EB05 28.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 35.6 | no trial data cached |
| Bone density decreased | 83 | 31.6 25.6–39.0ROR 33.2 · χ² 2,428 / p <1e-300 | 31.3 EB05 26.1 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious PRR 41.3 | no trial data cached |
| Emotional distress | 278 | 27.6 24.8–30.7ROR 32.7 · χ² 7,126 / p <1e-300 | 27.5 EB05 24.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 33.4 · 100% consumer | no trial data cached |
| Osteoporosis | 92 | 26.9 22.1–32.9ROR 28.4 · χ² 2,272 / p <1e-300 | 26.8 EB05 22.5 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.8 · ♀ 49% (drug 29%) | no trial data cached |
| Nephropathy | 17 | 21.8 13.6–35.1ROR 22.0 · χ² 317 / p 3e-71 | 21.3 EB05 13.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 25.6 | no trial data cached |
| Multiple fractures | 29 | 21.1 14.7–30.3ROR 21.4 · χ² 535 / p 1e-118 | 20.8 EB05 15.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 24.7 | no trial data cached |
| Vitamin d deficiency | 15 | 18.5 11.2–30.7ROR 18.7 · χ² 232 / p 1e-52 | 17.9 EB05 11.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.0 | no trial data cached |
| Proteinuria | 29 | 18.5 12.9–26.6ROR 18.8 · χ² 464 / p 4e-103 | 18.3 EB05 13.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 | no trial data cached |
| Glomerular filtration rate decreased | 17 | 16.9 10.5–27.2ROR 17.1 · χ² 239 / p 4e-54 | 16.3 EB05 10.3 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 18.9 | no trial data cached |
| Tooth loss | 26 | 15.0 10.2–22.0ROR 15.2 · χ² 326 / p 4e-73 | 14.6 EB05 10.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 | no trial data cached |
| Loss of personal independence in daily activities | 55 | 13.9 10.7–18.1ROR 14.4 · χ² 648 / p 3e-143 | 13.8 EB05 10.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 19.1 | no trial data cached |
| Foot fracture | 20 | 12.7 8.2–19.6ROR 12.8 · χ² 203 / p 2e-46 | 11.9 EB05 7.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 | no trial data cached |
| Product dose omission issue | 295 | 12.5 11.2–13.9ROR 14.8 · χ² 3,144 / p <1e-300 | 12.4 EB05 11.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Renal tubular necrosis | 10 | 12.3 6.6–22.7ROR 12.3 · χ² 92 / p 4e-22 | 10.2 EB05 5.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Anxiety | 285 | 12.0 10.8–13.4ROR 14.2 · χ² 2,910 / p <1e-300 | 12.0 EB05 10.9 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.4 · 88% consumer | no trial data cached |
| Renal failure (kidney failure) | 132 | 11.9 10.1–14.0ROR 12.8 · χ² 1,313 / p 1e-287 | 11.8 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.1 | no trial data cached |
| Blood creatinine increased | 64 | 11.8 9.3–15.0ROR 12.2 · χ² 622 / p 1e-137 | 11.6 EB05 9.3 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.0 | no trial data cached |
| Bone loss | 14 | 11.1 6.6–18.7ROR 11.2 · χ² 119 / p 6e-28 | 9.6 EB05 5.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.4 | no trial data cached |
| Renal impairment | 77 | 11.1 8.9–13.8ROR 11.6 · χ² 699 / p 3e-154 | 10.9 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 | no trial data cached |
| Dialysis | 12 | 10.2 5.8–17.9ROR 10.2 · χ² 90 / p 1e-21 | 8.4 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Ankle fracture | 13 | 10.1 5.9–17.4ROR 10.2 · χ² 98 / p 2e-23 | 8.5 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Rib fracture | 15 | 8.8 5.3–14.6ROR 8.9 · χ² 96 / p 5e-23 | 7.4 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.6 | no trial data cached |
| Renal disorder | 29 | 7.5 5.2–10.7ROR 7.6 · χ² 157 / p 3e-36 | 6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 | no trial data cached |
| Renal injury | 18 | 7.2 4.6–11.4ROR 7.3 · χ² 90 / p 1e-21 | 6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 87 | 6.9 5.6–8.4ROR 7.2 · χ² 434 / p 1e-96 | 6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.6 | no trial data cached |
| Drug resistance | 14 | 6.6 3.9–11.1ROR 6.6 · χ² 61 / p 3e-15 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Depression | 120 | 6.3 5.3–7.5ROR 6.7 · χ² 538 / p 2e-119 | 6.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · 74% consumer | no trial data cached |
| Impaired work ability | 11 | 6.2 3.4–11.1ROR 6.2 · χ² 43 / p 3e-11 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Dysstasia | 15 | 6.2 3.7–10.2ROR 6.2 · χ² 60 / p 5e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Product dispensing error | 11 | 6.1 3.4–11.0ROR 6.1 · χ² 42 / p 5e-11 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Pain | 311 | 6.1 5.5–6.7ROR 7.2 · χ² 1,356 / p 3e-297 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 · 79% consumer | no trial data cached |
| Osteonecrosis (bone death) | 16 | 5.8 3.6–9.5ROR 5.9 · χ² 59 / p 8e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Exposure during pregnancy | 21 | 4.1 2.7–6.2ROR 4.1 · χ² 46 / p 7e-12 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · ♀ 100% (drug 29%) | no trial data cached |
| Product storage error | 25 | 3.5 2.4–5.1ROR 3.5 · χ² 42 / p 5e-11 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pain | 311 | 6.1 5.5–6.7ROR 7.2 · χ² 1,356 / p 3e-297 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 · 79% consumer | no trial data cached |
| Product dose omission issue | 295 | 12.5 11.2–13.9ROR 14.8 · χ² 3,144 / p <1e-300 | 12.4 EB05 11.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Anxiety | 285 | 12.0 10.8–13.4ROR 14.2 · χ² 2,910 / p <1e-300 | 12.0 EB05 10.9 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.4 · 88% consumer | no trial data cached |
| Emotional distress | 278 | 27.6 24.8–30.7ROR 32.7 · χ² 7,126 / p <1e-300 | 27.5 EB05 24.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 33.4 · 100% consumer | no trial data cached |
| Anhedonia | 251 | 115.2 102.6–129.2ROR 134.4 · χ² 28,054 / p <1e-300 | 113.1 EB05 101.8 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 135.6 · 100% consumer | no trial data cached |
| Chronic kidney disease | 203 | 32.0 28.1–36.4ROR 36.0 · χ² 6,064 / p <1e-300 | 31.8 EB05 28.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 35.6 | no trial data cached |
| Renal failure (kidney failure) | 132 | 11.9 10.1–14.0ROR 12.8 · χ² 1,313 / p 1e-287 | 11.8 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.1 | no trial data cached |
| Depression | 120 | 6.3 5.3–7.5ROR 6.7 · χ² 538 / p 2e-119 | 6.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · 74% consumer | no trial data cached |
| Osteoporosis | 92 | 26.9 22.1–32.9ROR 28.4 · χ² 2,272 / p <1e-300 | 26.8 EB05 22.5 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.8 · ♀ 49% (drug 29%) | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 87 | 6.9 5.6–8.4ROR 7.2 · χ² 434 / p 1e-96 | 6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.6 | no trial data cached |
| Economic problem | 84 | 66.0 53.5–81.3ROR 69.3 · χ² 5,284 / p <1e-300 | 64.7 EB05 53.9 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 77.0 · 100% consumer | no trial data cached |
| Bone density decreased | 83 | 31.6 25.6–39.0ROR 33.2 · χ² 2,428 / p <1e-300 | 31.3 EB05 26.1 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious PRR 41.3 | no trial data cached |
| End stage renal disease | 83 | 54.5 44.1–67.2ROR 57.2 · χ² 4,288 / p <1e-300 | 53.6 EB05 44.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 59.6 | no trial data cached |
| Renal impairment | 77 | 11.1 8.9–13.8ROR 11.6 · χ² 699 / p 3e-154 | 10.9 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 | no trial data cached |
| Osteopenia | 69 | 54.7 43.4–68.9ROR 56.9 · χ² 3,569 / p <1e-300 | 53.7 EB05 43.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 65.6 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Anhedonia — n=251, PRR 115.2
- Osteopenia — n=69, PRR 54.7
- End stage renal disease — n=83, PRR 54.5
- Decreased activity — n=32, PRR 36.1
- Quality of life decreased — n=40, PRR 35.9
- Chronic kidney disease — n=203, PRR 32.0
- Emotional distress — n=278, PRR 27.6
- Multiple fractures — n=29, PRR 21.1
- Proteinuria — n=29, PRR 18.5
- Tooth loss — n=26, PRR 15.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Dolutegravir and Rilpivirine?
In FDA FAERS, the most frequently co-reported reaction terms for Dolutegravir and Rilpivirine are pain, anxiety, emotional distress, anhedonia, chronic kidney disease, renal failure. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Dolutegravir and Rilpivirine have an FDA boxed warning?
No. The FDA label retrieved for Dolutegravir and Rilpivirine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dolutegravir and Rilpivirine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 806653d1-bf35-4924-b999-ad5d21821cc1, effective 20251029; matched on
openfda.generic_name.exact:"DOLUTEGRAVIR SODIUM AND RILPIVIRINE HYDROCHLORIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 64 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.