Drug · FAERS side-effect profile with label screen
Elvitegravir combination (4 ingredients) side effects: what 10,002 FDA adverse event reports show
Drug class
No validated FDA label found
closest label found was a multi-ingredient product (Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide) and was not used
Who reports
10,002 reports · 78% serious · 199 with death outcome · 25% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Reporting / coding artifact 1Lab value / disease marker 10No label text to screen 29
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 776 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 |
|---|---|---|---|---|---|---|
| Bone demineralisation | 199 | 484.7 415.9–564.9ROR 494.5 · χ² 77,429 / p <1e-300 | 378.5 EB05 336.4 · IC025 +7.4 3/3 methods agree | No label text to screen | serious n=173 | no trial data cached |
| Bone loss | 2,423 | 398.9 383.7–414.7ROR 526.1 · χ² 806,406 / p <1e-300 | 333.7 EB05 322.7 · IC025 +8.2 3/3 methods agree | No label text to screen | serious PRR 264.3 · 99% consumer | no trial data cached |
| Skeletal injury | 1,659 | 395.7 376.9–415.4ROR 474.2 · χ² 548,165 / p <1e-300 | 331.0 EB05 317.9 · IC025 +8.2 3/3 methods agree | No label text to screen | serious PRR 252.5 · 100% consumer | no trial data cached |
| Bone density decreased | 4,533 | 350.7 342.2–359.4ROR 640.5 · χ² 1,353,178 / p <1e-300 | 299.6 EB05 292.4 · IC025 +8.1 3/3 methods agree | Lab value / disease marker | serious PRR 250.5 · 99% consumer | no trial data cached |
| Multiple fractures | 2,141 | 311.5 298.9–324.5ROR 396.0 · χ² 576,000 / p <1e-300 | 270.2 EB05 260.7 · IC025 +7.9 3/3 methods agree | No label text to screen | serious PRR 213.2 · 100% consumer | no trial data cached |
| Tooth loss | 2,275 | 256.6 246.8–266.8ROR 331.9 · χ² 515,606 / p <1e-300 | 228.0 EB05 220.2 · IC025 +7.7 3/3 methods agree | No label text to screen | serious PRR 182.1 · 100% consumer | no trial data cached |
| Tooth injury | 418 | 221.6 200.8–244.7ROR 231.3 · χ² 82,739 / p <1e-300 | 198.5 EB05 183.0 · IC025 +7.2 3/3 methods agree | No label text to screen | serious n=416 · 100% consumer | no trial data cached |
| Hiv-associated neurocognitive disorder | 10 | 204.7 106.9–392.0ROR 204.9 · χ² 1,664 / p <1e-300 | 138.0 EB05 80.1 · IC025 +3.2 3/3 methods agree | No label text to screen | serious n=10 | no trial data cached |
| Bone density abnormal | 299 | 180.5 160.6–202.8ROR 186.0 · χ² 48,924 / p <1e-300 | 164.3 EB05 149.3 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=251 · 100% consumer | no trial data cached |
| Osteopenia | 1,208 | 180.4 170.6–190.7ROR 205.0 · χ² 198,171 / p <1e-300 | 165.6 EB05 157.9 · IC025 +7.2 3/3 methods agree | No label text to screen | serious PRR 127.5 · 97% consumer | no trial data cached |
| Protein total abnormal | 100 | 173.8 141.8–212.9ROR 175.5 · χ² 15,688 / p <1e-300 | 155.7 EB05 131.7 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=97 | no trial data cached |
| Osteonecrosis (bone death) | 2,392 | 163.1 157.3–169.2ROR 214.1 · χ² 357,684 / p <1e-300 | 151.1 EB05 146.1 · IC025 +7.1 3/3 methods agree | No label text to screen | serious PRR 112.7 · 96% consumer | no trial data cached |
| Degenerative bone disease | 30 | 152.4 105.3–220.7ROR 152.9 · χ² 4,063 / p <1e-300 | 130.4 EB05 95.8 · IC025 +4.8 3/3 methods agree | No label text to screen | serious n=26 | no trial data cached |
| Renal injury | 1,928 | 143.9 138.0–150.1ROR 178.1 · χ² 256,095 / p <1e-300 | 134.5 EB05 129.5 · IC025 +6.9 3/3 methods agree | No label text to screen | serious PRR 99.9 · 100% consumer | no trial data cached |
| Anhedonia | 1,569 | 132.0 126.0–138.4ROR 156.4 · χ² 191,923 / p <1e-300 | 124.0 EB05 118.9 · IC025 +6.8 3/3 methods agree | No label text to screen | serious PRR 92.1 · 100% consumer | no trial data cached |
| Glomerular filtration rate abnormal | 69 | 108.2 85.0–137.7ROR 108.9 · χ² 6,861 / p <1e-300 | 100.1 EB05 81.8 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=67 | no trial data cached |
| Osteoporosis | 1,945 | 103.9 99.7–108.3ROR 128.8 · χ² 189,067 / p <1e-300 | 98.9 EB05 95.3 · IC025 +6.5 3/3 methods agree | No label text to screen | serious PRR 84.7 · 94% consumer | no trial data cached |
| Economic problem | 684 | 97.4 90.4–104.9ROR 104.4 · χ² 62,261 / p <1e-300 | 92.8 EB05 87.1 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious PRR 68.8 · 99% consumer | no trial data cached |
| Osteomalacia | 64 | 89.7 69.9–115.1ROR 90.3 · χ² 5,297 / p <1e-300 | 83.9 EB05 68.1 · IC025 +5.3 3/3 methods agree | No label text to screen | serious n=64 | no trial data cached |
| Blood hiv rna increased | 66 | 80.1 62.7–102.3ROR 80.6 · χ² 4,887 / p <1e-300 | 75.5 EB05 61.4 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=51 | no trial data cached |
| Hypothalamic pituitary adrenal axis suppression | 13 | 79.8 45.9–138.8ROR 79.9 · χ² 899 / p 7e-198 | 69.3 EB05 43.1 · IC025 +3.4 3/3 methods agree | No label text to screen | serious n=13 | no trial data cached |
| Chronic kidney disease | 2,631 | 74.5 72.1–77.1ROR 100.8 · χ² 184,791 / p <1e-300 | 71.9 EB05 69.6 · IC025 +6.1 3/3 methods agree | No label text to screen | serious PRR 54.1 · 98% consumer | no trial data cached |
| Teeth brittle | 34 | 69.8 49.6–98.2ROR 70.1 · χ² 2,165 / p <1e-300 | 65.2 EB05 48.8 · IC025 +4.5 3/3 methods agree | No label text to screen | serious n=24 | no trial data cached |
| Nephropathy | 279 | 64.2 57.1–72.2ROR 66.0 · χ² 16,788 / p <1e-300 | 62.1 EB05 56.2 · IC025 +5.6 3/3 methods agree | No label text to screen | serious PRR 49.0 · 95% consumer | no trial data cached |
| Vitamin d deficiency | 258 | 57.0 50.4–64.4ROR 58.5 · χ² 13,762 / p <1e-300 | 55.3 EB05 49.8 · IC025 +5.4 3/3 methods agree | No label text to screen | serious PRR 43.6 | no trial data cached |
| Fanconi syndrome acquired | 44 | 54.0 40.1–72.8ROR 54.3 · χ² 2,181 / p <1e-300 | 51.6 EB05 40.0 · IC025 +4.6 3/3 methods agree | No label text to screen | serious n=44 | no trial data cached |
| Genotype drug resistance test positive | 23 | 47.5 31.4–71.7ROR 47.6 · χ² 978 / p 6e-215 | 44.8 EB05 31.5 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=20 · 95% clinician | no trial data cached |
| Viral load increased | 85 | 46.6 37.6–57.8ROR 47.0 · χ² 3,668 / p <1e-300 | 45.2 EB05 37.7 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=48 | no trial data cached |
| Lipohypertrophy | 13 | 44.6 25.7–77.2ROR 44.6 · χ² 500 / p 4e-111 | 41.2 EB05 25.6 · IC025 +3.1 3/3 methods agree | No label text to screen | serious n=11 | no trial data cached |
| Protein total increased | 49 | 39.4 29.8–52.3ROR 39.6 · χ² 1,764 / p <1e-300 | 38.2 EB05 30.0 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=38 | no trial data cached |
| Glomerular filtration rate increased | 14 | 36.7 21.7–62.3ROR 36.8 · χ² 444 / p 8e-99 | 34.6 EB05 21.9 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Fracture | 321 | 36.1 32.4–40.3ROR 37.3 · χ² 10,754 / p <1e-300 | 35.5 EB05 32.3 · IC025 +4.9 3/3 methods agree | No label text to screen | serious PRR 28.8 · 98% consumer | no trial data cached |
| Hand fracture | 116 | 34.9 29.1–41.9ROR 35.3 · χ² 3,722 / p <1e-300 | 34.1 EB05 29.2 · IC025 +4.6 3/3 methods agree | No label text to screen | serious n=111 | no trial data cached |
| Renal failure (kidney failure) | 2,110 | 33.6 32.3–34.9ROR 42.3 · χ² 66,036 / p <1e-300 | 33.1 EB05 31.9 · IC025 +5.0 3/3 methods agree | No label text to screen | serious PRR 24.6 · 92% consumer | no trial data cached |
| Cd4 lymphocytes decreased | 34 | 33.5 23.9–47.0ROR 33.6 · χ² 1,024 / p 5e-225 | 32.5 EB05 24.3 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=29 | no trial data cached |
| Syphilis | 11 | 32.2 17.7–58.3ROR 32.2 · χ² 297 / p 7e-67 | 30.2 EB05 17.9 · IC025 +2.7 3/3 methods agree | No label text to screen | serious n=10 | no trial data cached |
| Emotional distress | 1,811 | 31.7 30.4–33.1ROR 38.5 · χ² 53,330 / p <1e-300 | 31.2 EB05 30.0 · IC025 +4.9 3/3 methods agree | No label text to screen | serious PRR 23.7 · 99% consumer | no trial data cached |
| Tooth fracture | 159 | 30.7 26.3–35.8ROR 31.1 · χ² 4,470 / p <1e-300 | 30.1 EB05 26.4 · IC025 +4.5 3/3 methods agree | No label text to screen | serious PRR 29.2 · 100% consumer | no trial data cached |
| Anogenital warts | 12 | 28.4 16.1–50.2ROR 28.5 · χ² 287 / p 1e-64 | 26.9 EB05 16.3 · IC025 +2.8 3/3 methods agree | No label text to screen | serious n=12 | no trial data cached |
| Vertebral foraminal stenosis | 10 | 25.7 13.8–47.9ROR 25.7 · χ² 210 / p 6e-48 | 24.1 EB05 13.6 · IC025 +2.5 3/3 methods agree | No label text to screen | serious n=8 | 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 |
|---|---|---|---|---|---|---|
| Bone density decreased | 4,533 | 350.7 342.2–359.4ROR 640.5 · χ² 1,353,178 / p <1e-300 | 299.6 EB05 292.4 · IC025 +8.1 3/3 methods agree | Lab value / disease marker | serious PRR 250.5 · 99% consumer | no trial data cached |
| Chronic kidney disease | 2,631 | 74.5 72.1–77.1ROR 100.8 · χ² 184,791 / p <1e-300 | 71.9 EB05 69.6 · IC025 +6.1 3/3 methods agree | No label text to screen | serious PRR 54.1 · 98% consumer | no trial data cached |
| Bone loss | 2,423 | 398.9 383.7–414.7ROR 526.1 · χ² 806,406 / p <1e-300 | 333.7 EB05 322.7 · IC025 +8.2 3/3 methods agree | No label text to screen | serious PRR 264.3 · 99% consumer | no trial data cached |
| Osteonecrosis (bone death) | 2,392 | 163.1 157.3–169.2ROR 214.1 · χ² 357,684 / p <1e-300 | 151.1 EB05 146.1 · IC025 +7.1 3/3 methods agree | No label text to screen | serious PRR 112.7 · 96% consumer | no trial data cached |
| Tooth loss | 2,275 | 256.6 246.8–266.8ROR 331.9 · χ² 515,606 / p <1e-300 | 228.0 EB05 220.2 · IC025 +7.7 3/3 methods agree | No label text to screen | serious PRR 182.1 · 100% consumer | no trial data cached |
| Multiple fractures | 2,141 | 311.5 298.9–324.5ROR 396.0 · χ² 576,000 / p <1e-300 | 270.2 EB05 260.7 · IC025 +7.9 3/3 methods agree | No label text to screen | serious PRR 213.2 · 100% consumer | no trial data cached |
| Renal failure (kidney failure) | 2,110 | 33.6 32.3–34.9ROR 42.3 · χ² 66,036 / p <1e-300 | 33.1 EB05 31.9 · IC025 +5.0 3/3 methods agree | No label text to screen | serious PRR 24.6 · 92% consumer | no trial data cached |
| Osteoporosis | 1,945 | 103.9 99.7–108.3ROR 128.8 · χ² 189,067 / p <1e-300 | 98.9 EB05 95.3 · IC025 +6.5 3/3 methods agree | No label text to screen | serious PRR 84.7 · 94% consumer | no trial data cached |
| Renal injury | 1,928 | 143.9 138.0–150.1ROR 178.1 · χ² 256,095 / p <1e-300 | 134.5 EB05 129.5 · IC025 +6.9 3/3 methods agree | No label text to screen | serious PRR 99.9 · 100% consumer | no trial data cached |
| Pain | 1,866 | 6.4 6.1–6.6ROR 7.6 · χ² 8,679 / p <1e-300 | 6.3 EB05 6.1 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 6.7 · 93% consumer | no trial data cached |
| Emotional distress | 1,811 | 31.7 30.4–33.1ROR 38.5 · χ² 53,330 / p <1e-300 | 31.2 EB05 30.0 · IC025 +4.9 3/3 methods agree | No label text to screen | serious PRR 23.7 · 99% consumer | no trial data cached |
| Skeletal injury | 1,659 | 395.7 376.9–415.4ROR 474.2 · χ² 548,165 / p <1e-300 | 331.0 EB05 317.9 · IC025 +8.2 3/3 methods agree | No label text to screen | serious PRR 252.5 · 100% consumer | no trial data cached |
| Anxiety | 1,643 | 12.1 11.6–12.7ROR 14.3 · χ² 16,915 / p <1e-300 | 12.1 EB05 11.6 · IC025 +3.5 3/3 methods agree | No label text to screen | serious PRR 11.8 · 95% consumer | no trial data cached |
| Anhedonia | 1,569 | 132.0 126.0–138.4ROR 156.4 · χ² 191,923 / p <1e-300 | 124.0 EB05 118.9 · IC025 +6.8 3/3 methods agree | No label text to screen | serious PRR 92.1 · 100% consumer | no trial data cached |
| Osteopenia | 1,208 | 180.4 170.6–190.7ROR 205.0 · χ² 198,171 / p <1e-300 | 165.6 EB05 157.9 · IC025 +7.2 3/3 methods agree | No label text to screen | serious PRR 127.5 · 97% consumer | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
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 Elvitegravir?
In FDA FAERS, the most frequently co-reported reaction terms for Elvitegravir are bone density decreased, chronic kidney disease, bone loss, osteonecrosis, tooth loss, multiple fractures. 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 Elvitegravir have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Elvitegravir 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 816 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.