Drug · FAERS side-effect profile with label screen
Elvitegravir side effects: what 8,951 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 Disoproxil Fumarate) and was not used
Who reports
8,951 reports · 86% serious · 143 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 9No label text to screen 30
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. 585 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 |
|---|---|---|---|---|---|---|
| Tooth injury | 1,972 | 1,942.4 1,836.3–2,054.6ROR 2,491.0 · χ² 2,078,316 / p <1e-300 | 1,045.0 EB05 1,006.8 · IC025 +9.6 3/3 methods agree | No label text to screen | serious n=1,970 · 100% consumer | no trial data cached |
| Skeletal injury | 3,023 | 956.1 921.4–992.1ROR 1,443.2 · χ² 2,040,514 / p <1e-300 | 673.7 EB05 653.8 · IC025 +9.2 3/3 methods agree | No label text to screen | serious PRR 467.2 · 100% consumer | no trial data cached |
| Bone demineralisation | 175 | 463.2 394.3–544.1ROR 472.4 · χ² 66,854 / p <1e-300 | 370.4 EB05 326.5 · IC025 +7.3 3/3 methods agree | No label text to screen | serious n=152 | no trial data cached |
| Bone density decreased | 4,593 | 398.0 388.7–407.4ROR 816.3 · χ² 1,553,496 / p <1e-300 | 339.2 EB05 331.0 · IC025 +8.3 3/3 methods agree | Lab value / disease marker | serious PRR 255.8 · 99% consumer | no trial data cached |
| Bone loss | 2,151 | 387.3 371.9–403.4ROR 509.5 · χ² 710,031 / p <1e-300 | 330.9 EB05 319.3 · IC025 +8.2 3/3 methods agree | No label text to screen | serious PRR 239.4 · 99% consumer | no trial data cached |
| Multiple fractures | 1,976 | 317.5 304.4–331.2ROR 407.2 · χ² 548,324 / p <1e-300 | 278.5 EB05 268.4 · IC025 +8.0 3/3 methods agree | No label text to screen | serious PRR 199.6 · 99% consumer | no trial data cached |
| Tooth loss | 2,479 | 316.0 304.7–327.7ROR 436.7 · χ² 685,172 / p <1e-300 | 277.5 EB05 268.5 · IC025 +8.0 3/3 methods agree | No label text to screen | serious PRR 202.9 · 100% consumer | no trial data cached |
| Renal injury | 3,306 | 290.3 281.8–299.0ROR 459.7 · χ² 847,584 / p <1e-300 | 257.6 EB05 250.3 · IC025 +7.9 3/3 methods agree | No label text to screen | serious PRR 173.5 · 99% consumer | no trial data cached |
| Bone density abnormal | 277 | 185.6 164.5–209.4ROR 191.5 · χ² 46,924 / p <1e-300 | 169.9 EB05 153.8 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=232 · 100% consumer | no trial data cached |
| Osteopenia | 1,089 | 180.2 170.0–190.9ROR 205.0 · χ² 179,951 / p <1e-300 | 166.7 EB05 158.6 · IC025 +7.2 3/3 methods agree | No label text to screen | serious PRR 116.7 · 95% consumer | no trial data cached |
| Osteonecrosis (bone death) | 2,110 | 159.3 153.2–165.7ROR 208.2 · χ² 310,904 / p <1e-300 | 148.9 EB05 143.7 · IC025 +7.1 3/3 methods agree | No label text to screen | serious PRR 100.8 · 98% consumer | no trial data cached |
| Degenerative bone disease | 28 | 158.2 107.9–231.9ROR 158.7 · χ² 3,948 / p <1e-300 | 134.7 EB05 97.8 · IC025 +4.7 3/3 methods agree | No label text to screen | serious n=26 | no trial data cached |
| Protein total abnormal | 81 | 154.8 123.7–193.7ROR 156.2 · χ² 11,458 / p <1e-300 | 140.4 EB05 116.6 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious n=79 | no trial data cached |
| Anhedonia | 1,636 | 154.3 147.4–161.5ROR 188.6 · χ² 233,696 / p <1e-300 | 144.4 EB05 138.7 · IC025 +7.0 3/3 methods agree | No label text to screen | serious PRR 97.5 · 100% consumer | no trial data cached |
| Renal dysplasia | 18 | 115.2 71.8–184.9ROR 115.4 · χ² 1,834 / p <1e-300 | 98.6 EB05 66.0 · IC025 +4.0 3/3 methods agree | No label text to screen | serious n=18 | no trial data cached |
| Economic problem | 679 | 108.0 100.3–116.3ROR 116.8 · χ² 68,700 / p <1e-300 | 102.9 EB05 96.6 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious PRR 68.1 · 99% consumer | no trial data cached |
| Teeth brittle | 46 | 106.8 79.5–143.5ROR 107.4 · χ² 4,509 / p <1e-300 | 98.1 EB05 76.5 · IC025 +5.1 3/3 methods agree | No label text to screen | serious n=33 | no trial data cached |
| Osteoporosis | 1,747 | 103.8 99.4–108.4ROR 128.7 · χ² 170,436 / p <1e-300 | 99.3 EB05 95.4 · IC025 +6.5 3/3 methods agree | No label text to screen | serious PRR 77.1 · 89% consumer | no trial data cached |
| Vitamin d deficiency | 409 | 102.6 93.1–113.0ROR 107.5 · χ² 39,323 / p <1e-300 | 97.8 EB05 90.1 · IC025 +6.3 3/3 methods agree | No label text to screen | serious PRR 72.3 · 97% consumer | no trial data cached |
| Osteomalacia | 64 | 100.3 78.1–128.7ROR 101.0 · χ² 5,934 / p <1e-300 | 93.5 EB05 75.8 · IC025 +5.4 3/3 methods agree | No label text to screen | serious n=64 | no trial data cached |
| Nephropathy | 346 | 89.7 80.7–99.6ROR 93.2 · χ² 29,133 / p <1e-300 | 86.0 EB05 78.6 · IC025 +6.1 3/3 methods agree | No label text to screen | serious PRR 61.5 · 95% consumer | no trial data cached |
| Fanconi syndrome acquired | 59 | 81.7 63.1–105.8ROR 82.2 · χ² 4,464 / p <1e-300 | 77.0 EB05 61.9 · IC025 +5.1 3/3 methods agree | No label text to screen | serious n=59 | no trial data cached |
| Glomerular filtration rate abnormal | 47 | 81.0 60.6–108.2ROR 81.4 · χ² 3,511 / p <1e-300 | 76.0 EB05 59.4 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=46 | no trial data cached |
| Chronic kidney disease | 2,512 | 79.4 76.7–82.1ROR 109.9 · χ² 188,552 / p <1e-300 | 76.7 EB05 74.2 · IC025 +6.2 3/3 methods agree | No label text to screen | serious PRR 52.4 · 99% consumer | no trial data cached |
| Hand fracture | 136 | 45.8 38.7–54.2ROR 46.5 · χ² 5,805 / p <1e-300 | 44.7 EB05 38.7 · IC025 +5.0 3/3 methods agree | No label text to screen | serious n=135 | no trial data cached |
| Single functional kidney | 12 | 43.2 24.4–76.4ROR 43.2 · χ² 445 / p 4e-99 | 39.9 EB05 24.3 · IC025 +3.0 3/3 methods agree | No label text to screen | serious n=12 | no trial data cached |
| Tooth fracture | 188 | 40.6 35.2–46.9ROR 41.5 · χ² 7,107 / p <1e-300 | 39.8 EB05 35.3 · IC025 +4.9 3/3 methods agree | No label text to screen | serious PRR 36.4 · 100% consumer | no trial data cached |
| Renal aplasia | 12 | 40.4 22.9–71.5ROR 40.5 · χ² 416 / p 1e-92 | 37.6 EB05 22.9 · IC025 +3.0 3/3 methods agree | No label text to screen | serious n=12 | no trial data cached |
| Vertebral foraminal stenosis | 14 | 40.3 23.8–68.4ROR 40.4 · χ² 490 / p 7e-109 | 37.8 EB05 23.9 · IC025 +3.2 3/3 methods agree | No label text to screen | serious n=13 | no trial data cached |
| Protein total increased | 44 | 39.5 29.3–53.2ROR 39.7 · χ² 1,586 / p <1e-300 | 38.3 EB05 29.7 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=36 | no trial data cached |
| Fracture | 303 | 38.1 34.1–42.6ROR 39.4 · χ² 10,736 / p <1e-300 | 37.4 EB05 34.0 · IC025 +5.0 3/3 methods agree | No label text to screen | serious PRR 27.4 · 98% consumer | no trial data cached |
| Renal failure (kidney failure) | 2,080 | 37.0 35.6–38.4ROR 47.9 · χ² 72,115 / p <1e-300 | 36.4 EB05 35.1 · IC025 +5.1 3/3 methods agree | No label text to screen | serious PRR 24.6 · 92% consumer | no trial data cached |
| Emotional distress | 1,813 | 35.5 34.0–37.0ROR 44.2 · χ² 60,140 / p <1e-300 | 34.9 EB05 33.6 · IC025 +5.0 3/3 methods agree | No label text to screen | serious PRR 24.0 · 100% consumer | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 15 | 33.1 19.9–55.1ROR 33.2 · χ² 429 / p 1e-95 | 31.5 EB05 20.2 · IC025 +3.1 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Glomerular filtration rate increased | 11 | 32.1 17.7–58.2ROR 32.2 · χ² 297 / p 6e-67 | 30.2 EB05 17.9 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=8 | no trial data cached |
| Genotype drug resistance test positive | 14 | 32.0 18.9–54.2ROR 32.0 · χ² 385 / p 6e-86 | 30.4 EB05 19.2 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Viral load increased | 51 | 31.0 23.5–40.8ROR 31.2 · χ² 1,431 / p <1e-300 | 30.3 EB05 23.9 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=40 | no trial data cached |
| Blood hiv rna increased | 23 | 30.4 20.2–45.9ROR 30.5 · χ² 617 / p 1e-136 | 29.4 EB05 20.6 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=20 | no trial data cached |
| Adrenal suppression | 10 | 28.1 15.1–52.4ROR 28.1 · χ² 232 / p 1e-52 | 26.4 EB05 15.1 · IC025 +2.5 3/3 methods agree | No label text to screen | serious n=9 | no trial data cached |
| Bone disorder | 216 | 27.9 24.4–31.8ROR 28.5 · χ² 5,504 / p <1e-300 | 27.5 EB05 24.5 · IC025 +4.5 3/3 methods agree | No label text to screen | serious PRR 21.7 · 100% consumer | 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 | 4,593 | 398.0 388.7–407.4ROR 816.3 · χ² 1,553,496 / p <1e-300 | 339.2 EB05 331.0 · IC025 +8.3 3/3 methods agree | Lab value / disease marker | serious PRR 255.8 · 99% consumer | no trial data cached |
| Renal injury | 3,306 | 290.3 281.8–299.0ROR 459.7 · χ² 847,584 / p <1e-300 | 257.6 EB05 250.3 · IC025 +7.9 3/3 methods agree | No label text to screen | serious PRR 173.5 · 99% consumer | no trial data cached |
| Skeletal injury | 3,023 | 956.1 921.4–992.1ROR 1,443.2 · χ² 2,040,514 / p <1e-300 | 673.7 EB05 653.8 · IC025 +9.2 3/3 methods agree | No label text to screen | serious PRR 467.2 · 100% consumer | no trial data cached |
| Chronic kidney disease | 2,512 | 79.4 76.7–82.1ROR 109.9 · χ² 188,552 / p <1e-300 | 76.7 EB05 74.2 · IC025 +6.2 3/3 methods agree | No label text to screen | serious PRR 52.4 · 99% consumer | no trial data cached |
| Tooth loss | 2,479 | 316.0 304.7–327.7ROR 436.7 · χ² 685,172 / p <1e-300 | 277.5 EB05 268.5 · IC025 +8.0 3/3 methods agree | No label text to screen | serious PRR 202.9 · 100% consumer | no trial data cached |
| Bone loss | 2,151 | 387.3 371.9–403.4ROR 509.5 · χ² 710,031 / p <1e-300 | 330.9 EB05 319.3 · IC025 +8.2 3/3 methods agree | No label text to screen | serious PRR 239.4 · 99% consumer | no trial data cached |
| Osteonecrosis (bone death) | 2,110 | 159.3 153.2–165.7ROR 208.2 · χ² 310,904 / p <1e-300 | 148.9 EB05 143.7 · IC025 +7.1 3/3 methods agree | No label text to screen | serious PRR 100.8 · 98% consumer | no trial data cached |
| Renal failure (kidney failure) | 2,080 | 37.0 35.6–38.4ROR 47.9 · χ² 72,115 / p <1e-300 | 36.4 EB05 35.1 · IC025 +5.1 3/3 methods agree | No label text to screen | serious PRR 24.6 · 92% consumer | no trial data cached |
| Multiple fractures | 1,976 | 317.5 304.4–331.2ROR 407.2 · χ² 548,324 / p <1e-300 | 278.5 EB05 268.4 · IC025 +8.0 3/3 methods agree | No label text to screen | serious PRR 199.6 · 99% consumer | no trial data cached |
| Tooth injury | 1,972 | 1,942.4 1,836.3–2,054.6ROR 2,491.0 · χ² 2,078,316 / p <1e-300 | 1,045.0 EB05 1,006.8 · IC025 +9.6 3/3 methods agree | No label text to screen | serious n=1,970 · 100% consumer | no trial data cached |
| Pain | 1,846 | 7.0 6.8–7.3ROR 8.6 · χ² 9,832 / p <1e-300 | 7.0 EB05 6.8 · IC025 +2.7 3/3 methods agree | No label text to screen | serious PRR 6.8 · 95% consumer | no trial data cached |
| Emotional distress | 1,813 | 35.5 34.0–37.0ROR 44.2 · χ² 60,140 / p <1e-300 | 34.9 EB05 33.6 · IC025 +5.0 3/3 methods agree | No label text to screen | serious PRR 24.0 · 100% consumer | no trial data cached |
| Osteoporosis | 1,747 | 103.8 99.4–108.4ROR 128.7 · χ² 170,436 / p <1e-300 | 99.3 EB05 95.4 · IC025 +6.5 3/3 methods agree | No label text to screen | serious PRR 77.1 · 89% consumer | no trial data cached |
| Anxiety | 1,694 | 14.0 13.4–14.6ROR 17.0 · χ² 20,574 / p <1e-300 | 13.9 EB05 13.4 · IC025 +3.7 3/3 methods agree | No label text to screen | serious PRR 12.4 · 96% consumer | no trial data cached |
| Anhedonia | 1,636 | 154.3 147.4–161.5ROR 188.6 · χ² 233,696 / p <1e-300 | 144.4 EB05 138.7 · IC025 +7.0 3/3 methods agree | No label text to screen | serious PRR 97.5 · 100% 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, renal injury, skeletal injury, chronic kidney disease, tooth loss, bone loss. 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, 625 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.