Bictegravir side effects: what 2,633 FDA adverse event reports show
Drug class
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Label matched
Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate (Biktarvy)
Who reports
2,633 reports · 93% serious · 246 with death outcome · 28% female
Used for
BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history or to replace the current anti.
What it is
BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) is a fixed dose combination tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration. BIC is an integrase strand transfer inhibitor (INSTI).
Boxed warning
POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 979 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Bone demineralisation | 278 | 414.3 361.5–474.8ROR 420.8 · χ² 83,919 / p <1e-300 | 298.4 EB05 270.1 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Viral load abnormal | 41 | 367.6 258.7–522.4ROR 368.4 · χ² 11,076 / p <1e-300 | 246.7 EB05 189.6 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Bone loss | 3,468 | 345.6 333.7–357.9ROR 427.7 · χ² 916,184 / p <1e-300 | 265.4 EB05 258.1 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Bone density decreased | 6,622 | 308.4 301.4–315.5ROR 487.1 · χ² 1,601,444 / p <1e-300 | 243.1 EB05 238.2 · IC025 +7.9 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Skeletal injury | 2,122 | 296.7 283.5–310.5ROR 336.2 · χ² 496,926 / p <1e-300 | 235.5 EB05 227.2 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Multiple fractures | 3,147 | 273.4 263.7–283.4ROR 331.1 · χ² 690,111 / p <1e-300 | 220.7 EB05 214.3 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Tooth loss | 3,426 | 228.8 221.3–236.7ROR 282.3 · χ² 648,398 / p <1e-300 | 190.8 EB05 185.5 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Bone density abnormal | 467 | 164.5 149.5–181.0ROR 168.8 · χ² 66,242 / p <1e-300 | 143.2 EB05 132.6 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Osteopenia | 1,881 | 163.8 156.5–171.5ROR 182.8 · χ² 266,431 / p <1e-300 | 143.3 EB05 137.9 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Tooth injury | 506 | 152.3 139.0–166.9ROR 156.7 · χ² 67,035 / p <1e-300 | 133.9 EB05 124.4 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Protein total abnormal | 150 | 151.0 127.4–178.9ROR 152.3 · χ² 19,620 / p <1e-300 | 131.4 EB05 114.6 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Osteonecrosis (bone death) | 3,385 | 132.5 128.2–136.8ROR 162.9 · χ² 396,429 / p <1e-300 | 118.8 EB05 115.5 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Product use in unapproved therapeutic environment | 73 | 112.3 88.3–142.7ROR 112.7 · χ² 7,234 / p <1e-300 | 99.8 EB05 82.0 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Degenerative bone disease | 38 | 109.3 78.4–152.4ROR 109.5 · χ² 3,625 / p <1e-300 | 95.2 EB05 72.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Renal injury | 2,488 | 105.2 101.2–109.3ROR 121.9 · χ² 235,482 / p <1e-300 | 96.4 EB05 93.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Anhedonia | 2,154 | 103.1 98.9–107.4ROR 116.9 · χ² 199,913 / p <1e-300 | 94.6 EB05 91.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Hiv viraemia | 16 | 96.6 58.0–160.9ROR 96.7 · χ² 1,310 / p 4e-287 | 80.9 EB05 52.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Viral load increased | 281 | 90.3 80.0–101.8ROR 91.7 · χ² 22,915 / p <1e-300 | 83.3 EB05 75.4 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Cd4 lymphocytes abnormal | 15 | 89.2 52.8–150.8ROR 89.3 · χ² 1,133 / p 1e-248 | 75.2 EB05 48.4 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Osteoporosis | 2,781 | 84.3 81.3–87.3ROR 99.5 · χ² 213,568 / p <1e-300 | 78.6 EB05 76.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Monkeypox | 17 | 83.0 50.8–135.8ROR 83.1 · χ² 1,209 / p 3e-265 | 71.5 EB05 47.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Blood hiv rna increased | 118 | 82.0 68.0–98.7ROR 82.5 · χ² 8,734 / p <1e-300 | 75.7 EB05 64.9 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Teeth brittle | 60 | 70.2 54.1–91.1ROR 70.4 · χ² 3,791 / p <1e-300 | 64.9 EB05 52.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Vitamin d deficiency | 504 | 63.4 58.1–69.3ROR 65.2 · χ² 29,308 / p <1e-300 | 60.0 EB05 55.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Genotype drug resistance test positive | 51 | 60.1 45.4–79.6ROR 60.3 · χ² 2,760 / p <1e-300 | 56.0 EB05 44.3 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Glomerular filtration rate abnormal | 68 | 59.1 46.4–75.4ROR 59.3 · χ² 3,640 / p <1e-300 | 55.4 EB05 45.2 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Chronic kidney disease | 3,644 | 58.1 56.4–59.8ROR 72.6 · χ² 195,233 / p <1e-300 | 55.3 EB05 53.8 · IC025 +5.7 3/3 methods agree | Labeled — boxed warning exact term | – | NCT02607956: 1/320 (0.3%) on Bictegravir (serious AE) |
| Osteomalacia | 74 | 58.0 45.9–73.2ROR 58.2 · χ² 3,890 / p <1e-300 | 54.5 EB05 44.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Fanconi syndrome acquired | 79 | 55.0 43.9–68.9ROR 55.2 · χ² 3,944 / p <1e-300 | 51.9 EB05 43.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Economic problem | 694 | 54.9 50.9–59.1ROR 57.0 · χ² 35,000 / p <1e-300 | 52.3 EB05 49.1 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Cd4 lymphocytes decreased | 88 | 49.4 40.0–61.2ROR 49.7 · χ² 3,957 / p <1e-300 | 47.0 EB05 39.3 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Nephropathy | 358 | 46.1 41.6–51.2ROR 47.1 · χ² 15,162 / p <1e-300 | 44.3 EB05 40.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Protein total increased | 91 | 41.3 33.5–50.9ROR 41.5 · χ² 3,418 / p <1e-300 | 39.6 EB05 33.2 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Viraemia | 45 | 38.9 28.9–52.3ROR 39.0 · χ² 1,569 / p <1e-300 | 37.1 EB05 28.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Virologic failure | 168 | 37.4 32.1–43.6ROR 37.7 · χ² 5,727 / p <1e-300 | 36.1 EB05 31.7 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Glomerular filtration rate increased | 24 | 35.4 23.6–53.1ROR 35.4 · χ² 745 / p 2e-164 | 33.5 EB05 23.7 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Immune reconstitution inflammatory syndrome | 130 | 31.0 26.1–36.9ROR 31.2 · χ² 3,648 / p <1e-300 | 30.1 EB05 26.0 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Hand fracture | 178 | 30.0 25.8–34.8ROR 30.3 · χ² 4,831 / p <1e-300 | 29.2 EB05 25.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | – | NCT02607956: 1/320 (0.3%) on Bictegravir (serious AE) |
| Syphilis | 18 | 29.5 18.5–47.1ROR 29.5 · χ² 456 / p 2e-101 | 28.0 EB05 18.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | – | NCT02607956: 34/320 (10.6%) on Bictegravir |
| Fracture | 459 | 28.9 26.4–31.7ROR 29.6 · χ² 12,040 / p <1e-300 | 28.2 EB05 26.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | – | NCT02607956: 1/325 (0.3%) on Bictegravir (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Bictegravir as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).
- NCT02607956 — Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegrav (N=657, PHASE3; 219 AE terms posted; arms: B/F/TAF; DTG + F/TAF; B/F/TAF to B/F/TAF; DTG + F/TAF to B/F/TAF)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 | 6,622 | 308.4 301.4–315.5ROR 487.1 · χ² 1,601,444 / p <1e-300 | 243.1 EB05 238.2 · IC025 +7.9 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Chronic kidney disease | 3,644 | 58.1 56.4–59.8ROR 72.6 · χ² 195,233 / p <1e-300 | 55.3 EB05 53.8 · IC025 +5.7 3/3 methods agree | Labeled — boxed warning exact term | – | NCT02607956: 1/320 (0.3%) on Bictegravir (serious AE) |
| Bone loss | 3,468 | 345.6 333.7–357.9ROR 427.7 · χ² 916,184 / p <1e-300 | 265.4 EB05 258.1 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Tooth loss | 3,426 | 228.8 221.3–236.7ROR 282.3 · χ² 648,398 / p <1e-300 | 190.8 EB05 185.5 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Osteonecrosis (bone death) | 3,385 | 132.5 128.2–136.8ROR 162.9 · χ² 396,429 / p <1e-300 | 118.8 EB05 115.5 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Multiple fractures | 3,147 | 273.4 263.7–283.4ROR 331.1 · χ² 690,111 / p <1e-300 | 220.7 EB05 214.3 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Renal failure (kidney failure) | 3,037 | 27.0 26.1–27.9ROR 32.3 · χ² 74,805 / p <1e-300 | 26.4 EB05 25.6 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning synonym match | – | not reported in cached trials |
| Osteoporosis | 2,781 | 84.3 81.3–87.3ROR 99.5 · χ² 213,568 / p <1e-300 | 78.6 EB05 76.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Pain | 2,546 | 4.8 4.7–5.0ROR 5.5 · χ² 7,935 / p <1e-300 | 4.8 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | – | NCT02607956: 1/320 (0.3%) on Bictegravir (serious AE) |
| Renal injury | 2,488 | 105.2 101.2–109.3ROR 121.9 · χ² 235,482 / p <1e-300 | 96.4 EB05 93.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Emotional distress | 2,435 | 23.8 22.9–24.7ROR 27.3 · χ² 52,358 / p <1e-300 | 23.3 EB05 22.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Anxiety | 2,282 | 9.4 9.0–9.7ROR 10.6 · χ² 17,167 / p <1e-300 | 9.3 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | – | NCT02607956: 16/320 (5.0%) on Bictegravir |
| Anhedonia | 2,154 | 103.1 98.9–107.4ROR 116.9 · χ² 199,913 / p <1e-300 | 94.6 EB05 91.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Skeletal injury | 2,122 | 296.7 283.5–310.5ROR 336.2 · χ² 496,926 / p <1e-300 | 235.5 EB05 227.2 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Osteopenia | 1,881 | 163.8 156.5–171.5ROR 182.8 · χ² 266,431 / p <1e-300 | 143.3 EB05 137.9 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
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.
- Bone demineralisation — n=278, PRR 414.3
- Bone loss — n=3,468, PRR 345.6
- Skeletal injury — n=2,122, PRR 296.7
- Multiple fractures — n=3,147, PRR 273.4
- Tooth loss — n=3,426, PRR 228.8
- Osteopenia — n=1,881, PRR 163.8
- Tooth injury — n=506, PRR 152.3
- Osteonecrosis — n=3,385, PRR 132.5
- Degenerative bone disease — n=38, PRR 109.3
- Renal injury — n=2,488, PRR 105.2
✓ 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 Bictegravir?
In FDA FAERS, the most frequently co-reported reaction terms for Bictegravir are bone density decreased, chronic kidney disease, bone loss, tooth loss, osteonecrosis, 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 Bictegravir have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY.
Do FAERS signals prove that Bictegravir 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 0476d7eb-1024-4821-bbe7-abaacfda32a2, effective 20240430; matched on
openfda.generic_name.exact:"BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE") - 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, 1,019 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 - ClinicalTrials.gov API v2 (query
BICTEGRAVIR, results-bearing studies sorted by enrollment)
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.