Abacavir and Dolutegravir and Lamivudine side effects: what 6,304 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Abacavir (Abacavir)
Who reports
6,304 reports · 54% serious · 325 with death outcome · 26% female
Used for
Abacavir tablet, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Abacavir tablets USP 300 mg, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
What it is
Abacavir sulfate is a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1.
Boxed warning
HYPERSENSITIVITY REACTIONS WARNING: HYPERSENSITIVITY REACTIONS See full prescribing information for complete boxed warning. Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir sulfate. ( 5.1 ) Hypersensitivity to abacavir is a multi-organ clinical syndrome.
Causality screen of the 40 strongest signals
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. 219 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 |
|---|---|---|---|---|---|---|
| Anhedonia | 628 | 80.7 74.9–87.0ROR 89.6 · χ² 48,250 / p <1e-300 | 78.6 EB05 73.6 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 90.9 · 100% consumer | no trial data cached |
| Economic problem | 231 | 50.6 44.5–57.5ROR 52.5 · χ² 11,016 / p <1e-300 | 49.6 EB05 44.5 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 56.7 · 97% consumer | no trial data cached |
| Osteopenia | 191 | 42.1 36.6–48.5ROR 43.4 · χ² 7,539 / p <1e-300 | 41.5 EB05 36.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 48.4 · 91% consumer | no trial data cached |
| Bone density decreased | 257 | 27.2 24.1–30.7ROR 28.3 · χ² 6,413 / p <1e-300 | 26.9 EB05 24.3 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 34.9 · 90% consumer | no trial data cached |
| Osteoporosis | 282 | 22.9 20.4–25.7ROR 23.9 · χ² 5,860 / p <1e-300 | 22.7 EB05 20.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 | no trial data cached |
| Chronic kidney disease | 473 | 20.6 18.9–22.5ROR 22.2 · χ² 8,796 / p <1e-300 | 20.5 EB05 19.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 · 76% consumer | no trial data cached |
| Multiple fractures | 97 | 19.6 16.1–23.9ROR 19.9 · χ² 1,682 / p <1e-300 | 19.4 EB05 16.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 | no trial data cached |
| Emotional distress | 697 | 19.2 17.9–20.6ROR 21.4 · χ² 11,991 / p <1e-300 | 19.1 EB05 17.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · 100% consumer | no trial data cached |
| End stage renal disease | 100 | 18.1 14.9–22.0ROR 18.4 · χ² 1,595 / p <1e-300 | 18.0 EB05 15.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 19.3 | no trial data cached |
| Bone loss | 82 | 18.0 14.5–22.4ROR 18.3 · χ² 1,297 / p 2e-284 | 17.9 EB05 14.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.7 | no trial data cached |
| Decreased activity | 49 | 15.3 11.5–20.2ROR 15.4 · χ² 637 / p 9e-141 | 15.0 EB05 11.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 24.0 | no trial data cached |
| Quality of life decreased | 59 | 14.7 11.4–18.9ROR 14.8 · χ² 735 / p 5e-162 | 14.5 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.6 | no trial data cached |
| Tooth loss | 87 | 13.9 11.3–17.1ROR 14.1 · χ² 1,026 / p 2e-225 | 13.8 EB05 11.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 | no trial data cached |
| Vitamin d deficiency | 40 | 13.7 10.0–18.7ROR 13.8 · χ² 456 / p 1e-101 | 13.4 EB05 10.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 | no trial data cached |
| Nephropathy | 38 | 13.5 9.8–18.6ROR 13.6 · χ² 426 / p 5e-95 | 13.2 EB05 9.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 | no trial data cached |
| Skeletal injury | 38 | 12.1 8.8–16.6ROR 12.2 · χ² 375 / p 7e-84 | 11.7 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | no trial data cached |
| Osteonecrosis (bone death) | 114 | 11.5 9.6–13.8ROR 11.7 · χ² 1,077 / p 2e-236 | 11.3 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Foot fracture | 57 | 10.0 7.7–12.9ROR 10.1 · χ² 451 / p 2e-100 | 9.6 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Blood creatinine increased | 194 | 9.9 8.6–11.4ROR 10.2 · χ² 1,541 / p <1e-300 | 9.8 EB05 8.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.9 | no trial data cached |
| Product dose omission in error | 78 | 9.7 7.8–12.1ROR 9.8 · χ² 598 / p 3e-132 | 9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · 92% consumer | no trial data cached |
| Product dose omission issue | 826 | 9.7 9.1–10.3ROR 11.0 · χ² 6,482 / p <1e-300 | 9.6 EB05 9.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Anxiety | 756 | 8.8 8.3–9.4ROR 9.9 · χ² 5,300 / p <1e-300 | 8.8 EB05 8.3 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.0 · 75% consumer | no trial data cached |
| Glomerular filtration rate decreased | 31 | 8.5 6.0–12.1ROR 8.6 · χ² 198 / p 3e-45 | 7.8 EB05 5.7 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 10.2 | no trial data cached |
| Renal impairment | 212 | 8.4 7.4–9.6ROR 8.7 · χ² 1,385 / p <1e-300 | 8.3 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Exposure during pregnancy | 156 | 8.4 7.2–9.8ROR 8.5 · χ² 1,004 / p 1e-220 | 8.2 EB05 7.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · ♀ 100% (drug 26%) | no trial data cached |
| Abortion induced | 23 | 8.1 5.4–12.2ROR 8.2 · χ² 136 / p 8e-32 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 100% (drug 26%) | no trial data cached |
| Renal injury | 71 | 7.9 6.3–9.9ROR 8.0 · χ² 419 / p 2e-93 | 7.6 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Renal failure (kidney failure) | 307 | 7.6 6.9–8.5ROR 8.0 · χ² 1,774 / p <1e-300 | 7.6 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Loss of personal independence in daily activities | 108 | 7.6 6.3–9.1ROR 7.7 · χ² 609 / p 1e-134 | 7.4 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · 83% consumer | no trial data cached |
| Coeliac disease | 22 | 7.5 4.9–11.3ROR 7.5 · χ² 117 / p 2e-27 | 6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · 100% clinician | no trial data cached |
| Inability to afford medication | 22 | 7.5 4.9–11.3ROR 7.5 · χ² 116 / p 2e-27 | 6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=3 · 73% consumer | no trial data cached |
| Product dose omission | 147 | 7.4 6.3–8.7ROR 7.5 · χ² 807 / p 7e-178 | 7.2 EB05 6.3 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 88% consumer | no trial data cached |
| Proteinuria | 41 | 7.2 5.3–9.8ROR 7.3 · χ² 214 / p 9e-49 | 6.8 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Dysstasia | 62 | 7.0 5.5–9.0ROR 7.1 · χ² 316 / p 7e-71 | 6.7 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Hepatitis c | 24 | 6.5 4.4–9.8ROR 6.6 · χ² 107 / p 2e-25 | 5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 | no trial data cached |
| Renal tubular necrosis | 19 | 6.4 4.1–10.1ROR 6.5 · χ² 82 / p 8e-20 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Wrist fracture | 23 | 6.4 4.2–9.6ROR 6.4 · χ² 99 / p 1e-23 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 55% (drug 26%) | no trial data cached |
| Bursitis | 22 | 6.1 4.0–9.2ROR 6.1 · χ² 88 / p 3e-21 | 5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · 95% clinician | no trial data cached |
| Rib fracture | 36 | 5.8 4.2–8.1ROR 5.9 · χ² 139 / p 2e-32 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Lymphoma | 27 | 5.8 4.0–8.5ROR 5.8 · χ² 102 / p 2e-24 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Product dose omission issue | 826 | 9.7 9.1–10.3ROR 11.0 · χ² 6,482 / p <1e-300 | 9.6 EB05 9.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Pain | 807 | 4.4 4.1–4.7ROR 4.9 · χ² 2,151 / p <1e-300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · 71% consumer | no trial data cached |
| Anxiety | 756 | 8.8 8.3–9.4ROR 9.9 · χ² 5,300 / p <1e-300 | 8.8 EB05 8.3 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.0 · 75% consumer | no trial data cached |
| Emotional distress | 697 | 19.2 17.9–20.6ROR 21.4 · χ² 11,991 / p <1e-300 | 19.1 EB05 17.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · 100% consumer | no trial data cached |
| Anhedonia | 628 | 80.7 74.9–87.0ROR 89.6 · χ² 48,250 / p <1e-300 | 78.6 EB05 73.6 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 90.9 · 100% consumer | no trial data cached |
| Chronic kidney disease | 473 | 20.6 18.9–22.5ROR 22.2 · χ² 8,796 / p <1e-300 | 20.5 EB05 19.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 · 76% consumer | no trial data cached |
| Depression | 315 | 4.6 4.1–5.1ROR 4.8 · χ² 889 / p 1e-195 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Renal failure (kidney failure) | 307 | 7.6 6.9–8.5ROR 8.0 · χ² 1,774 / p <1e-300 | 7.6 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Osteoporosis | 282 | 22.9 20.4–25.7ROR 23.9 · χ² 5,860 / p <1e-300 | 22.7 EB05 20.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 | no trial data cached |
| Bone density decreased | 257 | 27.2 24.1–30.7ROR 28.3 · χ² 6,413 / p <1e-300 | 26.9 EB05 24.3 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 34.9 · 90% consumer | no trial data cached |
| Economic problem | 231 | 50.6 44.5–57.5ROR 52.5 · χ² 11,016 / p <1e-300 | 49.6 EB05 44.5 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 56.7 · 97% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 227 | 2.8 2.5–3.2ROR 2.9 · χ² 270 / p 5e-61 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 | no trial data cached |
| Renal impairment | 212 | 8.4 7.4–9.6ROR 8.7 · χ² 1,385 / p <1e-300 | 8.3 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 203 | 4.4 3.9–5.1ROR 4.6 · χ² 540 / p 9e-120 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Rash | 194 | 1.5 1.3–1.7ROR 1.5 · χ² 31 / p 1e-8 | 1.5 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.7 | 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=628, PRR 80.7
- Osteopenia — n=191, PRR 42.1
- Osteoporosis — n=282, PRR 22.9
- Chronic kidney disease — n=473, PRR 20.6
- Multiple fractures — n=97, PRR 19.6
- Emotional distress — n=697, PRR 19.2
- End stage renal disease — n=100, PRR 18.1
- Bone loss — n=82, PRR 18.0
- Decreased activity — n=49, PRR 15.3
- Quality of life decreased — n=59, PRR 14.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Abacavir ↔ Hypersensitivity reaction.
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 Abacavir and Dolutegravir and Lamivudine?
In FDA FAERS, the most frequently co-reported reaction terms for Abacavir and Dolutegravir and Lamivudine are pain, anxiety, emotional distress, anhedonia, chronic kidney disease, depression. 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 Abacavir and Dolutegravir and Lamivudine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: HYPERSENSITIVITY REACTIONS WARNING: HYPERSENSITIVITY REACTIONS See full prescribing information for complete boxed warning. Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir sulfate. ( 5.1 ) Hypersensitivity to abacavir is a multi-organ clinical syndrome.
Do FAERS signals prove that Abacavir and Dolutegravir and Lamivudine 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 0d791375-e311-41f9-87b8-940657e6318c, effective 20201224; matched on
openfda.generic_name.exact:"ABACAVIR") - 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, 259 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.