Drug · FAERS side-effect profile with label screen
Cabotegravir side effects: what 8,005 FDA adverse event reports show
Drug class
Hiv-1 integrase strand transfer inhibitor (insti)
FDA label, Indications wording
Brand names
Apretude
openFDA label
Who reports
8,005 reports · 19% serious · 98 with death outcome · 25% female
openFDA FAERS counts, all years, deduplication not applied
Used for
APRETUDE is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior.
FDA label, Indications and Usage
What it is
APRETUDE contains cabotegravir extended-release injectable suspension, an HIV INSTI.
FDA label, Description section
Boxed warning
RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE‑EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, .
FDA 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 — boxed warning 1Labeled adverse reaction 2Labeled (related wording) 10Likely indication confounding 2Reporting / coding artifact 12Lab value / disease marker 4Not in label — unassessed 9
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 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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 527 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 |
|---|---|---|---|---|---|---|
| Product use in unapproved therapeutic environment | 255 | 1,164.9 1,006.4–1,348.4ROR 1,203.1 · χ² 203,424 / p <1e-300 | 756.6 EB05 681.8 · IC025 +8.1 3/3 methods agree | Reporting / coding artifact | serious n=14 · 98% clinician | no trial data cached |
| Single component of a two-component product administered | 11 | 377.9 200.8–711.3ROR 378.4 · χ² 3,285 / p <1e-300 | 210.0 EB05 125.1 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Disseminated mycobacterium avium complex infection | 26 | 364.1 241.6–548.6ROR 365.3 · χ² 7,933 / p <1e-300 | 258.5 EB05 185.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 25%) | no trial data cached |
| Viral load increased | 434 | 327.0 296.6–360.4ROR 345.6 · χ² 124,889 / p <1e-300 | 286.6 EB05 264.7 · IC025 +7.6 3/3 methods agree | Lab value / disease marker | serious n=54 · 93% clinician | no trial data cached |
| Viral load abnormal | 17 | 288.2 174.6–475.5ROR 288.8 · χ² 4,121 / p <1e-300 | 201.0 EB05 132.9 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Blood hiv rna increased | 161 | 257.8 219.6–302.7ROR 263.1 · χ² 37,211 / p <1e-300 | 228.1 EB05 200.0 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=54 | no trial data cached |
| Hiv infection | 156 | 142.2 121.2–166.9ROR 145.0 · χ² 20,602 / p <1e-300 | 132.7 EB05 116.1 · IC025 +6.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=156 · 92% clinician | no trial data cached |
| Virologic failure | 270 | 137.6 122.0–155.2ROR 142.3 · χ² 34,635 / p <1e-300 | 129.5 EB05 117.0 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=89 · 98% clinician | no trial data cached |
| Cryptosporidiosis infection | 26 | 135.9 91.7–201.5ROR 136.3 · χ² 3,180 / p <1e-300 | 118.1 EB05 84.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 25%) | no trial data cached |
| Viral mutation identified | 164 | 120.7 103.4–141.0ROR 123.2 · χ² 18,491 / p <1e-300 | 113.9 EB05 100.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=82 | no trial data cached |
| Product administered by wrong person | 16 | 118.8 72.0–196.0ROR 119.0 · χ² 1,676 / p <1e-300 | 100.3 EB05 65.5 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Abdominal lymphadenopathy | 26 | 81.6 55.3–120.5ROR 81.9 · χ² 1,929 / p <1e-300 | 74.9 EB05 53.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 25%) | no trial data cached |
| Pathogen resistance | 250 | 73.8 65.2–83.5ROR 76.1 · χ² 17,381 / p <1e-300 | 71.4 EB05 64.2 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 121.0 · 90% clinician | no trial data cached |
| Drug monitoring procedure incorrectly performed | 15 | 60.0 36.0–100.1ROR 60.1 · χ² 794 / p 6e-175 | 54.8 EB05 35.3 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Syphilis | 16 | 58.7 35.8–96.3ROR 58.8 · χ² 832 / p 3e-183 | 54.0 EB05 35.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Viraemia | 29 | 55.6 38.5–80.2ROR 55.8 · χ² 1,468 / p <1e-300 | 52.6 EB05 38.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=8 · 100% clinician | no trial data cached |
| Substance use | 27 | 46.6 31.8–68.1ROR 46.7 · χ² 1,138 / p 8e-250 | 44.4 EB05 32.1 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=27 · ♀ 0% (drug 25%) | no trial data cached |
| Injection site nodule | 183 | 44.2 38.3–51.1ROR 45.2 · χ² 7,565 / p <1e-300 | 43.3 EB05 38.3 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Injection site abscess | 39 | 41.7 30.4–57.1ROR 41.9 · χ² 1,484 / p <1e-300 | 40.3 EB05 30.8 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=13 · 92% clinician | no trial data cached |
| Cd4 lymphocytes decreased | 33 | 40.5 28.8–57.1ROR 40.7 · χ² 1,214 / p 3e-266 | 39.1 EB05 29.1 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=5 · 91% clinician | no trial data cached |
| Injection site discharge | 56 | 29.0 22.3–37.7ROR 29.2 · χ² 1,470 / p <1e-300 | 28.4 EB05 22.7 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=6 · ♀ 56% (drug 25%) | no trial data cached |
| Drug monitoring procedure not performed | 17 | 25.2 15.6–40.6ROR 25.2 · χ² 367 / p 4e-82 | 24.3 EB05 16.0 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Hepatitis b reactivation | 30 | 24.9 17.4–35.6ROR 25.0 · χ² 658 / p 2e-145 | 24.3 EB05 17.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=30 · 93% clinician | no trial data cached |
| Injection related reaction | 15 | 24.6 14.8–40.8ROR 24.6 · χ² 313 / p 2e-70 | 23.6 EB05 15.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Product complaint | 227 | 24.0 21.1–27.3ROR 24.6 · χ² 4,933 / p <1e-300 | 23.7 EB05 21.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=1 · 98% clinician | no trial data cached |
| Product administered at inappropriate site | 122 | 17.7 14.8–21.1ROR 17.9 · χ² 1,889 / p <1e-300 | 17.5 EB05 15.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=7 | no trial data cached |
| Nodule | 84 | 16.9 13.7–20.9ROR 17.1 · χ² 1,234 / p 1e-270 | 16.7 EB05 13.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 | no trial data cached |
| Injection site discomfort | 61 | 15.5 12.1–19.9ROR 15.6 · χ² 810 / p 2e-178 | 15.3 EB05 12.3 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=25 | no trial data cached |
| Occupational exposure to product | 38 | 15.4 11.2–21.2ROR 15.5 · χ² 496 / p 4e-110 | 15.1 EB05 11.4 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | ♀ 88% (drug 25%) · 100% clinician | no trial data cached |
| Induration | 10 | 14.7 7.9–27.4ROR 14.7 · χ² 114 / p 7e-27 | 12.9 EB05 6.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=4 | no trial data cached |
| Injection site indentation | 11 | 14.2 7.8–25.6ROR 14.2 · χ² 121 / p 2e-28 | 12.5 EB05 6.5 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Product preparation issue | 30 | 13.5 9.4–19.3ROR 13.6 · χ² 333 / p 9e-75 | 13.0 EB05 9.3 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | 100% clinician | no trial data cached |
| Injection site infection | 15 | 12.0 7.2–20.0ROR 12.0 · χ² 140 / p 1e-32 | 10.7 EB05 6.3 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=4 | no trial data cached |
| Labelled drug-drug interaction medication error | 36 | 10.6 7.6–14.7ROR 10.6 · χ² 301 / p 8e-68 | 10.0 EB05 7.4 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 92% clinician | no trial data cached |
| Product dose omission issue | 1,118 | 10.3 9.7–10.9ROR 11.8 · χ² 9,462 / p <1e-300 | 10.2 EB05 9.7 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Hepatitis b | 22 | 9.5 6.3–14.4ROR 9.5 · χ² 159 / p 1e-36 | 8.5 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 95% clinician | no trial data cached |
| Injection site induration | 45 | 9.1 6.8–12.2ROR 9.1 · χ² 315 / p 8e-71 | 8.6 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Wrong product administered | 22 | 8.7 5.7–13.2ROR 8.7 · χ² 141 / p 6e-33 | 7.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | 91% clinician | no trial data cached |
| Depressive symptom | 11 | 8.2 4.5–14.8ROR 8.2 · χ² 62 / p 1e-15 | 6.5 EB05 3.8 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | serious n=1 | no trial data cached |
| Injection site pain (pain where injected) | 925 | 8.0 7.5–8.5ROR 8.9 · χ² 5,707 / p <1e-300 | 7.9 EB05 7.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.0 | 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 |
|---|---|---|---|---|---|---|
| Product dose omission issue | 1,118 | 10.3 9.7–10.9ROR 11.8 · χ² 9,462 / p <1e-300 | 10.2 EB05 9.7 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Off label use (used outside approved label) | 1,045 | 3.1 3.0–3.3ROR 3.5 · χ² 1,593 / p <1e-300 | 3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 0.5 · 96% clinician | no trial data cached |
| Injection site pain (pain where injected) | 925 | 8.0 7.5–8.5ROR 8.9 · χ² 5,707 / p <1e-300 | 7.9 EB05 7.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.0 | no trial data cached |
| Viral load increased | 434 | 327.0 296.6–360.4ROR 345.6 · χ² 124,889 / p <1e-300 | 286.6 EB05 264.7 · IC025 +7.6 3/3 methods agree | Lab value / disease marker | serious n=54 · 93% clinician | no trial data cached |
| Pain | 407 | 1.7 1.6–1.9ROR 1.8 · χ² 128 / p 6e-30 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Virologic failure | 270 | 137.6 122.0–155.2ROR 142.3 · χ² 34,635 / p <1e-300 | 129.5 EB05 117.0 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=89 · 98% clinician | no trial data cached |
| Pyrexia (fever) | 256 | 1.9 1.7–2.2ROR 2.0 · χ² 116 / p 2e-27 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Product use in unapproved therapeutic environment | 255 | 1,164.9 1,006.4–1,348.4ROR 1,203.1 · χ² 203,424 / p <1e-300 | 756.6 EB05 681.8 · IC025 +8.1 3/3 methods agree | Reporting / coding artifact | serious n=14 · 98% clinician | no trial data cached |
| Inappropriate schedule of product administration | 252 | 3.7 3.3–4.2ROR 3.8 · χ² 504 / p 8e-112 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Pathogen resistance | 250 | 73.8 65.2–83.5ROR 76.1 · χ² 17,381 / p <1e-300 | 71.4 EB05 64.2 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 121.0 · 90% clinician | no trial data cached |
| Product complaint | 227 | 24.0 21.1–27.3ROR 24.6 · χ² 4,933 / p <1e-300 | 23.7 EB05 21.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=1 · 98% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 217 | 0.4 0.4–0.5ROR 0.4 · χ² 174 / p 5e-40 | 0.4 EB05 0.4 · IC025 -1.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Fatigue (tiredness) | 189 | 0.6 0.6–0.7ROR 0.6 · χ² 41 / p 9e-11 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Product storage error | 185 | 5.6 4.9–6.5ROR 5.7 · χ² 695 / p 2e-153 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 95% clinician | no trial data cached |
| Injection site nodule | 183 | 44.2 38.3–51.1ROR 45.2 · χ² 7,565 / p <1e-300 | 43.3 EB05 38.3 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | 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.
- Disseminated mycobacterium avium complex infection — n=26, PRR 364.1
- Virologic failure — n=270, PRR 137.6
- Cryptosporidiosis infection — n=26, PRR 135.9
- Viral mutation identified — n=164, PRR 120.7
- Abdominal lymphadenopathy — n=26, PRR 81.6
- Viraemia — n=29, PRR 55.6
- Hepatitis b reactivation — n=30, PRR 24.9
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 Cabotegravir?
In FDA FAERS, the most frequently co-reported reaction terms for Cabotegravir are injection site pain, viral load increased, pain, virologic failure, pyrexia, fatigue. 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 Cabotegravir have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE‑EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, .
Do FAERS signals prove that Cabotegravir 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 4338428e-43d4-4e02-ac9d-bd98e738a7da, effective 20250411; matched on
openfda.generic_name.exact:"CABOTEGRAVIR") - 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, 567 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.