Aripiprazole Lauroxil side effects: what 4,520 FDA adverse event reports show
Drug class
Atypical antipsychotic
Brand names
Aristada
Who reports
4,520 reports · 17% serious · 81 with death outcome · 49% female
Used for
ARISTADA is indicated for the treatment of schizophrenia in adults . ARISTADA is an atypical antipsychotic indicated for the treatment of schizophrenia in adults ( 1 ).
What it is
ARISTADA contains aripiprazole lauroxil, an atypical antipsychotic.
Boxed warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] .
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 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.
- 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. 99 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 |
|---|---|---|---|---|---|---|
| Needle issue | 637 | 105.4 98.0–113.4ROR 122.5 · χ² 64,368 / p <1e-300 | 102.7 EB05 96.2 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=25 | no trial data cached |
| Product administered at inappropriate site | 211 | 54.4 47.6–62.1ROR 57.0 · χ² 10,883 / p <1e-300 | 53.5 EB05 47.7 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=18 | no trial data cached |
| Hallucination, auditory | 175 | 51.4 44.4–59.5ROR 53.5 · χ² 8,514 / p <1e-300 | 50.6 EB05 44.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 35.9 | no trial data cached |
| Syringe issue | 166 | 44.2 38.1–51.4ROR 45.9 · χ² 6,910 / p <1e-300 | 43.6 EB05 38.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Schizophrenia | 102 | 39.1 32.3–47.4ROR 40.0 · χ² 3,722 / p <1e-300 | 38.5 EB05 32.7 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 51.3 | no trial data cached |
| Therapeutic response shortened | 180 | 26.3 22.8–30.4ROR 27.4 · χ² 4,339 / p <1e-300 | 26.1 EB05 23.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 24.2 | no trial data cached |
| Akathisia (inner restlessness) | 73 | 24.9 19.8–31.2ROR 25.3 · χ² 1,641 / p <1e-300 | 24.6 EB05 20.2 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.8 | no trial data cached |
| Paranoia | 89 | 23.9 19.4–29.4ROR 24.4 · χ² 1,921 / p <1e-300 | 23.7 EB05 19.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 23.5 | no trial data cached |
| Delusion | 75 | 22.5 18.0–28.2ROR 22.9 · χ² 1,514 / p <1e-300 | 22.3 EB05 18.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 28.8 | no trial data cached |
| Injection site induration | 54 | 19.4 14.8–25.2ROR 19.6 · χ² 918 / p 5e-202 | 19.2 EB05 15.2 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=5 · ♀ 75% (drug 49%) | no trial data cached |
| Product administration error | 83 | 19.3 15.6–23.9ROR 19.7 · χ² 1,419 / p <1e-300 | 19.2 EB05 15.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 22.7 | no trial data cached |
| Psychotic disorder | 119 | 18.7 15.7–22.3ROR 19.2 · χ² 1,972 / p <1e-300 | 18.6 EB05 15.9 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 37.5 | no trial data cached |
| Injection site mass | 145 | 18.3 15.6–21.4ROR 18.8 · χ² 2,344 / p <1e-300 | 18.2 EB05 15.8 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.4 · ♀ 71% (drug 49%) | no trial data cached |
| Injection site discomfort | 39 | 17.5 12.8–24.0ROR 17.7 · χ² 590 / p 1e-130 | 17.3 EB05 13.1 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=3 | no trial data cached |
| Mania | 57 | 16.1 12.4–20.8ROR 16.3 · χ² 790 / p 4e-174 | 15.9 EB05 12.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.0 | no trial data cached |
| Drug administered at inappropriate site | 33 | 14.3 10.2–20.1ROR 14.4 · χ² 394 / p 4e-88 | 14.0 EB05 10.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Wrong technique in device usage process | 131 | 13.3 11.2–15.7ROR 13.7 · χ² 1,476 / p <1e-300 | 13.2 EB05 11.4 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=3 · 97% clinician | no trial data cached |
| Restlessness | 86 | 10.9 8.8–13.4ROR 11.1 · χ² 761 / p 7e-168 | 10.7 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 | no trial data cached |
| Underdose | 169 | 10.7 9.2–12.4ROR 11.1 · χ² 1,482 / p <1e-300 | 10.6 EB05 9.3 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 · 74% consumer | no trial data cached |
| Apathy | 31 | 9.9 7.0–14.1ROR 10.0 · χ² 239 / p 4e-54 | 9.2 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Restless legs syndrome | 33 | 8.4 6.0–11.8ROR 8.5 · χ² 208 / p 2e-47 | 7.8 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Euphoric mood | 18 | 8.1 5.1–12.8ROR 8.1 · χ² 105 / p 7e-25 | 7.0 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Bipolar disorder | 19 | 8.0 5.1–12.6ROR 8.1 · χ² 110 / p 5e-26 | 7.0 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 | no trial data cached |
| Drug administration error | 54 | 8.0 6.2–10.5ROR 8.1 · χ² 326 / p 4e-73 | 7.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Agitation | 126 | 7.9 6.7–9.4ROR 8.1 · χ² 757 / p 6e-167 | 7.7 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Abnormal behaviour | 67 | 7.8 6.1–9.9ROR 7.9 · χ² 389 / p 5e-87 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 25% (drug 49%) | no trial data cached |
| Thinking abnormal | 29 | 7.2 5.0–10.3ROR 7.2 · χ² 148 / p 3e-34 | 6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.9 | no trial data cached |
| Increased appetite | 29 | 7.1 5.0–10.3ROR 7.2 · χ² 147 / p 4e-34 | 6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Hallucination, visual | 32 | 7.1 5.0–10.0ROR 7.1 · χ² 161 / p 4e-37 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Aggression | 74 | 6.8 5.5–8.6ROR 6.9 · χ² 363 / p 3e-81 | 6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.1 · ♀ 26% (drug 49%) | no trial data cached |
| Treatment noncompliance | 78 | 6.7 5.3–8.3ROR 6.7 · χ² 369 / p 1e-82 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 12.4 | no trial data cached |
| Injection site pain (pain where injected) | 434 | 6.6 6.1–7.2ROR 7.2 · χ² 2,094 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 | no trial data cached |
| Anger | 47 | 6.4 4.8–8.5ROR 6.5 · χ² 209 / p 1e-47 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Hallucination (hallucinations) | 102 | 6.3 5.2–7.6ROR 6.4 · χ² 451 / p 2e-100 | 6.1 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.4 | no trial data cached |
| Incorrect route of product administration | 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 | Reporting / coding artifact | serious PRR 7.3 | no trial data cached |
| Off label use (used outside approved label) | 1,124 | 6.0 5.7–6.3ROR 7.6 · χ² 4,873 / p <1e-300 | 6.0 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Injection site nodule | 14 | 5.9 3.5–10.0ROR 5.9 · χ² 52 / p 3e-13 | 5.0 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Pregnancy | 25 | 5.7 3.9–8.5ROR 5.8 · χ² 93 / p 3e-22 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · ♀ 100% (drug 49%) | no trial data cached |
| Product physical issue | 24 | 5.6 3.7–8.3ROR 5.6 · χ² 86 / p 1e-20 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Neuroleptic malignant syndrome | 14 | 5.5 3.2–9.2ROR 5.5 · χ² 47 / p 5e-12 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 18.3 | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,124 | 6.0 5.7–6.3ROR 7.6 · χ² 4,873 / p <1e-300 | 6.0 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Needle issue | 637 | 105.4 98.0–113.4ROR 122.5 · χ² 64,368 / p <1e-300 | 102.7 EB05 96.2 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=25 | no trial data cached |
| Injection site pain (pain where injected) | 434 | 6.6 6.1–7.2ROR 7.2 · χ² 2,094 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 | no trial data cached |
| Weight increased (weight gain) | 215 | 4.5 3.9–5.1ROR 4.6 · χ² 581 / p 1e-128 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.8 | no trial data cached |
| Product administered at inappropriate site | 211 | 54.4 47.6–62.1ROR 57.0 · χ² 10,883 / p <1e-300 | 53.5 EB05 47.7 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=18 | no trial data cached |
| Incorrect dose administered | 190 | 3.9 3.4–4.5ROR 4.0 · χ² 413 / p 4e-92 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Therapeutic response shortened | 180 | 26.3 22.8–30.4ROR 27.4 · χ² 4,339 / p <1e-300 | 26.1 EB05 23.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 24.2 | no trial data cached |
| Hallucination, auditory | 175 | 51.4 44.4–59.5ROR 53.5 · χ² 8,514 / p <1e-300 | 50.6 EB05 44.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 35.9 | no trial data cached |
| Underdose | 169 | 10.7 9.2–12.4ROR 11.1 · χ² 1,482 / p <1e-300 | 10.6 EB05 9.3 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 · 74% consumer | no trial data cached |
| Syringe issue | 166 | 44.2 38.1–51.4ROR 45.9 · χ² 6,910 / p <1e-300 | 43.6 EB05 38.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Anxiety | 153 | 2.5 2.1–2.9ROR 2.5 · χ² 136 / p 1e-31 | 2.5 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Injection site mass | 145 | 18.3 15.6–21.4ROR 18.8 · χ² 2,344 / p <1e-300 | 18.2 EB05 15.8 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.4 · ♀ 71% (drug 49%) | no trial data cached |
| Hospitalisation | 143 | 4.3 3.7–5.1ROR 4.5 · χ² 367 / p 4e-82 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 14.8 | no trial data cached |
| Wrong technique in device usage process | 131 | 13.3 11.2–15.7ROR 13.7 · χ² 1,476 / p <1e-300 | 13.2 EB05 11.4 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=3 · 97% clinician | no trial data cached |
| Agitation | 126 | 7.9 6.7–9.4ROR 8.1 · χ² 757 / p 6e-167 | 7.7 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | 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.
- Needle issue — n=637, PRR 105.4
- Hallucination, auditory — n=175, PRR 51.4
- Syringe issue — n=166, PRR 44.2
- Paranoia — n=89, PRR 23.9
- Delusion — n=75, PRR 22.5
- Mania — n=57, PRR 16.1
- Drug administered at inappropriate site — n=33, PRR 14.3
- Apathy — n=31, PRR 9.9
- Restless legs syndrome — n=33, PRR 8.4
- Agitation — n=126, PRR 7.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Aripiprazole (antipsychotics) ↔ Akathisia.
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 Aripiprazole Lauroxil?
In FDA FAERS, the most frequently co-reported reaction terms for Aripiprazole Lauroxil are needle issue, injection site pain, weight increased, hallucination, auditory, syringe issue, anxiety. 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 Aripiprazole Lauroxil have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] .
Do FAERS signals prove that Aripiprazole Lauroxil 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 17a8d11b-73b0-4833-a0b4-cf1ef85edefb, effective 20250128; matched on
openfda.generic_name.exact:"ARIPIPRAZOLE LAUROXIL") - 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, 139 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.