Brexpiprazole side effects: what 16,503 FDA adverse event reports show
Brand names
Rexulti
Who reports
16,503 reports · 42% serious · 1,085 with death outcome · 69% female
Used for
REXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to A.
What it is
Brexpiprazole, an atypical antipsychotic, is available as REXULTI ® (brexpiprazole) tablets. Brexpiprazole is 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1 H )-one.
Boxed warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.
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.
- 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. 986 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 |
|---|---|---|---|---|---|---|
| Schizoaffective disorder | 203 | 162.3 140.3–187.7ROR 164.3 · χ² 28,667 / p <1e-300 | 141.9 EB05 126.3 · IC025 +6.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=203 · ♀ 92% (drug 69%) | no trial data cached |
| Sinus rhythm | 44 | 141.7 103.8–193.5ROR 142.1 · χ² 5,397 / p <1e-300 | 120.8 EB05 93.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 100% (drug 69%) · 100% clinician | no trial data cached |
| Akathisia (inner restlessness) | 869 | 86.4 80.8–92.4ROR 91.1 · χ² 68,579 / p <1e-300 | 80.7 EB05 76.3 · IC025 +6.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 41.2 | no trial data cached |
| Spasmodic dysphonia | 16 | 72.9 44.0–120.6ROR 73.0 · χ² 1,005 / p 7e-221 | 63.9 EB05 41.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Discoloured vomit | 46 | 64.9 48.3–87.2ROR 65.1 · χ² 2,691 / p <1e-300 | 60.3 EB05 47.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 100% (drug 69%) | no trial data cached |
| Activation syndrome | 14 | 53.0 31.0–90.4ROR 53.0 · χ² 636 / p 1e-140 | 47.8 EB05 30.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Patient elopement | 13 | 50.1 28.8–87.2ROR 50.1 · χ² 555 / p 4e-123 | 45.2 EB05 28.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Lactation disorder | 18 | 48.6 30.4–77.8ROR 48.6 · χ² 763 / p 4e-168 | 44.8 EB05 30.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Inability to afford medication | 360 | 48.3 43.5–53.6ROR 49.3 · χ² 16,006 / p <1e-300 | 46.4 EB05 42.5 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=65 · 88% consumer | no trial data cached |
| Oculogyric crisis | 77 | 48.2 38.4–60.5ROR 48.4 · χ² 3,383 / p <1e-300 | 46.0 EB05 38.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=74 | no trial data cached |
| Social anxiety disorder | 24 | 48.0 32.0–72.2ROR 48.1 · χ² 1,020 / p 5e-224 | 44.8 EB05 31.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 69%) | no trial data cached |
| Tongue movement disturbance | 29 | 44.4 30.7–64.3ROR 44.5 · χ² 1,147 / p 1e-251 | 41.8 EB05 30.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Gambling disorder | 81 | 39.0 31.3–48.7ROR 39.2 · χ² 2,875 / p <1e-300 | 37.6 EB05 31.2 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=23 | no trial data cached |
| Compulsive shopping | 60 | 37.9 29.3–49.0ROR 38.0 · χ² 2,057 / p <1e-300 | 36.4 EB05 29.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=21 | no trial data cached |
| Gambling | 33 | 36.6 25.9–51.7ROR 36.6 · χ² 1,075 / p 6e-236 | 34.9 EB05 26.0 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning exact term | serious n=5 · ♀ 39% (drug 69%) | no trial data cached |
| Hallucination, tactile | 17 | 33.6 20.8–54.4ROR 33.6 · χ² 492 / p 2e-109 | 31.7 EB05 20.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Compulsions | 14 | 27.8 16.4–47.2ROR 27.8 · χ² 328 / p 1e-73 | 26.3 EB05 16.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Binge eating | 23 | 27.8 18.4–42.0ROR 27.8 · χ² 555 / p 5e-123 | 26.7 EB05 18.7 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=6 · ♀ 90% (drug 69%) | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 599 | 27.3 25.2–29.5ROR 28.3 · χ² 14,831 / p <1e-300 | 26.7 EB05 24.9 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 25.4 | no trial data cached |
| Cogwheel rigidity | 21 | 25.8 16.8–39.8ROR 25.8 · χ² 467 / p 8e-104 | 24.8 EB05 17.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Abulia | 17 | 24.1 14.9–39.0ROR 24.2 · χ² 348 / p 7e-78 | 23.1 EB05 15.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Soliloquy | 16 | 24.1 14.7–39.5ROR 24.1 · χ² 325 / p 5e-73 | 23.0 EB05 14.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Reduced facial expression | 17 | 21.9 13.6–35.4ROR 21.9 · χ² 313 / p 2e-70 | 21.0 EB05 13.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Drug administered to patient of inappropriate age | 121 | 21.5 18.0–25.7ROR 21.6 · χ² 2,305 / p <1e-300 | 21.1 EB05 18.1 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=16 · 70% consumer | no trial data cached |
| Personal relationship issue | 11 | 21.1 11.6–38.3ROR 21.1 · χ² 188 / p 4e-43 | 19.8 EB05 11.2 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Persecutory delusion | 40 | 20.9 15.3–28.6ROR 21.0 · χ² 727 / p 2e-160 | 20.4 EB05 15.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 28% (drug 69%) · 100% clinician | no trial data cached |
| Marasmus | 23 | 19.7 13.1–29.7ROR 19.7 · χ² 384 / p 9e-86 | 19.1 EB05 13.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 43% (drug 69%) · 100% clinician | no trial data cached |
| Parkinsonism | 146 | 19.3 16.4–22.7ROR 19.5 · χ² 2,478 / p <1e-300 | 19.0 EB05 16.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 | no trial data cached |
| Blood prolactin abnormal | 13 | 19.2 11.1–33.2ROR 19.2 · χ² 203 / p 2e-46 | 18.1 EB05 10.7 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=3 | no trial data cached |
| Compulsive sexual behaviour | 12 | 18.9 10.7–33.4ROR 18.9 · χ² 183 / p 5e-42 | 17.7 EB05 10.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Blood prolactin increased | 69 | 18.8 14.8–23.8ROR 18.9 · χ² 1,129 / p 7e-248 | 18.5 EB05 15.1 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=24 | no trial data cached |
| Hallucination, auditory | 232 | 18.8 16.5–21.4ROR 19.0 · χ² 3,833 / p <1e-300 | 18.5 EB05 16.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 | no trial data cached |
| Drug dose titration not performed | 25 | 18.7 12.6–27.7ROR 18.7 · χ² 395 / p 3e-88 | 18.1 EB05 12.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Hypomania | 52 | 18.2 13.8–23.9ROR 18.2 · χ² 814 / p 2e-179 | 17.8 EB05 14.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Hypersexuality | 25 | 17.5 11.8–26.0ROR 17.6 · χ² 368 / p 2e-82 | 17.0 EB05 11.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 · ♀ 29% (drug 69%) | no trial data cached |
| Insurance issue | 199 | 17.2 15.0–19.8ROR 17.4 · χ² 2,989 / p <1e-300 | 17.0 EB05 15.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 · 85% consumer | no trial data cached |
| Intrusive thoughts | 15 | 17.1 10.3–28.5ROR 17.1 · χ² 209 / p 1e-47 | 16.2 EB05 9.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Psychotic symptom | 26 | 16.4 11.1–24.1ROR 16.4 · χ² 356 / p 1e-79 | 15.9 EB05 11.2 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=24 | no trial data cached |
| Hyperphagia | 50 | 16.2 12.3–21.4ROR 16.3 · χ² 690 / p 3e-152 | 15.9 EB05 12.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=6 · 74% consumer | no trial data cached |
| Schizophrenia | 151 | 16.0 13.6–18.7ROR 16.1 · χ² 2,077 / p <1e-300 | 15.7 EB05 13.7 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 21.0 · ♀ 41% (drug 69%) | 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 |
|---|---|---|---|---|---|---|
| Weight increased (weight gain) | 1,702 | 9.8 9.3–10.2ROR 10.8 · χ² 13,436 / p <1e-300 | 9.7 EB05 9.3 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.5 | no trial data cached |
| Product use in unapproved indication | 1,348 | 7.0 6.7–7.4ROR 7.6 · χ² 7,028 / p <1e-300 | 7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 | no trial data cached |
| Off label use (used outside approved label) | 1,152 | 1.7 1.6–1.8ROR 1.7 · χ² 335 / p 3e-75 | 1.7 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.6 | no trial data cached |
| Drug ineffective (drug did not work) | 961 | 0.9 0.9–1.0ROR 0.9 · χ² 6 / p 0.008 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Akathisia (inner restlessness) | 869 | 86.4 80.8–92.4ROR 91.1 · χ² 68,579 / p <1e-300 | 80.7 EB05 76.3 · IC025 +6.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 41.2 | no trial data cached |
| Tremor (shaking) | 654 | 5.0 4.7–5.4ROR 5.2 · χ² 2,106 / p <1e-300 | 5.0 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Anxiety | 612 | 2.7 2.5–3.0ROR 2.8 · χ² 677 / p 2e-149 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 599 | 27.3 25.2–29.5ROR 28.3 · χ² 14,831 / p <1e-300 | 26.7 EB05 24.9 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 25.4 | no trial data cached |
| Depression | 584 | 3.3 3.0–3.5ROR 3.3 · χ² 916 / p 1e-201 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.3 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 565 | 7.9 7.3–8.5ROR 8.1 · χ² 3,378 / p <1e-300 | 7.8 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.9 | no trial data cached |
| Death | 554 | 0.8 0.8–0.9ROR 0.8 · χ² 23 / p 6e-7 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.1 | no trial data cached |
| Product use issue | 511 | 3.5 3.2–3.8ROR 3.6 · χ² 906 / p 3e-199 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Insomnia (trouble sleeping) | 507 | 2.4 2.2–2.6ROR 2.5 · χ² 425 / p 1e-94 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Fatigue (tiredness) | 506 | 0.8 0.8–0.9ROR 0.8 · χ² 19 / p 8e-6 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Feeling abnormal | 481 | 2.5 2.3–2.8ROR 2.6 · χ² 453 / p 7e-101 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · 73% consumer | 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.
- Sinus rhythm — n=44, PRR 141.7
- Discoloured vomit — n=46, PRR 64.9
- Oculogyric crisis — n=77, PRR 48.2
- Social anxiety disorder — n=24, PRR 48.0
- Tongue movement disturbance — n=29, PRR 44.4
- Cogwheel rigidity — n=21, PRR 25.8
- Persecutory delusion — n=40, PRR 20.9
- Marasmus — n=23, PRR 19.7
- Parkinsonism — n=146, PRR 19.3
- Hallucination, auditory — n=232, PRR 18.8
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 Brexpiprazole?
In FDA FAERS, the most frequently co-reported reaction terms for Brexpiprazole are weight increased, akathisia, tremor, anxiety, tardive dyskinesia, 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 Brexpiprazole have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.
Do FAERS signals prove that Brexpiprazole 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 2d301358-6291-4ec1-bd87-37b4ad9bd850, effective 20260506; matched on
openfda.generic_name.exact:"BREXPIPRAZOLE") - 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, 1,026 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.