Cariprazine side effects: what 9,250 FDA adverse event reports show
Brand names
Vraylar
Who reports
9,250 reports · 36% serious · 244 with death outcome · 67% female
Used for
1 . INDICATIONS AND USAGE VRAYLAR ® is indicated for: • Treatment of schizophrenia in adult and pediatric patients 13 years of age and older • Acute treatment of manic or mixed episodes associated with bipolar I disorder.
What it is
11 . DESCRIPTION The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form.
Boxed warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS 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.
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.
- 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. 955 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 |
|---|---|---|---|---|---|---|
| Manic symptom | 14 | 211.4 122.3–365.6ROR 211.7 · χ² 2,490 / p <1e-300 | 153.3 EB05 97.0 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Neglect of personal appearance | 11 | 106.9 58.4–195.7ROR 107.0 · χ² 1,003 / p 3e-220 | 87.1 EB05 51.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Spasmodic dysphonia | 12 | 96.1 54.0–171.3ROR 96.3 · χ² 994 / p 2e-218 | 80.8 EB05 49.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Red blood cell sedimentation rate decreased | 10 | 89.4 47.5–168.2ROR 89.5 · χ² 758 / p 4e-167 | 74.3 EB05 43.1 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Akathisia (inner restlessness) | 417 | 71.4 64.9–78.5ROR 74.7 · χ² 28,001 / p <1e-300 | 69.0 EB05 63.6 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 45.2 | no trial data cached |
| Delusion of grandeur | 12 | 62.4 35.2–110.7ROR 62.5 · χ² 647 / p 6e-143 | 55.6 EB05 33.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Oculogyric crisis | 48 | 52.8 39.7–70.3ROR 53.1 · χ² 2,335 / p <1e-300 | 50.7 EB05 39.7 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=27 · ♀ 89% (drug 67%) | no trial data cached |
| Hallucination, tactile | 14 | 49.1 28.9–83.4ROR 49.2 · χ² 600 / p 1e-132 | 45.3 EB05 28.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Lactation disorder | 10 | 47.4 25.3–88.6ROR 47.4 · χ² 400 / p 3e-89 | 42.9 EB05 24.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Social anxiety disorder | 13 | 45.6 26.3–79.0ROR 45.7 · χ² 513 / p 7e-114 | 42.2 EB05 26.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Orthostatic hypertension | 10 | 39.4 21.1–73.5ROR 39.4 · χ² 331 / p 4e-74 | 36.2 EB05 21.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=9 | no trial data cached |
| Anterograde amnesia | 10 | 38.8 20.8–72.5ROR 38.8 · χ² 326 / p 4e-73 | 35.8 EB05 20.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Tongue movement disturbance | 14 | 37.6 22.2–63.7ROR 37.6 · χ² 455 / p 3e-101 | 35.3 EB05 22.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Blunted affect | 11 | 34.9 19.3–63.3ROR 35.0 · χ² 324 / p 9e-73 | 32.6 EB05 19.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 375 | 30.2 27.3–33.4ROR 31.4 · χ² 10,437 / p <1e-300 | 29.8 EB05 27.3 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 13.0 | no trial data cached |
| Schizoaffective disorder | 20 | 25.5 16.4–39.7ROR 25.6 · χ² 442 / p 2e-98 | 24.7 EB05 16.9 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 | no trial data cached |
| Pleurothotonus | 10 | 25.1 13.5–46.8ROR 25.1 · χ² 206 / p 6e-47 | 23.6 EB05 13.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hypersexuality | 20 | 25.0 16.1–38.8ROR 25.0 · χ² 432 / p 4e-96 | 24.2 EB05 16.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Blood prolactin increased | 50 | 24.2 18.3–32.0ROR 24.3 · χ² 1,079 / p 8e-237 | 23.8 EB05 18.7 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=22 | no trial data cached |
| Distributive shock | 23 | 23.8 15.8–35.9ROR 23.9 · χ² 475 / p 1e-105 | 23.2 EB05 16.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Mania | 166 | 23.1 19.9–26.9ROR 23.5 · χ² 3,457 / p <1e-300 | 22.8 EB05 20.1 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.9 | no trial data cached |
| Gambling disorder | 27 | 22.7 15.6–33.2ROR 22.8 · χ² 534 / p 2e-118 | 22.2 EB05 16.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Gambling | 11 | 21.3 11.8–38.6ROR 21.3 · χ² 191 / p 8e-44 | 20.1 EB05 11.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Psychotic symptom | 19 | 21.3 13.6–33.4ROR 21.3 · χ² 344 / p 4e-77 | 20.7 EB05 13.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Hypomania | 33 | 20.4 14.5–28.8ROR 20.5 · χ² 586 / p 1e-129 | 20.1 EB05 14.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Parkinsonism | 87 | 20.4 16.5–25.2ROR 20.6 · χ² 1,571 / p <1e-300 | 20.1 EB05 16.8 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 28.5 | no trial data cached |
| Drug dose titration not performed | 15 | 19.9 12.0–33.1ROR 19.9 · χ² 248 / p 3e-56 | 19.1 EB05 12.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Compulsive shopping | 16 | 17.6 10.8–28.8ROR 17.7 · χ² 233 / p 7e-53 | 16.9 EB05 10.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Bipolar i disorder | 16 | 16.7 10.2–27.3ROR 16.7 · χ² 219 / p 9e-50 | 15.9 EB05 9.8 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=9 | no trial data cached |
| Product administration interrupted | 56 | 16.7 12.8–21.6ROR 16.8 · χ² 803 / p 6e-177 | 16.4 EB05 13.1 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=50 | no trial data cached |
| Persecutory delusion | 18 | 16.7 10.5–26.5ROR 16.7 · χ² 248 / p 4e-56 | 16.0 EB05 10.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Extrapyramidal disorder | 183 | 16.6 14.4–19.2ROR 17.0 · χ² 2,659 / p <1e-300 | 16.5 EB05 14.6 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.7 | no trial data cached |
| Libido increased | 14 | 15.7 9.3–26.6ROR 15.7 · χ² 177 / p 9e-41 | 14.7 EB05 8.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Bruxism | 37 | 15.6 11.3–21.6ROR 15.7 · χ² 489 / p 1e-108 | 15.3 EB05 11.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Hallucination, auditory | 108 | 15.5 12.8–18.7ROR 15.6 · χ² 1,439 / p <1e-300 | 15.3 EB05 13.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 · ♀ 38% (drug 67%) | no trial data cached |
| Tachyphrenia | 23 | 15.1 10.1–22.8ROR 15.2 · χ² 288 / p 7e-65 | 14.6 EB05 9.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=7 · 74% consumer | no trial data cached |
| Bipolar disorder | 72 | 15.0 11.9–18.9ROR 15.1 · χ² 921 / p 2e-202 | 14.8 EB05 12.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.4 | no trial data cached |
| Drooling | 45 | 14.9 11.1–20.0ROR 15.0 · χ² 567 / p 1e-125 | 14.7 EB05 11.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=18 | no trial data cached |
| Impulse-control disorder | 13 | 14.4 8.3–24.8ROR 14.4 · χ² 148 / p 3e-34 | 13.1 EB05 7.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Slow speech | 15 | 14.2 8.6–23.6ROR 14.3 · χ² 171 / p 3e-39 | 13.2 EB05 7.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | 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) | 1,058 | 2.8 2.6–2.9ROR 3.0 · χ² 1,240 / p 7e-272 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Drug ineffective (drug did not work) | 534 | 0.9 0.8–1.0ROR 0.9 · χ² 4 / p 0.023 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Weight increased (weight gain) | 477 | 4.9 4.5–5.3ROR 5.1 · χ² 1,471 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.1 | no trial data cached |
| Akathisia (inner restlessness) | 417 | 71.4 64.9–78.5ROR 74.7 · χ² 28,001 / p <1e-300 | 69.0 EB05 63.6 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 45.2 | no trial data cached |
| Anxiety | 382 | 3.0 2.8–3.4ROR 3.1 · χ² 526 / p 9e-117 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 375 | 30.2 27.3–33.4ROR 31.4 · χ² 10,437 / p <1e-300 | 29.8 EB05 27.3 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 13.0 | no trial data cached |
| Nausea | 364 | 1.0 0.9–1.2ROR 1.0 · χ² 1 / p 0.201 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Tremor (shaking) | 360 | 4.9 4.4–5.4ROR 5.1 · χ² 1,125 / p 5e-247 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Fatigue (tiredness) | 353 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.297 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Insomnia (trouble sleeping) | 343 | 2.9 2.6–3.2ROR 3.0 · χ² 435 / p 7e-97 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 329 | 8.2 7.3–9.1ROR 8.4 · χ² 2,061 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 13.4 | no trial data cached |
| Dizziness | 280 | 1.3 1.1–1.4ROR 1.3 · χ² 17 / p 2e-5 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Depression | 280 | 2.8 2.5–3.1ROR 2.8 · χ² 320 / p 7e-72 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.2 | no trial data cached |
| Somnolence (drowsiness) | 247 | 2.8 2.5–3.2ROR 2.8 · χ² 283 / p 7e-64 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Feeling abnormal | 225 | 2.1 1.9–2.4ROR 2.1 · χ² 134 / p 3e-31 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled (related wording) related wording | serious PRR 2.8 · 72% 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.
- Hypersexuality — n=20, PRR 25.0
- Distributive shock — n=23, PRR 23.8
- Gambling disorder — n=27, PRR 22.7
- Hypomania — n=33, PRR 20.4
- Bruxism — n=37, PRR 15.6
- Hallucination, auditory — n=108, PRR 15.5
- Tachyphrenia — n=23, PRR 15.1
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 Cariprazine?
In FDA FAERS, the most frequently co-reported reaction terms for Cariprazine are weight increased, akathisia, anxiety, tardive dyskinesia, nausea, tremor. 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 Cariprazine 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 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.
Do FAERS signals prove that Cariprazine 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 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f, effective 20251218; matched on
openfda.generic_name.exact:"CARIPRAZINE") - 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, 995 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.