Iloperidone side effects: what 1,469 FDA adverse event reports show
Brand names
Fanapt
Who reports
1,469 reports · 49% serious · 60 with death outcome · 51% female
Used for
FANAPT ® is indicated for: Treatment of schizophrenia in adults . Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults . FANAPT is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. ( 1 , 14.2 )
What it is
FANAPT is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives.
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. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] .
Causality screen of the 35 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. 14 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 |
|---|---|---|---|---|---|---|
| Coordination abnormal | 34 | 34.6 24.8–48.3ROR 35.4 · χ² 1,074 / p 7e-236 | 33.9 EB05 25.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 54.8 · ♀ 10% (drug 51%) · 94% clinician | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 41 | 33.6 24.8–45.4ROR 34.5 · χ² 1,262 / p 1e-276 | 33.0 EB05 25.4 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 24.1 | no trial data cached |
| Akathisia (inner restlessness) | 29 | 30.4 21.2–43.6ROR 31.0 · χ² 793 / p 7e-175 | 29.8 EB05 21.7 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.1 | no trial data cached |
| Affect lability | 20 | 29.6 19.1–45.7ROR 30.0 · χ² 523 / p 5e-116 | 28.8 EB05 19.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 48.5 · 90% clinician | no trial data cached |
| Psychomotor hyperactivity | 27 | 23.1 15.9–33.6ROR 23.6 · χ² 550 / p 8e-122 | 22.8 EB05 16.4 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 38.5 · ♀ 9% (drug 51%) · 96% clinician | no trial data cached |
| Sexual dysfunction | 16 | 19.6 12.0–31.9ROR 19.8 · χ² 263 / p 2e-59 | 19.0 EB05 12.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 | no trial data cached |
| Hallucination, auditory | 21 | 18.8 12.3–28.8ROR 19.1 · χ² 337 / p 1e-75 | 18.4 EB05 12.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 | no trial data cached |
| Dystonia | 25 | 18.3 12.4–27.1ROR 18.6 · χ² 393 / p 1e-87 | 18.0 EB05 12.7 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.2 · ♀ 23% (drug 51%) | no trial data cached |
| Bipolar disorder | 14 | 18.3 10.8–30.8ROR 18.4 · χ² 211 / p 4e-48 | 17.5 EB05 10.5 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.1 | no trial data cached |
| Dyskinesia (involuntary movements) | 51 | 18.0 13.7–23.5ROR 18.6 · χ² 800 / p 2e-176 | 17.8 EB05 14.0 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 23.1 · ♀ 23% (drug 51%) | no trial data cached |
| Schizophrenia | 15 | 17.6 10.6–29.1ROR 17.8 · χ² 219 / p 9e-50 | 16.9 EB05 10.4 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.2 | no trial data cached |
| Sedation | 31 | 17.0 12.0–24.1ROR 17.3 · χ² 450 / p 3e-100 | 16.7 EB05 12.2 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.2 · 97% clinician | no trial data cached |
| Poor quality sleep | 25 | 16.7 11.3–24.6ROR 17.0 · χ² 353 / p 5e-79 | 16.3 EB05 11.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 31.8 · ♀ 9% (drug 51%) | no trial data cached |
| Psychotic disorder | 32 | 15.5 11.0–21.8ROR 15.8 · χ² 419 / p 2e-93 | 15.2 EB05 11.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.5 | no trial data cached |
| Crying | 34 | 13.3 9.5–18.6ROR 13.6 · χ² 375 / p 7e-84 | 12.9 EB05 9.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 25.9 · ♀ 10% (drug 51%) | no trial data cached |
| Mania | 15 | 13.0 7.9–21.6ROR 13.2 · χ² 155 / p 8e-36 | 11.9 EB05 7.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.1 | no trial data cached |
| Aggression | 45 | 12.8 9.6–17.1ROR 13.2 · χ² 479 / p 2e-106 | 12.5 EB05 9.6 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.9 · ♀ 7% (drug 51%) | no trial data cached |
| Mood altered | 24 | 12.6 8.5–18.7ROR 12.8 · χ² 245 / p 2e-55 | 12.0 EB05 8.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 25.3 · ♀ 5% (drug 51%) · 92% clinician | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 24 | 12.0 8.1–17.9ROR 12.2 · χ² 232 / p 1e-52 | 11.3 EB05 7.6 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.8 · ♀ 23% (drug 51%) | no trial data cached |
| Neuroleptic malignant syndrome | 10 | 12.0 6.5–22.3ROR 12.1 · χ² 90 / p 1e-21 | 9.9 EB05 5.1 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 14.2 | no trial data cached |
| Speech disorder | 41 | 11.2 8.3–15.1ROR 11.5 · χ² 370 / p 9e-83 | 10.7 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.3 · ♀ 8% (drug 51%) | no trial data cached |
| Urinary incontinence | 23 | 11.1 7.4–16.6ROR 11.2 · χ² 201 / p 6e-46 | 10.3 EB05 6.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 · ♀ 78% (drug 51%) | no trial data cached |
| Electrocardiogram qt prolonged | 26 | 10.3 7.0–15.1ROR 10.5 · χ² 210 / p 8e-48 | 9.5 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 11.9 · 92% clinician | no trial data cached |
| Paranoia | 12 | 9.9 5.6–17.4ROR 10.0 · χ² 87 / p 5e-21 | 8.1 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Extrapyramidal disorder | 16 | 9.1 5.6–14.8ROR 9.2 · χ² 108 / p 2e-25 | 7.8 EB05 4.9 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 | no trial data cached |
| Bacterial infection | 11 | 8.5 4.7–15.2ROR 8.5 · χ² 65 / p 4e-16 | 6.7 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Increased appetite | 11 | 8.4 4.6–15.1ROR 8.4 · χ² 64 / p 6e-16 | 6.6 EB05 3.8 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Swollen tongue | 17 | 7.8 4.8–12.5ROR 7.8 · χ² 94 / p 2e-22 | 6.7 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 48 | 7.5 5.7–9.9ROR 7.7 · χ² 264 / p 1e-59 | 7.1 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 12% (drug 51%) | no trial data cached |
| Irritability | 30 | 7.1 5.0–10.1ROR 7.2 · χ² 152 / p 4e-35 | 6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 4% (drug 51%) | no trial data cached |
| Erectile dysfunction | 12 | 6.6 3.8–11.7ROR 6.7 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Depressed mood | 24 | 6.5 4.4–9.7ROR 6.6 · χ² 107 / p 3e-25 | 5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · ♀ 10% (drug 51%) | no trial data cached |
| Abnormal behaviour | 18 | 6.4 4.1–10.2ROR 6.5 · χ² 77 / p 7e-19 | 5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Nervousness | 23 | 6.2 4.2–9.4ROR 6.3 · χ² 96 / p 5e-23 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 10% (drug 51%) | no trial data cached |
| Eye disorder | 12 | 5.2 3.0–9.2ROR 5.3 · χ² 37 / p 6e-10 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 | 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 |
|---|---|---|---|---|---|---|
| Dyskinesia (involuntary movements) | 51 | 18.0 13.7–23.5ROR 18.6 · χ² 800 / p 2e-176 | 17.8 EB05 14.0 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 23.1 · ♀ 23% (drug 51%) | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 48 | 7.5 5.7–9.9ROR 7.7 · χ² 264 / p 1e-59 | 7.1 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 12% (drug 51%) | no trial data cached |
| Aggression | 45 | 12.8 9.6–17.1ROR 13.2 · χ² 479 / p 2e-106 | 12.5 EB05 9.6 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.9 · ♀ 7% (drug 51%) | no trial data cached |
| Speech disorder | 41 | 11.2 8.3–15.1ROR 11.5 · χ² 370 / p 9e-83 | 10.7 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.3 · ♀ 8% (drug 51%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 41 | 33.6 24.8–45.4ROR 34.5 · χ² 1,262 / p 1e-276 | 33.0 EB05 25.4 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 24.1 | no trial data cached |
| Crying | 34 | 13.3 9.5–18.6ROR 13.6 · χ² 375 / p 7e-84 | 12.9 EB05 9.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 25.9 · ♀ 10% (drug 51%) | no trial data cached |
| Coordination abnormal | 34 | 34.6 24.8–48.3ROR 35.4 · χ² 1,074 / p 7e-236 | 33.9 EB05 25.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 54.8 · ♀ 10% (drug 51%) · 94% clinician | no trial data cached |
| Psychotic disorder | 32 | 15.5 11.0–21.8ROR 15.8 · χ² 419 / p 2e-93 | 15.2 EB05 11.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.5 | no trial data cached |
| Sedation | 31 | 17.0 12.0–24.1ROR 17.3 · χ² 450 / p 3e-100 | 16.7 EB05 12.2 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.2 · 97% clinician | no trial data cached |
| Irritability | 30 | 7.1 5.0–10.1ROR 7.2 · χ² 152 / p 4e-35 | 6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 4% (drug 51%) | no trial data cached |
| Akathisia (inner restlessness) | 29 | 30.4 21.2–43.6ROR 31.0 · χ² 793 / p 7e-175 | 29.8 EB05 21.7 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.1 | no trial data cached |
| Psychomotor hyperactivity | 27 | 23.1 15.9–33.6ROR 23.6 · χ² 550 / p 8e-122 | 22.8 EB05 16.4 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 38.5 · ♀ 9% (drug 51%) · 96% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 26 | 10.3 7.0–15.1ROR 10.5 · χ² 210 / p 8e-48 | 9.5 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 11.9 · 92% clinician | no trial data cached |
| Poor quality sleep | 25 | 16.7 11.3–24.6ROR 17.0 · χ² 353 / p 5e-79 | 16.3 EB05 11.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 31.8 · ♀ 9% (drug 51%) | no trial data cached |
| Dystonia | 25 | 18.3 12.4–27.1ROR 18.6 · χ² 393 / p 1e-87 | 18.0 EB05 12.7 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.2 · ♀ 23% (drug 51%) | 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.
- Coordination abnormal — n=34, PRR 34.6
- Affect lability — n=20, PRR 29.6
- Hallucination, auditory — n=21, PRR 18.8
- Crying — n=34, PRR 13.3
- Speech disorder — n=41, PRR 11.2
- Suicidal ideation — n=48, PRR 7.5
- Irritability — n=30, PRR 7.1
- Depressed mood — n=24, PRR 6.5
- Nervousness — n=23, PRR 6.2
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 Iloperidone?
In FDA FAERS, the most frequently co-reported reaction terms for Iloperidone are dyskinesia, suicidal ideation, aggression, speech disorder, orthostatic hypotension, crying. 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 Iloperidone 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. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] .
Do FAERS signals prove that Iloperidone 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 33f60b40-3fca-11de-8f56-0002a5d5c51b, effective 20260506; matched on
openfda.generic_name.exact:"ILOPERIDONE") - 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, 49 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.