Paliperidone side effects: what 23,177 FDA adverse event reports show

Paliperidone · 1,042 reaction terms · 70,680 drug–reaction co-reports · data 2026-09-14

Drug class

Atypical Antipsychotic

FDA label (Established Pharmacologic Class) · compare the class

Who reports

23,177 reports · 49% serious · 827 with death outcome · 32% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1 ) Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1 ) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.

FDA label, Indications and Usage

What it is

Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone.

FDA label, Description section

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. Paliperidone Extended-Release Tablets are not approved for the treatment of patients with dementia-related psychosis.

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 2Labeled adverse reaction 6Labeled (related wording) 3Likely indication confounding 5Reporting / coding artifact 2Lab value / disease marker 6Not in label — unassessed 16

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. 1,002 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Ovarian germ cell cancer stage ii	10	4,457.3 976.7–20,342.3ROR 4,459.2 · χ² 6,701 / p <1e-300	307.0 EB05 178.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Anosognosia	390	934.6 811.3–1,076.6ROR 950.6 · χ² 177,112 / p <1e-300	446.7 EB05 410.7 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious n=382 · ♀ 80% (drug 32%)	not reported in cached trials
Blood prolactin abnormal	414	825.7 722.8–943.2ROR 840.6 · χ² 176,610 / p <1e-300	420.8 EB05 387.8 · IC025 +8.0 3/3 methods agree	Lab value / disease marker	serious n=390 · ♀ 82% (drug 32%)	not reported in cached trials
Hyperprolactinaemia (high prolactin hormone)	1,268	219.5 206.7–233.1ROR 232.2 · χ² 221,226 / p <1e-300	175.9 EB05 167.9 · IC025 +7.3 3/3 methods agree	Labeled — boxed warning exact term	serious n=378 · ♀ 10% (drug 32%) · 82% consumer	not reported in cached trials
Personality change due to a general medical condition	24	214.0 137.1–334.0ROR 214.2 · χ² 3,932 / p <1e-300	152.1 EB05 107.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 100% (drug 32%) · 100% clinician	not reported in cached trials
Disturbance in social behaviour	391	179.1 160.8–199.5ROR 182.2 · χ² 57,526 / p <1e-300	148.2 EB05 136.3 · IC025 +6.8 3/3 methods agree	Reporting / coding artifact	serious n=376 · ♀ 80% (drug 32%)	not reported in cached trials
Galactorrhoea	1,057	176.4 165.4–188.2ROR 184.8 · χ² 153,813 / p <1e-300	147.1 EB05 139.8 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious n=186 · 73% consumer	not reported in cached trials
Metamyelocyte count increased	21	147.4 92.9–233.9ROR 147.5 · χ² 2,496 / p <1e-300	113.8 EB05 78.5 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=21	not reported in cached trials
Abnormal weight gain	1,660	138.9 132.1–146.0ROR 149.5 · χ² 196,593 / p <1e-300	120.1 EB05 115.4 · IC025 +6.8 3/3 methods agree	Labeled (related wording) related wording	serious n=232 · ♀ 0% (drug 32%) · 98% consumer	not reported in cached trials
Gynaecomastia (male breast enlargement)	3,665	120.0 116.2–123.9ROR 142.3 · χ² 381,614 / p <1e-300	105.8 EB05 103.0 · IC025 +6.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 98.4 · ♀ 0% (drug 32%) · 92% consumer	not reported in cached trials
Myelocyte count increased	22	119.6 76.6–186.6ROR 119.7 · χ² 2,178 / p <1e-300	96.9 EB05 67.5 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=22	not reported in cached trials
Schizoaffective disorder bipolar type	21	90.4 57.7–141.7ROR 90.5 · χ² 1,606 / p <1e-300	76.7 EB05 52.9 · IC025 +4.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=20 · ♀ 55% (drug 32%)	not reported in cached trials
Blood prolactin increased	394	82.3 74.3–91.1ROR 83.7 · χ² 28,886 / p <1e-300	75.1 EB05 69.1 · IC025 +5.9 3/3 methods agree	Lab value / disease marker	serious n=162 · ♀ 58% (drug 32%)	not reported in cached trials
Jaw clicking	15	73.5 43.4–124.4ROR 73.5 · χ² 925 / p 2e-203	62.8 EB05 40.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Metabolic disorder	393	65.7 59.3–72.7ROR 66.8 · χ² 23,253 / p <1e-300	61.0 EB05 56.1 · IC025 +5.7 3/3 methods agree	Labeled (related wording) related wording	serious n=384 · ♀ 81% (drug 32%)	not reported in cached trials
Illiteracy	11	63.3 34.3–116.6ROR 63.3 · χ² 573 / p 8e-127	53.9 EB05 32.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Injury	4,329	59.0 57.4–60.7ROR 72.3 · χ² 232,248 / p <1e-300	55.4 EB05 54.0 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 0.5 · ♀ 1% (drug 32%) · 100% consumer	not reported in cached trials
Schizophrenia	669	52.6 48.7–56.8ROR 54.2 · χ² 31,959 / p <1e-300	49.7 EB05 46.6 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 59.1 · ♀ 52% (drug 32%)	NCT00589914: 15/606 (2.5%) on Paliperidone (serious AE)
Schizoaffective disorder	93	49.4 40.1–60.9ROR 49.6 · χ² 4,136 / p <1e-300	46.5 EB05 39.1 · IC025 +4.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=93 · ♀ 61% (drug 32%)	NCT01662648: 1/587 (0.2%) on Paliperidone (serious AE)
Hypometabolism	18	44.8 27.9–72.0ROR 44.9 · χ² 693 / p 5e-153	41.0 EB05 27.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Breast discharge	79	42.7 34.1–53.5ROR 42.8 · χ² 3,029 / p <1e-300	40.4 EB05 33.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=26 · ♀ 75% (drug 32%)	not reported in cached trials
Schizophreniform disorder	11	42.5 23.2–77.7ROR 42.5 · χ² 386 / p 3e-86	38.1 EB05 22.7 · IC025 +2.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=10	not reported in cached trials
Sexual dysfunction	484	39.1 35.7–42.8ROR 39.9 · χ² 17,179 / p <1e-300	37.4 EB05 34.7 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 60.7 · ♀ 69% (drug 32%)	not reported in cached trials
Self injurious behaviour	126	38.4 32.1–45.8ROR 38.6 · χ² 4,361 / p <1e-300	36.6 EB05 31.6 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=126	not reported in cached trials
Personality change	352	35.4 31.8–39.3ROR 35.9 · χ² 11,274 / p <1e-300	34.0 EB05 31.1 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 52.9 · ♀ 85% (drug 32%)	not reported in cached trials
Dystonia	711	34.3 31.8–36.9ROR 35.3 · χ² 22,100 / p <1e-300	33.0 EB05 31.0 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 37.9 · ♀ 63% (drug 32%)	NCT01662648: 1/512 (0.2%) on Paliperidone (serious AE)
Sedation complication	91	34.1 27.7–42.1ROR 34.3 · χ² 2,787 / p <1e-300	32.7 EB05 27.4 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious n=78	not reported in cached trials
Psychotic symptom	69	31.6 24.9–40.2ROR 31.7 · χ² 1,948 / p <1e-300	30.4 EB05 24.8 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious n=69	not reported in cached trials
Water intoxication	17	31.1 19.2–50.5ROR 31.1 · χ² 450 / p 3e-100	29.2 EB05 19.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Schizophrenia, paranoid type	12	30.7 17.3–54.6ROR 30.8 · χ² 306 / p 1e-68	28.5 EB05 17.3 · IC025 +2.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=11	NCT00589914: 1/606 (0.2%) on Paliperidone (serious AE)
Hypoaesthesia eye	19	30.3 19.2–47.9ROR 30.3 · χ² 493 / p 2e-109	28.6 EB05 19.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Obesity	514	30.1 27.6–32.8ROR 30.7 · χ² 13,961 / p <1e-300	29.1 EB05 27.1 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 30.7 · ♀ 5% (drug 32%) · 81% consumer	not reported in cached trials
Sedation	753	26.9 25.0–28.9ROR 27.7 · χ² 18,209 / p <1e-300	26.1 EB05 24.6 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 34.9 · ♀ 59% (drug 32%)	not reported in cached trials
Akathisia (inner restlessness)	392	26.7 24.2–29.5ROR 27.2 · χ² 9,404 / p <1e-300	25.9 EB05 23.9 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 30.8	NCT01662648: 1/587 (0.2%) on Paliperidone (serious AE)
Antipsychotic drug level decreased	15	26.2 15.7–43.8ROR 26.2 · χ² 329 / p 7e-74	24.8 EB05 15.8 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious n=15	not reported in cached trials
Housebound	11	25.8 14.2–47.0ROR 25.8 · χ² 231 / p 2e-52	24.0 EB05 14.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Oculogyric crisis	55	24.2 18.5–31.7ROR 24.3 · χ² 1,170 / p 8e-257	23.5 EB05 18.7 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious n=54 · ♀ 70% (drug 32%)	not reported in cached trials
Apraxia	38	23.7 17.2–32.8ROR 23.8 · χ² 784 / p 7e-173	22.9 EB05 17.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=38 · ♀ 100% (drug 32%) · 100% clinician	not reported in cached trials
Blood osmolarity decreased	16	23.5 14.3–38.5ROR 23.5 · χ² 314 / p 2e-70	22.3 EB05 14.4 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious n=16	not reported in cached trials
Neuroleptic malignant syndrome	289	22.5 20.0–25.3ROR 22.8 · χ² 5,775 / p <1e-300	21.9 EB05 19.9 · IC025 +4.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 25.7 · 90% clinician	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Paliperidone as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (5 of 40 signal terms matched).

NCT00589914 — Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia (N=1221, PHASE3; 29 AE terms posted; arms: R092670; RISPERDAL CONSTA)
NCT01662648 — Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophren (N=1117, PHASE3; 74 AE terms posted; arms: Paliperidone ER: Lack of Efficacy; Paliperidone ER: Lack of Tolerability, C)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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
Injury	4,329	59.0 57.4–60.7ROR 72.3 · χ² 232,248 / p <1e-300	55.4 EB05 54.0 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 0.5 · ♀ 1% (drug 32%) · 100% consumer	not reported in cached trials
Gynaecomastia (male breast enlargement)	3,665	120.0 116.2–123.9ROR 142.3 · χ² 381,614 / p <1e-300	105.8 EB05 103.0 · IC025 +6.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 98.4 · ♀ 0% (drug 32%) · 92% consumer	not reported in cached trials
Drug ineffective (drug did not work)	1,774	1.2 1.2–1.3ROR 1.2 · χ² 74 / p 4e-18	1.2 EB05 1.2 · IC025 +0.2	Reporting / coding artifact	serious PRR 2.9	not reported in cached trials
Abnormal weight gain	1,660	138.9 132.1–146.0ROR 149.5 · χ² 196,593 / p <1e-300	120.1 EB05 115.4 · IC025 +6.8 3/3 methods agree	Labeled (related wording) related wording	serious n=232 · ♀ 0% (drug 32%) · 98% consumer	not reported in cached trials
Off label use (used outside approved label)	1,546	1.6 1.5–1.7ROR 1.7 · χ² 374 / p 2e-83	1.6 EB05 1.5 · IC025 +0.6	Reporting / coding artifact	serious PRR 1.7	not reported in cached trials
Weight increased (weight gain)	1,380	5.6 5.3–5.9ROR 5.9 · χ² 5,275 / p <1e-300	5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 6.5	NCT01662648: 1/512 (0.2%) on Paliperidone (serious AE)
Hyperprolactinaemia (high prolactin hormone)	1,268	219.5 206.7–233.1ROR 232.2 · χ² 221,226 / p <1e-300	175.9 EB05 167.9 · IC025 +7.3 3/3 methods agree	Labeled — boxed warning exact term	serious n=378 · ♀ 10% (drug 32%) · 82% consumer	not reported in cached trials
Galactorrhoea	1,057	176.4 165.4–188.2ROR 184.8 · χ² 153,813 / p <1e-300	147.1 EB05 139.8 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious n=186 · 73% consumer	not reported in cached trials
Sedation	753	26.9 25.0–28.9ROR 27.7 · χ² 18,209 / p <1e-300	26.1 EB05 24.6 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 34.9 · ♀ 59% (drug 32%)	not reported in cached trials
Dystonia	711	34.3 31.8–36.9ROR 35.3 · χ² 22,100 / p <1e-300	33.0 EB05 31.0 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 37.9 · ♀ 63% (drug 32%)	NCT01662648: 1/512 (0.2%) on Paliperidone (serious AE)
Dyskinesia (involuntary movements)	708	16.1 14.9–17.3ROR 16.5 · χ² 9,821 / p <1e-300	15.8 EB05 14.8 · IC025 +3.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 22.5 · ♀ 71% (drug 32%)	NCT01662648: 1/512 (0.2%) on Paliperidone (serious AE)
Treatment noncompliance	676	11.4 10.6–12.3ROR 11.7 · χ² 6,327 / p <1e-300	11.2 EB05 10.5 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 13.3	not reported in cached trials
Suicide attempt	670	10.1 9.3–10.9ROR 10.3 · χ² 5,421 / p <1e-300	9.9 EB05 9.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.7 · ♀ 69% (drug 32%)	NCT00589914: 1/608 (0.2%) on Paliperidone (serious AE)
Schizophrenia	669	52.6 48.7–56.8ROR 54.2 · χ² 31,959 / p <1e-300	49.7 EB05 46.6 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 59.1 · ♀ 52% (drug 32%)	NCT00589914: 15/606 (2.5%) on Paliperidone (serious AE)
Product use in unapproved indication	623	2.3 2.1–2.5ROR 2.3 · χ² 466 / p 1e-103	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.4 · 71% consumer	not reported in cached trials

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.

Anosognosia — n=390, PRR 934.6
Personality change due to a general medical condition — n=24, PRR 214.0
Galactorrhoea — n=1,057, PRR 176.4
Injury — n=4,329, PRR 59.0
Breast discharge — n=79, PRR 42.7
Sexual dysfunction — n=484, PRR 39.1
Self injurious behaviour — n=126, PRR 38.4
Personality change — n=352, PRR 35.4
Apraxia — n=38, PRR 23.7

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 Paliperidone?

In FDA FAERS, the most frequently co-reported reaction terms for Paliperidone are injury, gynaecomastia, abnormal weight gain, weight increased, hyperprolactinaemia, galactorrhoea. 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 Paliperidone 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. Paliperidone Extended-Release Tablets are not approved for the treatment of patients with dementia-related psychosis.

Do FAERS signals prove that Paliperidone 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 1745a460-5e3a-4a1f-8eb3-64bb112f47a4, effective 20260430; matched on openfda.generic_name.exact:"PALIPERIDONE")
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, field patient.drug.openfda.generic_name.exact, 1,042 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
ClinicalTrials.gov API v2 (query PALIPERIDONE, results-bearing studies sorted by enrollment)

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.