Drug · FAERS side-effect profile with label screen

Fluphenazine side effects: what 112 FDA adverse event reports show

Fluphenazine Hydrochloride · 8 reaction terms · 83 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Fluphenazine Hydrochloride (Fluphenazine Hydrochloride)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

112 reports · 79% serious · 9 with death outcome · 51% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.

FDA label, Indications and Usage

What it is

DESCRIPTION Fluphenazine hydrochloride, USP is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride.

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. Analyses of seventeen plac.

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 8 strongest signals

Labeled adverse reaction 3Not in label — unassessed 5

What the badges mean

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.
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. 0 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
Parkinsonism	10	192.2 106.3–347.3ROR 210.9 · χ² 1,714 / p <1e-300	141.0 EB05 81.9 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 160.9	no trial data cached
Schizophrenia	11	169.5 96.7–297.1ROR 187.8 · χ² 1,677 / p <1e-300	131.3 EB05 78.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 115.6	no trial data cached
Hypercholesterolaemia	7	137.1 66.9–280.9ROR 146.1 · χ² 814 / p 2e-179	100.4 EB05 52.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 105.5	no trial data cached
Sedation	19	136.5 90.6–205.7ROR 164.2 · χ² 2,424 / p <1e-300	120.2 EB05 81.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 121.9	no trial data cached
Akathisia (inner restlessness)	8	109.8 56.3–214.1ROR 118.2 · χ² 757 / p 6e-167	87.5 EB05 47.5 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 99.1	no trial data cached
Thinking abnormal	9	90.0 48.1–168.4ROR 97.8 · χ² 706 / p 8e-156	76.0 EB05 42.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 101.9	no trial data cached
Dystonia	7	67.4 32.9–138.0ROR 71.8 · χ² 394 / p 6e-88	57.4 EB05 29.8 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 53.9	no trial data cached
Suicide attempt	12	37.0 21.7–63.1ROR 41.3 · χ² 386 / p 3e-86	35.1 EB05 21.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 26.8	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Sedation	19	136.5 90.6–205.7ROR 164.2 · χ² 2,424 / p <1e-300	120.2 EB05 81.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 121.9	no trial data cached
Suicide attempt	12	37.0 21.7–63.1ROR 41.3 · χ² 386 / p 3e-86	35.1 EB05 21.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 26.8	no trial data cached
Schizophrenia	11	169.5 96.7–297.1ROR 187.8 · χ² 1,677 / p <1e-300	131.3 EB05 78.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 115.6	no trial data cached
Parkinsonism	10	192.2 106.3–347.3ROR 210.9 · χ² 1,714 / p <1e-300	141.0 EB05 81.9 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 160.9	no trial data cached
Thinking abnormal	9	90.0 48.1–168.4ROR 97.8 · χ² 706 / p 8e-156	76.0 EB05 42.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 101.9	no trial data cached
Akathisia (inner restlessness)	8	109.8 56.3–214.1ROR 118.2 · χ² 757 / p 6e-167	87.5 EB05 47.5 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 99.1	no trial data cached
Dystonia	7	67.4 32.9–138.0ROR 71.8 · χ² 394 / p 6e-88	57.4 EB05 29.8 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 53.9	no trial data cached
Hypercholesterolaemia	7	137.1 66.9–280.9ROR 146.1 · χ² 814 / p 2e-179	100.4 EB05 52.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 105.5	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Fluphenazine?

In FDA FAERS, the most frequently co-reported reaction terms for Fluphenazine are sedation, suicide attempt, schizophrenia, parkinsonism, thinking abnormal, akathisia. 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 Fluphenazine 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. Analyses of seventeen plac.

Do FAERS signals prove that Fluphenazine 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 1991be2c-9629-4c3e-93f0-e40bcffc82b0, effective 20241115; matched on openfda.generic_name.exact:"FLUPHENAZINE HYDROCHLORIDE")
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, 8 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.