Fluphenazine Decanoate side effects: what 432 FDA adverse event reports show

Fluphenazine Decanoate · 30 reaction terms · 485 drug–reaction co-reports · data 2026-09-14

Drug class

Long-acting parenteral antipsychotic drug intended

FDA label, Indications wording

Who reports

432 reports · 86% serious · 47 with death outcome · 37% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics). Fluphenazine Decanoate Injection 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 decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. Fluphenazine Decanoate is 2-4-[3-(2-trifluoromethylphenothiazin-10-yl)-propyl]-piperazin-1 -yl]ethyl decanoate. It is a highly potent behavior modifier with a markedly extended duration of effect.

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 20 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 5Labeled (related wording) 1Likely indication confounding 3Not in label — unassessed 10

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.
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. 10 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
Neuroleptic malignant syndrome	42	172.0 129.0–229.4ROR 190.5 · χ² 6,951 / p <1e-300	159.1 EB05 122.7 · IC025 +5.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 115.8 · 95% clinician	no trial data cached
Parkinsonism	31	154.8 110.2–217.4ROR 166.7 · χ² 4,571 / p <1e-300	141.1 EB05 104.1 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 116.1	no trial data cached
Akathisia (inner restlessness)	32	114.1 81.7–159.3ROR 123.1 · χ² 3,468 / p <1e-300	106.7 EB05 79.1 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 95.4	no trial data cached
Hypercholesterolaemia	21	106.8 70.3–162.1ROR 112.2 · χ² 2,092 / p <1e-300	97.3 EB05 67.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 61.6	no trial data cached
Delusion	25	78.5 53.6–114.8ROR 83.2 · χ² 1,834 / p <1e-300	74.1 EB05 52.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 63.5	no trial data cached
Sedation	38	70.9 52.3–96.0ROR 77.6 · χ² 2,547 / p <1e-300	68.4 EB05 52.0 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 55.2	no trial data cached
Dystonia	26	64.9 44.7–94.3ROR 69.0 · χ² 1,572 / p <1e-300	62.0 EB05 44.5 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 48.1	no trial data cached
Schizophrenia	16	63.9 39.5–103.4ROR 66.4 · χ² 929 / p 3e-204	59.5 EB05 38.9 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 38.9	no trial data cached
Inappropriate antidiuretic hormone secretion	11	52.5 29.3–94.1ROR 53.9 · χ² 505 / p 4e-112	48.3 EB05 28.8 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 35.6	no trial data cached
Sexual dysfunction	12	49.9 28.6–87.3ROR 51.3 · χ² 527 / p 6e-117	46.5 EB05 28.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 45.8	no trial data cached
Salivary hypersecretion	10	48.6 26.3–89.8ROR 49.8 · χ² 420 / p 1e-93	44.7 EB05 26.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 44.3	no trial data cached
Extrapyramidal disorder	21	40.7 26.8–61.7ROR 42.7 · χ² 774 / p 1e-170	39.3 EB05 27.1 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 30.4	no trial data cached
Apathy	11	36.8 20.5–65.9ROR 37.7 · χ² 348 / p 6e-78	34.7 EB05 20.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 35.7	no trial data cached
Abnormal behaviour	24	29.2 19.8–43.1ROR 30.9 · χ² 627 / p 1e-138	28.6 EB05 20.2 · IC025 +3.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 23.7	no trial data cached
Dyskinesia (involuntary movements)	23	27.5 18.5–41.0ROR 29.0 · χ² 563 / p 1e-124	27.0 EB05 18.9 · IC025 +3.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 25.2 · ♀ 15% (drug 37%)	no trial data cached
Psychotic disorder	14	23.0 13.7–38.5ROR 23.8 · χ² 273 / p 1e-61	22.3 EB05 13.9 · IC025 +2.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 12.0	no trial data cached
Gynaecomastia (male breast enlargement)	14	21.7 13.0–36.4ROR 22.4 · χ² 257 / p 5e-58	21.0 EB05 13.0 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 43.7	no trial data cached
Aggression	21	20.3 13.4–30.9ROR 21.3 · χ² 368 / p 3e-82	19.9 EB05 13.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 16.3	no trial data cached
Rhabdomyolysis (muscle breakdown)	17	19.8 12.4–31.6ROR 20.6 · χ² 286 / p 2e-64	19.3 EB05 12.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Suicide attempt	20	16.0 10.4–24.5ROR 16.7 · χ² 267 / p 3e-60	15.5 EB05 10.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.8 · 70% consumer	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
Neuroleptic malignant syndrome	42	172.0 129.0–229.4ROR 190.5 · χ² 6,951 / p <1e-300	159.1 EB05 122.7 · IC025 +5.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 115.8 · 95% clinician	no trial data cached
Sedation	38	70.9 52.3–96.0ROR 77.6 · χ² 2,547 / p <1e-300	68.4 EB05 52.0 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 55.2	no trial data cached
Akathisia (inner restlessness)	32	114.1 81.7–159.3ROR 123.1 · χ² 3,468 / p <1e-300	106.7 EB05 79.1 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 95.4	no trial data cached
Parkinsonism	31	154.8 110.2–217.4ROR 166.7 · χ² 4,571 / p <1e-300	141.1 EB05 104.1 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 116.1	no trial data cached
Dystonia	26	64.9 44.7–94.3ROR 69.0 · χ² 1,572 / p <1e-300	62.0 EB05 44.5 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 48.1	no trial data cached
Delusion	25	78.5 53.6–114.8ROR 83.2 · χ² 1,834 / p <1e-300	74.1 EB05 52.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 63.5	no trial data cached
Abnormal behaviour	24	29.2 19.8–43.1ROR 30.9 · χ² 627 / p 1e-138	28.6 EB05 20.2 · IC025 +3.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 23.7	no trial data cached
Dyskinesia (involuntary movements)	23	27.5 18.5–41.0ROR 29.0 · χ² 563 / p 1e-124	27.0 EB05 18.9 · IC025 +3.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 25.2 · ♀ 15% (drug 37%)	no trial data cached
Aggression	21	20.3 13.4–30.9ROR 21.3 · χ² 368 / p 3e-82	19.9 EB05 13.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 16.3	no trial data cached
Extrapyramidal disorder	21	40.7 26.8–61.7ROR 42.7 · χ² 774 / p 1e-170	39.3 EB05 27.1 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 30.4	no trial data cached
Hypercholesterolaemia	21	106.8 70.3–162.1ROR 112.2 · χ² 2,092 / p <1e-300	97.3 EB05 67.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 61.6	no trial data cached
Suicide attempt	20	16.0 10.4–24.5ROR 16.7 · χ² 267 / p 3e-60	15.5 EB05 10.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.8 · 70% consumer	no trial data cached
Rhabdomyolysis (muscle breakdown)	17	19.8 12.4–31.6ROR 20.6 · χ² 286 / p 2e-64	19.3 EB05 12.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Schizophrenia	16	63.9 39.5–103.4ROR 66.4 · χ² 929 / p 3e-204	59.5 EB05 38.9 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 38.9	no trial data cached
Gynaecomastia (male breast enlargement)	14	21.7 13.0–36.4ROR 22.4 · χ² 257 / p 5e-58	21.0 EB05 13.0 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 43.7	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.

Hypercholesterolaemia — n=21, PRR 106.8
Delusion — n=25, PRR 78.5
Sedation — n=38, PRR 70.9
Aggression — n=21, PRR 20.3
Suicide attempt — n=20, PRR 16.0

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 Decanoate?

In FDA FAERS, the most frequently co-reported reaction terms for Fluphenazine Decanoate are neuroleptic malignant syndrome, sedation, akathisia, parkinsonism, dystonia, delusion. 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 Decanoate 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 Decanoate 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 3832d3d3-15ce-4d41-8431-11e9bd04cf4d, effective 20241114; matched on openfda.generic_name.exact:"FLUPHENAZINE DECANOATE")
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, 30 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.