Prochlorperazine Edisylate side effects: what 1,194 FDA adverse event reports show

Prochlorperazine Edisylate · 16 reaction terms · 172 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

1,194 reports · 71% serious · 161 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

To control severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine 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 Prochlorperazine edisylate, 2-Chloro-10-[3-(4-methyl-1-piperazinyl) propyl]phenothiazine 1,2-ethanedisulfonate (1:1), has the following structural formula:

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 place.

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 13 strongest signals

Labeled adverse reaction 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 10

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.
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. 3 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
Small intestinal obstruction	15	21.5 13.0–35.5ROR 21.8 · χ² 273 / p 1e-61	20.8 EB05 13.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 17.6	no trial data cached
Anorexia	11	14.8 8.2–26.6ROR 14.9 · χ² 128 / p 6e-30	13.3 EB05 6.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Cytokine release syndrome	12	11.1 6.3–19.4ROR 11.2 · χ² 100 / p 7e-24	9.3 EB05 5.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Taste disorder	12	10.5 6.0–18.5ROR 10.6 · χ² 94 / p 1e-22	8.8 EB05 4.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.9	no trial data cached
Cholecystitis	7	10.3 4.9–21.7ROR 10.4 · χ² 50 / p 7e-13	7.5 EB05 3.5 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Full blood count abnormal	5	8.3 3.5–20.0ROR 8.4 · χ² 25 / p 2e-7	5.3 EB05 2.4 · IC025 +0.8 3/3 methods agree	Lab value / disease marker	serious PRR 1.8	no trial data cached
Febrile neutropenia	30	8.0 5.6–11.3ROR 8.1 · χ² 176 / p 2e-40	7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.5	no trial data cached
Neurotoxicity	7	7.1 3.4–14.8ROR 7.1 · χ² 31 / p 1e-8	5.1 EB05 2.6 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Dystonia	7	6.3 3.0–13.2ROR 6.3 · χ² 26 / p 1e-7	4.7 EB05 2.4 · IC025 +0.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.7	no trial data cached
Malignant neoplasm progression	33	5.7 4.1–8.0ROR 5.8 · χ² 124 / p 5e-29	5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 4.4	no trial data cached
Neoplasm progression	10	5.0 2.7–9.3ROR 5.0 · χ² 28 / p 5e-8	4.2 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Plasma cell myeloma	8	3.6 1.8–7.2ROR 3.6 · χ² 13 / p 2e-4	3.1 EB05 1.7 · IC025 +0.4	Not in label — unassessed	serious PRR 2.0	no trial data cached
Premature baby	6	3.5 1.6–7.8ROR 3.5 · χ² 8 / p 0.002	2.9 EB05 1.5 · IC025 +0.1	Not in label — unassessed	serious PRR 2.9	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
Malignant neoplasm progression	33	5.7 4.1–8.0ROR 5.8 · χ² 124 / p 5e-29	5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 4.4	no trial data cached
Febrile neutropenia	30	8.0 5.6–11.3ROR 8.1 · χ² 176 / p 2e-40	7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.5	no trial data cached
Small intestinal obstruction	15	21.5 13.0–35.5ROR 21.8 · χ² 273 / p 1e-61	20.8 EB05 13.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 17.6	no trial data cached
Taste disorder	12	10.5 6.0–18.5ROR 10.6 · χ² 94 / p 1e-22	8.8 EB05 4.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.9	no trial data cached
Cytokine release syndrome	12	11.1 6.3–19.4ROR 11.2 · χ² 100 / p 7e-24	9.3 EB05 5.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Anorexia	11	14.8 8.2–26.6ROR 14.9 · χ² 128 / p 6e-30	13.3 EB05 6.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Neoplasm progression	10	5.0 2.7–9.3ROR 5.0 · χ² 28 / p 5e-8	4.2 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Plasma cell myeloma	8	3.6 1.8–7.2ROR 3.6 · χ² 13 / p 2e-4	3.1 EB05 1.7 · IC025 +0.4	Not in label — unassessed	serious PRR 2.0	no trial data cached
Dystonia	7	6.3 3.0–13.2ROR 6.3 · χ² 26 / p 1e-7	4.7 EB05 2.4 · IC025 +0.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.7	no trial data cached
Neurotoxicity	7	7.1 3.4–14.8ROR 7.1 · χ² 31 / p 1e-8	5.1 EB05 2.6 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Cholecystitis	7	10.3 4.9–21.7ROR 10.4 · χ² 50 / p 7e-13	7.5 EB05 3.5 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Premature baby	6	3.5 1.6–7.8ROR 3.5 · χ² 8 / p 0.002	2.9 EB05 1.5 · IC025 +0.1	Not in label — unassessed	serious PRR 2.9	no trial data cached
Full blood count abnormal	5	8.3 3.5–20.0ROR 8.4 · χ² 25 / p 2e-7	5.3 EB05 2.4 · IC025 +0.8 3/3 methods agree	Lab value / disease marker	serious PRR 1.8	no trial data cached
Tardive dyskinesia (persistent involuntary movements)	3	1.8 0.6–5.7ROR 1.9 · χ² 0 / p 0.245	1.7 EB05 0.7 · IC025 -1.3 PRR-only: not supported by EBGM or IC	Labeled — boxed warning exact term	serious PRR 1.8	no trial data cached
Extrapyramidal disorder	3	2.1 0.7–6.5ROR 2.1 · χ² 1 / p 0.185	1.9 EB05 0.8 · IC025 -1.2 PRR-only: not supported by EBGM or IC	Labeled (related wording) related wording	serious PRR 1.9	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.

Febrile neutropenia — n=30, PRR 8.0

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 Prochlorperazine Edisylate?

In FDA FAERS, the most frequently co-reported reaction terms for Prochlorperazine Edisylate are febrile neutropenia, small intestinal obstruction, taste disorder, cytokine release syndrome, anorexia, neoplasm progression. 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 Prochlorperazine Edisylate 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 place.

Do FAERS signals prove that Prochlorperazine Edisylate 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 11cb37c7-01b4-4223-b2ea-a3695639b80b, effective 20210426; matched on openfda.generic_name.exact:"PROCHLORPERAZINE EDISYLATE")
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, 16 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.