Prochlorperazine Maleate side effects: what 9,153 FDA adverse event reports show
Drug class
Not stated in label
Who reports
9,153 reports · 66% serious · 1,237 with death outcome · 58% female
Used for
For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).
What it is
DESCRIPTION Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- met.
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.
Causality screen of the 40 strongest signals
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.
- 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.
- 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. 984 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 |
|---|---|---|---|---|---|---|
| Abdominal transposition | 13 | 2,096.7 985.8–4,459.5ROR 2,099.7 · χ² 13,054 / p <1e-300 | 417.4 EB05 259.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Neurologic neglect syndrome | 21 | 89.1 57.7–137.8ROR 89.3 · χ² 1,677 / p <1e-300 | 79.8 EB05 55.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 100% (drug 58%) · 90% clinician | no trial data cached |
| Carotid artery thrombosis | 20 | 54.9 35.2–85.5ROR 55.0 · χ² 981 / p 1e-215 | 51.1 EB05 35.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Congenital cardiovascular anomaly | 13 | 35.5 20.6–61.4ROR 35.6 · χ² 396 / p 2e-88 | 33.4 EB05 20.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Adjustment disorder | 18 | 32.0 20.1–50.9ROR 32.1 · χ² 503 / p 1e-111 | 30.7 EB05 20.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Hospice care | 87 | 20.4 16.5–25.2ROR 20.6 · χ² 1,572 / p <1e-300 | 20.1 EB05 16.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Personality disorder | 23 | 20.1 13.4–30.3ROR 20.2 · χ² 396 / p 2e-88 | 19.6 EB05 13.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 58%) · 91% clinician | no trial data cached |
| Tumour pain | 10 | 17.4 9.4–32.4ROR 17.4 · χ² 138 / p 4e-32 | 15.9 EB05 8.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Alopecia areata | 10 | 13.1 7.0–24.4ROR 13.1 · χ² 99 / p 1e-23 | 11.1 EB05 5.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Pancreatic carcinoma metastatic | 16 | 12.9 7.9–21.1ROR 12.9 · χ² 163 / p 1e-37 | 11.8 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Cancer pain | 14 | 12.5 7.4–21.2ROR 12.6 · χ² 137 / p 7e-32 | 11.2 EB05 6.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Plasma cell myeloma recurrent | 17 | 12.0 7.4–19.3ROR 12.0 · χ² 159 / p 9e-37 | 10.8 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Gangrene | 31 | 11.8 8.3–16.7ROR 11.8 · χ² 293 / p 6e-66 | 11.2 EB05 8.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 92% (drug 58%) · 90% clinician | no trial data cached |
| Full blood count decreased | 102 | 11.6 9.6–14.1ROR 11.8 · χ² 977 / p 1e-214 | 11.4 EB05 9.6 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.6 | no trial data cached |
| Essential hypertension | 13 | 11.5 6.7–19.9ROR 11.6 · χ² 114 / p 6e-27 | 9.9 EB05 5.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Psychological trauma | 43 | 11.3 8.4–15.3ROR 11.4 · χ² 392 / p 1e-87 | 10.9 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 100% (drug 58%) · 100% consumer | no trial data cached |
| Lumbar spinal stenosis | 14 | 11.0 6.5–18.5ROR 11.0 · χ² 117 / p 2e-27 | 9.5 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Hair colour changes | 59 | 10.8 8.4–13.9ROR 10.8 · χ² 512 / p 1e-113 | 10.4 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=14 · ♀ 86% (drug 58%) | no trial data cached |
| Carbohydrate antigen 125 increased | 15 | 10.0 6.0–16.6ROR 10.0 · χ² 112 / p 1e-26 | 8.6 EB05 5.2 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Hair disorder | 35 | 9.6 6.9–13.4ROR 9.7 · χ² 262 / p 4e-59 | 9.0 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 58%) | no trial data cached |
| Tumour marker increased | 19 | 9.1 5.8–14.2ROR 9.1 · χ² 128 / p 6e-30 | 7.9 EB05 5.2 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious n=8 | no trial data cached |
| Plasma cell myeloma | 152 | 8.9 7.6–10.5ROR 9.1 · χ² 1,060 / p 7e-233 | 8.8 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Madarosis | 45 | 8.8 6.6–11.8ROR 8.9 · χ² 304 / p 3e-68 | 8.3 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=9 · ♀ 100% (drug 58%) | no trial data cached |
| Hair texture abnormal | 51 | 8.7 6.6–11.4ROR 8.7 · χ² 338 / p 9e-76 | 8.2 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=12 · ♀ 100% (drug 58%) | no trial data cached |
| Taste disorder | 72 | 8.3 6.6–10.4ROR 8.3 · χ² 450 / p 3e-100 | 7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Arterial occlusive disease | 28 | 8.1 5.6–11.8ROR 8.2 · χ² 168 / p 1e-38 | 7.4 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · ♀ 100% (drug 58%) | no trial data cached |
| Metastatic neoplasm | 15 | 8.0 4.8–13.3ROR 8.0 · χ² 85 / p 2e-20 | 6.7 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Failure to thrive | 18 | 7.9 5.0–12.6ROR 7.9 · χ² 102 / p 3e-24 | 6.8 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Full blood count abnormal | 34 | 7.4 5.3–10.4ROR 7.4 · χ² 181 / p 1e-41 | 6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 | no trial data cached |
| Blood magnesium decreased | 27 | 7.2 4.9–10.5ROR 7.2 · χ² 137 / p 6e-32 | 6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 | no trial data cached |
| Red blood cell count decreased | 85 | 6.8 5.5–8.4ROR 6.9 · χ² 415 / p 1e-92 | 6.6 EB05 5.5 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 | no trial data cached |
| Recurrent cancer | 12 | 6.8 3.9–12.0ROR 6.8 · χ² 53 / p 1e-13 | 5.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Red cell distribution width increased | 12 | 6.6 3.8–11.7ROR 6.6 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Sensory loss | 23 | 6.5 4.3–9.8ROR 6.5 · χ² 102 / p 3e-24 | 5.8 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 100% (drug 58%) | no trial data cached |
| Dermatitis acneiform | 17 | 6.4 4.0–10.4ROR 6.5 · χ² 73 / p 8e-18 | 5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Pathological fracture | 14 | 6.3 3.7–10.7ROR 6.3 · χ² 57 / p 2e-14 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Hemiplegia | 23 | 6.3 4.2–9.5ROR 6.3 · χ² 98 / p 3e-23 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 100% (drug 58%) | no trial data cached |
| Lymphoedema | 18 | 6.0 3.8–9.5ROR 6.0 · χ² 70 / p 4e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Cytopenia | 31 | 6.0 4.2–8.5ROR 6.0 · χ² 123 / p 9e-29 | 5.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Metastases to liver | 45 | 5.9 4.4–7.9ROR 5.9 · χ² 177 / p 9e-41 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | 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 |
|---|---|---|---|---|---|---|
| Nausea | 1,293 | 3.8 3.6–4.0ROR 4.2 · χ² 2,710 / p <1e-300 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.7 | no trial data cached |
| Fatigue (tiredness) | 1,286 | 3.8 3.6–4.0ROR 4.3 · χ² 2,741 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Diarrhoea (diarrhea) | 968 | 3.4 3.2–3.7ROR 3.7 · χ² 1,731 / p <1e-300 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Death | 698 | 1.9 1.7–2.0ROR 1.9 · χ² 286 / p 2e-64 | 1.9 EB05 1.7 · IC025 +0.8 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.6 | no trial data cached |
| Vomiting | 645 | 3.2 2.9–3.4ROR 3.3 · χ² 966 / p 2e-212 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.8 | no trial data cached |
| Asthenia (weakness) | 544 | 3.3 3.1–3.6ROR 3.5 · χ² 892 / p 3e-196 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Decreased appetite (loss of appetite) | 509 | 5.0 4.6–5.5ROR 5.3 · χ² 1,659 / p <1e-300 | 5.0 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Off label use (used outside approved label) | 451 | 1.2 1.1–1.3ROR 1.2 · χ² 14 / p 9e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
| Constipation | 423 | 4.5 4.1–4.9ROR 4.7 · χ² 1,150 / p 2e-252 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Pain | 406 | 1.5 1.4–1.7ROR 1.5 · χ² 72 / p 1e-17 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Dyspnoea (shortness of breath) | 395 | 1.6 1.5–1.8ROR 1.6 · χ² 90 / p 9e-22 | 1.6 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Pneumonia (lung infection) | 389 | 2.8 2.5–3.0ROR 2.8 · χ² 440 / p 5e-98 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.5 | no trial data cached |
| Rash | 369 | 1.9 1.8–2.2ROR 2.0 · χ² 173 / p 8e-40 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Headache | 357 | 1.3 1.2–1.4ROR 1.3 · χ² 26 / p 2e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Weight decreased (weight loss) | 336 | 2.8 2.5–3.1ROR 2.8 · χ² 380 / p 8e-85 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 | 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.
- Neurologic neglect syndrome — n=21, PRR 89.1
- Carotid artery thrombosis — n=20, PRR 54.9
- Hospice care — n=87, PRR 20.4
- Personality disorder — n=23, PRR 20.1
- Gangrene — n=31, PRR 11.8
- Psychological trauma — n=43, PRR 11.3
- Hair colour changes — n=59, PRR 10.8
- Hair disorder — n=35, PRR 9.6
- Plasma cell myeloma — n=152, PRR 8.9
- Madarosis — n=45, PRR 8.8
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?
In FDA FAERS, the most frequently co-reported reaction terms for Prochlorperazine are nausea, fatigue, diarrhoea, vomiting, asthenia, decreased appetite. 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 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 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 383744db-ba57-478a-8041-2ecc26d3e1ec, effective 20221009; matched on
openfda.generic_name.exact:"PROCHLORPERAZINE") - 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, 1,024 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.