Trifluoperazine side effects: what 122 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Trifluoperazine Hydrochloride (Trifluoperazine Hydrochloride)
Who reports
122 reports · 87% serious · 6 with death outcome · 49% female
Used for
For the management of schizophrenia. Trifluoperazine hydrochloride tablets, USP are effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine hydrochloride tablets are 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 (i.e., benzodiazepines).
What it is
DESCRIPTION Each film-coated tablet, for oral administration, contains trifluoperazine hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg trifluoperazine.
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 14 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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
- 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 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 |
|---|---|---|---|---|---|---|
| Euphoric mood | 45 | 753.9 597.2–951.7ROR 1,193.9 · χ² 32,957 / p <1e-300 | 568.2 EB05 442.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 12% (drug 49%) · 91% clinician | no trial data cached |
| Akathisia (inner restlessness) | 41 | 517.8 403.3–664.9ROR 779.4 · χ² 20,586 / p <1e-300 | 415.7 EB05 319.5 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 487.5 · ♀ 0% (drug 49%) · 90% clinician | no trial data cached |
| Obesity | 38 | 410.3 315.0–534.4ROR 595.4 · χ² 15,083 / p <1e-300 | 339.3 EB05 258.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 314.9 · ♀ 0% (drug 49%) | no trial data cached |
| Increased appetite | 40 | 366.5 284.2–472.7ROR 544.8 · χ² 14,200 / p <1e-300 | 311.3 EB05 238.4 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 628.9 · ♀ 0% (drug 49%) | no trial data cached |
| Leukaemia | 19 | 347.0 229.4–524.7ROR 410.8 · χ² 6,203 / p <1e-300 | 256.9 EB05 173.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 230.9 | no trial data cached |
| Prescribed overdose | 37 | 329.2 251.5–431.0ROR 472.1 · χ² 11,769 / p <1e-300 | 280.9 EB05 212.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 371.5 · ♀ 0% (drug 49%) | no trial data cached |
| Leukopenia (low white blood cells) | 41 | 141.4 110.1–181.4ROR 212.4 · χ² 5,583 / p <1e-300 | 132.6 EB05 101.9 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 97.2 · ♀ 3% (drug 49%) · 90% clinician | no trial data cached |
| Suicide attempt | 45 | 127.4 101.0–160.7ROR 201.2 · χ² 5,528 / p <1e-300 | 120.9 EB05 94.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 84.5 · ♀ 0% (drug 49%) · 91% clinician | no trial data cached |
| Irritability | 38 | 108.5 83.3–141.3ROR 157.1 · χ² 3,950 / p <1e-300 | 103.0 EB05 78.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 127.1 · ♀ 0% (drug 49%) | no trial data cached |
| Therapeutic product effect incomplete | 39 | 94.8 73.2–122.9ROR 138.9 · χ² 3,538 / p <1e-300 | 90.7 EB05 69.2 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 118.2 · ♀ 0% (drug 49%) | no trial data cached |
| Intentional self-injury | 9 | 76.7 40.9–143.9ROR 82.7 · χ² 599 / p 1e-132 | 66.4 EB05 37.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 51.3 | no trial data cached |
| Respiratory depression | 5 | 70.1 29.7–165.4ROR 73.1 · χ² 275 / p 5e-62 | 55.8 EB05 25.5 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 47.8 | no trial data cached |
| Toxicity to various agents | 45 | 46.1 36.5–58.1ROR 72.5 · χ² 1,956 / p <1e-300 | 45.3 EB05 35.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 31.4 · ♀ 2% (drug 49%) · 91% clinician | no trial data cached |
| Drug abuse | 15 | 30.8 19.2–49.5ROR 35.0 · χ² 405 / p 2e-90 | 29.8 EB05 19.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 20.7 | 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 |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 45 | 46.1 36.5–58.1ROR 72.5 · χ² 1,956 / p <1e-300 | 45.3 EB05 35.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 31.4 · ♀ 2% (drug 49%) · 91% clinician | no trial data cached |
| Suicide attempt | 45 | 127.4 101.0–160.7ROR 201.2 · χ² 5,528 / p <1e-300 | 120.9 EB05 94.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 84.5 · ♀ 0% (drug 49%) · 91% clinician | no trial data cached |
| Euphoric mood | 45 | 753.9 597.2–951.7ROR 1,193.9 · χ² 32,957 / p <1e-300 | 568.2 EB05 442.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 12% (drug 49%) · 91% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 41 | 141.4 110.1–181.4ROR 212.4 · χ² 5,583 / p <1e-300 | 132.6 EB05 101.9 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 97.2 · ♀ 3% (drug 49%) · 90% clinician | no trial data cached |
| Akathisia (inner restlessness) | 41 | 517.8 403.3–664.9ROR 779.4 · χ² 20,586 / p <1e-300 | 415.7 EB05 319.5 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 487.5 · ♀ 0% (drug 49%) · 90% clinician | no trial data cached |
| Increased appetite | 40 | 366.5 284.2–472.7ROR 544.8 · χ² 14,200 / p <1e-300 | 311.3 EB05 238.4 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 628.9 · ♀ 0% (drug 49%) | no trial data cached |
| Therapeutic product effect incomplete | 39 | 94.8 73.2–122.9ROR 138.9 · χ² 3,538 / p <1e-300 | 90.7 EB05 69.2 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 118.2 · ♀ 0% (drug 49%) | no trial data cached |
| Irritability | 38 | 108.5 83.3–141.3ROR 157.1 · χ² 3,950 / p <1e-300 | 103.0 EB05 78.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 127.1 · ♀ 0% (drug 49%) | no trial data cached |
| Obesity | 38 | 410.3 315.0–534.4ROR 595.4 · χ² 15,083 / p <1e-300 | 339.3 EB05 258.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 314.9 · ♀ 0% (drug 49%) | no trial data cached |
| Prescribed overdose | 37 | 329.2 251.5–431.0ROR 472.1 · χ² 11,769 / p <1e-300 | 280.9 EB05 212.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 371.5 · ♀ 0% (drug 49%) | no trial data cached |
| Leukaemia | 19 | 347.0 229.4–524.7ROR 410.8 · χ² 6,203 / p <1e-300 | 256.9 EB05 173.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 230.9 | no trial data cached |
| Drug abuse | 15 | 30.8 19.2–49.5ROR 35.0 · χ² 405 / p 2e-90 | 29.8 EB05 19.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 20.7 | no trial data cached |
| Intentional self-injury | 9 | 76.7 40.9–143.9ROR 82.7 · χ² 599 / p 1e-132 | 66.4 EB05 37.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 51.3 | no trial data cached |
| Respiratory depression | 5 | 70.1 29.7–165.4ROR 73.1 · χ² 275 / p 5e-62 | 55.8 EB05 25.5 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 47.8 | no trial data cached |
| Libido decreased (lower sex drive) | 3 | 41.6 13.6–127.3ROR 42.6 · χ² 82 / p 8e-20 | 28.9 EB05 5.7 · IC025 +0.5 3/3 methods agree | Not in label — unassessed | serious PRR 48.9 | 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.
- Euphoric mood — n=45, PRR 753.9
- Obesity — n=38, PRR 410.3
- Prescribed overdose — n=37, PRR 329.2
- Suicide attempt — n=45, PRR 127.4
- Irritability — n=38, PRR 108.5
- Toxicity to various agents — n=45, PRR 46.1
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 Trifluoperazine?
In FDA FAERS, the most frequently co-reported reaction terms for Trifluoperazine are toxicity to various agents, suicide attempt, euphoric mood, leukopenia, akathisia, increased 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 Trifluoperazine 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 Trifluoperazine 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 339ceb53-3b1c-459f-84eb-77bd4315c998, effective 20260130; matched on
openfda.generic_name.exact:"TRIFLUOPERAZINE 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, fieldpatient.drug.openfda.generic_name.exact, 15 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.