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Perphenazine side effects: what 2,076 FDA adverse event reports show

Perphenazine · 128 reaction terms · 5,012 drug–reaction co-reports · data 2026-09-14
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Drug class

Phenothiazine

FDA label (Established Pharmacologic Class)

Who reports

2,076 reports · 83% serious · 222 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.

FDA label, Indications and Usage

What it is

DESCRIPTION Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C 21 H 26 CIN 3 OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg and 16 mg of perphenazine.

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 40 strongest signals

Labeled — boxed warning 2Labeled adverse reaction 6Labeled (related wording) 6Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 2Outcome field, not a reaction 1Not in label — unassessed 21
What the badges mean

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. 88 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Euphoric mood154153.3
131.5–178.6ROR 165.5 · χ² 22,803 / p <1e-300
148.2 EB05 129.6 · IC025 +6.4
3/3 methods agree
Not in label — unassessedserious n=154 · ♀ 1% (drug 56%)no trial data cached
Akathisia (inner restlessness)186139.6
121.5–160.2ROR 153.2 · χ² 25,112 / p <1e-300
135.7 EB05 120.1 · IC025 +6.4
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 134.3 · ♀ 9% (drug 56%)no trial data cached
Leukaemia8389.7
72.6–110.8ROR 93.4 · χ² 7,129 / p <1e-300
87.2 EB05 72.5 · IC025 +5.5
3/3 methods agree
Not in label — unassessedserious PRR 62.0 · ♀ 0% (drug 56%)no trial data cached
Parkinsonism8588.8
72.0–109.5ROR 92.6 · χ² 7,231 / p <1e-300
86.4 EB05 72.0 · IC025 +5.5
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 68.9 · ♀ 89% (drug 56%) · 97% clinicianno trial data cached
Obesity9459.9
49.1–73.0ROR 62.6 · χ² 5,353 / p <1e-300
58.8 EB05 49.5 · IC025 +5.2
3/3 methods agree
Not in label — unassessedserious PRR 45.8 · ♀ 10% (drug 56%)no trial data cached
Neuroleptic malignant syndrome6252.9
41.4–67.7ROR 54.5 · χ² 3,093 / p <1e-300
51.9 EB05 41.9 · IC025 +4.8
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 36.6 · 96% clinicianno trial data cached
Myoclonus6151.9
40.5–66.5ROR 53.5 · χ² 2,983 / p <1e-300
50.9 EB05 41.1 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious PRR 37.8 · ♀ 100% (drug 56%) · 98% clinicianno trial data cached
Blood calcium decreased5045.0
34.2–59.2ROR 46.0 · χ² 2,097 / p <1e-300
44.1 EB05 34.7 · IC025 +4.5
3/3 methods agree
Lab value / disease markerserious PRR 38.8 · ♀ 93% (drug 56%) · 94% clinicianno trial data cached
Dystonia8644.8
36.4–55.2ROR 46.7 · χ² 3,628 / p <1e-300
44.2 EB05 36.9 · IC025 +4.8
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 33.3 · ♀ 95% (drug 56%) · 96% clinicianno trial data cached
Prescribed overdose7639.8
31.9–49.7ROR 41.3 · χ² 2,829 / p <1e-300
39.3 EB05 32.4 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious PRR 46.9 · ♀ 3% (drug 56%)no trial data cached
Tardive dyskinesia (persistent involuntary movements)10135.9
29.7–43.5ROR 37.7 · χ² 3,388 / p <1e-300
35.6 EB05 30.1 · IC025 +4.6
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 28.1 · ♀ 91% (drug 56%)no trial data cached
Orthostatic hypotension (dizziness on standing)5934.3
26.6–44.1ROR 35.2 · χ² 1,867 / p <1e-300
33.8 EB05 27.2 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious PRR 26.4 · ♀ 86% (drug 56%) · 95% clinicianno trial data cached
Cyst3931.8
23.3–43.4ROR 32.4 · χ² 1,130 / p 6e-248
31.3 EB05 23.9 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious PRR 28.8 · ♀ 97% (drug 56%)no trial data cached
Suicide attempt18130.2
26.2–34.7ROR 33.0 · χ² 5,076 / p <1e-300
30.0 EB05 26.5 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious PRR 20.9 · ♀ 6% (drug 56%)no trial data cached
Leukopenia (low white blood cells)14028.4
24.2–33.4ROR 30.4 · χ² 3,675 / p <1e-300
28.2 EB05 24.5 · IC025 +4.4
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 20.4 · ♀ 1% (drug 56%)no trial data cached
Sedation7328.4
22.6–35.5ROR 29.4 · χ² 1,897 / p <1e-300
28.1 EB05 23.1 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious PRR 24.8 · ♀ 77% (drug 56%) · 90% clinicianno trial data cached
Osteopenia4026.5
19.5–36.1ROR 27.0 · χ² 956 / p 3e-210
26.2 EB05 20.1 · IC025 +3.8
3/3 methods agree
Not in label — unassessedserious PRR 21.1 · ♀ 97% (drug 56%)no trial data cached
Blood potassium increased3823.7
17.3–32.5ROR 24.1 · χ² 803 / p 7e-177
23.4 EB05 17.8 · IC025 +3.7
3/3 methods agree
Lab value / disease markerserious PRR 21.3 · ♀ 100% (drug 56%)no trial data cached
Dyskinesia (involuntary movements)9122.7
18.6–27.8ROR 23.7 · χ² 1,866 / p <1e-300
22.6 EB05 18.9 · IC025 +4.0
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 20.7 · ♀ 91% (drug 56%) · 92% clinicianno trial data cached
Deformity2122.7
14.8–34.7ROR 22.9 · χ² 413 / p 4e-92
22.2 EB05 15.3 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious PRR 17.9no trial data cached
Therapeutic product effect incomplete14420.6
17.6–24.1ROR 22.1 · χ² 2,671 / p <1e-300
20.5 EB05 17.9 · IC025 +4.0
3/3 methods agree
Reporting / coding artifactserious PRR 26.6 · ♀ 4% (drug 56%) · 91% clinicianno trial data cached
Salivary hypersecretion1919.2
12.3–30.1ROR 19.4 · χ² 310 / p 1e-69
18.8 EB05 12.5 · IC025 +2.9
3/3 methods agree
Not in label — unassessedserious PRR 18.0no trial data cached
Hallucination, auditory2717.2
11.8–25.0ROR 17.4 · χ² 395 / p 4e-88
16.8 EB05 12.0 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious PRR 12.2no trial data cached
Depressed level of consciousness6115.6
12.2–20.0ROR 16.1 · χ² 821 / p 7e-181
15.5 EB05 12.4 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious PRR 11.1 · ♀ 94% (drug 56%) · 93% clinicianno trial data cached
Skin lesion3914.5
10.6–19.8ROR 14.7 · χ² 476 / p 7e-106
14.2 EB05 10.7 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious PRR 14.0 · ♀ 97% (drug 56%)no trial data cached
Hypothermia1313.0
7.5–22.3ROR 13.0 · χ² 132 / p 9e-31
11.6 EB05 6.5 · IC025 +2.2
3/3 methods agree
Not in label — unassessedserious PRR 9.1no trial data cached
Mania2112.9
8.4–19.8ROR 13.0 · χ² 219 / p 7e-50
12.2 EB05 8.0 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious PRR 8.4 · ♀ 29% (drug 56%)no trial data cached
Muscle rigidity1512.7
7.7–21.0ROR 12.8 · χ² 150 / p 9e-35
11.5 EB05 6.8 · IC025 +2.3
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 9.2no trial data cached
Cognitive disorder5812.6
9.8–16.3ROR 12.9 · χ² 609 / p 1e-134
12.4 EB05 9.8 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious PRR 12.2 · ♀ 88% (drug 56%) · 93% clinicianno trial data cached
Irritability6811.4
9.0–14.4ROR 11.8 · χ² 637 / p 8e-141
11.2 EB05 9.0 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious PRR 13.6 · ♀ 16% (drug 56%)no trial data cached
Schizophrenia1310.8
6.3–18.6ROR 10.9 · χ² 106 / p 4e-25
9.2 EB05 5.3 · IC025 +2.0
3/3 methods agree
Likely indication confounding
term in indications
serious PRR 7.2no trial data cached
Completed suicide (death by suicide)8810.6
8.6–13.0ROR 11.0 · χ² 755 / p 1e-166
10.4 EB05 8.6 · IC025 +3.0
3/3 methods agree
Outcome field, not a reaction
boxed warning mentions mortality
serious PRR 7.2 · ♀ 33% (drug 56%) · 96% clinicianno trial data cached
Osteoarthritis4410.5
7.8–14.0ROR 10.7 · χ² 368 / p 3e-82
10.0 EB05 7.6 · IC025 +2.7
3/3 methods agree
Not in label — unassessedserious PRR 7.9 · ♀ 94% (drug 56%)no trial data cached
Hepatomegaly1010.2
5.5–19.0ROR 10.3 · χ² 74 / p 3e-18
8.1 EB05 4.3 · IC025 +1.8
3/3 methods agree
Not in label — unassessedserious PRR 7.7no 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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Akathisia (inner restlessness)186139.6
121.5–160.2ROR 153.2 · χ² 25,112 / p <1e-300
135.7 EB05 120.1 · IC025 +6.4
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 134.3 · ♀ 9% (drug 56%)no trial data cached
Suicide attempt18130.2
26.2–34.7ROR 33.0 · χ² 5,076 / p <1e-300
30.0 EB05 26.5 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious PRR 20.9 · ♀ 6% (drug 56%)no trial data cached
Product use in unapproved indication1566.5
5.5–7.5ROR 6.9 · χ² 721 / p 3e-159
6.3 EB05 5.5 · IC025 +2.4
3/3 methods agree
Reporting / coding artifactserious PRR 9.7 · 91% clinicianno trial data cached
Euphoric mood154153.3
131.5–178.6ROR 165.5 · χ² 22,803 / p <1e-300
148.2 EB05 129.6 · IC025 +6.4
3/3 methods agree
Not in label — unassessedserious n=154 · ♀ 1% (drug 56%)no trial data cached
Therapeutic product effect incomplete14420.6
17.6–24.1ROR 22.1 · χ² 2,671 / p <1e-300
20.5 EB05 17.9 · IC025 +4.0
3/3 methods agree
Reporting / coding artifactserious PRR 26.6 · ♀ 4% (drug 56%) · 91% clinicianno trial data cached
Leukopenia (low white blood cells)14028.4
24.2–33.4ROR 30.4 · χ² 3,675 / p <1e-300
28.2 EB05 24.5 · IC025 +4.4
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 20.4 · ♀ 1% (drug 56%)no trial data cached
Drug interaction1318.3
7.1–9.9ROR 8.8 · χ² 845 / p 4e-186
8.2 EB05 7.1 · IC025 +2.7
3/3 methods agree
Reporting / coding artifactserious PRR 6.5 · 91% clinicianno trial data cached
Tardive dyskinesia (persistent involuntary movements)10135.9
29.7–43.5ROR 37.7 · χ² 3,388 / p <1e-300
35.6 EB05 30.1 · IC025 +4.6
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 28.1 · ♀ 91% (drug 56%)no trial data cached
Obesity9459.9
49.1–73.0ROR 62.6 · χ² 5,353 / p <1e-300
58.8 EB05 49.5 · IC025 +5.2
3/3 methods agree
Not in label — unassessedserious PRR 45.8 · ♀ 10% (drug 56%)no trial data cached
Dyskinesia (involuntary movements)9122.7
18.6–27.8ROR 23.7 · χ² 1,866 / p <1e-300
22.6 EB05 18.9 · IC025 +4.0
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 20.7 · ♀ 91% (drug 56%) · 92% clinicianno trial data cached
Completed suicide (death by suicide)8810.6
8.6–13.0ROR 11.0 · χ² 755 / p 1e-166
10.4 EB05 8.6 · IC025 +3.0
3/3 methods agree
Outcome field, not a reaction
boxed warning mentions mortality
serious PRR 7.2 · ♀ 33% (drug 56%) · 96% clinicianno trial data cached
Overdose874.1
3.3–5.0ROR 4.2 · χ² 199 / p 1e-45
4.0 EB05 3.3 · IC025 +1.6
3/3 methods agree
Reporting / coding artifactserious PRR 3.3 · ♀ 77% (drug 56%)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.

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 Perphenazine?

In FDA FAERS, the most frequently co-reported reaction terms for Perphenazine are toxicity to various agents, weight increased, akathisia, suicide attempt, increased appetite, euphoric mood. 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 Perphenazine 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 Perphenazine 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

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.