Ziprasidone Hydrochloride side effects: what 1,369 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,369 reports · 85% serious · 121 with death outcome · 64% female
Used for
Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding.
What it is
Ziprasidone capsules, USP contains the active moiety, ziprasidone in the form of ziprasidone hydrochloride, USP salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents.
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. Ziprasidone is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )].
Causality screen of the 40 strongest signals
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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 17 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 |
|---|---|---|---|---|---|---|
| Sexual dysfunction | 377 | 510.4 467.5–557.3ROR 703.6 · χ² 185,018 / p <1e-300 | 481.6 EB05 442.2 · IC025 +8.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 496.7 | no trial data cached |
| Personality change | 290 | 489.7 441.2–543.5ROR 620.8 · χ² 136,570 / p <1e-300 | 459.9 EB05 417.1 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious PRR 431.2 | no trial data cached |
| Dystonia | 372 | 298.0 273.0–325.4ROR 408.7 · χ² 107,806 / p <1e-300 | 288.0 EB05 264.2 · IC025 +7.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 217.7 | no trial data cached |
| Sedation | 389 | 231.7 212.8–252.2ROR 323.1 · χ² 87,883 / p <1e-300 | 225.7 EB05 207.5 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 211.1 · ♀ 85% (drug 64%) | no trial data cached |
| Schizophrenia | 180 | 229.8 200.3–263.6ROR 264.3 · χ² 40,183 / p <1e-300 | 221.0 EB05 195.2 · IC025 +6.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 158.7 | no trial data cached |
| Akathisia (inner restlessness) | 167 | 189.5 164.2–218.6ROR 215.6 · χ² 30,753 / p <1e-300 | 183.2 EB05 161.1 · IC025 +6.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 180.3 · ♀ 37% (drug 64%) | no trial data cached |
| Euphoric mood | 110 | 165.0 137.8–197.6ROR 179.3 · χ² 17,588 / p <1e-300 | 158.8 EB05 135.4 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=108 · ♀ 1% (drug 64%) | no trial data cached |
| Dyskinesia (involuntary movements) | 373 | 142.0 130.1–154.9ROR 194.6 · χ² 51,682 / p <1e-300 | 139.7 EB05 128.2 · IC025 +6.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 128.8 | no trial data cached |
| Leukaemia | 76 | 124.3 99.8–154.7ROR 131.5 · χ² 9,098 / p <1e-300 | 119.6 EB05 98.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 83.9 · ♀ 0% (drug 64%) | no trial data cached |
| Obesity | 112 | 108.1 90.5–129.2ROR 117.6 · χ² 11,704 / p <1e-300 | 105.5 EB05 90.1 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 84.3 · ♀ 34% (drug 64%) | no trial data cached |
| Suicide attempt | 425 | 107.7 99.5–116.6ROR 155.7 · χ² 44,643 / p <1e-300 | 106.5 EB05 98.2 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 72.5 | no trial data cached |
| Parkinsonism | 68 | 107.4 85.1–135.5ROR 112.9 · χ² 7,015 / p <1e-300 | 103.6 EB05 84.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 83.5 · ♀ 98% (drug 64%) | no trial data cached |
| Increased appetite | 112 | 91.7 76.7–109.5ROR 99.7 · χ² 9,903 / p <1e-300 | 89.8 EB05 76.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 157.1 · ♀ 4% (drug 64%) | no trial data cached |
| Insurance issue | 78 | 80.7 65.0–100.2ROR 85.5 · χ² 6,034 / p <1e-300 | 78.8 EB05 65.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 110.8 · ♀ 85% (drug 64%) | no trial data cached |
| Prescribed overdose | 60 | 47.6 37.1–60.9ROR 49.7 · χ² 2,683 / p <1e-300 | 46.8 EB05 37.6 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 54.7 · ♀ 13% (drug 64%) | no trial data cached |
| Neuroleptic malignant syndrome | 26 | 33.5 22.9–49.1ROR 34.1 · χ² 787 / p 2e-173 | 32.7 EB05 23.5 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 22.7 · 96% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 95 | 29.2 24.0–35.4ROR 31.3 · χ² 2,558 / p <1e-300 | 29.0 EB05 24.4 · IC025 +4.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 20.5 · ♀ 2% (drug 64%) | no trial data cached |
| Blood glucose increased | 316 | 25.6 23.2–28.2ROR 33.0 · χ² 7,498 / p <1e-300 | 25.5 EB05 23.2 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 42.6 | no trial data cached |
| Therapeutic product effect incomplete | 106 | 23.0 19.1–27.6ROR 24.8 · χ² 2,209 / p <1e-300 | 22.8 EB05 19.4 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 28.3 · ♀ 3% (drug 64%) | no trial data cached |
| Adverse drug reaction | 123 | 21.1 17.8–24.9ROR 23.0 · χ² 2,336 / p <1e-300 | 21.0 EB05 18.0 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 39.7 | no trial data cached |
| Extrapyramidal disorder | 28 | 17.1 11.8–24.7ROR 17.4 · χ² 408 / p 4e-91 | 16.8 EB05 12.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.4 · ♀ 85% (drug 64%) | no trial data cached |
| Paranoia | 19 | 16.8 10.7–26.3ROR 17.0 · χ² 267 / p 3e-60 | 16.3 EB05 10.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Diabetes mellitus | 81 | 16.2 13.1–20.0ROR 17.1 · χ² 1,143 / p 9e-251 | 16.1 EB05 13.3 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.6 · ♀ 88% (drug 64%) | no trial data cached |
| Completed suicide (death by suicide) | 81 | 14.7 11.9–18.2ROR 15.6 · χ² 1,027 / p 1e-225 | 14.6 EB05 12.1 · IC025 +3.4 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 9.9 · ♀ 85% (drug 64%) · 95% clinician | no trial data cached |
| Cognitive disorder | 44 | 14.5 10.8–19.4ROR 14.9 · χ² 539 / p 1e-119 | 14.3 EB05 10.9 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.7 · ♀ 98% (drug 64%) | no trial data cached |
| Hallucination, auditory | 15 | 14.4 8.7–23.9ROR 14.6 · χ² 174 / p 4e-40 | 13.5 EB05 8.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Weight increased (weight gain) | 205 | 14.1 12.4–16.0ROR 16.4 · χ² 2,503 / p <1e-300 | 14.0 EB05 12.5 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 17.0 · ♀ 39% (drug 64%) | no trial data cached |
| Condition aggravated | 272 | 13.8 12.4–15.3ROR 17.0 · χ² 3,257 / p <1e-300 | 13.7 EB05 12.4 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.9 | no trial data cached |
| Irritability | 53 | 13.5 10.3–17.5ROR 14.0 · χ² 601 / p 6e-133 | 13.3 EB05 10.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 · ♀ 4% (drug 64%) · 92% clinician | no trial data cached |
| Thinking abnormal | 16 | 13.1 8.0–21.3ROR 13.2 · χ² 167 / p 2e-38 | 12.0 EB05 7.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.8 | no trial data cached |
| Toxicity to various agents | 135 | 12.3 10.5–14.5ROR 13.5 · χ² 1,402 / p <1e-300 | 12.2 EB05 10.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · ♀ 12% (drug 64%) | no trial data cached |
| Mania | 13 | 12.1 7.0–20.8ROR 12.2 · χ² 122 / p 1e-28 | 10.6 EB05 6.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 | no trial data cached |
| Serotonin syndrome | 15 | 12.0 7.3–19.9ROR 12.1 · χ² 140 / p 1e-32 | 10.7 EB05 6.3 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.2 | no trial data cached |
| Delusion | 12 | 11.9 6.7–20.8ROR 12.0 · χ² 109 / p 9e-26 | 10.2 EB05 5.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 67 | 11.2 8.9–14.1ROR 11.7 · χ² 614 / p 9e-136 | 10.9 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · ♀ 88% (drug 64%) | no trial data cached |
| Psychotic disorder | 21 | 10.9 7.1–16.6ROR 11.0 · χ² 179 / p 4e-41 | 9.9 EB05 6.5 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.6 | no trial data cached |
| Product prescribing issue | 14 | 10.5 6.3–17.7ROR 10.6 · χ² 111 / p 2e-26 | 9.0 EB05 5.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 18.7 | no trial data cached |
| Electrocardiogram qt prolonged | 22 | 9.4 6.2–14.2ROR 9.5 · χ² 156 / p 4e-36 | 8.4 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.4 | no trial data cached |
| Disease recurrence | 27 | 8.7 6.0–12.6ROR 8.8 · χ² 176 / p 2e-40 | 7.9 EB05 5.6 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 | no trial data cached |
| Mental disorder | 23 | 8.1 5.4–12.1ROR 8.2 · χ² 136 / p 1e-31 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | 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 |
|---|---|---|---|---|---|---|
| Suicide attempt | 425 | 107.7 99.5–116.6ROR 155.7 · χ² 44,643 / p <1e-300 | 106.5 EB05 98.2 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 72.5 | no trial data cached |
| Sedation | 389 | 231.7 212.8–252.2ROR 323.1 · χ² 87,883 / p <1e-300 | 225.7 EB05 207.5 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 211.1 · ♀ 85% (drug 64%) | no trial data cached |
| Sexual dysfunction | 377 | 510.4 467.5–557.3ROR 703.6 · χ² 185,018 / p <1e-300 | 481.6 EB05 442.2 · IC025 +8.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 496.7 | no trial data cached |
| Dyskinesia (involuntary movements) | 373 | 142.0 130.1–154.9ROR 194.6 · χ² 51,682 / p <1e-300 | 139.7 EB05 128.2 · IC025 +6.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 128.8 | no trial data cached |
| Dystonia | 372 | 298.0 273.0–325.4ROR 408.7 · χ² 107,806 / p <1e-300 | 288.0 EB05 264.2 · IC025 +7.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 217.7 | no trial data cached |
| Blood glucose increased | 316 | 25.6 23.2–28.2ROR 33.0 · χ² 7,498 / p <1e-300 | 25.5 EB05 23.2 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 42.6 | no trial data cached |
| Personality change | 290 | 489.7 441.2–543.5ROR 620.8 · χ² 136,570 / p <1e-300 | 459.9 EB05 417.1 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious PRR 431.2 | no trial data cached |
| Condition aggravated | 272 | 13.8 12.4–15.3ROR 17.0 · χ² 3,257 / p <1e-300 | 13.7 EB05 12.4 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.9 | no trial data cached |
| Weight increased (weight gain) | 205 | 14.1 12.4–16.0ROR 16.4 · χ² 2,503 / p <1e-300 | 14.0 EB05 12.5 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 17.0 · ♀ 39% (drug 64%) | no trial data cached |
| Schizophrenia | 180 | 229.8 200.3–263.6ROR 264.3 · χ² 40,183 / p <1e-300 | 221.0 EB05 195.2 · IC025 +6.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 158.7 | no trial data cached |
| Akathisia (inner restlessness) | 167 | 189.5 164.2–218.6ROR 215.6 · χ² 30,753 / p <1e-300 | 183.2 EB05 161.1 · IC025 +6.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 180.3 · ♀ 37% (drug 64%) | no trial data cached |
| Toxicity to various agents | 135 | 12.3 10.5–14.5ROR 13.5 · χ² 1,402 / p <1e-300 | 12.2 EB05 10.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · ♀ 12% (drug 64%) | no trial data cached |
| Adverse drug reaction | 123 | 21.1 17.8–24.9ROR 23.0 · χ² 2,336 / p <1e-300 | 21.0 EB05 18.0 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 39.7 | no trial data cached |
| Increased appetite | 112 | 91.7 76.7–109.5ROR 99.7 · χ² 9,903 / p <1e-300 | 89.8 EB05 76.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 157.1 · ♀ 4% (drug 64%) | no trial data cached |
| Obesity | 112 | 108.1 90.5–129.2ROR 117.6 · χ² 11,704 / p <1e-300 | 105.5 EB05 90.1 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 84.3 · ♀ 34% (drug 64%) | 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.
- Personality change — n=290, PRR 489.7
- Sedation — n=389, PRR 231.7
- Euphoric mood — n=110, PRR 165.0
- Leukaemia — n=76, PRR 124.3
- Parkinsonism — n=68, PRR 107.4
- Increased appetite — n=112, PRR 91.7
- Insurance issue — n=78, PRR 80.7
- Irritability — n=53, PRR 13.5
- Toxicity to various agents — n=135, PRR 12.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ziprasidone ↔ QT prolongation.
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 Ziprasidone?
In FDA FAERS, the most frequently co-reported reaction terms for Ziprasidone are suicide attempt, sedation, sexual dysfunction, dyskinesia, dystonia, blood glucose increased. 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 Ziprasidone 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. Ziprasidone is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )].
Do FAERS signals prove that Ziprasidone 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 396cb4a6-01a1-f73f-2a37-39df9067bf98, effective 20260601; matched on
openfda.generic_name.exact:"ZIPRASIDONE") - 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, 57 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.