Ziprasidone HCL side effects: what 2,653 FDA adverse event reports show
Drug class
Not stated in label
Who reports
2,653 reports · 80% serious · 366 with death outcome · 60% 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. 90 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 | 384 | 268.6 244.4–295.2ROR 313.9 · χ² 98,769 / p <1e-300 | 256.4 EB05 235.6 · IC025 +7.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 278.3 · ♀ 82% (drug 60%) | no trial data cached |
| Personality change | 296 | 258.2 231.5–288.1ROR 290.5 · χ² 73,202 / p <1e-300 | 246.0 EB05 223.4 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 241.2 · ♀ 81% (drug 60%) | no trial data cached |
| Dystonia | 388 | 160.7 146.4–176.3ROR 188.0 · χ² 60,215 / p <1e-300 | 156.2 EB05 143.6 · IC025 +6.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 124.3 · ♀ 81% (drug 60%) | no trial data cached |
| Sedation | 405 | 124.6 113.9–136.4ROR 146.9 · χ² 48,827 / p <1e-300 | 122.0 EB05 112.3 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 120.0 · ♀ 83% (drug 60%) | no trial data cached |
| Schizophrenia | 187 | 123.3 107.3–141.8ROR 132.6 · χ² 22,229 / p <1e-300 | 120.0 EB05 106.2 · IC025 +6.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 90.7 | no trial data cached |
| Akathisia (inner restlessness) | 180 | 105.5 91.6–121.7ROR 113.1 · χ² 18,300 / p <1e-300 | 103.0 EB05 91.0 · IC025 +6.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 105.7 · ♀ 39% (drug 60%) | no trial data cached |
| Euphoric mood | 115 | 89.1 74.5–106.7ROR 93.1 · χ² 9,827 / p <1e-300 | 86.9 EB05 74.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=111 · ♀ 3% (drug 60%) | no trial data cached |
| Dyskinesia (involuntary movements) | 393 | 77.3 70.5–84.7ROR 90.5 · χ² 29,278 / p <1e-300 | 76.2 EB05 70.1 · IC025 +6.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 74.7 · ♀ 80% (drug 60%) | no trial data cached |
| Parkinsonism | 82 | 67.0 54.1–83.0ROR 69.1 · χ² 5,220 / p <1e-300 | 65.4 EB05 54.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 54.0 · ♀ 91% (drug 60%) | no trial data cached |
| Leukaemia | 76 | 64.2 51.4–80.1ROR 66.0 · χ² 4,626 / p <1e-300 | 62.7 EB05 51.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 46.1 · ♀ 0% (drug 60%) | no trial data cached |
| Obesity | 128 | 63.9 53.9–75.7ROR 67.0 · χ² 7,800 / p <1e-300 | 62.8 EB05 54.2 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 51.7 · ♀ 38% (drug 60%) | no trial data cached |
| Suicide attempt | 474 | 62.1 57.2–67.4ROR 75.4 · χ² 28,286 / p <1e-300 | 61.5 EB05 57.0 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 44.4 | no trial data cached |
| Increased appetite | 118 | 49.9 41.8–59.5ROR 52.2 · χ² 5,574 / p <1e-300 | 49.2 EB05 42.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 88.8 · ♀ 7% (drug 60%) | no trial data cached |
| Insurance issue | 80 | 42.8 34.4–53.1ROR 44.1 · χ² 3,205 / p <1e-300 | 42.1 EB05 34.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 62.5 · ♀ 85% (drug 60%) | no trial data cached |
| Neuroleptic malignant syndrome | 60 | 40.0 31.2–51.5ROR 40.9 · χ² 2,235 / p <1e-300 | 39.4 EB05 31.7 · IC025 +4.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 28.4 · 96% clinician | no trial data cached |
| Prescribed overdose | 71 | 29.1 23.1–36.6ROR 29.8 · χ² 1,892 / p <1e-300 | 28.8 EB05 23.6 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 35.6 · ♀ 22% (drug 60%) | no trial data cached |
| Completed suicide (death by suicide) | 231 | 21.7 19.2–24.6ROR 23.7 · χ² 4,555 / p <1e-300 | 21.6 EB05 19.4 · IC025 +4.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 15.6 · 97% clinician | no trial data cached |
| Hallucination, auditory | 41 | 20.4 15.0–27.6ROR 20.7 · χ² 736 / p 3e-162 | 20.2 EB05 15.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 | no trial data cached |
| Delusion | 32 | 16.4 11.6–23.1ROR 16.5 · χ² 445 / p 4e-99 | 16.1 EB05 11.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Psychotic disorder | 61 | 16.3 12.7–20.9ROR 16.7 · χ² 863 / p 6e-190 | 16.2 EB05 13.0 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.2 | no trial data cached |
| Extrapyramidal disorder | 51 | 16.1 12.3–21.1ROR 16.4 · χ² 706 / p 7e-156 | 15.9 EB05 12.5 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.6 · 92% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 101 | 16.0 13.2–19.4ROR 16.6 · χ² 1,408 / p <1e-300 | 15.9 EB05 13.5 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.8 · ♀ 4% (drug 60%) | no trial data cached |
| Respiratory arrest | 56 | 15.9 12.3–20.7ROR 16.3 · χ² 768 / p 2e-169 | 15.8 EB05 12.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · 98% clinician | no trial data cached |
| Mania | 32 | 15.4 10.9–21.7ROR 15.6 · χ² 416 / p 8e-93 | 15.1 EB05 11.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 | no trial data cached |
| Diabetes mellitus | 147 | 15.2 13.0–17.8ROR 16.0 · χ² 1,938 / p <1e-300 | 15.1 EB05 13.2 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.5 | no trial data cached |
| Paranoia | 33 | 15.1 10.7–21.2ROR 15.3 · χ² 419 / p 2e-93 | 14.8 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Electrocardiogram qt prolonged | 66 | 14.5 11.4–18.4ROR 14.9 · χ² 816 / p 7e-180 | 14.4 EB05 11.6 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.0 · 92% clinician | no trial data cached |
| Blood triglycerides increased | 31 | 13.8 9.7–19.6ROR 14.0 · χ² 356 / p 1e-79 | 13.5 EB05 9.7 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 13.1 | no trial data cached |
| Blood glucose increased | 329 | 13.8 12.4–15.2ROR 15.6 · χ² 3,908 / p <1e-300 | 13.7 EB05 12.5 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 24.3 | no trial data cached |
| Bipolar disorder | 18 | 13.0 8.2–20.6ROR 13.1 · χ² 187 / p 6e-43 | 12.1 EB05 7.6 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.7 | no trial data cached |
| Drug toxicity | 22 | 12.6 8.3–19.1ROR 12.7 · χ² 223 / p 9e-51 | 11.9 EB05 7.8 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 | no trial data cached |
| Therapeutic product effect incomplete | 111 | 12.4 10.3–14.9ROR 12.9 · χ² 1,156 / p 1e-253 | 12.3 EB05 10.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 15.9 · ♀ 4% (drug 60%) | no trial data cached |
| Adverse drug reaction | 128 | 11.3 9.6–13.4ROR 11.8 · χ² 1,197 / p 2e-262 | 11.2 EB05 9.6 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 22.8 · ♀ 81% (drug 60%) | no trial data cached |
| Serotonin syndrome | 27 | 11.2 7.7–16.2ROR 11.3 · χ² 240 / p 2e-54 | 10.5 EB05 7.3 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.1 · ♀ 17% (drug 60%) · 96% clinician | no trial data cached |
| Poisoning | 17 | 10.7 6.6–17.1ROR 10.7 · χ² 139 / p 2e-32 | 9.4 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Weight increased (weight gain) | 279 | 9.9 8.9–11.1ROR 10.9 · χ² 2,245 / p <1e-300 | 9.8 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 12.0 | no trial data cached |
| Irritability | 75 | 9.8 7.9–12.3ROR 10.1 · χ² 588 / p 3e-130 | 9.6 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · ♀ 17% (drug 60%) | no trial data cached |
| Sinus bradycardia | 12 | 9.8 5.6–17.2ROR 9.8 · χ² 86 / p 8e-21 | 8.1 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Thinking abnormal | 23 | 9.7 6.5–14.6ROR 9.8 · χ² 171 / p 2e-39 | 8.8 EB05 5.9 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.0 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 110 | 9.5 7.9–11.4ROR 9.9 · χ² 830 / p 1e-182 | 9.3 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 635 | 3.8 3.6–4.1ROR 4.7 · χ² 1,401 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 | no trial data cached |
| Suicide attempt | 474 | 62.1 57.2–67.4ROR 75.4 · χ² 28,286 / p <1e-300 | 61.5 EB05 57.0 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 44.4 | no trial data cached |
| Sedation | 405 | 124.6 113.9–136.4ROR 146.9 · χ² 48,827 / p <1e-300 | 122.0 EB05 112.3 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 120.0 · ♀ 83% (drug 60%) | no trial data cached |
| Dyskinesia (involuntary movements) | 393 | 77.3 70.5–84.7ROR 90.5 · χ² 29,278 / p <1e-300 | 76.2 EB05 70.1 · IC025 +6.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 74.7 · ♀ 80% (drug 60%) | no trial data cached |
| Dystonia | 388 | 160.7 146.4–176.3ROR 188.0 · χ² 60,215 / p <1e-300 | 156.2 EB05 143.6 · IC025 +6.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 124.3 · ♀ 81% (drug 60%) | no trial data cached |
| Sexual dysfunction | 384 | 268.6 244.4–295.2ROR 313.9 · χ² 98,769 / p <1e-300 | 256.4 EB05 235.6 · IC025 +7.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 278.3 · ♀ 82% (drug 60%) | no trial data cached |
| Blood glucose increased | 329 | 13.8 12.4–15.2ROR 15.6 · χ² 3,908 / p <1e-300 | 13.7 EB05 12.5 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 24.3 | no trial data cached |
| Condition aggravated | 318 | 8.3 7.5–9.2ROR 9.3 · χ² 2,070 / p <1e-300 | 8.3 EB05 7.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Personality change | 296 | 258.2 231.5–288.1ROR 290.5 · χ² 73,202 / p <1e-300 | 246.0 EB05 223.4 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 241.2 · ♀ 81% (drug 60%) | no trial data cached |
| Weight increased (weight gain) | 279 | 9.9 8.9–11.1ROR 10.9 · χ² 2,245 / p <1e-300 | 9.8 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 12.0 | no trial data cached |
| Completed suicide (death by suicide) | 231 | 21.7 19.2–24.6ROR 23.7 · χ² 4,555 / p <1e-300 | 21.6 EB05 19.4 · IC025 +4.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 15.6 · 97% clinician | no trial data cached |
| Schizophrenia | 187 | 123.3 107.3–141.8ROR 132.6 · χ² 22,229 / p <1e-300 | 120.0 EB05 106.2 · IC025 +6.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 90.7 | no trial data cached |
| Akathisia (inner restlessness) | 180 | 105.5 91.6–121.7ROR 113.1 · χ² 18,300 / p <1e-300 | 103.0 EB05 91.0 · IC025 +6.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 105.7 · ♀ 39% (drug 60%) | no trial data cached |
| Toxicity to various agents | 166 | 7.8 6.7–9.1ROR 8.3 · χ² 987 / p 5e-217 | 7.7 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 23% (drug 60%) · 90% clinician | no trial data cached |
| Diabetes mellitus | 147 | 15.2 13.0–17.8ROR 16.0 · χ² 1,938 / p <1e-300 | 15.1 EB05 13.2 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.5 | 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=296, PRR 258.2
- Sedation — n=405, PRR 124.6
- Euphoric mood — n=115, PRR 89.1
- Parkinsonism — n=82, PRR 67.0
- Leukaemia — n=76, PRR 64.2
- Increased appetite — n=118, PRR 49.9
- Insurance issue — n=80, PRR 42.8
- Hallucination, auditory — n=41, PRR 20.4
- Delusion — n=32, PRR 16.4
- Respiratory arrest — n=56, PRR 15.9
✓ 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, dyskinesia, dystonia, sexual dysfunction, 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, 130 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.