Ziprasidone Mesylate side effects: what 135 FDA adverse event reports show
Drug class
Not stated in label
Who reports
135 reports · 94% serious · 32 with death outcome · 74% 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.
- 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. 1,007 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 |
|---|---|---|---|---|---|---|
| Oculogyration | 21 | 273.5 171.7–435.8ROR 273.9 · χ² 4,575 / p <1e-300 | 190.8 EB05 131.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Anosognosia | 96 | 210.3 169.9–260.3ROR 211.7 · χ² 17,295 / p <1e-300 | 177.5 EB05 149.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=89 · ♀ 96% (drug 74%) | not reported in cached trials |
| Blood prolactin abnormal | 94 | 178.8 144.4–221.4ROR 180.0 · χ² 14,648 / p <1e-300 | 154.4 EB05 130.0 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=88 · ♀ 95% (drug 74%) | not reported in cached trials |
| Personality change due to a general medical condition | 10 | 128.0 67.1–244.2ROR 128.1 · χ² 1,044 / p 2e-229 | 96.6 EB05 56.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Electrocardiogram qt corrected interval prolonged | 59 | 118.4 90.9–154.3ROR 118.9 · χ² 6,244 / p <1e-300 | 105.9 EB05 85.1 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Schizophrenia, paranoid type | 20 | 85.8 54.7–134.7ROR 85.9 · χ² 1,504 / p <1e-300 | 75.5 EB05 51.6 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | – | not reported in cached trials |
| Insulin-requiring type 2 diabetes mellitus | 16 | 79.9 48.3–132.2ROR 80.0 · χ² 1,109 / p 2e-243 | 69.8 EB05 45.5 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Antipsychotic drug level below therapeutic | 32 | 71.4 50.1–101.8ROR 71.5 · χ² 2,051 / p <1e-300 | 65.6 EB05 48.6 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=26 · ♀ 0% (drug 74%) | not reported in cached trials |
| Schizoaffective disorder | 79 | 68.2 54.4–85.4ROR 68.5 · χ² 4,931 / p <1e-300 | 64.2 EB05 53.2 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 · ♀ 0% (drug 74%) | not reported in cached trials |
| Disturbance in social behaviour | 93 | 60.5 49.2–74.3ROR 60.9 · χ² 5,166 / p <1e-300 | 57.4 EB05 48.3 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=88 · ♀ 95% (drug 74%) | not reported in cached trials |
| Diabetic coma | 110 | 59.9 49.5–72.4ROR 60.3 · χ² 6,060 / p <1e-300 | 57.0 EB05 48.6 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Diabetic neuropathy | 162 | 49.7 42.6–58.1ROR 50.3 · χ² 7,436 / p <1e-300 | 47.9 EB05 42.0 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Diabetic complication | 79 | 47.0 37.6–58.8ROR 47.3 · χ² 3,402 / p <1e-300 | 45.1 EB05 37.4 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Diabetic eye disease | 13 | 43.6 25.1–75.7ROR 43.6 · χ² 485 / p 1e-107 | 40.1 EB05 24.9 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Diabetes mellitus non-insulin-dependent | 42 | 43.4 31.9–59.0ROR 43.5 · χ² 1,648 / p <1e-300 | 41.4 EB05 31.9 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Obesity | 410 | 39.0 35.4–43.0ROR 40.1 · χ² 14,760 / p <1e-300 | 37.9 EB05 35.0 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 179.8 · ♀ 0% (drug 74%) | not reported in cached trials |
| Type 2 diabetes mellitus | 827 | 37.1 34.7–39.7ROR 39.4 · χ² 28,355 / p <1e-300 | 36.2 EB05 34.2 · IC025 +5.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.0 | not reported in cached trials |
| Masked facies | 10 | 36.8 19.7–69.0ROR 36.9 · χ² 306 / p 8e-69 | 33.8 EB05 19.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Type 1 diabetes mellitus | 137 | 34.5 29.1–40.8ROR 34.8 · χ² 4,322 / p <1e-300 | 33.6 EB05 29.1 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Metabolic disorder | 132 | 34.4 29.0–40.9ROR 34.7 · χ² 4,151 / p <1e-300 | 33.5 EB05 29.0 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=88 · ♀ 95% (drug 74%) | not reported in cached trials |
| Tardive dyskinesia (persistent involuntary movements) | 631 | 33.5 31.0–36.2ROR 35.0 · χ² 19,440 / p <1e-300 | 32.7 EB05 30.6 · IC025 +4.9 3/3 methods agree | Labeled — boxed warning exact term | – | not reported in cached trials |
| Metabolic syndrome | 34 | 31.2 22.2–43.9ROR 31.3 · χ² 945 / p 8e-208 | 30.1 EB05 22.6 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Dystonia | 396 | 30.7 27.8–33.9ROR 31.6 · χ² 11,128 / p <1e-300 | 30.1 EB05 27.7 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 453.0 · ♀ 95% (drug 74%) | NCT01053429: 14/3,391 (0.4%) on Ziprasidone |
| Glycosuria | 27 | 30.1 20.6–44.1ROR 30.2 · χ² 716 / p 4e-158 | 29.0 EB05 20.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | – | not reported in cached trials |
| Borderline personality disorder | 14 | 29.8 17.5–50.5ROR 29.8 · χ² 354 / p 3e-79 | 28.2 EB05 17.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Bipolar disorder | 211 | 29.1 25.4–33.3ROR 29.5 · χ² 5,580 / p <1e-300 | 28.4 EB05 25.4 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | – | NCT00312494: 1/216 (0.5%) on Ziprasidone; 1/217 (0.5%) control (serious AE) |
| Neuroleptic malignant syndrome | 226 | 28.6 25.1–32.6ROR 29.1 · χ² 5,890 / p <1e-300 | 28.1 EB05 25.1 · IC025 +4.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 16.1 | not reported in cached trials |
| Hyperlipidaemia | 208 | 26.1 22.8–29.9ROR 26.5 · χ² 4,913 / p <1e-300 | 25.6 EB05 22.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | not reported in cached trials |
| Protrusion tongue | 10 | 26.0 13.9–48.6ROR 26.0 · χ² 212 / p 2e-48 | 24.3 EB05 13.8 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Akathisia (inner restlessness) | 232 | 25.6 22.5–29.1ROR 26.0 · χ² 5,362 / p <1e-300 | 25.1 EB05 22.5 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 258.0 · ♀ 0% (drug 74%) | NCT01053429: 80/3,391 (2.4%) on Ziprasidone |
| Bipolar i disorder | 37 | 25.4 18.4–35.2ROR 25.5 · χ² 829 / p 1e-182 | 24.7 EB05 18.7 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | – | NCT00312494: 1/216 (0.5%) on Ziprasidone; 1/217 (0.5%) control (serious AE) |
| Disinhibition | 26 | 24.2 16.5–35.7ROR 24.3 · χ² 547 / p 3e-121 | 23.5 EB05 16.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 74%) | not reported in cached trials |
| Blood prolactin increased | 76 | 24.2 19.3–30.3ROR 24.3 · χ² 1,638 / p <1e-300 | 23.7 EB05 19.5 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Homicidal ideation | 63 | 23.2 18.1–29.8ROR 23.3 · χ² 1,297 / p 2e-284 | 22.7 EB05 18.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Schizophrenia | 183 | 22.6 19.5–26.1ROR 22.9 · χ² 3,699 / p <1e-300 | 22.2 EB05 19.6 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 567.1 · ♀ 96% (drug 74%) | NCT01053429: 1/3,391 (0.0%) on Ziprasidone |
| Mania | 247 | 22.6 19.9–25.6ROR 22.9 · χ² 4,995 / p <1e-300 | 22.2 EB05 20.0 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | – | not reported in cached trials |
| Blood triglycerides increased | 261 | 22.1 19.6–24.9ROR 22.5 · χ² 5,162 / p <1e-300 | 21.8 EB05 19.6 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning synonym match | – | not reported in cached trials |
| Eye rolling | 10 | 20.9 11.2–39.1ROR 20.9 · χ² 168 / p 1e-38 | 19.5 EB05 10.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Priapism | 48 | 20.7 15.6–27.6ROR 20.8 · χ² 870 / p 1e-191 | 20.3 EB05 15.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | – | not reported in cached trials |
| Diabetic nephropathy | 30 | 20.3 14.2–29.1ROR 20.4 · χ² 524 / p 2e-116 | 19.8 EB05 14.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ziprasidone as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (5 of 40 signal terms matched).
- NCT01053429 — A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule (N=3391, phase n/a; 64 AE terms posted; arms: Ziprasidone HCl (Zeldox))
- NCT00312494 — 3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic (N=680, PHASE3; 39 AE terms posted; arms: Ziprasidone (Higher Dose); Ziprasidone (Lower Dose); Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Weight increased (weight gain) | 964 | 6.4 6.0–6.8ROR 6.8 · χ² 4,438 / p <1e-300 | 6.4 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 20.7 · ♀ 0% (drug 74%) | NCT01053429: 1/3,391 (0.0%) on Ziprasidone |
| Diabetes mellitus | 959 | 18.8 17.6–19.9ROR 20.0 · χ² 15,952 / p <1e-300 | 18.5 EB05 17.6 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning exact term | – | not reported in cached trials |
| Drug ineffective (drug did not work) | 956 | 1.1 1.0–1.1ROR 1.1 · χ² 5 / p 0.012 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 22.7 | NCT01053429: 2/3,391 (0.1%) on Ziprasidone |
| Type 2 diabetes mellitus | 827 | 37.1 34.7–39.7ROR 39.4 · χ² 28,355 / p <1e-300 | 36.2 EB05 34.2 · IC025 +5.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.0 | not reported in cached trials |
| Anxiety | 734 | 3.8 3.6–4.1ROR 4.0 · χ² 1,538 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.5 | NCT01053429: 39/3,391 (1.2%) on Ziprasidone |
| Insomnia (trouble sleeping) | 685 | 3.8 3.5–4.1ROR 3.9 · χ² 1,429 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 | NCT01053429: 58/3,391 (1.7%) on Ziprasidone |
| Depression | 659 | 4.3 4.0–4.6ROR 4.4 · χ² 1,664 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.6 | not reported in cached trials |
| Somnolence (drowsiness) | 643 | 4.7 4.4–5.1ROR 4.9 · χ² 1,908 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.8 | NCT01053429: 72/3,391 (2.1%) on Ziprasidone |
| Tardive dyskinesia (persistent involuntary movements) | 631 | 33.5 31.0–36.2ROR 35.0 · χ² 19,440 / p <1e-300 | 32.7 EB05 30.6 · IC025 +4.9 3/3 methods agree | Labeled — boxed warning exact term | – | not reported in cached trials |
| Tremor (shaking) | 609 | 5.4 5.0–5.9ROR 5.6 · χ² 2,209 / p <1e-300 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | – | NCT01053429: 12/3,391 (0.4%) on Ziprasidone |
| Nausea | 607 | 1.1 1.1–1.2ROR 1.1 · χ² 10 / p 6e-4 | 1.1 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 0.2 | NCT01053429: 24/3,391 (0.7%) on Ziprasidone |
| Fatigue (tiredness) | 599 | 1.1 1.1–1.2ROR 1.1 · χ² 11 / p 5e-4 | 1.1 EB05 1.1 · IC025 +0.1 | Labeled (related wording) related wording | – | NCT00312494: 3/216 (1.4%) on Ziprasidone; 5/217 (2.3%) control |
| Feeling abnormal | 561 | 3.5 3.2–3.7ROR 3.6 · χ² 986 / p 1e-216 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Dizziness | 519 | 1.5 1.4–1.7ROR 1.6 · χ² 101 / p 5e-24 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 0.3 | NCT01053429: 1/3,391 (0.0%) on Ziprasidone (serious AE) |
| Headache | 497 | 1.2 1.1–1.3ROR 1.2 · χ² 13 / p 1e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 0.3 | NCT01053429: 20/3,391 (0.6%) on Ziprasidone |
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.
- Oculogyration — n=21, PRR 273.5
- Anosognosia — n=96, PRR 210.3
- Hyperlipidaemia — n=208, PRR 26.1
- Disinhibition — n=26, PRR 24.2
- Homicidal ideation — n=63, PRR 23.2
- Diabetic nephropathy — n=30, PRR 20.3
✓ 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 weight increased, diabetes mellitus, type 2 diabetes mellitus, anxiety, insomnia, depression. 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, 1,047 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 - ClinicalTrials.gov API v2 (query
ZIPRASIDONE, results-bearing studies sorted by enrollment)
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.