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What the label lists and what reports show

Ziprasidone side effects

Ziprasidone's FDA label: “The most common reaction associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients [see Warnings and Precautions ( 5.9 )].” FAERS holds 6,148 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is suicide attempt (644 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the ziprasidone FDA label on DailyMed (effective July 20, 2026, Apotex Corp.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common reaction associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients [see Warnings and Precautions ( 5.9 )].

From the label: adverse reactions, continued

The following adverse reactions are described in more detail in other sections of the prescribing information: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions ( 5.2 )] QT Prolongation and Risk of Sudden Death [see Contraindications ( 4.2 ), Warnings and Precautions ( 5.3 )] Serotonin Syndrome [see Contraindications ( 4.3 ), Warnings and Precautions ( 5.4 ), Drug Interactions ( 7.1 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.5 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.6 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.7 )] Metabolic Changes [see Warnings and Precautions ( 5.8 )] Rash [see Warnings and Precautions ( 5.9 )] Orthostatic Hypotension [see Warnings and Precautions ( 5.10 )] Falls [see Warnings and Precautions ( 5.11 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.12 )] Seizures [see Warnings and Precautions ( 5.13 )] Dysphagia [see Warnings and Precautions ( 5.14 )] Hyperprolactinemia [see Warnings and Precautions ( 5.15 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.16 )] Priapism [see Warnings and Precautions ( 5.17 )] …

Source: FDA drug label, Apotex Corp., effective July 20, 2026 (SPL set ccfd5ba2-7271-f3dd-4c98-7418c1a4b54a), via openFDA; the full label on DailyMed

What do FAERS reports show?

6,148 reports list ziprasidone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 931 are coded as a death and 2,159 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)1,103
  • Suicide Attempt644
  • Completed Suicide (an outcome recorded in the report)556
  • Sedation551
  • Dyskinesia (named in the label)548
  • Dystonia (named in the label)497
  • Sexual Dysfunction (named in the label)480
  • Weight Increased475
  • Condition Aggravated (a use or a product term, not a reaction)468
  • Blood Prolactin Abnormal458
  • Metabolic Disorder426
  • Blood Glucose Increased423
  • Toxicity To Various Agents414
  • Anosognosia405
  • Disturbance In Social Behaviour392
  • Personality Change369
  • Schizophrenia (a use or a product term, not a reaction)289
  • Akathisia (named in the label)286
  • Anxiety (named in the label)263
  • Suicidal Ideation257
  • Off Label Use (a use or a product term, not a reaction)251
  • Drug Interaction (a use or a product term, not a reaction)250
  • Depression241
  • Insomnia (named in the label)235
  • Neuroleptic Malignant Syndrome (named in the label)207

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ziprasidone: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions