Ziprasidone: adverse event reports filed with FDA

2,434

reports as suspect product

0% of all reports · about 108 a year

141

reports, 12 months to June 2026

83 in the 12 months before

89.6%

marked serious by the reporter

70.7% across the class

21.9%

record death among outcomes, as reported

534 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Ziprasidone reports recording the termmedian drug in atypical antipsychotic

1. Drug ineffectivethe medicine did not work as expected18.6%452
2. Completed suicidedeath by suicide13.8%337
3. Toxicity to various agentspoisoning or toxic effect of one or more substances11%268
4. Suicide attempta suicide attempt9.6%234
5. Weight increasedweight gain8.4%205
6. Sedationdrowsiness from a medicine6.5%159
7. Dyskinesiainvoluntary movements6.3%154
8. Akathisiainner restlessness and an urge to move5.8%142
9. Neuroleptic malignant syndromea rare severe reaction with fever and rigidity5.8%142
10. Condition aggravatedthe condition being treated got worse5.8%140
11. Dystoniainvoluntary muscle contractions5.5%135
12. Drug interactionan interaction between medicines5.2%126
13. Off label useused for a purpose or in a way not on the label5.1%125
14. Suicidal ideationthoughts of suicide5%121
15. Sexual dysfunctiona sexual problem4.7%114
16. Blood prolactin abnormal4.5%109
17. Schizophreniaschizophrenia4.4%107
18. Anxietyanxiety4.3%104
19. Obesity4.3%104
20. Metabolic disorder4.2%103
21. Anosognosia4.1%101
22. Blood glucose increasedraised blood sugar reading4.1%100
23. Disturbance in social behaviour4%97
24. Insomniadifficulty sleeping3.8%93
25. Irritabilityirritability3.8%92
26. Personality change3.7%91
27. Therapeutic product effect incomplete3.6%88
28. Dyslipidaemia3.6%87
29. Aggressionaggressive behaviour3.5%86
30. Product use in unapproved indicationused for a purpose not on the label3.5%86

Top 30 of 550 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 37 drugs in the atypical antipsychotic class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 683,680 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 63.2% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 2,434 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ziprasidone is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the atypical antipsychotic class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Ziprasidone as a suspect or interacting product; reports listing it only as a concomitant medication (1,301) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.