Ziprasidone hydrochloride: adverse event reports filed with FDA

1,010

reports as suspect product

0% of all reports · about 48 a year

19

reports, 12 months to June 2026

22 in the 12 months before

92.5%

marked serious by the reporter

70.7% across the class

10%

record death among outcomes, as reported

101 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 hydrochloride reports recording the termmedian drug in atypical antipsychotic

1. Drug ineffectivethe medicine did not work as expected47%475
2. Suicide attempta suicide attempt41.4%418
3. Sedationdrowsiness from a medicine37.8%382
4. Sexual dysfunctiona sexual problem36.9%373
5. Dystoniainvoluntary muscle contractions36.4%368
6. Dyskinesiainvoluntary movements36.3%367
7. Blood prolactin abnormal35.8%362
8. Anosognosia31.3%316
9. Blood glucose increasedraised blood sugar reading30.8%311
10. Metabolic disorder30.8%311
11. Disturbance in social behaviour30.5%308
12. Personality change28.3%286
13. Condition aggravatedthe condition being treated got worse25.1%254
14. Weight increasedweight gain18.2%184
15. Schizophreniaschizophrenia17.4%176
16. Akathisiainner restlessness and an urge to move16.3%165
17. Toxicity to various agentspoisoning or toxic effect of one or more substances12.8%129
18. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine11.8%119
19. Euphoric mood10.9%110
20. Increased appetite10.9%110
21. Antipsychotic drug level below therapeutic10.7%108
22. Disinhibition10.7%108
23. Obsessive-compulsive disorder10.7%108
24. Dyslipidaemia10.5%106
25. Therapeutic product effect incomplete10.4%105
26. Therapeutic product effect variable10.2%103
27. Obesity9.7%98
28. Leukopenialow white blood cells8.7%88
29. Leukaemia7.5%76
30. Completed suicidedeath by suicide7.4%75

Top 30 of 282 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. 31.4% 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 1,010 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ziprasidone hydrochloride 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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (366) 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.