Ziprasidone hydrochloride adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Ziprasidone hydrochloride
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Atypical antipsychotic

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From September 2005 to June 2026, FDA received 1,010 adverse event reports that name Ziprasidone hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 366 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 19 reports in the 12 months to June 2026 and 22 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 19 (under 0.1%) name Ziprasidone hydrochloride. Reports for patients aged 18 to 44 were 58.7% of the reports that name Ziprasidone hydrochloride and 12.3% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Ziprasidone hydrochloride is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 7 reports that name Ziprasidone hydrochloride.
In January to March 2026, FDA received 3.
In April to June 2025, FDA received 3.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 124 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 991 of the 1,010 reports (98.1%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 124 terms.

Reaction terms in the reports that name Ziprasidone hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,010 reports
Drug ineffectivethe medicine did not work as expected	475	47%
Suicide attempta suicide attempt	418	41.4%
Sedationdrowsiness	382	37.8%
Sexual dysfunctiona sexual problem	373	36.9%
Dystoniainvoluntary muscle contractions	368	36.4%
Dyskinesiainvoluntary movements	367	36.3%
Blood prolactin abnormal	362	35.8%
Anosognosia	316	31.3%
Blood glucose increasedraised blood sugar reading	311	30.8%
Metabolic disorder	311	30.8%
Disturbance in social behaviour	308	30.5%
Personality change	286	28.3%
Condition aggravatedthe condition being treated got worse	254	25.1%
Weight increasedweight gain	184	18.2%
Schizophrenia	176	17.4%
Akathisiainner restlessness and an urge to move	165	16.3%
Toxicity to various agentspoisoning or toxic effect of one or more substances	129	12.8%
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)	119	11.8%
Euphoric mood	110	10.9%
Increased appetite	110	10.9%
Antipsychotic drug level below therapeutic	108	10.7%
Disinhibition	108	10.7%
Obsessive-compulsive disorder	108	10.7%
Dyslipidaemia	106	10.5%
Therapeutic product effect incomplete	105	10.4%
Therapeutic product effect variable	103	10.2%
Obesity	98	9.7%
Leukopenialow white blood cells	88	8.7%
Leukaemia	76	7.5%
Completed suicidedeath by suicide	75	7.4%
Insurance issue	72	7.1%
Product use in unapproved indicationused for a purpose not on the label	66	6.5%
Orthostatic hypertension	65	6.4%
Diabetes mellitusdiabetes	64	6.3%
Parkinsonism	64	6.3%
Hypertensionhigh blood pressure	58	5.7%
Prescribed overdose	58	5.7%
Off label useused for a purpose or in a way not on the label	57	5.6%
Metabolic syndrome	53	5.2%
Suicidal ideationthoughts of suicide	53	5.2%
Irritability	48	4.8%
Anxiety	45	4.5%
Depressionlow mood	43	4.3%
Insomniadifficulty sleeping	42	4.2%
Schizoaffective disorder	38	3.8%
Cognitive disorderproblems with thinking or memory	37	3.7%
Dizzinesslight-headedness or unsteadiness	35	3.5%
Oculogyric crisis	34	3.4%
Posture abnormal	31	3.1%
Impulse-control disorder	30	3%

Download all 124 terms of Ziprasidone hydrochloride (CSV)

The counts add to more than 1,010 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Ziprasidone with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Ziprasidone	Generic name	2,434
Ziprasidone hydrochloride (this page)	Generic name	1,010
Geodon	Brand name	8,566

Sum of the separately reported names: 12,010. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Ziprasidone hydrochloride, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2005	2	2	2	0	0	0	0	0	0
2007	1	1	1	0	0	0	0	0	0
2008	1	0	0	0	0	0	0	0	1
2009	1	1	0	0	1	0	0	1	0
2010	4	4	0	0	2	0	0	2	0
2011	89	86	17	8	28	3	0	52	3
2012	88	84	20	5	24	3	0	57	4
2013	15	13	1	0	8	0	0	9	2
2014	15	14	8	0	6	0	0	2	1
2015	5	2	1	0	0	0	0	2	3
2016	5	1	0	0	0	0	0	1	4
2017	19	14	3	5	8	1	0	11	5
2018	20	17	4	2	6	0	0	17	3
2019	77	72	1	2	11	0	0	70	5
2020	95	90	7	3	26	1	2	84	5
2021	152	146	9	2	33	2	1	142	6
2022	156	130	7	3	35	0	0	122	26
2023	126	124	8	2	56	1	0	121	2
2024	61	60	7	0	36	7	0	57	1
2025	51	48	1	5	36	0	0	44	3
2026	27	25	4	0	9	0	0	24	2

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Ziprasidone hydrochloride, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Ziprasidone hydrochloride, by the year in which FDA received them
Year	Reports
2005	2
2008	2
2009	1
2010	2
2011	84
2012	99
2013	14
2014	16
2015	5
2016	10
2017	26
2018	35
2019	106
2020	127
2021	160
2022	151
2023	100
2024	40
2025	20
2026	10

Reports that name Ziprasidone hydrochloride, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Ziprasidone hydrochloride
Age	Reports	Share
Under 2	0	0%
2 to 11	9	0.9%
12 to 17	33	3.3%
18 to 44	593	58.7%
45 to 64	121	12%
65 to 74	29	2.9%
75 and over	4	0.4%
Age not given	221	21.9%

Sex of the patient in the reports that name Ziprasidone hydrochloride
Sex	Reports	Share
Female	596	59%
Male	344	34.1%
Unknown or not given	70	6.9%

Type of reporter in the reports that name Ziprasidone hydrochloride
Reporter	Reports	Share
Physician	232	23%
Pharmacist	44	4.4%
Other health professional	470	46.5%
Lawyer	3	0.3%
Consumer or non-health professional	242	24%
Not given	19	1.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 31.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Ziprasidone hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Schizophrenia	487	48.2%
Bipolar disorder	30	3%
Schizoaffective disorder	16	1.6%
Psychotic disorder	12	1.2%
Depression	10	1%
Autism spectrum disorder	8	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,010 reports.

Drugs in the same reports

Other drugs that the reports of Ziprasidone hydrochloride name, in any role, in order of name
Drug	Reports that name the two
Abilify	304
Aripiprazole	435
Clozapine	424
Latuda	315
Olanzapine	438
Quetiapine fumarate	480
Risperdal	326
Risperidone	434
Saphris	395
Zyprexa	373

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Ziprasidone same ingredient
Geodon same ingredient
Ziprasidone hcl same class
Zyprexa same class
Zyprexa Zydis same class
Vraylar same class
Zirabev next in the A to Z list
Zithromac next in the A to Z list
Zioptan next in the A to Z list
Zithromax next in the A to Z list
Zinplava next in the A to Z list
Zmax next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Ziprasidone hydrochlorideThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Ziprasidone hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/ziprasidone-hydrochloride/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Ziprasidone hydrochloride as a suspect or interacting product. The 366 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Ziprasidone hydrochloride was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Ziprasidone hydrochloride?

No. It is a count of what people reported to FDA: 1,010 reports from September 2005 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (46.5%), consumer or non-health professional (24%) and physician (23%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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