Zolinza (vorinostat) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Vorinostat
Class: Histone deacetylase inhibitor
Also reported as: Zolinza Capsules 100mg

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 March 2007 to June 2026, FDA received 630 adverse event reports that name Zolinza. In these reports the drug is a suspect or interacting product.

In the same period, 76 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 3 reports in the 12 months to June 2026 and 5 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, 3 (under 0.1%) name Zolinza. Reports from consumers or other non-health professionals were 18.3% of the reports that name Zolinza and 45.8% 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 Zolinza 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 1 report that names Zolinza.
In January to March 2026, FDA received 2.
In April to June 2025, FDA received 0.

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 52 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 605 of the 630 reports (96%).

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 52 terms.

Reaction terms in the reports that name Zolinza, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 630 reports
Product use in unapproved indicationused for a purpose not on the label	51	8.1%
Platelet count decreasedlow platelet count	50	7.9%
Nauseafeeling sick	44	7%
Fatiguetiredness	40	6.3%
Diarrhoealoose or frequent stools	39	6.2%
Dehydration	36	5.7%
Deaththe patient died; cause not stated by this term	33	5.2%
Off label useused for a purpose or in a way not on the label	32	5.1%
Thrombocytopenialow platelets	31	4.9%
Decreased appetitereduced appetite	29	4.6%
Vomitingbeing sick	25	4%
Anaemialow red blood cells	24	3.8%
Weight decreasedweight loss	22	3.5%
Pyrexiafever	19	3%
Drug ineffectivethe medicine did not work as expected	18	2.9%
Dysgeusiaaltered taste	18	2.9%
Disease progressionthe disease advanced	17	2.7%
Mycosis fungoides	16	2.5%
Malaisegeneral feeling of being unwell	14	2.2%
Febrile neutropeniafever with low white blood cells	13	2.1%
Product use issuea problem in how the product was used	13	2.1%
Adverse eventan unwanted medical event, type not specified	11	1.7%
Headachehead pain	11	1.7%
Alopeciahair loss	10	1.6%
Astheniaweakness or lack of energy	10	1.6%
Blood creatinine increasedraised creatinine, a kidney test	10	1.6%
Pulmonary embolisma blood clot in the lung	10	1.6%
Sepsisa severe body-wide response to infection	10	1.6%
Syncopefainting	10	1.6%
Hypokalaemialow blood potassium	9	1.4%
Neutropenialow neutrophils, a type of white blood cell	9	1.4%
Rashskin rash	9	1.4%
Renal failurekidney failure	9	1.4%
Renal impairmentreduced kidney function	9	1.4%
Anorexia	8	1.3%
Deep vein thrombosisa blood clot in a deep vein	8	1.3%
Dizzinesslight-headedness or unsteadiness	8	1.3%
Electrocardiogram QT prolongeda QT prolongation on the ECG	8	1.3%
Product administered to patient of inappropriate age	8	1.3%
Constipation	7	1.1%
Pruritusitching	7	1.1%
Therapy cessation	7	1.1%
Torsade de pointesa serious irregular heart rhythm	7	1.1%
Hospitalisationadmission to hospital	6	1%
White blood cell count decreasedlow white cell count	6	1%
Abdominal painstomach or belly pain	5	0.8%
Hepatic function abnormal	5	0.8%
No adverse eventno adverse event was reported	5	0.8%
Oedema peripheralswelling of the legs, ankles or hands	5	0.8%
Painpain, site not specified	5	0.8%

Download all 52 terms of Zolinza (CSV)

The counts add to more than 630 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 Vorinostat with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Vorinostat	Generic name	1,441
Zolinza (this page)	Brand name	630

Sum of the separately reported names: 2,071. 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 Zolinza, 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	Other Serious (Important Medical Events)	Not serious
2007	50	28	11	11	13	4	13	22
2008	30	12	5	0	7	1	3	18
2009	26	16	4	2	11	5	4	10
2010	18	17	6	3	12	2	2	1
2011	20	20	7	2	11	3	7	0
2012	47	46	11	9	35	0	13	1
2013	54	48	12	7	28	3	16	6
2014	52	44	20	10	25	6	21	8
2015	69	48	12	13	22	5	29	21
2016	45	33	8	4	14	1	18	12
2017	31	19	5	4	9	1	13	12
2018	32	18	9	0	7	1	7	14
2019	29	3	0	0	1	0	3	26
2020	27	11	3	1	5	0	6	16
2021	23	9	2	3	4	0	4	14
2022	44	23	4	1	14	0	12	21
2023	19	5	0	0	2	0	4	14
2024	8	7	2	2	3	0	6	1
2025	3	1	0	1	0	0	0	2
2026	3	3	1	0	1	0	1	0

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 Zolinza, 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 Zolinza, by the year in which FDA received them
Year	Reports
2007	40
2008	33
2009	30
2010	21
2011	19
2012	77
2013	63
2014	41
2015	70
2016	29
2017	29
2018	28
2019	30
2020	27
2021	24
2022	40
2023	17
2024	7
2025	2
2026	3

Reports that name Zolinza, 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 Zolinza
Age	Reports	Share
Under 2	21	3.3%
2 to 11	25	4%
12 to 17	18	2.9%
18 to 44	47	7.5%
45 to 64	159	25.2%
65 to 74	107	17%
75 and over	86	13.7%
Age not given	167	26.5%

Sex of the patient in the reports that name Zolinza
Sex	Reports	Share
Female	245	38.9%
Male	298	47.3%
Unknown or not given	87	13.8%

Type of reporter in the reports that name Zolinza
Reporter	Reports	Share
Physician	172	27.3%
Pharmacist	83	13.2%
Other health professional	207	32.9%
Lawyer	0	0%
Consumer or non-health professional	115	18.3%
Not given	53	8.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 75.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Zolinza record
Indication as recorded (MedDRA)	Reports	Share
Mycosis fungoides	153	24.3%
Cutaneous t-cell lymphoma	31	4.9%
Acute myeloid leukaemia	23	3.7%
T-cell lymphoma	22	3.5%
Acute lymphocytic leukaemia	16	2.5%
Neoplasm malignant	12	1.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 630 reports.

Pages near this one

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

Official pages

DailyMed labels for ZolinzaThe 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. Zolinza: adverse event reports that FDA received. https://reportedreactions.com/drug/zolinza/ 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 Zolinza as a suspect or interacting product. The 76 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 Zolinza 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 Zolinza?

No. It is a count of what people reported to FDA: 630 reports from March 2007 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 (32.9%), physician (27.3%) and consumer or non-health professional (18.3%). 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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