Gemzar adverse event reports that FDA received

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

Name type: Product name as reported

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 January 2004 to June 2026, FDA received 8,242 adverse event reports that name Gemzar. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 2,836 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 66 reports in the 12 months to June 2026 and 116 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, 66 (under 0.1%) name Gemzar. Reports from physicians were 46.6% of the reports that name Gemzar and 21.9% 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 Gemzar 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 10 reports that name Gemzar.
In January to March 2026, FDA received 21.
In April to June 2025, FDA received 27.

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 586 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 all 8,242 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 586 terms.

Reaction terms in the reports that name Gemzar, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 8,242 reports
Malignant neoplasm progression	857	10.4%
Pyrexiafever	505	6.1%
Thrombocytopenialow platelets	502	6.1%
Off label useused for a purpose or in a way not on the label	457	5.5%
Anaemialow red blood cells	448	5.4%
Deaththe patient died; cause not stated by this term	414	5%
Dyspnoeashortness of breath	414	5%
Nauseafeeling sick	399	4.8%
Interstitial lung diseasescarring or inflammation of lung tissue	370	4.5%
Platelet count decreasedlow platelet count	352	4.3%
Vomitingbeing sick	323	3.9%
White blood cell count decreasedlow white cell count	292	3.5%
Pleural effusionfluid around the lung	268	3.3%
Neoplasm progression	266	3.2%
Fatiguetiredness	263	3.2%
Astheniaweakness or lack of energy	259	3.1%
Diarrhoealoose or frequent stools	253	3.1%
Neutropenialow neutrophils, a type of white blood cell	251	3%
Oedema peripheralswelling of the legs, ankles or hands	237	2.9%
Pneumonialung infection	230	2.8%
Haemoglobin decreasedlow haemoglobin	207	2.5%
Disease progressionthe disease advanced	202	2.5%
General physical health deteriorationgeneral decline in health	201	2.4%
Pancytopenialow counts of all blood cells	201	2.4%
Rashskin rash	198	2.4%
Renal failurekidney failure	198	2.4%
Abdominal painstomach or belly pain	189	2.3%
Dehydration	180	2.2%
Decreased appetitereduced appetite	176	2.1%
Febrile neutropeniafever with low white blood cells	168	2%
Sepsisa severe body-wide response to infection	168	2%
Ascitesfluid in the abdomen	154	1.9%
Pulmonary embolisma blood clot in the lung	152	1.8%
Haemolytic uraemic syndrome	148	1.8%
Pneumonitis	140	1.7%
Neutrophil count decreased	139	1.7%
Malaisegeneral feeling of being unwell	138	1.7%
Painpain, site not specified	137	1.7%
Deep vein thrombosisa blood clot in a deep vein	130	1.6%
Respiratory failurethe lungs could not supply enough oxygen	129	1.6%
Thrombotic microangiopathy	128	1.6%
Constipation	127	1.5%
Erythemaskin redness	124	1.5%
Bone marrow failure	123	1.5%
Leukopenialow white blood cells	120	1.5%
Chillschills or shivering	118	1.4%
Renal failure acute	117	1.4%
Aspartate aminotransferase increasedraised liver enzyme (AST)	116	1.4%
Cardiac failureheart failure	116	1.4%
Hypertensionhigh blood pressure	115	1.4%

Download all 586 terms of Gemzar (CSV)

The counts add to more than 8,242 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.

Outcomes by year

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

Outcomes in the reports that name Gemzar, 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
2004	641	622	162	52	430	18	173	19
2005	658	642	152	66	380	27	274	16
2006	519	511	121	41	266	28	260	8
2007	481	473	124	29	263	21	231	8
2008	555	541	123	34	285	20	296	14
2009	443	442	133	29	230	11	220	1
2010	568	562	207	30	226	14	305	6
2011	400	397	149	31	194	3	197	3
2012	427	422	208	33	193	10	182	5
2013	276	271	99	27	130	8	120	5
2014	265	259	69	21	118	2	145	6
2015	924	746	256	37	226	4	433	178
2016	296	277	56	21	139	12	170	19
2017	278	247	34	26	122	5	158	31
2018	221	202	27	12	96	2	117	19
2019	246	234	24	19	118	3	143	12
2020	203	193	37	10	93	3	112	10
2021	235	229	36	20	100	4	131	6
2022	153	150	18	16	81	1	78	3
2023	165	162	19	21	86	2	89	3
2024	134	125	13	12	70	1	70	9
2025	113	107	15	13	46	1	67	6
2026	41	38	6	7	10	0	32	3

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 Gemzar, 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 Gemzar, by the year in which FDA received them
Year	Reports
2004	573
2005	631
2006	554
2007	460
2008	466
2009	632
2010	577
2011	412
2012	481
2013	260
2014	262
2015	905
2016	287
2017	282
2018	217
2019	228
2020	200
2021	245
2022	143
2023	160
2024	133
2025	101
2026	31

Reports that name Gemzar, 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 Gemzar
Age	Reports	Share
Under 2	1	under 0.1%
2 to 11	2	under 0.1%
12 to 17	16	0.2%
18 to 44	354	4.3%
45 to 64	2,322	28.2%
65 to 74	1,792	21.7%
75 and over	898	10.9%
Age not given	2,857	34.7%

Sex of the patient in the reports that name Gemzar
Sex	Reports	Share
Female	3,767	45.7%
Male	3,927	47.6%
Unknown or not given	548	6.6%

Type of reporter in the reports that name Gemzar
Reporter	Reports	Share
Physician	3,839	46.6%
Pharmacist	419	5.1%
Other health professional	1,259	15.3%
Lawyer	11	0.1%
Consumer or non-health professional	2,520	30.6%
Not given	194	2.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 33.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Gemzar record
Indication as recorded (MedDRA)	Reports	Share
Pancreatic carcinoma	1,297	15.7%
Non-small cell lung cancer	592	7.2%
Breast cancer metastatic	253	3.1%
Breast cancer	247	3%
Lung neoplasm malignant	241	2.9%
Ovarian cancer	236	2.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 8,242 reports.

Drugs in the same reports

Other drugs that the reports of Gemzar name, in any role, in order of name
Drug	Reports that name the two
Abraxane	287
Alimta	210
Avastin	247
Carboplatin	1,118
Cisplatin	949
Dexamethasone	309
Oxaliplatin	217
Paclitaxel	239
Taxol	263
Taxotere	327

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for GemzarThe 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. Gemzar: adverse event reports that FDA received. https://reportedreactions.com/drug/gemzar/ 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 Gemzar as a suspect or interacting product. The 2,836 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 Gemzar 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 Gemzar?

No. It is a count of what people reported to FDA: 8,242 reports from January 2004 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?

Physician (46.6%), consumer or non-health professional (30.6%) and other health professional (15.3%). 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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