Pemetrexed disodium adverse event reports that FDA received

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

Name type: Generic name
Class: Folate analog metabolic inhibitor
Also reported as: Pemetrexed Disodium For Injection

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 2,942 adverse event reports that name Pemetrexed disodium. In these reports the drug is a suspect or interacting product.

In the same period, 820 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 397 reports in the 12 months to June 2026 and 286 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, 397 (under 0.1%) name Pemetrexed disodium. Reports from consumers or other non-health professionals were 16.7% of the reports that name Pemetrexed disodium 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 Pemetrexed disodium 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 89 reports that name Pemetrexed disodium.
In January to March 2026, FDA received 85.
In April to June 2025, FDA received 58.

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 252 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 2,903 of the 2,942 reports (98.7%).

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 252 terms.

Reaction terms in the reports that name Pemetrexed disodium, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,942 reports
Myelosuppression	385	13.1%
Malignant neoplasm progression	282	9.6%
Anaemialow red blood cells	157	5.3%
Diarrhoealoose or frequent stools	148	5%
Nauseafeeling sick	145	4.9%
Neutropenialow neutrophils, a type of white blood cell	123	4.2%
White blood cell count decreasedlow white cell count	117	4%
Deaththe patient died; cause not stated by this term	112	3.8%
Febrile neutropeniafever with low white blood cells	111	3.8%
Platelet count decreasedlow platelet count	111	3.8%
Neutrophil count decreased	109	3.7%
Pancytopenialow counts of all blood cells	105	3.6%
Rashskin rash	105	3.6%
Pyrexiafever	99	3.4%
Astheniaweakness or lack of energy	97	3.3%
Vomitingbeing sick	96	3.3%
Fatiguetiredness	93	3.2%
Pneumonialung infection	87	3%
Dyspnoeashortness of breath	79	2.7%
Off label useused for a purpose or in a way not on the label	79	2.7%
Renal impairmentreduced kidney function	78	2.7%
Thrombocytopenialow platelets	78	2.7%
Decreased appetitereduced appetite	75	2.5%
Pneumonitis	69	2.3%
General physical health deteriorationgeneral decline in health	61	2.1%
Interstitial lung diseasescarring or inflammation of lung tissue	60	2%
Acute kidney injurysudden loss of kidney function	56	1.9%
Hepatic function abnormal	52	1.8%
Leukopenialow white blood cells	52	1.8%
Sepsisa severe body-wide response to infection	47	1.6%
Haemoglobin decreasedlow haemoglobin	44	1.5%
Dehydration	41	1.4%
Pleural effusionfluid around the lung	40	1.4%
Pruritusitching	40	1.4%
Pulmonary embolisma blood clot in the lung	39	1.3%
Respiratory failurethe lungs could not supply enough oxygen	37	1.3%
Hepatotoxicityliver injury	35	1.2%
Inappropriate schedule of product administrationthe product was taken at the wrong times	35	1.2%
Bone marrow failure	34	1.2%
Renal failurekidney failure	34	1.2%
Neuropathy peripheralnerve damage in hands or feet	33	1.1%
Abdominal painstomach or belly pain	32	1.1%
Constipation	32	1.1%
Mucosal inflammation	32	1.1%
Drug ineffectivethe medicine did not work as expected	30	1%
Alanine aminotransferase increasedraised liver enzyme (ALT)	29	1%
Blood creatinine increasedraised creatinine, a kidney test	29	1%
Colitisinflamed bowel	29	1%
Malaisegeneral feeling of being unwell	28	1%
Tubulointerstitial nephritis	27	0.9%

Download all 252 terms of Pemetrexed disodium (CSV)

The counts add to more than 2,942 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 Pemetrexed with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Pemetrexed	Generic name	18,409
Pemetrexed disodium (this page)	Generic name	2,942
Alimta	Brand name	11,274

Sum of the separately reported names: 32,625. 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 Pemetrexed disodium, 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
2004	24	24	3	5	21	0	0	5	0
2005	8	8	4	0	6	0	0	2	0
2006	11	11	4	1	10	0	0	2	0
2007	13	13	2	2	12	2	0	7	0
2008	13	13	5	3	10	0	0	2	0
2009	7	7	1	1	7	0	0	2	0
2010	41	41	8	8	34	1	0	8	0
2011	76	76	25	15	61	0	0	13	0
2012	105	105	41	20	82	4	0	25	0
2013	29	29	9	2	17	0	0	14	0
2014	12	12	2	2	8	0	0	9	0
2015	11	11	2	2	5	0	0	5	0
2016	25	25	5	1	14	1	0	19	0
2017	47	45	7	5	35	1	0	33	2
2018	123	116	16	17	75	2	0	83	7
2019	386	379	82	44	225	24	0	291	7
2020	366	362	83	42	190	11	0	256	4
2021	305	302	57	20	158	5	0	223	3
2022	271	268	46	24	169	10	2	190	3
2023	187	187	32	23	89	2	0	137	0
2024	313	309	33	31	172	12	0	202	4
2025	369	366	23	29	179	16	0	227	3
2026	200	200	18	12	117	3	0	107	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 Pemetrexed disodium, 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 Pemetrexed disodium, by the year in which FDA received them
Year	Reports
2004	21
2005	9
2006	11
2007	16
2008	13
2009	8
2010	46
2011	79
2012	109
2013	24
2014	13
2015	12
2016	23
2017	62
2018	185
2019	422
2020	376
2021	316
2022	220
2023	162
2024	294
2025	347
2026	174

Reports that name Pemetrexed disodium, 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 Pemetrexed disodium
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	0	0%
18 to 44	83	2.8%
45 to 64	1,047	35.6%
65 to 74	957	32.5%
75 and over	405	13.8%
Age not given	450	15.3%

Sex of the patient in the reports that name Pemetrexed disodium
Sex	Reports	Share
Female	909	30.9%
Male	1,674	56.9%
Unknown or not given	359	12.2%

Type of reporter in the reports that name Pemetrexed disodium
Reporter	Reports	Share
Physician	863	29.3%
Pharmacist	153	5.2%
Other health professional	1,408	47.9%
Lawyer	0	0%
Consumer or non-health professional	490	16.7%
Not given	28	1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 12.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Pemetrexed disodium record
Indication as recorded (MedDRA)	Reports	Share
Non-small cell lung cancer	822	27.9%
Lung neoplasm malignant	477	16.2%
Lung adenocarcinoma	349	11.9%
Lung adenocarcinoma stage iv	175	5.9%
Non-small cell lung cancer stage iv	106	3.6%
Non-small cell lung cancer metastatic	74	2.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,942 reports.

Drugs in the same reports

Other drugs that the reports of Pemetrexed disodium name, in any role, in order of name
Drug	Reports that name the two
Avastin	153
Bevacizumab	210
Carboplatin	1,760
Cisplatin	668
Dexamethasone	254
Folic acid	399
Keytruda	781
Nivolumab	289
Pembrolizumab	495
Sodium chloride	220

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

Pemetrexed same ingredient
Alimta same ingredient
Pralatrexate same class
Otrexup same class
Rasuvo same class
Methotrexate sodium same class
Penicillamine next in the A to Z list
Pembrolizumab next in the A to Z list
Penicillin next in the A to Z list
Pemazyre next in the A to Z list
Penicillin g next in the A to Z list
Pegylated Liposomal Irinotecan 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 Pemetrexed disodiumThe 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. Pemetrexed disodium: adverse event reports that FDA received. https://reportedreactions.com/drug/pemetrexed-disodium/ 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 Pemetrexed disodium as a suspect or interacting product. The 820 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 Pemetrexed disodium 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 Pemetrexed disodium?

No. It is a count of what people reported to FDA: 2,942 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?

Other health professional (47.9%), physician (29.3%) and consumer or non-health professional (16.7%). 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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