Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

G-Csf adverse event reports that FDA received

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 . The data have the reports that FDA received through .

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 .

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 .

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

Reports on file

From January 2004 to December 2020, FDA received 1,454 adverse event reports that name G-Csf. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,814 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received no report that names G-Csf in the five years to June 2026. The latest report was received in December 2020.

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 . The site read the page on .

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which G-Csf 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 .

Data version

openFDA FAERS release of 1 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 .

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 . The site read the page on .

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

FDA received no report that names G-Csf in April to June 2026, in January to March 2026 or in April to June 2025.

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 updatesFeed 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 195 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 1,444 of the 1,454 reports (99.3%).

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.

The table shows the first 50 of 195 terms.

Reaction terms in the reports that name G-Csf, most reports first
Reaction term (MedDRA) and plain meaningReportsShare of the 1,454 reports
Febrile neutropeniafever with low white blood cells21815%
Pyrexiafever14710.1%
Neutropenialow neutrophils, a type of white blood cell1339.1%
Deaththe patient died; cause not stated by this term946.5%
Nauseafeeling sick865.9%
Haematotoxicity845.8%
Diarrhoealoose or frequent stools825.6%
Vomitingbeing sick735%
Sepsisa severe body-wide response to infection714.9%
Hypotensionlow blood pressure694.7%
Thrombocytopenialow platelets684.7%
Pneumonialung infection614.2%
Disease progressionthe disease advanced563.9%
Mucosal inflammation513.5%
Platelet count decreasedlow platelet count493.4%
Dehydration483.3%
Haemoglobin decreasedlow haemoglobin463.2%
Off label useused for a purpose or in a way not on the label443%
Abdominal painstomach or belly pain402.8%
Dyspnoeashortness of breath402.8%
Neutrophil count decreased402.8%
Anaemialow red blood cells392.7%
Pleural effusionfluid around the lung392.7%
Pulmonary embolisma blood clot in the lung392.7%
Respiratory failurethe lungs could not supply enough oxygen392.7%
Renal failurekidney failure372.5%
White blood cell count decreasedlow white cell count372.5%
Fatiguetiredness362.5%
Infectionan infection, type not specified352.4%
Drug resistance332.3%
Staphylococcal infection332.3%
Blood culture positive322.2%
Product use in unapproved indicationused for a purpose not on the label322.2%
Septic shockshock arising from infection322.2%
Acute myeloid leukaemia recurrent281.9%
Chillschills or shivering281.9%
Pancytopenialow counts of all blood cells281.9%
Multi-organ failure251.7%
Bone marrow failure241.7%
Hypoxialow oxygen241.7%
Tachycardiafast heart rate241.7%
Acute lymphocytic leukaemia recurrent231.6%
Hypertensionhigh blood pressure221.5%
Painpain, site not specified211.4%
Respiratory distressdifficulty breathing211.4%
Hypokalaemialow blood potassium201.4%
Astheniaweakness or lack of energy191.3%
Constipation191.3%
Leukopenialow white blood cells191.3%
Pulmonary oedemafluid in the lungs191.3%

Download all 195 terms of G-Csf (CSV)

The counts add to more than 1,454 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 .

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 G-Csf, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA fileReportsSeriousDeathLife-threateningHospitalization (initial or prolonged)Disability or Permanent DamageCongenital Anomaly/Birth DefectOther Serious (Important Medical Events)Not serious
20041094160011
20051108414257006126
2006827112061003511
20079781717700416
2008605860531032
2009767480670012
2010393740340012
2011424290311060
201290891847320231
2013989831145420430
20141261262232300980
20151161148341320902
201694922881610692
201768652322310393
20181241245013100770
201996931725500453
202012612022194200686

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 .

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 .

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 G-Csf, by the year in which FDA received them
0100200200420072010201320162019
Show the figures of the chart as a table
Reports that name G-Csf, by the year in which FDA received them
YearReports
20049
2005111
200682
200797
200861
200976
201039
201145
2012104
201391
2014137
2015107
201690
2017102
201895
201986
2020122

FDA received no report that names G-Csf in the five years to June 2026. FDA received the latest report in December 2020.

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 G-Csf
AgeReportsShareShare as a bar
Under 2201.4%
2 to 11745.1%
12 to 17271.9%
18 to 4419613.5%
45 to 6419513.4%
65 to 74976.7%
75 and over463.2%
Age not given79955%
Sex of the patient in the reports that name G-Csf
SexReportsShareShare as a bar
Female53837%
Male62843.2%
Unknown or not given28819.8%
Type of reporter in the reports that name G-Csf
ReporterReportsShareShare as a bar
Physician51735.6%
Pharmacist70.5%
Other health professional39227%
Lawyer00%
Consumer or non-health professional553.8%
Not given48333.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 43.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of G-Csf record
Indication as recorded (MedDRA)ReportsShare
Acute myeloid leukaemia1157.9%
Diffuse large b-cell lymphoma845.8%
Prophylaxis704.8%
Peripheral blood stem cell apheresis604.1%
Acute lymphocytic leukaemia453.1%
Ovarian cancer332.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,454 reports.

Pages near this one

These links are for navigation. No count selected them.

Official pages

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

Cite this page

Reported Reactions. G-Csf: adverse event reports that FDA received. https://reportedreactions.com/drug/g-csf/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names G-Csf as a suspect or interacting product. The 1,814 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 G-Csf 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 . The site read the page on .

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 G-Csf?

No. It is a count of what people reported to FDA: 1,454 reports from January 2004 to December 2020. 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 (35.6%), other health professional (27%) and consumer or non-health professional (3.8%). 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 .

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.