Graft versus host disease adverse event reports that record this term

Kind of term: MedDRA preferred term

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.

Reports on file

From January 2004 to June 2026, FDA received 7,124 adverse event reports that record the MedDRA preferred term Graft versus host disease. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 284 reports in the 12 months to June 2026 and 410 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 1,247 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 284 (under 0.1%) record this term. Reports for female patients were 29.4% of the reports that record this term and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

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

Drugs in these reports

The table has the 119 drug pages with 25 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

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.

Drugs that the reports with the term Graft versus host disease name as a suspect product, in order of name
Drug	Class	Reports with this term
Acyclovir	Herpes simplex virus nucleoside analog DNA polymerase inhibitor	64
Adcetris	CD30-directed immunoconjugate	34
Adriamycin		27
Alemtuzumab	CD52-directed cytolytic antibody	129
Alkeran		43
Amphotericin b	Lipid-based polyene antifungal	30
Amsacrine		26
Anti-thymocyte globulin (rabbit)	Immunoglobulin G	42
Antithymocyte Immunoglobulin		81
Atovaquone	Antimalarial	28
Azacitidine	Nucleoside metabolic inhibitor	68
Azathioprine	Purine antimetabolite	71
Bactrim	Dihydrofolate reductase inhibitor antibacterial	35
Basiliximab	Interleukin-2 receptor blocking antibody	133
Blinatumomab		43
Blincyto		47
Bortezomib	Proteasome inhibitor	34
Budesonide	Corticosteroid	77
Busulfan	Alkylating drug	655
Busulfex		131
Campath	CD52-directed cytolytic antibody	71
Carboplatin	Platinum-based drug	40
Ceftazidime	Cephalosporin antibacterial	26
CellCept	Antimetabolite immunosuppressant	63
Ciclosporin		438
Ciprofloxacin	Fluoroquinolone antibacterial	37
Cisplatin	Platinum-based drug	83
Clofarabine	Nucleoside metabolic inhibitor	31
Corticosteroids		25
Cyclophosphamide	Alkylating drug	869
Cyclosporin A		31
Cyclosporine	Calcineurin inhibitor immunosuppressant	1,154
Cyclosporine a		26
Cytarabine	Nucleoside metabolic inhibitor	267
Dasatinib	Kinase inhibitor	26
Daunorubicin		60
Defitelio		76
Dexamethasone	Corticosteroid	208
Doxorubicin	Anthracycline topoisomerase inhibitor	71
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	48
Enbrel	Tumor necrosis factor blocker	25
Envarsus	Calcineurin inhibitor immunosuppressant	27
Etanercept	Tumor necrosis factor blocker	50
Etoposide	Topoisomerase inhibitor	203
Everolimus	Kinase inhibitor	30
Exjade	Iron chelator	55
Filgrastim	Leukocyte growth factor	61
Fluconazole	Azole antifungal	66
Fludara		147
Fludarabine	Nucleoside metabolic inhibitor	493
Fludarabine phosphate	Nucleoside metabolic inhibitor	256
Ganciclovir	Cytomegalovirus nucleoside analog DNA polymerase inhibitor	119
Gemcitabine	Nucleoside metabolic inhibitor	55
Gilteritinib		25
Gleevec	Kinase inhibitor	39
Glivec		35
Human immunoglobulin g	Human immunoglobulin G	27
Hydrocortisone	Corticosteroid	67
Hydroxyurea	Antimetabolite	26
Ibrutinib (form s4)	Kinase inhibitor	34
Iclusig	Kinase inhibitor	51
Idarubicin		52
Ifosfamide	Alkylating drug	32
Imatinib	Kinase inhibitor	100
Imbruvica	Kinase inhibitor	45
Infliximab	Tumor necrosis factor blocker	28
Jakafi	Janus kinase inhibitor	270
Jakavi		49
Lapine t-lymphocyte immune globulin		36
Lenalidomide	Thalidomide analog	44
Melphalan	Alkylating drug	285
Melphalan hydrochloride		42
Methotrexate	Folate analog metabolic inhibitor	780
Methotrexate sodium	Folate analog metabolic inhibitor	62
Methylprednisolone	Corticosteroid	456
Midostaurin		42
Mycophenolate		74
Mycophenolate mofetil	Antimetabolite immunosuppressant	1,062
Mycophenolic acid	Antimetabolite immunosuppressant	85
Neoral	Calcineurin inhibitor immunosuppressant	71
Nivolumab	Programmed death Receptor-1 blocking antibody	58
Oxaliplatin	Platinum-based drug	37
Ponatinib		80
Posaconazole	Azole antifungal	50
Prednisolone	Corticosteroid	313
Prednisone	Corticosteroid	485
Procytox		26
Procytox 2000mg/Vial		32
Prograf	Calcineurin inhibitor immunosuppressant	330
Rapamune		49
Revlimid	Thalidomide analog	143
Rezurock		33
Rituxan	CD20-directed cytolytic antibody	36
Rituximab	CD20-directed cytolytic antibody	258
Ruxolitinib	Janus kinase inhibitor	201
Sandimmune	Calcineurin inhibitor immunosuppressant	51
Sirolimus	Kinase inhibitor	120
Soliris	Complement inhibitor	130
Sorafenib	Kinase inhibitor	48
Sprycel	Kinase inhibitor	25
Sulfamethoxazole, trimethoprim	Dihydrofolate reductase inhibitor antibacterial	36
Tacrolimus	Calcineurin inhibitor immunosuppressant	990
Thalidomide		55
Thiotepa	Alkylating drug	240
Thymocyte Immune Globulin		65
Thymoglobulin	Immunoglobulin G	151
Thymoglobuline		28
Treosulfan		59
Valganciclovir	Cytomegalovirus nucleoside analog DNA polymerase inhibitor	51
Valganciclovir hydrochloride	Cytomegalovirus nucleoside analog DNA polymerase inhibitor	30
Vancomycin	Glycopeptide antibacterial	53
Velcade	Proteasome inhibitor	54
Venclexta	BCL-2 inhibitor	30
Venetoclax	BCL-2 inhibitor	34
Vfend	Azole antifungal	37
Vidaza	Nucleoside metabolic inhibitor	46
Vincristine		113
Voriconazole	Azole antifungal	117
Xospata		43

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 42 pharmacologic classes with 25 or more reports that record this term. The rows are in order of name.

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.

Pharmacologic classes of the drugs that the reports with the term Graft versus host disease name, in order of name
Class	Reports with this term
Alkylating drug	2,119
Anthracycline topoisomerase inhibitor	136
Antimalarial	30
Antimetabolite	26
Antimetabolite immunosuppressant	1,213
Azole antifungal	310
BCL-2 inhibitor	64
Benzodiazepine	36
Calcineurin inhibitor immunosuppressant	2,628
CD20-directed cytolytic antibody	307
CD22-directed immunoconjugate	26
CD30-directed immunoconjugate	43
CD52-directed cytolytic antibody	200
Cephalosporin antibacterial	34
Complement inhibitor	134
Corticosteroid	1,696
Cytomegalovirus nucleoside analog DNA polymerase inhibitor	209
Dihydrofolate reductase inhibitor antibacterial	82
Echinocandin antifungal	65
Fluoroquinolone antibacterial	65
Folate analog metabolic inhibitor	842
Glycopeptide antibacterial	53
Herpes simplex virus nucleoside analog DNA polymerase inhibitor	78
Human immunoglobulin G	44
Immunoglobulin G	202
Interleukin-2 receptor blocking antibody	151
Iron chelator	58
Janus kinase inhibitor	471
Kinase inhibitor	570
Leukocyte growth factor	84
Lipid-based polyene antifungal	35
Loop diuretic	39
Nucleoside metabolic inhibitor	1,256
Platinum-based drug	160
Programmed death Receptor-1 blocking antibody	94
Proteasome inhibitor	108
Purine antimetabolite	81
Pyrophosphate analog DNA polymerase inhibitor	31
Thalidomide analog	200
Thrombopoietin receptor agonist	35
Topoisomerase inhibitor	225
Tumor necrosis factor blocker	124

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Graft versus host disease, 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.

Patients in these reports

Age of the patient in the reports that record Graft versus host disease
Age	Reports	Share
Under 2	214	3%
2 to 11	532	7.5%
12 to 17	325	4.6%
18 to 44	1,282	18%
45 to 64	1,785	25.1%
65 to 74	412	5.8%
75 and over	30	0.4%
Age not given	2,544	35.7%

Sex of the patient in the reports that record Graft versus host disease
Sex	Reports	Share
Female	2,096	29.4%
Male	3,171	44.5%
Unknown or not given	1,857	26.1%

Age and sex are as the report gives them. 31.5% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

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. Graft versus host disease: adverse event reports that record this term. https://reportedreactions.com/reaction/graft-versus-host-disease/ 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.

The count has the reports with each spelling of one MedDRA preferred term. 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

What does Graft versus host disease mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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