Myelodysplastic syndrome 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 14,252 adverse event reports that record the MedDRA preferred term Myelodysplastic syndrome. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 692 reports in the 12 months to June 2026 and 724 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 810 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, 692 (0.1%) record this term. Reports for female patients were 38.8% 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 105 drug pages with 50 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 Myelodysplastic syndrome name as a suspect product, in order of name
Drug	Class	Reports with this term
Adriamycin		108
Alkeran		82
Aranesp	Erythropoiesis-stimulating agent	104
Aspirin	Nonsteroidal anti-inflammatory drug	61
Avastin	Vascular endothelial growth factor inhibitor	73
Axicabtagene ciloleucel	CD19-directed chimeric antigen receptor	209
Azacitidine	Nucleoside metabolic inhibitor	288
Azathioprine	Purine antimetabolite	128
Bendamustine		149
Bendamustine hydrochloride	Alkylating drug	85
Bevacizumab	Vascular endothelial growth factor inhibitor	157
Bicnu		59
Bleomycin	Cytoprotective agent	107
Bortezomib	Proteasome inhibitor	160
Brexucabtagene autoleucel		50
Busulfan	Alkylating drug	99
Capecitabine	Nucleoside metabolic inhibitor	91
Carboplatin	Platinum-based drug	809
Carfilzomib	Proteasome inhibitor	91
Carmustine	Alkylating drug	279
Chlorambucil	Alkylating drug	90
Cisplatin	Platinum-based drug	571
Cladribine	Purine antimetabolite	62
Cyclophosphamide	Alkylating drug	2,010
Cyclosporine	Calcineurin inhibitor immunosuppressant	131
Cytarabine	Nucleoside metabolic inhibitor	821
Dacarbazine	Alkylating drug	81
Daratumumab	CD38-directed cytolytic antibody	98
Darbepoetin alfa	Erythropoiesis-stimulating agent	73
Daunorubicin		57
Dexamethasone	Corticosteroid	870
Docetaxel	Microtubule inhibitor	142
Doxil	Anthracycline topoisomerase inhibitor	69
Doxorubicin	Anthracycline topoisomerase inhibitor	798
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	505
Enbrel	Tumor necrosis factor blocker	109
Endoxan		63
Etoposide	Topoisomerase inhibitor	1,133
Exjade	Iron chelator	324
Filgrastim	Leukocyte growth factor	85
Fludara		77
Fludarabine	Nucleoside metabolic inhibitor	457
Fludarabine phosphate	Nucleoside metabolic inhibitor	230
Fluorouracil	Nucleoside metabolic inhibitor	150
Gemcitabine	Nucleoside metabolic inhibitor	173
Gemcitabine hydrochloride	Nucleoside metabolic inhibitor	71
Humira		222
Ibrutinib (form s4)	Kinase inhibitor	60
Idarubicin		84
Idarubicin hydrochloride	Anthracycline topoisomerase inhibitor	58
Ifosfamide	Alkylating drug	519
Imbruvica	Kinase inhibitor	55
Irinotecan		84
Jakafi	Janus kinase inhibitor	53
Kymriah	CD19-directed chimeric antigen receptor	62
Lenalidomide	Thalidomide analog	386
Lynparza	Poly(ADP-Ribose) polymerase inhibitor	301
Mabthera		123
Melphalan	Alkylating drug	599
Mercaptopurine	Nucleoside metabolic inhibitor	116
Mesna	Cytoprotective agent	71
Methotrexate	Folate analog metabolic inhibitor	856
Methotrexate sodium	Folate analog metabolic inhibitor	117
Methylprednisolone	Corticosteroid	116
Mitoxantrone	Topoisomerase inhibitor	195
Mycophenolate mofetil	Antimetabolite immunosuppressant	141
Neupogen	Leukocyte growth factor	61
Niraparib	Poly(ADP-Ribose) polymerase inhibitor	73
Nplate	Thrombopoietin receptor agonist	202
Obinutuzumab	CD20-directed cytolytic antibody	52
Olaparib	Poly(ADP-Ribose) polymerase inhibitor	175
Oxaliplatin	Platinum-based drug	133
Paclitaxel	Microtubule inhibitor	452
Pantoprazole	Proton pump inhibitor	60
Pomalidomide	Thalidomide analog	76
Prednisolone	Corticosteroid	369
Prednisone	Corticosteroid	852
Procarbazine		139
Procrit	Erythropoiesis-stimulating agent	71
Promacta	Thrombopoietin receptor agonist	71
Radiotherapy		51
Reblozyl		52
Remicade	Tumor necrosis factor blocker	85
Revlimid	Thalidomide analog	1,717
Rituxan	CD20-directed cytolytic antibody	70
Rituximab	CD20-directed cytolytic antibody	1,244
Simvastatin	HMG-CoA reductase inhibitor	56
Soliris	Complement inhibitor	300
Tacrolimus	Calcineurin inhibitor immunosuppressant	117
Taxol		72
Temozolomide	Alkylating drug	66
Thalidomide		137
Thalomid		114
Tretinoin	Retinoid	56
Velcade	Proteasome inhibitor	165
Venclexta	BCL-2 inhibitor	159
Venetoclax	BCL-2 inhibitor	144
Vidaza	Nucleoside metabolic inhibitor	362
Vinblastine		67
Vincristine		943
Vincristine sulfate	Vinca alkaloid	309
Yescarta	CD19-directed chimeric antigen receptor	60
Zejula	Poly(ADP-Ribose) polymerase inhibitor	79
Zevalin		59
Zometa		52

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 48 pharmacologic classes with 50 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 Myelodysplastic syndrome name, in order of name
Class	Reports with this term
Alkylating drug	4,002
Angiotensin 2 receptor blocker	106
Anthracycline topoisomerase inhibitor	1,464
Antimalarial	61
Antimetabolite	57
Antimetabolite immunosuppressant	161
Antirheumatic agent	60
Atypical antipsychotic	62
Azole antifungal	55
BCL-2 inhibitor	303
beta-Adrenergic blocker	83
Bisphosphonate	67
Calcineurin inhibitor immunosuppressant	289
CD19-directed chimeric antigen receptor	353
CD20-directed cytolytic antibody	1,383
CD38-directed cytolytic antibody	153
Complement inhibitor	334
Corticosteroid	2,246
Cytoprotective agent	223
Erythropoiesis-stimulating agent	333
Factor Xa inhibitor	134
Folate analog metabolic inhibitor	985
HER2/neu receptor antagonist	85
HMG-CoA reductase inhibitor	102
Interleukin-6 receptor antagonist	70
Iron chelator	371
Janus kinase inhibitor	149
Kinase inhibitor	436
Leukocyte growth factor	203
Loop diuretic	62
Microtubule inhibitor	598
Nonsteroidal anti-inflammatory drug	124
Nucleoside metabolic inhibitor	2,827
Opioid agonist	65
P2Y12 platelet inhibitor	99
Platinum-based drug	1,513
Poly(ADP-Ribose) polymerase inhibitor	667
Programmed death Receptor-1 blocking antibody	151
Proteasome inhibitor	465
Proton pump inhibitor	98
Purine antimetabolite	208
Retinoid	63
Thalidomide analog	2,201
Thrombopoietin receptor agonist	348
Topoisomerase inhibitor	1,436
Tumor necrosis factor blocker	315
Vascular endothelial growth factor inhibitor	232
Vinca alkaloid	345

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

Reports by month

Reports that record Myelodysplastic syndrome, 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 Myelodysplastic syndrome
Age	Reports	Share
Under 2	7	under 0.1%
2 to 11	210	1.5%
12 to 17	146	1%
18 to 44	672	4.7%
45 to 64	2,878	20.2%
65 to 74	2,837	19.9%
75 and over	2,523	17.7%
Age not given	4,979	34.9%

Sex of the patient in the reports that record Myelodysplastic syndrome
Sex	Reports	Share
Female	5,526	38.8%
Male	6,285	44.1%
Unknown or not given	2,441	17.1%

Age and sex are as the report gives them. 40.9% 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. Myelodysplastic syndrome: adverse event reports that record this term. https://reportedreactions.com/reaction/myelodysplastic-syndrome/ 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 Myelodysplastic syndrome 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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