Reported Reactions

Adverse event reports that FDA received

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Thrombotic microangiopathy 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 . 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 June 2026, FDA received 9,551 adverse event reports that record the MedDRA preferred term Thrombotic microangiopathy. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 867 reports in the 12 months to June 2026 and 764 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 683 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, 867 (0.1%) record this term. Reports for patients aged 45 to 64 were 30.4% of the reports that record this term and 20% 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 128 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 .

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 . The site read the page on .

Drugs that the reports with the term Thrombotic microangiopathy name as a suspect product, in order of name
DrugClassReports with this term
AbraxaneMicrotubule inhibitor38
AcyclovirHerpes simplex virus nucleoside analog DNA polymerase inhibitor39
AlemtuzumabCD52-directed cytolytic antibody99
Alkeran41
Anti-thymocyte globulin (rabbit)Immunoglobulin G35
Antithymocyte Immunoglobulin55
AtezolizumabProgrammed death Receptor-1 blocking antibody34
Atorvastatin28
AtovaquoneAntimalarial71
AvastinVascular endothelial growth factor inhibitor130
AzathioprinePurine antimetabolite125
BactrimDihydrofolate reductase inhibitor antibacterial51
BasiliximabInterleukin-2 receptor blocking antibody193
BelataceptSelective T cell costimulation blocker62
BevacizumabVascular endothelial growth factor inhibitor315
BortezomibProteasome inhibitor108
BudesonideCorticosteroid34
BusulfanAlkylating drug283
Busulfex103
CapecitabineNucleoside metabolic inhibitor56
CarboplatinPlatinum-based drug312
CarfilzomibProteasome inhibitor257
CellCeptAntimetabolite immunosuppressant143
Certican53
Ciclosporin178
CiprofloxacinFluoroquinolone antibacterial26
CisplatinPlatinum-based drug121
ClopidogrelP2Y12 platelet inhibitor47
CyclophosphamideAlkylating drug655
CyclosporineCalcineurin inhibitor immunosuppressant739
CytarabineNucleoside metabolic inhibitor97
DaratumumabCD38-directed cytolytic antibody41
DarzalexCD38-directed cytolytic antibody31
Defitelio47
DexamethasoneCorticosteroid320
DocetaxelMicrotubule inhibitor75
DoxorubicinAnthracycline topoisomerase inhibitor90
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor48
EculizumabComplement inhibitor103
EnvarsusCalcineurin inhibitor immunosuppressant61
EtanerceptTumor necrosis factor blocker33
EtoposideTopoisomerase inhibitor294
EverolimusKinase inhibitor184
FilgrastimLeukocyte growth factor46
Fludara65
FludarabineNucleoside metabolic inhibitor386
Fludarabine phosphateNucleoside metabolic inhibitor131
FluorouracilNucleoside metabolic inhibitor71
FurosemideLoop diuretic51
GanciclovirCytomegalovirus nucleoside analog DNA polymerase inhibitor91
GemcitabineNucleoside metabolic inhibitor678
Gemcitabine hydrochlorideNucleoside metabolic inhibitor252
Gemcitabine/Gemcitabine Hydrochloride43
Gemzar128
Human immunoglobulin gHuman immunoglobulin G48
HydrocortisoneCorticosteroid57
IbuprofenNonsteroidal anti-inflammatory drug31
IfosfamideAlkylating drug29
ImatinibKinase inhibitor37
IsatuximabCD38-directed cytolytic antibody60
KeytrudaProgrammed death Receptor-1 blocking antibody33
KyprolisProteasome inhibitor149
Lacosamide59
LansoprazoleProton pump inhibitor58
Lapine t-lymphocyte immune globulin56
LenalidomideThalidomide analog121
Levetiracetam46
LevofloxacinFluoroquinolone antibacterial45
MelphalanAlkylating drug330
Melphalan hydrochloride29
MethotrexateFolate analog metabolic inhibitor446
Methotrexate sodiumFolate analog metabolic inhibitor73
MethylprednisoloneCorticosteroid368
MetronidazoleNitroimidazole antimicrobial25
MidazolamBenzodiazepine36
Mycophenolate32
Mycophenolate mofetilAntimetabolite immunosuppressant946
Mycophenolate sodium49
Mycophenolic acidAntimetabolite immunosuppressant134
MyforticAntimetabolite immunosuppressant26
NeoralCalcineurin inhibitor immunosuppressant88
Opana Er36
OxaliplatinPlatinum-based drug151
OxazepamBenzodiazepine31
PaclitaxelMicrotubule inhibitor163
Paxlovid31
PembrolizumabProgrammed death Receptor-1 blocking antibody49
Phenobarbital39
PhenytoinAnti-epileptic agent37
PomalidomideThalidomide analog55
PosaconazoleAzole antifungal27
PrednisoloneCorticosteroid382
PrednisoneCorticosteroid356
PrografCalcineurin inhibitor immunosuppressant423
PropofolGeneral anesthetic40
QuetiapineAtypical antipsychotic34
QuinineAntimalarial54
Quinine sulfateAntimalarial37
Rapamune77
RebifInterferon beta55
RevlimidThalidomide analog44
RituximabCD20-directed cytolytic antibody278
RuxolitinibJanus kinase inhibitor121
SandimmuneCalcineurin inhibitor immunosuppressant33
SimulectInterleukin-2 receptor blocking antibody47
SirolimusKinase inhibitor315
SolirisComplement inhibitor644
Solu-medrolCorticosteroid27
Sulfamethoxazole and trimethoprimDihydrofolate reductase inhibitor antibacterial47
Sulfamethoxazole, trimethoprimDihydrofolate reductase inhibitor antibacterial58
Sunitinib29
SutentKinase inhibitor30
TacrolimusCalcineurin inhibitor immunosuppressant2,185
ThiotepaAlkylating drug238
Thymocyte Immune Globulin111
ThymoglobulinImmunoglobulin G142
Thymoglobuline43
TrastuzumabHER2/neu receptor antagonist40
Treosulfan50
UltomirisComplement inhibitor30
ValganciclovirCytomegalovirus nucleoside analog DNA polymerase inhibitor67
Valganciclovir hydrochlorideCytomegalovirus nucleoside analog DNA polymerase inhibitor37
VancomycinGlycopeptide antibacterial49
VelcadeProteasome inhibitor59
VenetoclaxBCL-2 inhibitor26
Vincristine59
Vincristine sulfateVinca alkaloid34
Zolgensma50

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 55 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 .

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 . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Thrombotic microangiopathy name, in order of name
ClassReports with this term
Alkylating drug1,592
Anthracycline topoisomerase inhibitor148
Anti-epileptic agent71
Antimalarial180
Antimetabolite immunosuppressant1,249
Antirheumatic agent30
Atypical antipsychotic49
Azole antifungal95
BCL-2 inhibitor28
Benzodiazepine73
Biguanide25
Calcineurin inhibitor immunosuppressant3,533
CD20-directed cytolytic antibody291
CD38-directed cytolytic antibody140
CD52-directed cytolytic antibody111
Cephalosporin antibacterial46
Complement inhibitor783
Corticosteroid1,592
Cytomegalovirus nucleoside analog DNA polymerase inhibitor197
Cytoprotective agent45
Dihydrofolate reductase inhibitor antibacterial170
Fluoroquinolone antibacterial71
Folate analog metabolic inhibitor544
General anesthetic42
Glycopeptide antibacterial56
HER2/neu receptor antagonist65
Herpes simplex virus nucleoside analog DNA polymerase inhibitor59
Human immunoglobulin G72
Immunoglobulin G180
Interferon beta66
Interleukin-2 receptor blocking antibody240
Janus kinase inhibitor146
Kinase inhibitor767
Leukocyte growth factor52
Loop diuretic62
Microtubule inhibitor276
Nitroimidazole antimicrobial36
Nonsteroidal anti-inflammatory drug56
Nucleoside metabolic inhibitor1,724
Opioid agonist30
P2Y12 platelet inhibitor78
Penicillin-class antibacterial44
Platinum-based drug584
Programmed death Receptor-1 blocking antibody177
Proteasome inhibitor596
Proton pump inhibitor83
Purine antimetabolite131
Pyrophosphate analog DNA polymerase inhibitor33
Selective T cell costimulation blocker62
Thalidomide analog220
Topoisomerase inhibitor313
Tumor necrosis factor blocker73
Vascular endothelial growth factor inhibitor463
Vascular endothelial growth factor receptor 2 antagonist29
Vinca alkaloid51

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

Reports by month

Reports that record Thrombotic microangiopathy, by month, five years to June 2026
010020020222023202420252026

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 Thrombotic microangiopathy
AgeReportsShareShare as a bar
Under 22422.5%
2 to 115125.4%
12 to 173123.3%
18 to 441,94120.3%
45 to 642,90630.4%
65 to 741,28413.4%
75 and over4484.7%
Age not given1,90620%
Sex of the patient in the reports that record Thrombotic microangiopathy
SexReportsShareShare as a bar
Female4,23144.3%
Male3,85940.4%
Unknown or not given1,46115.3%

Age and sex are as the report gives them. 31% 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

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

Cite this page

Reported Reactions. Thrombotic microangiopathy: adverse event reports that record this term. https://reportedreactions.com/reaction/thrombotic-microangiopathy/ 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 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 Thrombotic microangiopathy 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 .

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 .

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 .