Reported Reactions

Adverse event reports that FDA received

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Ischaemic stroke 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 17,601 adverse event reports that record the MedDRA preferred term Ischaemic stroke. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 911 reports in the 12 months to June 2026 and 813 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 650 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, 911 (0.1%) record this term. Reports for patients 75 and over were 25.7% of the reports that record this term and 9.5% 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 .

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 Ischaemic stroke name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen141
Acetylsalicylic Acid216
Actilyse61
AdalimumabTumor necrosis factor blocker53
Alteplase136
AmlodipineCalcium channel blocker108
AnastrozoleAromatase inhibitor58
Androgel106
ApixabanFactor Xa inhibitor292
AspirinNonsteroidal anti-inflammatory drug540
AtezolizumabProgrammed death Receptor-1 blocking antibody54
Atorvastatin210
Avandia292
AvastinVascular endothelial growth factor inhibitor113
BactrimDihydrofolate reductase inhibitor antibacterial72
BevacizumabVascular endothelial growth factor inhibitor125
Bextra235
Bisoprololbeta-Adrenergic blocker92
CapecitabineNucleoside metabolic inhibitor76
CarboplatinPlatinum-based drug182
Carvedilolalpha-Adrenergic blocker53
CelebrexNonsteroidal anti-inflammatory drug416
Cholecalciferol52
CisplatinPlatinum-based drug137
ClopidogrelP2Y12 platelet inhibitor208
Comirnaty83
CosentyxInterleukin-17A antagonist56
Coumadin62
CrestorHMG-CoA reductase inhibitor62
CyclophosphamideAlkylating drug149
Dabigatran92
DapagliflozinSodium-Glucose cotransporter 2 inhibitor76
DexamethasoneCorticosteroid273
DoxorubicinAnthracycline topoisomerase inhibitor63
Edoxaban58
EliquisFactor Xa inhibitor527
EnbrelTumor necrosis factor blocker62
EsomeprazoleProton pump inhibitor91
EtoposideTopoisomerase inhibitor66
FluorouracilNucleoside metabolic inhibitor144
Folic acid54
FurosemideLoop diuretic197
Heparin108
Heparin sodiumAnti-coagulant70
Humira239
HydrochlorothiazideThiazide diuretic52
IbuprofenNonsteroidal anti-inflammatory drug66
ImbruvicaKinase inhibitor53
IrbesartanAngiotensin 2 receptor blocker112
Kardegic126
KeytrudaProgrammed death Receptor-1 blocking antibody81
LansoprazoleProton pump inhibitor84
LasixLoop diuretic55
LenalidomideThalidomide analog73
LetrozoleAromatase inhibitor158
Leucovorin calciumFolate analog55
Levetiracetam97
Levothyroxine81
Lixiana55
LovenoxLow molecular weight heparin74
LucentisVascular endothelial growth factor inhibitor82
MetforminBiguanide125
Metformin hydrochlorideBiguanide63
MethotrexateFolate analog metabolic inhibitor146
Mycophenolate mofetilAntimetabolite immunosuppressant53
NitroglycerinNitrate vasodilator67
NivolumabProgrammed death Receptor-1 blocking antibody87
NuvaringEstrogen50
OlanzapineAtypical antipsychotic54
OmeprazoleProton pump inhibitor141
OxaliplatinPlatinum-based drug118
OxycodoneOpioid agonist52
PaclitaxelMicrotubule inhibitor101
PantoprazoleProton pump inhibitor127
Paracetamol71
PembrolizumabProgrammed death Receptor-1 blocking antibody59
PemetrexedFolate analog metabolic inhibitor55
PlavixP2Y12 platelet inhibitor193
PradaxaDirect thrombin inhibitor2,148
PrednisoloneCorticosteroid112
PrednisoneCorticosteroid268
Propranololbeta-Adrenergic blocker52
QuetiapineAtypical antipsychotic61
RamiprilAngiotensin converting enzyme inhibitor205
RevlimidThalidomide analog206
RituximabCD20-directed cytolytic antibody170
RivaroxabanFactor Xa inhibitor229
RosuvastatinHMG-CoA reductase inhibitor76
SildenafilPhosphodiesterase 5 inhibitor54
SimvastatinHMG-CoA reductase inhibitor109
SpironolactoneAldosterone antagonist101
TacrolimusCalcineurin inhibitor immunosuppressant102
TadalafilPhosphodiesterase 5 inhibitor56
TasignaKinase inhibitor70
TocilizumabInterleukin-6 receptor antagonist66
Valacyclovir hydrochlorideHerpes simplex virus nucleoside analog DNA polymerase inhibitor85
VelcadeProteasome inhibitor63
Vincristine59
Vioxx861
WarfarinVitamin K antagonist131
Warfarin sodiumVitamin K antagonist106
XareltoFactor Xa inhibitor1,772
Yasmin56
Yaz73
Zopiclone94

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 100 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 Ischaemic stroke name, in order of name
ClassReports with this term
Aldosterone antagonist118
Alkylating drug207
Angiotensin 2 receptor blocker283
Angiotensin converting enzyme inhibitor250
Anthracycline topoisomerase inhibitor110
Antimetabolite immunosuppressant109
Aromatase inhibitor291
Atypical antipsychotic281
Benzodiazepine156
beta-Adrenergic blocker323
Biguanide224
Calcineurin inhibitor immunosuppressant157
Calcium channel blocker151
CD20-directed cytolytic antibody208
Corticosteroid773
Direct thrombin inhibitor2,168
Erythropoiesis-stimulating agent119
Estrogen105
Factor Xa inhibitor2,857
Folate analog metabolic inhibitor287
HMG-CoA reductase inhibitor352
Insulin analog138
Janus kinase inhibitor141
Kinase inhibitor623
Loop diuretic267
Low molecular weight heparin115
Microtubule inhibitor149
Nonsteroidal anti-inflammatory drug1,158
Nucleoside metabolic inhibitor401
Opioid agonist179
P2Y12 platelet inhibitor540
Phosphodiesterase 5 inhibitor143
Platinum-based drug437
Programmed death Receptor-1 blocking antibody338
Proteasome inhibitor143
Proton pump inhibitor532
Serotonin reuptake inhibitor201
Sodium-Glucose cotransporter 2 inhibitor130
Thalidomide analog313
Tumor necrosis factor blocker254
Vascular endothelial growth factor inhibitor376
Vitamin K antagonist237

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

Reports by month

Reports that record Ischaemic stroke, 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 Ischaemic stroke
AgeReportsShareShare as a bar
Under 2190.1%
2 to 11560.3%
12 to 17750.4%
18 to 441,3897.9%
45 to 643,82021.7%
65 to 743,54520.1%
75 and over4,52725.7%
Age not given4,17023.7%
Sex of the patient in the reports that record Ischaemic stroke
SexReportsShareShare as a bar
Female8,01245.5%
Male7,57143%
Unknown or not given2,01811.5%

Age and sex are as the report gives them. 29.1% of these reports give the United States as the country.

Terms near this one

Official pages

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

Cite this page

Reported Reactions. Ischaemic stroke: adverse event reports that record this term. https://reportedreactions.com/reaction/ischaemic-stroke/ 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 Ischaemic stroke 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 .