Reported Reactions

Adverse event reports that FDA received

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Dyspnoea exertional 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 36,920 adverse event reports that record the MedDRA preferred term Dyspnoea exertional. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 2,300 reports in the 12 months to June 2026 and 2,761 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 59 drug pages with 250 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 Dyspnoea exertional name as a suspect product, in order of name
DrugClassReports with this term
AdempasSoluble guanylate cyclase stimulator822
Advair HfaCorticosteroid513
Albuterolbeta2-Adrenergic agonist766
Albuterol sulfatebeta2-Adrenergic agonist1,134
Alvesco325
AmbrisentanEndothelin receptor antagonist1,247
AmlodipineCalcium channel blocker364
AspirinNonsteroidal anti-inflammatory drug678
Atorvastatin253
Bisoprololbeta-Adrenergic blocker481
Breo ElliptaCorticosteroid489
BudesonideCorticosteroid273
Budesonide Formoterol Fumarate317
CarboplatinPlatinum-based drug351
ClopidogrelP2Y12 platelet inhibitor261
CyclophosphamideAlkylating drug275
DigoxinCardiac glycoside280
DupixentInterleukin-4 receptor alpha antagonist671
EnbrelTumor necrosis factor blocker354
EntrestoAngiotensin 2 receptor blocker712
EsbrietPyridone270
FurosemideLoop diuretic367
Humira571
IbranceKinase inhibitor264
IbuprofenNonsteroidal anti-inflammatory drug266
Ipratropium bromideAnticholinergic469
JakafiJanus kinase inhibitor313
LetairisEndothelin receptor antagonist491
MepolizumabInterleukin-5 antagonist775
MethotrexateFolate analog metabolic inhibitor543
Metoprololbeta-Adrenergic blocker270
NucalaInterleukin-5 antagonist458
OfevKinase inhibitor861
OmalizumabAnti-IgE394
OpsumitEndothelin receptor antagonist1,604
OrenitramProstacycline vasodilator957
PantoprazoleProton pump inhibitor502
PrednisoneCorticosteroid1,381
RamiprilAngiotensin converting enzyme inhibitor340
RemodulinProstacycline vasodilator1,152
RevlimidThalidomide analog341
RibavirinNucleoside analog antiviral260
RituximabCD20-directed cytolytic antibody416
RivaroxabanFactor Xa inhibitor259
Salbutamol253
SingulairLeukotriene receptor antagonist589
SolirisComplement inhibitor439
SymbicortCorticosteroid835
TadalafilPhosphodiesterase 5 inhibitor329
Tiotropium bromideAnticholinergic1,115
TracleerEndothelin receptor antagonist457
TreprostinilProstacycline vasodilator277
TyvasoProstacycline vasodilator1,086
Tyvaso DPIProstacycline vasodilator574
UptraviProstacyclin receptor agonist903
VeletriProstacycline vasodilator847
Vioxx275
XareltoFactor Xa inhibitor412
XolairAnti-IgE727

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 250 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 Dyspnoea exertional name, in order of name
ClassReports with this term
Aldosterone antagonist311
Alkylating drug366
alpha-Adrenergic blocker349
Angiotensin 2 receptor blocker1,298
Angiotensin converting enzyme inhibitor629
Anti-IgE1,123
Anticholinergic2,492
Antimetabolite immunosuppressant340
Aromatase inhibitor356
beta-Adrenergic blocker1,127
beta2-Adrenergic agonist2,136
Biguanide323
Bisphosphonate396
Calcineurin inhibitor immunosuppressant262
Calcium channel blocker456
Cardiac glycoside282
CD20-directed cytolytic antibody635
Complement inhibitor538
Corticosteroid5,640
Endothelin receptor antagonist4,057
Factor Xa inhibitor1,123
Fluoroquinolone antibacterial339
Folate analog metabolic inhibitor740
HER2/neu receptor antagonist423
HMG-CoA reductase inhibitor1,030
Interferon alpha270
Interleukin-4 receptor alpha antagonist697
Interleukin-5 antagonist1,233
Janus kinase inhibitor580
Kinase inhibitor2,909
Leukotriene receptor antagonist981
Loop diuretic659
Macrolide antimicrobial346
Microtubule inhibitor393
Nonsteroidal anti-inflammatory drug1,450
Nucleoside analog antiviral288
Nucleoside metabolic inhibitor551
Opioid agonist336
P2Y12 platelet inhibitor650
PCSK9 inhibitor392
Phosphodiesterase 5 inhibitor980
Platinum-based drug607
Poly(ADP-Ribose) polymerase inhibitor368
Programmed death Receptor-1 blocking antibody468
Prostacyclin receptor agonist978
Prostacycline vasodilator5,017
Proteasome inhibitor267
Proton pump inhibitor1,107
Provitamin D2 compound252
Pyridone300
Serotonin reuptake inhibitor366
Soluble guanylate cyclase stimulator842
Thalidomide analog621
Tumor necrosis factor blocker817
Vascular endothelial growth factor inhibitor313

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

Reports by month

Reports that record Dyspnoea exertional, by month, five years to June 2026
025050020222023202420252026

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 Dyspnoea exertional
AgeReportsShareShare as a bar
Under 218under 0.1%
2 to 11940.3%
12 to 171570.4%
18 to 442,9768.1%
45 to 649,53325.8%
65 to 747,25119.6%
75 and over6,02116.3%
Age not given10,87029.4%
Sex of the patient in the reports that record Dyspnoea exertional
SexReportsShareShare as a bar
Female20,05054.3%
Male14,10038.2%
Unknown or not given2,7707.5%

Age and sex are as the report gives them. 57.8% 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. Dyspnoea exertional: adverse event reports that record this term. https://reportedreactions.com/reaction/dyspnoea-exertional/ 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.

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 Dyspnoea exertional 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 .