Reported Reactions

Adverse event reports that FDA received

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Presyncope 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 June 2006 to June 2026, FDA received 23,876 adverse event reports that record the MedDRA preferred term Presyncope. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,528 reports in the 12 months to June 2026 and 1,381 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 445 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, 1,528 (0.1%) record this term. Reports for patients 75 and over were 15.4% 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 137 drug pages with 100 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 Presyncope name as a suspect product, in order of name
DrugClassReports with this term
Aceclofenac190
Acetaminophen287
AdalimumabTumor necrosis factor blocker245
AdempasSoluble guanylate cyclase stimulator142
Agomelatine178
Alendronate sodiumBisphosphonate104
Alendronic Acid163
AliskirenRenin inhibitor184
AmbrisentanEndothelin receptor antagonist225
AmlodipineCalcium channel blocker144
AnastrozoleAromatase inhibitor219
AspirinNonsteroidal anti-inflammatory drug314
Atenololbeta-Adrenergic blocker136
Atorvastatin173
Atorvastatin calciumHMG-CoA reductase inhibitor169
Bisoprololbeta-Adrenergic blocker438
Bisoprolol fumaratebeta-Adrenergic blocker242
BrinzolamideCarbonic anhydrase inhibitor192
BuprenorphinePartial opioid agonist190
ByettaGLP-1 receptor agonist135
CarboplatinPlatinum-based drug136
Carvedilolalpha-Adrenergic blocker217
CelecoxibNonsteroidal anti-inflammatory drug208
Cholecalciferol266
Cilazapril Anhydrous188
ClopidogrelP2Y12 platelet inhibitor116
Codeine141
Codeine phosphate108
Codeine sulfateOpioid agonist159
Copaxone107
Cymbalta123
DexamethasoneCorticosteroid132
DigoxinCardiac glycoside157
Diltiazem136
Diltiazem hydrochlorideCalcium channel blocker158
DocetaxelMicrotubule inhibitor279
Domperidone162
Donepezil183
DupixentInterleukin-4 receptor alpha antagonist165
Dutasteride5-alpha reductase inhibitor199
EnbrelTumor necrosis factor blocker229
Enoxaparin sodiumLow molecular weight heparin180
EntrestoAngiotensin 2 receptor blocker230
Escherichia coli184
EscitalopramSerotonin reuptake inhibitor177
Escitalopram oxalateSerotonin reuptake inhibitor135
EsomeprazoleProton pump inhibitor191
EtanerceptTumor necrosis factor blocker214
ExemestaneAromatase inhibitor195
EzetimibeDietary cholesterol absorption inhibitor224
FenofibratePeroxisome proliferator receptor alpha agonist192
FluoxetineSerotonin reuptake inhibitor117
Fluoxetine hydrochlorideSerotonin reuptake inhibitor122
FluvastatinHMG-CoA reductase inhibitor195
ForteoParathyroid hormone analog180
FosamaxBisphosphonate101
FurosemideLoop diuretic286
Ginkgo174
Glucosamine177
HumalogInsulin analog113
Human immunoglobulin gHuman immunoglobulin G203
Humira364
HydrochlorothiazideThiazide diuretic282
Hydromorphone117
Hydromorphone hydrochlorideOpioid agonist114
Ibandronic Acid139
IbuprofenNonsteroidal anti-inflammatory drug112
ImatinibKinase inhibitor173
IndomethacinNonsteroidal anti-inflammatory drug180
Indomethacin sodium127
InflectraTumor necrosis factor blocker104
Iodine107
Isosorbide mononitrateNitrate vasodilator108
LasixLoop diuretic220
Ledipasvir186
LetairisEndothelin receptor antagonist234
LetrozoleAromatase inhibitor217
LisinoprilAngiotensin converting enzyme inhibitor133
Lyrica173
MetforminBiguanide150
MethotrexateFolate analog metabolic inhibitor156
Metoprololbeta-Adrenergic blocker204
MirenaProgestin430
Mirtazapine219
Mycophenolate mofetilAntimetabolite immunosuppressant120
Mycophenolic acidAntimetabolite immunosuppressant132
NilotinibKinase inhibitor175
Nimesulide185
NitroglycerinNitrate vasodilator238
Norfloxacin199
Northera307
OmeprazoleProton pump inhibitor104
OpsumitEndothelin receptor antagonist292
OrenitramProstacycline vasodilator116
OxaliplatinPlatinum-based drug141
OzempicGLP-1 receptor agonist106
PaclitaxelMicrotubule inhibitor138
PantoprazoleProton pump inhibitor109
ParaGard T 380ACopper-containing intrauterine device148
Pentazocine148
Pentoxifylline196
PitavastatinHMG-CoA reductase inhibitor186
Potassium iodide185
Pravastatin125
Pravastatin sodiumHMG-CoA reductase inhibitor134
PrednisoneCorticosteroid186
Pregabalin266
Propranololbeta-Adrenergic blocker178
RamiprilAngiotensin converting enzyme inhibitor366
RemicadeTumor necrosis factor blocker230
RemodulinProstacycline vasodilator261
RepathaPCSK9 inhibitor107
RevlimidThalidomide analog186
RibavirinNucleoside analog antiviral268
RituximabCD20-directed cytolytic antibody210
SertralineSerotonin reuptake inhibitor199
Sertraline hydrochlorideSerotonin reuptake inhibitor173
SimvastatinHMG-CoA reductase inhibitor252
Sodium picosulfate204
SofosbuvirHepatitis C virus nucleotide analog NS5B polymerase inhibitor187
Tamsulosin128
Tamsulosin hydrochloridealpha-Adrenergic blocker264
TelmisartanAngiotensin 2 receptor blocker211
TocilizumabInterleukin-6 receptor antagonist199
TracleerEndothelin receptor antagonist149
Tramadol hydrochlorideOpioid agonist174
TyvasoProstacycline vasodilator191
UptraviProstacyclin receptor agonist134
VeletriProstacycline vasodilator104
VenlafaxineSerotonin and norepinephrine reuptake inhibitor112
Venlafaxine hydrochlorideSerotonin and norepinephrine reuptake inhibitor212
Verapamil165
Verapamil hydrochlorideCalcium channel blocker124
Vortioxetine183
XareltoFactor Xa inhibitor195
XyzalHistamine-1 receptor antagonist145
Zoledronic acidBisphosphonate209

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 35 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 Presyncope name, in order of name
ClassReports with this term
alpha-Adrenergic blocker658
Angiotensin 2 receptor blocker939
Angiotensin converting enzyme inhibitor575
Antimetabolite immunosuppressant282
Aromatase inhibitor643
Atypical antipsychotic516
beta-Adrenergic blocker1,470
Bisphosphonate531
Calcium channel blocker488
CD20-directed cytolytic antibody328
Corticosteroid617
Endothelin receptor antagonist925
Factor Xa inhibitor415
GLP-1 receptor agonist590
Histamine-1 receptor antagonist311
HMG-CoA reductase inhibitor1,124
Human immunoglobulin G264
Insulin analog344
Kinase inhibitor713
Loop diuretic584
Microtubule inhibitor472
Nitrate vasodilator350
Nonsteroidal anti-inflammatory drug1,092
Nucleoside analog antiviral268
Nucleoside metabolic inhibitor265
Opioid agonist561
Platinum-based drug375
Progestin628
Prostacycline vasodilator799
Proton pump inhibitor605
Serotonin and norepinephrine reuptake inhibitor450
Serotonin reuptake inhibitor1,151
Thalidomide analog326
Thiazide diuretic335
Tumor necrosis factor blocker1,192

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

Reports by month

Reports that record Presyncope, 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 Presyncope
AgeReportsShareShare as a bar
Under 2300.1%
2 to 111220.5%
12 to 173651.5%
18 to 444,18417.5%
45 to 645,42922.7%
65 to 743,46914.5%
75 and over3,66915.4%
Age not given6,60827.7%
Sex of the patient in the reports that record Presyncope
SexReportsShareShare as a bar
Female13,86258.1%
Male7,92233.2%
Unknown or not given2,0928.8%

Age and sex are as the report gives them. 56.9% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Presyncope: adverse event reports that record this term. https://reportedreactions.com/reaction/presyncope/ 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 Presyncope 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 .