Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

Loss of consciousness adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
passing out

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 126,134 adverse event reports that record the MedDRA preferred term Loss of consciousness. In plain words, the term means: passing out. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 6,497 reports in the 12 months to June 2026 and 6,579 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 108 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, 6,497 (0.5%) record this term. Reports for patients aged 18 to 44 were 16.8% of the reports that record this term and 12.3% 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.

Plain meaning

Passing out. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 67 drug pages with 500 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 Loss of consciousness name as a suspect product, in order of name
DrugClassReports with this term
AbilifyAtypical antipsychotic556
Acetaminophen648
ActemraInterleukin-6 receptor antagonist954
Alcohol584
AlprazolamBenzodiazepine863
AmbrisentanEndothelin receptor antagonist751
AmlodipineCalcium channel blocker762
AravaAntirheumatic agent554
AspirinNonsteroidal anti-inflammatory drug626
AvonexInterferon beta918
CarboplatinPlatinum-based drug532
ChantixPartial cholinergic nicotinic agonist992
CimziaTumor necrosis factor blocker589
CitalopramSerotonin reuptake inhibitor500
ClonazepamBenzodiazepine648
ClozapineAtypical antipsychotic525
Copaxone692
CosentyxInterleukin-17A antagonist500
Cymbalta963
DiazepamBenzodiazepine904
DupixentInterleukin-4 receptor alpha antagonist626
EnbrelTumor necrosis factor blocker1,718
EntrestoAngiotensin 2 receptor blocker1,128
FentanylOpioid agonist837
ForteoParathyroid hormone analog802
FurosemideLoop diuretic511
GabapentinAnti-epileptic agent780
GilenyaSphingosine 1-phosphate receptor modulator627
HumalogInsulin analog932
Humira4,993
IbuprofenNonsteroidal anti-inflammatory drug754
ImbruvicaKinase inhibitor596
LamotrigineAnti-epileptic agent512
LantusInsulin analog684
LisinoprilAngiotensin converting enzyme inhibitor510
LorazepamBenzodiazepine862
Lyrica1,521
MetforminBiguanide648
MethotrexateFolate analog metabolic inhibitor1,232
Mirtazapine547
Morphine sulfateOpioid agonist655
Northera768
OlanzapineAtypical antipsychotic666
OpsumitEndothelin receptor antagonist506
OrenciaSelective T cell costimulation modulator746
OxaliplatinPlatinum-based drug581
Oxycodone hydrochlorideOpioid agonist860
OxyContinOpioid agonist1,078
PaclitaxelMicrotubule inhibitor588
PrednisoneCorticosteroid874
Pregabalin721
QuetiapineAtypical antipsychotic919
RamiprilAngiotensin converting enzyme inhibitor686
RebifInterferon beta755
RemicadeTumor necrosis factor blocker1,356
RevlimidThalidomide analog1,316
RinvoqJanus kinase inhibitor669
RituximabCD20-directed cytolytic antibody800
SeroquelAtypical antipsychotic842
SertralineSerotonin reuptake inhibitor585
SimponiTumor necrosis factor blocker582
SkyriziInterleukin-23 antagonist732
Tramadol900
TysabriIntegrin receptor antagonist819
XanaxBenzodiazepine582
XeljanzJanus kinase inhibitor613
XyremCentral nervous system depressant705

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 1,000 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 Loss of consciousness name, in order of name
ClassReports with this term
Angiotensin 2 receptor blocker2,840
Angiotensin converting enzyme inhibitor1,369
Anti-epileptic agent3,102
Antimalarial1,192
Atypical antipsychotic6,832
Benzodiazepine5,201
beta-Adrenergic blocker2,316
Biguanide1,090
Calcium channel blocker1,068
CD20-directed cytolytic antibody1,798
Corticosteroid3,748
Endothelin receptor antagonist2,001
Factor Xa inhibitor1,256
Folate analog metabolic inhibitor1,553
gamma-Aminobutyric acid A receptor positive modulator1,030
GLP-1 receptor agonist1,649
Histamine-1 receptor antagonist1,385
HMG-CoA reductase inhibitor1,141
Insulin analog3,216
Integrin receptor antagonist1,199
Interferon beta1,758
Interleukin-6 receptor antagonist1,232
Janus kinase inhibitor1,554
Kinase inhibitor3,525
Mood stabilizer1,061
Nonsteroidal anti-inflammatory drug3,982
Opioid agonist7,422
Partial cholinergic nicotinic agonist1,016
Platinum-based drug1,373
Prostacycline vasodilator1,621
Proton pump inhibitor1,687
Serotonin and norepinephrine reuptake inhibitor1,466
Serotonin reuptake inhibitor4,073
Thalidomide analog1,825
Tumor necrosis factor blocker5,727

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

Reports by month

Reports that record Loss of consciousness, by month, five years to June 2026
05001,00020222023202420252026

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 Loss of consciousness
AgeReportsShareShare as a bar
Under 24100.3%
2 to 111,5551.2%
12 to 172,3101.8%
18 to 4421,15516.8%
45 to 6429,29723.2%
65 to 7416,69213.2%
75 and over17,18613.6%
Age not given37,52929.8%
Sex of the patient in the reports that record Loss of consciousness
SexReportsShareShare as a bar
Female69,19854.9%
Male48,44438.4%
Unknown or not given8,4926.7%

Age and sex are as the report gives them. 51.8% 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

Embed this card on your site

Copy this code into your page. The card shows the figures above with their source. A line under the card links to this page.

How embedding works. It is free. Keep the link in the card and the link line under it.

Reported Reactions. Loss of consciousness: adverse event reports that record this term. https://reportedreactions.com/reaction/loss-of-consciousness/ 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 Loss of consciousness mean in an adverse event report?

In plain words: passing out. 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 .