Reported Reactions

Adverse event reports that FDA received

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Apnoea adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
pauses in breathing

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 7,682 adverse event reports that record the MedDRA preferred term Apnoea. In plain words, the term means: pauses in breathing. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 318 reports in the 12 months to June 2026 and 325 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 1,203 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, 318 (under 0.1%) record this term. Reports for patients under 2 were 11.9% of the reports that record this term and 0.5% 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.

Plain meaning

Pauses in breathing. 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 76 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 Apnoea name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen74
Alcohol34
AlprazolamBenzodiazepine30
AmlodipineCalcium channel blocker43
AspirinNonsteroidal anti-inflammatory drug31
AtivanBenzodiazepine32
Baclofengamma-Aminobutyric acid-ergic agonist70
BeyfortusRespiratory syncytial virus Anti-F protein monoclonal antibody26
BupivacaineAmide local anesthetic31
Bupropion hydrochlorideAminoketone26
CitalopramSerotonin reuptake inhibitor38
ClobazamBenzodiazepine25
ClonazepamBenzodiazepine48
ClonidineCentral alpha-2 adrenergic agonist43
Cocaine42
CyclophosphamideAlkylating drug51
CytarabineNucleoside metabolic inhibitor30
DexamethasoneCorticosteroid53
Dexmedetomidine hydrochlorideCentral alpha-2 adrenergic agonist25
DiazepamBenzodiazepine80
DigoxinCardiac glycoside48
EscitalopramSerotonin reuptake inhibitor31
FentanylOpioid agonist257
Fentanyl citrateOpioid agonist75
FluoxetineSerotonin reuptake inhibitor38
GabapentinAnti-epileptic agent56
Humira134
Hydromorphone38
IbuprofenNonsteroidal anti-inflammatory drug81
Ketamine31
LamotrigineAnti-epileptic agent88
Levetiracetam109
LidocaineAmide local anesthetic80
Lioresal (baclofen)gamma-Aminobutyric acid-ergic agonist28
LorazepamBenzodiazepine93
Lyrica27
MetforminBiguanide49
MethadoneOpioid agonist46
MethotrexateFolate analog metabolic inhibitor72
Metoprololbeta-Adrenergic blocker25
MidazolamBenzodiazepine80
MorphineOpioid agonist148
Morphine sulfateOpioid agonist124
NaproxenNonsteroidal anti-inflammatory drug25
OlanzapineAtypical antipsychotic63
OndansetronSerotonin-3 receptor antagonist49
OxazepamBenzodiazepine29
OxycodoneOpioid agonist33
Oxycodone hydrochlorideOpioid agonist29
OxyContinOpioid agonist62
PaclitaxelMicrotubule inhibitor27
PaxilSerotonin reuptake inhibitor59
Phenobarbital38
PrednisoneCorticosteroid39
Pregabalin28
PropofolGeneral anesthetic123
QuetiapineAtypical antipsychotic88
Quetiapine fumarateAtypical antipsychotic40
RamiprilAngiotensin converting enzyme inhibitor42
RemicadeTumor necrosis factor blocker34
Remifentanil47
SeroquelAtypical antipsychotic36
SertralineSerotonin reuptake inhibitor39
SevofluraneGeneral anesthetic80
SynagisRespiratory syncytial virus Anti-F protein monoclonal antibody272
TacrolimusCalcineurin inhibitor immunosuppressant31
TemazepamBenzodiazepine33
Topiramate41
Tramadol188
Tramadol hclOpioid agonist28
Tramadol hydrochlorideOpioid agonist43
Valproic acidAnti-epileptic agent30
Vincristine sulfateVinca alkaloid47
XyremCentral nervous system depressant178
XywavCentral nervous system depressant27
Zofran28

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 50 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 Apnoea name, in order of name
ClassReports with this term
Alkylating drug71
Amide local anesthetic156
Aminoketone60
Angiotensin 2 receptor blocker46
Angiotensin converting enzyme inhibitor65
Anthracycline topoisomerase inhibitor25
Anti-epileptic agent248
Anticholinergic26
Antimalarial25
Atypical antipsychotic375
Benzodiazepine492
beta-Adrenergic blocker88
beta2-Adrenergic agonist36
Biguanide67
Calcineurin inhibitor immunosuppressant48
Calcium channel blocker50
Cardiac glycoside48
CD20-directed cytolytic antibody26
Central alpha-2 adrenergic agonist117
Central nervous system depressant218
Central nervous system stimulant31
Cephalosporin antibacterial30
Corticosteroid158
Depolarizing neuromuscular blocker30
Endothelin receptor antagonist33
Folate analog metabolic inhibitor74
gamma-Aminobutyric acid A receptor positive modulator33
gamma-Aminobutyric acid-ergic agonist100
General anesthetic239
Histamine-1 receptor antagonist37
Hydrolytic lysosomal glycosaminoglycan-specific enzyme49
Interleukin-5 antagonist31
Leukotriene receptor antagonist27
Microtubule inhibitor36
Mood stabilizer37
Nondepolarizing neuromuscular blocker55
Nonsteroidal anti-inflammatory drug198
Nucleoside metabolic inhibitor63
Opioid agonist975
P2Y12 platelet inhibitor31
Partial opioid agonist27
Platinum-based drug47
Proton pump inhibitor74
Recombinant human growth hormone27
Respiratory syncytial virus Anti-F protein monoclonal antibody305
Serotonin and norepinephrine reuptake inhibitor76
Serotonin reuptake inhibitor291
Serotonin-3 receptor antagonist53
Tumor necrosis factor blocker83
Vinca alkaloid49

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

Reports by month

Reports that record Apnoea, by month, five years to June 2026
05010020222023202420252026

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 Apnoea
AgeReportsShareShare as a bar
Under 291411.9%
2 to 114325.6%
12 to 172863.7%
18 to 441,17815.3%
45 to 641,28416.7%
65 to 746218.1%
75 and over6158%
Age not given2,35230.6%
Sex of the patient in the reports that record Apnoea
SexReportsShareShare as a bar
Female3,58846.7%
Male3,26942.6%
Unknown or not given82510.7%

Age and sex are as the report gives them. 44% 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. Apnoea: adverse event reports that record this term. https://reportedreactions.com/reaction/apnoea/ 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 Apnoea mean in an adverse event report?

In plain words: pauses in breathing. 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 .