Reported Reactions

Adverse event reports that FDA received

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Acute respiratory failure 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 18,865 adverse event reports that record the MedDRA preferred term Acute respiratory failure. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,433 reports in the 12 months to June 2026 and 1,369 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 134 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 Acute respiratory failure name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen113
Acetylsalicylic Acid104
AdempasSoluble guanylate cyclase stimulator121
Advair HfaCorticosteroid53
AggrastatPlatelet aggregation inhibitor92
AllopurinolXanthine oxidase inhibitor66
AlprazolamBenzodiazepine67
AmbrisentanEndothelin receptor antagonist349
Amiodarone105
AmlodipineCalcium channel blocker144
ApixabanFactor Xa inhibitor50
AspirinNonsteroidal anti-inflammatory drug182
AtezolizumabProgrammed death Receptor-1 blocking antibody54
Atorvastatin103
Avandia81
AzacitidineNucleoside metabolic inhibitor51
AzathioprinePurine antimetabolite60
AzithromycinMacrolide antimicrobial83
Baclofengamma-Aminobutyric acid-ergic agonist69
Bamlanivimab94
BevacizumabVascular endothelial growth factor inhibitor82
Bisoprololbeta-Adrenergic blocker76
BortezomibProteasome inhibitor51
CarboplatinPlatinum-based drug240
CarfilzomibProteasome inhibitor84
Casirivimab Imdevimab59
CeftriaxoneCephalosporin antibacterial67
CisplatinPlatinum-based drug184
ClopidogrelP2Y12 platelet inhibitor74
ClozapineAtypical antipsychotic135
ColchicineAlkaloid55
Cordarone50
Coumadin54
CyclophosphamideAlkylating drug363
CyclosporineCalcineurin inhibitor immunosuppressant149
CytarabineNucleoside metabolic inhibitor177
DaratumumabCD38-directed cytolytic antibody67
DexamethasoneCorticosteroid415
DiazepamBenzodiazepine69
DigoxinCardiac glycoside66
DocetaxelMicrotubule inhibitor58
DoxorubicinAnthracycline topoisomerase inhibitor165
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor80
EliquisFactor Xa inhibitor123
EnbrelTumor necrosis factor blocker82
EsbrietPyridone76
EtoposideTopoisomerase inhibitor194
EverolimusKinase inhibitor63
FentanylOpioid agonist120
FludarabineNucleoside metabolic inhibitor75
FluorouracilNucleoside metabolic inhibitor102
FosamaxBisphosphonate68
FurosemideLoop diuretic115
GabapentinAnti-epileptic agent85
GemcitabineNucleoside metabolic inhibitor73
Heparin58
Heparin sodiumAnti-coagulant56
Humira205
HydrocortisoneCorticosteroid66
HydroxychloroquineAntimalarial74
IbuprofenNonsteroidal anti-inflammatory drug66
ImbruvicaKinase inhibitor93
InfliximabTumor necrosis factor blocker53
IpilimumabCTLA-4-directed blocking antibody58
JakafiJanus kinase inhibitor74
KeytrudaProgrammed death Receptor-1 blocking antibody121
LasixLoop diuretic51
LenalidomideThalidomide analog124
LetairisEndothelin receptor antagonist127
LevofloxacinFluoroquinolone antibacterial61
LinezolidOxazolidinone antibacterial63
LisinoprilAngiotensin converting enzyme inhibitor96
LorazepamBenzodiazepine95
MelphalanAlkylating drug78
MeropenemPenem antibacterial99
MetforminBiguanide145
Metformin hydrochlorideBiguanide56
MethotrexateFolate analog metabolic inhibitor367
MethylprednisoloneCorticosteroid289
MidazolamBenzodiazepine60
MorphineOpioid agonist67
Morphine sulfateOpioid agonist77
Mycophenolate mofetilAntimetabolite immunosuppressant383
Mycophenolic acidAntimetabolite immunosuppressant81
NexiumProton pump inhibitor92
NivolumabProgrammed death Receptor-1 blocking antibody165
OcrevusCD20-directed cytolytic antibody50
OfevKinase inhibitor109
OlanzapineAtypical antipsychotic97
OmeprazoleProton pump inhibitor107
OpdivoProgrammed death Receptor-1 blocking antibody81
OpsumitEndothelin receptor antagonist397
OrenitramProstacycline vasodilator73
OxaliplatinPlatinum-based drug144
Oxycodone hydrochlorideOpioid agonist73
OxyContinOpioid agonist75
PaclitaxelMicrotubule inhibitor157
PantoprazoleProton pump inhibitor65
Pantoprazole sodiumProton pump inhibitor73
PembrolizumabProgrammed death Receptor-1 blocking antibody79
PirfenidonePyridone52
PlavixP2Y12 platelet inhibitor61
PomalystThalidomide analog82
PradaxaDirect thrombin inhibitor192
PrednisoloneCorticosteroid227
PrednisoneCorticosteroid762
PrevacidProton pump inhibitor82
PrilosecProton pump inhibitor76
PropofolGeneral anesthetic82
QuetiapineAtypical antipsychotic53
RamiprilAngiotensin converting enzyme inhibitor55
RemdesivirSARS-CoV-2 nucleotide analog RNA polymerase inhibitor106
RemicadeTumor necrosis factor blocker70
RemodulinProstacycline vasodilator276
RevlimidThalidomide analog246
RinvoqJanus kinase inhibitor67
RisperidoneAtypical antipsychotic69
RituximabCD20-directed cytolytic antibody376
TacrolimusCalcineurin inhibitor immunosuppressant442
Tiotropium bromideAnticholinergic99
TocilizumabInterleukin-6 receptor antagonist91
TracleerEndothelin receptor antagonist206
Tramadol79
TysabriIntegrin receptor antagonist86
TyvasoProstacycline vasodilator133
UptraviProstacyclin receptor agonist110
VancomycinGlycopeptide antibacterial100
VelcadeProteasome inhibitor89
VeletriProstacycline vasodilator80
VenetoclaxBCL-2 inhibitor72
Vincristine159
Vincristine sulfateVinca alkaloid93
Vioxx69
XareltoFactor Xa inhibitor357

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 54 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 Acute respiratory failure name, in order of name
ClassReports with this term
Alkylating drug617
Angiotensin 2 receptor blocker123
Angiotensin converting enzyme inhibitor181
Anthracycline topoisomerase inhibitor290
Anti-epileptic agent238
Anticholinergic149
Antimetabolite immunosuppressant519
Atypical antipsychotic541
Azole antifungal104
BCL-2 inhibitor109
Benzodiazepine399
beta-Adrenergic blocker195
Biguanide219
Bisphosphonate103
Calcineurin inhibitor immunosuppressant674
Calcium channel blocker152
CD20-directed cytolytic antibody495
CD38-directed cytolytic antibody110
Cephalosporin antibacterial151
Corticosteroid2,002
Direct thrombin inhibitor193
Endothelin receptor antagonist1,135
Factor Xa inhibitor557
Folate analog metabolic inhibitor513
General anesthetic109
Glycopeptide antibacterial120
Integrin receptor antagonist103
Interleukin-6 receptor antagonist145
Janus kinase inhibitor266
Kinase inhibitor869
Loop diuretic184
Macrolide antimicrobial117
Microtubule inhibitor235
Nonsteroidal anti-inflammatory drug357
Nucleoside metabolic inhibitor642
Opioid agonist689
P2Y12 platelet inhibitor176
Penem antibacterial101
Penicillin-class antibacterial104
Phosphodiesterase 5 inhibitor167
Platinum-based drug568
Programmed death Receptor-1 blocking antibody524
Prostacyclin receptor agonist118
Prostacycline vasodilator649
Proteasome inhibitor263
Proton pump inhibitor771
Pyridone128
SARS-CoV-2 nucleotide analog RNA polymerase inhibitor121
Serotonin reuptake inhibitor131
Soluble guanylate cyclase stimulator121
Thalidomide analog486
Topoisomerase inhibitor230
Tumor necrosis factor blocker291
Vascular endothelial growth factor inhibitor131

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

Reports by month

Reports that record Acute respiratory failure, 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 Acute respiratory failure
AgeReportsShareShare as a bar
Under 22701.4%
2 to 112951.6%
12 to 172441.3%
18 to 442,26912%
45 to 644,96526.3%
65 to 743,77920%
75 and over3,39418%
Age not given3,64919.3%
Sex of the patient in the reports that record Acute respiratory failure
SexReportsShareShare as a bar
Female8,69046.1%
Male8,70046.1%
Unknown or not given1,4757.8%

Age and sex are as the report gives them. 61.6% 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. Acute respiratory failure: adverse event reports that record this term. https://reportedreactions.com/reaction/acute-respiratory-failure/ 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 Acute respiratory failure 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 .