Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

Nasal congestion adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
a blocked nose

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 57,673 adverse event reports that record the MedDRA preferred term Nasal congestion. In plain words, the term means: a blocked nose. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 3,976 reports in the 12 months to June 2026 and 4,166 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.

Plain meaning

A blocked nose. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 54 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 Nasal congestion name as a suspect product, in order of name
DrugClassReports with this term
ActemraInterleukin-6 receptor antagonist517
AdcircaPhosphodiesterase 5 inhibitor436
AdempasSoluble guanylate cyclase stimulator422
Advair HfaCorticosteroid343
Albuterolbeta2-Adrenergic agonist576
Albuterol sulfatebeta2-Adrenergic agonist511
AmbrisentanEndothelin receptor antagonist1,282
AspirinNonsteroidal anti-inflammatory drug294
Breo ElliptaCorticosteroid332
BudesonideCorticosteroid288
CialisPhosphodiesterase 5 inhibitor266
CosentyxInterleukin-17A antagonist1,125
DupixentInterleukin-4 receptor alpha antagonist4,409
EnbrelTumor necrosis factor blocker3,061
EntrestoAngiotensin 2 receptor blocker370
ForteoParathyroid hormone analog250
GilenyaSphingosine 1-phosphate receptor modulator337
Humira2,777
IbranceKinase inhibitor328
InflectraTumor necrosis factor blocker793
InfliximabTumor necrosis factor blocker662
Ipratropium bromideAnticholinergic367
KesimptaCD20-directed cytolytic antibody347
LetairisEndothelin receptor antagonist1,961
MepolizumabInterleukin-5 antagonist472
MethotrexateFolate analog metabolic inhibitor679
NucalaInterleukin-5 antagonist717
OcrevusCD20-directed cytolytic antibody309
OmalizumabAnti-IgE884
OpsumitEndothelin receptor antagonist1,424
OrenitramProstacycline vasodilator549
OtezlaPhosphodiesterase 4 inhibitor415
Paxlovid1,344
PrednisoneCorticosteroid1,290
Pulmicort Turbuhaler311
RemicadeTumor necrosis factor blocker368
RemodulinProstacycline vasodilator668
RepathaPCSK9 inhibitor647
RevlimidThalidomide analog515
RituximabCD20-directed cytolytic antibody605
SingulairLeukotriene receptor antagonist664
SolirisComplement inhibitor261
SymbicortCorticosteroid697
SynagisRespiratory syncytial virus Anti-F protein monoclonal antibody346
Tiotropium bromideAnticholinergic671
TracleerEndothelin receptor antagonist269
TyvasoProstacycline vasodilator701
UptraviProstacyclin receptor agonist491
VedolizumabIntegrin receptor antagonist381
ViagraPhosphodiesterase 5 inhibitor374
XeljanzJanus kinase inhibitor1,375
XolairAnti-IgE1,271
XyremCentral nervous system depressant254
Zenhale254

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 52 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 Nasal congestion name, in order of name
ClassReports with this term
Angiotensin 2 receptor blocker808
Angiotensin converting enzyme inhibitor290
Anti-epileptic agent266
Anti-IgE2,165
Anticholinergic1,672
Atypical antipsychotic653
Benzodiazepine351
beta-Adrenergic blocker352
beta2-Adrenergic agonist1,224
Biguanide354
Bisphosphonate254
Calcium channel blocker257
CD20-directed cytolytic antibody1,570
Central nervous system depressant372
Complement inhibitor302
Corticosteroid5,355
Endothelin receptor antagonist5,114
Factor Xa inhibitor323
Folate analog metabolic inhibitor822
GLP-1 receptor agonist448
Histamine-1 receptor antagonist1,085
HMG-CoA reductase inhibitor632
Human immunoglobulin G353
Hydrolytic lysosomal glycosaminoglycan-specific enzyme297
Insulin analog348
Integrin receptor antagonist728
Interleukin-17A antagonist1,221
Interleukin-4 receptor alpha antagonist4,531
Interleukin-5 antagonist1,191
Interleukin-6 receptor antagonist703
Janus kinase inhibitor1,703
Kinase inhibitor1,477
Leukotriene receptor antagonist1,121
Macrolide antimicrobial341
Nonsteroidal anti-inflammatory drug933
Opioid agonist489
Parathyroid hormone analog252
PCSK9 inhibitor844
Phosphodiesterase 4 inhibitor422
Phosphodiesterase 5 inhibitor1,648
Prostacyclin receptor agonist526
Prostacycline vasodilator2,566
Proton pump inhibitor917
Radiographic contrast agent421
Respiratory syncytial virus Anti-F protein monoclonal antibody364
Selective T cell costimulation modulator316
Serotonin and norepinephrine reuptake inhibitor338
Serotonin reuptake inhibitor512
Soluble guanylate cyclase stimulator432
Sphingosine 1-phosphate receptor modulator391
Thalidomide analog725
Tumor necrosis factor blocker5,594

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

Reports by month

Reports that record Nasal congestion, 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 Nasal congestion
AgeReportsShareShare as a bar
Under 24830.8%
2 to 119421.6%
12 to 178391.5%
18 to 449,20816%
45 to 6416,94329.4%
65 to 747,49113%
75 and over4,0937.1%
Age not given17,67430.6%
Sex of the patient in the reports that record Nasal congestion
SexReportsShareShare as a bar
Female35,82062.1%
Male17,25429.9%
Unknown or not given4,5998%

Age and sex are as the report gives them. 76% 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. Nasal congestion: adverse event reports that record this term. https://reportedreactions.com/reaction/nasal-congestion/ 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 Nasal congestion mean in an adverse event report?

In plain words: a blocked nose. 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 .