Reported Reactions

Adverse event reports that FDA received

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Productive cough adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
a cough with phlegm

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 46,628 adverse event reports that record the MedDRA preferred term Productive cough. In plain words, the term means: a cough with phlegm. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 3,531 reports in the 12 months to June 2026 and 3,661 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 223 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, 3,531 (0.3%) record this term. Reports for patients aged 65 to 74 were 18.1% of the reports that record this term and 11.3% 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

A cough with phlegm. 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 84 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 Productive cough name as a suspect product, in order of name
DrugClassReports with this term
ActemraInterleukin-6 receptor antagonist449
Advair DiskusCorticosteroid309
Advair HfaCorticosteroid1,004
Albuterolbeta2-Adrenergic agonist1,299
Albuterol sulfatebeta2-Adrenergic agonist1,614
Alvesco449
AmbrisentanEndothelin receptor antagonist347
AmlodipineCalcium channel blocker409
Anoro ElliptaAnticholinergic266
ArikayceAminoglycoside antibacterial567
AspirinNonsteroidal anti-inflammatory drug520
AzithromycinMacrolide antimicrobial451
Azithromycin Anhydrous292
Breo ElliptaCorticosteroid790
BudesonideCorticosteroid585
Budesonide Formoterol Fumarate511
Calcium carbonateBlood coagulation factor285
CarboplatinPlatinum-based drug284
Ciclesonide294
ClonazepamBenzodiazepine298
Combivent316
CosentyxInterleukin-17A antagonist584
CyclophosphamideAlkylating drug313
DexamethasoneCorticosteroid357
Diltiazem274
DupixentInterleukin-4 receptor alpha antagonist2,079
Dutasteride5-alpha reductase inhibitor263
EliquisFactor Xa inhibitor337
EnbrelTumor necrosis factor blocker2,075
EntrestoAngiotensin 2 receptor blocker438
ErgocalciferolProvitamin D2 compound528
EsbrietPyridone482
FloventCorticosteroid343
FurosemideLoop diuretic322
GlycopyrrolateAnticholinergic267
Humira1,824
IbranceKinase inhibitor264
ImbruvicaKinase inhibitor267
InflectraTumor necrosis factor blocker409
InfliximabTumor necrosis factor blocker380
Ipratropium bromideAnticholinergic597
LevofloxacinFluoroquinolone antibacterial491
MepolizumabInterleukin-5 antagonist1,157
MetforminBiguanide376
MethotrexateFolate analog metabolic inhibitor912
MontelukastLeukotriene receptor antagonist342
Montelukast sodiumLeukotriene receptor antagonist389
NucalaInterleukin-5 antagonist1,065
OfevKinase inhibitor1,088
OmalizumabAnti-IgE1,024
OmeprazoleProton pump inhibitor270
Omnaris378
OpsumitEndothelin receptor antagonist619
PantoprazoleProton pump inhibitor668
Pantoprazole sodiumProton pump inhibitor278
PrednisoloneCorticosteroid308
PrednisoneCorticosteroid2,397
Pulmicort Turbuhaler452
RamiprilAngiotensin converting enzyme inhibitor292
RemodulinProstacycline vasodilator261
RepathaPCSK9 inhibitor254
RevlimidThalidomide analog481
RituximabCD20-directed cytolytic antibody719
Rosuvastatin calciumHMG-CoA reductase inhibitor283
Salbutamol476
Salbutamol sulfate361
SandostatinSomatostatin analog261
Sandostatin LAR Depot259
SingulairLeukotriene receptor antagonist877
SymbicortCorticosteroid1,355
TheophyllineMethylxanthine292
Tiotropium bromideAnticholinergic2,071
Tiotropium bromide monohydrate253
Trelegy ElliptaAnticholinergic528
Trikafta515
TyvasoProstacycline vasodilator870
Tyvaso DPIProstacycline vasodilator631
Umeclidinium bromide357
UptraviProstacyclin receptor agonist258
VedolizumabIntegrin receptor antagonist293
Ventolin Hfabeta2-Adrenergic agonist251
XeljanzJanus kinase inhibitor470
XolairAnti-IgE1,535
Zenhale497

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 39 pharmacologic classes with 500 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 Productive cough name, in order of name
ClassReports with this term
alpha-Adrenergic blocker663
Aminoglycoside antibacterial852
Angiotensin 2 receptor blocker1,250
Angiotensin converting enzyme inhibitor528
Anti-IgE2,568
Anticholinergic4,399
Benzodiazepine597
beta-Adrenergic blocker529
beta2-Adrenergic agonist3,380
Biguanide556
Calcium channel blocker635
CD20-directed cytolytic antibody1,364
Cephalosporin antibacterial519
Corticosteroid9,714
Endothelin receptor antagonist1,440
Factor Xa inhibitor915
Fluoroquinolone antibacterial1,125
Folate analog metabolic inhibitor1,189
HMG-CoA reductase inhibitor787
Interleukin-17A antagonist625
Interleukin-4 receptor alpha antagonist2,179
Interleukin-5 antagonist2,224
Interleukin-6 receptor antagonist536
Janus kinase inhibitor739
Kinase inhibitor3,130
Leukotriene receptor antagonist1,608
Loop diuretic561
Macrolide antimicrobial740
Nonsteroidal anti-inflammatory drug1,074
Nucleoside metabolic inhibitor506
Opioid agonist643
Platinum-based drug539
Prostacycline vasodilator2,313
Proton pump inhibitor1,683
Provitamin D2 compound769
Pyridone519
Serotonin reuptake inhibitor914
Thalidomide analog751
Tumor necrosis factor blocker3,532

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

Reports by month

Reports that record Productive cough, by month, five years to June 2026
025050020222023202420252026

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 Productive cough
AgeReportsShareShare as a bar
Under 21970.4%
2 to 114871%
12 to 173950.8%
18 to 444,66810%
45 to 6412,32126.4%
65 to 748,44418.1%
75 and over6,45013.8%
Age not given13,66629.3%
Sex of the patient in the reports that record Productive cough
SexReportsShareShare as a bar
Female25,58554.9%
Male17,45437.4%
Unknown or not given3,5897.7%

Age and sex are as the report gives them. 56.5% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Productive cough: adverse event reports that record this term. https://reportedreactions.com/reaction/productive-cough/ 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 Productive cough mean in an adverse event report?

In plain words: a cough with phlegm. 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 .