Reported Reactions

Adverse event reports that FDA received

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Pulmonary mass 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 14,671 adverse event reports that record the MedDRA preferred term Pulmonary mass. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 873 reports in the 12 months to June 2026 and 982 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 678 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, 873 (0.1%) record this term. Reports for patients aged 45 to 64 were 28.9% of the reports that record this term and 20% 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.

Data version

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

Drugs in these reports

The table has the 74 drug pages with 100 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 Pulmonary mass name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen167
ActemraInterleukin-6 receptor antagonist361
Advair HfaCorticosteroid217
AfinitorKinase inhibitor112
Albuterolbeta2-Adrenergic agonist264
Albuterol sulfatebeta2-Adrenergic agonist333
Alendronate sodiumBisphosphonate153
AravaAntirheumatic agent280
Aredia149
AvastinVascular endothelial growth factor inhibitor112
AzithromycinMacrolide antimicrobial113
Bisoprololbeta-Adrenergic blocker122
Breo ElliptaCorticosteroid189
BudesonideCorticosteroid195
Budesonide Formoterol Fumarate156
CarboplatinPlatinum-based drug141
CimziaTumor necrosis factor blocker205
CosentyxInterleukin-17A antagonist171
CyclophosphamideAlkylating drug199
CytarabineNucleoside metabolic inhibitor128
DexamethasoneCorticosteroid125
DiazepamBenzodiazepine117
DocetaxelMicrotubule inhibitor132
DupixentInterleukin-4 receptor alpha antagonist141
EnbrelTumor necrosis factor blocker796
Formoterol fumaratebeta2-Adrenergic agonist110
FosamaxBisphosphonate177
FulvestrantEstrogen receptor antagonist106
Humira1,412
HydroxychloroquineAntimalarial137
Hydroxychloroquine sulfateAntimalarial142
ImbruvicaKinase inhibitor164
Ipratropium bromideAnticholinergic177
JanuviaDipeptidyl peptidase 4 inhibitor145
KeytrudaProgrammed death Receptor-1 blocking antibody114
KisqaliKinase inhibitor130
LeflunomideAntirheumatic agent217
LetrozoleAromatase inhibitor158
MeloxicamNonsteroidal anti-inflammatory drug105
MepolizumabInterleukin-5 antagonist320
MethotrexateFolate analog metabolic inhibitor967
Methotrexate sodiumFolate analog metabolic inhibitor216
MontelukastLeukotriene receptor antagonist106
Mycophenolate mofetilAntimetabolite immunosuppressant239
NucalaInterleukin-5 antagonist170
NuvaringEstrogen102
OmalizumabAnti-IgE222
OrenciaSelective T cell costimulation modulator113
PlaquenilAntimalarial121
PrednisoloneCorticosteroid107
PrednisoneCorticosteroid805
Pulmicort Turbuhaler206
RemicadeTumor necrosis factor blocker344
RevlimidThalidomide analog183
RinvoqJanus kinase inhibitor107
RituxanCD20-directed cytolytic antibody172
RituximabCD20-directed cytolytic antibody394
Rosuvastatin calciumHMG-CoA reductase inhibitor173
Salbutamol152
Salbutamol sulfate101
SimponiTumor necrosis factor blocker215
SingulairLeukotriene receptor antagonist251
SpironolactoneAldosterone antagonist104
SulfasalazineAminosalicylate167
SymbicortCorticosteroid294
Synthroidl-Thyroxine154
TacrolimusCalcineurin inhibitor immunosuppressant299
Tiotropium107
Tiotropium bromideAnticholinergic528
TrastuzumabHER2/neu receptor antagonist106
Trichlormethiazide100
XeljanzJanus kinase inhibitor203
XolairAnti-IgE153
Zometa257

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 60 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 Pulmonary mass name, in order of name
ClassReports with this term
Aldosterone antagonist109
Alkylating drug279
Aminosalicylate181
Angiotensin 2 receptor blocker271
Anthracycline topoisomerase inhibitor131
Anti-IgE375
Anticholinergic959
Antimalarial402
Antimetabolite immunosuppressant323
Antirheumatic agent497
Aromatase inhibitor334
Atypical antipsychotic154
Azole antifungal199
Benzodiazepine184
beta-Adrenergic blocker192
beta2-Adrenergic agonist765
Biguanide132
Bisphosphonate471
Calcineurin inhibitor immunosuppressant369
CD20-directed cytolytic antibody649
Corticosteroid2,463
Dipeptidyl peptidase 4 inhibitor147
Endothelin receptor antagonist179
Estrogen114
Estrogen receptor antagonist137
Factor Xa inhibitor102
Fluoroquinolone antibacterial143
Folate analog metabolic inhibitor1,214
GLP-1 receptor agonist126
HER2/neu receptor antagonist264
Histamine-2 receptor antagonist116
HMG-CoA reductase inhibitor361
Integrin receptor antagonist174
Interleukin-17A antagonist216
Interleukin-23 antagonist102
Interleukin-4 receptor alpha antagonist163
Interleukin-5 antagonist490
Interleukin-6 receptor antagonist422
Janus kinase inhibitor429
Kinase inhibitor1,478
l-Thyroxine226
Leukotriene receptor antagonist407
Loop diuretic137
Macrolide antimicrobial138
Microtubule inhibitor236
Nitrate vasodilator102
Nonsteroidal anti-inflammatory drug277
Nucleoside metabolic inhibitor480
Opioid agonist235
Platinum-based drug293
Poly(ADP-Ribose) polymerase inhibitor127
Programmed death Receptor-1 blocking antibody310
Proton pump inhibitor617
Purine antimetabolite113
RANK ligand inhibitor120
Selective T cell costimulation modulator190
Serotonin reuptake inhibitor202
Thalidomide analog255
Tumor necrosis factor blocker1,881
Vascular endothelial growth factor inhibitor165

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

Reports by month

Reports that record Pulmonary mass, 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 Pulmonary mass
AgeReportsShareShare as a bar
Under 280.1%
2 to 11830.6%
12 to 17910.6%
18 to 441,0287%
45 to 644,23528.9%
65 to 742,83719.3%
75 and over1,68911.5%
Age not given4,70032%
Sex of the patient in the reports that record Pulmonary mass
SexReportsShareShare as a bar
Female8,42657.4%
Male5,18035.3%
Unknown or not given1,0657.3%

Age and sex are as the report gives them. 52.9% 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. Pulmonary mass: adverse event reports that record this term. https://reportedreactions.com/reaction/pulmonary-mass/ 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 Pulmonary mass 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 .