Reported Reactions

Adverse event reports that FDA received

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COVID-19 pneumonia 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 December 2014 to June 2026, FDA received 11,733 adverse event reports that record the MedDRA preferred term COVID-19 pneumonia. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 527 reports in the 12 months to June 2026 and 885 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 955 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, 527 (under 0.1%) record this term. Reports for male patients were 44.9% of the reports that record this term and 34.6% 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 93 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 COVID-19 pneumonia name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen136
ActemraInterleukin-6 receptor antagonist70
AdalimumabTumor necrosis factor blocker76
AllopurinolXanthine oxidase inhibitor50
ApixabanFactor Xa inhibitor202
Atorvastatin50
AzacitidineNucleoside metabolic inhibitor59
AzathioprinePurine antimetabolite99
AzithromycinMacrolide antimicrobial61
Bamlanivimab300
Bendamustine153
Bendamustine hydrochlorideAlkylating drug103
BortezomibProteasome inhibitor139
CarboplatinPlatinum-based drug117
CarfilzomibProteasome inhibitor132
Casirivimab Imdevimab81
CeftriaxoneCephalosporin antibacterial57
CellCeptAntimetabolite immunosuppressant70
CisplatinPlatinum-based drug97
Comirnaty77
CosentyxInterleukin-17A antagonist126
CyclophosphamideAlkylating drug484
CyclosporineCalcineurin inhibitor immunosuppressant144
CytarabineNucleoside metabolic inhibitor96
DaratumumabCD38-directed cytolytic antibody179
DarzalexCD38-directed cytolytic antibody104
DexamethasoneCorticosteroid739
DoxorubicinAnthracycline topoisomerase inhibitor212
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor83
DupixentInterleukin-4 receptor alpha antagonist101
EliquisFactor Xa inhibitor119
EnbrelTumor necrosis factor blocker50
EntrestoAngiotensin 2 receptor blocker84
Etesevimab78
EtoposideTopoisomerase inhibitor143
EverolimusKinase inhibitor72
FludarabineNucleoside metabolic inhibitor97
Folic acid52
FurosemideLoop diuretic91
GazyvaCD20-directed cytolytic antibody84
GemcitabineNucleoside metabolic inhibitor56
Human immunoglobulin gHuman immunoglobulin G146
Humira167
HydroxychloroquineAntimalarial203
Ibrutinib (form s4)Kinase inhibitor67
IfosfamideAlkylating drug56
ImbruvicaKinase inhibitor135
IndapamideThiazide-like diuretic56
IsatuximabCD38-directed cytolytic antibody72
IxazomibProteasome inhibitor71
LeflunomideAntirheumatic agent93
LenalidomideThalidomide analog383
LevofloxacinFluoroquinolone antibacterial66
MelphalanAlkylating drug51
MepolizumabInterleukin-5 antagonist51
MeropenemPenem antibacterial64
MethotrexateFolate analog metabolic inhibitor404
Methotrexate sodiumFolate analog metabolic inhibitor96
MethylprednisoloneCorticosteroid307
Mycophenolate mofetilAntimetabolite immunosuppressant576
Mycophenolate sodium58
Mycophenolic acidAntimetabolite immunosuppressant110
ObinutuzumabCD20-directed cytolytic antibody209
OcrelizumabCD20-directed cytolytic antibody126
OcrevusCD20-directed cytolytic antibody549
OlanzapineAtypical antipsychotic56
OmeprazoleProton pump inhibitor76
OxaliplatinPlatinum-based drug62
Polatuzumab vedotin52
PomalidomideThalidomide analog107
PomalystThalidomide analog132
PrednisoloneCorticosteroid496
PrednisoneCorticosteroid799
RamiprilAngiotensin converting enzyme inhibitor68
RemdesivirSARS-CoV-2 nucleotide analog RNA polymerase inhibitor176
RemicadeTumor necrosis factor blocker99
RemodulinProstacycline vasodilator52
RevlimidThalidomide analog389
RinvoqJanus kinase inhibitor143
RituxanCD20-directed cytolytic antibody55
RituximabCD20-directed cytolytic antibody1,497
SimponiTumor necrosis factor blocker88
SkyriziInterleukin-23 antagonist71
Sotrovimab67
TacrolimusCalcineurin inhibitor immunosuppressant634
TocilizumabInterleukin-6 receptor antagonist264
VedolizumabIntegrin receptor antagonist56
VeklurySARS-CoV-2 nucleotide analog RNA polymerase inhibitor111
VenclextaBCL-2 inhibitor87
VenetoclaxBCL-2 inhibitor172
Vincristine236
Vincristine sulfateVinca alkaloid73
XeljanzJanus kinase inhibitor143

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 59 pharmacologic classes with 50 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 COVID-19 pneumonia name, in order of name
ClassReports with this term
Alkylating drug735
Angiotensin 2 receptor blocker110
Angiotensin converting enzyme inhibitor78
Anthracycline topoisomerase inhibitor298
Anticholinergic91
Antimalarial212
Antimetabolite immunosuppressant801
Antirheumatic agent111
Atypical antipsychotic158
BCL-2 inhibitor259
Benzodiazepine62
beta-Adrenergic blocker66
beta2-Adrenergic agonist61
Biguanide50
Calcineurin inhibitor immunosuppressant820
CD20-directed cytolytic antibody2,610
CD38-directed cytolytic antibody357
Cephalosporin antibacterial75
Corticosteroid2,543
Cytochrome P450 3A inhibitor84
Endothelin receptor antagonist77
Factor Xa inhibitor360
Fluoroquinolone antibacterial75
Folate analog metabolic inhibitor525
Histamine-1 receptor antagonist57
Human immunoglobulin G206
Insulin analog59
Integrin receptor antagonist99
Interleukin-12 antagonist54
Interleukin-17A antagonist149
Interleukin-23 antagonist99
Interleukin-4 receptor alpha antagonist112
Interleukin-5 antagonist61
Interleukin-6 receptor antagonist371
Janus kinase inhibitor507
Kinase inhibitor531
Loop diuretic132
Macrolide antimicrobial95
Nonsteroidal anti-inflammatory drug107
Nucleoside metabolic inhibitor384
Opioid agonist84
Osmotic laxative54
Penem antibacterial66
Platinum-based drug276
Programmed death Receptor-1 blocking antibody192
Prostacycline vasodilator178
Proteasome inhibitor406
Proton pump inhibitor256
Purine antimetabolite149
SARS-CoV-2 nucleotide analog RNA polymerase inhibitor287
Selective T cell costimulation modulator86
Sphingosine 1-phosphate receptor modulator81
Thalidomide analog1,011
Thiazide-like diuretic56
Topoisomerase inhibitor150
Tumor necrosis factor blocker452
Vascular endothelial growth factor inhibitor51
Vinca alkaloid73
Xanthine oxidase inhibitor50

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

Reports by month

Reports that record COVID-19 pneumonia, 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 COVID-19 pneumonia
AgeReportsShareShare as a bar
Under 2170.1%
2 to 11680.6%
12 to 17420.4%
18 to 441,20010.2%
45 to 643,42029.1%
65 to 742,33119.9%
75 and over1,80315.4%
Age not given2,85224.3%
Sex of the patient in the reports that record COVID-19 pneumonia
SexReportsShareShare as a bar
Female5,18244.2%
Male5,26344.9%
Unknown or not given1,28811%

Age and sex are as the report gives them. 44% 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. COVID-19 pneumonia: adverse event reports that record this term. https://reportedreactions.com/reaction/covid-19-pneumonia/ 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 COVID-19 pneumonia 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 .