Reported Reactions

Adverse event reports that FDA received

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Cytomegalovirus infection 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 16,337 adverse event reports that record the MedDRA preferred term Cytomegalovirus infection. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 962 reports in the 12 months to June 2026 and 1,246 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 632 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, 962 (0.1%) record this term. Reports for female patients were 36.9% of the reports that record this term and 52.7% 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 122 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 Cytomegalovirus infection name as a suspect product, in order of name
DrugClassReports with this term
AbataceptSelective T cell costimulation modulator51
ActemraInterleukin-6 receptor antagonist51
AcyclovirHerpes simplex virus nucleoside analog DNA polymerase inhibitor107
AdalimumabTumor necrosis factor blocker92
AlemtuzumabCD52-directed cytolytic antibody527
Alkeran58
AllopurinolXanthine oxidase inhibitor59
Anti-thymocyte globulin (rabbit)Immunoglobulin G145
Antithymocyte Immunoglobulin248
Atg-Fresenius53
AzathioprinePurine antimetabolite573
BasiliximabInterleukin-2 receptor blocking antibody622
BelataceptSelective T cell costimulation blocker130
Bendamustine242
Bendamustine hydrochlorideAlkylating drug208
Blinatumomab54
BortezomibProteasome inhibitor153
BudesonideCorticosteroid92
BusulfanAlkylating drug673
Busulfex114
CampathCD52-directed cytolytic antibody203
CarboplatinPlatinum-based drug154
CellCeptAntimetabolite immunosuppressant393
Certican61
Ciclosporin690
CiprofloxacinFluoroquinolone antibacterial54
CisplatinPlatinum-based drug179
CyclophosphamideAlkylating drug1,840
Cyclophosphamide/Cyclophosphamide Monohydrate55
Cyclosporin A64
CyclosporineCalcineurin inhibitor immunosuppressant1,512
CytarabineNucleoside metabolic inhibitor418
Daclizumab102
DaratumumabCD38-directed cytolytic antibody117
DarzalexCD38-directed cytolytic antibody107
DexamethasoneCorticosteroid753
DoxorubicinAnthracycline topoisomerase inhibitor288
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor178
EculizumabComplement inhibitor56
EnbrelTumor necrosis factor blocker75
EntyvioIntegrin receptor antagonist63
EnvarsusCalcineurin inhibitor immunosuppressant159
EtanerceptTumor necrosis factor blocker84
EtoposideTopoisomerase inhibitor431
EverolimusKinase inhibitor256
FilgrastimLeukocyte growth factor87
FluconazoleAzole antifungal50
Fludara107
FludarabineNucleoside metabolic inhibitor938
Fludarabine phosphateNucleoside metabolic inhibitor344
FoscarnetPyrophosphate analog DNA polymerase inhibitor124
Foscarnet sodiumPyrophosphate analog DNA polymerase inhibitor55
GanciclovirCytomegalovirus nucleoside analog DNA polymerase inhibitor674
Ganciclovir sodiumCytomegalovirus nucleoside analog DNA polymerase inhibitor54
GazyvaCD20-directed cytolytic antibody71
Human immunoglobulin gHuman immunoglobulin G91
Humira151
HydrocortisoneCorticosteroid61
HydroxychloroquineAntimalarial80
IfosfamideAlkylating drug100
InfliximabTumor necrosis factor blocker289
Infliximab Recombinant61
Lapine t-lymphocyte immune globulin104
LeflunomideAntirheumatic agent110
LenalidomideThalidomide analog128
Mabthera82
Maribavir164
MedrolCorticosteroid59
MelphalanAlkylating drug360
MercaptopurineNucleoside metabolic inhibitor64
MeropenemPenem antibacterial57
MethotrexateFolate analog metabolic inhibitor1,078
Methotrexate sodiumFolate analog metabolic inhibitor100
MethylprednisoloneCorticosteroid1,702
Methylprednisolone sodium succinateCorticosteroid105
Mycophenolate129
Mycophenolate mofetilAntimetabolite immunosuppressant3,928
Mycophenolate sodium107
Mycophenolic acidAntimetabolite immunosuppressant542
MyforticAntimetabolite immunosuppressant181
NeoralCalcineurin inhibitor immunosuppressant245
ObinutuzumabCD20-directed cytolytic antibody95
Polatuzumab vedotin85
Polivy54
PomalidomideThalidomide analog51
PrednisoloneCorticosteroid1,999
PrednisoneCorticosteroid2,032
Predonine93
Prevymis59
PrografCalcineurin inhibitor immunosuppressant426
Rapamune52
RemicadeTumor necrosis factor blocker483
RevlimidThalidomide analog85
RinvoqJanus kinase inhibitor64
RituxanCD20-directed cytolytic antibody123
RituximabCD20-directed cytolytic antibody1,615
RuxolitinibJanus kinase inhibitor203
SandimmuneCalcineurin inhibitor immunosuppressant65
SimponiTumor necrosis factor blocker52
SimulectInterleukin-2 receptor blocking antibody140
SirolimusKinase inhibitor290
SolirisComplement inhibitor102
Solu-medrolCorticosteroid78
StelaraInterleukin-12 antagonist58
Sulfamethoxazole and trimethoprimDihydrofolate reductase inhibitor antibacterial50
TacrolimusCalcineurin inhibitor immunosuppressant3,568
Thalidomide51
ThiotepaAlkylating drug464
Thymocyte Immune Globulin187
ThymoglobulinImmunoglobulin G335
Thymoglobuline98
TocilizumabInterleukin-6 receptor antagonist128
Treosulfan234
ValcyteCytomegalovirus nucleoside analog DNA polymerase inhibitor279
ValganciclovirCytomegalovirus nucleoside analog DNA polymerase inhibitor742
Valganciclovir hydrochlorideCytomegalovirus nucleoside analog DNA polymerase inhibitor136
VancomycinGlycopeptide antibacterial67
VedolizumabIntegrin receptor antagonist99
VelcadeProteasome inhibitor192
Vincristine386
Vincristine sulfateVinca alkaloid146
VoriconazoleAzole antifungal56

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 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 Cytomegalovirus infection name, in order of name
ClassReports with this term
Alkylating drug3,790
Aminosalicylate64
Anthracycline topoisomerase inhibitor504
Antimalarial94
Antimetabolite immunosuppressant5,044
Antirheumatic agent114
Azole antifungal193
BCL-2 inhibitor54
Calcineurin inhibitor immunosuppressant5,976
CD19-directed chimeric antigen receptor72
CD20-directed cytolytic antibody1,959
CD30-directed immunoconjugate83
CD38-directed cytolytic antibody238
CD52-directed cytolytic antibody752
Cephalosporin antibacterial51
Complement inhibitor158
Corticosteroid6,960
CTLA-4-directed blocking antibody69
Cytochrome P450 3A inhibitor75
Cytomegalovirus nucleoside analog DNA polymerase inhibitor1,885
Dihydrofolate reductase inhibitor antibacterial144
Fluoroquinolone antibacterial76
Folate analog metabolic inhibitor1,197
Glycopeptide antibacterial72
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor93
Herpes simplex virus nucleoside analog DNA polymerase inhibitor141
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor69
Human immunoglobulin G141
Immunoglobulin G488
Integrin receptor antagonist205
Interleukin-12 antagonist70
Interleukin-2 receptor blocking antibody762
Interleukin-6 receptor antagonist179
Janus kinase inhibitor390
Kinase inhibitor833
Leukocyte growth factor101
Microtubule inhibitor58
Nucleoside metabolic inhibitor1,890
Penem antibacterial70
Platinum-based drug360
Programmed death Receptor-1 blocking antibody209
Proteasome inhibitor401
Proton pump inhibitor94
Purine antimetabolite596
Pyrophosphate analog DNA polymerase inhibitor216
Selective T cell costimulation blocker153
Selective T cell costimulation modulator57
Thalidomide analog295
Topoisomerase inhibitor470
Tumor necrosis factor blocker1,118
Vinca alkaloid165
Xanthine oxidase inhibitor59

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

Reports by month

Reports that record Cytomegalovirus infection, 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 Cytomegalovirus infection
AgeReportsShareShare as a bar
Under 22881.8%
2 to 118995.5%
12 to 175373.3%
18 to 443,12819.1%
45 to 644,29726.3%
65 to 741,93911.9%
75 and over8105%
Age not given4,43927.2%
Sex of the patient in the reports that record Cytomegalovirus infection
SexReportsShareShare as a bar
Female6,03636.9%
Male7,29644.7%
Unknown or not given3,00518.4%

Age and sex are as the report gives them. 20.9% 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. Cytomegalovirus infection: adverse event reports that record this term. https://reportedreactions.com/reaction/cytomegalovirus-infection/ 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 Cytomegalovirus infection 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 .