Reported Reactions

Adverse event reports that FDA received

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Dermatitis adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
inflamed skin

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 20,381 adverse event reports that record the MedDRA preferred term Dermatitis. In plain words, the term means: inflamed skin. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,939 reports in the 12 months to June 2026 and 1,796 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 367 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, 1,939 (0.1%) record this term. Reports for patients aged 18 to 44 were 19% of the reports that record this term and 12.3% 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

Inflamed skin. 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 98 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 Dermatitis name as a suspect product, in order of name
DrugClassReports with this term
ActemraInterleukin-6 receptor antagonist161
AdalimumabTumor necrosis factor blocker70
AfinitorKinase inhibitor59
Alendronate sodiumBisphosphonate70
AllopurinolXanthine oxidase inhibitor70
AmlodipineCalcium channel blocker59
AmoxicillinPenicillin-class antibacterial50
AravaAntirheumatic agent104
AtezolizumabProgrammed death Receptor-1 blocking antibody120
AvastinVascular endothelial growth factor inhibitor68
AzathioprinePurine antimetabolite94
BevacizumabVascular endothelial growth factor inhibitor83
CabometyxKinase inhibitor50
CapecitabineNucleoside metabolic inhibitor124
CarboplatinPlatinum-based drug255
CelebrexNonsteroidal anti-inflammatory drug90
CetuximabEpidermal growth factor receptor antagonist113
CimziaTumor necrosis factor blocker102
CisplatinPlatinum-based drug181
Clobetasol64
CosentyxInterleukin-17A antagonist292
CyclophosphamideAlkylating drug109
CyclosporineCalcineurin inhibitor immunosuppressant86
DexamethasoneCorticosteroid86
DifferinRetinoid54
DocetaxelMicrotubule inhibitor187
DoxorubicinAnthracycline topoisomerase inhibitor64
DoxycyclineTetracycline-class drug76
DupilumabInterleukin-4 receptor alpha antagonist179
DupixentInterleukin-4 receptor alpha antagonist4,577
EnbrelTumor necrosis factor blocker399
ErbituxEpidermal growth factor receptor antagonist83
EtoposideTopoisomerase inhibitor65
FluorouracilNucleoside metabolic inhibitor171
FosamaxBisphosphonate133
GemcitabineNucleoside metabolic inhibitor56
GilenyaSphingosine 1-phosphate receptor modulator51
HerceptinHER2/neu receptor antagonist61
Humira657
HydrocortisoneCorticosteroid72
HydroxychloroquineAntimalarial72
Hydroxychloroquine sulfateAntimalarial61
IbuprofenNonsteroidal anti-inflammatory drug52
InflectraTumor necrosis factor blocker52
InfliximabTumor necrosis factor blocker137
IpilimumabCTLA-4-directed blocking antibody116
IsotretinoinRetinoid63
KeytrudaProgrammed death Receptor-1 blocking antibody123
KisqaliKinase inhibitor57
LamictalAnti-epileptic agent50
LeflunomideAntirheumatic agent87
LenalidomideThalidomide analog52
LetrozoleAromatase inhibitor93
LevofloxacinFluoroquinolone antibacterial52
Lyrica99
MethotrexateFolate analog metabolic inhibitor427
Methotrexate sodiumFolate analog metabolic inhibitor84
Mycophenolate mofetilAntimetabolite immunosuppressant81
Myochrysine50
NaproxenNonsteroidal anti-inflammatory drug100
NivolumabProgrammed death Receptor-1 blocking antibody178
OmeprazoleProton pump inhibitor57
OpdivoProgrammed death Receptor-1 blocking antibody82
OrenciaSelective T cell costimulation modulator166
OtezlaPhosphodiesterase 4 inhibitor53
OxaliplatinPlatinum-based drug89
PaclitaxelMicrotubule inhibitor141
PanitumumabEpidermal growth factor receptor antagonist50
PegasysInterferon alpha57
PembrolizumabProgrammed death Receptor-1 blocking antibody136
PlaquenilAntimalarial52
PrednisoloneCorticosteroid81
PrednisoneCorticosteroid219
Proactiv Solution Daily Protection Plus Sunscreen Spf 30138
ProliaRANK ligand inhibitor258
RemicadeTumor necrosis factor blocker226
RevlimidThalidomide analog113
RibavirinNucleoside analog antiviral100
RinvoqJanus kinase inhibitor83
RituxanCD20-directed cytolytic antibody54
RituximabCD20-directed cytolytic antibody201
SimponiTumor necrosis factor blocker62
SkyriziInterleukin-23 antagonist78
StelaraInterleukin-12 antagonist73
SulfasalazineAminosalicylate140
TacrolimusCalcineurin inhibitor immunosuppressant106
TocilizumabInterleukin-6 receptor antagonist52
TrametinibKinase inhibitor54
TrastuzumabHER2/neu receptor antagonist77
Triamcinolone53
TysabriIntegrin receptor antagonist55
VancomycinGlycopeptide antibacterial58
VectibixEpidermal growth factor receptor antagonist86
Vioxx82
XeljanzJanus kinase inhibitor94
XolairAnti-IgE122
YervoyCTLA-4-directed blocking antibody72
Zometa69

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 43 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 Dermatitis name, in order of name
ClassReports with this term
Alkylating drug279
Aminosalicylate142
Anthracycline topoisomerase inhibitor108
Anti-epileptic agent147
Anti-IgE150
Antimalarial185
Antimetabolite immunosuppressant100
Antirheumatic agent191
Aromatase inhibitor186
Azole antifungal113
Bisphosphonate266
Calcineurin inhibitor immunosuppressant205
CD20-directed cytolytic antibody333
Corticosteroid707
CTLA-4-directed blocking antibody205
Epidermal growth factor receptor antagonist332
Fluoroquinolone antibacterial101
Folate analog metabolic inhibitor580
HER2/neu receptor antagonist203
HMG-CoA reductase inhibitor122
Integrin receptor antagonist100
Interleukin-17A antagonist332
Interleukin-4 receptor alpha antagonist4,756
Interleukin-6 receptor antagonist217
Janus kinase inhibitor237
Kinase inhibitor912
Microtubule inhibitor346
Nonsteroidal anti-inflammatory drug422
Nucleoside analog antiviral103
Nucleoside metabolic inhibitor460
Opioid agonist139
Phosphodiesterase 4 inhibitor108
Platinum-based drug525
Programmed death Receptor-1 blocking antibody664
Proton pump inhibitor129
Purine antimetabolite107
RANK ligand inhibitor329
Retinoid221
Selective T cell costimulation modulator194
Tetracycline-class drug121
Thalidomide analog189
Tumor necrosis factor blocker1,138
Vascular endothelial growth factor inhibitor162

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

Reports by month

Reports that record Dermatitis, 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 Dermatitis
AgeReportsShareShare as a bar
Under 21390.7%
2 to 115482.7%
12 to 171,0875.3%
18 to 443,88219%
45 to 644,72023.2%
65 to 742,29411.3%
75 and over1,4707.2%
Age not given6,24130.6%
Sex of the patient in the reports that record Dermatitis
SexReportsShareShare as a bar
Female11,58456.8%
Male6,75533.1%
Unknown or not given2,04210%

Age and sex are as the report gives them. 66.7% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Dermatitis: adverse event reports that record this term. https://reportedreactions.com/reaction/dermatitis/ 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 Dermatitis mean in an adverse event report?

In plain words: inflamed skin. 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 .