Reported Reactions

Adverse event reports that FDA received

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Dermatitis acneiform 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 February 2004 to June 2026, FDA received 5,968 adverse event reports that record the MedDRA preferred term Dermatitis acneiform. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 413 reports in the 12 months to June 2026 and 406 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 1,087 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, 413 (under 0.1%) record this term. Reports for male patients were 45.9% 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 139 drug pages with 10 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 acneiform name as a suspect product, in order of name
DrugClassReports with this term
5 Fu10
5-fluorouracil23
5-Fu28
5-Fu Fluorouracil12
AbraxaneMicrotubule inhibitor17
AdalimumabTumor necrosis factor blocker23
Ado-trastuzumab emtansine11
AfatinibKinase inhibitor25
AfinitorKinase inhibitor23
Amivantamab56
AtezolizumabProgrammed death Receptor-1 blocking antibody27
AvastinVascular endothelial growth factor inhibitor104
Avmapki Fakzynja Co-Pack13
AzathioprinePurine antimetabolite29
BevacizumabVascular endothelial growth factor inhibitor153
Braftovi52
CabometyxKinase inhibitor54
Calcium folinateFolate analog28
Calcium Levofolinate60
CapecitabineNucleoside metabolic inhibitor78
CarboplatinPlatinum-based drug153
CetuximabEpidermal growth factor receptor antagonist291
CisplatinPlatinum-based drug94
ClindamycinLincosamide antibacterial17
Clobetasol11
CobimetinibKinase inhibitor41
CosentyxInterleukin-17A antagonist40
CotellicKinase inhibitor12
CyclophosphamideAlkylating drug33
DabrafenibKinase inhibitor39
DexamethasoneCorticosteroid31
DocetaxelMicrotubule inhibitor92
DoxorubicinAnthracycline topoisomerase inhibitor16
DoxycyclineTetracycline-class drug38
DupixentInterleukin-4 receptor alpha antagonist114
Elplat13
EnbrelTumor necrosis factor blocker73
EntyvioIntegrin receptor antagonist10
ErbituxEpidermal growth factor receptor antagonist531
ErlotinibKinase inhibitor243
Erlotinib hydrochlorideKinase inhibitor41
EverolimusKinase inhibitor11
FemaraAromatase inhibitor16
Filgotinib11
FilgrastimLeukocyte growth factor15
FluorouracilNucleoside metabolic inhibitor500
Folinic Acid103
GefitinibKinase inhibitor13
GemcitabineNucleoside metabolic inhibitor31
Gemcitabine hydrochlorideNucleoside metabolic inhibitor34
Gemzar14
GilotrifKinase inhibitor121
GolimumabTumor necrosis factor blocker10
HerceptinHER2/neu receptor antagonist47
Humira167
IbranceKinase inhibitor10
ImbruvicaKinase inhibitor32
InflectraTumor necrosis factor blocker22
InfliximabTumor necrosis factor blocker46
IpilimumabCTLA-4-directed blocking antibody20
IressaKinase inhibitor60
Irinotecan189
Irinotecan hcl55
Irinotecan hydrochlorideTopoisomerase inhibitor54
IsotretinoinRetinoid12
JakafiJanus kinase inhibitor37
KeytrudaProgrammed death Receptor-1 blocking antibody17
KisqaliKinase inhibitor11
KoselugoKinase inhibitor56
LamictalAnti-epileptic agent25
LansoprazoleProton pump inhibitor27
LapatinibKinase inhibitor15
LazcluzeKinase inhibitor13
LenvimaKinase inhibitor12
Leucovorin137
Leucovorin calciumFolate analog56
Levoleucovorin calciumFolate analog39
MalaroneAntimalarial12
MekinistKinase inhibitor89
Mektovi38
MercaptopurineNucleoside metabolic inhibitor10
MesalamineAminosalicylate12
MethotrexateFolate analog metabolic inhibitor36
Mycophenolate mofetilAntimetabolite immunosuppressant20
Necitumumab39
NintedanibKinase inhibitor10
NivolumabProgrammed death Receptor-1 blocking antibody51
OmeprazoleProton pump inhibitor20
OpdivoProgrammed death Receptor-1 blocking antibody35
OsimertinibKinase inhibitor28
OxaliplatinPlatinum-based drug456
Ozanimod11
PaclitaxelMicrotubule inhibitor85
PanitumumabEpidermal growth factor receptor antagonist489
PantoprazoleProton pump inhibitor23
PembrolizumabProgrammed death Receptor-1 blocking antibody17
PemetrexedFolate analog metabolic inhibitor62
PerjetaHER2/neu receptor antagonist31
PertuzumabHER2/neu receptor antagonist43
PrednisoloneCorticosteroid12
PrednisoneCorticosteroid38
ProliaRANK ligand inhibitor10
RabeprazoleProton pump inhibitor21
Radiation Therapy16
RamucirumabVascular endothelial growth factor receptor 2 antagonist12
RemicadeTumor necrosis factor blocker16
RepathaPCSK9 inhibitor13
RevlimidThalidomide analog42
RinvoqJanus kinase inhibitor34
Risankizumab12
RituximabCD20-directed cytolytic antibody37
Rybrevant65
SelumetinibKinase inhibitor17
SkyriziInterleukin-23 antagonist12
SpironolactoneAldosterone antagonist12
SprycelKinase inhibitor11
SulfasalazineAminosalicylate11
SutentKinase inhibitor11
TacrolimusCalcineurin inhibitor immunosuppressant24
TafinlarKinase inhibitor29
TagrissoKinase inhibitor69
Tarceva334
Taxol12
Taxotere20
Tipiracil Hydrochloride Trifluridine11
TofacitinibJanus kinase inhibitor10
TrametinibKinase inhibitor84
TrastuzumabHER2/neu receptor antagonist71
TykerbKinase inhibitor66
UpadacitinibJanus kinase inhibitor18
UstekinumabInterleukin-12 antagonist16
VectibixEpidermal growth factor receptor antagonist556
VedolizumabIntegrin receptor antagonist23
VemurafenibKinase inhibitor45
Vincristine11
XeljanzJanus kinase inhibitor44
XelodaNucleoside metabolic inhibitor32
ZelborafKinase inhibitor30
Zoledronic acidBisphosphonate14

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 45 pharmacologic classes with 10 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 acneiform name, in order of name
ClassReports with this term
Aldosterone antagonist12
Alkylating drug48
Aminosalicylate23
Anthracycline topoisomerase inhibitor22
Anti-epileptic agent41
Antimalarial27
Antimetabolite immunosuppressant20
Aromatase inhibitor31
Azole antifungal11
Bisphosphonate14
Calcineurin inhibitor immunosuppressant36
CD20-directed cytolytic antibody47
Corticosteroid105
CTLA-4-directed blocking antibody26
Epidermal growth factor receptor antagonist1,867
Fluoroquinolone antibacterial13
Folate analog123
Folate analog metabolic inhibitor110
HER2/neu receptor antagonist192
Integrin receptor antagonist39
Interleukin-12 antagonist16
Interleukin-17A antagonist40
Interleukin-23 antagonist12
Interleukin-4 receptor alpha antagonist119
Interleukin-6 receptor antagonist18
Janus kinase inhibitor145
Kinase inhibitor1,408
Leukocyte growth factor25
Lincosamide antibacterial19
Microtubule inhibitor194
Nucleoside analog antiviral14
Nucleoside metabolic inhibitor701
PCSK9 inhibitor13
Platinum-based drug703
Programmed death Receptor-1 blocking antibody154
Proton pump inhibitor104
Purine antimetabolite29
RANK ligand inhibitor16
Retinoid25
Tetracycline-class drug51
Thalidomide analog48
Topoisomerase inhibitor76
Tumor necrosis factor blocker199
Vascular endothelial growth factor inhibitor265
Vascular endothelial growth factor receptor 2 antagonist20

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

Reports by month

Reports that record Dermatitis acneiform, by month, five years to June 2026
05010020222023202420252026

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 acneiform
AgeReportsShareShare as a bar
Under 2120.2%
2 to 11741.2%
12 to 171202%
18 to 4476012.7%
45 to 641,70328.5%
65 to 741,10518.5%
75 and over5098.5%
Age not given1,68528.2%
Sex of the patient in the reports that record Dermatitis acneiform
SexReportsShareShare as a bar
Female2,53742.5%
Male2,73945.9%
Unknown or not given69211.6%

Age and sex are as the report gives them. 43.6% 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. Dermatitis acneiform: adverse event reports that record this term. https://reportedreactions.com/reaction/dermatitis-acneiform/ 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 acneiform 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 .