Reported Reactions

Adverse event reports that FDA received

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Skin fissures 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 18,627 adverse event reports that record the MedDRA preferred term Skin fissures. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 2,247 reports in the 12 months to June 2026 and 2,364 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 324 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, 2,247 (0.2%) record this term. Reports for patients aged 18 to 44 were 20.2% 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.

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 25 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 Skin fissures name as a suspect product, in order of name
DrugClassReports with this term
ActemraInterleukin-6 receptor antagonist92
AdbryInterleukin-13 antagonist41
Ado-trastuzumab emtansine32
AmlodipineCalcium channel blocker28
AnakinraInterleukin-1 receptor antagonist48
AnastrozoleAromatase inhibitor26
AubagioPyrimidine synthesis inhibitor25
AvastinVascular endothelial growth factor inhibitor55
BevacizumabVascular endothelial growth factor inhibitor45
Bimzelx26
CabometyxKinase inhibitor203
CapecitabineNucleoside metabolic inhibitor234
CetuximabEpidermal growth factor receptor antagonist52
Clobetasol45
CosentyxInterleukin-17A antagonist876
CyclosporineCalcineurin inhibitor immunosuppressant37
DenosumabRANK ligand inhibitor27
DifferinRetinoid34
DocetaxelMicrotubule inhibitor73
DoxycyclineTetracycline-class drug25
DupilumabInterleukin-4 receptor alpha antagonist150
DupixentInterleukin-4 receptor alpha antagonist7,040
EnbrelTumor necrosis factor blocker487
Enhertu34
ErbituxEpidermal growth factor receptor antagonist151
Erelzi29
ErlotinibKinase inhibitor47
EtanerceptTumor necrosis factor blocker41
EucrisaPhosphodiesterase 4 inhibitor48
FaslodexEstrogen receptor antagonist35
FluorouracilNucleoside metabolic inhibitor124
FulvestrantEstrogen receptor antagonist47
GilotrifKinase inhibitor64
HerceptinHER2/neu receptor antagonist117
Human immunoglobulin gHuman immunoglobulin G29
Humira779
Humira 40 Mg/0 8 Ml Pen25
HydrocortisoneCorticosteroid51
HydroxychloroquineAntimalarial25
Hydroxychloroquine sulfateAntimalarial28
IbranceKinase inhibitor85
ImbruvicaKinase inhibitor178
InflectraTumor necrosis factor blocker35
InfliximabTumor necrosis factor blocker88
InlytaKinase inhibitor25
Irinotecan52
Kadcyla80
KisqaliKinase inhibitor76
LansoprazoleProton pump inhibitor28
LapatinibKinase inhibitor44
LeflunomideAntirheumatic agent64
LetrozoleAromatase inhibitor51
Leucovorin54
Lyrica33
MetforminBiguanide25
MethotrexateFolate analog metabolic inhibitor255
Methotrexate sodiumFolate analog metabolic inhibitor49
NaproxenNonsteroidal anti-inflammatory drug63
Navelbine29
Nemluvio42
NexavarKinase inhibitor106
OcrevusCD20-directed cytolytic antibody29
OtezlaPhosphodiesterase 4 inhibitor178
OxaliplatinPlatinum-based drug117
PaclitaxelMicrotubule inhibitor25
PanitumumabEpidermal growth factor receptor antagonist38
PegasysInterferon alpha56
PerjetaHER2/neu receptor antagonist70
PertuzumabHER2/neu receptor antagonist57
PlaquenilAntimalarial28
PrednisoneCorticosteroid67
Proactiv Solution Daily Protection Plus Sunscreen Spf 30207
ProliaRANK ligand inhibitor38
RemicadeTumor necrosis factor blocker66
RevlimidThalidomide analog62
RibavirinNucleoside analog antiviral52
RinvoqJanus kinase inhibitor99
RituxanCD20-directed cytolytic antibody38
RituximabCD20-directed cytolytic antibody80
SkyriziInterleukin-23 antagonist252
StelaraInterleukin-12 antagonist62
StivargaKinase inhibitor111
SulfasalazineAminosalicylate60
SutentKinase inhibitor176
TagrissoKinase inhibitor51
Tarceva169
Taxotere48
TrastuzumabHER2/neu receptor antagonist89
Trastuzumab deruxtecan26
Triamcinolone34
TucatinibKinase inhibitor57
TukysaKinase inhibitor59
TykerbKinase inhibitor127
VectibixEpidermal growth factor receptor antagonist248
XeljanzJanus kinase inhibitor69
XelodaNucleoside metabolic inhibitor373
XgevaRANK ligand inhibitor41
Zometa28

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 53 pharmacologic classes with 25 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 Skin fissures name, in order of name
ClassReports with this term
Alkylating drug42
Aminosalicylate64
Angiotensin 2 receptor blocker59
Angiotensin converting enzyme inhibitor28
Anthracycline topoisomerase inhibitor55
Anti-epileptic agent48
Antimalarial81
Antirheumatic agent76
Aromatase inhibitor83
Atypical antipsychotic53
beta-Adrenergic blocker34
Biguanide28
Calcineurin inhibitor immunosuppressant67
Calcium channel blocker35
CD20-directed cytolytic antibody159
Corticosteroid284
Cytoprotective agent36
Epidermal growth factor receptor antagonist489
Estrogen receptor antagonist84
Factor Xa inhibitor50
Folate analog metabolic inhibitor309
GLP-1 receptor agonist25
HER2/neu receptor antagonist333
HMG-CoA reductase inhibitor44
Human immunoglobulin G39
Interferon alpha58
Interleukin-1 receptor antagonist58
Interleukin-12 antagonist62
Interleukin-13 antagonist44
Interleukin-17A antagonist909
Interleukin-23 antagonist278
Interleukin-4 receptor alpha antagonist7,190
Interleukin-6 receptor antagonist99
Janus kinase inhibitor197
Kinase inhibitor1,637
Leukocyte growth factor29
Microtubule inhibitor98
Nonsteroidal anti-inflammatory drug142
Nucleoside analog antiviral52
Nucleoside metabolic inhibitor741
Paramagnetic contrast agent27
Phosphodiesterase 4 inhibitor228
Platinum-based drug141
Programmed death Receptor-1 blocking antibody49
Proton pump inhibitor64
Pyrimidine synthesis inhibitor25
RANK ligand inhibitor106
Retinoid90
Sodium-Glucose cotransporter 2 inhibitor36
Tetracycline-class drug25
Thalidomide analog73
Tumor necrosis factor blocker774
Vascular endothelial growth factor inhibitor106

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

Reports by month

Reports that record Skin fissures, 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 Skin fissures
AgeReportsShareShare as a bar
Under 2910.5%
2 to 117614.1%
12 to 171,0115.4%
18 to 443,76420.2%
45 to 644,58724.6%
65 to 741,96110.5%
75 and over9054.9%
Age not given5,54729.8%
Sex of the patient in the reports that record Skin fissures
SexReportsShareShare as a bar
Female11,07259.4%
Male6,53435.1%
Unknown or not given1,0215.5%

Age and sex are as the report gives them. 82.8% 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. Skin fissures: adverse event reports that record this term. https://reportedreactions.com/reaction/skin-fissures/ 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 Skin fissures 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 .