Reported Reactions

Adverse event reports that FDA received

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Skin haemorrhage 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 April 2004 to June 2026, FDA received 14,240 adverse event reports that record the MedDRA preferred term Skin haemorrhage. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,437 reports in the 12 months to June 2026 and 1,551 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 472 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, 1,437 (0.1%) record this term. Reports for female patients were 56% 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 109 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 haemorrhage name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen175
Acetylsalicylic Acid51
AcitretinRetinoid28
ActemraInterleukin-6 receptor antagonist29
AdalimumabTumor necrosis factor blocker29
AliskirenRenin inhibitor84
Aliskiren hemifumarateRenin inhibitor150
AllopurinolXanthine oxidase inhibitor40
Altace160
AmlodipineCalcium channel blocker131
Amlodipine besylateDihydropyridine calcium channel blocker136
ApixabanFactor Xa inhibitor41
AspirinNonsteroidal anti-inflammatory drug275
AtacandAngiotensin 2 receptor blocker127
Atorvastatin53
Bisoprololbeta-Adrenergic blocker181
Bisoprolol fumaratebeta-Adrenergic blocker44
BrilintaP2Y12 platelet inhibitor40
CabometyxKinase inhibitor33
Calcium carbonateBlood coagulation factor169
CandesartanAngiotensin 2 receptor blocker142
Candesartan cilexetilAngiotensin 2 receptor blocker91
Ciclosporin43
Clobetasol26
ClopidogrelP2Y12 platelet inhibitor77
CosentyxInterleukin-17A antagonist985
Coumadin26
CyclosporineCalcineurin inhibitor immunosuppressant62
Cymbalta27
DexamethasoneCorticosteroid42
DiphenhydramineHistamine-1 receptor antagonist60
Diphenhydramine hydrochlorideHistamine-1 receptor antagonist129
DupilumabInterleukin-4 receptor alpha antagonist109
DupixentInterleukin-4 receptor alpha antagonist4,098
EliquisFactor Xa inhibitor135
EnbrelTumor necrosis factor blocker732
EntrestoAngiotensin 2 receptor blocker37
ErgocalciferolProvitamin D2 compound207
EsomeprazoleProton pump inhibitor112
Esomeprazole magnesiumProton pump inhibitor83
Esomeprazole Magnesium Naproxen77
Esomeprazole sodiumProton pump inhibitor28
ForteoParathyroid hormone analog29
GabapentinAnti-epileptic agent33
Gliclazide176
GravolHistamine-1 receptor antagonist171
Humira706
IbranceKinase inhibitor40
ImbruvicaKinase inhibitor249
IrbesartanAngiotensin 2 receptor blocker191
JakafiJanus kinase inhibitor76
JanuviaDipeptidyl peptidase 4 inhibitor163
KisqaliKinase inhibitor26
Levothyroxine37
Levothyroxine sodiuml-Thyroxine134
LipitorHMG-CoA reductase inhibitor168
LisinoprilAngiotensin converting enzyme inhibitor172
Lyrica62
MetforminBiguanide193
Metformin hydrochlorideBiguanide79
MethotrexateFolate analog metabolic inhibitor434
Methotrexate sodiumFolate analog metabolic inhibitor56
MethylprednisoloneCorticosteroid40
Methylprednisolone sodium succinateCorticosteroid156
MorphineOpioid agonist119
Morphine sulfateOpioid agonist106
NaproxenNonsteroidal anti-inflammatory drug31
Nemluvio47
NexiumProton pump inhibitor59
Nexium 24HRProton pump inhibitor38
OmalizumabAnti-IgE39
OmeprazoleProton pump inhibitor42
OndansetronSerotonin-3 receptor antagonist128
Ondansetron hydrochlorideSerotonin-3 receptor antagonist62
OtezlaPhosphodiesterase 4 inhibitor158
PantoprazoleProton pump inhibitor28
PlavixP2Y12 platelet inhibitor84
PradaxaDirect thrombin inhibitor99
PrednisoloneCorticosteroid43
Prednisolone sodium phosphateCorticosteroid26
PrednisoneCorticosteroid295
Proactiv Solution Daily Protection Plus Sunscreen Spf 3085
ProchlorperazinePhenothiazine172
ProliaRANK ligand inhibitor88
RamiprilAngiotensin converting enzyme inhibitor93
RemicadeTumor necrosis factor blocker61
RepathaPCSK9 inhibitor71
RevlimidThalidomide analog101
RibavirinNucleoside analog antiviral29
RinvoqJanus kinase inhibitor82
RituxanCD20-directed cytolytic antibody44
RituximabCD20-directed cytolytic antibody233
RivaroxabanFactor Xa inhibitor28
SimvastatinHMG-CoA reductase inhibitor45
Sitagliptin phosphateDipeptidyl peptidase 4 inhibitor31
SkyriziInterleukin-23 antagonist154
StelaraInterleukin-12 antagonist80
SutentKinase inhibitor63
Synthroidl-Thyroxine150
TacrolimusCalcineurin inhibitor immunosuppressant30
Tums Ultra28
ValsartanAngiotensin 2 receptor blocker25
VectibixEpidermal growth factor receptor antagonist67
XareltoFactor Xa inhibitor280
XeljanzJanus kinase inhibitor53
XolairAnti-IgE55
ZestrilAngiotensin converting enzyme inhibitor73
Zofran52
Zolpidemgamma-Aminobutyric acid A receptor positive modulator102

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 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 haemorrhage name, in order of name
ClassReports with this term
Alkylating drug39
Angiotensin 2 receptor blocker627
Angiotensin converting enzyme inhibitor345
Anti-epileptic agent45
Anti-IgE94
Antimetabolite immunosuppressant32
Aromatase inhibitor29
Atypical antipsychotic26
BCL-2 inhibitor26
beta-Adrenergic blocker256
Biguanide272
Blood coagulation factor176
Calcineurin inhibitor immunosuppressant111
Calcium channel blocker137
CD20-directed cytolytic antibody295
Corticosteroid692
Dihydropyridine calcium channel blocker136
Dipeptidyl peptidase 4 inhibitor196
Direct thrombin inhibitor101
Epidermal growth factor receptor antagonist95
Factor Xa inhibitor501
Fluoroquinolone antibacterial30
Folate analog metabolic inhibitor497
gamma-Aminobutyric acid A receptor positive modulator110
Histamine-1 receptor antagonist439
HMG-CoA reductase inhibitor240
Insulin analog60
Interleukin-12 antagonist82
Interleukin-17A antagonist1,007
Interleukin-23 antagonist175
Interleukin-4 receptor alpha antagonist4,207
Interleukin-6 receptor antagonist43
Janus kinase inhibitor231
Kinase inhibitor613
l-Thyroxine288
Loop diuretic37
Nonsteroidal anti-inflammatory drug422
Nucleoside analog antiviral29
Nucleoside metabolic inhibitor83
Opioid agonist261
P2Y12 platelet inhibitor209
Parathyroid hormone analog29
PCSK9 inhibitor95
Phenothiazine172
Phosphodiesterase 4 inhibitor182
Platinum-based drug27
Prostacycline vasodilator37
Proton pump inhibitor422
Provitamin D2 compound207
RANK ligand inhibitor92
Renin inhibitor84
Retinoid61
Serotonin reuptake inhibitor75
Serotonin-3 receptor antagonist190
Thalidomide analog124
Thrombopoietin receptor agonist44
Tumor necrosis factor blocker892
Vitamin K antagonist32
Xanthine oxidase inhibitor40

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

Reports by month

Reports that record Skin haemorrhage, 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 Skin haemorrhage
AgeReportsShareShare as a bar
Under 21000.7%
2 to 115694%
12 to 175353.8%
18 to 442,14115%
45 to 643,15022.1%
65 to 741,80912.7%
75 and over1,4159.9%
Age not given4,52131.7%
Sex of the patient in the reports that record Skin haemorrhage
SexReportsShareShare as a bar
Female7,98156%
Male5,35637.6%
Unknown or not given9036.3%

Age and sex are as the report gives them. 78.1% 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 haemorrhage: adverse event reports that record this term. https://reportedreactions.com/reaction/skin-haemorrhage/ 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 haemorrhage 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 .