Skin 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 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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 11,002 adverse event reports that record the MedDRA preferred term Skin infection. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 754 reports in the 12 months to June 2026 and 706 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 114 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Skin infection name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	54
Actemra	Interleukin-6 receptor antagonist	131
Adalimumab	Tumor necrosis factor blocker	129
Ambrisentan	Endothelin receptor antagonist	27
Amoxicillin	Penicillin-class antibacterial	28
Arava	Antirheumatic agent	38
Atezolizumab	Programmed death Receptor-1 blocking antibody	26
Avonex	Interferon beta	29
Azacitidine	Nucleoside metabolic inhibitor	35
Azathioprine	Purine antimetabolite	98
Basiliximab	Interleukin-2 receptor blocking antibody	32
Bendamustine		33
Betamethasone		34
Betnovate		26
Bevacizumab	Vascular endothelial growth factor inhibitor	51
Carboplatin	Platinum-based drug	39
Certolizumab pegol	Tumor necrosis factor blocker	71
Ciclosporin		29
Cimzia	Tumor necrosis factor blocker	76
Cisplatin	Platinum-based drug	32
Clonazepam	Benzodiazepine	25
Cosentyx	Interleukin-17A antagonist	286
Cyclophosphamide	Alkylating drug	239
Cyclosporine	Calcineurin inhibitor immunosuppressant	117
Cytarabine	Nucleoside metabolic inhibitor	45
Dexamethasone	Corticosteroid	110
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose		42
Docetaxel	Microtubule inhibitor	64
Doxorubicin	Anthracycline topoisomerase inhibitor	95
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	36
Doxycycline	Tetracycline-class drug	25
Dupixent	Interleukin-4 receptor alpha antagonist	357
Enbrel	Tumor necrosis factor blocker	539
Etanercept	Tumor necrosis factor blocker	61
Etoposide	Topoisomerase inhibitor	38
Eumovate		32
Fludarabine	Nucleoside metabolic inhibitor	27
Fluorouracil	Nucleoside metabolic inhibitor	44
Fosamax	Bisphosphonate	25
Foscarbidopa/foslevodopa		25
Furosemide	Loop diuretic	39
GAMMAGARD Liquid	Human immunoglobulin G	28
Gemcitabine	Nucleoside metabolic inhibitor	37
Gilenya	Sphingosine 1-phosphate receptor modulator	47
Hizentra	Human immunoglobulin G	61
Human immunoglobulin g	Human immunoglobulin G	163
Human Immunoglobulin G Hyaluronidase Recombinant Human		31
Humira		744
Humira 40 Mg/0 8 Ml Pen		28
Hydrocortisone	Corticosteroid	60
Hydroxychloroquine	Antimalarial	26
Ibrance	Kinase inhibitor	39
Ibrutinib	Kinase inhibitor	52
Ibuprofen	Nonsteroidal anti-inflammatory drug	48
Imbruvica	Kinase inhibitor	108
Inflectra	Tumor necrosis factor blocker	141
Infliximab	Tumor necrosis factor blocker	172
Infliximab Recombinant		28
Ipilimumab	CTLA-4-directed blocking antibody	29
Jakafi	Janus kinase inhibitor	33
Kesimpta	CD20-directed cytolytic antibody	31
Leflunomide	Antirheumatic agent	38
Lenalidomide	Thalidomide analog	49
Letrozole	Aromatase inhibitor	31
Levofloxacin	Fluoroquinolone antibacterial	30
Methotrexate	Folate analog metabolic inhibitor	353
Methotrexate sodium	Folate analog metabolic inhibitor	64
Methylprednisolone	Corticosteroid	84
Metoclopramide	Dopamine-2 receptor antagonist	27
Mycophenolate mofetil	Antimetabolite immunosuppressant	204
Nivolumab	Programmed death Receptor-1 blocking antibody	50
Ocrevus	CD20-directed cytolytic antibody	145
Omalizumab	Anti-IgE	34
Opsumit	Endothelin receptor antagonist	53
Orencia	Selective T cell costimulation modulator	83
Otezla	Phosphodiesterase 4 inhibitor	46
Paclitaxel	Microtubule inhibitor	48
Pantoprazole	Proton pump inhibitor	34
Pegasys	Interferon alpha	29
Pembrolizumab	Programmed death Receptor-1 blocking antibody	28
Pertuzumab	HER2/neu receptor antagonist	46
Pomalyst	Thalidomide analog	48
Prednisolone	Corticosteroid	176
Prednisone	Corticosteroid	279
Prolia	RANK ligand inhibitor	115
Rebif	Interferon beta	37
Remicade	Tumor necrosis factor blocker	242
Remodulin	Prostacycline vasodilator	90
Revlimid	Thalidomide analog	159
Ribavirin	Nucleoside analog antiviral	45
Rinvoq	Janus kinase inhibitor	119
Rituxan	CD20-directed cytolytic antibody	46
Rituximab	CD20-directed cytolytic antibody	426
Secukinumab	Interleukin-17A antagonist	25
Simponi	Tumor necrosis factor blocker	106
Sirolimus	Kinase inhibitor	27
Skyrizi	Interleukin-23 antagonist	111
Soliris	Complement inhibitor	28
Stelara	Interleukin-12 antagonist	143
Sulfasalazine	Aminosalicylate	34
Tacrolimus	Calcineurin inhibitor immunosuppressant	180
Taltz	Interleukin-17A antagonist	55
Tocilizumab	Interleukin-6 receptor antagonist	59
Trastuzumab	HER2/neu receptor antagonist	59
Tysabri	Integrin receptor antagonist	123
Vedolizumab	Integrin receptor antagonist	80
Veletri	Prostacycline vasodilator	28
Venclexta	BCL-2 inhibitor	31
Venetoclax	BCL-2 inhibitor	86
Vincristine		92
Vincristine sulfate	Vinca alkaloid	25
Vyalev		35
Xeljanz	Janus kinase inhibitor	224
Xolair	Anti-IgE	84

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 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Skin infection name, in order of name
Class	Reports with this term
Alkylating drug	287
Anthracycline topoisomerase inhibitor	141
Anti-epileptic agent	62
Anti-IgE	118
Antimalarial	65
Antimetabolite immunosuppressant	237
Antirheumatic agent	76
Atypical antipsychotic	52
Azole antifungal	59
BCL-2 inhibitor	117
Benzodiazepine	77
Calcineurin inhibitor immunosuppressant	310
CD20-directed cytolytic antibody	723
Corticosteroid	830
Endothelin receptor antagonist	126
Epidermal growth factor receptor antagonist	58
Fluoroquinolone antibacterial	59
Folate analog metabolic inhibitor	431
HER2/neu receptor antagonist	132
Human immunoglobulin G	288
Integrin receptor antagonist	220
Interferon beta	74
Interleukin-12 antagonist	160
Interleukin-17A antagonist	366
Interleukin-23 antagonist	133
Interleukin-4 receptor alpha antagonist	379
Interleukin-6 receptor antagonist	213
Janus kinase inhibitor	427
Kinase inhibitor	521
Microtubule inhibitor	133
Nonsteroidal anti-inflammatory drug	109
Nucleoside metabolic inhibitor	238
Opioid agonist	101
Phosphodiesterase 4 inhibitor	62
Platinum-based drug	94
Programmed death Receptor-1 blocking antibody	127
Prostacycline vasodilator	138
Proteasome inhibitor	55
Proton pump inhibitor	93
Purine antimetabolite	118
RANK ligand inhibitor	119
Selective T cell costimulation modulator	137
Thalidomide analog	265
Tumor necrosis factor blocker	1,584
Vascular endothelial growth factor inhibitor	64

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

Reports by month

Reports that record Skin infection, by month, five years to June 2026

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 infection
Age	Reports	Share
Under 2	38	0.3%
2 to 11	192	1.7%
12 to 17	248	2.3%
18 to 44	1,741	15.8%
45 to 64	2,828	25.7%
65 to 74	1,218	11.1%
75 and over	747	6.8%
Age not given	3,990	36.3%

Sex of the patient in the reports that record Skin infection
Sex	Reports	Share
Female	6,058	55.1%
Male	3,573	32.5%
Unknown or not given	1,371	12.5%

Age and sex are as the report gives them. 58% 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

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Skin infection: adverse event reports that record this term. https://reportedreactions.com/reaction/skin-infection/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 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 Oct 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 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 2 Oct 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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