Application site reaction adverse event reports that record this term

Kind of term: MedDRA preferred term
Plain meaning: a reaction where the product was applied

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 6,858 adverse event reports that record the MedDRA preferred term Application site reaction. In plain words, the term means: a reaction where the product was applied. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 127 reports in the 12 months to June 2026 and 90 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 1,364 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, 127 (under 0.1%) record this term. Reports for female patients were 66.8% 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.

Plain meaning

A reaction where the product was applied. 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 5 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 Application site reaction name as a suspect product, in order of name
Drug	Class	Reports with this term
Abreva	Non-Standardized chemical allergen	120
Aldara		37
Altabax		7
Androderm		12
Androgel		39
Atenolol	beta-Adrenergic blocker	7
Axiron		13
Buprenorphine	Partial opioid agonist	22
Butrans	Partial opioid agonist	853
Candesartan cilexetil	Angiotensin 2 receptor blocker	5
Catapres-TTS-1	Central alpha-2 adrenergic agonist	16
Chloraprep		26
Chloraprep Single Swabstick		178
Chloraprep with Tint		25
Chlorhexidine gluconate		7
Climara	Estrogen	54
Climara Pro	Estrogen	22
Clonidine	Central alpha-2 adrenergic agonist	14
Clonidine transdermal system	Central alpha-2 adrenergic agonist	12
CombiPatch (estradiol/norethindrone acetate transdermal system)	Estrogen	50
Commit		12
Cosmetics		6
Daytrana	Central nervous system stimulant	37
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose		25
Diclofenac	Nonsteroidal anti-inflammatory drug	8
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	47
Duloxetine	Serotonin and norepinephrine reuptake inhibitor	11
Duragesic		72
Duragesic-100		145
Duragesic-50		8
Elidel		6
Emsam	Monoamine oxidase inhibitor	70
Equate Nicotine	Cholinergic nicotinic agonist	67
Equate Nts 21mg		15
Equate Nts 21mg Clear		7
Estradiol	Estrogen	55
Estradiol Transdermal System	Estrogen	92
Estradiol/Norethisterone Acetate		6
Eucrisa	Phosphodiesterase 4 inhibitor	11
Exelon	Cholinesterase inhibitor	55
Fentanyl	Opioid agonist	61
Fentanyl citrate	Opioid agonist	24
Fentanyl Transdermal System		176
Fentanyl Unknown Strength		12
Fentanyl-100		46
Flector	Nonsteroidal anti-inflammatory drug	12
Flolan		7
Gabapentin	Anti-epileptic agent	5
Imiquimod		8
Levulan Kerastick		12
Lidocaine patch	Amide local anesthetic	11
Mens Rogaine Extra Strength		41
Methylphenidate	Central nervous system stimulant	7
Minivelle	Estrogen	6
Minoxidil	Arteriolar vasodilator	74
Mupirocin		6
Neulasta	Leukocyte growth factor	35
Neupro	Nonergot dopamine agonist	188
Nicoderm Cq	Cholinergic nicotinic agonist	850
Nicoderm Cq Clear 14mg		52
Nicoderm Cq Clear 21mg		88
Nicorette	Cholinergic nicotinic agonist	43
Nicorette Otc		5
Nicotine	Cholinergic nicotinic agonist	33
Nicotine transdermal system	Cholinergic nicotinic agonist	5
Nicotine transdermal system patch	Cholinergic nicotinic agonist	6
Opsumit	Endothelin receptor antagonist	5
Opzelura	Janus kinase inhibitor	5
Ortho Evra		1,091
Oxytrol	Cholinergic muscarinic antagonist	5
Oxytrol for Women	Cholinergic muscarinic antagonist	21
Picato		239
Picato Gel		10
Protopic		6
Qutenza		7
Regranex		5
Rivastigmine	Cholinesterase inhibitor	11
Rogaine		15
Rotigotine	Nonergot dopamine agonist	21
Sancuso	Serotonin-3 receptor antagonist	5
Sandostatin	Somatostatin analog	5
Sandostatin LAR Depot		7
Sandoz Fentanyl Transdermal System		6
Saphris	Atypical antipsychotic	7
Simponi	Tumor necrosis factor blocker	9
Testosterone	Androgen	8
Transderm Scop	Anticholinergic	33
Twirla	Estrogen	7
Valchlor	Alkylating drug	20
Veletri	Prostacycline vasodilator	6
Vivelle-Dot	Estrogen	5
Womens Rogaine		15
Womens Rogaine Unscented	Arteriolar vasodilator	26
Xelstrym	Central nervous system stimulant	13
Xolair	Anti-IgE	7
Xulane	Estrogen	23
Zecuity		85
Zyclara		5

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 37 pharmacologic classes with 5 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 Application site reaction name, in order of name
Class	Reports with this term
Alkylating drug	20
Amide local anesthetic	15
Aminoglycoside antibacterial	7
Androgen	8
Androgen receptor inhibitor	5
Angiotensin 2 receptor blocker	8
Anti-epileptic agent	5
Anti-IgE	10
Anticholinergic	35
Arteriolar vasodilator	100
Atypical antipsychotic	9
Azole antifungal	8
beta-Adrenergic blocker	7
Central alpha-2 adrenergic agonist	42
Central nervous system stimulant	44
Cholinergic muscarinic antagonist	26
Cholinergic nicotinic agonist	1,008
Cholinesterase inhibitor	66
Corticosteroid	7
Endothelin receptor antagonist	5
Estrogen	319
Janus kinase inhibitor	5
Leukocyte growth factor	35
Monoamine oxidase inhibitor	70
Non-Standardized chemical allergen	120
Nonergot dopamine agonist	211
Nonsteroidal anti-inflammatory drug	71
Opioid agonist	101
Partial opioid agonist	875
Phosphodiesterase 4 inhibitor	11
Prostacycline vasodilator	11
Prostaglandin analog	5
Retinoid	5
Serotonin and norepinephrine reuptake inhibitor	16
Serotonin-3 receptor antagonist	5
Somatostatin analog	5
Tumor necrosis factor blocker	11

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

Reports by month

Reports that record Application site reaction, 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 Application site reaction
Age	Reports	Share
Under 2	19	0.3%
2 to 11	43	0.6%
12 to 17	59	0.9%
18 to 44	1,330	19.4%
45 to 64	1,182	17.2%
65 to 74	496	7.2%
75 and over	281	4.1%
Age not given	3,448	50.3%

Sex of the patient in the reports that record Application site reaction
Sex	Reports	Share
Female	4,583	66.8%
Male	1,511	22%
Unknown or not given	764	11.1%

Age and sex are as the report gives them. 75.8% 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. Application site reaction: adverse event reports that record this term. https://reportedreactions.com/reaction/application-site-reaction/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 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 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 Application site reaction mean in an adverse event report?

In plain words: a reaction where the product was applied. 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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