MedDRA preferred term · a reaction where the product was applied

Application site reaction: adverse event reports recording this term

6,858 reports to FDA record it, 2004–2026; 0% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

6,858
reports recording the term: 0% of all reports; 127
reports, 12 months to June 2026: 90 in the 12 months before; 18.3%
marked serious by the reporter: 57.4% across all reports; 0.4%
record death among outcomes, as reported: 9.1% across all reports

6,858 reports in FDA's adverse event database record the MedDRA term "Application site reaction" (in plain words, a reaction where the product was applied): 0% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

127 reports recorded it in the 12 months to June 2026, up 41% from 90 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 18.3% are marked serious, 0.4% include death among the outcomes and 4.4% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Ortho Evra, Butrans and Nicoderm Cq. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Ortho Evra	—	1,091	7.4%
Butrans	Partial opioid agonist	853	1.4%
Nicoderm Cq	Cholinergic nicotinic agonist	850	5.5%
Picato	—	239	5%
Neupro	Nonergot dopamine agonist	188	3%
Chloraprep Single Swabstick	—	178	72.4%
Fentanyl Transdermal System	—	176	1.4%
Duragesic-100	—	145	1.5%
Abreva	Non-Standardized chemical allergen	120	0.9%
Estradiol Transdermal System	Estrogen	92	1.5%
Nicoderm Cq Clear 21mg	—	88	12.6%
Zecuity	—	85	2.9%
Minoxidil	Arteriolar vasodilator	74	0.3%
Duragesic	—	72	0.2%
Emsam	Monoamine oxidase inhibitor	70	5.2%
Equate Nicotine	Cholinergic nicotinic agonist	67	4%
Fentanyl	Opioid agonist	61	0.1%
Estradiol	Estrogen	55	0.4%
Exelon	Cholinesterase inhibitor	55	0.4%
Climara	Estrogen	54	1.7%
Nicoderm Cq Clear 14mg	—	52	18.1%
CombiPatch (estradiol/norethindrone acetate transdermal system)	Estrogen	50	1.4%
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	47	0.1%
Fentanyl-100	—	46	1.1%
Nicorette	Cholinergic nicotinic agonist	43	0.3%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Cholinergic nicotinic agonist	1,008	1.9%	0.4%
Partial opioid agonist	875	0.9%	0%
Estrogen	319	0.3%	0%
Nonergot dopamine agonist	211	1.1%	0.1%
Non-Standardized chemical allergen	120	0.8%	0%
Opioid agonist	101	0%	0%
Arteriolar vasodilator	100	0.2%	0.1%
Nonsteroidal anti-inflammatory drug	71	0%	0%
Monoamine oxidase inhibitor	70	1.2%	0%
Cholinesterase inhibitor	66	0.3%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.3%19

2 to 110.6%43

12 to 170.9%59

18 to 4419.4%1,330

45 to 6417.2%1,182

65 to 747.2%496

75 and over4.1%281

Age not given50.3%3,448

Patient sex

Female66.8%4,583

Male22%1,511

Not given11.1%764

Grey bar: all 20,646,523 reports in the database. 75.8% of these reports give the United States as the country.

Questions about "Application site reaction"

What does "Application site reaction" mean in an adverse event report?

In plain language: a reaction where the product was applied. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record application site reaction?

6,858 reports through June 2026 (0% of all reports), 127 of them in the latest 12 months.

Which drugs appear most often in these reports?

Ortho Evra (1,091), Butrans (853), Nicoderm Cq (850), Picato (239) and Neupro (188). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.