MedDRA preferred term

Application site rash: adverse event reports recording this term

13,618 reports to FDA record it, 2005–2026; 0.1% 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.

13,618
reports recording the term: 0.1% of all reports; 471
reports, 12 months to June 2026: 339 in the 12 months before; 11.5%
marked serious by the reporter: 57.4% across all reports; 0.2%
record death among outcomes, as reported: 9.1% across all reports

"Application site rash" is a MedDRA preferred term recorded in 13,618 adverse event reports received by FDA, 0.1% of the database, from July 2005 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

471 reports recorded it in the 12 months to June 2026, up 39% from 339 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, 11.5% are marked serious, 0.2% include death among the outcomes and 2.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Butrans, Nicoderm Cq and Estradiol Transdermal System. 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
Butrans	Partial opioid agonist	2,927	4.9%
Nicoderm Cq	Cholinergic nicotinic agonist	887	5.8%
Estradiol Transdermal System	Estrogen	586	9.8%
Minoxidil	Arteriolar vasodilator	418	1.5%
Zecuity	—	341	11.8%
Fentanyl Transdermal System	—	328	2.6%
Daytrana	Central nervous system stimulant	325	2.4%
Oxytrol for Women	Cholinergic muscarinic antagonist	318	5.1%
Estradiol	Estrogen	301	1.9%
Mens Rogaine Extra Strength	—	270	2.2%
Climara	Estrogen	250	7.9%
Equate Nicotine	Cholinergic nicotinic agonist	208	12.3%
Axiron	—	207	3.3%
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	195	0.4%
Climara Pro	Estrogen	188	9.6%
Duragesic-100	—	182	1.9%
Chloraprep with Tint	—	178	13.5%
Neupro	Nonergot dopamine agonist	175	2.8%
CombiPatch (estradiol/norethindrone acetate transdermal system)	Estrogen	173	4.8%
Fentanyl	Opioid agonist	173	0.3%
Womens Rogaine Unscented	Arteriolar vasodilator	148	1.3%
Androgel	—	145	0.8%
Pennsaid	—	134	7.1%
Emsam	Monoamine oxidase inhibitor	128	9.6%
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose	—	126	0.2%

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 0.1% 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
Partial opioid agonist	3,077	3.2%	0%
Estrogen	1,773	1.4%	0%
Cholinergic nicotinic agonist	1,416	2.6%	1.9%
Arteriolar vasodilator	566	1.3%	0.7%
Central nervous system stimulant	340	0.3%	0%
Cholinergic muscarinic antagonist	339	1.8%	0%
Central alpha-2 adrenergic agonist	300	0.9%	0%
Nonsteroidal anti-inflammatory drug	290	0.1%	0%
Opioid agonist	204	0%	0%
Nonergot dopamine agonist	190	1%	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 20.1%11

2 to 111.2%169

12 to 170.7%90

18 to 449.8%1,337

45 to 6418.4%2,510

65 to 747.2%978

75 and over5.1%698

Age not given57.5%7,825

Patient sex

Female61.9%8,433

Male28.8%3,917

Not given9.3%1,268

Grey bar: all 20,646,523 reports in the database. 96.7% of these reports give the United States as the country.

Questions about "Application site rash"

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

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 rash?

13,618 reports through June 2026 (0.1% of all reports), 471 of them in the latest 12 months.

Which drugs appear most often in these reports?

Butrans (2,927), Nicoderm Cq (887), Estradiol Transdermal System (586), Minoxidil (418) and Zecuity (341). 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.