MedDRA preferred term · redness where the product was applied

Application site erythema: adverse event reports recording this term

25,943 reports to FDA record it, 2004–2026; 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.

25,943
reports recording the term: 0.1% of all reports; 787
reports, 12 months to June 2026: 742 in the 12 months before; 17%
marked serious by the reporter: 57.4% across all reports; 0.3%
record death among outcomes, as reported: 9.1% across all reports

25,943 reports in FDA's adverse event database record the MedDRA term "Application site erythema" (in plain words, redness where the product was applied): 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

787 reports recorded it in the 12 months to June 2026, close to the 742 of 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, 17% are marked serious, 0.3% include death among the outcomes and 3.1% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Nicoderm Cq, Picato and Zecuity. 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
Nicoderm Cq	Cholinergic nicotinic agonist	2,875	18.7%
Picato	—	2,220	46.1%
Zecuity	—	1,857	64.2%
Daytrana	Central nervous system stimulant	1,654	12.1%
Butrans	Partial opioid agonist	1,579	2.6%
Oxytrol for Women	Cholinergic muscarinic antagonist	802	12.8%
Estradiol Transdermal System	Estrogen	794	13.3%
Minoxidil	Arteriolar vasodilator	584	2%
CombiPatch (estradiol/norethindrone acetate transdermal system)	Estrogen	562	15.6%
Fentanyl Transdermal System	—	477	3.7%
Exelon	Cholinesterase inhibitor	394	2.9%
Estradiol	Estrogen	382	2.5%
Neupro	Nonergot dopamine agonist	359	5.7%
Equate Nicotine	Cholinergic nicotinic agonist	246	14.5%
Abreva	Non-Standardized chemical allergen	242	1.8%
Mens Rogaine Extra Strength	—	242	1.9%
Eucrisa	Phosphodiesterase 4 inhibitor	231	3%
Fentanyl	Opioid agonist	229	0.4%
Nicotine	Cholinergic nicotinic agonist	226	2.5%
Valchlor	Alkylating drug	211	10%
Duragesic-100	—	207	2.1%
Nicoderm Cq Clear 21mg	—	206	29.4%
Emsam	Monoamine oxidase inhibitor	192	14.4%
Womens Rogaine Unscented	Arteriolar vasodilator	177	1.6%
Clonidine	Central alpha-2 adrenergic agonist	176	1.5%

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
Cholinergic nicotinic agonist	3,704	6.8%	3.1%
Estrogen	2,315	1.8%	0%
Partial opioid agonist	1,786	1.9%	0%
Central nervous system stimulant	1,699	1.5%	0%
Cholinergic muscarinic antagonist	912	4.9%	0%
Arteriolar vasodilator	761	1.8%	0.8%
Central alpha-2 adrenergic agonist	485	1.5%	0%
Cholinesterase inhibitor	469	1.8%	0%
Nonergot dopamine agonist	444	2.3%	0.1%
Opioid agonist	283	0%	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%66

2 to 112.7%688

12 to 171.2%305

18 to 4413.3%3,459

45 to 6422.9%5,937

65 to 749.8%2,537

75 and over6.3%1,623

Age not given43.7%11,328

Patient sex

Female64%16,599

Male26.8%6,963

Not given9.2%2,381

Grey bar: all 20,646,523 reports in the database. 93.1% of these reports give the United States as the country.

Questions about "Application site erythema"

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

In plain language: redness 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 erythema?

25,943 reports through June 2026 (0.1% of all reports), 787 of them in the latest 12 months.

Which drugs appear most often in these reports?

Nicoderm Cq (2,875), Picato (2,220), Zecuity (1,857), Daytrana (1,654) and Butrans (1,579). 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.