MedDRA preferred term · itching where the product was applied

Application site pruritus: adverse event reports recording this term

22,383 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.

22,383
reports recording the term: 0.1% of all reports; 878
reports, 12 months to June 2026: 845 in the 12 months before; 12.2%
marked serious by the reporter: 57.4% across all reports; 0.3%
record death among outcomes, as reported: 9.1% across all reports

"Application site pruritus" (in plain words, itching where the product was applied) is a MedDRA preferred term recorded in 22,383 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

878 reports recorded it in the 12 months to June 2026, close to the 845 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, 12.2% are marked serious, 0.3% include death among the outcomes and 2.6% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Nicoderm Cq, Minoxidil and Butrans. 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	2,790	18.1%
Minoxidil	Arteriolar vasodilator	2,520	8.8%
Butrans	Partial opioid agonist	2,133	3.6%
Estradiol Transdermal System	Estrogen	882	14.7%
Daytrana	Central nervous system stimulant	798	5.8%
Zecuity	—	671	23.2%
Mens Rogaine Extra Strength	—	560	4.5%
Oxytrol for Women	Cholinergic muscarinic antagonist	521	8.3%
CombiPatch (estradiol/norethindrone acetate transdermal system)	Estrogen	506	14%
Picato	—	467	9.7%
Fentanyl Transdermal System	—	452	3.5%
Womens Rogaine Unscented	Arteriolar vasodilator	388	3.4%
Estradiol	Estrogen	375	2.4%
Neupro	Nonergot dopamine agonist	359	5.7%
Exelon	Cholinesterase inhibitor	291	2.1%
Equate Nicotine	Cholinergic nicotinic agonist	231	13.7%
Valchlor	Alkylating drug	215	10.2%
Womens Rogaine	—	211	4.3%
Nicoderm Cq Clear 21mg	—	209	29.9%
Fentanyl	Opioid agonist	204	0.4%
Nicotine transdermal system patch	Cholinergic nicotinic agonist	204	4.6%
Buprenorphine	Partial opioid agonist	199	1%
Nicotine	Cholinergic nicotinic agonist	197	2.2%
Clonidine	Central alpha-2 adrenergic agonist	190	1.6%
Clonidine transdermal system	Central alpha-2 adrenergic agonist	189	21.6%

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	3,642	6.7%	3.4%
Arteriolar vasodilator	2,908	6.7%	1.7%
Partial opioid agonist	2,404	2.5%	0%
Estrogen	2,353	1.8%	0%
Central nervous system stimulant	808	0.7%	0%
Cholinergic muscarinic antagonist	602	3.2%	0%
Central alpha-2 adrenergic agonist	539	1.7%	0%
Nonergot dopamine agonist	440	2.3%	0%
Cholinesterase inhibitor	330	1.3%	0%
Opioid agonist	268	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 20.1%15

2 to 111.5%334

12 to 170.7%154

18 to 4412.2%2,737

45 to 6420.6%4,620

65 to 749.2%2,051

75 and over6.1%1,363

Age not given49.6%11,109

Patient sex

Female61.3%13,719

Male28.7%6,434

Not given10%2,230

Grey bar: all 20,646,523 reports in the database. 94.5% of these reports give the United States as the country.

Questions about "Application site pruritus"

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

In plain language: itching 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 pruritus?

22,383 reports through June 2026 (0.1% of all reports), 878 of them in the latest 12 months.

Which drugs appear most often in these reports?

Nicoderm Cq (2,790), Minoxidil (2,520), Butrans (2,133), Estradiol Transdermal System (882) and Daytrana (798). 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.