MedDRA preferred term · irritated skin

Skin irritation: adverse event reports recording this term

45,264 reports to FDA record it, 2004–2026; 0.2% 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.

45,264
reports recording the term: 0.2% of all reports; 1,923
reports, 12 months to June 2026: 1,846 in the 12 months before; 13.3%
marked serious by the reporter: 57.4% across all reports; 0.5%
record death among outcomes, as reported: 9.1% across all reports

"Skin irritation" (in plain words, irritated skin) is a MedDRA preferred term recorded in 45,264 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

1,923 reports recorded it in the 12 months to June 2026, close to the 1,846 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, 13.3% are marked serious, 0.5% include death among the outcomes and 4.3% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Dupixent, Proactiv Solution Daily Protection Plus Sunscreen Spf 30 and Humira. 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
Dupixent	Interleukin-4 receptor alpha antagonist	2,601	0.6%
Proactiv Solution Daily Protection Plus Sunscreen Spf 30	—	1,514	14.1%
Humira	—	713	0.1%
Butrans	Partial opioid agonist	505	0.8%
Differin	Retinoid	487	10%
Adapalene	Retinoid	478	10.1%
Cosentyx	Interleukin-17A antagonist	418	0.3%
Enbrel	Tumor necrosis factor blocker	355	0.1%
Mens Rogaine Extra Strength	—	305	2.4%
Otezla	Phosphodiesterase 4 inhibitor	182	0.1%
Womens Rogaine Unscented	Arteriolar vasodilator	166	1.5%
Revlimid	Thalidomide analog	163	0%
Oxytrol for Women	Cholinergic muscarinic antagonist	162	2.6%
Cabometyx	Kinase inhibitor	144	0.3%
Skyrizi	Interleukin-23 antagonist	140	0.2%
Remodulin	Prostacycline vasodilator	138	0.3%
Womens Rogaine	—	136	2.8%
Minoxidil	Arteriolar vasodilator	118	0.4%
Nicoderm Cq	Cholinergic nicotinic agonist	108	0.7%
Valchlor	Alkylating drug	106	5%
Prolia	RANK ligand inhibitor	101	0.1%
Ketoconazole	Azole antifungal	97	2.4%
Methotrexate	Folate analog metabolic inhibitor	97	0%
Prednisone	Corticosteroid	96	0.1%
Estradiol	Estrogen	95	0.6%

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 0.2% 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
Interleukin-4 receptor alpha antagonist	2,676	0.6%	0.6%
Retinoid	1,004	1.5%	0%
Kinase inhibitor	793	0.1%	0%
Tumor necrosis factor blocker	622	0.1%	0%
Partial opioid agonist	557	0.6%	0%
Interleukin-17A antagonist	444	0.2%	0.1%
Corticosteroid	424	0.1%	0%
Prostacycline vasodilator	340	0.3%	0.2%
Nonsteroidal anti-inflammatory drug	299	0.1%	0%
Arteriolar vasodilator	284	0.7%	0.2%

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 20.2%81

2 to 111.3%598

12 to 1712.2%5,536

18 to 4423.2%10,512

45 to 6410.4%4,696

65 to 744.1%1,873

75 and over2.7%1,218

Age not given45.8%20,750

Patient sex

Female65.2%29,522

Male23.4%10,583

Not given11.4%5,159

Grey bar: all 20,646,523 reports in the database. 93% of these reports give the United States as the country.

Questions about "Skin irritation"

What does "Skin irritation" mean in an adverse event report?

In plain language: irritated skin. 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 skin irritation?

45,264 reports through June 2026 (0.2% of all reports), 1,923 of them in the latest 12 months.

Which drugs appear most often in these reports?

Dupixent (2,601), Proactiv Solution Daily Protection Plus Sunscreen Spf 30 (1,514), Humira (713), Butrans (505) and Differin (487). 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.