MedDRA preferred term

Product adhesion issue: adverse event reports recording this term

34,987 reports to FDA record it, 2008–2026; 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.

34,987
reports recording the term: 0.2% of all reports; 2,934
reports, 12 months to June 2026: 2,687 in the 12 months before; 7.4%
marked serious by the reporter: 57.4% across all reports; 0.1%
record death among outcomes, as reported: 9.1% across all reports

"Product adhesion issue" is a MedDRA preferred term recorded in 34,987 adverse event reports received by FDA, 0.2% of the database, from September 2008 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

2,934 reports recorded it in the 12 months to June 2026, close to the 2,687 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, 7.4% are marked serious, 0.1% include death among the outcomes and 1.7% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Ethinyl Estradiol Norelgestromin, Estradiol Transdermal System and Lidocaine patch. 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
Ethinyl Estradiol Norelgestromin	—	3,341	98%
Estradiol Transdermal System	Estrogen	2,975	49.7%
Lidocaine patch	Amide local anesthetic	2,862	64%
Fentanyl Transdermal System	—	2,621	20.6%
Butrans	Partial opioid agonist	2,052	3.4%
Neupro	Nonergot dopamine agonist	1,680	26.9%
Estradiol	Estrogen	1,425	9.2%
Nicotine transdermal system patch	Cholinergic nicotinic agonist	1,192	26.7%
Fentanyl	Opioid agonist	1,082	2%
Buprenorphine	Partial opioid agonist	850	4.4%
Daytrana	Central nervous system stimulant	804	5.9%
Duragesic	—	803	2.6%
CombiPatch (estradiol/norethindrone acetate transdermal system)	Estrogen	774	21.5%
Nicotine	Cholinergic nicotinic agonist	716	7.9%
Oxytrol for Women	Cholinergic muscarinic antagonist	675	10.7%
Xulane	Estrogen	670	43.6%
Climara Pro	Estrogen	666	34.2%
Duragesic-100	—	666	6.8%
Climara	Estrogen	626	19.9%
Buprenorphine Transdermal System	Partial opioid agonist	569	59.6%
Twirla	Estrogen	539	53.2%
Lidocaine	Amide local anesthetic	516	3.7%
Minivelle	Estrogen	437	15.5%
Clonidine	Central alpha-2 adrenergic agonist	330	2.8%
Norelgestromin/Ethinyl Estradiol Transdermal System	—	311	97.2%

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 0.2% 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
Estrogen	8,371	6.6%	0%
Partial opioid agonist	3,745	3.9%	1.9%
Amide local anesthetic	3,389	8.1%	0%
Cholinergic nicotinic agonist	2,227	4.1%	0.6%
Nonergot dopamine agonist	1,900	9.9%	0%
Opioid agonist	1,360	0.1%	0%
Central nervous system stimulant	904	0.8%	0%
Cholinergic muscarinic antagonist	801	4.3%	0%
Cholinesterase inhibitor	499	1.9%	0%
Central alpha-2 adrenergic agonist	492	1.5%	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%10

2 to 110.6%225

12 to 170.8%266

18 to 445.3%1,857

45 to 6413.8%4,825

65 to 744.6%1,622

75 and over3.3%1,168

Age not given71.5%25,014

Patient sex

Female67.7%23,685

Male17.9%6,263

Not given14.4%5,039

Grey bar: all 20,646,523 reports in the database. 92.6% of these reports give the United States as the country.

Questions about "Product adhesion issue"

What does "Product adhesion issue" 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 product adhesion issue?

34,987 reports through June 2026 (0.2% of all reports), 2,934 of them in the latest 12 months.

Which drugs appear most often in these reports?

Ethinyl Estradiol Norelgestromin (3,341), Estradiol Transdermal System (2,975), Lidocaine patch (2,862), Fentanyl Transdermal System (2,621) and Butrans (2,052). 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.