MedDRA preferred term · a problem with the product itself

Product quality issue: adverse event reports recording this term

133,054 reports to FDA record it, 2005–2026; 0.6% 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.

133,054
reports recording the term: 0.6% of all reports; 4,282
reports, 12 months to June 2026: 3,468 in the 12 months before; 23.9%
marked serious by the reporter: 57.4% across all reports; 1.5%
record death among outcomes, as reported: 9.1% across all reports

"Product quality issue" (in plain words, a problem with the product itself) is a MedDRA preferred term recorded in 133,054 adverse event reports received by FDA, 0.6% of the database, from January 2005 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

4,282 reports recorded it in the 12 months to June 2026, up 23% from 3,468 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, 23.9% are marked serious, 1.5% include death among the outcomes and 6.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Nexplanon, Daytrana and Tiotropium bromide. 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
Nexplanon	Progestin	5,509	12.6%
Daytrana	Central nervous system stimulant	5,129	37.4%
Tiotropium bromide	Anticholinergic	5,013	6.5%
Dulera	Corticosteroid	3,059	42.1%
Asmanex	Corticosteroid	2,701	56.2%
Lidocaine patch	Amide local anesthetic	2,676	59.8%
Proventil	—	2,564	61.7%
Advair Diskus	Corticosteroid	1,888	9.2%
Combivent	—	1,679	14.4%
Bydureon	—	1,569	8%
Duragesic	—	1,473	4.8%
Advair Diskus 100/50	—	1,414	10.3%
Duragesic-100	—	1,394	14.3%
Ventolin Hfa	beta2-Adrenergic agonist	1,385	6.1%
Albuterol sulfate	beta2-Adrenergic agonist	1,272	2.8%
Fentanyl Transdermal System	—	1,258	9.9%
Lantus	Insulin analog	1,256	3.2%
Nasonex	Corticosteroid	1,057	19.6%
Vyvanse	Central nervous system stimulant	1,043	5.9%
Fentanyl	Opioid agonist	1,037	1.9%
Tanzeum	—	1,003	11.9%
Solostar	—	987	8.2%
Humira	—	974	0.2%
Symbicort	Corticosteroid	954	2.4%
Nicotine transdermal system patch	Cholinergic nicotinic agonist	941	21.1%

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 0.6% 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
Corticosteroid	18,348	2.3%	1.4%
Central nervous system stimulant	7,429	6.8%	1.2%
Anticholinergic	6,953	4.4%	1%
Progestin	5,789	2%	0.2%
Nonsteroidal anti-inflammatory drug	5,470	1%	0.5%
Tumor necrosis factor blocker	5,025	0.5%	0.3%
Opioid agonist	4,307	0.4%	0.2%
Insulin analog	3,938	1.4%	0.6%
Estrogen	3,503	2.7%	1.2%
beta2-Adrenergic agonist	3,248	3.5%	2.8%

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 20.5%705

2 to 112.7%3,657

12 to 171.5%2,047

18 to 4410.7%14,180

45 to 6416.1%21,445

65 to 749.5%12,579

75 and over6.9%9,223

Age not given52%69,218

Patient sex

Female57.2%76,045

Male29.3%39,018

Not given13.5%17,991

Grey bar: all 20,646,523 reports in the database. 92.3% of these reports give the United States as the country.

Questions about "Product quality issue"

What does "Product quality issue" mean in an adverse event report?

In plain language: a problem with the product itself. 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 quality issue?

133,054 reports through June 2026 (0.6% of all reports), 4,282 of them in the latest 12 months.

Which drugs appear most often in these reports?

Nexplanon (5,509), Daytrana (5,129), Tiotropium bromide (5,013), Dulera (3,059) and Asmanex (2,701). 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.