MedDRA preferred term · a problem with the label

Product label issue: adverse event reports recording this term

6,616 reports to FDA record it, 2009–2026; 0% 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.

6,616
reports recording the term: 0% of all reports; 584
reports, 12 months to June 2026: 478 in the 12 months before; 32.4%
marked serious by the reporter: 57.4% across all reports; 1.8%
record death among outcomes, as reported: 9.1% across all reports

6,616 reports in FDA's adverse event database record the MedDRA term "Product label issue" (in plain words, a problem with the label): 0% of all reports received between April 2009 and June 2026. Coders pick the term that best matches the reporter's description.

584 reports recorded it in the 12 months to June 2026, up 22% from 478 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, 32.4% are marked serious, 1.8% include death among the outcomes and 7.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Xarelto, Tremfya and Stelara. 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
Xarelto	Factor Xa inhibitor	386	0.3%
Tremfya	Interleukin-23 antagonist	205	0.6%
Stelara	Interleukin-12 antagonist	181	0.2%
Imodium Multi-Symptom Relief	—	150	2.8%
TYLENOL Extra Strength	—	129	1.6%
Zyrtec	Histamine-1 receptor antagonist	107	0.5%
MiraLAX	Osmotic laxative	91	0.2%
Simponi	Tumor necrosis factor blocker	81	0.1%
Tylenol 8 HR Arthritis Pain	—	64	1.3%
Advil	Nonsteroidal anti-inflammatory drug	58	0.3%
Eliquis	Factor Xa inhibitor	45	0%
Imodium A-D	Opioid agonist	44	1.3%
Paxlovid	—	44	0.1%
Albuterol sulfate	beta2-Adrenergic agonist	42	0.1%
Breztri	Corticosteroid	40	0.6%
Humira	—	38	0%
Symbicort	Corticosteroid	38	0.1%
Ibuprofen	Nonsteroidal anti-inflammatory drug	35	0%
Aleve	Nonsteroidal anti-inflammatory drug	34	0.1%
Ozempic	GLP-1 receptor agonist	32	0.1%
Lyrica	—	30	0%
Omeprazole	Proton pump inhibitor	29	0%
Womens Rogaine Unscented	Arteriolar vasodilator	27	0.2%
Diclofenac	Nonsteroidal anti-inflammatory drug	26	0.1%
Risperdal Consta	—	24	0.2%

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% 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
Factor Xa inhibitor	433	0.1%	0%
Nonsteroidal anti-inflammatory drug	249	0%	0%
Interleukin-23 antagonist	224	0.2%	0%
Interleukin-12 antagonist	183	0.2%	0.1%
Histamine-1 receptor antagonist	164	0.1%	0%
Corticosteroid	154	0%	0%
Opioid agonist	134	0%	0%
Osmotic laxative	109	0.1%	0%
Tumor necrosis factor blocker	108	0%	0%
Proton pump inhibitor	59	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 20.7%47

2 to 111.5%98

12 to 171%63

18 to 448.7%578

45 to 6416.1%1,064

65 to 7411.1%735

75 and over13.1%868

Age not given47.8%3,163

Patient sex

Female51.1%3,383

Male28.7%1,900

Not given20.1%1,333

Grey bar: all 20,646,523 reports in the database. 90.3% of these reports give the United States as the country.

Questions about "Product label issue"

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

In plain language: a problem with the label. 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 label issue?

6,616 reports through June 2026 (0% of all reports), 584 of them in the latest 12 months.

Which drugs appear most often in these reports?

Xarelto (386), Tremfya (205), Stelara (181), Imodium Multi-Symptom Relief (150) and TYLENOL Extra Strength (129). 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.