MedDRA preferred term

Product label confusion: adverse event reports recording this term

5,742 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.

5,742
reports recording the term: 0% of all reports; 613
reports, 12 months to June 2026: 511 in the 12 months before; 25.6%
marked serious by the reporter: 57.4% across all reports; 10.9%
record death among outcomes, as reported: 9.1% across all reports

"Product label confusion" is a MedDRA preferred term recorded in 5,742 adverse event reports received by FDA, 0% of the database, from April 2009 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

613 reports recorded it in the 12 months to June 2026, up 20% from 511 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, 25.6% are marked serious, 10.9% include death among the outcomes and 17% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Rituximab, Leflunomide and Diclofenac sodium. 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
Rituximab	CD20-directed cytolytic antibody	581	0.4%
Leflunomide	Antirheumatic agent	539	1.5%
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	508	1%
Cosentyx	Interleukin-17A antagonist	493	0.3%
Methotrexate	Folate analog metabolic inhibitor	486	0.2%
Erelzi	—	457	3.4%
Aimovig	—	439	0.8%
Enbrel	Tumor necrosis factor blocker	432	0.1%
Humira	—	421	0.1%
Prednisone	Corticosteroid	421	0.2%
Adalimumab	Tumor necrosis factor blocker	415	1.1%
Arava	Antirheumatic agent	414	1.2%
Candesartan	Angiotensin 2 receptor blocker	413	4.1%
Acetaminophen	Nonsteroidal anti-inflammatory drug	401	0.5%
Actemra	Interleukin-6 receptor antagonist	400	0.5%
Sulfasalazine	Aminosalicylate	399	1%
Ozempic	GLP-1 receptor agonist	385	0.7%
Orencia	Selective T cell costimulation modulator	367	0.3%
Simponi	Tumor necrosis factor blocker	367	0.5%
Gold Sodium Thiomalate	—	364	13.8%
Desoximetasone	Corticosteroid	358	2.9%
Cimzia	Tumor necrosis factor blocker	356	0.4%
Topiramate	—	352	1.4%
Infliximab	Tumor necrosis factor blocker	342	0.7%
Folic acid	Vitamin B12	334	1.4%

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
Tumor necrosis factor blocker	2,919	0.3%	0.2%
Corticosteroid	2,845	0.4%	0%
Nonsteroidal anti-inflammatory drug	2,058	0.4%	0%
Antirheumatic agent	953	1.3%	1.4%
Interleukin-6 receptor antagonist	839	0.6%	0.8%
Opioid agonist	837	0.1%	0%
Antimalarial	755	0.8%	0.1%
Histamine-1 receptor antagonist	685	0.5%	0%
CD20-directed cytolytic antibody	647	0.2%	0%
Bisphosphonate	572	0.6%	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%39

2 to 111.3%72

12 to 170.7%43

18 to 4414.1%807

45 to 647.5%428

65 to 745.2%297

75 and over5.8%334

Age not given64.8%3,722

Patient sex

Female44.9%2,576

Male20.6%1,185

Not given34.5%1,981

Grey bar: all 20,646,523 reports in the database. 82.8% of these reports give the United States as the country.

Questions about "Product label confusion"

What does "Product label confusion" 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 label confusion?

5,742 reports through June 2026 (0% of all reports), 613 of them in the latest 12 months.

Which drugs appear most often in these reports?

Rituximab (581), Leflunomide (539), Diclofenac sodium (508), Cosentyx (493) and Methotrexate (486). 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.