Product label issue adverse event reports that record this term
- Kind of term
- MedDRA preferred term
- Plain meaning
- a problem with the label
What a report is
A report is not proof that the drug was the cause of the event.
FDA says:
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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Reports on file
From April 2009 to June 2026, FDA received 6,616 adverse event reports that record the MedDRA preferred term Product label issue. In plain words, the term means: a problem with the label. The person who codes a report selects the term that agrees best with the description of the reporter.
FDA received 584 reports in the 12 months to June 2026 and 478 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.
By reports in the 12 months to June 2026, this term was number 899 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 584 (under 0.1%) record this term. Reports for male patients were 28.7% of the reports that record this term and 34.6% of all drug reports.
The number of people who use the product is not in the data. A count is not a rate.
MedDRA
The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.
Plain meaning
A problem with the label. The words are from the fixed dictionary of this site. They add nothing to a report.
Data version
openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.
Drugs in these reports
The table has the 81 drug pages with 10 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.
FDA says:
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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
| Drug | Class | Reports with this term |
|---|---|---|
| Acetaminophen | 19 | |
| Advil | Nonsteroidal anti-inflammatory drug | 58 |
| Advil pm | Nonsteroidal anti-inflammatory drug | 12 |
| Albuterol sulfate | beta2-Adrenergic agonist | 42 |
| Aleve | Nonsteroidal anti-inflammatory drug | 34 |
| Amoxicillin | Penicillin-class antibacterial | 13 |
| Aspirin | Nonsteroidal anti-inflammatory drug | 10 |
| Botox | Acetylcholine release inhibitor | 14 |
| Breztri | Corticosteroid | 40 |
| Bydureon | 17 | |
| Bydureon Bcise | 17 | |
| Claritin | 15 | |
| Cosmetics | 12 | |
| Cyclobenzaprine hydrochloride | Muscle relaxant | 11 |
| Diclofenac | Nonsteroidal anti-inflammatory drug | 26 |
| Dulera | Corticosteroid | 10 |
| Duragesic | 12 | |
| Eliquis | Factor Xa inhibitor | 45 |
| Enbrel | Tumor necrosis factor blocker | 10 |
| Enoxaparin sodium | Low molecular weight heparin | 10 |
| Entresto | Angiotensin 2 receptor blocker | 15 |
| Epinephrine | Catecholamine | 17 |
| Erleada | 17 | |
| Estradiol | Estrogen | 23 |
| Fentanyl | Opioid agonist | 21 |
| Fentanyl Transdermal System | 19 | |
| Finasteride | 5-alpha reductase inhibitor | 13 |
| Furosemide | Loop diuretic | 13 |
| Genotropin | 22 | |
| Guselkumab | Interleukin-23 antagonist | 14 |
| Humira | 38 | |
| Ibuprofen | Nonsteroidal anti-inflammatory drug | 35 |
| Imodium | Opioid agonist | 12 |
| Imodium A-D | Opioid agonist | 44 |
| Imodium Multi-Symptom Relief | 150 | |
| Invega Sustenna | Atypical antipsychotic | 14 |
| Invokana | Sodium-Glucose cotransporter 2 inhibitor | 23 |
| Januvia | Dipeptidyl peptidase 4 inhibitor | 11 |
| Ketoconazole | Azole antifungal | 16 |
| Lansoprazole | Proton pump inhibitor | 10 |
| Linzess | Guanylate Cyclase-C agonist | 17 |
| Lyrica | 30 | |
| Meloxicam | Nonsteroidal anti-inflammatory drug | 13 |
| Mens Rogaine Extra Strength | 19 | |
| MiraLAX | Osmotic laxative | 91 |
| Morphine sulfate | Opioid agonist | 13 |
| Muse | 15 | |
| Myrbetriq | beta3-Adrenergic agonist | 16 |
| Naltrexone hydrochloride and bupropion hydrochloride | Aminoketone | 15 |
| Naproxen | Nonsteroidal anti-inflammatory drug | 12 |
| Nexium 24HR | Proton pump inhibitor | 12 |
| Omeprazole | Proton pump inhibitor | 29 |
| Oxycodone hydrochloride | Opioid agonist | 10 |
| Ozempic | GLP-1 receptor agonist | 32 |
| Parsabiv | Calcium-sensing receptor agonist | 17 |
| Paxlovid | 44 | |
| Pepcid Ac Maximum Strength | Histamine-2 receptor antagonist | 10 |
| Pregabalin | 14 | |
| Proventil | 11 | |
| Ramipril | Angiotensin converting enzyme inhibitor | 15 |
| Restasis | Calcineurin inhibitor immunosuppressant | 18 |
| Risperdal | Atypical antipsychotic | 18 |
| Risperdal Consta | 24 | |
| Sertraline | Serotonin reuptake inhibitor | 12 |
| Simponi | Tumor necrosis factor blocker | 81 |
| Stelara | Interleukin-12 antagonist | 181 |
| Symbicort | Corticosteroid | 38 |
| Synthroid | l-Thyroxine | 12 |
| Tramadol | 13 | |
| Tremfya | Interleukin-23 antagonist | 205 |
| Tylenol 8 HR Arthritis Pain | 64 | |
| TYLENOL Extra Strength | 129 | |
| Tylenol Regular Strength | 22 | |
| Vascepa | 14 | |
| Velcade | Proteasome inhibitor | 11 |
| Vyvanse | Central nervous system stimulant | 18 |
| Womens Rogaine Unscented | Arteriolar vasodilator | 27 |
| Xarelto | Factor Xa inhibitor | 386 |
| Xeljanz | Janus kinase inhibitor | 19 |
| Xiidra | 22 | |
| Zyrtec | Histamine-1 receptor antagonist | 107 |
The page of each drug has the count of each reaction term in its reaction lookup.
Drug classes in these reports
The table has the 55 pharmacologic classes with 10 or more reports that record this term. The rows are in order of name.
FDA says:
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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
A class with many reports in all has many reports for almost every term.
Reports by month
FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.
Patients in these reports
| Age | Reports | Share | Share as a bar |
|---|---|---|---|
| Under 2 | 47 | 0.7% | |
| 2 to 11 | 98 | 1.5% | |
| 12 to 17 | 63 | 1% | |
| 18 to 44 | 578 | 8.7% | |
| 45 to 64 | 1,064 | 16.1% | |
| 65 to 74 | 735 | 11.1% | |
| 75 and over | 868 | 13.1% | |
| Age not given | 3,163 | 47.8% |
| Sex | Reports | Share | Share as a bar |
|---|---|---|---|
| Female | 3,383 | 51.1% | |
| Male | 1,900 | 28.7% | |
| Unknown or not given | 1,333 | 20.1% |
Age and sex are as the report gives them. 90.3% of these reports give the United States as the country.
Terms near this one
- Product dose omission in error
- Product dose omission issue
- Product formulation issue
- Product label confusion
- Product leakage
- Product odour abnormal
- Product packaging issue
- Product packaging quantity issue
These are the next terms in the A to Z list. The links are for navigation.
Official pages
- MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
- MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
- FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.
The site checked these addresses on . The links open in a new tab.
Cite this page
Reported Reactions. Product label issue: adverse event reports that record this term. https://reportedreactions.com/reaction/product-label-issue/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .
Where the data come from
The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.
The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.
Questions
What does Product label issue mean in an adverse event report?
In plain words: a problem with the label. It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.
Does a drug in the table mean that the drug was responsible for this reaction?
No. FDA says:
No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
What does this page tell a person who has this symptom?
This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.
If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on .